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UNIVERSITY OF PENNSYLVANIA - PERELMAN SCHOOL OF MEDICINE Curriculum Vitae Date: 03/02/2017 Kelly C. Wade, M.D., Ph.D., M.S.C.E. Address: CHOP Newborn Care Pennsylvania Hospital 800 Spruce Street Philadelphia, PA 19107 USA If you are not a U.S. citizen or holder of a permanent visa. please indicate the type of visa you have: none (U.S. citizen) Education: 1989 1993 1996 1997 2010 B.S. M.S. Ph.D. M.D. M.S.C.E. University of California, Davis (Science) Yale School ofMedicine (Genetics) Yale School ofMedicine (Genetics) Yale School of Medicine (Medicine) University of Pennsylvania (Clinical Epidemiology and Biostatistics) Postgraduate Training and Fellowship Appointments: 1997-2000 Pediatric Residency, Combined Program, Children's Hospital ofBoston & Boston Medical Center 2000-2001 ChiefResident in Pediatrics, Children's Hospital ofBoston 2001-2004 Fellowship in Neonatal-Perinatal Medicine, Children's Hospital of Philadelphia Military Service: [none] Faculty Appointments: 2008-2014 Assistant Professor of Clinical Pediatrics, University of Pennsylvania School of Medicine 2014-present Associate Professor of Clinical Pediatrics, University of Pennsylvania School of Medicine Hospital and/or Administrative Appointments: 2004-present Attending Neonatologist, Department of Pediatrics, Children's Hospital of Philadelphia 2004-present Attending Neonatologist, Section on Newborn Pediatrics, Pennsylvania Hospital 2004-2008 Instructor in Pediatrics, Department of Pediatrics, University ofPennsylvania School of Medicine, University of Pennsylvania

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Page 1: Kelly C. Wade, M.D., Ph.D., M.S.C.E. - U S Food and Drug ... · PDF file2001-2004 Fellowship in Neonatal-Perinatal Medicine, ... Publication Review Committee 2014- present: ... "Update

UNIVERSITY OF PENNSYLVANIA - PERELMAN SCHOOL OF MEDICINE Curriculum Vitae

Date 03022017

Kelly C Wade MD PhD MSCE

Address CHOP Newborn Care Pennsylvania Hospital 800 Spruce Street Philadelphia PA 19107 USA

Ifyou are not a US citizen or holder of a permanent visa please indicate the type of visa you have none (US citizen)

Education 1989 1993 1996 1997 2010

BS MS PhD MD MSCE

University ofCalifornia Davis (Science) Yale School ofMedicine (Genetics) Yale School ofMedicine (Genetics) Yale School of Medicine (Medicine) University of Pennsylvania (Clinical Epidemiology and Biostatistics)

Postgraduate Training and Fellowship Appointments 1997-2000 Pediatric Residency Combined Program Childrens Hospital

ofBoston amp Boston Medical Center 2000-2001 ChiefResident in Pediatrics Childrens Hospital ofBoston 2001-2004 Fellowship in Neonatal-Perinatal Medicine Childrens

Hospital of Philadelphia

Military Service [none]

Faculty Appointments 2008-2014 Assistant Professor ofClinical Pediatrics University of

Pennsylvania School ofMedicine 2014-present Associate Professor of Clinical Pediatrics University of

Pennsylvania School ofMedicine

Hospital andor Administrative Appointments 2004-present Attending Neonatologist Department ofPediatrics Childrens

Hospital of Philadelphia 2004-present Attending Neonatologist Section on Newborn Pediatrics

Pennsylvania Hospital 2004-2008 Instructor in Pediatrics Department of Pediatrics University

ofPennsylvania School of Medicine University of Pennsylvania

Kelly C Wade MD PhD MSCE Page 2

2005-2008 Adjunct Phannacologist Division of Clinical Phannacology and Therapeutics

2010-2014 Associate Director ofNurseries Academics and Policy Pennsylvania Hospital

20 14-present Associate Director of Therapeutics and Education CHOP Newborn Care at Pennsylvania Hospital

Other Appointments [none]

Specialty Certification 2000 American Board ofPediatrics 2005 Neonatal-Perinatal Medicine American Board of Pediatrics

Licensure 2001 Pennsylvania

Awards Honors and Membership in Honorary Societies 1988 Phi Beta Kappa 1990-1997 Medical Scientist Training Program Fellowship 1997 Janet Glasgow Memorial Achievement Citation 1997 MDPhD Thesis Prize Yale School of Medicine 1997 Farr Thesis Prize Yale School of Medicine 2001 Sydney Farber House Staff Award Childrens Hospital Boston 2002 Ethel Foerderer Foundation Research Grant Genetic

Contribution to BPD 2002 Selected Participant at NICHD Aspen Conference 2003 Forest Phannaceutical Advancing Newborn Medicine

Research Grant for Genetic Contribution to BPD 2005 CHOP Faculty Honor Roll 2006 CHOP Faculty Honor Roll 2010 PRO-LC Physician of the Year (Pennsylvania Resource

Organization for Lactation Consultants) 2012 2012 Harrison Fund Recipient Pennsylvania Hospital

Memberships in Professional and Scientific Societies and Other Professional Activities National

1997-Present American Academy of Pediatrics Executive Committee member (since 2012) and Membership Chair (2017) for the Section ofClinical Phannacology and Therapeutics NeoPrep Planning Committee member Section ofPerinatal Pediatrics (2014-present)

2006-2007 American College of Clinical Phannacology

2006-2007 American Society of Microbiology

Kelly C Wade MD PhD MSCE Page 3

2010-Present NICHD Pediatric Trials Network (2010- present Executive Committee 2013- present Publication Review Committee 2014- present Caffeine Protocol Development Group 2013-2015 Adverse Event Standards Committee 2013-2015 Timolol Protocol Development Group)

20 I 0-Present Society for Pediatric Research

20I0-2016 eROP-Telemedicine for the evaluation of Retinopathy ofPrematurity (NEI funded clinical trial) (Protocol Development Committee (20IO) Executive Committee (201 0-present) Chair Safety Committee (20 I 0-present) Editorial Committee (20I3-present))

2013-Present Food and Drug Administration (Neonatal Subcommittee of the Pediatric Advisory Committee)

2015-Present International Neonatal Consortium (Invited participant in the following working groups Clinical Pharmacology Infectious Disease Research Culture in NICU Adverse Event reporting in Neonates)

2016-Present American Society for Health-System Pharmacists (Standard for Safety Project compounded oral liquid medications)

20 16-present Food and Drug Administration (Member of the Pediatric Advisory Committee)

Local 2008-Present Philadelphia Perinatal Society

Editorial Positions 20 1 0-Present Peer reviewer Journal of Peri nato logy 201I-Present Peer reviewer Journal Of Pediatrics 20 13-Present Peer reviewer Pediatric Infectious Disease Journal 20I4-Present Peer reviewer for the Journal Drugs 20 16-present Peer reviewer for Antimicrobial Agents and Chemotherapy 2017-Present Peer reviewer European Journal of Pediatrics 20I7-present Peer reviewer Ophthalmology

Academic and Institutional Committees 1997-2001 Boston Combined Residency Program Training Committee 1998-2001 Co-Chair Childrens Hospital Memorial Service Committee I999-2001 Boston Combined Residency Program Selection Committee 2000-200I Childrens Hospital Boston Investigational Review Board 2000-2001 Chair Childrens Hospital Grand Rounds Organizing Committee

Kelly C Wade MD PhD MSCE Page 4

2001-2004 Neonatology Clinical Research Group Childrens Hospital of Philadelphia

2002-2004 Co-Chair Neonatology Fellows Scheduling Committee 2002-2003 Neonatology Consensus Committee Ventilation of Premature

Infants 2003-2004 Neonatology Consensus Committee Limits of Resuscitation 2004-2005 Chair Neonatology Consensus Committee Caring and Responsible

End of Life Guidelines 2006-2008 Therapeutic Standards Committee Childrens Hospital of

Philadelphia 2006-2008 Pediatric Pharmacology Research Unit Re-engineering Task Force 2006-2008 Pediatric Pharmacology Research Unit Network Steering

Committee 2006-2008 Pediatric Pharmacology Research Unit Executive Committee 2006-2008 Neonatology Database Committee Childrens Hospital of

Philadelphia 2006-2008 Fetal Palliative Care Consultant Group 2007-2012 Neonatology Fellow Selection Committee Childrens Hospital of

Philadelphia 2009-Present Pharmacy and Therapeutics Committee Pennsylvania Hospital 2009-2013 Breastfeeding Committee for NICU Pennsylvania Hospital 2010-Present Neonatal Intensive Care Unit Based Clinical Leadership Group

Pennsylvania Hospital 2010-Present ICN Management Committee Pennsylvania Hospital 2010-Present Post-partum amp Newborn Care Unit Based Clinical Leadership

Group Pennsylvania Hospital 2011-Present CHOP Newborn Care Patient Safety Collaborative 2012-2014 Physician Leader NICHQ Best-Fed Beginnings Team Pennsylvania

Hospital 2014-Present CHOP Newborn Care Network Guidelines for glucose monitoring

of newborns at risk for hypogycemia

Major Academic and Clinical Teaching Responsibilities 2003 A Family Based Association Study to Evaluate Genetic

Susceptibility to Bronchopulmonary Dysplasia Pulmonary Division Research Conference Childrens Hospital of Philadelphia P A

2003 Update on Molecular Biology for Neonatologists Childrens Hospital of Philadelphia Neonatal Fellows Physiology Conference Philadelphia P A

2005 CARE Caring and Responsible End of Life Guidelines Consensus Conference Childrens Hospital ofPhiladelphia PA

2006 End of Life Care in the NICU Bimonthly Resident Lecture Childrens Hospital ofPhiladelphia PA

2006 A Multicentered PPRU Study of Fluconazole in Infants Nursing Research Conference Childrens Hospital of Philadelphia PA

Kelly C Wade MD PhD MSCE Page 5

2008-2013

2008-Present

2008-Present 2010

201 0-Present 2010

2011

2012-Present

2012

2012

2012

2013 2013

2013

2014-Present

2014

20 14-Present

2014-Present

2015-Present

2015-Present

Faculty Doctoring I II III University ofPennsylvania School of Medicine Course Director Pediatrics 305D Well Newborn Perelman School of Medicine Pennsylvania Hospital Faculty Perinatal and Neonatal Case Review Noon Conference Lecturer Pharmacokinetics Tools to Use at the Bedside Fellowship Physiology Conference Childrens Hospital of Philadelphia Chair Neonatology Academic Conference Pennsylvania Hospital Lecturer Update on GBS Screening Guidelines CHOP Newborn Care Academic Conference Lecturer Hot Topics from the Pediatric Academic Society Annual Meeting CHOP Newborn Care Academic Conference Faculty Neonatal Fellow Simulation Education Communication Workshops 2-4 times per year Lecturer Transitions in Care- NICU to Pediatric Office CHOP Newborn Care Academic Conference OB GYN Grand Rounds Morbidity and Mortality Conference Neonatal HSV Lecturer Hot Topics from the Pediatric Academic Society Annual Meeting CHOP Newborn Care Academic Conference Faculty CHOP Neonatal Fellow Simulation Boot Camp Lecturer Hot Topics from the Pediatric Academic Society Annual Meeting CHOP Newborn Care Academic Conference Lecturer CHOP Network NAS Algorithm amp Inter-rater Reliability Program CHOP Newborn Care Academic Conference Lecturer UPENN Nursing School NURS776 High Risk Neonate Theory 2 lectures per year Guiding Drug Principles to Improve Infectious Disease Outcomes and Treatment ofViral and Fungal Infections in the NICU Lecturer CHOP Newborn Care at Chester County Antibiotic Dosing in the NICU Faculty Lecturer CHOP Physician Assistant Residency Program in Neonatology 3 Lectures per year Basic Pharmacokinetics to improve drug dosing Treatment ofviral and fungal infections Exchange Transfusion for RH isoimmunization Resident Choice Course Director CHOP Pediatric Residency Independent Elective Unit in Neonatology Lecturer Delivery Room Care and Neonatal Resuscitation Review CHOP Resident Pennsylvania Hospital NICU elective Orientation lecture and simulation 5-7 times per year Instructor Neonatal Resuscitation Program UPENN Newborn Care at Pennsylvania Hospital

Kelly C Wade MD PhD MSCE Page 6

2017-Present Lecturer Clinical Toxicology- medication in Pregnancy and lactation 90 minutes lecture at CHOP Neonatal Fellow Physiology Conference

2017 Maternal Toxoplasmosis Infection in Pregnancy One lecture given as part ofNeonatology Morbidity and Mortality Conference

Lectures by Invitation (Last 5 years) Jan 2012 Pharmacokinetics NEOPREP Conference American Academy of

Pediatrics New Orleans LA May 2012 Improving Outcomes by Using the Right Drug Right Dose amp

Right Timing Topic Symposium Antimicrobials and Antivirals in the NICU Pediatric Academic Society Meeting Boston MA

May 2012 An Introduction to Pharmacokinetic and Pharmacodynamic of Antimicrobial Therapy Topic Symposium Antimicrobials and Antivirals in the NICU Pediatric Academic Society Meeting Boston MA

Jun2012 Pharmacologic Considerations during Therapeutic Hypothermia Contemporary Forums Neonatal Pharmacology Conference Washington DC

Oct 2012 Pharmacokinetics basic concepts to Use at the Bedside Contemporary Forums The Fetus and Newborn Conference San Francisco CA

Oct 2012 The Use of Antiviral and Antifungal Medication Contemporary Forums The Fetus and Newborn Conference San Francisco CA

Oct 2012 Pharmacologic Considerations During Therapeutic Hypothermia Contemporary Forums The Fetus and Newborn Conference San Francisco CA

Apr 2013 Evidenced Based Care of the Late Preterm Infant Center City Pediatrics Philadelphia P A

Jun 2013 Pharmacologic Considerations During Therapeutic Hypothermia Contemporary Forums Neonatal Pharmacology Conference San Diego CA

Jun 2013 Improved Treatments for Viral and Fungal Infections in Neonates Contemporary Forums Neonatal Pharmacology Conference San Diego CA

Nov 2013 Improved Dosing Guidance for Antibiotics and Antifungals Contemporary Forums The Fetus amp Newborn Conference Washington DC

Nov 2013 11 Using PharmacokineticsPharmacodynamics Knowledge to Individualize Dosing Contemporary Forums The Fetus amp Newborn Conference Washington DC

Jan2014 General Principles of Pharmacology Academy of Pediatrics NeoPrep Conference San Diego CA

Feb2014 Clinical Pharmacology ofFluconazole Columbian Association of Neonatology Annual Conference on Nutrition and Pharmacology Bogata Columbia

Kelly C Wade MD PhD MSCE Page 7

Feb2014

Feb2014

May2014

Nov 2014

Nov 2014

Mar 2015

May 2015

Oct 2015

Oct 2015

Jan2016 Feb2016

Apr 2016

Apr 2016

May 2016

Sep2016

Sep2016

Apr 2017

Clinical Pharmacology ofVancomycin Columbian Association of Neonatology Annual Conference on Nutrition and Pharmacology Bogata Columbia Basic Pharmacokinetics to Improve Dosing Columbian Association ofNeonatology Annual Conference on Nutrition and Pharmacology Bogata Columbia Improving outcomes from neonatal infections using PKPD principles Neonatal Pharmacology Conference Contemporary Forums Boston MA Current dosing for serious infections The Fetus and the Newborn Conference Contemporary Forums Las Vegas NV Choosing the right dose using PKPD principles The Fetus and the Newborn Conference Contemporary Forums Las Vegas NV Safety during ROP evaluations A Neonatologists Perspective Workshop Telemedicine for the detection of serious acute phase ROP time for a paradigm shift American Academy of Pediatric Ophthalmology Annual Meeting New Orleans LA Whats New in Neonatal Pharmacology Neonatal Pharmacology Conference Contemporary Forums Scottsdale AZ New Guidelines for Antiviral and Antifungal Therapies The Fetus and the Newborn Conference Contemporary Forums San Diego CA Whats New for Antibiotics in the NICU The Fetus and the Newborn Conference Contemporary Forums San Diego CA Pharmacokinetics AAP NeoPrep Conference Atlanta GA Reducing Medication Errors in the NICU The NEO Conference MedNax Pediatric Group Orlando FL Whats New for Antimicrobial Therapy in the NICU Neonatal Pharmacology Meeting Contemporary Forums Las Vegas NV Reducing Medication Errors in the NICU Neonatal Pharmacology Conference Contemporary Forums Las Vegas NV New Guidelines for Antiviral and Antifungal Therapies 13th Annual CHOP Neonatal Nursing Symposium Philadelphia PA Strategies to reduce medication errors in the NICU Contemporary Forums Fetus and Newborn Conferences New Orleans LA PK knowledge to improve drug dosing in the NICU Contemporary Forums Fetus and Newborn Conferences New Orleans LA Whats new in neonatal pharmacology Neonatal Pharmacology Conference Contemporary Forums San Diego CA

Organizing Roles in Scientific Meetings Jun 2011 Co-Chair 11th Annual Neonatal Pharmacology Conference

Contemporary Forums San Fransisco CA

Kelly C Wade MD PhD MSCE Page 8

May 2012 Co-Chair Topic Symposium Antimicrobials and Antivirals in the NICU Getting the Dose RIGHT Every Time Pedaitric Academic Society Meeting Boston MA

Jun2012 Co-Chair 12th Annual Neonatal Pharmacology Conference Contemporary Forums Washington DC

Jun 2013 Chair 13th Annual Neonatal Pharmacology Conference Contemporary Forums San Diego California

Jan2014 Planning Committee Member NEOPREP conference American Academy of Pediatrics Elk Grove Village IL

May2014 Co-Chair 14th Annual Neonatal Pharmacology Conference Contemporary Forums Boston MA

May 2015 Co-chair 15th Annual Neonatal Pharmacology Conference Contemporary Forums Scottsdale AZ

Jan2016 Co-Chair NEOPREP Conference American Academy ofPediatrics Atlanta GA

Apr 2016 Chair 16th Annual Neonatal Pharmacology Conference Contemporary Forums Las Vegas NV

Apr 2017 Chair 17th Annual Neonatal Pharmacology Conference Contemporary Forums San Diego CA

Jan2018 Chair NeoPREP American Academy ofPediatrics Atlanta GA

Bibliography Research Publications peer reviewed (print or other media)

1 Cant K Knowles B Mooseker M Cooley L Drosophila singed a fascin homolog is required for actin bundle formation during oogenesis and bristle extension Journal Cell Biology 125 369 Apr 1994

2 Robinson D Cant K Cooley L Morphogenesis of a Drosophila ring canal Development 120 2015 Jul1994

3 Cant K Cooley L Single amino acid mutations in Drosophila fascin disrupt actin bundle formation in vivo Genetics 143 249 Jan 1996

4 Cant K Knowles B Mahajan-Miklos S Heintzelman M Cooley L Drosophila fascin mutants are rescued by overepression ofvillin like protein quail Journal Cell Science 111 213-221 Jan 1998

Kelly C Wade MD PhD MSCE Page 9

5 Alexander SW Wade KC Hibberd PL Parsons SK Evaluation ofrisk prediction criteria for episodes of febrile neutropenia in children with cancer Journal ofPediatric HematologyOncology 24(1) 38-42 Jan 2002

6 Gonzales LW Guttentag SH Wade KC Postle AD Ballard PL Differentiation ofhuman pulmonary type II cells in vitro by glucocorticoid plus cAMP American Journal ofPhysiology- Lung Cellular amp Molecular Physiology 283(5) L940-51 Nov 2002

7 Daugherty BL Mateescu M Patel AS Wade K Kimura S Gonzales LW Guttentag S Ballard PL Koval M Developmental regulation of claudin localization by fetal alveolar epithelial cells American Journal of PhysiologyshyLung Cellular amp Molecular Physiology 287(6) L1266-73 Dec 2004

8 Wade KC Guttentag SH Gonzales LW Maschhoff KL Gonzales J Kolla V Singhal S Ballard PL Gene induction during differentiation of human pulmonary type II cells in vitro American Journal ofRespiratory Cell amp Molecular Biology 34(6) 727-37 Jun 2006

9 Cohen-Wolkowiez M Benjamin DK Jr Fowler VG Jr Wade KC Alexander BD Worley G Goldstein RF Smith PB Mortality and neurodevelopmental outcome after Staphylococcus aureus bacteremia in infants Pediatric Infectious Disease Journal 26(12) 1159-61 Dec 2007

10 Lorch SA Wade KC Bakewell-Sachs S Medoff-Cooper B Escobar GJ Silber JH Racial differences in the use ofrespiratory medications in premature infants after discharge from the neonatal intensive care unit Journal of Pediatrics 151(6) 604-10 610e1 Dec 2007

11 Cohen-Wolkowiez M Smith PB Benjamin DK Jr Fowler VG Jr Wade KC Daptomycin use in infants report of two cases with peak and trough drug concentrations Journal ofPerinatology 28(3) 233-4 Mar 2008

12 Wade KC Lorch SA Bakewell-Sachs S Medoff-Cooper B Silber JH Escobar GJ Pediatric care for preterm infants after NICU discharge high number of office visits and prescription medications Journal of Perinatology 28(10) 696-701 Oct 2008

13 Wade KC Wu D Kaufinan DA Ward RM Benjamin OK Jr Sullivan JE Ramey N Jayaraman B Hoppu K Adamson PC Gastonguay MR Barrett JS National Institute of Child Health and Development Pediatric Pharmacology Research Unit Network Population pharmacokinetics of fluconazole in young infants Antimicrobial Agents amp Chemotherapy 52(11) 4043-9 Nov 2008

Kelly C Wade MD PhD MSCE Page 10

14 Bruno CJ Smith LP Zur KB Wade KC Congenital subglottic cyst in a term neonate Archives ofDisease in Childhood Fetal amp Neonatal Edition 94(4) F240 Jul 2009

15 Wade KC Benjamin DK Jr Kaufman DA Ward RM Smith PB Jayaraman B Adamson PC Gastonguay MR Barrett JS Fluconazole dosing for the prevention or treatment ofinvasive candidiasis in young infants Pediatric Infectious Disease Journal28(8) 717-23 Aug 2009

16 Wu D Wade KC Paul DJ Barrett JS A rapid and sensitive LC-MSMS method for determination of fluconazole in human plasma and its application in infants with Candida infections Therapeutic Drug Monitoring 31 (6) 703-9 Dec 2009

17 Kimberlin DW Shalabi M Abzug J Lang D Jacobs RF Storchm G Bradley JS Wade KC Ramilo 0 Romero JR Shelton M Leach C Guzman-Cottrill J Robinson J Abughali N Englund J Griffin J Jester P Cloud GA Whitley RJ NIAID Collaborative Antiviral Study Group Safety ofoseltamivir compared with the adamantanes in children less than 12 months ofage Pediatric Infectious Disease Journal 29(3) 195 Mar 2010

18 Lorch SA Wade KC Bakewell-Sachs S Medoff-Cooper 8 Silber JH Escobar GJ Antibiotic use in premature infants after discharge from the neonatal intensive care unit Clinical Pediatrics 49(3) 249 Apr 2010

19 Wade KC Ellenberg JH Grosser T Brensinger CM Kimmel SE Hennessy S Exogenous estrogen does not attenuate the association between rofecoxib and myocardial infarction in perimenopausal women Journal Cardiovascular Pharmacology 57(2) 194 Feb 2011

20 Piper L Smith PB Hornik CP Cheifetz IM Barrett JS Moorthy G Hope WW Wade KC Cohen-Wolkowiez M Benjamin OK Fluconazole loading dose pharmacokinetics and safety in infants Pediatric Infectious Disease Journal 30(5) 375 May 2011

21 Smith PB Cohen-Wolkowiez M Castro LM Poindexter B Bidegain M Weitkamp JH Schelonka RL Ward RM Wade K Valencia G Burchfield D Arrieta A Bhatt-Mehta V Walsh M Kantak A Rasmussen M Sullivan J E Finer N Brozanski BS Sanchez P van den Anker J Blumer J Keams GL Capparelli EV Anand R Benjamin OK Population pharmacokinetics of meropenem in plasma and cerebrospinal fluid ofinfants with suspected or complicated intra-abdominal infections Pediatric Infectious Disease Journal 30( 1 0) 844 Oct 2011

Kelly C Wade MD PhD MSCE Page 11

22 Mossabeb R Wade KC Finnegan K Sivieri E Abbasi S Language development survey provides a useful screening tool for language delay in preterm infants Clinical Pediatrics 51(7) 638 July 2012

23 Watt KM Benjamin OK Jr Cheifetz IM Moorthy G Wade KC Smith PB Brouwer KL Capparelli EV Cohen-Wolkowietz M Pharmacokinetics and safety of fluconazole in young infants supported with extracorporeal membrane oxygenation Pediatric Infectious Disease Journal 31(10) 1042-7 Oct 2012

24 Watt Kevin M Benjamin Daniel K Cheifetz Ira M Moorthy Ganesh Wade Kelly C Smith P Brian Brouwer Kim L R Capparelli Edmund V Cohen-Wolkowiez Michael Pharmacokinetics and safety of fluconazole in young infants supported with extracorporeal membrane oxygenation The Pediatric infectious disease journal 31 ( 1 0) 1042-7 Oct 2012

25 Cohen-Wolkowiez Michael Poindexter Brenda Bidegain Margarita Weitkamp Joern-Hendrik Schelonka Robert L Randolph David A Ward Robert M Wade Kelly Valencia Gloria Burchfield David Arrieta Antonio Mehta Varsha Walsh Michele Kantak Anand Rasmussen Maynard Sullivan Janice E Finer Neil Rich Wade Brozanski Beverly S van den Anker John Blumer Jeffrey Laughon Matthew Watt Kevin M Keams Gregory L Capparelli Edmund V Martz Karen Berezny Katherine Benjamin Daniel K Smith P Brian Safety and effectiveness of meropenem in infants with suspected or complicated intra-abdominal infections Clinical infectious diseases an official publication ofthe Infectious Diseases Society of America 55(11) 1495-502 Dec 2012

26 Reiss Errol Lasker Brent A Lott Timothy J Bendel Catherine M Kaufman David A Hazen Kevin C Wade Kelly C McGowan Karin L Lockhart Shawn R Genotyping of Candida parapsilosis from three neonatal intensive care units (NICUs) using a panel of five multilocus microsatellite markers broad genetic diversity and a cluster ofrelated strains in one NICU Infection genetics and evolution journal of molecular epidemiology and evolutionary genetics in infectious diseases 12(8) 1654-60 Dec 2012

27 Benjamin Daniel K Hudak Mark L Duara Shahnaz Randolph David A Bidegain Margarita Mundakel Gratias T Natarajan Girija Burchfield David J White Robert D Shattuck Karen E Neu Natalie Bendel Catherine M Kim M Roger Finer Neil N Stewart Dan L Arrieta Antonio C Wade Kelly C Kaufman David A Manzoni Paolo Prather Kristi 0 Testoni Daniela Berezny Katherine Y Smith P Brian Effect of fluconazole prophylaxis on candidiasis and mortality in premature infants a randomized clinical trial JAMA the Journal ofthe American Medical Association 311(17) 1742-9 May 2014

28 Monk Heather M Motsney Adam J Wade Kelly C Safety ofRotavirus Vaccine in the NICU Pediatrics 133(6) el555-60 May 2014

Kelly C Wade MD PhD MSCE Page 12

29 e-ROP Cooperative Group Telemedicine approaches to evaluating acute-phase retinopathy ofprematurity study design Ophthalmic epidemiology 21 ( 4 ) 256shy67 Aug 2014

30 Quinn Graham E Ying Gui-shuang Daniel Ebenezer Hildebrand P Lloyd Ells Anna Baumritter Agnieshka Kemper Alex R Schron Eleanor B Wade Kelly Validity of a telemedicine system for the evaluation of acute-phase retinopathy of prematurity JAMA ophthalmology 132(10) 1178-84 Oct 2014

31 Kemper Alex R Wade Kelly C Hornik Christoph P Ying Gui-Shuang Baumritter Agnieshka Quinn Graham E Retinopathy of Prematurity Risk Prediction for Infants with Birth Weight Less than 1251 Grams The Journal ofpediatrics 166(2) 257-6le2 Nov 2014

32 Ying Gui-Shuang Quinn Graham E Wade Kelly C Repka Michael X Baumritter Agnieshka Daniel Ebenezer Predictors for the Development ofReferralshyWarranted Retinopathy of Prematurity in the Telemedicine Approaches to Evaluating Acute-Phase Retinopathy ofPrematurity (e-ROP) Study JAMA ophthalmology 133(3) 304-11 Dec 2014

33 Watt Kevin M Gonzalez Daniel Benjamin Daniel K Brouwer Kim L R Wade Kelly C Capparelli Edmund Barrett Jeffrey Cohen-Wolkowiez Michael Fluconazole population pharmacokinetics and dosing for prevention and treatment of invasive Candidiasis in children supported with extracorporeal membrane oxygenation Antimicrobial agents and chemotherapy 59(7) 3935-43 Jul2015

34 Wade Kelly C Pistilli Maxwell Baumritter Agnieshka Karp Karen Gong Alice Kemper Alex R Ying Gui-Shuang Quinn Graham Safety ofRetinopathy of Prematurity Examination and Imaging in Premature Infants The Journal of pediatrics 167(5) 994-1000e2 Nov 2015

35 Kemper Alex R Prosser Lisa A Wade Kelly C Repka Michael X Ying Gui-Shuang Baumritter Agnieshka Quinn Graham E A Comparison of Strategies for Retinopathy ofPrematurity Detection Pediatrics 137(1) 1-10 Jan 2016

36 Frommelt Peter Juern Anna Siegel Dawn Holland Kristen Seefeldt Marcia Yu JiaDe Uhing Michael Wade Kelly Drolet Beth Adverse Events in Young and Preterm Infants Receiving Topical Timolol for Infantile Hemangioma Pediatric dermatology 33(4) 405-14 Jul2016

37 Quinn Graham E Barr Charles Bremer Don Fellows Rae Gong Alice Hoffman Robert Repka Michael X Shepard Jennifer Siatkowski R Michael Wade Kelly Ying Gui-Shuang Changes in Course of Retinopathy of Prematurity from 1986 to 2013 Comparison ofThree Studies in the United States Ophthalmology 123(7) 1595-600 Jul2016

Kelly C Wade MD PhD MSCE Page 13

38 Momper Jeremiah D Capparelli Edmund V Wade Kelly C Kantak Anand Dhanireddy Ramasubbareddy Cummings James J Nedrelow Jonathan H Hudak Mark L Mundakel Gratias T Natarajan Girija Gao Jamie Laughon Matt Smith P Brian Benjamin Daniel K Population Pharmacokinetics of Fluconazole in Premature Infants with Birth Weights Less than 750 Grams Antimicrobial agents and chemotherapy 60(9) 5539-45 Sep 2016

39 Quinn Graham E Ying Gui-Shuang Repka Michael X Siatkowski R Michael Hoffman Robert Mills Monte D Morrison David Daniel Ebenezer Baumritter Agnieshka Hildebrand P Lloyd Schron Eleanor B Ells AnnaL Wade Kelly Kemper Alex R Timely implementation ofa retinopathy of prematurity telemedicine system Journal ofAAPOS the official publication of the American Association for Pediatric Ophthalmology and Strabismus 20(5) 425-430e I Oct 2016

Research Publications peer-reviewed reviews 1 Laughon MM Benjamin DK Capparelli EV Keams GL Berezny K Paul IM

Wade K Barrett J Smith PB Cohen-Wolkowiez M Innovative clinical trial design for pediatric therapeutics Expert Review of Clinical Pharmacology 4(5) 643-52 Sep 2011

2 Wade Kelly C Monk Heather M New antifungal and antiviral dosing Clinics in perinatology 42(1) 177-94 x Mar 2015

3 England Amanda Wade Kelly Smith P Brian Berezny Katherine Laughon Matthew Optimizing operational efficiencies in early phase trials The Pediatric Trials Network experience Contemporary clinical trials 47 376-82 Mar 2016

Research Publications non-peer reviewed 1 Cant K Genetic and biochemical characterization of Drosophila singed a homolog of

the actin bundling protein fascin Yale University New Haven CT May 1996 Notes PhD Thesis

Abstracts (Last 3 years) 1 Kelly C Wade Maxwell Pistilli Karen Karp Gui-shuang Ying Agnieshka Baumritter

Alice Gong Alex Kemper Graham Quinn and on behalfof e-ROP cooperative group Safety ofROP screening in extremely premature infants Abstract presented at PAS Annual Meeting San Diego CA 2015

2 Kelly Wade Maxwell Pistilli Karen Karp Gui-shuang Ying Agnieshka Baumritter Alice Gong Alex Kemper Graham Quinn and on behalf of the e-ROP collaborative group Adverse Events Between 32-44 weeks PMA in an Observational ROP Study Abstract presented at PAS annual meeting San Diego CA 2015

Kelly C Wade MD PhD MSCE Page 14

3 Kelly C Wade Gui-shuang Ying Agnieshka Baumritter Alex R Kemper Graham E Quinn and on behalf of the eROP investigators Identifying which low birth weight premature infants are at LOW risk for developing ROP Abstract presented at PAS Annual Meeting Baltimore MD 2016

Editorials Reviews Chapters including participation in committee reports (print or other media)

1 Wade KC Aplenc R Genetic susceptibility to neonatal disease Neo Review Illinois American Academy of Pediatrics July 2004

2 Wade KC Benjamin Jr DK Clinical Pharmacology of Anti-Infective Drugs Infectious Diseases ofthe Fetus and Newborn Infant 7th Edition Remington amp Klein Wilson Nizet Maldonado (eds) Saunders Page 1160-1211 2010 Notes Chapter

3 Quinn Graham E Need for Telemedicine in Retinopathy of Prematurity in MiddleshyIncome Countries-Reply JAMA ophthalmology Dec 2014

4 Wade KC and Benjamin OK Jr Clinical Pharmacology ofAnti-Infective Drugs Infectious Diseases ofthe Fetus and Newborn Infant 8th Edition Remington Klein Wilson Nizet Maldonado (eds) Elsevier 2014 Notes Book Chapter

5 Wade KC Pharmacokinetics Fanaroff and Martins Neonatal-Perinatal Medicine 1Oth Edition Martin RJ Fanaroff AA and Walsh MC (eds) Elsevier 2014 Notes Book Chapter

Books [none]

Alternative Media [none]

Patents [none]

Page 2: Kelly C. Wade, M.D., Ph.D., M.S.C.E. - U S Food and Drug ... · PDF file2001-2004 Fellowship in Neonatal-Perinatal Medicine, ... Publication Review Committee 2014- present: ... "Update

Kelly C Wade MD PhD MSCE Page 2

2005-2008 Adjunct Phannacologist Division of Clinical Phannacology and Therapeutics

2010-2014 Associate Director ofNurseries Academics and Policy Pennsylvania Hospital

20 14-present Associate Director of Therapeutics and Education CHOP Newborn Care at Pennsylvania Hospital

Other Appointments [none]

Specialty Certification 2000 American Board ofPediatrics 2005 Neonatal-Perinatal Medicine American Board of Pediatrics

Licensure 2001 Pennsylvania

Awards Honors and Membership in Honorary Societies 1988 Phi Beta Kappa 1990-1997 Medical Scientist Training Program Fellowship 1997 Janet Glasgow Memorial Achievement Citation 1997 MDPhD Thesis Prize Yale School of Medicine 1997 Farr Thesis Prize Yale School of Medicine 2001 Sydney Farber House Staff Award Childrens Hospital Boston 2002 Ethel Foerderer Foundation Research Grant Genetic

Contribution to BPD 2002 Selected Participant at NICHD Aspen Conference 2003 Forest Phannaceutical Advancing Newborn Medicine

Research Grant for Genetic Contribution to BPD 2005 CHOP Faculty Honor Roll 2006 CHOP Faculty Honor Roll 2010 PRO-LC Physician of the Year (Pennsylvania Resource

Organization for Lactation Consultants) 2012 2012 Harrison Fund Recipient Pennsylvania Hospital

Memberships in Professional and Scientific Societies and Other Professional Activities National

1997-Present American Academy of Pediatrics Executive Committee member (since 2012) and Membership Chair (2017) for the Section ofClinical Phannacology and Therapeutics NeoPrep Planning Committee member Section ofPerinatal Pediatrics (2014-present)

2006-2007 American College of Clinical Phannacology

2006-2007 American Society of Microbiology

Kelly C Wade MD PhD MSCE Page 3

2010-Present NICHD Pediatric Trials Network (2010- present Executive Committee 2013- present Publication Review Committee 2014- present Caffeine Protocol Development Group 2013-2015 Adverse Event Standards Committee 2013-2015 Timolol Protocol Development Group)

20 I 0-Present Society for Pediatric Research

20I0-2016 eROP-Telemedicine for the evaluation of Retinopathy ofPrematurity (NEI funded clinical trial) (Protocol Development Committee (20IO) Executive Committee (201 0-present) Chair Safety Committee (20 I 0-present) Editorial Committee (20I3-present))

2013-Present Food and Drug Administration (Neonatal Subcommittee of the Pediatric Advisory Committee)

2015-Present International Neonatal Consortium (Invited participant in the following working groups Clinical Pharmacology Infectious Disease Research Culture in NICU Adverse Event reporting in Neonates)

2016-Present American Society for Health-System Pharmacists (Standard for Safety Project compounded oral liquid medications)

20 16-present Food and Drug Administration (Member of the Pediatric Advisory Committee)

Local 2008-Present Philadelphia Perinatal Society

Editorial Positions 20 1 0-Present Peer reviewer Journal of Peri nato logy 201I-Present Peer reviewer Journal Of Pediatrics 20 13-Present Peer reviewer Pediatric Infectious Disease Journal 20I4-Present Peer reviewer for the Journal Drugs 20 16-present Peer reviewer for Antimicrobial Agents and Chemotherapy 2017-Present Peer reviewer European Journal of Pediatrics 20I7-present Peer reviewer Ophthalmology

Academic and Institutional Committees 1997-2001 Boston Combined Residency Program Training Committee 1998-2001 Co-Chair Childrens Hospital Memorial Service Committee I999-2001 Boston Combined Residency Program Selection Committee 2000-200I Childrens Hospital Boston Investigational Review Board 2000-2001 Chair Childrens Hospital Grand Rounds Organizing Committee

Kelly C Wade MD PhD MSCE Page 4

2001-2004 Neonatology Clinical Research Group Childrens Hospital of Philadelphia

2002-2004 Co-Chair Neonatology Fellows Scheduling Committee 2002-2003 Neonatology Consensus Committee Ventilation of Premature

Infants 2003-2004 Neonatology Consensus Committee Limits of Resuscitation 2004-2005 Chair Neonatology Consensus Committee Caring and Responsible

End of Life Guidelines 2006-2008 Therapeutic Standards Committee Childrens Hospital of

Philadelphia 2006-2008 Pediatric Pharmacology Research Unit Re-engineering Task Force 2006-2008 Pediatric Pharmacology Research Unit Network Steering

Committee 2006-2008 Pediatric Pharmacology Research Unit Executive Committee 2006-2008 Neonatology Database Committee Childrens Hospital of

Philadelphia 2006-2008 Fetal Palliative Care Consultant Group 2007-2012 Neonatology Fellow Selection Committee Childrens Hospital of

Philadelphia 2009-Present Pharmacy and Therapeutics Committee Pennsylvania Hospital 2009-2013 Breastfeeding Committee for NICU Pennsylvania Hospital 2010-Present Neonatal Intensive Care Unit Based Clinical Leadership Group

Pennsylvania Hospital 2010-Present ICN Management Committee Pennsylvania Hospital 2010-Present Post-partum amp Newborn Care Unit Based Clinical Leadership

Group Pennsylvania Hospital 2011-Present CHOP Newborn Care Patient Safety Collaborative 2012-2014 Physician Leader NICHQ Best-Fed Beginnings Team Pennsylvania

Hospital 2014-Present CHOP Newborn Care Network Guidelines for glucose monitoring

of newborns at risk for hypogycemia

Major Academic and Clinical Teaching Responsibilities 2003 A Family Based Association Study to Evaluate Genetic

Susceptibility to Bronchopulmonary Dysplasia Pulmonary Division Research Conference Childrens Hospital of Philadelphia P A

2003 Update on Molecular Biology for Neonatologists Childrens Hospital of Philadelphia Neonatal Fellows Physiology Conference Philadelphia P A

2005 CARE Caring and Responsible End of Life Guidelines Consensus Conference Childrens Hospital ofPhiladelphia PA

2006 End of Life Care in the NICU Bimonthly Resident Lecture Childrens Hospital ofPhiladelphia PA

2006 A Multicentered PPRU Study of Fluconazole in Infants Nursing Research Conference Childrens Hospital of Philadelphia PA

Kelly C Wade MD PhD MSCE Page 5

2008-2013

2008-Present

2008-Present 2010

201 0-Present 2010

2011

2012-Present

2012

2012

2012

2013 2013

2013

2014-Present

2014

20 14-Present

2014-Present

2015-Present

2015-Present

Faculty Doctoring I II III University ofPennsylvania School of Medicine Course Director Pediatrics 305D Well Newborn Perelman School of Medicine Pennsylvania Hospital Faculty Perinatal and Neonatal Case Review Noon Conference Lecturer Pharmacokinetics Tools to Use at the Bedside Fellowship Physiology Conference Childrens Hospital of Philadelphia Chair Neonatology Academic Conference Pennsylvania Hospital Lecturer Update on GBS Screening Guidelines CHOP Newborn Care Academic Conference Lecturer Hot Topics from the Pediatric Academic Society Annual Meeting CHOP Newborn Care Academic Conference Faculty Neonatal Fellow Simulation Education Communication Workshops 2-4 times per year Lecturer Transitions in Care- NICU to Pediatric Office CHOP Newborn Care Academic Conference OB GYN Grand Rounds Morbidity and Mortality Conference Neonatal HSV Lecturer Hot Topics from the Pediatric Academic Society Annual Meeting CHOP Newborn Care Academic Conference Faculty CHOP Neonatal Fellow Simulation Boot Camp Lecturer Hot Topics from the Pediatric Academic Society Annual Meeting CHOP Newborn Care Academic Conference Lecturer CHOP Network NAS Algorithm amp Inter-rater Reliability Program CHOP Newborn Care Academic Conference Lecturer UPENN Nursing School NURS776 High Risk Neonate Theory 2 lectures per year Guiding Drug Principles to Improve Infectious Disease Outcomes and Treatment ofViral and Fungal Infections in the NICU Lecturer CHOP Newborn Care at Chester County Antibiotic Dosing in the NICU Faculty Lecturer CHOP Physician Assistant Residency Program in Neonatology 3 Lectures per year Basic Pharmacokinetics to improve drug dosing Treatment ofviral and fungal infections Exchange Transfusion for RH isoimmunization Resident Choice Course Director CHOP Pediatric Residency Independent Elective Unit in Neonatology Lecturer Delivery Room Care and Neonatal Resuscitation Review CHOP Resident Pennsylvania Hospital NICU elective Orientation lecture and simulation 5-7 times per year Instructor Neonatal Resuscitation Program UPENN Newborn Care at Pennsylvania Hospital

Kelly C Wade MD PhD MSCE Page 6

2017-Present Lecturer Clinical Toxicology- medication in Pregnancy and lactation 90 minutes lecture at CHOP Neonatal Fellow Physiology Conference

2017 Maternal Toxoplasmosis Infection in Pregnancy One lecture given as part ofNeonatology Morbidity and Mortality Conference

Lectures by Invitation (Last 5 years) Jan 2012 Pharmacokinetics NEOPREP Conference American Academy of

Pediatrics New Orleans LA May 2012 Improving Outcomes by Using the Right Drug Right Dose amp

Right Timing Topic Symposium Antimicrobials and Antivirals in the NICU Pediatric Academic Society Meeting Boston MA

May 2012 An Introduction to Pharmacokinetic and Pharmacodynamic of Antimicrobial Therapy Topic Symposium Antimicrobials and Antivirals in the NICU Pediatric Academic Society Meeting Boston MA

Jun2012 Pharmacologic Considerations during Therapeutic Hypothermia Contemporary Forums Neonatal Pharmacology Conference Washington DC

Oct 2012 Pharmacokinetics basic concepts to Use at the Bedside Contemporary Forums The Fetus and Newborn Conference San Francisco CA

Oct 2012 The Use of Antiviral and Antifungal Medication Contemporary Forums The Fetus and Newborn Conference San Francisco CA

Oct 2012 Pharmacologic Considerations During Therapeutic Hypothermia Contemporary Forums The Fetus and Newborn Conference San Francisco CA

Apr 2013 Evidenced Based Care of the Late Preterm Infant Center City Pediatrics Philadelphia P A

Jun 2013 Pharmacologic Considerations During Therapeutic Hypothermia Contemporary Forums Neonatal Pharmacology Conference San Diego CA

Jun 2013 Improved Treatments for Viral and Fungal Infections in Neonates Contemporary Forums Neonatal Pharmacology Conference San Diego CA

Nov 2013 Improved Dosing Guidance for Antibiotics and Antifungals Contemporary Forums The Fetus amp Newborn Conference Washington DC

Nov 2013 11 Using PharmacokineticsPharmacodynamics Knowledge to Individualize Dosing Contemporary Forums The Fetus amp Newborn Conference Washington DC

Jan2014 General Principles of Pharmacology Academy of Pediatrics NeoPrep Conference San Diego CA

Feb2014 Clinical Pharmacology ofFluconazole Columbian Association of Neonatology Annual Conference on Nutrition and Pharmacology Bogata Columbia

Kelly C Wade MD PhD MSCE Page 7

Feb2014

Feb2014

May2014

Nov 2014

Nov 2014

Mar 2015

May 2015

Oct 2015

Oct 2015

Jan2016 Feb2016

Apr 2016

Apr 2016

May 2016

Sep2016

Sep2016

Apr 2017

Clinical Pharmacology ofVancomycin Columbian Association of Neonatology Annual Conference on Nutrition and Pharmacology Bogata Columbia Basic Pharmacokinetics to Improve Dosing Columbian Association ofNeonatology Annual Conference on Nutrition and Pharmacology Bogata Columbia Improving outcomes from neonatal infections using PKPD principles Neonatal Pharmacology Conference Contemporary Forums Boston MA Current dosing for serious infections The Fetus and the Newborn Conference Contemporary Forums Las Vegas NV Choosing the right dose using PKPD principles The Fetus and the Newborn Conference Contemporary Forums Las Vegas NV Safety during ROP evaluations A Neonatologists Perspective Workshop Telemedicine for the detection of serious acute phase ROP time for a paradigm shift American Academy of Pediatric Ophthalmology Annual Meeting New Orleans LA Whats New in Neonatal Pharmacology Neonatal Pharmacology Conference Contemporary Forums Scottsdale AZ New Guidelines for Antiviral and Antifungal Therapies The Fetus and the Newborn Conference Contemporary Forums San Diego CA Whats New for Antibiotics in the NICU The Fetus and the Newborn Conference Contemporary Forums San Diego CA Pharmacokinetics AAP NeoPrep Conference Atlanta GA Reducing Medication Errors in the NICU The NEO Conference MedNax Pediatric Group Orlando FL Whats New for Antimicrobial Therapy in the NICU Neonatal Pharmacology Meeting Contemporary Forums Las Vegas NV Reducing Medication Errors in the NICU Neonatal Pharmacology Conference Contemporary Forums Las Vegas NV New Guidelines for Antiviral and Antifungal Therapies 13th Annual CHOP Neonatal Nursing Symposium Philadelphia PA Strategies to reduce medication errors in the NICU Contemporary Forums Fetus and Newborn Conferences New Orleans LA PK knowledge to improve drug dosing in the NICU Contemporary Forums Fetus and Newborn Conferences New Orleans LA Whats new in neonatal pharmacology Neonatal Pharmacology Conference Contemporary Forums San Diego CA

Organizing Roles in Scientific Meetings Jun 2011 Co-Chair 11th Annual Neonatal Pharmacology Conference

Contemporary Forums San Fransisco CA

Kelly C Wade MD PhD MSCE Page 8

May 2012 Co-Chair Topic Symposium Antimicrobials and Antivirals in the NICU Getting the Dose RIGHT Every Time Pedaitric Academic Society Meeting Boston MA

Jun2012 Co-Chair 12th Annual Neonatal Pharmacology Conference Contemporary Forums Washington DC

Jun 2013 Chair 13th Annual Neonatal Pharmacology Conference Contemporary Forums San Diego California

Jan2014 Planning Committee Member NEOPREP conference American Academy of Pediatrics Elk Grove Village IL

May2014 Co-Chair 14th Annual Neonatal Pharmacology Conference Contemporary Forums Boston MA

May 2015 Co-chair 15th Annual Neonatal Pharmacology Conference Contemporary Forums Scottsdale AZ

Jan2016 Co-Chair NEOPREP Conference American Academy ofPediatrics Atlanta GA

Apr 2016 Chair 16th Annual Neonatal Pharmacology Conference Contemporary Forums Las Vegas NV

Apr 2017 Chair 17th Annual Neonatal Pharmacology Conference Contemporary Forums San Diego CA

Jan2018 Chair NeoPREP American Academy ofPediatrics Atlanta GA

Bibliography Research Publications peer reviewed (print or other media)

1 Cant K Knowles B Mooseker M Cooley L Drosophila singed a fascin homolog is required for actin bundle formation during oogenesis and bristle extension Journal Cell Biology 125 369 Apr 1994

2 Robinson D Cant K Cooley L Morphogenesis of a Drosophila ring canal Development 120 2015 Jul1994

3 Cant K Cooley L Single amino acid mutations in Drosophila fascin disrupt actin bundle formation in vivo Genetics 143 249 Jan 1996

4 Cant K Knowles B Mahajan-Miklos S Heintzelman M Cooley L Drosophila fascin mutants are rescued by overepression ofvillin like protein quail Journal Cell Science 111 213-221 Jan 1998

Kelly C Wade MD PhD MSCE Page 9

5 Alexander SW Wade KC Hibberd PL Parsons SK Evaluation ofrisk prediction criteria for episodes of febrile neutropenia in children with cancer Journal ofPediatric HematologyOncology 24(1) 38-42 Jan 2002

6 Gonzales LW Guttentag SH Wade KC Postle AD Ballard PL Differentiation ofhuman pulmonary type II cells in vitro by glucocorticoid plus cAMP American Journal ofPhysiology- Lung Cellular amp Molecular Physiology 283(5) L940-51 Nov 2002

7 Daugherty BL Mateescu M Patel AS Wade K Kimura S Gonzales LW Guttentag S Ballard PL Koval M Developmental regulation of claudin localization by fetal alveolar epithelial cells American Journal of PhysiologyshyLung Cellular amp Molecular Physiology 287(6) L1266-73 Dec 2004

8 Wade KC Guttentag SH Gonzales LW Maschhoff KL Gonzales J Kolla V Singhal S Ballard PL Gene induction during differentiation of human pulmonary type II cells in vitro American Journal ofRespiratory Cell amp Molecular Biology 34(6) 727-37 Jun 2006

9 Cohen-Wolkowiez M Benjamin DK Jr Fowler VG Jr Wade KC Alexander BD Worley G Goldstein RF Smith PB Mortality and neurodevelopmental outcome after Staphylococcus aureus bacteremia in infants Pediatric Infectious Disease Journal 26(12) 1159-61 Dec 2007

10 Lorch SA Wade KC Bakewell-Sachs S Medoff-Cooper B Escobar GJ Silber JH Racial differences in the use ofrespiratory medications in premature infants after discharge from the neonatal intensive care unit Journal of Pediatrics 151(6) 604-10 610e1 Dec 2007

11 Cohen-Wolkowiez M Smith PB Benjamin DK Jr Fowler VG Jr Wade KC Daptomycin use in infants report of two cases with peak and trough drug concentrations Journal ofPerinatology 28(3) 233-4 Mar 2008

12 Wade KC Lorch SA Bakewell-Sachs S Medoff-Cooper B Silber JH Escobar GJ Pediatric care for preterm infants after NICU discharge high number of office visits and prescription medications Journal of Perinatology 28(10) 696-701 Oct 2008

13 Wade KC Wu D Kaufinan DA Ward RM Benjamin OK Jr Sullivan JE Ramey N Jayaraman B Hoppu K Adamson PC Gastonguay MR Barrett JS National Institute of Child Health and Development Pediatric Pharmacology Research Unit Network Population pharmacokinetics of fluconazole in young infants Antimicrobial Agents amp Chemotherapy 52(11) 4043-9 Nov 2008

Kelly C Wade MD PhD MSCE Page 10

14 Bruno CJ Smith LP Zur KB Wade KC Congenital subglottic cyst in a term neonate Archives ofDisease in Childhood Fetal amp Neonatal Edition 94(4) F240 Jul 2009

15 Wade KC Benjamin DK Jr Kaufman DA Ward RM Smith PB Jayaraman B Adamson PC Gastonguay MR Barrett JS Fluconazole dosing for the prevention or treatment ofinvasive candidiasis in young infants Pediatric Infectious Disease Journal28(8) 717-23 Aug 2009

16 Wu D Wade KC Paul DJ Barrett JS A rapid and sensitive LC-MSMS method for determination of fluconazole in human plasma and its application in infants with Candida infections Therapeutic Drug Monitoring 31 (6) 703-9 Dec 2009

17 Kimberlin DW Shalabi M Abzug J Lang D Jacobs RF Storchm G Bradley JS Wade KC Ramilo 0 Romero JR Shelton M Leach C Guzman-Cottrill J Robinson J Abughali N Englund J Griffin J Jester P Cloud GA Whitley RJ NIAID Collaborative Antiviral Study Group Safety ofoseltamivir compared with the adamantanes in children less than 12 months ofage Pediatric Infectious Disease Journal 29(3) 195 Mar 2010

18 Lorch SA Wade KC Bakewell-Sachs S Medoff-Cooper 8 Silber JH Escobar GJ Antibiotic use in premature infants after discharge from the neonatal intensive care unit Clinical Pediatrics 49(3) 249 Apr 2010

19 Wade KC Ellenberg JH Grosser T Brensinger CM Kimmel SE Hennessy S Exogenous estrogen does not attenuate the association between rofecoxib and myocardial infarction in perimenopausal women Journal Cardiovascular Pharmacology 57(2) 194 Feb 2011

20 Piper L Smith PB Hornik CP Cheifetz IM Barrett JS Moorthy G Hope WW Wade KC Cohen-Wolkowiez M Benjamin OK Fluconazole loading dose pharmacokinetics and safety in infants Pediatric Infectious Disease Journal 30(5) 375 May 2011

21 Smith PB Cohen-Wolkowiez M Castro LM Poindexter B Bidegain M Weitkamp JH Schelonka RL Ward RM Wade K Valencia G Burchfield D Arrieta A Bhatt-Mehta V Walsh M Kantak A Rasmussen M Sullivan J E Finer N Brozanski BS Sanchez P van den Anker J Blumer J Keams GL Capparelli EV Anand R Benjamin OK Population pharmacokinetics of meropenem in plasma and cerebrospinal fluid ofinfants with suspected or complicated intra-abdominal infections Pediatric Infectious Disease Journal 30( 1 0) 844 Oct 2011

Kelly C Wade MD PhD MSCE Page 11

22 Mossabeb R Wade KC Finnegan K Sivieri E Abbasi S Language development survey provides a useful screening tool for language delay in preterm infants Clinical Pediatrics 51(7) 638 July 2012

23 Watt KM Benjamin OK Jr Cheifetz IM Moorthy G Wade KC Smith PB Brouwer KL Capparelli EV Cohen-Wolkowietz M Pharmacokinetics and safety of fluconazole in young infants supported with extracorporeal membrane oxygenation Pediatric Infectious Disease Journal 31(10) 1042-7 Oct 2012

24 Watt Kevin M Benjamin Daniel K Cheifetz Ira M Moorthy Ganesh Wade Kelly C Smith P Brian Brouwer Kim L R Capparelli Edmund V Cohen-Wolkowiez Michael Pharmacokinetics and safety of fluconazole in young infants supported with extracorporeal membrane oxygenation The Pediatric infectious disease journal 31 ( 1 0) 1042-7 Oct 2012

25 Cohen-Wolkowiez Michael Poindexter Brenda Bidegain Margarita Weitkamp Joern-Hendrik Schelonka Robert L Randolph David A Ward Robert M Wade Kelly Valencia Gloria Burchfield David Arrieta Antonio Mehta Varsha Walsh Michele Kantak Anand Rasmussen Maynard Sullivan Janice E Finer Neil Rich Wade Brozanski Beverly S van den Anker John Blumer Jeffrey Laughon Matthew Watt Kevin M Keams Gregory L Capparelli Edmund V Martz Karen Berezny Katherine Benjamin Daniel K Smith P Brian Safety and effectiveness of meropenem in infants with suspected or complicated intra-abdominal infections Clinical infectious diseases an official publication ofthe Infectious Diseases Society of America 55(11) 1495-502 Dec 2012

26 Reiss Errol Lasker Brent A Lott Timothy J Bendel Catherine M Kaufman David A Hazen Kevin C Wade Kelly C McGowan Karin L Lockhart Shawn R Genotyping of Candida parapsilosis from three neonatal intensive care units (NICUs) using a panel of five multilocus microsatellite markers broad genetic diversity and a cluster ofrelated strains in one NICU Infection genetics and evolution journal of molecular epidemiology and evolutionary genetics in infectious diseases 12(8) 1654-60 Dec 2012

27 Benjamin Daniel K Hudak Mark L Duara Shahnaz Randolph David A Bidegain Margarita Mundakel Gratias T Natarajan Girija Burchfield David J White Robert D Shattuck Karen E Neu Natalie Bendel Catherine M Kim M Roger Finer Neil N Stewart Dan L Arrieta Antonio C Wade Kelly C Kaufman David A Manzoni Paolo Prather Kristi 0 Testoni Daniela Berezny Katherine Y Smith P Brian Effect of fluconazole prophylaxis on candidiasis and mortality in premature infants a randomized clinical trial JAMA the Journal ofthe American Medical Association 311(17) 1742-9 May 2014

28 Monk Heather M Motsney Adam J Wade Kelly C Safety ofRotavirus Vaccine in the NICU Pediatrics 133(6) el555-60 May 2014

Kelly C Wade MD PhD MSCE Page 12

29 e-ROP Cooperative Group Telemedicine approaches to evaluating acute-phase retinopathy ofprematurity study design Ophthalmic epidemiology 21 ( 4 ) 256shy67 Aug 2014

30 Quinn Graham E Ying Gui-shuang Daniel Ebenezer Hildebrand P Lloyd Ells Anna Baumritter Agnieshka Kemper Alex R Schron Eleanor B Wade Kelly Validity of a telemedicine system for the evaluation of acute-phase retinopathy of prematurity JAMA ophthalmology 132(10) 1178-84 Oct 2014

31 Kemper Alex R Wade Kelly C Hornik Christoph P Ying Gui-Shuang Baumritter Agnieshka Quinn Graham E Retinopathy of Prematurity Risk Prediction for Infants with Birth Weight Less than 1251 Grams The Journal ofpediatrics 166(2) 257-6le2 Nov 2014

32 Ying Gui-Shuang Quinn Graham E Wade Kelly C Repka Michael X Baumritter Agnieshka Daniel Ebenezer Predictors for the Development ofReferralshyWarranted Retinopathy of Prematurity in the Telemedicine Approaches to Evaluating Acute-Phase Retinopathy ofPrematurity (e-ROP) Study JAMA ophthalmology 133(3) 304-11 Dec 2014

33 Watt Kevin M Gonzalez Daniel Benjamin Daniel K Brouwer Kim L R Wade Kelly C Capparelli Edmund Barrett Jeffrey Cohen-Wolkowiez Michael Fluconazole population pharmacokinetics and dosing for prevention and treatment of invasive Candidiasis in children supported with extracorporeal membrane oxygenation Antimicrobial agents and chemotherapy 59(7) 3935-43 Jul2015

34 Wade Kelly C Pistilli Maxwell Baumritter Agnieshka Karp Karen Gong Alice Kemper Alex R Ying Gui-Shuang Quinn Graham Safety ofRetinopathy of Prematurity Examination and Imaging in Premature Infants The Journal of pediatrics 167(5) 994-1000e2 Nov 2015

35 Kemper Alex R Prosser Lisa A Wade Kelly C Repka Michael X Ying Gui-Shuang Baumritter Agnieshka Quinn Graham E A Comparison of Strategies for Retinopathy ofPrematurity Detection Pediatrics 137(1) 1-10 Jan 2016

36 Frommelt Peter Juern Anna Siegel Dawn Holland Kristen Seefeldt Marcia Yu JiaDe Uhing Michael Wade Kelly Drolet Beth Adverse Events in Young and Preterm Infants Receiving Topical Timolol for Infantile Hemangioma Pediatric dermatology 33(4) 405-14 Jul2016

37 Quinn Graham E Barr Charles Bremer Don Fellows Rae Gong Alice Hoffman Robert Repka Michael X Shepard Jennifer Siatkowski R Michael Wade Kelly Ying Gui-Shuang Changes in Course of Retinopathy of Prematurity from 1986 to 2013 Comparison ofThree Studies in the United States Ophthalmology 123(7) 1595-600 Jul2016

Kelly C Wade MD PhD MSCE Page 13

38 Momper Jeremiah D Capparelli Edmund V Wade Kelly C Kantak Anand Dhanireddy Ramasubbareddy Cummings James J Nedrelow Jonathan H Hudak Mark L Mundakel Gratias T Natarajan Girija Gao Jamie Laughon Matt Smith P Brian Benjamin Daniel K Population Pharmacokinetics of Fluconazole in Premature Infants with Birth Weights Less than 750 Grams Antimicrobial agents and chemotherapy 60(9) 5539-45 Sep 2016

39 Quinn Graham E Ying Gui-Shuang Repka Michael X Siatkowski R Michael Hoffman Robert Mills Monte D Morrison David Daniel Ebenezer Baumritter Agnieshka Hildebrand P Lloyd Schron Eleanor B Ells AnnaL Wade Kelly Kemper Alex R Timely implementation ofa retinopathy of prematurity telemedicine system Journal ofAAPOS the official publication of the American Association for Pediatric Ophthalmology and Strabismus 20(5) 425-430e I Oct 2016

Research Publications peer-reviewed reviews 1 Laughon MM Benjamin DK Capparelli EV Keams GL Berezny K Paul IM

Wade K Barrett J Smith PB Cohen-Wolkowiez M Innovative clinical trial design for pediatric therapeutics Expert Review of Clinical Pharmacology 4(5) 643-52 Sep 2011

2 Wade Kelly C Monk Heather M New antifungal and antiviral dosing Clinics in perinatology 42(1) 177-94 x Mar 2015

3 England Amanda Wade Kelly Smith P Brian Berezny Katherine Laughon Matthew Optimizing operational efficiencies in early phase trials The Pediatric Trials Network experience Contemporary clinical trials 47 376-82 Mar 2016

Research Publications non-peer reviewed 1 Cant K Genetic and biochemical characterization of Drosophila singed a homolog of

the actin bundling protein fascin Yale University New Haven CT May 1996 Notes PhD Thesis

Abstracts (Last 3 years) 1 Kelly C Wade Maxwell Pistilli Karen Karp Gui-shuang Ying Agnieshka Baumritter

Alice Gong Alex Kemper Graham Quinn and on behalfof e-ROP cooperative group Safety ofROP screening in extremely premature infants Abstract presented at PAS Annual Meeting San Diego CA 2015

2 Kelly Wade Maxwell Pistilli Karen Karp Gui-shuang Ying Agnieshka Baumritter Alice Gong Alex Kemper Graham Quinn and on behalf of the e-ROP collaborative group Adverse Events Between 32-44 weeks PMA in an Observational ROP Study Abstract presented at PAS annual meeting San Diego CA 2015

Kelly C Wade MD PhD MSCE Page 14

3 Kelly C Wade Gui-shuang Ying Agnieshka Baumritter Alex R Kemper Graham E Quinn and on behalf of the eROP investigators Identifying which low birth weight premature infants are at LOW risk for developing ROP Abstract presented at PAS Annual Meeting Baltimore MD 2016

Editorials Reviews Chapters including participation in committee reports (print or other media)

1 Wade KC Aplenc R Genetic susceptibility to neonatal disease Neo Review Illinois American Academy of Pediatrics July 2004

2 Wade KC Benjamin Jr DK Clinical Pharmacology of Anti-Infective Drugs Infectious Diseases ofthe Fetus and Newborn Infant 7th Edition Remington amp Klein Wilson Nizet Maldonado (eds) Saunders Page 1160-1211 2010 Notes Chapter

3 Quinn Graham E Need for Telemedicine in Retinopathy of Prematurity in MiddleshyIncome Countries-Reply JAMA ophthalmology Dec 2014

4 Wade KC and Benjamin OK Jr Clinical Pharmacology ofAnti-Infective Drugs Infectious Diseases ofthe Fetus and Newborn Infant 8th Edition Remington Klein Wilson Nizet Maldonado (eds) Elsevier 2014 Notes Book Chapter

5 Wade KC Pharmacokinetics Fanaroff and Martins Neonatal-Perinatal Medicine 1Oth Edition Martin RJ Fanaroff AA and Walsh MC (eds) Elsevier 2014 Notes Book Chapter

Books [none]

Alternative Media [none]

Patents [none]

Page 3: Kelly C. Wade, M.D., Ph.D., M.S.C.E. - U S Food and Drug ... · PDF file2001-2004 Fellowship in Neonatal-Perinatal Medicine, ... Publication Review Committee 2014- present: ... "Update

Kelly C Wade MD PhD MSCE Page 3

2010-Present NICHD Pediatric Trials Network (2010- present Executive Committee 2013- present Publication Review Committee 2014- present Caffeine Protocol Development Group 2013-2015 Adverse Event Standards Committee 2013-2015 Timolol Protocol Development Group)

20 I 0-Present Society for Pediatric Research

20I0-2016 eROP-Telemedicine for the evaluation of Retinopathy ofPrematurity (NEI funded clinical trial) (Protocol Development Committee (20IO) Executive Committee (201 0-present) Chair Safety Committee (20 I 0-present) Editorial Committee (20I3-present))

2013-Present Food and Drug Administration (Neonatal Subcommittee of the Pediatric Advisory Committee)

2015-Present International Neonatal Consortium (Invited participant in the following working groups Clinical Pharmacology Infectious Disease Research Culture in NICU Adverse Event reporting in Neonates)

2016-Present American Society for Health-System Pharmacists (Standard for Safety Project compounded oral liquid medications)

20 16-present Food and Drug Administration (Member of the Pediatric Advisory Committee)

Local 2008-Present Philadelphia Perinatal Society

Editorial Positions 20 1 0-Present Peer reviewer Journal of Peri nato logy 201I-Present Peer reviewer Journal Of Pediatrics 20 13-Present Peer reviewer Pediatric Infectious Disease Journal 20I4-Present Peer reviewer for the Journal Drugs 20 16-present Peer reviewer for Antimicrobial Agents and Chemotherapy 2017-Present Peer reviewer European Journal of Pediatrics 20I7-present Peer reviewer Ophthalmology

Academic and Institutional Committees 1997-2001 Boston Combined Residency Program Training Committee 1998-2001 Co-Chair Childrens Hospital Memorial Service Committee I999-2001 Boston Combined Residency Program Selection Committee 2000-200I Childrens Hospital Boston Investigational Review Board 2000-2001 Chair Childrens Hospital Grand Rounds Organizing Committee

Kelly C Wade MD PhD MSCE Page 4

2001-2004 Neonatology Clinical Research Group Childrens Hospital of Philadelphia

2002-2004 Co-Chair Neonatology Fellows Scheduling Committee 2002-2003 Neonatology Consensus Committee Ventilation of Premature

Infants 2003-2004 Neonatology Consensus Committee Limits of Resuscitation 2004-2005 Chair Neonatology Consensus Committee Caring and Responsible

End of Life Guidelines 2006-2008 Therapeutic Standards Committee Childrens Hospital of

Philadelphia 2006-2008 Pediatric Pharmacology Research Unit Re-engineering Task Force 2006-2008 Pediatric Pharmacology Research Unit Network Steering

Committee 2006-2008 Pediatric Pharmacology Research Unit Executive Committee 2006-2008 Neonatology Database Committee Childrens Hospital of

Philadelphia 2006-2008 Fetal Palliative Care Consultant Group 2007-2012 Neonatology Fellow Selection Committee Childrens Hospital of

Philadelphia 2009-Present Pharmacy and Therapeutics Committee Pennsylvania Hospital 2009-2013 Breastfeeding Committee for NICU Pennsylvania Hospital 2010-Present Neonatal Intensive Care Unit Based Clinical Leadership Group

Pennsylvania Hospital 2010-Present ICN Management Committee Pennsylvania Hospital 2010-Present Post-partum amp Newborn Care Unit Based Clinical Leadership

Group Pennsylvania Hospital 2011-Present CHOP Newborn Care Patient Safety Collaborative 2012-2014 Physician Leader NICHQ Best-Fed Beginnings Team Pennsylvania

Hospital 2014-Present CHOP Newborn Care Network Guidelines for glucose monitoring

of newborns at risk for hypogycemia

Major Academic and Clinical Teaching Responsibilities 2003 A Family Based Association Study to Evaluate Genetic

Susceptibility to Bronchopulmonary Dysplasia Pulmonary Division Research Conference Childrens Hospital of Philadelphia P A

2003 Update on Molecular Biology for Neonatologists Childrens Hospital of Philadelphia Neonatal Fellows Physiology Conference Philadelphia P A

2005 CARE Caring and Responsible End of Life Guidelines Consensus Conference Childrens Hospital ofPhiladelphia PA

2006 End of Life Care in the NICU Bimonthly Resident Lecture Childrens Hospital ofPhiladelphia PA

2006 A Multicentered PPRU Study of Fluconazole in Infants Nursing Research Conference Childrens Hospital of Philadelphia PA

Kelly C Wade MD PhD MSCE Page 5

2008-2013

2008-Present

2008-Present 2010

201 0-Present 2010

2011

2012-Present

2012

2012

2012

2013 2013

2013

2014-Present

2014

20 14-Present

2014-Present

2015-Present

2015-Present

Faculty Doctoring I II III University ofPennsylvania School of Medicine Course Director Pediatrics 305D Well Newborn Perelman School of Medicine Pennsylvania Hospital Faculty Perinatal and Neonatal Case Review Noon Conference Lecturer Pharmacokinetics Tools to Use at the Bedside Fellowship Physiology Conference Childrens Hospital of Philadelphia Chair Neonatology Academic Conference Pennsylvania Hospital Lecturer Update on GBS Screening Guidelines CHOP Newborn Care Academic Conference Lecturer Hot Topics from the Pediatric Academic Society Annual Meeting CHOP Newborn Care Academic Conference Faculty Neonatal Fellow Simulation Education Communication Workshops 2-4 times per year Lecturer Transitions in Care- NICU to Pediatric Office CHOP Newborn Care Academic Conference OB GYN Grand Rounds Morbidity and Mortality Conference Neonatal HSV Lecturer Hot Topics from the Pediatric Academic Society Annual Meeting CHOP Newborn Care Academic Conference Faculty CHOP Neonatal Fellow Simulation Boot Camp Lecturer Hot Topics from the Pediatric Academic Society Annual Meeting CHOP Newborn Care Academic Conference Lecturer CHOP Network NAS Algorithm amp Inter-rater Reliability Program CHOP Newborn Care Academic Conference Lecturer UPENN Nursing School NURS776 High Risk Neonate Theory 2 lectures per year Guiding Drug Principles to Improve Infectious Disease Outcomes and Treatment ofViral and Fungal Infections in the NICU Lecturer CHOP Newborn Care at Chester County Antibiotic Dosing in the NICU Faculty Lecturer CHOP Physician Assistant Residency Program in Neonatology 3 Lectures per year Basic Pharmacokinetics to improve drug dosing Treatment ofviral and fungal infections Exchange Transfusion for RH isoimmunization Resident Choice Course Director CHOP Pediatric Residency Independent Elective Unit in Neonatology Lecturer Delivery Room Care and Neonatal Resuscitation Review CHOP Resident Pennsylvania Hospital NICU elective Orientation lecture and simulation 5-7 times per year Instructor Neonatal Resuscitation Program UPENN Newborn Care at Pennsylvania Hospital

Kelly C Wade MD PhD MSCE Page 6

2017-Present Lecturer Clinical Toxicology- medication in Pregnancy and lactation 90 minutes lecture at CHOP Neonatal Fellow Physiology Conference

2017 Maternal Toxoplasmosis Infection in Pregnancy One lecture given as part ofNeonatology Morbidity and Mortality Conference

Lectures by Invitation (Last 5 years) Jan 2012 Pharmacokinetics NEOPREP Conference American Academy of

Pediatrics New Orleans LA May 2012 Improving Outcomes by Using the Right Drug Right Dose amp

Right Timing Topic Symposium Antimicrobials and Antivirals in the NICU Pediatric Academic Society Meeting Boston MA

May 2012 An Introduction to Pharmacokinetic and Pharmacodynamic of Antimicrobial Therapy Topic Symposium Antimicrobials and Antivirals in the NICU Pediatric Academic Society Meeting Boston MA

Jun2012 Pharmacologic Considerations during Therapeutic Hypothermia Contemporary Forums Neonatal Pharmacology Conference Washington DC

Oct 2012 Pharmacokinetics basic concepts to Use at the Bedside Contemporary Forums The Fetus and Newborn Conference San Francisco CA

Oct 2012 The Use of Antiviral and Antifungal Medication Contemporary Forums The Fetus and Newborn Conference San Francisco CA

Oct 2012 Pharmacologic Considerations During Therapeutic Hypothermia Contemporary Forums The Fetus and Newborn Conference San Francisco CA

Apr 2013 Evidenced Based Care of the Late Preterm Infant Center City Pediatrics Philadelphia P A

Jun 2013 Pharmacologic Considerations During Therapeutic Hypothermia Contemporary Forums Neonatal Pharmacology Conference San Diego CA

Jun 2013 Improved Treatments for Viral and Fungal Infections in Neonates Contemporary Forums Neonatal Pharmacology Conference San Diego CA

Nov 2013 Improved Dosing Guidance for Antibiotics and Antifungals Contemporary Forums The Fetus amp Newborn Conference Washington DC

Nov 2013 11 Using PharmacokineticsPharmacodynamics Knowledge to Individualize Dosing Contemporary Forums The Fetus amp Newborn Conference Washington DC

Jan2014 General Principles of Pharmacology Academy of Pediatrics NeoPrep Conference San Diego CA

Feb2014 Clinical Pharmacology ofFluconazole Columbian Association of Neonatology Annual Conference on Nutrition and Pharmacology Bogata Columbia

Kelly C Wade MD PhD MSCE Page 7

Feb2014

Feb2014

May2014

Nov 2014

Nov 2014

Mar 2015

May 2015

Oct 2015

Oct 2015

Jan2016 Feb2016

Apr 2016

Apr 2016

May 2016

Sep2016

Sep2016

Apr 2017

Clinical Pharmacology ofVancomycin Columbian Association of Neonatology Annual Conference on Nutrition and Pharmacology Bogata Columbia Basic Pharmacokinetics to Improve Dosing Columbian Association ofNeonatology Annual Conference on Nutrition and Pharmacology Bogata Columbia Improving outcomes from neonatal infections using PKPD principles Neonatal Pharmacology Conference Contemporary Forums Boston MA Current dosing for serious infections The Fetus and the Newborn Conference Contemporary Forums Las Vegas NV Choosing the right dose using PKPD principles The Fetus and the Newborn Conference Contemporary Forums Las Vegas NV Safety during ROP evaluations A Neonatologists Perspective Workshop Telemedicine for the detection of serious acute phase ROP time for a paradigm shift American Academy of Pediatric Ophthalmology Annual Meeting New Orleans LA Whats New in Neonatal Pharmacology Neonatal Pharmacology Conference Contemporary Forums Scottsdale AZ New Guidelines for Antiviral and Antifungal Therapies The Fetus and the Newborn Conference Contemporary Forums San Diego CA Whats New for Antibiotics in the NICU The Fetus and the Newborn Conference Contemporary Forums San Diego CA Pharmacokinetics AAP NeoPrep Conference Atlanta GA Reducing Medication Errors in the NICU The NEO Conference MedNax Pediatric Group Orlando FL Whats New for Antimicrobial Therapy in the NICU Neonatal Pharmacology Meeting Contemporary Forums Las Vegas NV Reducing Medication Errors in the NICU Neonatal Pharmacology Conference Contemporary Forums Las Vegas NV New Guidelines for Antiviral and Antifungal Therapies 13th Annual CHOP Neonatal Nursing Symposium Philadelphia PA Strategies to reduce medication errors in the NICU Contemporary Forums Fetus and Newborn Conferences New Orleans LA PK knowledge to improve drug dosing in the NICU Contemporary Forums Fetus and Newborn Conferences New Orleans LA Whats new in neonatal pharmacology Neonatal Pharmacology Conference Contemporary Forums San Diego CA

Organizing Roles in Scientific Meetings Jun 2011 Co-Chair 11th Annual Neonatal Pharmacology Conference

Contemporary Forums San Fransisco CA

Kelly C Wade MD PhD MSCE Page 8

May 2012 Co-Chair Topic Symposium Antimicrobials and Antivirals in the NICU Getting the Dose RIGHT Every Time Pedaitric Academic Society Meeting Boston MA

Jun2012 Co-Chair 12th Annual Neonatal Pharmacology Conference Contemporary Forums Washington DC

Jun 2013 Chair 13th Annual Neonatal Pharmacology Conference Contemporary Forums San Diego California

Jan2014 Planning Committee Member NEOPREP conference American Academy of Pediatrics Elk Grove Village IL

May2014 Co-Chair 14th Annual Neonatal Pharmacology Conference Contemporary Forums Boston MA

May 2015 Co-chair 15th Annual Neonatal Pharmacology Conference Contemporary Forums Scottsdale AZ

Jan2016 Co-Chair NEOPREP Conference American Academy ofPediatrics Atlanta GA

Apr 2016 Chair 16th Annual Neonatal Pharmacology Conference Contemporary Forums Las Vegas NV

Apr 2017 Chair 17th Annual Neonatal Pharmacology Conference Contemporary Forums San Diego CA

Jan2018 Chair NeoPREP American Academy ofPediatrics Atlanta GA

Bibliography Research Publications peer reviewed (print or other media)

1 Cant K Knowles B Mooseker M Cooley L Drosophila singed a fascin homolog is required for actin bundle formation during oogenesis and bristle extension Journal Cell Biology 125 369 Apr 1994

2 Robinson D Cant K Cooley L Morphogenesis of a Drosophila ring canal Development 120 2015 Jul1994

3 Cant K Cooley L Single amino acid mutations in Drosophila fascin disrupt actin bundle formation in vivo Genetics 143 249 Jan 1996

4 Cant K Knowles B Mahajan-Miklos S Heintzelman M Cooley L Drosophila fascin mutants are rescued by overepression ofvillin like protein quail Journal Cell Science 111 213-221 Jan 1998

Kelly C Wade MD PhD MSCE Page 9

5 Alexander SW Wade KC Hibberd PL Parsons SK Evaluation ofrisk prediction criteria for episodes of febrile neutropenia in children with cancer Journal ofPediatric HematologyOncology 24(1) 38-42 Jan 2002

6 Gonzales LW Guttentag SH Wade KC Postle AD Ballard PL Differentiation ofhuman pulmonary type II cells in vitro by glucocorticoid plus cAMP American Journal ofPhysiology- Lung Cellular amp Molecular Physiology 283(5) L940-51 Nov 2002

7 Daugherty BL Mateescu M Patel AS Wade K Kimura S Gonzales LW Guttentag S Ballard PL Koval M Developmental regulation of claudin localization by fetal alveolar epithelial cells American Journal of PhysiologyshyLung Cellular amp Molecular Physiology 287(6) L1266-73 Dec 2004

8 Wade KC Guttentag SH Gonzales LW Maschhoff KL Gonzales J Kolla V Singhal S Ballard PL Gene induction during differentiation of human pulmonary type II cells in vitro American Journal ofRespiratory Cell amp Molecular Biology 34(6) 727-37 Jun 2006

9 Cohen-Wolkowiez M Benjamin DK Jr Fowler VG Jr Wade KC Alexander BD Worley G Goldstein RF Smith PB Mortality and neurodevelopmental outcome after Staphylococcus aureus bacteremia in infants Pediatric Infectious Disease Journal 26(12) 1159-61 Dec 2007

10 Lorch SA Wade KC Bakewell-Sachs S Medoff-Cooper B Escobar GJ Silber JH Racial differences in the use ofrespiratory medications in premature infants after discharge from the neonatal intensive care unit Journal of Pediatrics 151(6) 604-10 610e1 Dec 2007

11 Cohen-Wolkowiez M Smith PB Benjamin DK Jr Fowler VG Jr Wade KC Daptomycin use in infants report of two cases with peak and trough drug concentrations Journal ofPerinatology 28(3) 233-4 Mar 2008

12 Wade KC Lorch SA Bakewell-Sachs S Medoff-Cooper B Silber JH Escobar GJ Pediatric care for preterm infants after NICU discharge high number of office visits and prescription medications Journal of Perinatology 28(10) 696-701 Oct 2008

13 Wade KC Wu D Kaufinan DA Ward RM Benjamin OK Jr Sullivan JE Ramey N Jayaraman B Hoppu K Adamson PC Gastonguay MR Barrett JS National Institute of Child Health and Development Pediatric Pharmacology Research Unit Network Population pharmacokinetics of fluconazole in young infants Antimicrobial Agents amp Chemotherapy 52(11) 4043-9 Nov 2008

Kelly C Wade MD PhD MSCE Page 10

14 Bruno CJ Smith LP Zur KB Wade KC Congenital subglottic cyst in a term neonate Archives ofDisease in Childhood Fetal amp Neonatal Edition 94(4) F240 Jul 2009

15 Wade KC Benjamin DK Jr Kaufman DA Ward RM Smith PB Jayaraman B Adamson PC Gastonguay MR Barrett JS Fluconazole dosing for the prevention or treatment ofinvasive candidiasis in young infants Pediatric Infectious Disease Journal28(8) 717-23 Aug 2009

16 Wu D Wade KC Paul DJ Barrett JS A rapid and sensitive LC-MSMS method for determination of fluconazole in human plasma and its application in infants with Candida infections Therapeutic Drug Monitoring 31 (6) 703-9 Dec 2009

17 Kimberlin DW Shalabi M Abzug J Lang D Jacobs RF Storchm G Bradley JS Wade KC Ramilo 0 Romero JR Shelton M Leach C Guzman-Cottrill J Robinson J Abughali N Englund J Griffin J Jester P Cloud GA Whitley RJ NIAID Collaborative Antiviral Study Group Safety ofoseltamivir compared with the adamantanes in children less than 12 months ofage Pediatric Infectious Disease Journal 29(3) 195 Mar 2010

18 Lorch SA Wade KC Bakewell-Sachs S Medoff-Cooper 8 Silber JH Escobar GJ Antibiotic use in premature infants after discharge from the neonatal intensive care unit Clinical Pediatrics 49(3) 249 Apr 2010

19 Wade KC Ellenberg JH Grosser T Brensinger CM Kimmel SE Hennessy S Exogenous estrogen does not attenuate the association between rofecoxib and myocardial infarction in perimenopausal women Journal Cardiovascular Pharmacology 57(2) 194 Feb 2011

20 Piper L Smith PB Hornik CP Cheifetz IM Barrett JS Moorthy G Hope WW Wade KC Cohen-Wolkowiez M Benjamin OK Fluconazole loading dose pharmacokinetics and safety in infants Pediatric Infectious Disease Journal 30(5) 375 May 2011

21 Smith PB Cohen-Wolkowiez M Castro LM Poindexter B Bidegain M Weitkamp JH Schelonka RL Ward RM Wade K Valencia G Burchfield D Arrieta A Bhatt-Mehta V Walsh M Kantak A Rasmussen M Sullivan J E Finer N Brozanski BS Sanchez P van den Anker J Blumer J Keams GL Capparelli EV Anand R Benjamin OK Population pharmacokinetics of meropenem in plasma and cerebrospinal fluid ofinfants with suspected or complicated intra-abdominal infections Pediatric Infectious Disease Journal 30( 1 0) 844 Oct 2011

Kelly C Wade MD PhD MSCE Page 11

22 Mossabeb R Wade KC Finnegan K Sivieri E Abbasi S Language development survey provides a useful screening tool for language delay in preterm infants Clinical Pediatrics 51(7) 638 July 2012

23 Watt KM Benjamin OK Jr Cheifetz IM Moorthy G Wade KC Smith PB Brouwer KL Capparelli EV Cohen-Wolkowietz M Pharmacokinetics and safety of fluconazole in young infants supported with extracorporeal membrane oxygenation Pediatric Infectious Disease Journal 31(10) 1042-7 Oct 2012

24 Watt Kevin M Benjamin Daniel K Cheifetz Ira M Moorthy Ganesh Wade Kelly C Smith P Brian Brouwer Kim L R Capparelli Edmund V Cohen-Wolkowiez Michael Pharmacokinetics and safety of fluconazole in young infants supported with extracorporeal membrane oxygenation The Pediatric infectious disease journal 31 ( 1 0) 1042-7 Oct 2012

25 Cohen-Wolkowiez Michael Poindexter Brenda Bidegain Margarita Weitkamp Joern-Hendrik Schelonka Robert L Randolph David A Ward Robert M Wade Kelly Valencia Gloria Burchfield David Arrieta Antonio Mehta Varsha Walsh Michele Kantak Anand Rasmussen Maynard Sullivan Janice E Finer Neil Rich Wade Brozanski Beverly S van den Anker John Blumer Jeffrey Laughon Matthew Watt Kevin M Keams Gregory L Capparelli Edmund V Martz Karen Berezny Katherine Benjamin Daniel K Smith P Brian Safety and effectiveness of meropenem in infants with suspected or complicated intra-abdominal infections Clinical infectious diseases an official publication ofthe Infectious Diseases Society of America 55(11) 1495-502 Dec 2012

26 Reiss Errol Lasker Brent A Lott Timothy J Bendel Catherine M Kaufman David A Hazen Kevin C Wade Kelly C McGowan Karin L Lockhart Shawn R Genotyping of Candida parapsilosis from three neonatal intensive care units (NICUs) using a panel of five multilocus microsatellite markers broad genetic diversity and a cluster ofrelated strains in one NICU Infection genetics and evolution journal of molecular epidemiology and evolutionary genetics in infectious diseases 12(8) 1654-60 Dec 2012

27 Benjamin Daniel K Hudak Mark L Duara Shahnaz Randolph David A Bidegain Margarita Mundakel Gratias T Natarajan Girija Burchfield David J White Robert D Shattuck Karen E Neu Natalie Bendel Catherine M Kim M Roger Finer Neil N Stewart Dan L Arrieta Antonio C Wade Kelly C Kaufman David A Manzoni Paolo Prather Kristi 0 Testoni Daniela Berezny Katherine Y Smith P Brian Effect of fluconazole prophylaxis on candidiasis and mortality in premature infants a randomized clinical trial JAMA the Journal ofthe American Medical Association 311(17) 1742-9 May 2014

28 Monk Heather M Motsney Adam J Wade Kelly C Safety ofRotavirus Vaccine in the NICU Pediatrics 133(6) el555-60 May 2014

Kelly C Wade MD PhD MSCE Page 12

29 e-ROP Cooperative Group Telemedicine approaches to evaluating acute-phase retinopathy ofprematurity study design Ophthalmic epidemiology 21 ( 4 ) 256shy67 Aug 2014

30 Quinn Graham E Ying Gui-shuang Daniel Ebenezer Hildebrand P Lloyd Ells Anna Baumritter Agnieshka Kemper Alex R Schron Eleanor B Wade Kelly Validity of a telemedicine system for the evaluation of acute-phase retinopathy of prematurity JAMA ophthalmology 132(10) 1178-84 Oct 2014

31 Kemper Alex R Wade Kelly C Hornik Christoph P Ying Gui-Shuang Baumritter Agnieshka Quinn Graham E Retinopathy of Prematurity Risk Prediction for Infants with Birth Weight Less than 1251 Grams The Journal ofpediatrics 166(2) 257-6le2 Nov 2014

32 Ying Gui-Shuang Quinn Graham E Wade Kelly C Repka Michael X Baumritter Agnieshka Daniel Ebenezer Predictors for the Development ofReferralshyWarranted Retinopathy of Prematurity in the Telemedicine Approaches to Evaluating Acute-Phase Retinopathy ofPrematurity (e-ROP) Study JAMA ophthalmology 133(3) 304-11 Dec 2014

33 Watt Kevin M Gonzalez Daniel Benjamin Daniel K Brouwer Kim L R Wade Kelly C Capparelli Edmund Barrett Jeffrey Cohen-Wolkowiez Michael Fluconazole population pharmacokinetics and dosing for prevention and treatment of invasive Candidiasis in children supported with extracorporeal membrane oxygenation Antimicrobial agents and chemotherapy 59(7) 3935-43 Jul2015

34 Wade Kelly C Pistilli Maxwell Baumritter Agnieshka Karp Karen Gong Alice Kemper Alex R Ying Gui-Shuang Quinn Graham Safety ofRetinopathy of Prematurity Examination and Imaging in Premature Infants The Journal of pediatrics 167(5) 994-1000e2 Nov 2015

35 Kemper Alex R Prosser Lisa A Wade Kelly C Repka Michael X Ying Gui-Shuang Baumritter Agnieshka Quinn Graham E A Comparison of Strategies for Retinopathy ofPrematurity Detection Pediatrics 137(1) 1-10 Jan 2016

36 Frommelt Peter Juern Anna Siegel Dawn Holland Kristen Seefeldt Marcia Yu JiaDe Uhing Michael Wade Kelly Drolet Beth Adverse Events in Young and Preterm Infants Receiving Topical Timolol for Infantile Hemangioma Pediatric dermatology 33(4) 405-14 Jul2016

37 Quinn Graham E Barr Charles Bremer Don Fellows Rae Gong Alice Hoffman Robert Repka Michael X Shepard Jennifer Siatkowski R Michael Wade Kelly Ying Gui-Shuang Changes in Course of Retinopathy of Prematurity from 1986 to 2013 Comparison ofThree Studies in the United States Ophthalmology 123(7) 1595-600 Jul2016

Kelly C Wade MD PhD MSCE Page 13

38 Momper Jeremiah D Capparelli Edmund V Wade Kelly C Kantak Anand Dhanireddy Ramasubbareddy Cummings James J Nedrelow Jonathan H Hudak Mark L Mundakel Gratias T Natarajan Girija Gao Jamie Laughon Matt Smith P Brian Benjamin Daniel K Population Pharmacokinetics of Fluconazole in Premature Infants with Birth Weights Less than 750 Grams Antimicrobial agents and chemotherapy 60(9) 5539-45 Sep 2016

39 Quinn Graham E Ying Gui-Shuang Repka Michael X Siatkowski R Michael Hoffman Robert Mills Monte D Morrison David Daniel Ebenezer Baumritter Agnieshka Hildebrand P Lloyd Schron Eleanor B Ells AnnaL Wade Kelly Kemper Alex R Timely implementation ofa retinopathy of prematurity telemedicine system Journal ofAAPOS the official publication of the American Association for Pediatric Ophthalmology and Strabismus 20(5) 425-430e I Oct 2016

Research Publications peer-reviewed reviews 1 Laughon MM Benjamin DK Capparelli EV Keams GL Berezny K Paul IM

Wade K Barrett J Smith PB Cohen-Wolkowiez M Innovative clinical trial design for pediatric therapeutics Expert Review of Clinical Pharmacology 4(5) 643-52 Sep 2011

2 Wade Kelly C Monk Heather M New antifungal and antiviral dosing Clinics in perinatology 42(1) 177-94 x Mar 2015

3 England Amanda Wade Kelly Smith P Brian Berezny Katherine Laughon Matthew Optimizing operational efficiencies in early phase trials The Pediatric Trials Network experience Contemporary clinical trials 47 376-82 Mar 2016

Research Publications non-peer reviewed 1 Cant K Genetic and biochemical characterization of Drosophila singed a homolog of

the actin bundling protein fascin Yale University New Haven CT May 1996 Notes PhD Thesis

Abstracts (Last 3 years) 1 Kelly C Wade Maxwell Pistilli Karen Karp Gui-shuang Ying Agnieshka Baumritter

Alice Gong Alex Kemper Graham Quinn and on behalfof e-ROP cooperative group Safety ofROP screening in extremely premature infants Abstract presented at PAS Annual Meeting San Diego CA 2015

2 Kelly Wade Maxwell Pistilli Karen Karp Gui-shuang Ying Agnieshka Baumritter Alice Gong Alex Kemper Graham Quinn and on behalf of the e-ROP collaborative group Adverse Events Between 32-44 weeks PMA in an Observational ROP Study Abstract presented at PAS annual meeting San Diego CA 2015

Kelly C Wade MD PhD MSCE Page 14

3 Kelly C Wade Gui-shuang Ying Agnieshka Baumritter Alex R Kemper Graham E Quinn and on behalf of the eROP investigators Identifying which low birth weight premature infants are at LOW risk for developing ROP Abstract presented at PAS Annual Meeting Baltimore MD 2016

Editorials Reviews Chapters including participation in committee reports (print or other media)

1 Wade KC Aplenc R Genetic susceptibility to neonatal disease Neo Review Illinois American Academy of Pediatrics July 2004

2 Wade KC Benjamin Jr DK Clinical Pharmacology of Anti-Infective Drugs Infectious Diseases ofthe Fetus and Newborn Infant 7th Edition Remington amp Klein Wilson Nizet Maldonado (eds) Saunders Page 1160-1211 2010 Notes Chapter

3 Quinn Graham E Need for Telemedicine in Retinopathy of Prematurity in MiddleshyIncome Countries-Reply JAMA ophthalmology Dec 2014

4 Wade KC and Benjamin OK Jr Clinical Pharmacology ofAnti-Infective Drugs Infectious Diseases ofthe Fetus and Newborn Infant 8th Edition Remington Klein Wilson Nizet Maldonado (eds) Elsevier 2014 Notes Book Chapter

5 Wade KC Pharmacokinetics Fanaroff and Martins Neonatal-Perinatal Medicine 1Oth Edition Martin RJ Fanaroff AA and Walsh MC (eds) Elsevier 2014 Notes Book Chapter

Books [none]

Alternative Media [none]

Patents [none]

Page 4: Kelly C. Wade, M.D., Ph.D., M.S.C.E. - U S Food and Drug ... · PDF file2001-2004 Fellowship in Neonatal-Perinatal Medicine, ... Publication Review Committee 2014- present: ... "Update

Kelly C Wade MD PhD MSCE Page 4

2001-2004 Neonatology Clinical Research Group Childrens Hospital of Philadelphia

2002-2004 Co-Chair Neonatology Fellows Scheduling Committee 2002-2003 Neonatology Consensus Committee Ventilation of Premature

Infants 2003-2004 Neonatology Consensus Committee Limits of Resuscitation 2004-2005 Chair Neonatology Consensus Committee Caring and Responsible

End of Life Guidelines 2006-2008 Therapeutic Standards Committee Childrens Hospital of

Philadelphia 2006-2008 Pediatric Pharmacology Research Unit Re-engineering Task Force 2006-2008 Pediatric Pharmacology Research Unit Network Steering

Committee 2006-2008 Pediatric Pharmacology Research Unit Executive Committee 2006-2008 Neonatology Database Committee Childrens Hospital of

Philadelphia 2006-2008 Fetal Palliative Care Consultant Group 2007-2012 Neonatology Fellow Selection Committee Childrens Hospital of

Philadelphia 2009-Present Pharmacy and Therapeutics Committee Pennsylvania Hospital 2009-2013 Breastfeeding Committee for NICU Pennsylvania Hospital 2010-Present Neonatal Intensive Care Unit Based Clinical Leadership Group

Pennsylvania Hospital 2010-Present ICN Management Committee Pennsylvania Hospital 2010-Present Post-partum amp Newborn Care Unit Based Clinical Leadership

Group Pennsylvania Hospital 2011-Present CHOP Newborn Care Patient Safety Collaborative 2012-2014 Physician Leader NICHQ Best-Fed Beginnings Team Pennsylvania

Hospital 2014-Present CHOP Newborn Care Network Guidelines for glucose monitoring

of newborns at risk for hypogycemia

Major Academic and Clinical Teaching Responsibilities 2003 A Family Based Association Study to Evaluate Genetic

Susceptibility to Bronchopulmonary Dysplasia Pulmonary Division Research Conference Childrens Hospital of Philadelphia P A

2003 Update on Molecular Biology for Neonatologists Childrens Hospital of Philadelphia Neonatal Fellows Physiology Conference Philadelphia P A

2005 CARE Caring and Responsible End of Life Guidelines Consensus Conference Childrens Hospital ofPhiladelphia PA

2006 End of Life Care in the NICU Bimonthly Resident Lecture Childrens Hospital ofPhiladelphia PA

2006 A Multicentered PPRU Study of Fluconazole in Infants Nursing Research Conference Childrens Hospital of Philadelphia PA

Kelly C Wade MD PhD MSCE Page 5

2008-2013

2008-Present

2008-Present 2010

201 0-Present 2010

2011

2012-Present

2012

2012

2012

2013 2013

2013

2014-Present

2014

20 14-Present

2014-Present

2015-Present

2015-Present

Faculty Doctoring I II III University ofPennsylvania School of Medicine Course Director Pediatrics 305D Well Newborn Perelman School of Medicine Pennsylvania Hospital Faculty Perinatal and Neonatal Case Review Noon Conference Lecturer Pharmacokinetics Tools to Use at the Bedside Fellowship Physiology Conference Childrens Hospital of Philadelphia Chair Neonatology Academic Conference Pennsylvania Hospital Lecturer Update on GBS Screening Guidelines CHOP Newborn Care Academic Conference Lecturer Hot Topics from the Pediatric Academic Society Annual Meeting CHOP Newborn Care Academic Conference Faculty Neonatal Fellow Simulation Education Communication Workshops 2-4 times per year Lecturer Transitions in Care- NICU to Pediatric Office CHOP Newborn Care Academic Conference OB GYN Grand Rounds Morbidity and Mortality Conference Neonatal HSV Lecturer Hot Topics from the Pediatric Academic Society Annual Meeting CHOP Newborn Care Academic Conference Faculty CHOP Neonatal Fellow Simulation Boot Camp Lecturer Hot Topics from the Pediatric Academic Society Annual Meeting CHOP Newborn Care Academic Conference Lecturer CHOP Network NAS Algorithm amp Inter-rater Reliability Program CHOP Newborn Care Academic Conference Lecturer UPENN Nursing School NURS776 High Risk Neonate Theory 2 lectures per year Guiding Drug Principles to Improve Infectious Disease Outcomes and Treatment ofViral and Fungal Infections in the NICU Lecturer CHOP Newborn Care at Chester County Antibiotic Dosing in the NICU Faculty Lecturer CHOP Physician Assistant Residency Program in Neonatology 3 Lectures per year Basic Pharmacokinetics to improve drug dosing Treatment ofviral and fungal infections Exchange Transfusion for RH isoimmunization Resident Choice Course Director CHOP Pediatric Residency Independent Elective Unit in Neonatology Lecturer Delivery Room Care and Neonatal Resuscitation Review CHOP Resident Pennsylvania Hospital NICU elective Orientation lecture and simulation 5-7 times per year Instructor Neonatal Resuscitation Program UPENN Newborn Care at Pennsylvania Hospital

Kelly C Wade MD PhD MSCE Page 6

2017-Present Lecturer Clinical Toxicology- medication in Pregnancy and lactation 90 minutes lecture at CHOP Neonatal Fellow Physiology Conference

2017 Maternal Toxoplasmosis Infection in Pregnancy One lecture given as part ofNeonatology Morbidity and Mortality Conference

Lectures by Invitation (Last 5 years) Jan 2012 Pharmacokinetics NEOPREP Conference American Academy of

Pediatrics New Orleans LA May 2012 Improving Outcomes by Using the Right Drug Right Dose amp

Right Timing Topic Symposium Antimicrobials and Antivirals in the NICU Pediatric Academic Society Meeting Boston MA

May 2012 An Introduction to Pharmacokinetic and Pharmacodynamic of Antimicrobial Therapy Topic Symposium Antimicrobials and Antivirals in the NICU Pediatric Academic Society Meeting Boston MA

Jun2012 Pharmacologic Considerations during Therapeutic Hypothermia Contemporary Forums Neonatal Pharmacology Conference Washington DC

Oct 2012 Pharmacokinetics basic concepts to Use at the Bedside Contemporary Forums The Fetus and Newborn Conference San Francisco CA

Oct 2012 The Use of Antiviral and Antifungal Medication Contemporary Forums The Fetus and Newborn Conference San Francisco CA

Oct 2012 Pharmacologic Considerations During Therapeutic Hypothermia Contemporary Forums The Fetus and Newborn Conference San Francisco CA

Apr 2013 Evidenced Based Care of the Late Preterm Infant Center City Pediatrics Philadelphia P A

Jun 2013 Pharmacologic Considerations During Therapeutic Hypothermia Contemporary Forums Neonatal Pharmacology Conference San Diego CA

Jun 2013 Improved Treatments for Viral and Fungal Infections in Neonates Contemporary Forums Neonatal Pharmacology Conference San Diego CA

Nov 2013 Improved Dosing Guidance for Antibiotics and Antifungals Contemporary Forums The Fetus amp Newborn Conference Washington DC

Nov 2013 11 Using PharmacokineticsPharmacodynamics Knowledge to Individualize Dosing Contemporary Forums The Fetus amp Newborn Conference Washington DC

Jan2014 General Principles of Pharmacology Academy of Pediatrics NeoPrep Conference San Diego CA

Feb2014 Clinical Pharmacology ofFluconazole Columbian Association of Neonatology Annual Conference on Nutrition and Pharmacology Bogata Columbia

Kelly C Wade MD PhD MSCE Page 7

Feb2014

Feb2014

May2014

Nov 2014

Nov 2014

Mar 2015

May 2015

Oct 2015

Oct 2015

Jan2016 Feb2016

Apr 2016

Apr 2016

May 2016

Sep2016

Sep2016

Apr 2017

Clinical Pharmacology ofVancomycin Columbian Association of Neonatology Annual Conference on Nutrition and Pharmacology Bogata Columbia Basic Pharmacokinetics to Improve Dosing Columbian Association ofNeonatology Annual Conference on Nutrition and Pharmacology Bogata Columbia Improving outcomes from neonatal infections using PKPD principles Neonatal Pharmacology Conference Contemporary Forums Boston MA Current dosing for serious infections The Fetus and the Newborn Conference Contemporary Forums Las Vegas NV Choosing the right dose using PKPD principles The Fetus and the Newborn Conference Contemporary Forums Las Vegas NV Safety during ROP evaluations A Neonatologists Perspective Workshop Telemedicine for the detection of serious acute phase ROP time for a paradigm shift American Academy of Pediatric Ophthalmology Annual Meeting New Orleans LA Whats New in Neonatal Pharmacology Neonatal Pharmacology Conference Contemporary Forums Scottsdale AZ New Guidelines for Antiviral and Antifungal Therapies The Fetus and the Newborn Conference Contemporary Forums San Diego CA Whats New for Antibiotics in the NICU The Fetus and the Newborn Conference Contemporary Forums San Diego CA Pharmacokinetics AAP NeoPrep Conference Atlanta GA Reducing Medication Errors in the NICU The NEO Conference MedNax Pediatric Group Orlando FL Whats New for Antimicrobial Therapy in the NICU Neonatal Pharmacology Meeting Contemporary Forums Las Vegas NV Reducing Medication Errors in the NICU Neonatal Pharmacology Conference Contemporary Forums Las Vegas NV New Guidelines for Antiviral and Antifungal Therapies 13th Annual CHOP Neonatal Nursing Symposium Philadelphia PA Strategies to reduce medication errors in the NICU Contemporary Forums Fetus and Newborn Conferences New Orleans LA PK knowledge to improve drug dosing in the NICU Contemporary Forums Fetus and Newborn Conferences New Orleans LA Whats new in neonatal pharmacology Neonatal Pharmacology Conference Contemporary Forums San Diego CA

Organizing Roles in Scientific Meetings Jun 2011 Co-Chair 11th Annual Neonatal Pharmacology Conference

Contemporary Forums San Fransisco CA

Kelly C Wade MD PhD MSCE Page 8

May 2012 Co-Chair Topic Symposium Antimicrobials and Antivirals in the NICU Getting the Dose RIGHT Every Time Pedaitric Academic Society Meeting Boston MA

Jun2012 Co-Chair 12th Annual Neonatal Pharmacology Conference Contemporary Forums Washington DC

Jun 2013 Chair 13th Annual Neonatal Pharmacology Conference Contemporary Forums San Diego California

Jan2014 Planning Committee Member NEOPREP conference American Academy of Pediatrics Elk Grove Village IL

May2014 Co-Chair 14th Annual Neonatal Pharmacology Conference Contemporary Forums Boston MA

May 2015 Co-chair 15th Annual Neonatal Pharmacology Conference Contemporary Forums Scottsdale AZ

Jan2016 Co-Chair NEOPREP Conference American Academy ofPediatrics Atlanta GA

Apr 2016 Chair 16th Annual Neonatal Pharmacology Conference Contemporary Forums Las Vegas NV

Apr 2017 Chair 17th Annual Neonatal Pharmacology Conference Contemporary Forums San Diego CA

Jan2018 Chair NeoPREP American Academy ofPediatrics Atlanta GA

Bibliography Research Publications peer reviewed (print or other media)

1 Cant K Knowles B Mooseker M Cooley L Drosophila singed a fascin homolog is required for actin bundle formation during oogenesis and bristle extension Journal Cell Biology 125 369 Apr 1994

2 Robinson D Cant K Cooley L Morphogenesis of a Drosophila ring canal Development 120 2015 Jul1994

3 Cant K Cooley L Single amino acid mutations in Drosophila fascin disrupt actin bundle formation in vivo Genetics 143 249 Jan 1996

4 Cant K Knowles B Mahajan-Miklos S Heintzelman M Cooley L Drosophila fascin mutants are rescued by overepression ofvillin like protein quail Journal Cell Science 111 213-221 Jan 1998

Kelly C Wade MD PhD MSCE Page 9

5 Alexander SW Wade KC Hibberd PL Parsons SK Evaluation ofrisk prediction criteria for episodes of febrile neutropenia in children with cancer Journal ofPediatric HematologyOncology 24(1) 38-42 Jan 2002

6 Gonzales LW Guttentag SH Wade KC Postle AD Ballard PL Differentiation ofhuman pulmonary type II cells in vitro by glucocorticoid plus cAMP American Journal ofPhysiology- Lung Cellular amp Molecular Physiology 283(5) L940-51 Nov 2002

7 Daugherty BL Mateescu M Patel AS Wade K Kimura S Gonzales LW Guttentag S Ballard PL Koval M Developmental regulation of claudin localization by fetal alveolar epithelial cells American Journal of PhysiologyshyLung Cellular amp Molecular Physiology 287(6) L1266-73 Dec 2004

8 Wade KC Guttentag SH Gonzales LW Maschhoff KL Gonzales J Kolla V Singhal S Ballard PL Gene induction during differentiation of human pulmonary type II cells in vitro American Journal ofRespiratory Cell amp Molecular Biology 34(6) 727-37 Jun 2006

9 Cohen-Wolkowiez M Benjamin DK Jr Fowler VG Jr Wade KC Alexander BD Worley G Goldstein RF Smith PB Mortality and neurodevelopmental outcome after Staphylococcus aureus bacteremia in infants Pediatric Infectious Disease Journal 26(12) 1159-61 Dec 2007

10 Lorch SA Wade KC Bakewell-Sachs S Medoff-Cooper B Escobar GJ Silber JH Racial differences in the use ofrespiratory medications in premature infants after discharge from the neonatal intensive care unit Journal of Pediatrics 151(6) 604-10 610e1 Dec 2007

11 Cohen-Wolkowiez M Smith PB Benjamin DK Jr Fowler VG Jr Wade KC Daptomycin use in infants report of two cases with peak and trough drug concentrations Journal ofPerinatology 28(3) 233-4 Mar 2008

12 Wade KC Lorch SA Bakewell-Sachs S Medoff-Cooper B Silber JH Escobar GJ Pediatric care for preterm infants after NICU discharge high number of office visits and prescription medications Journal of Perinatology 28(10) 696-701 Oct 2008

13 Wade KC Wu D Kaufinan DA Ward RM Benjamin OK Jr Sullivan JE Ramey N Jayaraman B Hoppu K Adamson PC Gastonguay MR Barrett JS National Institute of Child Health and Development Pediatric Pharmacology Research Unit Network Population pharmacokinetics of fluconazole in young infants Antimicrobial Agents amp Chemotherapy 52(11) 4043-9 Nov 2008

Kelly C Wade MD PhD MSCE Page 10

14 Bruno CJ Smith LP Zur KB Wade KC Congenital subglottic cyst in a term neonate Archives ofDisease in Childhood Fetal amp Neonatal Edition 94(4) F240 Jul 2009

15 Wade KC Benjamin DK Jr Kaufman DA Ward RM Smith PB Jayaraman B Adamson PC Gastonguay MR Barrett JS Fluconazole dosing for the prevention or treatment ofinvasive candidiasis in young infants Pediatric Infectious Disease Journal28(8) 717-23 Aug 2009

16 Wu D Wade KC Paul DJ Barrett JS A rapid and sensitive LC-MSMS method for determination of fluconazole in human plasma and its application in infants with Candida infections Therapeutic Drug Monitoring 31 (6) 703-9 Dec 2009

17 Kimberlin DW Shalabi M Abzug J Lang D Jacobs RF Storchm G Bradley JS Wade KC Ramilo 0 Romero JR Shelton M Leach C Guzman-Cottrill J Robinson J Abughali N Englund J Griffin J Jester P Cloud GA Whitley RJ NIAID Collaborative Antiviral Study Group Safety ofoseltamivir compared with the adamantanes in children less than 12 months ofage Pediatric Infectious Disease Journal 29(3) 195 Mar 2010

18 Lorch SA Wade KC Bakewell-Sachs S Medoff-Cooper 8 Silber JH Escobar GJ Antibiotic use in premature infants after discharge from the neonatal intensive care unit Clinical Pediatrics 49(3) 249 Apr 2010

19 Wade KC Ellenberg JH Grosser T Brensinger CM Kimmel SE Hennessy S Exogenous estrogen does not attenuate the association between rofecoxib and myocardial infarction in perimenopausal women Journal Cardiovascular Pharmacology 57(2) 194 Feb 2011

20 Piper L Smith PB Hornik CP Cheifetz IM Barrett JS Moorthy G Hope WW Wade KC Cohen-Wolkowiez M Benjamin OK Fluconazole loading dose pharmacokinetics and safety in infants Pediatric Infectious Disease Journal 30(5) 375 May 2011

21 Smith PB Cohen-Wolkowiez M Castro LM Poindexter B Bidegain M Weitkamp JH Schelonka RL Ward RM Wade K Valencia G Burchfield D Arrieta A Bhatt-Mehta V Walsh M Kantak A Rasmussen M Sullivan J E Finer N Brozanski BS Sanchez P van den Anker J Blumer J Keams GL Capparelli EV Anand R Benjamin OK Population pharmacokinetics of meropenem in plasma and cerebrospinal fluid ofinfants with suspected or complicated intra-abdominal infections Pediatric Infectious Disease Journal 30( 1 0) 844 Oct 2011

Kelly C Wade MD PhD MSCE Page 11

22 Mossabeb R Wade KC Finnegan K Sivieri E Abbasi S Language development survey provides a useful screening tool for language delay in preterm infants Clinical Pediatrics 51(7) 638 July 2012

23 Watt KM Benjamin OK Jr Cheifetz IM Moorthy G Wade KC Smith PB Brouwer KL Capparelli EV Cohen-Wolkowietz M Pharmacokinetics and safety of fluconazole in young infants supported with extracorporeal membrane oxygenation Pediatric Infectious Disease Journal 31(10) 1042-7 Oct 2012

24 Watt Kevin M Benjamin Daniel K Cheifetz Ira M Moorthy Ganesh Wade Kelly C Smith P Brian Brouwer Kim L R Capparelli Edmund V Cohen-Wolkowiez Michael Pharmacokinetics and safety of fluconazole in young infants supported with extracorporeal membrane oxygenation The Pediatric infectious disease journal 31 ( 1 0) 1042-7 Oct 2012

25 Cohen-Wolkowiez Michael Poindexter Brenda Bidegain Margarita Weitkamp Joern-Hendrik Schelonka Robert L Randolph David A Ward Robert M Wade Kelly Valencia Gloria Burchfield David Arrieta Antonio Mehta Varsha Walsh Michele Kantak Anand Rasmussen Maynard Sullivan Janice E Finer Neil Rich Wade Brozanski Beverly S van den Anker John Blumer Jeffrey Laughon Matthew Watt Kevin M Keams Gregory L Capparelli Edmund V Martz Karen Berezny Katherine Benjamin Daniel K Smith P Brian Safety and effectiveness of meropenem in infants with suspected or complicated intra-abdominal infections Clinical infectious diseases an official publication ofthe Infectious Diseases Society of America 55(11) 1495-502 Dec 2012

26 Reiss Errol Lasker Brent A Lott Timothy J Bendel Catherine M Kaufman David A Hazen Kevin C Wade Kelly C McGowan Karin L Lockhart Shawn R Genotyping of Candida parapsilosis from three neonatal intensive care units (NICUs) using a panel of five multilocus microsatellite markers broad genetic diversity and a cluster ofrelated strains in one NICU Infection genetics and evolution journal of molecular epidemiology and evolutionary genetics in infectious diseases 12(8) 1654-60 Dec 2012

27 Benjamin Daniel K Hudak Mark L Duara Shahnaz Randolph David A Bidegain Margarita Mundakel Gratias T Natarajan Girija Burchfield David J White Robert D Shattuck Karen E Neu Natalie Bendel Catherine M Kim M Roger Finer Neil N Stewart Dan L Arrieta Antonio C Wade Kelly C Kaufman David A Manzoni Paolo Prather Kristi 0 Testoni Daniela Berezny Katherine Y Smith P Brian Effect of fluconazole prophylaxis on candidiasis and mortality in premature infants a randomized clinical trial JAMA the Journal ofthe American Medical Association 311(17) 1742-9 May 2014

28 Monk Heather M Motsney Adam J Wade Kelly C Safety ofRotavirus Vaccine in the NICU Pediatrics 133(6) el555-60 May 2014

Kelly C Wade MD PhD MSCE Page 12

29 e-ROP Cooperative Group Telemedicine approaches to evaluating acute-phase retinopathy ofprematurity study design Ophthalmic epidemiology 21 ( 4 ) 256shy67 Aug 2014

30 Quinn Graham E Ying Gui-shuang Daniel Ebenezer Hildebrand P Lloyd Ells Anna Baumritter Agnieshka Kemper Alex R Schron Eleanor B Wade Kelly Validity of a telemedicine system for the evaluation of acute-phase retinopathy of prematurity JAMA ophthalmology 132(10) 1178-84 Oct 2014

31 Kemper Alex R Wade Kelly C Hornik Christoph P Ying Gui-Shuang Baumritter Agnieshka Quinn Graham E Retinopathy of Prematurity Risk Prediction for Infants with Birth Weight Less than 1251 Grams The Journal ofpediatrics 166(2) 257-6le2 Nov 2014

32 Ying Gui-Shuang Quinn Graham E Wade Kelly C Repka Michael X Baumritter Agnieshka Daniel Ebenezer Predictors for the Development ofReferralshyWarranted Retinopathy of Prematurity in the Telemedicine Approaches to Evaluating Acute-Phase Retinopathy ofPrematurity (e-ROP) Study JAMA ophthalmology 133(3) 304-11 Dec 2014

33 Watt Kevin M Gonzalez Daniel Benjamin Daniel K Brouwer Kim L R Wade Kelly C Capparelli Edmund Barrett Jeffrey Cohen-Wolkowiez Michael Fluconazole population pharmacokinetics and dosing for prevention and treatment of invasive Candidiasis in children supported with extracorporeal membrane oxygenation Antimicrobial agents and chemotherapy 59(7) 3935-43 Jul2015

34 Wade Kelly C Pistilli Maxwell Baumritter Agnieshka Karp Karen Gong Alice Kemper Alex R Ying Gui-Shuang Quinn Graham Safety ofRetinopathy of Prematurity Examination and Imaging in Premature Infants The Journal of pediatrics 167(5) 994-1000e2 Nov 2015

35 Kemper Alex R Prosser Lisa A Wade Kelly C Repka Michael X Ying Gui-Shuang Baumritter Agnieshka Quinn Graham E A Comparison of Strategies for Retinopathy ofPrematurity Detection Pediatrics 137(1) 1-10 Jan 2016

36 Frommelt Peter Juern Anna Siegel Dawn Holland Kristen Seefeldt Marcia Yu JiaDe Uhing Michael Wade Kelly Drolet Beth Adverse Events in Young and Preterm Infants Receiving Topical Timolol for Infantile Hemangioma Pediatric dermatology 33(4) 405-14 Jul2016

37 Quinn Graham E Barr Charles Bremer Don Fellows Rae Gong Alice Hoffman Robert Repka Michael X Shepard Jennifer Siatkowski R Michael Wade Kelly Ying Gui-Shuang Changes in Course of Retinopathy of Prematurity from 1986 to 2013 Comparison ofThree Studies in the United States Ophthalmology 123(7) 1595-600 Jul2016

Kelly C Wade MD PhD MSCE Page 13

38 Momper Jeremiah D Capparelli Edmund V Wade Kelly C Kantak Anand Dhanireddy Ramasubbareddy Cummings James J Nedrelow Jonathan H Hudak Mark L Mundakel Gratias T Natarajan Girija Gao Jamie Laughon Matt Smith P Brian Benjamin Daniel K Population Pharmacokinetics of Fluconazole in Premature Infants with Birth Weights Less than 750 Grams Antimicrobial agents and chemotherapy 60(9) 5539-45 Sep 2016

39 Quinn Graham E Ying Gui-Shuang Repka Michael X Siatkowski R Michael Hoffman Robert Mills Monte D Morrison David Daniel Ebenezer Baumritter Agnieshka Hildebrand P Lloyd Schron Eleanor B Ells AnnaL Wade Kelly Kemper Alex R Timely implementation ofa retinopathy of prematurity telemedicine system Journal ofAAPOS the official publication of the American Association for Pediatric Ophthalmology and Strabismus 20(5) 425-430e I Oct 2016

Research Publications peer-reviewed reviews 1 Laughon MM Benjamin DK Capparelli EV Keams GL Berezny K Paul IM

Wade K Barrett J Smith PB Cohen-Wolkowiez M Innovative clinical trial design for pediatric therapeutics Expert Review of Clinical Pharmacology 4(5) 643-52 Sep 2011

2 Wade Kelly C Monk Heather M New antifungal and antiviral dosing Clinics in perinatology 42(1) 177-94 x Mar 2015

3 England Amanda Wade Kelly Smith P Brian Berezny Katherine Laughon Matthew Optimizing operational efficiencies in early phase trials The Pediatric Trials Network experience Contemporary clinical trials 47 376-82 Mar 2016

Research Publications non-peer reviewed 1 Cant K Genetic and biochemical characterization of Drosophila singed a homolog of

the actin bundling protein fascin Yale University New Haven CT May 1996 Notes PhD Thesis

Abstracts (Last 3 years) 1 Kelly C Wade Maxwell Pistilli Karen Karp Gui-shuang Ying Agnieshka Baumritter

Alice Gong Alex Kemper Graham Quinn and on behalfof e-ROP cooperative group Safety ofROP screening in extremely premature infants Abstract presented at PAS Annual Meeting San Diego CA 2015

2 Kelly Wade Maxwell Pistilli Karen Karp Gui-shuang Ying Agnieshka Baumritter Alice Gong Alex Kemper Graham Quinn and on behalf of the e-ROP collaborative group Adverse Events Between 32-44 weeks PMA in an Observational ROP Study Abstract presented at PAS annual meeting San Diego CA 2015

Kelly C Wade MD PhD MSCE Page 14

3 Kelly C Wade Gui-shuang Ying Agnieshka Baumritter Alex R Kemper Graham E Quinn and on behalf of the eROP investigators Identifying which low birth weight premature infants are at LOW risk for developing ROP Abstract presented at PAS Annual Meeting Baltimore MD 2016

Editorials Reviews Chapters including participation in committee reports (print or other media)

1 Wade KC Aplenc R Genetic susceptibility to neonatal disease Neo Review Illinois American Academy of Pediatrics July 2004

2 Wade KC Benjamin Jr DK Clinical Pharmacology of Anti-Infective Drugs Infectious Diseases ofthe Fetus and Newborn Infant 7th Edition Remington amp Klein Wilson Nizet Maldonado (eds) Saunders Page 1160-1211 2010 Notes Chapter

3 Quinn Graham E Need for Telemedicine in Retinopathy of Prematurity in MiddleshyIncome Countries-Reply JAMA ophthalmology Dec 2014

4 Wade KC and Benjamin OK Jr Clinical Pharmacology ofAnti-Infective Drugs Infectious Diseases ofthe Fetus and Newborn Infant 8th Edition Remington Klein Wilson Nizet Maldonado (eds) Elsevier 2014 Notes Book Chapter

5 Wade KC Pharmacokinetics Fanaroff and Martins Neonatal-Perinatal Medicine 1Oth Edition Martin RJ Fanaroff AA and Walsh MC (eds) Elsevier 2014 Notes Book Chapter

Books [none]

Alternative Media [none]

Patents [none]

Page 5: Kelly C. Wade, M.D., Ph.D., M.S.C.E. - U S Food and Drug ... · PDF file2001-2004 Fellowship in Neonatal-Perinatal Medicine, ... Publication Review Committee 2014- present: ... "Update

Kelly C Wade MD PhD MSCE Page 5

2008-2013

2008-Present

2008-Present 2010

201 0-Present 2010

2011

2012-Present

2012

2012

2012

2013 2013

2013

2014-Present

2014

20 14-Present

2014-Present

2015-Present

2015-Present

Faculty Doctoring I II III University ofPennsylvania School of Medicine Course Director Pediatrics 305D Well Newborn Perelman School of Medicine Pennsylvania Hospital Faculty Perinatal and Neonatal Case Review Noon Conference Lecturer Pharmacokinetics Tools to Use at the Bedside Fellowship Physiology Conference Childrens Hospital of Philadelphia Chair Neonatology Academic Conference Pennsylvania Hospital Lecturer Update on GBS Screening Guidelines CHOP Newborn Care Academic Conference Lecturer Hot Topics from the Pediatric Academic Society Annual Meeting CHOP Newborn Care Academic Conference Faculty Neonatal Fellow Simulation Education Communication Workshops 2-4 times per year Lecturer Transitions in Care- NICU to Pediatric Office CHOP Newborn Care Academic Conference OB GYN Grand Rounds Morbidity and Mortality Conference Neonatal HSV Lecturer Hot Topics from the Pediatric Academic Society Annual Meeting CHOP Newborn Care Academic Conference Faculty CHOP Neonatal Fellow Simulation Boot Camp Lecturer Hot Topics from the Pediatric Academic Society Annual Meeting CHOP Newborn Care Academic Conference Lecturer CHOP Network NAS Algorithm amp Inter-rater Reliability Program CHOP Newborn Care Academic Conference Lecturer UPENN Nursing School NURS776 High Risk Neonate Theory 2 lectures per year Guiding Drug Principles to Improve Infectious Disease Outcomes and Treatment ofViral and Fungal Infections in the NICU Lecturer CHOP Newborn Care at Chester County Antibiotic Dosing in the NICU Faculty Lecturer CHOP Physician Assistant Residency Program in Neonatology 3 Lectures per year Basic Pharmacokinetics to improve drug dosing Treatment ofviral and fungal infections Exchange Transfusion for RH isoimmunization Resident Choice Course Director CHOP Pediatric Residency Independent Elective Unit in Neonatology Lecturer Delivery Room Care and Neonatal Resuscitation Review CHOP Resident Pennsylvania Hospital NICU elective Orientation lecture and simulation 5-7 times per year Instructor Neonatal Resuscitation Program UPENN Newborn Care at Pennsylvania Hospital

Kelly C Wade MD PhD MSCE Page 6

2017-Present Lecturer Clinical Toxicology- medication in Pregnancy and lactation 90 minutes lecture at CHOP Neonatal Fellow Physiology Conference

2017 Maternal Toxoplasmosis Infection in Pregnancy One lecture given as part ofNeonatology Morbidity and Mortality Conference

Lectures by Invitation (Last 5 years) Jan 2012 Pharmacokinetics NEOPREP Conference American Academy of

Pediatrics New Orleans LA May 2012 Improving Outcomes by Using the Right Drug Right Dose amp

Right Timing Topic Symposium Antimicrobials and Antivirals in the NICU Pediatric Academic Society Meeting Boston MA

May 2012 An Introduction to Pharmacokinetic and Pharmacodynamic of Antimicrobial Therapy Topic Symposium Antimicrobials and Antivirals in the NICU Pediatric Academic Society Meeting Boston MA

Jun2012 Pharmacologic Considerations during Therapeutic Hypothermia Contemporary Forums Neonatal Pharmacology Conference Washington DC

Oct 2012 Pharmacokinetics basic concepts to Use at the Bedside Contemporary Forums The Fetus and Newborn Conference San Francisco CA

Oct 2012 The Use of Antiviral and Antifungal Medication Contemporary Forums The Fetus and Newborn Conference San Francisco CA

Oct 2012 Pharmacologic Considerations During Therapeutic Hypothermia Contemporary Forums The Fetus and Newborn Conference San Francisco CA

Apr 2013 Evidenced Based Care of the Late Preterm Infant Center City Pediatrics Philadelphia P A

Jun 2013 Pharmacologic Considerations During Therapeutic Hypothermia Contemporary Forums Neonatal Pharmacology Conference San Diego CA

Jun 2013 Improved Treatments for Viral and Fungal Infections in Neonates Contemporary Forums Neonatal Pharmacology Conference San Diego CA

Nov 2013 Improved Dosing Guidance for Antibiotics and Antifungals Contemporary Forums The Fetus amp Newborn Conference Washington DC

Nov 2013 11 Using PharmacokineticsPharmacodynamics Knowledge to Individualize Dosing Contemporary Forums The Fetus amp Newborn Conference Washington DC

Jan2014 General Principles of Pharmacology Academy of Pediatrics NeoPrep Conference San Diego CA

Feb2014 Clinical Pharmacology ofFluconazole Columbian Association of Neonatology Annual Conference on Nutrition and Pharmacology Bogata Columbia

Kelly C Wade MD PhD MSCE Page 7

Feb2014

Feb2014

May2014

Nov 2014

Nov 2014

Mar 2015

May 2015

Oct 2015

Oct 2015

Jan2016 Feb2016

Apr 2016

Apr 2016

May 2016

Sep2016

Sep2016

Apr 2017

Clinical Pharmacology ofVancomycin Columbian Association of Neonatology Annual Conference on Nutrition and Pharmacology Bogata Columbia Basic Pharmacokinetics to Improve Dosing Columbian Association ofNeonatology Annual Conference on Nutrition and Pharmacology Bogata Columbia Improving outcomes from neonatal infections using PKPD principles Neonatal Pharmacology Conference Contemporary Forums Boston MA Current dosing for serious infections The Fetus and the Newborn Conference Contemporary Forums Las Vegas NV Choosing the right dose using PKPD principles The Fetus and the Newborn Conference Contemporary Forums Las Vegas NV Safety during ROP evaluations A Neonatologists Perspective Workshop Telemedicine for the detection of serious acute phase ROP time for a paradigm shift American Academy of Pediatric Ophthalmology Annual Meeting New Orleans LA Whats New in Neonatal Pharmacology Neonatal Pharmacology Conference Contemporary Forums Scottsdale AZ New Guidelines for Antiviral and Antifungal Therapies The Fetus and the Newborn Conference Contemporary Forums San Diego CA Whats New for Antibiotics in the NICU The Fetus and the Newborn Conference Contemporary Forums San Diego CA Pharmacokinetics AAP NeoPrep Conference Atlanta GA Reducing Medication Errors in the NICU The NEO Conference MedNax Pediatric Group Orlando FL Whats New for Antimicrobial Therapy in the NICU Neonatal Pharmacology Meeting Contemporary Forums Las Vegas NV Reducing Medication Errors in the NICU Neonatal Pharmacology Conference Contemporary Forums Las Vegas NV New Guidelines for Antiviral and Antifungal Therapies 13th Annual CHOP Neonatal Nursing Symposium Philadelphia PA Strategies to reduce medication errors in the NICU Contemporary Forums Fetus and Newborn Conferences New Orleans LA PK knowledge to improve drug dosing in the NICU Contemporary Forums Fetus and Newborn Conferences New Orleans LA Whats new in neonatal pharmacology Neonatal Pharmacology Conference Contemporary Forums San Diego CA

Organizing Roles in Scientific Meetings Jun 2011 Co-Chair 11th Annual Neonatal Pharmacology Conference

Contemporary Forums San Fransisco CA

Kelly C Wade MD PhD MSCE Page 8

May 2012 Co-Chair Topic Symposium Antimicrobials and Antivirals in the NICU Getting the Dose RIGHT Every Time Pedaitric Academic Society Meeting Boston MA

Jun2012 Co-Chair 12th Annual Neonatal Pharmacology Conference Contemporary Forums Washington DC

Jun 2013 Chair 13th Annual Neonatal Pharmacology Conference Contemporary Forums San Diego California

Jan2014 Planning Committee Member NEOPREP conference American Academy of Pediatrics Elk Grove Village IL

May2014 Co-Chair 14th Annual Neonatal Pharmacology Conference Contemporary Forums Boston MA

May 2015 Co-chair 15th Annual Neonatal Pharmacology Conference Contemporary Forums Scottsdale AZ

Jan2016 Co-Chair NEOPREP Conference American Academy ofPediatrics Atlanta GA

Apr 2016 Chair 16th Annual Neonatal Pharmacology Conference Contemporary Forums Las Vegas NV

Apr 2017 Chair 17th Annual Neonatal Pharmacology Conference Contemporary Forums San Diego CA

Jan2018 Chair NeoPREP American Academy ofPediatrics Atlanta GA

Bibliography Research Publications peer reviewed (print or other media)

1 Cant K Knowles B Mooseker M Cooley L Drosophila singed a fascin homolog is required for actin bundle formation during oogenesis and bristle extension Journal Cell Biology 125 369 Apr 1994

2 Robinson D Cant K Cooley L Morphogenesis of a Drosophila ring canal Development 120 2015 Jul1994

3 Cant K Cooley L Single amino acid mutations in Drosophila fascin disrupt actin bundle formation in vivo Genetics 143 249 Jan 1996

4 Cant K Knowles B Mahajan-Miklos S Heintzelman M Cooley L Drosophila fascin mutants are rescued by overepression ofvillin like protein quail Journal Cell Science 111 213-221 Jan 1998

Kelly C Wade MD PhD MSCE Page 9

5 Alexander SW Wade KC Hibberd PL Parsons SK Evaluation ofrisk prediction criteria for episodes of febrile neutropenia in children with cancer Journal ofPediatric HematologyOncology 24(1) 38-42 Jan 2002

6 Gonzales LW Guttentag SH Wade KC Postle AD Ballard PL Differentiation ofhuman pulmonary type II cells in vitro by glucocorticoid plus cAMP American Journal ofPhysiology- Lung Cellular amp Molecular Physiology 283(5) L940-51 Nov 2002

7 Daugherty BL Mateescu M Patel AS Wade K Kimura S Gonzales LW Guttentag S Ballard PL Koval M Developmental regulation of claudin localization by fetal alveolar epithelial cells American Journal of PhysiologyshyLung Cellular amp Molecular Physiology 287(6) L1266-73 Dec 2004

8 Wade KC Guttentag SH Gonzales LW Maschhoff KL Gonzales J Kolla V Singhal S Ballard PL Gene induction during differentiation of human pulmonary type II cells in vitro American Journal ofRespiratory Cell amp Molecular Biology 34(6) 727-37 Jun 2006

9 Cohen-Wolkowiez M Benjamin DK Jr Fowler VG Jr Wade KC Alexander BD Worley G Goldstein RF Smith PB Mortality and neurodevelopmental outcome after Staphylococcus aureus bacteremia in infants Pediatric Infectious Disease Journal 26(12) 1159-61 Dec 2007

10 Lorch SA Wade KC Bakewell-Sachs S Medoff-Cooper B Escobar GJ Silber JH Racial differences in the use ofrespiratory medications in premature infants after discharge from the neonatal intensive care unit Journal of Pediatrics 151(6) 604-10 610e1 Dec 2007

11 Cohen-Wolkowiez M Smith PB Benjamin DK Jr Fowler VG Jr Wade KC Daptomycin use in infants report of two cases with peak and trough drug concentrations Journal ofPerinatology 28(3) 233-4 Mar 2008

12 Wade KC Lorch SA Bakewell-Sachs S Medoff-Cooper B Silber JH Escobar GJ Pediatric care for preterm infants after NICU discharge high number of office visits and prescription medications Journal of Perinatology 28(10) 696-701 Oct 2008

13 Wade KC Wu D Kaufinan DA Ward RM Benjamin OK Jr Sullivan JE Ramey N Jayaraman B Hoppu K Adamson PC Gastonguay MR Barrett JS National Institute of Child Health and Development Pediatric Pharmacology Research Unit Network Population pharmacokinetics of fluconazole in young infants Antimicrobial Agents amp Chemotherapy 52(11) 4043-9 Nov 2008

Kelly C Wade MD PhD MSCE Page 10

14 Bruno CJ Smith LP Zur KB Wade KC Congenital subglottic cyst in a term neonate Archives ofDisease in Childhood Fetal amp Neonatal Edition 94(4) F240 Jul 2009

15 Wade KC Benjamin DK Jr Kaufman DA Ward RM Smith PB Jayaraman B Adamson PC Gastonguay MR Barrett JS Fluconazole dosing for the prevention or treatment ofinvasive candidiasis in young infants Pediatric Infectious Disease Journal28(8) 717-23 Aug 2009

16 Wu D Wade KC Paul DJ Barrett JS A rapid and sensitive LC-MSMS method for determination of fluconazole in human plasma and its application in infants with Candida infections Therapeutic Drug Monitoring 31 (6) 703-9 Dec 2009

17 Kimberlin DW Shalabi M Abzug J Lang D Jacobs RF Storchm G Bradley JS Wade KC Ramilo 0 Romero JR Shelton M Leach C Guzman-Cottrill J Robinson J Abughali N Englund J Griffin J Jester P Cloud GA Whitley RJ NIAID Collaborative Antiviral Study Group Safety ofoseltamivir compared with the adamantanes in children less than 12 months ofage Pediatric Infectious Disease Journal 29(3) 195 Mar 2010

18 Lorch SA Wade KC Bakewell-Sachs S Medoff-Cooper 8 Silber JH Escobar GJ Antibiotic use in premature infants after discharge from the neonatal intensive care unit Clinical Pediatrics 49(3) 249 Apr 2010

19 Wade KC Ellenberg JH Grosser T Brensinger CM Kimmel SE Hennessy S Exogenous estrogen does not attenuate the association between rofecoxib and myocardial infarction in perimenopausal women Journal Cardiovascular Pharmacology 57(2) 194 Feb 2011

20 Piper L Smith PB Hornik CP Cheifetz IM Barrett JS Moorthy G Hope WW Wade KC Cohen-Wolkowiez M Benjamin OK Fluconazole loading dose pharmacokinetics and safety in infants Pediatric Infectious Disease Journal 30(5) 375 May 2011

21 Smith PB Cohen-Wolkowiez M Castro LM Poindexter B Bidegain M Weitkamp JH Schelonka RL Ward RM Wade K Valencia G Burchfield D Arrieta A Bhatt-Mehta V Walsh M Kantak A Rasmussen M Sullivan J E Finer N Brozanski BS Sanchez P van den Anker J Blumer J Keams GL Capparelli EV Anand R Benjamin OK Population pharmacokinetics of meropenem in plasma and cerebrospinal fluid ofinfants with suspected or complicated intra-abdominal infections Pediatric Infectious Disease Journal 30( 1 0) 844 Oct 2011

Kelly C Wade MD PhD MSCE Page 11

22 Mossabeb R Wade KC Finnegan K Sivieri E Abbasi S Language development survey provides a useful screening tool for language delay in preterm infants Clinical Pediatrics 51(7) 638 July 2012

23 Watt KM Benjamin OK Jr Cheifetz IM Moorthy G Wade KC Smith PB Brouwer KL Capparelli EV Cohen-Wolkowietz M Pharmacokinetics and safety of fluconazole in young infants supported with extracorporeal membrane oxygenation Pediatric Infectious Disease Journal 31(10) 1042-7 Oct 2012

24 Watt Kevin M Benjamin Daniel K Cheifetz Ira M Moorthy Ganesh Wade Kelly C Smith P Brian Brouwer Kim L R Capparelli Edmund V Cohen-Wolkowiez Michael Pharmacokinetics and safety of fluconazole in young infants supported with extracorporeal membrane oxygenation The Pediatric infectious disease journal 31 ( 1 0) 1042-7 Oct 2012

25 Cohen-Wolkowiez Michael Poindexter Brenda Bidegain Margarita Weitkamp Joern-Hendrik Schelonka Robert L Randolph David A Ward Robert M Wade Kelly Valencia Gloria Burchfield David Arrieta Antonio Mehta Varsha Walsh Michele Kantak Anand Rasmussen Maynard Sullivan Janice E Finer Neil Rich Wade Brozanski Beverly S van den Anker John Blumer Jeffrey Laughon Matthew Watt Kevin M Keams Gregory L Capparelli Edmund V Martz Karen Berezny Katherine Benjamin Daniel K Smith P Brian Safety and effectiveness of meropenem in infants with suspected or complicated intra-abdominal infections Clinical infectious diseases an official publication ofthe Infectious Diseases Society of America 55(11) 1495-502 Dec 2012

26 Reiss Errol Lasker Brent A Lott Timothy J Bendel Catherine M Kaufman David A Hazen Kevin C Wade Kelly C McGowan Karin L Lockhart Shawn R Genotyping of Candida parapsilosis from three neonatal intensive care units (NICUs) using a panel of five multilocus microsatellite markers broad genetic diversity and a cluster ofrelated strains in one NICU Infection genetics and evolution journal of molecular epidemiology and evolutionary genetics in infectious diseases 12(8) 1654-60 Dec 2012

27 Benjamin Daniel K Hudak Mark L Duara Shahnaz Randolph David A Bidegain Margarita Mundakel Gratias T Natarajan Girija Burchfield David J White Robert D Shattuck Karen E Neu Natalie Bendel Catherine M Kim M Roger Finer Neil N Stewart Dan L Arrieta Antonio C Wade Kelly C Kaufman David A Manzoni Paolo Prather Kristi 0 Testoni Daniela Berezny Katherine Y Smith P Brian Effect of fluconazole prophylaxis on candidiasis and mortality in premature infants a randomized clinical trial JAMA the Journal ofthe American Medical Association 311(17) 1742-9 May 2014

28 Monk Heather M Motsney Adam J Wade Kelly C Safety ofRotavirus Vaccine in the NICU Pediatrics 133(6) el555-60 May 2014

Kelly C Wade MD PhD MSCE Page 12

29 e-ROP Cooperative Group Telemedicine approaches to evaluating acute-phase retinopathy ofprematurity study design Ophthalmic epidemiology 21 ( 4 ) 256shy67 Aug 2014

30 Quinn Graham E Ying Gui-shuang Daniel Ebenezer Hildebrand P Lloyd Ells Anna Baumritter Agnieshka Kemper Alex R Schron Eleanor B Wade Kelly Validity of a telemedicine system for the evaluation of acute-phase retinopathy of prematurity JAMA ophthalmology 132(10) 1178-84 Oct 2014

31 Kemper Alex R Wade Kelly C Hornik Christoph P Ying Gui-Shuang Baumritter Agnieshka Quinn Graham E Retinopathy of Prematurity Risk Prediction for Infants with Birth Weight Less than 1251 Grams The Journal ofpediatrics 166(2) 257-6le2 Nov 2014

32 Ying Gui-Shuang Quinn Graham E Wade Kelly C Repka Michael X Baumritter Agnieshka Daniel Ebenezer Predictors for the Development ofReferralshyWarranted Retinopathy of Prematurity in the Telemedicine Approaches to Evaluating Acute-Phase Retinopathy ofPrematurity (e-ROP) Study JAMA ophthalmology 133(3) 304-11 Dec 2014

33 Watt Kevin M Gonzalez Daniel Benjamin Daniel K Brouwer Kim L R Wade Kelly C Capparelli Edmund Barrett Jeffrey Cohen-Wolkowiez Michael Fluconazole population pharmacokinetics and dosing for prevention and treatment of invasive Candidiasis in children supported with extracorporeal membrane oxygenation Antimicrobial agents and chemotherapy 59(7) 3935-43 Jul2015

34 Wade Kelly C Pistilli Maxwell Baumritter Agnieshka Karp Karen Gong Alice Kemper Alex R Ying Gui-Shuang Quinn Graham Safety ofRetinopathy of Prematurity Examination and Imaging in Premature Infants The Journal of pediatrics 167(5) 994-1000e2 Nov 2015

35 Kemper Alex R Prosser Lisa A Wade Kelly C Repka Michael X Ying Gui-Shuang Baumritter Agnieshka Quinn Graham E A Comparison of Strategies for Retinopathy ofPrematurity Detection Pediatrics 137(1) 1-10 Jan 2016

36 Frommelt Peter Juern Anna Siegel Dawn Holland Kristen Seefeldt Marcia Yu JiaDe Uhing Michael Wade Kelly Drolet Beth Adverse Events in Young and Preterm Infants Receiving Topical Timolol for Infantile Hemangioma Pediatric dermatology 33(4) 405-14 Jul2016

37 Quinn Graham E Barr Charles Bremer Don Fellows Rae Gong Alice Hoffman Robert Repka Michael X Shepard Jennifer Siatkowski R Michael Wade Kelly Ying Gui-Shuang Changes in Course of Retinopathy of Prematurity from 1986 to 2013 Comparison ofThree Studies in the United States Ophthalmology 123(7) 1595-600 Jul2016

Kelly C Wade MD PhD MSCE Page 13

38 Momper Jeremiah D Capparelli Edmund V Wade Kelly C Kantak Anand Dhanireddy Ramasubbareddy Cummings James J Nedrelow Jonathan H Hudak Mark L Mundakel Gratias T Natarajan Girija Gao Jamie Laughon Matt Smith P Brian Benjamin Daniel K Population Pharmacokinetics of Fluconazole in Premature Infants with Birth Weights Less than 750 Grams Antimicrobial agents and chemotherapy 60(9) 5539-45 Sep 2016

39 Quinn Graham E Ying Gui-Shuang Repka Michael X Siatkowski R Michael Hoffman Robert Mills Monte D Morrison David Daniel Ebenezer Baumritter Agnieshka Hildebrand P Lloyd Schron Eleanor B Ells AnnaL Wade Kelly Kemper Alex R Timely implementation ofa retinopathy of prematurity telemedicine system Journal ofAAPOS the official publication of the American Association for Pediatric Ophthalmology and Strabismus 20(5) 425-430e I Oct 2016

Research Publications peer-reviewed reviews 1 Laughon MM Benjamin DK Capparelli EV Keams GL Berezny K Paul IM

Wade K Barrett J Smith PB Cohen-Wolkowiez M Innovative clinical trial design for pediatric therapeutics Expert Review of Clinical Pharmacology 4(5) 643-52 Sep 2011

2 Wade Kelly C Monk Heather M New antifungal and antiviral dosing Clinics in perinatology 42(1) 177-94 x Mar 2015

3 England Amanda Wade Kelly Smith P Brian Berezny Katherine Laughon Matthew Optimizing operational efficiencies in early phase trials The Pediatric Trials Network experience Contemporary clinical trials 47 376-82 Mar 2016

Research Publications non-peer reviewed 1 Cant K Genetic and biochemical characterization of Drosophila singed a homolog of

the actin bundling protein fascin Yale University New Haven CT May 1996 Notes PhD Thesis

Abstracts (Last 3 years) 1 Kelly C Wade Maxwell Pistilli Karen Karp Gui-shuang Ying Agnieshka Baumritter

Alice Gong Alex Kemper Graham Quinn and on behalfof e-ROP cooperative group Safety ofROP screening in extremely premature infants Abstract presented at PAS Annual Meeting San Diego CA 2015

2 Kelly Wade Maxwell Pistilli Karen Karp Gui-shuang Ying Agnieshka Baumritter Alice Gong Alex Kemper Graham Quinn and on behalf of the e-ROP collaborative group Adverse Events Between 32-44 weeks PMA in an Observational ROP Study Abstract presented at PAS annual meeting San Diego CA 2015

Kelly C Wade MD PhD MSCE Page 14

3 Kelly C Wade Gui-shuang Ying Agnieshka Baumritter Alex R Kemper Graham E Quinn and on behalf of the eROP investigators Identifying which low birth weight premature infants are at LOW risk for developing ROP Abstract presented at PAS Annual Meeting Baltimore MD 2016

Editorials Reviews Chapters including participation in committee reports (print or other media)

1 Wade KC Aplenc R Genetic susceptibility to neonatal disease Neo Review Illinois American Academy of Pediatrics July 2004

2 Wade KC Benjamin Jr DK Clinical Pharmacology of Anti-Infective Drugs Infectious Diseases ofthe Fetus and Newborn Infant 7th Edition Remington amp Klein Wilson Nizet Maldonado (eds) Saunders Page 1160-1211 2010 Notes Chapter

3 Quinn Graham E Need for Telemedicine in Retinopathy of Prematurity in MiddleshyIncome Countries-Reply JAMA ophthalmology Dec 2014

4 Wade KC and Benjamin OK Jr Clinical Pharmacology ofAnti-Infective Drugs Infectious Diseases ofthe Fetus and Newborn Infant 8th Edition Remington Klein Wilson Nizet Maldonado (eds) Elsevier 2014 Notes Book Chapter

5 Wade KC Pharmacokinetics Fanaroff and Martins Neonatal-Perinatal Medicine 1Oth Edition Martin RJ Fanaroff AA and Walsh MC (eds) Elsevier 2014 Notes Book Chapter

Books [none]

Alternative Media [none]

Patents [none]

Page 6: Kelly C. Wade, M.D., Ph.D., M.S.C.E. - U S Food and Drug ... · PDF file2001-2004 Fellowship in Neonatal-Perinatal Medicine, ... Publication Review Committee 2014- present: ... "Update

Kelly C Wade MD PhD MSCE Page 6

2017-Present Lecturer Clinical Toxicology- medication in Pregnancy and lactation 90 minutes lecture at CHOP Neonatal Fellow Physiology Conference

2017 Maternal Toxoplasmosis Infection in Pregnancy One lecture given as part ofNeonatology Morbidity and Mortality Conference

Lectures by Invitation (Last 5 years) Jan 2012 Pharmacokinetics NEOPREP Conference American Academy of

Pediatrics New Orleans LA May 2012 Improving Outcomes by Using the Right Drug Right Dose amp

Right Timing Topic Symposium Antimicrobials and Antivirals in the NICU Pediatric Academic Society Meeting Boston MA

May 2012 An Introduction to Pharmacokinetic and Pharmacodynamic of Antimicrobial Therapy Topic Symposium Antimicrobials and Antivirals in the NICU Pediatric Academic Society Meeting Boston MA

Jun2012 Pharmacologic Considerations during Therapeutic Hypothermia Contemporary Forums Neonatal Pharmacology Conference Washington DC

Oct 2012 Pharmacokinetics basic concepts to Use at the Bedside Contemporary Forums The Fetus and Newborn Conference San Francisco CA

Oct 2012 The Use of Antiviral and Antifungal Medication Contemporary Forums The Fetus and Newborn Conference San Francisco CA

Oct 2012 Pharmacologic Considerations During Therapeutic Hypothermia Contemporary Forums The Fetus and Newborn Conference San Francisco CA

Apr 2013 Evidenced Based Care of the Late Preterm Infant Center City Pediatrics Philadelphia P A

Jun 2013 Pharmacologic Considerations During Therapeutic Hypothermia Contemporary Forums Neonatal Pharmacology Conference San Diego CA

Jun 2013 Improved Treatments for Viral and Fungal Infections in Neonates Contemporary Forums Neonatal Pharmacology Conference San Diego CA

Nov 2013 Improved Dosing Guidance for Antibiotics and Antifungals Contemporary Forums The Fetus amp Newborn Conference Washington DC

Nov 2013 11 Using PharmacokineticsPharmacodynamics Knowledge to Individualize Dosing Contemporary Forums The Fetus amp Newborn Conference Washington DC

Jan2014 General Principles of Pharmacology Academy of Pediatrics NeoPrep Conference San Diego CA

Feb2014 Clinical Pharmacology ofFluconazole Columbian Association of Neonatology Annual Conference on Nutrition and Pharmacology Bogata Columbia

Kelly C Wade MD PhD MSCE Page 7

Feb2014

Feb2014

May2014

Nov 2014

Nov 2014

Mar 2015

May 2015

Oct 2015

Oct 2015

Jan2016 Feb2016

Apr 2016

Apr 2016

May 2016

Sep2016

Sep2016

Apr 2017

Clinical Pharmacology ofVancomycin Columbian Association of Neonatology Annual Conference on Nutrition and Pharmacology Bogata Columbia Basic Pharmacokinetics to Improve Dosing Columbian Association ofNeonatology Annual Conference on Nutrition and Pharmacology Bogata Columbia Improving outcomes from neonatal infections using PKPD principles Neonatal Pharmacology Conference Contemporary Forums Boston MA Current dosing for serious infections The Fetus and the Newborn Conference Contemporary Forums Las Vegas NV Choosing the right dose using PKPD principles The Fetus and the Newborn Conference Contemporary Forums Las Vegas NV Safety during ROP evaluations A Neonatologists Perspective Workshop Telemedicine for the detection of serious acute phase ROP time for a paradigm shift American Academy of Pediatric Ophthalmology Annual Meeting New Orleans LA Whats New in Neonatal Pharmacology Neonatal Pharmacology Conference Contemporary Forums Scottsdale AZ New Guidelines for Antiviral and Antifungal Therapies The Fetus and the Newborn Conference Contemporary Forums San Diego CA Whats New for Antibiotics in the NICU The Fetus and the Newborn Conference Contemporary Forums San Diego CA Pharmacokinetics AAP NeoPrep Conference Atlanta GA Reducing Medication Errors in the NICU The NEO Conference MedNax Pediatric Group Orlando FL Whats New for Antimicrobial Therapy in the NICU Neonatal Pharmacology Meeting Contemporary Forums Las Vegas NV Reducing Medication Errors in the NICU Neonatal Pharmacology Conference Contemporary Forums Las Vegas NV New Guidelines for Antiviral and Antifungal Therapies 13th Annual CHOP Neonatal Nursing Symposium Philadelphia PA Strategies to reduce medication errors in the NICU Contemporary Forums Fetus and Newborn Conferences New Orleans LA PK knowledge to improve drug dosing in the NICU Contemporary Forums Fetus and Newborn Conferences New Orleans LA Whats new in neonatal pharmacology Neonatal Pharmacology Conference Contemporary Forums San Diego CA

Organizing Roles in Scientific Meetings Jun 2011 Co-Chair 11th Annual Neonatal Pharmacology Conference

Contemporary Forums San Fransisco CA

Kelly C Wade MD PhD MSCE Page 8

May 2012 Co-Chair Topic Symposium Antimicrobials and Antivirals in the NICU Getting the Dose RIGHT Every Time Pedaitric Academic Society Meeting Boston MA

Jun2012 Co-Chair 12th Annual Neonatal Pharmacology Conference Contemporary Forums Washington DC

Jun 2013 Chair 13th Annual Neonatal Pharmacology Conference Contemporary Forums San Diego California

Jan2014 Planning Committee Member NEOPREP conference American Academy of Pediatrics Elk Grove Village IL

May2014 Co-Chair 14th Annual Neonatal Pharmacology Conference Contemporary Forums Boston MA

May 2015 Co-chair 15th Annual Neonatal Pharmacology Conference Contemporary Forums Scottsdale AZ

Jan2016 Co-Chair NEOPREP Conference American Academy ofPediatrics Atlanta GA

Apr 2016 Chair 16th Annual Neonatal Pharmacology Conference Contemporary Forums Las Vegas NV

Apr 2017 Chair 17th Annual Neonatal Pharmacology Conference Contemporary Forums San Diego CA

Jan2018 Chair NeoPREP American Academy ofPediatrics Atlanta GA

Bibliography Research Publications peer reviewed (print or other media)

1 Cant K Knowles B Mooseker M Cooley L Drosophila singed a fascin homolog is required for actin bundle formation during oogenesis and bristle extension Journal Cell Biology 125 369 Apr 1994

2 Robinson D Cant K Cooley L Morphogenesis of a Drosophila ring canal Development 120 2015 Jul1994

3 Cant K Cooley L Single amino acid mutations in Drosophila fascin disrupt actin bundle formation in vivo Genetics 143 249 Jan 1996

4 Cant K Knowles B Mahajan-Miklos S Heintzelman M Cooley L Drosophila fascin mutants are rescued by overepression ofvillin like protein quail Journal Cell Science 111 213-221 Jan 1998

Kelly C Wade MD PhD MSCE Page 9

5 Alexander SW Wade KC Hibberd PL Parsons SK Evaluation ofrisk prediction criteria for episodes of febrile neutropenia in children with cancer Journal ofPediatric HematologyOncology 24(1) 38-42 Jan 2002

6 Gonzales LW Guttentag SH Wade KC Postle AD Ballard PL Differentiation ofhuman pulmonary type II cells in vitro by glucocorticoid plus cAMP American Journal ofPhysiology- Lung Cellular amp Molecular Physiology 283(5) L940-51 Nov 2002

7 Daugherty BL Mateescu M Patel AS Wade K Kimura S Gonzales LW Guttentag S Ballard PL Koval M Developmental regulation of claudin localization by fetal alveolar epithelial cells American Journal of PhysiologyshyLung Cellular amp Molecular Physiology 287(6) L1266-73 Dec 2004

8 Wade KC Guttentag SH Gonzales LW Maschhoff KL Gonzales J Kolla V Singhal S Ballard PL Gene induction during differentiation of human pulmonary type II cells in vitro American Journal ofRespiratory Cell amp Molecular Biology 34(6) 727-37 Jun 2006

9 Cohen-Wolkowiez M Benjamin DK Jr Fowler VG Jr Wade KC Alexander BD Worley G Goldstein RF Smith PB Mortality and neurodevelopmental outcome after Staphylococcus aureus bacteremia in infants Pediatric Infectious Disease Journal 26(12) 1159-61 Dec 2007

10 Lorch SA Wade KC Bakewell-Sachs S Medoff-Cooper B Escobar GJ Silber JH Racial differences in the use ofrespiratory medications in premature infants after discharge from the neonatal intensive care unit Journal of Pediatrics 151(6) 604-10 610e1 Dec 2007

11 Cohen-Wolkowiez M Smith PB Benjamin DK Jr Fowler VG Jr Wade KC Daptomycin use in infants report of two cases with peak and trough drug concentrations Journal ofPerinatology 28(3) 233-4 Mar 2008

12 Wade KC Lorch SA Bakewell-Sachs S Medoff-Cooper B Silber JH Escobar GJ Pediatric care for preterm infants after NICU discharge high number of office visits and prescription medications Journal of Perinatology 28(10) 696-701 Oct 2008

13 Wade KC Wu D Kaufinan DA Ward RM Benjamin OK Jr Sullivan JE Ramey N Jayaraman B Hoppu K Adamson PC Gastonguay MR Barrett JS National Institute of Child Health and Development Pediatric Pharmacology Research Unit Network Population pharmacokinetics of fluconazole in young infants Antimicrobial Agents amp Chemotherapy 52(11) 4043-9 Nov 2008

Kelly C Wade MD PhD MSCE Page 10

14 Bruno CJ Smith LP Zur KB Wade KC Congenital subglottic cyst in a term neonate Archives ofDisease in Childhood Fetal amp Neonatal Edition 94(4) F240 Jul 2009

15 Wade KC Benjamin DK Jr Kaufman DA Ward RM Smith PB Jayaraman B Adamson PC Gastonguay MR Barrett JS Fluconazole dosing for the prevention or treatment ofinvasive candidiasis in young infants Pediatric Infectious Disease Journal28(8) 717-23 Aug 2009

16 Wu D Wade KC Paul DJ Barrett JS A rapid and sensitive LC-MSMS method for determination of fluconazole in human plasma and its application in infants with Candida infections Therapeutic Drug Monitoring 31 (6) 703-9 Dec 2009

17 Kimberlin DW Shalabi M Abzug J Lang D Jacobs RF Storchm G Bradley JS Wade KC Ramilo 0 Romero JR Shelton M Leach C Guzman-Cottrill J Robinson J Abughali N Englund J Griffin J Jester P Cloud GA Whitley RJ NIAID Collaborative Antiviral Study Group Safety ofoseltamivir compared with the adamantanes in children less than 12 months ofage Pediatric Infectious Disease Journal 29(3) 195 Mar 2010

18 Lorch SA Wade KC Bakewell-Sachs S Medoff-Cooper 8 Silber JH Escobar GJ Antibiotic use in premature infants after discharge from the neonatal intensive care unit Clinical Pediatrics 49(3) 249 Apr 2010

19 Wade KC Ellenberg JH Grosser T Brensinger CM Kimmel SE Hennessy S Exogenous estrogen does not attenuate the association between rofecoxib and myocardial infarction in perimenopausal women Journal Cardiovascular Pharmacology 57(2) 194 Feb 2011

20 Piper L Smith PB Hornik CP Cheifetz IM Barrett JS Moorthy G Hope WW Wade KC Cohen-Wolkowiez M Benjamin OK Fluconazole loading dose pharmacokinetics and safety in infants Pediatric Infectious Disease Journal 30(5) 375 May 2011

21 Smith PB Cohen-Wolkowiez M Castro LM Poindexter B Bidegain M Weitkamp JH Schelonka RL Ward RM Wade K Valencia G Burchfield D Arrieta A Bhatt-Mehta V Walsh M Kantak A Rasmussen M Sullivan J E Finer N Brozanski BS Sanchez P van den Anker J Blumer J Keams GL Capparelli EV Anand R Benjamin OK Population pharmacokinetics of meropenem in plasma and cerebrospinal fluid ofinfants with suspected or complicated intra-abdominal infections Pediatric Infectious Disease Journal 30( 1 0) 844 Oct 2011

Kelly C Wade MD PhD MSCE Page 11

22 Mossabeb R Wade KC Finnegan K Sivieri E Abbasi S Language development survey provides a useful screening tool for language delay in preterm infants Clinical Pediatrics 51(7) 638 July 2012

23 Watt KM Benjamin OK Jr Cheifetz IM Moorthy G Wade KC Smith PB Brouwer KL Capparelli EV Cohen-Wolkowietz M Pharmacokinetics and safety of fluconazole in young infants supported with extracorporeal membrane oxygenation Pediatric Infectious Disease Journal 31(10) 1042-7 Oct 2012

24 Watt Kevin M Benjamin Daniel K Cheifetz Ira M Moorthy Ganesh Wade Kelly C Smith P Brian Brouwer Kim L R Capparelli Edmund V Cohen-Wolkowiez Michael Pharmacokinetics and safety of fluconazole in young infants supported with extracorporeal membrane oxygenation The Pediatric infectious disease journal 31 ( 1 0) 1042-7 Oct 2012

25 Cohen-Wolkowiez Michael Poindexter Brenda Bidegain Margarita Weitkamp Joern-Hendrik Schelonka Robert L Randolph David A Ward Robert M Wade Kelly Valencia Gloria Burchfield David Arrieta Antonio Mehta Varsha Walsh Michele Kantak Anand Rasmussen Maynard Sullivan Janice E Finer Neil Rich Wade Brozanski Beverly S van den Anker John Blumer Jeffrey Laughon Matthew Watt Kevin M Keams Gregory L Capparelli Edmund V Martz Karen Berezny Katherine Benjamin Daniel K Smith P Brian Safety and effectiveness of meropenem in infants with suspected or complicated intra-abdominal infections Clinical infectious diseases an official publication ofthe Infectious Diseases Society of America 55(11) 1495-502 Dec 2012

26 Reiss Errol Lasker Brent A Lott Timothy J Bendel Catherine M Kaufman David A Hazen Kevin C Wade Kelly C McGowan Karin L Lockhart Shawn R Genotyping of Candida parapsilosis from three neonatal intensive care units (NICUs) using a panel of five multilocus microsatellite markers broad genetic diversity and a cluster ofrelated strains in one NICU Infection genetics and evolution journal of molecular epidemiology and evolutionary genetics in infectious diseases 12(8) 1654-60 Dec 2012

27 Benjamin Daniel K Hudak Mark L Duara Shahnaz Randolph David A Bidegain Margarita Mundakel Gratias T Natarajan Girija Burchfield David J White Robert D Shattuck Karen E Neu Natalie Bendel Catherine M Kim M Roger Finer Neil N Stewart Dan L Arrieta Antonio C Wade Kelly C Kaufman David A Manzoni Paolo Prather Kristi 0 Testoni Daniela Berezny Katherine Y Smith P Brian Effect of fluconazole prophylaxis on candidiasis and mortality in premature infants a randomized clinical trial JAMA the Journal ofthe American Medical Association 311(17) 1742-9 May 2014

28 Monk Heather M Motsney Adam J Wade Kelly C Safety ofRotavirus Vaccine in the NICU Pediatrics 133(6) el555-60 May 2014

Kelly C Wade MD PhD MSCE Page 12

29 e-ROP Cooperative Group Telemedicine approaches to evaluating acute-phase retinopathy ofprematurity study design Ophthalmic epidemiology 21 ( 4 ) 256shy67 Aug 2014

30 Quinn Graham E Ying Gui-shuang Daniel Ebenezer Hildebrand P Lloyd Ells Anna Baumritter Agnieshka Kemper Alex R Schron Eleanor B Wade Kelly Validity of a telemedicine system for the evaluation of acute-phase retinopathy of prematurity JAMA ophthalmology 132(10) 1178-84 Oct 2014

31 Kemper Alex R Wade Kelly C Hornik Christoph P Ying Gui-Shuang Baumritter Agnieshka Quinn Graham E Retinopathy of Prematurity Risk Prediction for Infants with Birth Weight Less than 1251 Grams The Journal ofpediatrics 166(2) 257-6le2 Nov 2014

32 Ying Gui-Shuang Quinn Graham E Wade Kelly C Repka Michael X Baumritter Agnieshka Daniel Ebenezer Predictors for the Development ofReferralshyWarranted Retinopathy of Prematurity in the Telemedicine Approaches to Evaluating Acute-Phase Retinopathy ofPrematurity (e-ROP) Study JAMA ophthalmology 133(3) 304-11 Dec 2014

33 Watt Kevin M Gonzalez Daniel Benjamin Daniel K Brouwer Kim L R Wade Kelly C Capparelli Edmund Barrett Jeffrey Cohen-Wolkowiez Michael Fluconazole population pharmacokinetics and dosing for prevention and treatment of invasive Candidiasis in children supported with extracorporeal membrane oxygenation Antimicrobial agents and chemotherapy 59(7) 3935-43 Jul2015

34 Wade Kelly C Pistilli Maxwell Baumritter Agnieshka Karp Karen Gong Alice Kemper Alex R Ying Gui-Shuang Quinn Graham Safety ofRetinopathy of Prematurity Examination and Imaging in Premature Infants The Journal of pediatrics 167(5) 994-1000e2 Nov 2015

35 Kemper Alex R Prosser Lisa A Wade Kelly C Repka Michael X Ying Gui-Shuang Baumritter Agnieshka Quinn Graham E A Comparison of Strategies for Retinopathy ofPrematurity Detection Pediatrics 137(1) 1-10 Jan 2016

36 Frommelt Peter Juern Anna Siegel Dawn Holland Kristen Seefeldt Marcia Yu JiaDe Uhing Michael Wade Kelly Drolet Beth Adverse Events in Young and Preterm Infants Receiving Topical Timolol for Infantile Hemangioma Pediatric dermatology 33(4) 405-14 Jul2016

37 Quinn Graham E Barr Charles Bremer Don Fellows Rae Gong Alice Hoffman Robert Repka Michael X Shepard Jennifer Siatkowski R Michael Wade Kelly Ying Gui-Shuang Changes in Course of Retinopathy of Prematurity from 1986 to 2013 Comparison ofThree Studies in the United States Ophthalmology 123(7) 1595-600 Jul2016

Kelly C Wade MD PhD MSCE Page 13

38 Momper Jeremiah D Capparelli Edmund V Wade Kelly C Kantak Anand Dhanireddy Ramasubbareddy Cummings James J Nedrelow Jonathan H Hudak Mark L Mundakel Gratias T Natarajan Girija Gao Jamie Laughon Matt Smith P Brian Benjamin Daniel K Population Pharmacokinetics of Fluconazole in Premature Infants with Birth Weights Less than 750 Grams Antimicrobial agents and chemotherapy 60(9) 5539-45 Sep 2016

39 Quinn Graham E Ying Gui-Shuang Repka Michael X Siatkowski R Michael Hoffman Robert Mills Monte D Morrison David Daniel Ebenezer Baumritter Agnieshka Hildebrand P Lloyd Schron Eleanor B Ells AnnaL Wade Kelly Kemper Alex R Timely implementation ofa retinopathy of prematurity telemedicine system Journal ofAAPOS the official publication of the American Association for Pediatric Ophthalmology and Strabismus 20(5) 425-430e I Oct 2016

Research Publications peer-reviewed reviews 1 Laughon MM Benjamin DK Capparelli EV Keams GL Berezny K Paul IM

Wade K Barrett J Smith PB Cohen-Wolkowiez M Innovative clinical trial design for pediatric therapeutics Expert Review of Clinical Pharmacology 4(5) 643-52 Sep 2011

2 Wade Kelly C Monk Heather M New antifungal and antiviral dosing Clinics in perinatology 42(1) 177-94 x Mar 2015

3 England Amanda Wade Kelly Smith P Brian Berezny Katherine Laughon Matthew Optimizing operational efficiencies in early phase trials The Pediatric Trials Network experience Contemporary clinical trials 47 376-82 Mar 2016

Research Publications non-peer reviewed 1 Cant K Genetic and biochemical characterization of Drosophila singed a homolog of

the actin bundling protein fascin Yale University New Haven CT May 1996 Notes PhD Thesis

Abstracts (Last 3 years) 1 Kelly C Wade Maxwell Pistilli Karen Karp Gui-shuang Ying Agnieshka Baumritter

Alice Gong Alex Kemper Graham Quinn and on behalfof e-ROP cooperative group Safety ofROP screening in extremely premature infants Abstract presented at PAS Annual Meeting San Diego CA 2015

2 Kelly Wade Maxwell Pistilli Karen Karp Gui-shuang Ying Agnieshka Baumritter Alice Gong Alex Kemper Graham Quinn and on behalf of the e-ROP collaborative group Adverse Events Between 32-44 weeks PMA in an Observational ROP Study Abstract presented at PAS annual meeting San Diego CA 2015

Kelly C Wade MD PhD MSCE Page 14

3 Kelly C Wade Gui-shuang Ying Agnieshka Baumritter Alex R Kemper Graham E Quinn and on behalf of the eROP investigators Identifying which low birth weight premature infants are at LOW risk for developing ROP Abstract presented at PAS Annual Meeting Baltimore MD 2016

Editorials Reviews Chapters including participation in committee reports (print or other media)

1 Wade KC Aplenc R Genetic susceptibility to neonatal disease Neo Review Illinois American Academy of Pediatrics July 2004

2 Wade KC Benjamin Jr DK Clinical Pharmacology of Anti-Infective Drugs Infectious Diseases ofthe Fetus and Newborn Infant 7th Edition Remington amp Klein Wilson Nizet Maldonado (eds) Saunders Page 1160-1211 2010 Notes Chapter

3 Quinn Graham E Need for Telemedicine in Retinopathy of Prematurity in MiddleshyIncome Countries-Reply JAMA ophthalmology Dec 2014

4 Wade KC and Benjamin OK Jr Clinical Pharmacology ofAnti-Infective Drugs Infectious Diseases ofthe Fetus and Newborn Infant 8th Edition Remington Klein Wilson Nizet Maldonado (eds) Elsevier 2014 Notes Book Chapter

5 Wade KC Pharmacokinetics Fanaroff and Martins Neonatal-Perinatal Medicine 1Oth Edition Martin RJ Fanaroff AA and Walsh MC (eds) Elsevier 2014 Notes Book Chapter

Books [none]

Alternative Media [none]

Patents [none]

Page 7: Kelly C. Wade, M.D., Ph.D., M.S.C.E. - U S Food and Drug ... · PDF file2001-2004 Fellowship in Neonatal-Perinatal Medicine, ... Publication Review Committee 2014- present: ... "Update

Kelly C Wade MD PhD MSCE Page 7

Feb2014

Feb2014

May2014

Nov 2014

Nov 2014

Mar 2015

May 2015

Oct 2015

Oct 2015

Jan2016 Feb2016

Apr 2016

Apr 2016

May 2016

Sep2016

Sep2016

Apr 2017

Clinical Pharmacology ofVancomycin Columbian Association of Neonatology Annual Conference on Nutrition and Pharmacology Bogata Columbia Basic Pharmacokinetics to Improve Dosing Columbian Association ofNeonatology Annual Conference on Nutrition and Pharmacology Bogata Columbia Improving outcomes from neonatal infections using PKPD principles Neonatal Pharmacology Conference Contemporary Forums Boston MA Current dosing for serious infections The Fetus and the Newborn Conference Contemporary Forums Las Vegas NV Choosing the right dose using PKPD principles The Fetus and the Newborn Conference Contemporary Forums Las Vegas NV Safety during ROP evaluations A Neonatologists Perspective Workshop Telemedicine for the detection of serious acute phase ROP time for a paradigm shift American Academy of Pediatric Ophthalmology Annual Meeting New Orleans LA Whats New in Neonatal Pharmacology Neonatal Pharmacology Conference Contemporary Forums Scottsdale AZ New Guidelines for Antiviral and Antifungal Therapies The Fetus and the Newborn Conference Contemporary Forums San Diego CA Whats New for Antibiotics in the NICU The Fetus and the Newborn Conference Contemporary Forums San Diego CA Pharmacokinetics AAP NeoPrep Conference Atlanta GA Reducing Medication Errors in the NICU The NEO Conference MedNax Pediatric Group Orlando FL Whats New for Antimicrobial Therapy in the NICU Neonatal Pharmacology Meeting Contemporary Forums Las Vegas NV Reducing Medication Errors in the NICU Neonatal Pharmacology Conference Contemporary Forums Las Vegas NV New Guidelines for Antiviral and Antifungal Therapies 13th Annual CHOP Neonatal Nursing Symposium Philadelphia PA Strategies to reduce medication errors in the NICU Contemporary Forums Fetus and Newborn Conferences New Orleans LA PK knowledge to improve drug dosing in the NICU Contemporary Forums Fetus and Newborn Conferences New Orleans LA Whats new in neonatal pharmacology Neonatal Pharmacology Conference Contemporary Forums San Diego CA

Organizing Roles in Scientific Meetings Jun 2011 Co-Chair 11th Annual Neonatal Pharmacology Conference

Contemporary Forums San Fransisco CA

Kelly C Wade MD PhD MSCE Page 8

May 2012 Co-Chair Topic Symposium Antimicrobials and Antivirals in the NICU Getting the Dose RIGHT Every Time Pedaitric Academic Society Meeting Boston MA

Jun2012 Co-Chair 12th Annual Neonatal Pharmacology Conference Contemporary Forums Washington DC

Jun 2013 Chair 13th Annual Neonatal Pharmacology Conference Contemporary Forums San Diego California

Jan2014 Planning Committee Member NEOPREP conference American Academy of Pediatrics Elk Grove Village IL

May2014 Co-Chair 14th Annual Neonatal Pharmacology Conference Contemporary Forums Boston MA

May 2015 Co-chair 15th Annual Neonatal Pharmacology Conference Contemporary Forums Scottsdale AZ

Jan2016 Co-Chair NEOPREP Conference American Academy ofPediatrics Atlanta GA

Apr 2016 Chair 16th Annual Neonatal Pharmacology Conference Contemporary Forums Las Vegas NV

Apr 2017 Chair 17th Annual Neonatal Pharmacology Conference Contemporary Forums San Diego CA

Jan2018 Chair NeoPREP American Academy ofPediatrics Atlanta GA

Bibliography Research Publications peer reviewed (print or other media)

1 Cant K Knowles B Mooseker M Cooley L Drosophila singed a fascin homolog is required for actin bundle formation during oogenesis and bristle extension Journal Cell Biology 125 369 Apr 1994

2 Robinson D Cant K Cooley L Morphogenesis of a Drosophila ring canal Development 120 2015 Jul1994

3 Cant K Cooley L Single amino acid mutations in Drosophila fascin disrupt actin bundle formation in vivo Genetics 143 249 Jan 1996

4 Cant K Knowles B Mahajan-Miklos S Heintzelman M Cooley L Drosophila fascin mutants are rescued by overepression ofvillin like protein quail Journal Cell Science 111 213-221 Jan 1998

Kelly C Wade MD PhD MSCE Page 9

5 Alexander SW Wade KC Hibberd PL Parsons SK Evaluation ofrisk prediction criteria for episodes of febrile neutropenia in children with cancer Journal ofPediatric HematologyOncology 24(1) 38-42 Jan 2002

6 Gonzales LW Guttentag SH Wade KC Postle AD Ballard PL Differentiation ofhuman pulmonary type II cells in vitro by glucocorticoid plus cAMP American Journal ofPhysiology- Lung Cellular amp Molecular Physiology 283(5) L940-51 Nov 2002

7 Daugherty BL Mateescu M Patel AS Wade K Kimura S Gonzales LW Guttentag S Ballard PL Koval M Developmental regulation of claudin localization by fetal alveolar epithelial cells American Journal of PhysiologyshyLung Cellular amp Molecular Physiology 287(6) L1266-73 Dec 2004

8 Wade KC Guttentag SH Gonzales LW Maschhoff KL Gonzales J Kolla V Singhal S Ballard PL Gene induction during differentiation of human pulmonary type II cells in vitro American Journal ofRespiratory Cell amp Molecular Biology 34(6) 727-37 Jun 2006

9 Cohen-Wolkowiez M Benjamin DK Jr Fowler VG Jr Wade KC Alexander BD Worley G Goldstein RF Smith PB Mortality and neurodevelopmental outcome after Staphylococcus aureus bacteremia in infants Pediatric Infectious Disease Journal 26(12) 1159-61 Dec 2007

10 Lorch SA Wade KC Bakewell-Sachs S Medoff-Cooper B Escobar GJ Silber JH Racial differences in the use ofrespiratory medications in premature infants after discharge from the neonatal intensive care unit Journal of Pediatrics 151(6) 604-10 610e1 Dec 2007

11 Cohen-Wolkowiez M Smith PB Benjamin DK Jr Fowler VG Jr Wade KC Daptomycin use in infants report of two cases with peak and trough drug concentrations Journal ofPerinatology 28(3) 233-4 Mar 2008

12 Wade KC Lorch SA Bakewell-Sachs S Medoff-Cooper B Silber JH Escobar GJ Pediatric care for preterm infants after NICU discharge high number of office visits and prescription medications Journal of Perinatology 28(10) 696-701 Oct 2008

13 Wade KC Wu D Kaufinan DA Ward RM Benjamin OK Jr Sullivan JE Ramey N Jayaraman B Hoppu K Adamson PC Gastonguay MR Barrett JS National Institute of Child Health and Development Pediatric Pharmacology Research Unit Network Population pharmacokinetics of fluconazole in young infants Antimicrobial Agents amp Chemotherapy 52(11) 4043-9 Nov 2008

Kelly C Wade MD PhD MSCE Page 10

14 Bruno CJ Smith LP Zur KB Wade KC Congenital subglottic cyst in a term neonate Archives ofDisease in Childhood Fetal amp Neonatal Edition 94(4) F240 Jul 2009

15 Wade KC Benjamin DK Jr Kaufman DA Ward RM Smith PB Jayaraman B Adamson PC Gastonguay MR Barrett JS Fluconazole dosing for the prevention or treatment ofinvasive candidiasis in young infants Pediatric Infectious Disease Journal28(8) 717-23 Aug 2009

16 Wu D Wade KC Paul DJ Barrett JS A rapid and sensitive LC-MSMS method for determination of fluconazole in human plasma and its application in infants with Candida infections Therapeutic Drug Monitoring 31 (6) 703-9 Dec 2009

17 Kimberlin DW Shalabi M Abzug J Lang D Jacobs RF Storchm G Bradley JS Wade KC Ramilo 0 Romero JR Shelton M Leach C Guzman-Cottrill J Robinson J Abughali N Englund J Griffin J Jester P Cloud GA Whitley RJ NIAID Collaborative Antiviral Study Group Safety ofoseltamivir compared with the adamantanes in children less than 12 months ofage Pediatric Infectious Disease Journal 29(3) 195 Mar 2010

18 Lorch SA Wade KC Bakewell-Sachs S Medoff-Cooper 8 Silber JH Escobar GJ Antibiotic use in premature infants after discharge from the neonatal intensive care unit Clinical Pediatrics 49(3) 249 Apr 2010

19 Wade KC Ellenberg JH Grosser T Brensinger CM Kimmel SE Hennessy S Exogenous estrogen does not attenuate the association between rofecoxib and myocardial infarction in perimenopausal women Journal Cardiovascular Pharmacology 57(2) 194 Feb 2011

20 Piper L Smith PB Hornik CP Cheifetz IM Barrett JS Moorthy G Hope WW Wade KC Cohen-Wolkowiez M Benjamin OK Fluconazole loading dose pharmacokinetics and safety in infants Pediatric Infectious Disease Journal 30(5) 375 May 2011

21 Smith PB Cohen-Wolkowiez M Castro LM Poindexter B Bidegain M Weitkamp JH Schelonka RL Ward RM Wade K Valencia G Burchfield D Arrieta A Bhatt-Mehta V Walsh M Kantak A Rasmussen M Sullivan J E Finer N Brozanski BS Sanchez P van den Anker J Blumer J Keams GL Capparelli EV Anand R Benjamin OK Population pharmacokinetics of meropenem in plasma and cerebrospinal fluid ofinfants with suspected or complicated intra-abdominal infections Pediatric Infectious Disease Journal 30( 1 0) 844 Oct 2011

Kelly C Wade MD PhD MSCE Page 11

22 Mossabeb R Wade KC Finnegan K Sivieri E Abbasi S Language development survey provides a useful screening tool for language delay in preterm infants Clinical Pediatrics 51(7) 638 July 2012

23 Watt KM Benjamin OK Jr Cheifetz IM Moorthy G Wade KC Smith PB Brouwer KL Capparelli EV Cohen-Wolkowietz M Pharmacokinetics and safety of fluconazole in young infants supported with extracorporeal membrane oxygenation Pediatric Infectious Disease Journal 31(10) 1042-7 Oct 2012

24 Watt Kevin M Benjamin Daniel K Cheifetz Ira M Moorthy Ganesh Wade Kelly C Smith P Brian Brouwer Kim L R Capparelli Edmund V Cohen-Wolkowiez Michael Pharmacokinetics and safety of fluconazole in young infants supported with extracorporeal membrane oxygenation The Pediatric infectious disease journal 31 ( 1 0) 1042-7 Oct 2012

25 Cohen-Wolkowiez Michael Poindexter Brenda Bidegain Margarita Weitkamp Joern-Hendrik Schelonka Robert L Randolph David A Ward Robert M Wade Kelly Valencia Gloria Burchfield David Arrieta Antonio Mehta Varsha Walsh Michele Kantak Anand Rasmussen Maynard Sullivan Janice E Finer Neil Rich Wade Brozanski Beverly S van den Anker John Blumer Jeffrey Laughon Matthew Watt Kevin M Keams Gregory L Capparelli Edmund V Martz Karen Berezny Katherine Benjamin Daniel K Smith P Brian Safety and effectiveness of meropenem in infants with suspected or complicated intra-abdominal infections Clinical infectious diseases an official publication ofthe Infectious Diseases Society of America 55(11) 1495-502 Dec 2012

26 Reiss Errol Lasker Brent A Lott Timothy J Bendel Catherine M Kaufman David A Hazen Kevin C Wade Kelly C McGowan Karin L Lockhart Shawn R Genotyping of Candida parapsilosis from three neonatal intensive care units (NICUs) using a panel of five multilocus microsatellite markers broad genetic diversity and a cluster ofrelated strains in one NICU Infection genetics and evolution journal of molecular epidemiology and evolutionary genetics in infectious diseases 12(8) 1654-60 Dec 2012

27 Benjamin Daniel K Hudak Mark L Duara Shahnaz Randolph David A Bidegain Margarita Mundakel Gratias T Natarajan Girija Burchfield David J White Robert D Shattuck Karen E Neu Natalie Bendel Catherine M Kim M Roger Finer Neil N Stewart Dan L Arrieta Antonio C Wade Kelly C Kaufman David A Manzoni Paolo Prather Kristi 0 Testoni Daniela Berezny Katherine Y Smith P Brian Effect of fluconazole prophylaxis on candidiasis and mortality in premature infants a randomized clinical trial JAMA the Journal ofthe American Medical Association 311(17) 1742-9 May 2014

28 Monk Heather M Motsney Adam J Wade Kelly C Safety ofRotavirus Vaccine in the NICU Pediatrics 133(6) el555-60 May 2014

Kelly C Wade MD PhD MSCE Page 12

29 e-ROP Cooperative Group Telemedicine approaches to evaluating acute-phase retinopathy ofprematurity study design Ophthalmic epidemiology 21 ( 4 ) 256shy67 Aug 2014

30 Quinn Graham E Ying Gui-shuang Daniel Ebenezer Hildebrand P Lloyd Ells Anna Baumritter Agnieshka Kemper Alex R Schron Eleanor B Wade Kelly Validity of a telemedicine system for the evaluation of acute-phase retinopathy of prematurity JAMA ophthalmology 132(10) 1178-84 Oct 2014

31 Kemper Alex R Wade Kelly C Hornik Christoph P Ying Gui-Shuang Baumritter Agnieshka Quinn Graham E Retinopathy of Prematurity Risk Prediction for Infants with Birth Weight Less than 1251 Grams The Journal ofpediatrics 166(2) 257-6le2 Nov 2014

32 Ying Gui-Shuang Quinn Graham E Wade Kelly C Repka Michael X Baumritter Agnieshka Daniel Ebenezer Predictors for the Development ofReferralshyWarranted Retinopathy of Prematurity in the Telemedicine Approaches to Evaluating Acute-Phase Retinopathy ofPrematurity (e-ROP) Study JAMA ophthalmology 133(3) 304-11 Dec 2014

33 Watt Kevin M Gonzalez Daniel Benjamin Daniel K Brouwer Kim L R Wade Kelly C Capparelli Edmund Barrett Jeffrey Cohen-Wolkowiez Michael Fluconazole population pharmacokinetics and dosing for prevention and treatment of invasive Candidiasis in children supported with extracorporeal membrane oxygenation Antimicrobial agents and chemotherapy 59(7) 3935-43 Jul2015

34 Wade Kelly C Pistilli Maxwell Baumritter Agnieshka Karp Karen Gong Alice Kemper Alex R Ying Gui-Shuang Quinn Graham Safety ofRetinopathy of Prematurity Examination and Imaging in Premature Infants The Journal of pediatrics 167(5) 994-1000e2 Nov 2015

35 Kemper Alex R Prosser Lisa A Wade Kelly C Repka Michael X Ying Gui-Shuang Baumritter Agnieshka Quinn Graham E A Comparison of Strategies for Retinopathy ofPrematurity Detection Pediatrics 137(1) 1-10 Jan 2016

36 Frommelt Peter Juern Anna Siegel Dawn Holland Kristen Seefeldt Marcia Yu JiaDe Uhing Michael Wade Kelly Drolet Beth Adverse Events in Young and Preterm Infants Receiving Topical Timolol for Infantile Hemangioma Pediatric dermatology 33(4) 405-14 Jul2016

37 Quinn Graham E Barr Charles Bremer Don Fellows Rae Gong Alice Hoffman Robert Repka Michael X Shepard Jennifer Siatkowski R Michael Wade Kelly Ying Gui-Shuang Changes in Course of Retinopathy of Prematurity from 1986 to 2013 Comparison ofThree Studies in the United States Ophthalmology 123(7) 1595-600 Jul2016

Kelly C Wade MD PhD MSCE Page 13

38 Momper Jeremiah D Capparelli Edmund V Wade Kelly C Kantak Anand Dhanireddy Ramasubbareddy Cummings James J Nedrelow Jonathan H Hudak Mark L Mundakel Gratias T Natarajan Girija Gao Jamie Laughon Matt Smith P Brian Benjamin Daniel K Population Pharmacokinetics of Fluconazole in Premature Infants with Birth Weights Less than 750 Grams Antimicrobial agents and chemotherapy 60(9) 5539-45 Sep 2016

39 Quinn Graham E Ying Gui-Shuang Repka Michael X Siatkowski R Michael Hoffman Robert Mills Monte D Morrison David Daniel Ebenezer Baumritter Agnieshka Hildebrand P Lloyd Schron Eleanor B Ells AnnaL Wade Kelly Kemper Alex R Timely implementation ofa retinopathy of prematurity telemedicine system Journal ofAAPOS the official publication of the American Association for Pediatric Ophthalmology and Strabismus 20(5) 425-430e I Oct 2016

Research Publications peer-reviewed reviews 1 Laughon MM Benjamin DK Capparelli EV Keams GL Berezny K Paul IM

Wade K Barrett J Smith PB Cohen-Wolkowiez M Innovative clinical trial design for pediatric therapeutics Expert Review of Clinical Pharmacology 4(5) 643-52 Sep 2011

2 Wade Kelly C Monk Heather M New antifungal and antiviral dosing Clinics in perinatology 42(1) 177-94 x Mar 2015

3 England Amanda Wade Kelly Smith P Brian Berezny Katherine Laughon Matthew Optimizing operational efficiencies in early phase trials The Pediatric Trials Network experience Contemporary clinical trials 47 376-82 Mar 2016

Research Publications non-peer reviewed 1 Cant K Genetic and biochemical characterization of Drosophila singed a homolog of

the actin bundling protein fascin Yale University New Haven CT May 1996 Notes PhD Thesis

Abstracts (Last 3 years) 1 Kelly C Wade Maxwell Pistilli Karen Karp Gui-shuang Ying Agnieshka Baumritter

Alice Gong Alex Kemper Graham Quinn and on behalfof e-ROP cooperative group Safety ofROP screening in extremely premature infants Abstract presented at PAS Annual Meeting San Diego CA 2015

2 Kelly Wade Maxwell Pistilli Karen Karp Gui-shuang Ying Agnieshka Baumritter Alice Gong Alex Kemper Graham Quinn and on behalf of the e-ROP collaborative group Adverse Events Between 32-44 weeks PMA in an Observational ROP Study Abstract presented at PAS annual meeting San Diego CA 2015

Kelly C Wade MD PhD MSCE Page 14

3 Kelly C Wade Gui-shuang Ying Agnieshka Baumritter Alex R Kemper Graham E Quinn and on behalf of the eROP investigators Identifying which low birth weight premature infants are at LOW risk for developing ROP Abstract presented at PAS Annual Meeting Baltimore MD 2016

Editorials Reviews Chapters including participation in committee reports (print or other media)

1 Wade KC Aplenc R Genetic susceptibility to neonatal disease Neo Review Illinois American Academy of Pediatrics July 2004

2 Wade KC Benjamin Jr DK Clinical Pharmacology of Anti-Infective Drugs Infectious Diseases ofthe Fetus and Newborn Infant 7th Edition Remington amp Klein Wilson Nizet Maldonado (eds) Saunders Page 1160-1211 2010 Notes Chapter

3 Quinn Graham E Need for Telemedicine in Retinopathy of Prematurity in MiddleshyIncome Countries-Reply JAMA ophthalmology Dec 2014

4 Wade KC and Benjamin OK Jr Clinical Pharmacology ofAnti-Infective Drugs Infectious Diseases ofthe Fetus and Newborn Infant 8th Edition Remington Klein Wilson Nizet Maldonado (eds) Elsevier 2014 Notes Book Chapter

5 Wade KC Pharmacokinetics Fanaroff and Martins Neonatal-Perinatal Medicine 1Oth Edition Martin RJ Fanaroff AA and Walsh MC (eds) Elsevier 2014 Notes Book Chapter

Books [none]

Alternative Media [none]

Patents [none]

Page 8: Kelly C. Wade, M.D., Ph.D., M.S.C.E. - U S Food and Drug ... · PDF file2001-2004 Fellowship in Neonatal-Perinatal Medicine, ... Publication Review Committee 2014- present: ... "Update

Kelly C Wade MD PhD MSCE Page 8

May 2012 Co-Chair Topic Symposium Antimicrobials and Antivirals in the NICU Getting the Dose RIGHT Every Time Pedaitric Academic Society Meeting Boston MA

Jun2012 Co-Chair 12th Annual Neonatal Pharmacology Conference Contemporary Forums Washington DC

Jun 2013 Chair 13th Annual Neonatal Pharmacology Conference Contemporary Forums San Diego California

Jan2014 Planning Committee Member NEOPREP conference American Academy of Pediatrics Elk Grove Village IL

May2014 Co-Chair 14th Annual Neonatal Pharmacology Conference Contemporary Forums Boston MA

May 2015 Co-chair 15th Annual Neonatal Pharmacology Conference Contemporary Forums Scottsdale AZ

Jan2016 Co-Chair NEOPREP Conference American Academy ofPediatrics Atlanta GA

Apr 2016 Chair 16th Annual Neonatal Pharmacology Conference Contemporary Forums Las Vegas NV

Apr 2017 Chair 17th Annual Neonatal Pharmacology Conference Contemporary Forums San Diego CA

Jan2018 Chair NeoPREP American Academy ofPediatrics Atlanta GA

Bibliography Research Publications peer reviewed (print or other media)

1 Cant K Knowles B Mooseker M Cooley L Drosophila singed a fascin homolog is required for actin bundle formation during oogenesis and bristle extension Journal Cell Biology 125 369 Apr 1994

2 Robinson D Cant K Cooley L Morphogenesis of a Drosophila ring canal Development 120 2015 Jul1994

3 Cant K Cooley L Single amino acid mutations in Drosophila fascin disrupt actin bundle formation in vivo Genetics 143 249 Jan 1996

4 Cant K Knowles B Mahajan-Miklos S Heintzelman M Cooley L Drosophila fascin mutants are rescued by overepression ofvillin like protein quail Journal Cell Science 111 213-221 Jan 1998

Kelly C Wade MD PhD MSCE Page 9

5 Alexander SW Wade KC Hibberd PL Parsons SK Evaluation ofrisk prediction criteria for episodes of febrile neutropenia in children with cancer Journal ofPediatric HematologyOncology 24(1) 38-42 Jan 2002

6 Gonzales LW Guttentag SH Wade KC Postle AD Ballard PL Differentiation ofhuman pulmonary type II cells in vitro by glucocorticoid plus cAMP American Journal ofPhysiology- Lung Cellular amp Molecular Physiology 283(5) L940-51 Nov 2002

7 Daugherty BL Mateescu M Patel AS Wade K Kimura S Gonzales LW Guttentag S Ballard PL Koval M Developmental regulation of claudin localization by fetal alveolar epithelial cells American Journal of PhysiologyshyLung Cellular amp Molecular Physiology 287(6) L1266-73 Dec 2004

8 Wade KC Guttentag SH Gonzales LW Maschhoff KL Gonzales J Kolla V Singhal S Ballard PL Gene induction during differentiation of human pulmonary type II cells in vitro American Journal ofRespiratory Cell amp Molecular Biology 34(6) 727-37 Jun 2006

9 Cohen-Wolkowiez M Benjamin DK Jr Fowler VG Jr Wade KC Alexander BD Worley G Goldstein RF Smith PB Mortality and neurodevelopmental outcome after Staphylococcus aureus bacteremia in infants Pediatric Infectious Disease Journal 26(12) 1159-61 Dec 2007

10 Lorch SA Wade KC Bakewell-Sachs S Medoff-Cooper B Escobar GJ Silber JH Racial differences in the use ofrespiratory medications in premature infants after discharge from the neonatal intensive care unit Journal of Pediatrics 151(6) 604-10 610e1 Dec 2007

11 Cohen-Wolkowiez M Smith PB Benjamin DK Jr Fowler VG Jr Wade KC Daptomycin use in infants report of two cases with peak and trough drug concentrations Journal ofPerinatology 28(3) 233-4 Mar 2008

12 Wade KC Lorch SA Bakewell-Sachs S Medoff-Cooper B Silber JH Escobar GJ Pediatric care for preterm infants after NICU discharge high number of office visits and prescription medications Journal of Perinatology 28(10) 696-701 Oct 2008

13 Wade KC Wu D Kaufinan DA Ward RM Benjamin OK Jr Sullivan JE Ramey N Jayaraman B Hoppu K Adamson PC Gastonguay MR Barrett JS National Institute of Child Health and Development Pediatric Pharmacology Research Unit Network Population pharmacokinetics of fluconazole in young infants Antimicrobial Agents amp Chemotherapy 52(11) 4043-9 Nov 2008

Kelly C Wade MD PhD MSCE Page 10

14 Bruno CJ Smith LP Zur KB Wade KC Congenital subglottic cyst in a term neonate Archives ofDisease in Childhood Fetal amp Neonatal Edition 94(4) F240 Jul 2009

15 Wade KC Benjamin DK Jr Kaufman DA Ward RM Smith PB Jayaraman B Adamson PC Gastonguay MR Barrett JS Fluconazole dosing for the prevention or treatment ofinvasive candidiasis in young infants Pediatric Infectious Disease Journal28(8) 717-23 Aug 2009

16 Wu D Wade KC Paul DJ Barrett JS A rapid and sensitive LC-MSMS method for determination of fluconazole in human plasma and its application in infants with Candida infections Therapeutic Drug Monitoring 31 (6) 703-9 Dec 2009

17 Kimberlin DW Shalabi M Abzug J Lang D Jacobs RF Storchm G Bradley JS Wade KC Ramilo 0 Romero JR Shelton M Leach C Guzman-Cottrill J Robinson J Abughali N Englund J Griffin J Jester P Cloud GA Whitley RJ NIAID Collaborative Antiviral Study Group Safety ofoseltamivir compared with the adamantanes in children less than 12 months ofage Pediatric Infectious Disease Journal 29(3) 195 Mar 2010

18 Lorch SA Wade KC Bakewell-Sachs S Medoff-Cooper 8 Silber JH Escobar GJ Antibiotic use in premature infants after discharge from the neonatal intensive care unit Clinical Pediatrics 49(3) 249 Apr 2010

19 Wade KC Ellenberg JH Grosser T Brensinger CM Kimmel SE Hennessy S Exogenous estrogen does not attenuate the association between rofecoxib and myocardial infarction in perimenopausal women Journal Cardiovascular Pharmacology 57(2) 194 Feb 2011

20 Piper L Smith PB Hornik CP Cheifetz IM Barrett JS Moorthy G Hope WW Wade KC Cohen-Wolkowiez M Benjamin OK Fluconazole loading dose pharmacokinetics and safety in infants Pediatric Infectious Disease Journal 30(5) 375 May 2011

21 Smith PB Cohen-Wolkowiez M Castro LM Poindexter B Bidegain M Weitkamp JH Schelonka RL Ward RM Wade K Valencia G Burchfield D Arrieta A Bhatt-Mehta V Walsh M Kantak A Rasmussen M Sullivan J E Finer N Brozanski BS Sanchez P van den Anker J Blumer J Keams GL Capparelli EV Anand R Benjamin OK Population pharmacokinetics of meropenem in plasma and cerebrospinal fluid ofinfants with suspected or complicated intra-abdominal infections Pediatric Infectious Disease Journal 30( 1 0) 844 Oct 2011

Kelly C Wade MD PhD MSCE Page 11

22 Mossabeb R Wade KC Finnegan K Sivieri E Abbasi S Language development survey provides a useful screening tool for language delay in preterm infants Clinical Pediatrics 51(7) 638 July 2012

23 Watt KM Benjamin OK Jr Cheifetz IM Moorthy G Wade KC Smith PB Brouwer KL Capparelli EV Cohen-Wolkowietz M Pharmacokinetics and safety of fluconazole in young infants supported with extracorporeal membrane oxygenation Pediatric Infectious Disease Journal 31(10) 1042-7 Oct 2012

24 Watt Kevin M Benjamin Daniel K Cheifetz Ira M Moorthy Ganesh Wade Kelly C Smith P Brian Brouwer Kim L R Capparelli Edmund V Cohen-Wolkowiez Michael Pharmacokinetics and safety of fluconazole in young infants supported with extracorporeal membrane oxygenation The Pediatric infectious disease journal 31 ( 1 0) 1042-7 Oct 2012

25 Cohen-Wolkowiez Michael Poindexter Brenda Bidegain Margarita Weitkamp Joern-Hendrik Schelonka Robert L Randolph David A Ward Robert M Wade Kelly Valencia Gloria Burchfield David Arrieta Antonio Mehta Varsha Walsh Michele Kantak Anand Rasmussen Maynard Sullivan Janice E Finer Neil Rich Wade Brozanski Beverly S van den Anker John Blumer Jeffrey Laughon Matthew Watt Kevin M Keams Gregory L Capparelli Edmund V Martz Karen Berezny Katherine Benjamin Daniel K Smith P Brian Safety and effectiveness of meropenem in infants with suspected or complicated intra-abdominal infections Clinical infectious diseases an official publication ofthe Infectious Diseases Society of America 55(11) 1495-502 Dec 2012

26 Reiss Errol Lasker Brent A Lott Timothy J Bendel Catherine M Kaufman David A Hazen Kevin C Wade Kelly C McGowan Karin L Lockhart Shawn R Genotyping of Candida parapsilosis from three neonatal intensive care units (NICUs) using a panel of five multilocus microsatellite markers broad genetic diversity and a cluster ofrelated strains in one NICU Infection genetics and evolution journal of molecular epidemiology and evolutionary genetics in infectious diseases 12(8) 1654-60 Dec 2012

27 Benjamin Daniel K Hudak Mark L Duara Shahnaz Randolph David A Bidegain Margarita Mundakel Gratias T Natarajan Girija Burchfield David J White Robert D Shattuck Karen E Neu Natalie Bendel Catherine M Kim M Roger Finer Neil N Stewart Dan L Arrieta Antonio C Wade Kelly C Kaufman David A Manzoni Paolo Prather Kristi 0 Testoni Daniela Berezny Katherine Y Smith P Brian Effect of fluconazole prophylaxis on candidiasis and mortality in premature infants a randomized clinical trial JAMA the Journal ofthe American Medical Association 311(17) 1742-9 May 2014

28 Monk Heather M Motsney Adam J Wade Kelly C Safety ofRotavirus Vaccine in the NICU Pediatrics 133(6) el555-60 May 2014

Kelly C Wade MD PhD MSCE Page 12

29 e-ROP Cooperative Group Telemedicine approaches to evaluating acute-phase retinopathy ofprematurity study design Ophthalmic epidemiology 21 ( 4 ) 256shy67 Aug 2014

30 Quinn Graham E Ying Gui-shuang Daniel Ebenezer Hildebrand P Lloyd Ells Anna Baumritter Agnieshka Kemper Alex R Schron Eleanor B Wade Kelly Validity of a telemedicine system for the evaluation of acute-phase retinopathy of prematurity JAMA ophthalmology 132(10) 1178-84 Oct 2014

31 Kemper Alex R Wade Kelly C Hornik Christoph P Ying Gui-Shuang Baumritter Agnieshka Quinn Graham E Retinopathy of Prematurity Risk Prediction for Infants with Birth Weight Less than 1251 Grams The Journal ofpediatrics 166(2) 257-6le2 Nov 2014

32 Ying Gui-Shuang Quinn Graham E Wade Kelly C Repka Michael X Baumritter Agnieshka Daniel Ebenezer Predictors for the Development ofReferralshyWarranted Retinopathy of Prematurity in the Telemedicine Approaches to Evaluating Acute-Phase Retinopathy ofPrematurity (e-ROP) Study JAMA ophthalmology 133(3) 304-11 Dec 2014

33 Watt Kevin M Gonzalez Daniel Benjamin Daniel K Brouwer Kim L R Wade Kelly C Capparelli Edmund Barrett Jeffrey Cohen-Wolkowiez Michael Fluconazole population pharmacokinetics and dosing for prevention and treatment of invasive Candidiasis in children supported with extracorporeal membrane oxygenation Antimicrobial agents and chemotherapy 59(7) 3935-43 Jul2015

34 Wade Kelly C Pistilli Maxwell Baumritter Agnieshka Karp Karen Gong Alice Kemper Alex R Ying Gui-Shuang Quinn Graham Safety ofRetinopathy of Prematurity Examination and Imaging in Premature Infants The Journal of pediatrics 167(5) 994-1000e2 Nov 2015

35 Kemper Alex R Prosser Lisa A Wade Kelly C Repka Michael X Ying Gui-Shuang Baumritter Agnieshka Quinn Graham E A Comparison of Strategies for Retinopathy ofPrematurity Detection Pediatrics 137(1) 1-10 Jan 2016

36 Frommelt Peter Juern Anna Siegel Dawn Holland Kristen Seefeldt Marcia Yu JiaDe Uhing Michael Wade Kelly Drolet Beth Adverse Events in Young and Preterm Infants Receiving Topical Timolol for Infantile Hemangioma Pediatric dermatology 33(4) 405-14 Jul2016

37 Quinn Graham E Barr Charles Bremer Don Fellows Rae Gong Alice Hoffman Robert Repka Michael X Shepard Jennifer Siatkowski R Michael Wade Kelly Ying Gui-Shuang Changes in Course of Retinopathy of Prematurity from 1986 to 2013 Comparison ofThree Studies in the United States Ophthalmology 123(7) 1595-600 Jul2016

Kelly C Wade MD PhD MSCE Page 13

38 Momper Jeremiah D Capparelli Edmund V Wade Kelly C Kantak Anand Dhanireddy Ramasubbareddy Cummings James J Nedrelow Jonathan H Hudak Mark L Mundakel Gratias T Natarajan Girija Gao Jamie Laughon Matt Smith P Brian Benjamin Daniel K Population Pharmacokinetics of Fluconazole in Premature Infants with Birth Weights Less than 750 Grams Antimicrobial agents and chemotherapy 60(9) 5539-45 Sep 2016

39 Quinn Graham E Ying Gui-Shuang Repka Michael X Siatkowski R Michael Hoffman Robert Mills Monte D Morrison David Daniel Ebenezer Baumritter Agnieshka Hildebrand P Lloyd Schron Eleanor B Ells AnnaL Wade Kelly Kemper Alex R Timely implementation ofa retinopathy of prematurity telemedicine system Journal ofAAPOS the official publication of the American Association for Pediatric Ophthalmology and Strabismus 20(5) 425-430e I Oct 2016

Research Publications peer-reviewed reviews 1 Laughon MM Benjamin DK Capparelli EV Keams GL Berezny K Paul IM

Wade K Barrett J Smith PB Cohen-Wolkowiez M Innovative clinical trial design for pediatric therapeutics Expert Review of Clinical Pharmacology 4(5) 643-52 Sep 2011

2 Wade Kelly C Monk Heather M New antifungal and antiviral dosing Clinics in perinatology 42(1) 177-94 x Mar 2015

3 England Amanda Wade Kelly Smith P Brian Berezny Katherine Laughon Matthew Optimizing operational efficiencies in early phase trials The Pediatric Trials Network experience Contemporary clinical trials 47 376-82 Mar 2016

Research Publications non-peer reviewed 1 Cant K Genetic and biochemical characterization of Drosophila singed a homolog of

the actin bundling protein fascin Yale University New Haven CT May 1996 Notes PhD Thesis

Abstracts (Last 3 years) 1 Kelly C Wade Maxwell Pistilli Karen Karp Gui-shuang Ying Agnieshka Baumritter

Alice Gong Alex Kemper Graham Quinn and on behalfof e-ROP cooperative group Safety ofROP screening in extremely premature infants Abstract presented at PAS Annual Meeting San Diego CA 2015

2 Kelly Wade Maxwell Pistilli Karen Karp Gui-shuang Ying Agnieshka Baumritter Alice Gong Alex Kemper Graham Quinn and on behalf of the e-ROP collaborative group Adverse Events Between 32-44 weeks PMA in an Observational ROP Study Abstract presented at PAS annual meeting San Diego CA 2015

Kelly C Wade MD PhD MSCE Page 14

3 Kelly C Wade Gui-shuang Ying Agnieshka Baumritter Alex R Kemper Graham E Quinn and on behalf of the eROP investigators Identifying which low birth weight premature infants are at LOW risk for developing ROP Abstract presented at PAS Annual Meeting Baltimore MD 2016

Editorials Reviews Chapters including participation in committee reports (print or other media)

1 Wade KC Aplenc R Genetic susceptibility to neonatal disease Neo Review Illinois American Academy of Pediatrics July 2004

2 Wade KC Benjamin Jr DK Clinical Pharmacology of Anti-Infective Drugs Infectious Diseases ofthe Fetus and Newborn Infant 7th Edition Remington amp Klein Wilson Nizet Maldonado (eds) Saunders Page 1160-1211 2010 Notes Chapter

3 Quinn Graham E Need for Telemedicine in Retinopathy of Prematurity in MiddleshyIncome Countries-Reply JAMA ophthalmology Dec 2014

4 Wade KC and Benjamin OK Jr Clinical Pharmacology ofAnti-Infective Drugs Infectious Diseases ofthe Fetus and Newborn Infant 8th Edition Remington Klein Wilson Nizet Maldonado (eds) Elsevier 2014 Notes Book Chapter

5 Wade KC Pharmacokinetics Fanaroff and Martins Neonatal-Perinatal Medicine 1Oth Edition Martin RJ Fanaroff AA and Walsh MC (eds) Elsevier 2014 Notes Book Chapter

Books [none]

Alternative Media [none]

Patents [none]

Page 9: Kelly C. Wade, M.D., Ph.D., M.S.C.E. - U S Food and Drug ... · PDF file2001-2004 Fellowship in Neonatal-Perinatal Medicine, ... Publication Review Committee 2014- present: ... "Update

Kelly C Wade MD PhD MSCE Page 9

5 Alexander SW Wade KC Hibberd PL Parsons SK Evaluation ofrisk prediction criteria for episodes of febrile neutropenia in children with cancer Journal ofPediatric HematologyOncology 24(1) 38-42 Jan 2002

6 Gonzales LW Guttentag SH Wade KC Postle AD Ballard PL Differentiation ofhuman pulmonary type II cells in vitro by glucocorticoid plus cAMP American Journal ofPhysiology- Lung Cellular amp Molecular Physiology 283(5) L940-51 Nov 2002

7 Daugherty BL Mateescu M Patel AS Wade K Kimura S Gonzales LW Guttentag S Ballard PL Koval M Developmental regulation of claudin localization by fetal alveolar epithelial cells American Journal of PhysiologyshyLung Cellular amp Molecular Physiology 287(6) L1266-73 Dec 2004

8 Wade KC Guttentag SH Gonzales LW Maschhoff KL Gonzales J Kolla V Singhal S Ballard PL Gene induction during differentiation of human pulmonary type II cells in vitro American Journal ofRespiratory Cell amp Molecular Biology 34(6) 727-37 Jun 2006

9 Cohen-Wolkowiez M Benjamin DK Jr Fowler VG Jr Wade KC Alexander BD Worley G Goldstein RF Smith PB Mortality and neurodevelopmental outcome after Staphylococcus aureus bacteremia in infants Pediatric Infectious Disease Journal 26(12) 1159-61 Dec 2007

10 Lorch SA Wade KC Bakewell-Sachs S Medoff-Cooper B Escobar GJ Silber JH Racial differences in the use ofrespiratory medications in premature infants after discharge from the neonatal intensive care unit Journal of Pediatrics 151(6) 604-10 610e1 Dec 2007

11 Cohen-Wolkowiez M Smith PB Benjamin DK Jr Fowler VG Jr Wade KC Daptomycin use in infants report of two cases with peak and trough drug concentrations Journal ofPerinatology 28(3) 233-4 Mar 2008

12 Wade KC Lorch SA Bakewell-Sachs S Medoff-Cooper B Silber JH Escobar GJ Pediatric care for preterm infants after NICU discharge high number of office visits and prescription medications Journal of Perinatology 28(10) 696-701 Oct 2008

13 Wade KC Wu D Kaufinan DA Ward RM Benjamin OK Jr Sullivan JE Ramey N Jayaraman B Hoppu K Adamson PC Gastonguay MR Barrett JS National Institute of Child Health and Development Pediatric Pharmacology Research Unit Network Population pharmacokinetics of fluconazole in young infants Antimicrobial Agents amp Chemotherapy 52(11) 4043-9 Nov 2008

Kelly C Wade MD PhD MSCE Page 10

14 Bruno CJ Smith LP Zur KB Wade KC Congenital subglottic cyst in a term neonate Archives ofDisease in Childhood Fetal amp Neonatal Edition 94(4) F240 Jul 2009

15 Wade KC Benjamin DK Jr Kaufman DA Ward RM Smith PB Jayaraman B Adamson PC Gastonguay MR Barrett JS Fluconazole dosing for the prevention or treatment ofinvasive candidiasis in young infants Pediatric Infectious Disease Journal28(8) 717-23 Aug 2009

16 Wu D Wade KC Paul DJ Barrett JS A rapid and sensitive LC-MSMS method for determination of fluconazole in human plasma and its application in infants with Candida infections Therapeutic Drug Monitoring 31 (6) 703-9 Dec 2009

17 Kimberlin DW Shalabi M Abzug J Lang D Jacobs RF Storchm G Bradley JS Wade KC Ramilo 0 Romero JR Shelton M Leach C Guzman-Cottrill J Robinson J Abughali N Englund J Griffin J Jester P Cloud GA Whitley RJ NIAID Collaborative Antiviral Study Group Safety ofoseltamivir compared with the adamantanes in children less than 12 months ofage Pediatric Infectious Disease Journal 29(3) 195 Mar 2010

18 Lorch SA Wade KC Bakewell-Sachs S Medoff-Cooper 8 Silber JH Escobar GJ Antibiotic use in premature infants after discharge from the neonatal intensive care unit Clinical Pediatrics 49(3) 249 Apr 2010

19 Wade KC Ellenberg JH Grosser T Brensinger CM Kimmel SE Hennessy S Exogenous estrogen does not attenuate the association between rofecoxib and myocardial infarction in perimenopausal women Journal Cardiovascular Pharmacology 57(2) 194 Feb 2011

20 Piper L Smith PB Hornik CP Cheifetz IM Barrett JS Moorthy G Hope WW Wade KC Cohen-Wolkowiez M Benjamin OK Fluconazole loading dose pharmacokinetics and safety in infants Pediatric Infectious Disease Journal 30(5) 375 May 2011

21 Smith PB Cohen-Wolkowiez M Castro LM Poindexter B Bidegain M Weitkamp JH Schelonka RL Ward RM Wade K Valencia G Burchfield D Arrieta A Bhatt-Mehta V Walsh M Kantak A Rasmussen M Sullivan J E Finer N Brozanski BS Sanchez P van den Anker J Blumer J Keams GL Capparelli EV Anand R Benjamin OK Population pharmacokinetics of meropenem in plasma and cerebrospinal fluid ofinfants with suspected or complicated intra-abdominal infections Pediatric Infectious Disease Journal 30( 1 0) 844 Oct 2011

Kelly C Wade MD PhD MSCE Page 11

22 Mossabeb R Wade KC Finnegan K Sivieri E Abbasi S Language development survey provides a useful screening tool for language delay in preterm infants Clinical Pediatrics 51(7) 638 July 2012

23 Watt KM Benjamin OK Jr Cheifetz IM Moorthy G Wade KC Smith PB Brouwer KL Capparelli EV Cohen-Wolkowietz M Pharmacokinetics and safety of fluconazole in young infants supported with extracorporeal membrane oxygenation Pediatric Infectious Disease Journal 31(10) 1042-7 Oct 2012

24 Watt Kevin M Benjamin Daniel K Cheifetz Ira M Moorthy Ganesh Wade Kelly C Smith P Brian Brouwer Kim L R Capparelli Edmund V Cohen-Wolkowiez Michael Pharmacokinetics and safety of fluconazole in young infants supported with extracorporeal membrane oxygenation The Pediatric infectious disease journal 31 ( 1 0) 1042-7 Oct 2012

25 Cohen-Wolkowiez Michael Poindexter Brenda Bidegain Margarita Weitkamp Joern-Hendrik Schelonka Robert L Randolph David A Ward Robert M Wade Kelly Valencia Gloria Burchfield David Arrieta Antonio Mehta Varsha Walsh Michele Kantak Anand Rasmussen Maynard Sullivan Janice E Finer Neil Rich Wade Brozanski Beverly S van den Anker John Blumer Jeffrey Laughon Matthew Watt Kevin M Keams Gregory L Capparelli Edmund V Martz Karen Berezny Katherine Benjamin Daniel K Smith P Brian Safety and effectiveness of meropenem in infants with suspected or complicated intra-abdominal infections Clinical infectious diseases an official publication ofthe Infectious Diseases Society of America 55(11) 1495-502 Dec 2012

26 Reiss Errol Lasker Brent A Lott Timothy J Bendel Catherine M Kaufman David A Hazen Kevin C Wade Kelly C McGowan Karin L Lockhart Shawn R Genotyping of Candida parapsilosis from three neonatal intensive care units (NICUs) using a panel of five multilocus microsatellite markers broad genetic diversity and a cluster ofrelated strains in one NICU Infection genetics and evolution journal of molecular epidemiology and evolutionary genetics in infectious diseases 12(8) 1654-60 Dec 2012

27 Benjamin Daniel K Hudak Mark L Duara Shahnaz Randolph David A Bidegain Margarita Mundakel Gratias T Natarajan Girija Burchfield David J White Robert D Shattuck Karen E Neu Natalie Bendel Catherine M Kim M Roger Finer Neil N Stewart Dan L Arrieta Antonio C Wade Kelly C Kaufman David A Manzoni Paolo Prather Kristi 0 Testoni Daniela Berezny Katherine Y Smith P Brian Effect of fluconazole prophylaxis on candidiasis and mortality in premature infants a randomized clinical trial JAMA the Journal ofthe American Medical Association 311(17) 1742-9 May 2014

28 Monk Heather M Motsney Adam J Wade Kelly C Safety ofRotavirus Vaccine in the NICU Pediatrics 133(6) el555-60 May 2014

Kelly C Wade MD PhD MSCE Page 12

29 e-ROP Cooperative Group Telemedicine approaches to evaluating acute-phase retinopathy ofprematurity study design Ophthalmic epidemiology 21 ( 4 ) 256shy67 Aug 2014

30 Quinn Graham E Ying Gui-shuang Daniel Ebenezer Hildebrand P Lloyd Ells Anna Baumritter Agnieshka Kemper Alex R Schron Eleanor B Wade Kelly Validity of a telemedicine system for the evaluation of acute-phase retinopathy of prematurity JAMA ophthalmology 132(10) 1178-84 Oct 2014

31 Kemper Alex R Wade Kelly C Hornik Christoph P Ying Gui-Shuang Baumritter Agnieshka Quinn Graham E Retinopathy of Prematurity Risk Prediction for Infants with Birth Weight Less than 1251 Grams The Journal ofpediatrics 166(2) 257-6le2 Nov 2014

32 Ying Gui-Shuang Quinn Graham E Wade Kelly C Repka Michael X Baumritter Agnieshka Daniel Ebenezer Predictors for the Development ofReferralshyWarranted Retinopathy of Prematurity in the Telemedicine Approaches to Evaluating Acute-Phase Retinopathy ofPrematurity (e-ROP) Study JAMA ophthalmology 133(3) 304-11 Dec 2014

33 Watt Kevin M Gonzalez Daniel Benjamin Daniel K Brouwer Kim L R Wade Kelly C Capparelli Edmund Barrett Jeffrey Cohen-Wolkowiez Michael Fluconazole population pharmacokinetics and dosing for prevention and treatment of invasive Candidiasis in children supported with extracorporeal membrane oxygenation Antimicrobial agents and chemotherapy 59(7) 3935-43 Jul2015

34 Wade Kelly C Pistilli Maxwell Baumritter Agnieshka Karp Karen Gong Alice Kemper Alex R Ying Gui-Shuang Quinn Graham Safety ofRetinopathy of Prematurity Examination and Imaging in Premature Infants The Journal of pediatrics 167(5) 994-1000e2 Nov 2015

35 Kemper Alex R Prosser Lisa A Wade Kelly C Repka Michael X Ying Gui-Shuang Baumritter Agnieshka Quinn Graham E A Comparison of Strategies for Retinopathy ofPrematurity Detection Pediatrics 137(1) 1-10 Jan 2016

36 Frommelt Peter Juern Anna Siegel Dawn Holland Kristen Seefeldt Marcia Yu JiaDe Uhing Michael Wade Kelly Drolet Beth Adverse Events in Young and Preterm Infants Receiving Topical Timolol for Infantile Hemangioma Pediatric dermatology 33(4) 405-14 Jul2016

37 Quinn Graham E Barr Charles Bremer Don Fellows Rae Gong Alice Hoffman Robert Repka Michael X Shepard Jennifer Siatkowski R Michael Wade Kelly Ying Gui-Shuang Changes in Course of Retinopathy of Prematurity from 1986 to 2013 Comparison ofThree Studies in the United States Ophthalmology 123(7) 1595-600 Jul2016

Kelly C Wade MD PhD MSCE Page 13

38 Momper Jeremiah D Capparelli Edmund V Wade Kelly C Kantak Anand Dhanireddy Ramasubbareddy Cummings James J Nedrelow Jonathan H Hudak Mark L Mundakel Gratias T Natarajan Girija Gao Jamie Laughon Matt Smith P Brian Benjamin Daniel K Population Pharmacokinetics of Fluconazole in Premature Infants with Birth Weights Less than 750 Grams Antimicrobial agents and chemotherapy 60(9) 5539-45 Sep 2016

39 Quinn Graham E Ying Gui-Shuang Repka Michael X Siatkowski R Michael Hoffman Robert Mills Monte D Morrison David Daniel Ebenezer Baumritter Agnieshka Hildebrand P Lloyd Schron Eleanor B Ells AnnaL Wade Kelly Kemper Alex R Timely implementation ofa retinopathy of prematurity telemedicine system Journal ofAAPOS the official publication of the American Association for Pediatric Ophthalmology and Strabismus 20(5) 425-430e I Oct 2016

Research Publications peer-reviewed reviews 1 Laughon MM Benjamin DK Capparelli EV Keams GL Berezny K Paul IM

Wade K Barrett J Smith PB Cohen-Wolkowiez M Innovative clinical trial design for pediatric therapeutics Expert Review of Clinical Pharmacology 4(5) 643-52 Sep 2011

2 Wade Kelly C Monk Heather M New antifungal and antiviral dosing Clinics in perinatology 42(1) 177-94 x Mar 2015

3 England Amanda Wade Kelly Smith P Brian Berezny Katherine Laughon Matthew Optimizing operational efficiencies in early phase trials The Pediatric Trials Network experience Contemporary clinical trials 47 376-82 Mar 2016

Research Publications non-peer reviewed 1 Cant K Genetic and biochemical characterization of Drosophila singed a homolog of

the actin bundling protein fascin Yale University New Haven CT May 1996 Notes PhD Thesis

Abstracts (Last 3 years) 1 Kelly C Wade Maxwell Pistilli Karen Karp Gui-shuang Ying Agnieshka Baumritter

Alice Gong Alex Kemper Graham Quinn and on behalfof e-ROP cooperative group Safety ofROP screening in extremely premature infants Abstract presented at PAS Annual Meeting San Diego CA 2015

2 Kelly Wade Maxwell Pistilli Karen Karp Gui-shuang Ying Agnieshka Baumritter Alice Gong Alex Kemper Graham Quinn and on behalf of the e-ROP collaborative group Adverse Events Between 32-44 weeks PMA in an Observational ROP Study Abstract presented at PAS annual meeting San Diego CA 2015

Kelly C Wade MD PhD MSCE Page 14

3 Kelly C Wade Gui-shuang Ying Agnieshka Baumritter Alex R Kemper Graham E Quinn and on behalf of the eROP investigators Identifying which low birth weight premature infants are at LOW risk for developing ROP Abstract presented at PAS Annual Meeting Baltimore MD 2016

Editorials Reviews Chapters including participation in committee reports (print or other media)

1 Wade KC Aplenc R Genetic susceptibility to neonatal disease Neo Review Illinois American Academy of Pediatrics July 2004

2 Wade KC Benjamin Jr DK Clinical Pharmacology of Anti-Infective Drugs Infectious Diseases ofthe Fetus and Newborn Infant 7th Edition Remington amp Klein Wilson Nizet Maldonado (eds) Saunders Page 1160-1211 2010 Notes Chapter

3 Quinn Graham E Need for Telemedicine in Retinopathy of Prematurity in MiddleshyIncome Countries-Reply JAMA ophthalmology Dec 2014

4 Wade KC and Benjamin OK Jr Clinical Pharmacology ofAnti-Infective Drugs Infectious Diseases ofthe Fetus and Newborn Infant 8th Edition Remington Klein Wilson Nizet Maldonado (eds) Elsevier 2014 Notes Book Chapter

5 Wade KC Pharmacokinetics Fanaroff and Martins Neonatal-Perinatal Medicine 1Oth Edition Martin RJ Fanaroff AA and Walsh MC (eds) Elsevier 2014 Notes Book Chapter

Books [none]

Alternative Media [none]

Patents [none]

Page 10: Kelly C. Wade, M.D., Ph.D., M.S.C.E. - U S Food and Drug ... · PDF file2001-2004 Fellowship in Neonatal-Perinatal Medicine, ... Publication Review Committee 2014- present: ... "Update

Kelly C Wade MD PhD MSCE Page 10

14 Bruno CJ Smith LP Zur KB Wade KC Congenital subglottic cyst in a term neonate Archives ofDisease in Childhood Fetal amp Neonatal Edition 94(4) F240 Jul 2009

15 Wade KC Benjamin DK Jr Kaufman DA Ward RM Smith PB Jayaraman B Adamson PC Gastonguay MR Barrett JS Fluconazole dosing for the prevention or treatment ofinvasive candidiasis in young infants Pediatric Infectious Disease Journal28(8) 717-23 Aug 2009

16 Wu D Wade KC Paul DJ Barrett JS A rapid and sensitive LC-MSMS method for determination of fluconazole in human plasma and its application in infants with Candida infections Therapeutic Drug Monitoring 31 (6) 703-9 Dec 2009

17 Kimberlin DW Shalabi M Abzug J Lang D Jacobs RF Storchm G Bradley JS Wade KC Ramilo 0 Romero JR Shelton M Leach C Guzman-Cottrill J Robinson J Abughali N Englund J Griffin J Jester P Cloud GA Whitley RJ NIAID Collaborative Antiviral Study Group Safety ofoseltamivir compared with the adamantanes in children less than 12 months ofage Pediatric Infectious Disease Journal 29(3) 195 Mar 2010

18 Lorch SA Wade KC Bakewell-Sachs S Medoff-Cooper 8 Silber JH Escobar GJ Antibiotic use in premature infants after discharge from the neonatal intensive care unit Clinical Pediatrics 49(3) 249 Apr 2010

19 Wade KC Ellenberg JH Grosser T Brensinger CM Kimmel SE Hennessy S Exogenous estrogen does not attenuate the association between rofecoxib and myocardial infarction in perimenopausal women Journal Cardiovascular Pharmacology 57(2) 194 Feb 2011

20 Piper L Smith PB Hornik CP Cheifetz IM Barrett JS Moorthy G Hope WW Wade KC Cohen-Wolkowiez M Benjamin OK Fluconazole loading dose pharmacokinetics and safety in infants Pediatric Infectious Disease Journal 30(5) 375 May 2011

21 Smith PB Cohen-Wolkowiez M Castro LM Poindexter B Bidegain M Weitkamp JH Schelonka RL Ward RM Wade K Valencia G Burchfield D Arrieta A Bhatt-Mehta V Walsh M Kantak A Rasmussen M Sullivan J E Finer N Brozanski BS Sanchez P van den Anker J Blumer J Keams GL Capparelli EV Anand R Benjamin OK Population pharmacokinetics of meropenem in plasma and cerebrospinal fluid ofinfants with suspected or complicated intra-abdominal infections Pediatric Infectious Disease Journal 30( 1 0) 844 Oct 2011

Kelly C Wade MD PhD MSCE Page 11

22 Mossabeb R Wade KC Finnegan K Sivieri E Abbasi S Language development survey provides a useful screening tool for language delay in preterm infants Clinical Pediatrics 51(7) 638 July 2012

23 Watt KM Benjamin OK Jr Cheifetz IM Moorthy G Wade KC Smith PB Brouwer KL Capparelli EV Cohen-Wolkowietz M Pharmacokinetics and safety of fluconazole in young infants supported with extracorporeal membrane oxygenation Pediatric Infectious Disease Journal 31(10) 1042-7 Oct 2012

24 Watt Kevin M Benjamin Daniel K Cheifetz Ira M Moorthy Ganesh Wade Kelly C Smith P Brian Brouwer Kim L R Capparelli Edmund V Cohen-Wolkowiez Michael Pharmacokinetics and safety of fluconazole in young infants supported with extracorporeal membrane oxygenation The Pediatric infectious disease journal 31 ( 1 0) 1042-7 Oct 2012

25 Cohen-Wolkowiez Michael Poindexter Brenda Bidegain Margarita Weitkamp Joern-Hendrik Schelonka Robert L Randolph David A Ward Robert M Wade Kelly Valencia Gloria Burchfield David Arrieta Antonio Mehta Varsha Walsh Michele Kantak Anand Rasmussen Maynard Sullivan Janice E Finer Neil Rich Wade Brozanski Beverly S van den Anker John Blumer Jeffrey Laughon Matthew Watt Kevin M Keams Gregory L Capparelli Edmund V Martz Karen Berezny Katherine Benjamin Daniel K Smith P Brian Safety and effectiveness of meropenem in infants with suspected or complicated intra-abdominal infections Clinical infectious diseases an official publication ofthe Infectious Diseases Society of America 55(11) 1495-502 Dec 2012

26 Reiss Errol Lasker Brent A Lott Timothy J Bendel Catherine M Kaufman David A Hazen Kevin C Wade Kelly C McGowan Karin L Lockhart Shawn R Genotyping of Candida parapsilosis from three neonatal intensive care units (NICUs) using a panel of five multilocus microsatellite markers broad genetic diversity and a cluster ofrelated strains in one NICU Infection genetics and evolution journal of molecular epidemiology and evolutionary genetics in infectious diseases 12(8) 1654-60 Dec 2012

27 Benjamin Daniel K Hudak Mark L Duara Shahnaz Randolph David A Bidegain Margarita Mundakel Gratias T Natarajan Girija Burchfield David J White Robert D Shattuck Karen E Neu Natalie Bendel Catherine M Kim M Roger Finer Neil N Stewart Dan L Arrieta Antonio C Wade Kelly C Kaufman David A Manzoni Paolo Prather Kristi 0 Testoni Daniela Berezny Katherine Y Smith P Brian Effect of fluconazole prophylaxis on candidiasis and mortality in premature infants a randomized clinical trial JAMA the Journal ofthe American Medical Association 311(17) 1742-9 May 2014

28 Monk Heather M Motsney Adam J Wade Kelly C Safety ofRotavirus Vaccine in the NICU Pediatrics 133(6) el555-60 May 2014

Kelly C Wade MD PhD MSCE Page 12

29 e-ROP Cooperative Group Telemedicine approaches to evaluating acute-phase retinopathy ofprematurity study design Ophthalmic epidemiology 21 ( 4 ) 256shy67 Aug 2014

30 Quinn Graham E Ying Gui-shuang Daniel Ebenezer Hildebrand P Lloyd Ells Anna Baumritter Agnieshka Kemper Alex R Schron Eleanor B Wade Kelly Validity of a telemedicine system for the evaluation of acute-phase retinopathy of prematurity JAMA ophthalmology 132(10) 1178-84 Oct 2014

31 Kemper Alex R Wade Kelly C Hornik Christoph P Ying Gui-Shuang Baumritter Agnieshka Quinn Graham E Retinopathy of Prematurity Risk Prediction for Infants with Birth Weight Less than 1251 Grams The Journal ofpediatrics 166(2) 257-6le2 Nov 2014

32 Ying Gui-Shuang Quinn Graham E Wade Kelly C Repka Michael X Baumritter Agnieshka Daniel Ebenezer Predictors for the Development ofReferralshyWarranted Retinopathy of Prematurity in the Telemedicine Approaches to Evaluating Acute-Phase Retinopathy ofPrematurity (e-ROP) Study JAMA ophthalmology 133(3) 304-11 Dec 2014

33 Watt Kevin M Gonzalez Daniel Benjamin Daniel K Brouwer Kim L R Wade Kelly C Capparelli Edmund Barrett Jeffrey Cohen-Wolkowiez Michael Fluconazole population pharmacokinetics and dosing for prevention and treatment of invasive Candidiasis in children supported with extracorporeal membrane oxygenation Antimicrobial agents and chemotherapy 59(7) 3935-43 Jul2015

34 Wade Kelly C Pistilli Maxwell Baumritter Agnieshka Karp Karen Gong Alice Kemper Alex R Ying Gui-Shuang Quinn Graham Safety ofRetinopathy of Prematurity Examination and Imaging in Premature Infants The Journal of pediatrics 167(5) 994-1000e2 Nov 2015

35 Kemper Alex R Prosser Lisa A Wade Kelly C Repka Michael X Ying Gui-Shuang Baumritter Agnieshka Quinn Graham E A Comparison of Strategies for Retinopathy ofPrematurity Detection Pediatrics 137(1) 1-10 Jan 2016

36 Frommelt Peter Juern Anna Siegel Dawn Holland Kristen Seefeldt Marcia Yu JiaDe Uhing Michael Wade Kelly Drolet Beth Adverse Events in Young and Preterm Infants Receiving Topical Timolol for Infantile Hemangioma Pediatric dermatology 33(4) 405-14 Jul2016

37 Quinn Graham E Barr Charles Bremer Don Fellows Rae Gong Alice Hoffman Robert Repka Michael X Shepard Jennifer Siatkowski R Michael Wade Kelly Ying Gui-Shuang Changes in Course of Retinopathy of Prematurity from 1986 to 2013 Comparison ofThree Studies in the United States Ophthalmology 123(7) 1595-600 Jul2016

Kelly C Wade MD PhD MSCE Page 13

38 Momper Jeremiah D Capparelli Edmund V Wade Kelly C Kantak Anand Dhanireddy Ramasubbareddy Cummings James J Nedrelow Jonathan H Hudak Mark L Mundakel Gratias T Natarajan Girija Gao Jamie Laughon Matt Smith P Brian Benjamin Daniel K Population Pharmacokinetics of Fluconazole in Premature Infants with Birth Weights Less than 750 Grams Antimicrobial agents and chemotherapy 60(9) 5539-45 Sep 2016

39 Quinn Graham E Ying Gui-Shuang Repka Michael X Siatkowski R Michael Hoffman Robert Mills Monte D Morrison David Daniel Ebenezer Baumritter Agnieshka Hildebrand P Lloyd Schron Eleanor B Ells AnnaL Wade Kelly Kemper Alex R Timely implementation ofa retinopathy of prematurity telemedicine system Journal ofAAPOS the official publication of the American Association for Pediatric Ophthalmology and Strabismus 20(5) 425-430e I Oct 2016

Research Publications peer-reviewed reviews 1 Laughon MM Benjamin DK Capparelli EV Keams GL Berezny K Paul IM

Wade K Barrett J Smith PB Cohen-Wolkowiez M Innovative clinical trial design for pediatric therapeutics Expert Review of Clinical Pharmacology 4(5) 643-52 Sep 2011

2 Wade Kelly C Monk Heather M New antifungal and antiviral dosing Clinics in perinatology 42(1) 177-94 x Mar 2015

3 England Amanda Wade Kelly Smith P Brian Berezny Katherine Laughon Matthew Optimizing operational efficiencies in early phase trials The Pediatric Trials Network experience Contemporary clinical trials 47 376-82 Mar 2016

Research Publications non-peer reviewed 1 Cant K Genetic and biochemical characterization of Drosophila singed a homolog of

the actin bundling protein fascin Yale University New Haven CT May 1996 Notes PhD Thesis

Abstracts (Last 3 years) 1 Kelly C Wade Maxwell Pistilli Karen Karp Gui-shuang Ying Agnieshka Baumritter

Alice Gong Alex Kemper Graham Quinn and on behalfof e-ROP cooperative group Safety ofROP screening in extremely premature infants Abstract presented at PAS Annual Meeting San Diego CA 2015

2 Kelly Wade Maxwell Pistilli Karen Karp Gui-shuang Ying Agnieshka Baumritter Alice Gong Alex Kemper Graham Quinn and on behalf of the e-ROP collaborative group Adverse Events Between 32-44 weeks PMA in an Observational ROP Study Abstract presented at PAS annual meeting San Diego CA 2015

Kelly C Wade MD PhD MSCE Page 14

3 Kelly C Wade Gui-shuang Ying Agnieshka Baumritter Alex R Kemper Graham E Quinn and on behalf of the eROP investigators Identifying which low birth weight premature infants are at LOW risk for developing ROP Abstract presented at PAS Annual Meeting Baltimore MD 2016

Editorials Reviews Chapters including participation in committee reports (print or other media)

1 Wade KC Aplenc R Genetic susceptibility to neonatal disease Neo Review Illinois American Academy of Pediatrics July 2004

2 Wade KC Benjamin Jr DK Clinical Pharmacology of Anti-Infective Drugs Infectious Diseases ofthe Fetus and Newborn Infant 7th Edition Remington amp Klein Wilson Nizet Maldonado (eds) Saunders Page 1160-1211 2010 Notes Chapter

3 Quinn Graham E Need for Telemedicine in Retinopathy of Prematurity in MiddleshyIncome Countries-Reply JAMA ophthalmology Dec 2014

4 Wade KC and Benjamin OK Jr Clinical Pharmacology ofAnti-Infective Drugs Infectious Diseases ofthe Fetus and Newborn Infant 8th Edition Remington Klein Wilson Nizet Maldonado (eds) Elsevier 2014 Notes Book Chapter

5 Wade KC Pharmacokinetics Fanaroff and Martins Neonatal-Perinatal Medicine 1Oth Edition Martin RJ Fanaroff AA and Walsh MC (eds) Elsevier 2014 Notes Book Chapter

Books [none]

Alternative Media [none]

Patents [none]

Page 11: Kelly C. Wade, M.D., Ph.D., M.S.C.E. - U S Food and Drug ... · PDF file2001-2004 Fellowship in Neonatal-Perinatal Medicine, ... Publication Review Committee 2014- present: ... "Update

Kelly C Wade MD PhD MSCE Page 11

22 Mossabeb R Wade KC Finnegan K Sivieri E Abbasi S Language development survey provides a useful screening tool for language delay in preterm infants Clinical Pediatrics 51(7) 638 July 2012

23 Watt KM Benjamin OK Jr Cheifetz IM Moorthy G Wade KC Smith PB Brouwer KL Capparelli EV Cohen-Wolkowietz M Pharmacokinetics and safety of fluconazole in young infants supported with extracorporeal membrane oxygenation Pediatric Infectious Disease Journal 31(10) 1042-7 Oct 2012

24 Watt Kevin M Benjamin Daniel K Cheifetz Ira M Moorthy Ganesh Wade Kelly C Smith P Brian Brouwer Kim L R Capparelli Edmund V Cohen-Wolkowiez Michael Pharmacokinetics and safety of fluconazole in young infants supported with extracorporeal membrane oxygenation The Pediatric infectious disease journal 31 ( 1 0) 1042-7 Oct 2012

25 Cohen-Wolkowiez Michael Poindexter Brenda Bidegain Margarita Weitkamp Joern-Hendrik Schelonka Robert L Randolph David A Ward Robert M Wade Kelly Valencia Gloria Burchfield David Arrieta Antonio Mehta Varsha Walsh Michele Kantak Anand Rasmussen Maynard Sullivan Janice E Finer Neil Rich Wade Brozanski Beverly S van den Anker John Blumer Jeffrey Laughon Matthew Watt Kevin M Keams Gregory L Capparelli Edmund V Martz Karen Berezny Katherine Benjamin Daniel K Smith P Brian Safety and effectiveness of meropenem in infants with suspected or complicated intra-abdominal infections Clinical infectious diseases an official publication ofthe Infectious Diseases Society of America 55(11) 1495-502 Dec 2012

26 Reiss Errol Lasker Brent A Lott Timothy J Bendel Catherine M Kaufman David A Hazen Kevin C Wade Kelly C McGowan Karin L Lockhart Shawn R Genotyping of Candida parapsilosis from three neonatal intensive care units (NICUs) using a panel of five multilocus microsatellite markers broad genetic diversity and a cluster ofrelated strains in one NICU Infection genetics and evolution journal of molecular epidemiology and evolutionary genetics in infectious diseases 12(8) 1654-60 Dec 2012

27 Benjamin Daniel K Hudak Mark L Duara Shahnaz Randolph David A Bidegain Margarita Mundakel Gratias T Natarajan Girija Burchfield David J White Robert D Shattuck Karen E Neu Natalie Bendel Catherine M Kim M Roger Finer Neil N Stewart Dan L Arrieta Antonio C Wade Kelly C Kaufman David A Manzoni Paolo Prather Kristi 0 Testoni Daniela Berezny Katherine Y Smith P Brian Effect of fluconazole prophylaxis on candidiasis and mortality in premature infants a randomized clinical trial JAMA the Journal ofthe American Medical Association 311(17) 1742-9 May 2014

28 Monk Heather M Motsney Adam J Wade Kelly C Safety ofRotavirus Vaccine in the NICU Pediatrics 133(6) el555-60 May 2014

Kelly C Wade MD PhD MSCE Page 12

29 e-ROP Cooperative Group Telemedicine approaches to evaluating acute-phase retinopathy ofprematurity study design Ophthalmic epidemiology 21 ( 4 ) 256shy67 Aug 2014

30 Quinn Graham E Ying Gui-shuang Daniel Ebenezer Hildebrand P Lloyd Ells Anna Baumritter Agnieshka Kemper Alex R Schron Eleanor B Wade Kelly Validity of a telemedicine system for the evaluation of acute-phase retinopathy of prematurity JAMA ophthalmology 132(10) 1178-84 Oct 2014

31 Kemper Alex R Wade Kelly C Hornik Christoph P Ying Gui-Shuang Baumritter Agnieshka Quinn Graham E Retinopathy of Prematurity Risk Prediction for Infants with Birth Weight Less than 1251 Grams The Journal ofpediatrics 166(2) 257-6le2 Nov 2014

32 Ying Gui-Shuang Quinn Graham E Wade Kelly C Repka Michael X Baumritter Agnieshka Daniel Ebenezer Predictors for the Development ofReferralshyWarranted Retinopathy of Prematurity in the Telemedicine Approaches to Evaluating Acute-Phase Retinopathy ofPrematurity (e-ROP) Study JAMA ophthalmology 133(3) 304-11 Dec 2014

33 Watt Kevin M Gonzalez Daniel Benjamin Daniel K Brouwer Kim L R Wade Kelly C Capparelli Edmund Barrett Jeffrey Cohen-Wolkowiez Michael Fluconazole population pharmacokinetics and dosing for prevention and treatment of invasive Candidiasis in children supported with extracorporeal membrane oxygenation Antimicrobial agents and chemotherapy 59(7) 3935-43 Jul2015

34 Wade Kelly C Pistilli Maxwell Baumritter Agnieshka Karp Karen Gong Alice Kemper Alex R Ying Gui-Shuang Quinn Graham Safety ofRetinopathy of Prematurity Examination and Imaging in Premature Infants The Journal of pediatrics 167(5) 994-1000e2 Nov 2015

35 Kemper Alex R Prosser Lisa A Wade Kelly C Repka Michael X Ying Gui-Shuang Baumritter Agnieshka Quinn Graham E A Comparison of Strategies for Retinopathy ofPrematurity Detection Pediatrics 137(1) 1-10 Jan 2016

36 Frommelt Peter Juern Anna Siegel Dawn Holland Kristen Seefeldt Marcia Yu JiaDe Uhing Michael Wade Kelly Drolet Beth Adverse Events in Young and Preterm Infants Receiving Topical Timolol for Infantile Hemangioma Pediatric dermatology 33(4) 405-14 Jul2016

37 Quinn Graham E Barr Charles Bremer Don Fellows Rae Gong Alice Hoffman Robert Repka Michael X Shepard Jennifer Siatkowski R Michael Wade Kelly Ying Gui-Shuang Changes in Course of Retinopathy of Prematurity from 1986 to 2013 Comparison ofThree Studies in the United States Ophthalmology 123(7) 1595-600 Jul2016

Kelly C Wade MD PhD MSCE Page 13

38 Momper Jeremiah D Capparelli Edmund V Wade Kelly C Kantak Anand Dhanireddy Ramasubbareddy Cummings James J Nedrelow Jonathan H Hudak Mark L Mundakel Gratias T Natarajan Girija Gao Jamie Laughon Matt Smith P Brian Benjamin Daniel K Population Pharmacokinetics of Fluconazole in Premature Infants with Birth Weights Less than 750 Grams Antimicrobial agents and chemotherapy 60(9) 5539-45 Sep 2016

39 Quinn Graham E Ying Gui-Shuang Repka Michael X Siatkowski R Michael Hoffman Robert Mills Monte D Morrison David Daniel Ebenezer Baumritter Agnieshka Hildebrand P Lloyd Schron Eleanor B Ells AnnaL Wade Kelly Kemper Alex R Timely implementation ofa retinopathy of prematurity telemedicine system Journal ofAAPOS the official publication of the American Association for Pediatric Ophthalmology and Strabismus 20(5) 425-430e I Oct 2016

Research Publications peer-reviewed reviews 1 Laughon MM Benjamin DK Capparelli EV Keams GL Berezny K Paul IM

Wade K Barrett J Smith PB Cohen-Wolkowiez M Innovative clinical trial design for pediatric therapeutics Expert Review of Clinical Pharmacology 4(5) 643-52 Sep 2011

2 Wade Kelly C Monk Heather M New antifungal and antiviral dosing Clinics in perinatology 42(1) 177-94 x Mar 2015

3 England Amanda Wade Kelly Smith P Brian Berezny Katherine Laughon Matthew Optimizing operational efficiencies in early phase trials The Pediatric Trials Network experience Contemporary clinical trials 47 376-82 Mar 2016

Research Publications non-peer reviewed 1 Cant K Genetic and biochemical characterization of Drosophila singed a homolog of

the actin bundling protein fascin Yale University New Haven CT May 1996 Notes PhD Thesis

Abstracts (Last 3 years) 1 Kelly C Wade Maxwell Pistilli Karen Karp Gui-shuang Ying Agnieshka Baumritter

Alice Gong Alex Kemper Graham Quinn and on behalfof e-ROP cooperative group Safety ofROP screening in extremely premature infants Abstract presented at PAS Annual Meeting San Diego CA 2015

2 Kelly Wade Maxwell Pistilli Karen Karp Gui-shuang Ying Agnieshka Baumritter Alice Gong Alex Kemper Graham Quinn and on behalf of the e-ROP collaborative group Adverse Events Between 32-44 weeks PMA in an Observational ROP Study Abstract presented at PAS annual meeting San Diego CA 2015

Kelly C Wade MD PhD MSCE Page 14

3 Kelly C Wade Gui-shuang Ying Agnieshka Baumritter Alex R Kemper Graham E Quinn and on behalf of the eROP investigators Identifying which low birth weight premature infants are at LOW risk for developing ROP Abstract presented at PAS Annual Meeting Baltimore MD 2016

Editorials Reviews Chapters including participation in committee reports (print or other media)

1 Wade KC Aplenc R Genetic susceptibility to neonatal disease Neo Review Illinois American Academy of Pediatrics July 2004

2 Wade KC Benjamin Jr DK Clinical Pharmacology of Anti-Infective Drugs Infectious Diseases ofthe Fetus and Newborn Infant 7th Edition Remington amp Klein Wilson Nizet Maldonado (eds) Saunders Page 1160-1211 2010 Notes Chapter

3 Quinn Graham E Need for Telemedicine in Retinopathy of Prematurity in MiddleshyIncome Countries-Reply JAMA ophthalmology Dec 2014

4 Wade KC and Benjamin OK Jr Clinical Pharmacology ofAnti-Infective Drugs Infectious Diseases ofthe Fetus and Newborn Infant 8th Edition Remington Klein Wilson Nizet Maldonado (eds) Elsevier 2014 Notes Book Chapter

5 Wade KC Pharmacokinetics Fanaroff and Martins Neonatal-Perinatal Medicine 1Oth Edition Martin RJ Fanaroff AA and Walsh MC (eds) Elsevier 2014 Notes Book Chapter

Books [none]

Alternative Media [none]

Patents [none]

Page 12: Kelly C. Wade, M.D., Ph.D., M.S.C.E. - U S Food and Drug ... · PDF file2001-2004 Fellowship in Neonatal-Perinatal Medicine, ... Publication Review Committee 2014- present: ... "Update

Kelly C Wade MD PhD MSCE Page 12

29 e-ROP Cooperative Group Telemedicine approaches to evaluating acute-phase retinopathy ofprematurity study design Ophthalmic epidemiology 21 ( 4 ) 256shy67 Aug 2014

30 Quinn Graham E Ying Gui-shuang Daniel Ebenezer Hildebrand P Lloyd Ells Anna Baumritter Agnieshka Kemper Alex R Schron Eleanor B Wade Kelly Validity of a telemedicine system for the evaluation of acute-phase retinopathy of prematurity JAMA ophthalmology 132(10) 1178-84 Oct 2014

31 Kemper Alex R Wade Kelly C Hornik Christoph P Ying Gui-Shuang Baumritter Agnieshka Quinn Graham E Retinopathy of Prematurity Risk Prediction for Infants with Birth Weight Less than 1251 Grams The Journal ofpediatrics 166(2) 257-6le2 Nov 2014

32 Ying Gui-Shuang Quinn Graham E Wade Kelly C Repka Michael X Baumritter Agnieshka Daniel Ebenezer Predictors for the Development ofReferralshyWarranted Retinopathy of Prematurity in the Telemedicine Approaches to Evaluating Acute-Phase Retinopathy ofPrematurity (e-ROP) Study JAMA ophthalmology 133(3) 304-11 Dec 2014

33 Watt Kevin M Gonzalez Daniel Benjamin Daniel K Brouwer Kim L R Wade Kelly C Capparelli Edmund Barrett Jeffrey Cohen-Wolkowiez Michael Fluconazole population pharmacokinetics and dosing for prevention and treatment of invasive Candidiasis in children supported with extracorporeal membrane oxygenation Antimicrobial agents and chemotherapy 59(7) 3935-43 Jul2015

34 Wade Kelly C Pistilli Maxwell Baumritter Agnieshka Karp Karen Gong Alice Kemper Alex R Ying Gui-Shuang Quinn Graham Safety ofRetinopathy of Prematurity Examination and Imaging in Premature Infants The Journal of pediatrics 167(5) 994-1000e2 Nov 2015

35 Kemper Alex R Prosser Lisa A Wade Kelly C Repka Michael X Ying Gui-Shuang Baumritter Agnieshka Quinn Graham E A Comparison of Strategies for Retinopathy ofPrematurity Detection Pediatrics 137(1) 1-10 Jan 2016

36 Frommelt Peter Juern Anna Siegel Dawn Holland Kristen Seefeldt Marcia Yu JiaDe Uhing Michael Wade Kelly Drolet Beth Adverse Events in Young and Preterm Infants Receiving Topical Timolol for Infantile Hemangioma Pediatric dermatology 33(4) 405-14 Jul2016

37 Quinn Graham E Barr Charles Bremer Don Fellows Rae Gong Alice Hoffman Robert Repka Michael X Shepard Jennifer Siatkowski R Michael Wade Kelly Ying Gui-Shuang Changes in Course of Retinopathy of Prematurity from 1986 to 2013 Comparison ofThree Studies in the United States Ophthalmology 123(7) 1595-600 Jul2016

Kelly C Wade MD PhD MSCE Page 13

38 Momper Jeremiah D Capparelli Edmund V Wade Kelly C Kantak Anand Dhanireddy Ramasubbareddy Cummings James J Nedrelow Jonathan H Hudak Mark L Mundakel Gratias T Natarajan Girija Gao Jamie Laughon Matt Smith P Brian Benjamin Daniel K Population Pharmacokinetics of Fluconazole in Premature Infants with Birth Weights Less than 750 Grams Antimicrobial agents and chemotherapy 60(9) 5539-45 Sep 2016

39 Quinn Graham E Ying Gui-Shuang Repka Michael X Siatkowski R Michael Hoffman Robert Mills Monte D Morrison David Daniel Ebenezer Baumritter Agnieshka Hildebrand P Lloyd Schron Eleanor B Ells AnnaL Wade Kelly Kemper Alex R Timely implementation ofa retinopathy of prematurity telemedicine system Journal ofAAPOS the official publication of the American Association for Pediatric Ophthalmology and Strabismus 20(5) 425-430e I Oct 2016

Research Publications peer-reviewed reviews 1 Laughon MM Benjamin DK Capparelli EV Keams GL Berezny K Paul IM

Wade K Barrett J Smith PB Cohen-Wolkowiez M Innovative clinical trial design for pediatric therapeutics Expert Review of Clinical Pharmacology 4(5) 643-52 Sep 2011

2 Wade Kelly C Monk Heather M New antifungal and antiviral dosing Clinics in perinatology 42(1) 177-94 x Mar 2015

3 England Amanda Wade Kelly Smith P Brian Berezny Katherine Laughon Matthew Optimizing operational efficiencies in early phase trials The Pediatric Trials Network experience Contemporary clinical trials 47 376-82 Mar 2016

Research Publications non-peer reviewed 1 Cant K Genetic and biochemical characterization of Drosophila singed a homolog of

the actin bundling protein fascin Yale University New Haven CT May 1996 Notes PhD Thesis

Abstracts (Last 3 years) 1 Kelly C Wade Maxwell Pistilli Karen Karp Gui-shuang Ying Agnieshka Baumritter

Alice Gong Alex Kemper Graham Quinn and on behalfof e-ROP cooperative group Safety ofROP screening in extremely premature infants Abstract presented at PAS Annual Meeting San Diego CA 2015

2 Kelly Wade Maxwell Pistilli Karen Karp Gui-shuang Ying Agnieshka Baumritter Alice Gong Alex Kemper Graham Quinn and on behalf of the e-ROP collaborative group Adverse Events Between 32-44 weeks PMA in an Observational ROP Study Abstract presented at PAS annual meeting San Diego CA 2015

Kelly C Wade MD PhD MSCE Page 14

3 Kelly C Wade Gui-shuang Ying Agnieshka Baumritter Alex R Kemper Graham E Quinn and on behalf of the eROP investigators Identifying which low birth weight premature infants are at LOW risk for developing ROP Abstract presented at PAS Annual Meeting Baltimore MD 2016

Editorials Reviews Chapters including participation in committee reports (print or other media)

1 Wade KC Aplenc R Genetic susceptibility to neonatal disease Neo Review Illinois American Academy of Pediatrics July 2004

2 Wade KC Benjamin Jr DK Clinical Pharmacology of Anti-Infective Drugs Infectious Diseases ofthe Fetus and Newborn Infant 7th Edition Remington amp Klein Wilson Nizet Maldonado (eds) Saunders Page 1160-1211 2010 Notes Chapter

3 Quinn Graham E Need for Telemedicine in Retinopathy of Prematurity in MiddleshyIncome Countries-Reply JAMA ophthalmology Dec 2014

4 Wade KC and Benjamin OK Jr Clinical Pharmacology ofAnti-Infective Drugs Infectious Diseases ofthe Fetus and Newborn Infant 8th Edition Remington Klein Wilson Nizet Maldonado (eds) Elsevier 2014 Notes Book Chapter

5 Wade KC Pharmacokinetics Fanaroff and Martins Neonatal-Perinatal Medicine 1Oth Edition Martin RJ Fanaroff AA and Walsh MC (eds) Elsevier 2014 Notes Book Chapter

Books [none]

Alternative Media [none]

Patents [none]

Page 13: Kelly C. Wade, M.D., Ph.D., M.S.C.E. - U S Food and Drug ... · PDF file2001-2004 Fellowship in Neonatal-Perinatal Medicine, ... Publication Review Committee 2014- present: ... "Update

Kelly C Wade MD PhD MSCE Page 13

38 Momper Jeremiah D Capparelli Edmund V Wade Kelly C Kantak Anand Dhanireddy Ramasubbareddy Cummings James J Nedrelow Jonathan H Hudak Mark L Mundakel Gratias T Natarajan Girija Gao Jamie Laughon Matt Smith P Brian Benjamin Daniel K Population Pharmacokinetics of Fluconazole in Premature Infants with Birth Weights Less than 750 Grams Antimicrobial agents and chemotherapy 60(9) 5539-45 Sep 2016

39 Quinn Graham E Ying Gui-Shuang Repka Michael X Siatkowski R Michael Hoffman Robert Mills Monte D Morrison David Daniel Ebenezer Baumritter Agnieshka Hildebrand P Lloyd Schron Eleanor B Ells AnnaL Wade Kelly Kemper Alex R Timely implementation ofa retinopathy of prematurity telemedicine system Journal ofAAPOS the official publication of the American Association for Pediatric Ophthalmology and Strabismus 20(5) 425-430e I Oct 2016

Research Publications peer-reviewed reviews 1 Laughon MM Benjamin DK Capparelli EV Keams GL Berezny K Paul IM

Wade K Barrett J Smith PB Cohen-Wolkowiez M Innovative clinical trial design for pediatric therapeutics Expert Review of Clinical Pharmacology 4(5) 643-52 Sep 2011

2 Wade Kelly C Monk Heather M New antifungal and antiviral dosing Clinics in perinatology 42(1) 177-94 x Mar 2015

3 England Amanda Wade Kelly Smith P Brian Berezny Katherine Laughon Matthew Optimizing operational efficiencies in early phase trials The Pediatric Trials Network experience Contemporary clinical trials 47 376-82 Mar 2016

Research Publications non-peer reviewed 1 Cant K Genetic and biochemical characterization of Drosophila singed a homolog of

the actin bundling protein fascin Yale University New Haven CT May 1996 Notes PhD Thesis

Abstracts (Last 3 years) 1 Kelly C Wade Maxwell Pistilli Karen Karp Gui-shuang Ying Agnieshka Baumritter

Alice Gong Alex Kemper Graham Quinn and on behalfof e-ROP cooperative group Safety ofROP screening in extremely premature infants Abstract presented at PAS Annual Meeting San Diego CA 2015

2 Kelly Wade Maxwell Pistilli Karen Karp Gui-shuang Ying Agnieshka Baumritter Alice Gong Alex Kemper Graham Quinn and on behalf of the e-ROP collaborative group Adverse Events Between 32-44 weeks PMA in an Observational ROP Study Abstract presented at PAS annual meeting San Diego CA 2015

Kelly C Wade MD PhD MSCE Page 14

3 Kelly C Wade Gui-shuang Ying Agnieshka Baumritter Alex R Kemper Graham E Quinn and on behalf of the eROP investigators Identifying which low birth weight premature infants are at LOW risk for developing ROP Abstract presented at PAS Annual Meeting Baltimore MD 2016

Editorials Reviews Chapters including participation in committee reports (print or other media)

1 Wade KC Aplenc R Genetic susceptibility to neonatal disease Neo Review Illinois American Academy of Pediatrics July 2004

2 Wade KC Benjamin Jr DK Clinical Pharmacology of Anti-Infective Drugs Infectious Diseases ofthe Fetus and Newborn Infant 7th Edition Remington amp Klein Wilson Nizet Maldonado (eds) Saunders Page 1160-1211 2010 Notes Chapter

3 Quinn Graham E Need for Telemedicine in Retinopathy of Prematurity in MiddleshyIncome Countries-Reply JAMA ophthalmology Dec 2014

4 Wade KC and Benjamin OK Jr Clinical Pharmacology ofAnti-Infective Drugs Infectious Diseases ofthe Fetus and Newborn Infant 8th Edition Remington Klein Wilson Nizet Maldonado (eds) Elsevier 2014 Notes Book Chapter

5 Wade KC Pharmacokinetics Fanaroff and Martins Neonatal-Perinatal Medicine 1Oth Edition Martin RJ Fanaroff AA and Walsh MC (eds) Elsevier 2014 Notes Book Chapter

Books [none]

Alternative Media [none]

Patents [none]

Page 14: Kelly C. Wade, M.D., Ph.D., M.S.C.E. - U S Food and Drug ... · PDF file2001-2004 Fellowship in Neonatal-Perinatal Medicine, ... Publication Review Committee 2014- present: ... "Update

Kelly C Wade MD PhD MSCE Page 14

3 Kelly C Wade Gui-shuang Ying Agnieshka Baumritter Alex R Kemper Graham E Quinn and on behalf of the eROP investigators Identifying which low birth weight premature infants are at LOW risk for developing ROP Abstract presented at PAS Annual Meeting Baltimore MD 2016

Editorials Reviews Chapters including participation in committee reports (print or other media)

1 Wade KC Aplenc R Genetic susceptibility to neonatal disease Neo Review Illinois American Academy of Pediatrics July 2004

2 Wade KC Benjamin Jr DK Clinical Pharmacology of Anti-Infective Drugs Infectious Diseases ofthe Fetus and Newborn Infant 7th Edition Remington amp Klein Wilson Nizet Maldonado (eds) Saunders Page 1160-1211 2010 Notes Chapter

3 Quinn Graham E Need for Telemedicine in Retinopathy of Prematurity in MiddleshyIncome Countries-Reply JAMA ophthalmology Dec 2014

4 Wade KC and Benjamin OK Jr Clinical Pharmacology ofAnti-Infective Drugs Infectious Diseases ofthe Fetus and Newborn Infant 8th Edition Remington Klein Wilson Nizet Maldonado (eds) Elsevier 2014 Notes Book Chapter

5 Wade KC Pharmacokinetics Fanaroff and Martins Neonatal-Perinatal Medicine 1Oth Edition Martin RJ Fanaroff AA and Walsh MC (eds) Elsevier 2014 Notes Book Chapter

Books [none]

Alternative Media [none]

Patents [none]