UNIVERSITY OF COLORADO ANSCHUTZ MEDICAL …...2013-2015 Faculty-member-at-large, Executive Council 2012, 15-16 Member, Departmental Appointments, Promotions, and Tenure Committee (DAPTCO)

Updated: Sep 2017

Elaine H. Morrato

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CURRICULUM VITAE

ELAINE H. MORRATO

CURRENT POSITION

UNIVERSITY OF COLORADO ANSCHUTZ MEDICAL CAMPUS

Primary Appointment

Colorado School of Public Health, Interim Dean and Associate Dean for Public Health Practice

Associate Professor (with tenure), Department of Health Systems, Management and Policy

Secondary Appointments

School of Medicine, Department of Pediatrics

Skaggs School of Pharmacy and Pharmaceutical Sciences, Department of Clinical Pharmacy

13001 East 19th Place, Room E3311

Mail Stop B119

Aurora, CO 80045-0508

303-724-7304 (phone)

303-724-4495 (fax)

Email: [email protected]

EDUCATION

2004-2006 Pharmaceutical Outcomes Research Fellowship, Department of Clinical Pharmacy,

School of Pharmacy, University of Colorado Denver, CO

Advisors: Robert Valuck, PhD and Patrick Sullivan, PhD

2006 Dr.P.H., General Epidemiology, The Johns Hopkins University, The Johns Hopkins

Bloomberg School of Public Health, Baltimore, MD. Dissertation: Impact of

nefazodone (Serzone®) hepatic risk minimization recommendations: a case study

evaluation of an FDA Boxed Warning.

Advisor: Manning Feinleib, MD DrPH

2003 M.P.H., Epidemiology, The Johns Hopkins University, The Johns Hopkins Bloomberg

School of Public Health, Baltimore, MD. Masters Capstone Project: FDA pediatric drug

policy: Characteristics of drugs granted exclusivity.

Advisor: Manning Feinleib, MD DrPH

1988 B.S. (Honors) summa cum laude, Biology/Biochemistry, Purdue University, West

Lafayette, IN. Honors thesis: Spectral analysis of thermodynamic properties in non-

Watson-Crick base pairing and DNA secondary structure

CONTINUING EDUCATION

2014-2015 Leadership for Innovative Team Science (LITeS), a select senior and mid-career faculty

development program, Colorado Clinical & Translational Sciences Institute, Aurora, CO.

2012 Kellogg Executive Education Program, Marketing and Sales Certificate, Kellogg School

of Management, Northwestern University, Chicago, IL.

2010 Institute on Systems Science and Health (ISSH), Social Network Analysis Track,

Mailman School of Public Health, Columbia University, New York, NY. Sponsored by

the National Institutes of Health and the Centers for Disease Control and Prevention.

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Elaine H. Morrato

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ACADEMIC APPOINTMENTS AND POSITIONS

APPOINTMENTS

University of Colorado Anschutz Medical Campus, Aurora, CO

2012- Associate Professor (with tenure), Department of Health Systems, Management & Policy,

Colorado School of Public Health

2009 - 2012 Assistant Professor, Department of Health Systems, Management & Policy, Colorado

School of Public Health

2006 - 2009 Assistant Professor, Division of General Pediatrics, Department of Pediatrics, School of

Medicine

POSITIONS

University of Colorado Anschutz Medical Campus, Aurora, CO

2016- Interim Dean, Colorado School of Public Health

2016- Postdoctoral Research Faculty, Developmental Psychobiology Research Group (DPRG)

T32 Training Program, MH015442, Development of Psychopathology, Psychobiology &

Behavior, Mark L. Laudenslager, Program Director.

2015- Associate Dean for Public Health Practice, Colorado School of Public Health

2015-2016 Co-Director, Dissemination and Implementation Science Program, Adult and Child

Consortium for Health Outcomes Research and Delivery Science (ACCORDS), School

of Medicine

2010-2014 Associate Director, Children’s Outcomes Research (COR) Program, School of Medicine

2011-2013 Comparative Effectiveness Research (CER) Core Leader, Colorado Health Outcomes and

the Children’s Outcomes Research Programs, School of Medicine

2006-2010 Senior Methodologist, Children’s Outcomes Research (COR) Program, School of Medicine

PROFESSIONAL POSITIONS

SCIENTIFIC CONSULTING

2015 Operationalizing pharmaceutical risk management and risk communication planning into

the drug development processes. Amgen, Inc.

2013 Colorado All-Payer Claims Database: data validity and feasibility assessment for

outcomes research. Janssen Scientific Affairs, LLC.

2013 Mock FDA Review Panel, Rx-to-OTC switch candidate. Merck & Co., Inc.

2013 Dextromethorphan Blue Ribbon Panel to review educational efforts to curb abuse among

adolescents. Consumer Healthcare Products Association.

2002-2005 Health Care New Business Development, Pharmaceutical and Wellness Market Research

Services, Information Resources, Inc., Chicago, IL.

U.S. FOOD AND DRUG ADMINISTRATION, ROCKVILLE, MD

2002-2003 Student research, Office of Drug Safety, Project: Effectiveness of risk management plans:

a case study of pemoline using pharmacy claims data. Advisor: Judy Staffa, RPh PhD.

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Elaine H. Morrato

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THE PROCTER & GAMBLE COMPANY, CINCINNATI, OH

2000-2002 Section Head, Global Phase III Project Leader, Cardiovascular New Drug Development,

Pharmaceutical Division

2000-2002 Section Head, Global Risk Management Team Leader, Cardiovascular New Drug

Development, Pharmaceutical Division

1997-2000 Section Head, Global Phase IIIb/IV Project Leader, Cardiac Technical Brand Manager,


1996-1997 Section Head, U.S. Launch Team Leader for Helidac® (tetracycline, metronidazole,

bismuth-subsalicylate), North America Product Development, Pharmaceutical Division

1994-1997 Section Head, Technical Brand Manager, Asacol® (mesalamine) and Macrobid®

(nitrofurantoin monohydrate/macrocrystals), North America Product Development,


1993-1994 Senior Scientist, Global Products Research Team Leader for Over-the Counter Cholesterol-

Lowering Drugs, Product Development, U.S. Healthcare Division

1992-1993 Senior Scientist, National Product Launch Team Leader, Metamucil® Sunrise Smooth

Sugar-Free Regular Flavor, Product Development, U.S. Healthcare Division

1988-1992 Scientist, Professional Oral Care Products, Product Development, U.S. Healthcare Division

MONSANTO CHEMICAL COMPANY, ST. LOUIS, MO

1987 Research Intern, Mammalian cell culture and cardiovascular pharmaceutical research

1986 Market Research Interviewer, Agriculture Products

HONORS AND AWARDS

ACADEMIC

2006 Delta Omega Honorary Society in Public Health (Alpha Chapter), Bloomberg School of

Public Health, The Johns Hopkins University

2004 Campaign for Epidemiology Award, Bloomberg School of Public Health, The Johns

Hopkins University

2003 Master of Public Health Capstone Award for Outstanding Achievement, Johns Hopkins,

Bloomberg School of Public Health

1988 Helen B. Schleman Award for Women, top academic female graduate, Purdue University

1988 AWS Very Important Woman Award, top graduating female leader, Purdue University

1988 School of Science Outstanding Senior, Department of Biology, Purdue University

1987 Mortar Board Honor Society for achievements in scholarship, leadership, and service,

Purdue University

1987 Phi Beta Kappa Society, Purdue University

1987 American Chemical Society Award for Outstanding Junior in Analytical Chemistry,

Purdue University

1984-1985 School of Science Research Scholarship, Purdue University

1984 National Presidential Scholar Finalist and National Merit Scholar

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Elaine H. Morrato

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SCIENTIFIC

2017 Mentored Student: RK Johnson. Winner of the Spotlight Poster Session: Benefit Risk

Assessment, Communication and Evaluation (BRACE) at the 32nd International

Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE),

Montreal, Canada, August 25-28, 2017.

2017 Mentored Student: KE Lind. Best Student Poster Finalist, at the AcademyHealth 2017

Annual Research Meeting, New Orleans, LA, June 25-27, 2017.

2015 “Best Poster”, Spotlight Poster Session “Benefit Risk Assessment, Communication and

Evaluation (BRACE)” at the 31st International Conference on Pharmacoepidemiology &

Therapeutic Risk Management (ICPE), Boston, MA. August 22-26, 2015.

2013 Outstanding Reviewer Recognition for 2013, Pharmacoepidemiology and Drug Safety



2010 Top 100 poster showcased in the President’s Poster Session and Reception at the 70th

Scientific Sessions of the American Diabetes Association, Orlando, FL June 25-29, 2010.

2010 Featured poster in “Pediatrics – Type 1 Diabetes – Care and Outcomes” at the 70th

Scientific Sessions of the American Diabetes Association, Orlando, FL June 25-29, 2010.

2008 Best research poster presented at the 2008 NCDEU (New Clinical Drug Evaluation Unit)

Meeting. CME Institute, Physicians Postgraduate Press, Inc., The Journal of Clinical

Psychiatry (October 2008)

2005 Best Podium Presentation, First Western Pharmacoeconomics Conference, Salt Lake City, UT

2004 Poster Finalist, 9th Annual Meeting of the International Society for Pharmacoeconomic and

Outcomes Research, Washington, D.C.

PHARMACEUTICAL INDUSTRY

1996 Asacol™ (mesalamine) Product Brand Team, Health Care Sector Outstanding

Achievement Award, The Procter & Gamble Company

1994 Team of the Year, Sunrise Smooth Metamucil Sugar-Free Regular Flavor National

Launch, U.S. Health Care Division, The Procter & Gamble Company.

PROFESSIONAL AFFILIATIONS

PROFESSIONAL SOCIETIES

2005- Member, International Society for Pharmacoepidemiology

Founding member of the Benefit-Risk Assessment, Communication and Evaluation

(BRACE) Special Interest Group (established 2012)

2007-2012 Member, American Diabetes Association

2005-2008 Member, International Society for Pharmacoeconomics and Outcomes Research

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PROFESSIONAL SERVICE AND COMMITTEES

INTERNATIONAL

2017 Moderator, Podium/Oral Session, “The "ACE" of BRACE”, 33rd International

Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE 2017),

Montreal, Canada. August 26-30, 2017.

2006-2007 Co-Chair, Policy Advocacy Working Group, Retrospective Database Special Interest

Group of the International Society for Pharmacoeconomics and Outcomes Research

2005-2006 Member, Policy Advocacy Working Group, Retrospective Database Special Interest

NATIONAL

2017 Expert Panel, "Addressing Barriers to Wide-scale Adoption of IPS Supported

Employment" Substance Abuse and Mental Health Services Administration’s

(SAMHSA’s) Center for Mental Health Services (CMHS). Rockville, MD. August 8, 2017.

2016 Discussant, “Policy Topics: Prescription Drugs, De-Implementation, and Military

Behavioral Health” 9th Annual Conference on the Science of Dissemination and

Implementation, Washington, D.C., December 14-15, 2016.

2015-present Colorado School of Public Health representative, Public Health Practice Section,

Association of Schools and Programs in Public Health

2015 Planning Committee and Moderator, Patient Engagement in Benefit-Risk Assessment

throughout the Life Cycle of Medical Product. Sponsored by the Drug Information

Association (DIA) and the Patient-Centered Outcomes Research Institute (PCORI).

Rockville, MD, September 17-18, 2015.

See: http://www.pcori.org/research-results/2015/patient-engagement-benefit-risk-

assessment-throughout-life-cycle-medical

2014 Member, Conjoint Committee on Continuing Education Long-Acting Opioid Analgesics

REMS Meeting, Accreditation Council for Continuing Medical Education Office,

Chicago, IL, February 24, 2014.

2014-2018 Standing member and Chair since 2017, FDA Pulmonary-Allergy Drugs Advisory

Committee, Center for Drug Evaluation and Research (see CV Appendix A)

2013-present Invited voting member, drug safety and risk management expertise, various FDA

Advisory Committees, Center for Drug Evaluation and Research (see CV Appendix A)

2011 Work Group presentation, Morrato EH, Meissner P, Concannon TW, Tobin J, Shah N.

“Key Informant Interviews: CER Dissemination and Implementation among CTSA

Institutions (preliminary findings)”. CER Collaboration, Information Dissemination,

Implementation Work Group, Presented at the Annual Comparative Effectiveness

Research Key Function Committee Meeting, October 11, 2011. Rockville, MD.

2010-2013 Comparative Effectiveness Research (CER) Key Function Committee, National Center

for Research Resources (NCRR) of NIH and the National Clinical and Translational

Science Award (CTSA) Consortium

2010-2011 Organizing Committee, Conference on Adipogenic and Metabolic Effects of

Antipsychotic Drugs (NIMH/NIDDK R13MH086166)

2009-2013 Standing Member, FDA Drug Safety and Risk Management Advisory Committee, Center

for Drug Evaluation and Research (see Appendix A)

http://www.pcori.org/research-results/2015/patient-engagement-benefit-risk-assessment-throughout-life-cycle-medical

http://www.pcori.org/research-results/2015/patient-engagement-benefit-risk-assessment-throughout-life-cycle-medical

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2008 Consultant, FDA Risk Communication Advisory Committee, “Research Regarding

Direct to Consumer Advertising of Prescription Drugs” (May 15-16, 2008)

2006-2009 Contributor, American Psychiatric Association (APA) Council on Research Workgroup

on Antipsychotics and Metabolic Risk. Newcomer JW, Blonde L, Ader M, Beaser R,

Marder S, Nemeroff C.

UNIVERSITY OF COLORADO ANSCHUTZ MEDICAL CAMPUS

2016-present Aurora Community Campus Partnership Steering Committee (see: http://com-cam.org/)

2016 Consultant, National Academy of State Health Policy (NASHP) Learning Collaborative

From Engagement to Evidence: Using PCOR and CER to Inform State Policymaking in

collaboration with the Colorado Department of Public Health and Environment, Office of

Behavioral Health, and Health Care Policy& Financing

2015-present Colorado Public Health Improvement Steering Committee (PHISC) representing the


2008-2011 Member, Pediatric Scientific and Advisory Review Committee of the Colorado Clinical

Translational Research Center (CTRC) of the Colorado Clinical Translational Sciences

Institute (CCTSI)

2009-2010 Member, Sub-committee on Outcomes and Community Research, Development of

Children’s Hospital Colorado Strategic Research Plan, School of Medicine

2009 Chair, Faculty Search Committee, Director of the Qualitative Methods Core, Colorado

Health Outcomes Program, School of Medicine

COLORADO SCHOOL OF PUBLIC HEALTH

2015 Member, Faculty Search Committee, Associate Dean for Finance and Administration,


2014-2015 Department representative, Education and Curriculum Committee

2013-2015 Faculty-member-at-large, Executive Council

2012, 15-16 Member, Departmental Appointments, Promotions, and Tenure Committee (DAPTCO)

2012-2014 Chair, Faculty Senate Finance Committee

2011-2012 Member, Faculty Search Committee, Associate Professor in Oral Health Epidemiology,

Department of Epidemiology

2010 Member, Founding Steering Committee for the Doctor of Public Health Program

2009-2012 Faculty Senator, Health Systems, Management and Policy Department

2009-2011 Member, Faculty Search Committee, Assistant/Associate Professor in Health Services

Research, Department of Health Systems, Management & Policy

2007 Reviewer, Doctorate of Public Health program proposal. Colorado School of Public

Health Initiative, University of Colorado at Denver and Health Sciences

OTHER SERVICE

2007-2008 Co-chair, Bergen Valley and Bergen Meadow Elementary School Science Fair,

Evergreen, CO

2004 Student representative to faculty, Doctorate of Public Health Program Executive

Committee, Johns Hopkins Bloomberg School of Public Health

http://com-cam.org/

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Elaine H. Morrato

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1998-1999 Member, Committee to develop the Pharmaceuticals Division Technical Brand Training

Manual on Best Practices. The Procter & Gamble Company.

1986-1988 President, School of Science Student Council, Purdue University

BOARD CERTIFICATION

2008 Board Certification in Public Health (Inaugural Class), National Board of Public Health

Examiners (Recertified 2012, 2015, 2017)

REVIEW, REFEREE, and EDITORIAL ACTIVITIES

GRANT REVIEW COMMITTEES AND STUDY SECTIONS

Standing Study Section, Permanent Member

2018 Invited to serve on the HSQR (Healthcare Patient Safety and Quality Improvement

Research) study section, Agency for Healthcare Research and Quality (AHRQ), pending

completion of FDA Advisory Committee service. AHRQ appointment process underway.

Invited Reviewer

2017 Special Emphasis Panel/Scientific Review Group 2017/10 HSQR SRO1 1, Healthcare

Patient Safety and Quality Improvement Research, Agency for Healthcare Research and

Quality (AHRQ), June 22-23, 2017.

Special Emphasis Panel ZMH1 ERB-K 05 M, Mental Health Services Research, National

Institute of Mental Health, April 7, 2017.

Special Emphasis Panel ZMH1 ERB-B (06) S, Fellowships and Dissertation Grants,

National Institute of Mental Health, March 1, 2017.

2016 Special Emphasis Panel ZMH1 ERB-K (01), Clinical Trials to Test the Effectiveness of

Treatment, Preventive, and Services Interventions (RFA-MH-15-320 and RFA-MH-15-

325), National Institute of Mental Health, November 30, 2016.

External Advisory Committee for the Merck Foundation’s Initiative: The Alliance to

Advance Patient-Centered Cancer Care. October 28, 2016.

Mental Health Services Research (SERV) Committee, National Institute of Mental

Health, June 2, 2016.

Special Emphasis Panel ZMH1 ERB-K (04), Clinical Trials to Test the Effectiveness of

Treatment, Preventive, and Services Interventions (RFA-MH-15-320 and RFA-MH-15-

325). National Institute of Mental Health, March 4, 2016.

2015 Special Emphasis Panel ZMH1 ERB-K (09), Fellowship and Dissertation Awards. National

Institute of Mental Health, July 14, 2015.

2014 Special Emphasis Panel, ZMH1 ZMH1 ERB-K (04), Mental Health Services, National

Institute of Mental Health, November 17, 2014.

Special Emphasis Panel, ZMH1 ZMH1 ERB-K (02) Mental Health Services. National

Institute of Mental Health, November 4, 2014.

Mental Health Services Research Committee (SERV), National Institute of Mental

Health. June 11, 2014.

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Elaine H. Morrato

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Special Emphasis Panel, ZMH1 ERB-I (03), Improving Health and Reducing Premature

Mortality in People with Severe Mental Illness (RFA-MH-14-060). National Institute of

Mental Health, March 5, 2014.

2013 Cycle III Merit Review, Communication and Dissemination. Patient Centered Outcomes

Research Institute (PCORI), July 18-19, 2013.

2012 Cycle I Merit Review, Assessment of Prevention, Diagnosis, and Treatment Options.

Patient Centered Outcomes Research Institute. October 2012.

Invited reviewer, Special Emphasis Panel ZHS1 HSR-X (03), Dissemination by Health

Professionals Associations. Agency for Healthcare Research and Quality, June 21, 2012.

2009 Special Emphasis Panel, 2009 ZRG1 HDM-P (58), Challenge Grants in Health and

Science Research. National Institutes of Health, July 20, 2009.

EDITORIAL REVIEW FOR BOOK PUBLISHERS

2016 Book prospectus: In the Margins: Health Behaviors and System Distrust among the

Socioeconomically Disadvantaged, Routledge publishers, member of the Taylor &

Francis Group, London.

MANUSCRIPT REVIEW FOR SCIENTIFIC JOURNALS

2017 Medical Care (2), BMJ Quality & Safety, Pediatrics, Drug Safety (2)

2016 Health Affairs, Pediatrics, Psychiatric Services, Medical Care, Therapeutic Innovation &

Regulatory Science (2), Journal of Clinical Psychiatry

2015 JAMA Internal Medicine, Journal of Clinical Psychiatry (2), BMC Psychiatry.

2014 Medical Care (2), Journal of General Internal Medicine, Pediatrics, New England Journal

of Medicine (2), Psychiatric Services, BMC Psychiatry, General Hospital Psychiatry

2013 JAMA Pediatrics, Medical Care, Pediatrics, Journal of General Internal Medicine,

Psychiatric Services, Pharmacoepidemiology & Drug Safety, General Hospital Psychiatry

2012 Value in Health, Psychiatric Services (2), American Journal of Managed Care (3),

BioMed Central Health Services Research, Pharmacy and Therapeutics Journal (2), Journal of Child and Adolescent Psychopharmacology (2), General Hospital Psychiatry,

2011 Archives of General Psychiatry, Medical Care, The Milbank Quarterly, American Journal

of Managed Care (2), Nature Reviews in Endocrinology, BioMed Central Public Health,

Journal of Psychopharmacology, Journal of Child and Adolescent Psychopharmacology,

Irish Journal of Psychological Medicine

2010 Pharmacoepidemiology and Drug Safety, Value in Health (2), Diabetologia, European

Journal of Cardiovascular Prevention and Rehabilitation, BioMed Central Health

Services Research (2), Journal of Psychopharmacology, Journal of Clinical

Psychopharmacology, Clinical Schizophrenia and Related Psychoses, Progress in Neuro-

Psychopharmacology & Biological Psychiatry, General Hospital Psychiatry

2009 Archives of Internal Medicine, Pharmacoepidemiology & Drug Safety, American Journal

of Managed Care, Diabetologia, Journal of Child and Adolescent Psychopharmacology,

Neuro-Psychopharmacology and Biological Psychiatry, Social Psychiatry and Psychiatric

Epidemiology, BioMed Central Psychiatry, Journal of Diabetes and its Complications

2008 Journal of Clinical Psychopharmacology, Health Policy, American Journal of Psychiatry,

Journal of Health Services Research and Policy

2006 Schizophrenia Bulletin

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REVIEWER FOR PROFESSIONAL SOCIETIES AND SCIENTIFIC CONFERENCES

2007-9, 11-12, Scientific abstracts, International Conference on Pharmacoepidemiology and Therapeutic

15-17 Risk Management

2008 Symposium abstracts, “Contributed Health Decisions Case Study”, International Society for

Pharmacoeconomics and Outcomes Research

INVITED LECTURES, PRESENTATIONS, WORKSHOPS

INTERNATIONAL

1. Speaker, “Pragmatic Approaches from Implementation Science to Better Risk Management

Programs”, sponsored by the Benefit-Risk Assessment, Communication and Evaluation

(BRACE) Special Interest Group, International Society for Pharmacoepidemiology Educational

Webinar Series. October 10, 2017.

2. Speaker and Panelist, “Pragmatic Design Considerations: The PRECIS-2 Framework” in Session:

“Are Pragmatic Clinical Trials Ready for Prime Time?”, Duke Industry Statistics Symposium

2017. September 6-8, 2017, Durham, NC. [International sponsorship: Amgen, Boehringer-

Ingelheim, Janssen, Parexel, PPD, Quintiles and SAS and pharmaceutical industry participation]

3. Speaker, “Pragmatic Approaches from Implementation Science to Better Risk Management

Programs”, sponsored by the Benefit-Risk Assessment, Communication and Evaluation

(BRACE) Special Interest Group, International Society for Pharmacoepidemiology Educational

Webinar Series. October 20, 2016.

4. Speaker, “Introduction to Pragmatic Trials and the PRECIS-2 Framework”, 7th International

Dermato-Epidemiology Association (IDEA) Congress and 2nd Keratinocyte Carcinoma

Consortium (KeraCon) Meeting. Aurora, CO. September 28-30, 2016.

5. Speaker and Panelist, Mind the Gaps - and Address Them! The science of designing,

implementing and evaluating benefit-risk communication for medicinal products. Drug

Information Association 2016 52nd Annual Meeting, Philadelphia, PA, June 26-30, 2016. [DIA

meeting is premier global forum convening health care product development professionals]

6. Speaker, “Practical Approaches to Designing, Implementing, and Evaluating REMS and Risk

Minimization Programs” Amgen Inc., Thousand Oaks, CA, April 13, 2015

7. Symposium Moderator, Benefit-Risk Assessment, Communication and Evaluation (BRACE):

Embrace the challenges and opportunities. Sponsored by the Benefit-Risk Assessment,

Communication and Evaluation (BRACE) Special Interest Group. 29th International Conference on

Pharmacoepidemiology and Therapeutic Risk Management, Montreal, Canada, August 25-28, 2013.

8. Speaker, “Methodologic issues in epidemiologic and pharmacovigilance studies of APD

metabolic effects”, Conference on Adipogenic and Metabolic Effects of Antipsychotic Drugs with

funding in part from the National Institute of Mental Health and the National Institute of Diabetes

and Digestive and Kidney Disease (R13MH086166), Newark, NJ, July 11-12, 2011.

9. Speaker and Panelist, Mol P, Bahri P, Avorn J, Benkimoun P, Aria A, Morrato EH, Dal Pan G,

Haaijer-Ruskamp F, Straus S. “Intended and Unintended Consequences: The case example of

SSRI suicidality risk communication” in the Symposium “Regulatory Risk Communication: Are

We Getting Ahead?" 26th International Conference on Pharmacoepidemiology & Therapeutic

Risk Management, Brighton, UK, August 19-22, 2010.

10. Speaker, “Comparative Effectiveness Research Funding in the United States” Cochrane Skin

Group Annual Meeting, University of Colorado Denver, Aurora, CO, October 16-17, 2010.

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Elaine H. Morrato

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11. Speaker, “Utilization of Retrospective Databases to Inform Evidence Based Drug Policy Making”

International Society for Pharmacoeconomics and Outcomes Research 11th Annual International

Meeting. Philadelphia, PA, May 2006.

12. Speaker, “HELIDAC Therapy: A Newly FDA-Cleared Therapy Designed for Compliance,”

International Business Communications Meeting on H. pylori, January 1997.

NATIONAL

1. Grand Rounds, “Advancing Dissemination and Implementation Science at the Colorado Clinical

and Translational Science Institute”, Cincinnati Clinical and Translational Sciences Institute.

Cincinnati, OH, December 15, 2017.

2. Grand Rounds, “The Professional Practice Gap in Healthcare Dissemination and Implementation:

Applications for Mental Health”, The Zucker Hillside Hospital, A division of North Shore, Long

Island Jewish Health System, Department of Psychiatry, Glen Oaks, NY. April 26, 2017.

3. Speaker, “Dissemination and Uptake of CER” in the conference Comparative Effectiveness and

Patient-Centered Outcomes Research: Enhancing Uptake and Use by Patients, Clinicians and

Payers, sponsored by the Academy of Managed Care Pharmacy and the PhRMA Foundation,

Washington, D.C., January 26-27, 2017

4. Webinar, “An Introduction to Implementation Science”, Palliative Care Research Cooperative

Group Webinar, Denver, CO, July 13, 2016.

5. Speaker, “An Introduction to Implementation Science”, Palliative Care Research Cooperative

Group Investigator Meeting, Denver, CO, March 24, 2016.

6. Speaker, “Metabolic Screening: Prioritizing Implementation Strategies for Mental Health”

(findings from R21 MH097045). SMINET Learning Consortium: Applying Evidence to Improve

Care and Outcomes in Severe Mental Illness AHRQ 1R18HS023258, February 22, 2016.

7. Symposium, Morrato EH, Sheridan S, Miller T. “Implementation of Appropriate Use of Clinical

Preventive Services: Setting a National Research Agenda”. Agency for Healthcare Research and

Quality Annual Research Meeting with Academy Health, Arlington, VA. October 5, 2015.

8. Speaker, Public Workshop on Risk Evaluation and Mitigation Strategies: Understanding and

Evaluating Their Impact on the Health Care Delivery System and Patient Access, Silver Spring,

MD, October 5-6, 2015, Docket No. FDA-2013–N–0502

9. Speaker, FDA meeting with the Conjoint Committee on Continuing Education Long-Acting

Opioid Analgesics REMS Meeting, Accreditation Council for Continuing Medical Education

Office, Washington, D.C., July 22, 2015.

10. Speaker, “Metabolic Screening: Prioritizing Implementation Strategies for Mental Health

Patients”. Missouri CMHC Healthcare Home Operations Meeting. August 18, 2014.

11. CME Symposium, Miller T, Harris R, Baker D, and Morrato EH. “The Importance of

Population Thinking in Prevention” Preventive Medicine 2014. New Orleans, LA, February 19-

22, 2014.

12. Speaker, “Marketing: What Can We Learn to Improve Health Dissemination and

Implementation?” University of Washington Centers for Comparative & Health Systems

Effectiveness, CHASE Alliance. Seattle, WA, March 11, 2013.

13. CME Lecturer, “Metabolic Monitoring among Persons with Mental Illnesses: Lessons Learned,

Insights for Future Direction”, Physical Health and Behavioral Health Integration: Preventing

Diabetes among People with Mental Illness. APS Healthcare and Maine Department of Health

and Human Services Data Forum and the Center for Health Services Research on

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Pharmacotherapy, Chronic Disease Management, and Outcomes and the Center for Education

and Research on Mental Health Therapeutics, Rutgers University. January 31, 2013.

14. Panelist, Expert Workshop on Strengthening Risk Evaluation and Mitigation Strategies (REMS)

through Systematic Analysis, Standardized Design, and Evidence-Based Assessment. The

Engelberg Center for Health Care Reform, Brookings Institution, Washington, DC, September

25, 2013.

15. Panelist, Expert Workshop on the Safety and Long-Term Efficacy of Extended-Release and

Long-Acting Opioid Analgesics, co-hosted by the FDA’s Center for Drug Evaluation and

Research and the Clinical Trials Transformation Initiative (CTTI), Silver Spring, MD, August 12-

13, 2013.

16. Contributor, principles for good comparative effectiveness research, as published in: The GRACE

Checklist for Rating the Quality of Observational Studies of Comparative Effectiveness: A Tale

of Hope and Caution. Dreyer NA, Velentgas P, Westrich K, Dubois R. J Manag Care Pharm.

2014; 20(3):301-8.

17. Panelist, Public Workshop on “Risk Evaluation and Mitigation Strategy (REMS) Assessments:

Social Science Methodologies to Assess Goals Related to Knowledge” Public Workshop, Silver

Spring, MD, June 7, 2012, Docket No. FDA-2012-N-0408

18. Speaker, “Mixed methods in health services research to understand real-world acceptance of

safety recommendations for pscyhopharmacologic treatments” in the symposium on “Balancing

Benefits, Risks and Cost for New Treatments in Vulnerable Populations: Lessons from Child

Psychiatry on the Need for a New Standard of Diverse Methodologies”. Co-Chairs: Correll C

and Newcomer JW. Panelists: Arango C, Nicol G, Morrato E, Kymes S. 51st American College

of Neuropsychopharmacology (ACNP) Annual Meeting in Hollywood, FL, December 2-6, 2012.

19. CME lecturer, “Metabolic Monitoring: Current Knowledge, Future Directions”, Integrating

Behavioral Health and Primary Care: Antipsychotic Medications and Cardiometabolic

Monitoring. CalOptima, Beacon Health Strategies, Orange County Health Care Agency, and the

Center for Health Services Research on Pharmacotherapy, Chronic Disease Management, and

Outcomes and the Center for Education and Research on Mental Health Therapeutics, Rutgers

University. Orange County, CA, June 13, 2012.

20. Speaker, “Dissemination and Implementation of CER Evidence: What Can We Learn from the

Consumer Products Industry?” DARTNet Comparative Effectiveness Research (CER) Learning

Group, May 24, 2012.

21. Speaker, “Drug Safety Policy in the U.S.: Current Direction and Public Health Considerations”

Mental Health Concentration Seminar, Rollins School of Public Health, Emory University,

January 25, 2012.

22. Speaker,“Diffusion of Drug Warnings Among Physicians: Getting the most out of electronic

patient data” U.S. Food and Drug Administration Center for Drug Evaluation and Research,

Office of Surveillance and Epidemiology Seminar Series, Silver Spring, MD, June 23, 2011.

23. Think Tank Leader, Morrato EH, Marosits M, Dearing JW. Social Network Science and Social

Media Tools, 4th Annual National Institutes of Health Conference on the Science of

Dissemination and Implementation, Bethesda, MD, March 21-22, 2011.

24. Panel Discussant, Eggleston M, Frasso R, Harris HS, Masterson EA, Morrato EH, Navarro

Silvera S. “Everything you ever wanted to know about being Certified in Public Health, but didn't

know who to ask" 138th American Public Health Association Annual Meeting, Denver, CO

November 6-10, 2010.

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25. Plenary Panel, Morrato EH, “Synthesis, generation and translation of comparative effectiveness

evidence and patient-centered outcomes research” in “Health Care Reform: How will we measure

progress?” The Culture of Data 2010: Health Reform and Health Disparities: Where from here?,

U.S. Department of Health and Human Services U.S. Public Health Service Region VIII, The

Arvada Center for the Performing Arts, Arvada, CO, October 8, 2010.

26. Speaker, Morrato EH, “Diffusion of Drug Warnings The Case Example of Antipsychotics and

Metabolic Risk”, Rocky Mountain Poison Control and Drug Center, Denver Health Association,

Denver, CO, September 2, 2010.

27. Symposium Speaker, Newcomer JW, Haupt D, Morrato EH, Parks J. “Why psychiatry is a

branch of medicine: an update on screening and monitoring cardiometabolic risk during mental

health treatment.” 60th Institute on Psychiatric Services. Chicago, IL, October 2-5, 2008.

28. Visiting Professor, Morrato EH, “Atypical antipsychotic drugs and metabolic testing: Assessing

response to the FDA warnings”, U.S. Food and Drug Administration Center for Drug Evaluation

and Research (CDER) Visiting Professor Lecture Series (VPLS), Rockville, MD, July 2008.

29. CME Poster Presentation, Morrato EH, Newcomer JW, Kamat S, Baser O, Harnett J, Cuffel B.

Impact of the atypical antipsychotic FDA Warning on risk of hyperglycemia and diabetes and

metabolic monitoring practices. NCDEU CME Poster Session 2008. Best research posters

presented at the 2008 NCDEU (New Clinical Drug Evaluation Unit) Meeting. CME Institute,

Physicians Postgraduate Press, Inc., The Journal of Clinical Psychiatry, October 2008.

30. CME Lecturer, Morrato EH, “Prevalence of baseline serum glucose and lipid testing in users of

second-generation antipsychotic drugs: A retrospective, population based study of Medicaid

claims data”, Schizophrenia CME E-Journal Club, Editor: John M. Kane, Albert Einstein College

of Medicine, May 2008.

31. CME Lecturer, Morrato EH, “Physical Activity in U.S. Adults with Diabetes and At Risk For

Developing Diabetes”, Primary Care Edition of the Cardiometabolic E-Journal Club, Editor:

Jorge Plutzky, Brigham and Women's Hospital, Harvard Medical School, January 2008.

32. Speaker, Morrato EH, “Drug safety: Can it be managed?” Graduate Summer Institute of

Epidemiology and Biostatistics Seminar Series, The Johns Hopkins Bloomberg School of Public

Health, Baltimore, MD, June 2007.

33. Speaker, Morrato EH, “Epidemiology of pediatric surgery” Pediatric National Surgical Quality

Improvement Program (NSQIP): protocol development meeting, American College of Surgeons,

Chicago, IL, April 2007.

34. Speaker, “Impact of Nefazodone (Serzone®) Hepatic Risk Minimization Recommendations: A

Case Study Evaluation of an FDA Boxed Warning”, Office of Drug Safety Research Seminar,

U.S. Food and Drug Administration, Rockville, MD, June 2006.

REGIONAL AND LOCAL

1. Speaker, “Best Practices on Open Innovation”, Silicon Flatirons Roundtable: Building a Great

Health Care Innovation Ecosystem, Denver, CO, June 2017.

2. Speaker, Morrato EH, Thomas D. “Using Big Data for Dissemination and Implementation

Science Research: Linking Survey, Claims, and Geospatial Data Analyses to Study Diabetes

Screening Implementation in Missouri Medicaid Patients with Mental Illness”, Insights and

Innovation in Improving Health Seminar Series, Adult and Child Consortium for Health

Outcomes Research and Delivery Science, University of Colorado Anschutz Medical Campus,

Aurora, CO, April 2017

3. Speaker, “FDA, Prescription Drugs and You”, Tuesday Morning Class, Denver, CO, December 2015.

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Elaine H. Morrato

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4. Speaker, “Pulling Back the Curtain: the FDA, Prescription Drugs, and You”, The University of

Colorado Boulder Directors Club, Vail, CO, June 2015.

5. Speaker, “Dissemination and Implementation Science: Resources and Opportunities”,

Department of Medicine Faculty Conference on Research and Innovation, University of Colorado

Anschutz Medical Campus, January 2014.

6. Workshop Faculty, Rabin B, Morrato EH. “Dissemination and Implementation Science and

Practice 101” Skill-Building Session, Public Health in the Rockies Conference, Breckenridge,

CO, September 2013.

7. Speaker, “The Field of Healthcare Marketing: Implications for Dissemination and

Implementation Practice”, Insights and Innovation in Improving Health Seminar Series, Center

for Research in Implementation Science and Prevention (CRISP), University of Colorado,

Anschutz Medical Campus (January 2013)

8. Speaker, “Dissemination and Implementation”, Qualitative Methods Showcase, University of

Colorado, Anschutz Medical Campus (October 2012)

9. Speaker, “Questions concerning periodontal disease prevalence in adolescents with diabetes:

clinical and health education implications”, Colorado Health Outcomes Research Seminar,

University of Colorado Denver, Aurora, CO (November 2010)

10. Speaker, Barnard J, Morrato EH “Caregivers’ and Relatives’ Expectations for Spinal) Surgery

(CARES) Study”, Colorado Health Outcomes Research Seminar, University of Colorado Denver,

Aurora, CO (February 2009).

11. Speaker, “Influences of Individual and Geographic Factors on Drug Safety Practices:

Applications for Antipsychotics and Diabetes Risk”, Colorado Health Outcomes Methods and

Applications Seminar, University of Colorado Denver, Aurora, CO (January 2009).

12. Speaker, Benton K, Morrato EH “Epidemiology of Pediatric Surgery: Results from KID 2003”,

Colorado Health Outcomes Research Seminar, University of Colorado Denver, Aurora, CO

(April 2008)

13. Speaker, “Understanding Quality of Life issues for children undergoing spinal fusion surgery for

scoliosis: the special case of children with neuromuscular disorders”, Qualitative Methods

Research Forum, University of Colorado Denver, Denver, CO (November 2007)

14. Speaker, “PHIS and KID: Secondary data sources for pediatric hospitalization outcomes”, Colorado

Health Outcomes Research Seminar, University of Colorado at Denver and Health Sciences Center,

Aurora, CO (April 2007)

15. Speaker, “Specificity and sensitivity: Implications for clinical decision making and research” Rehab

Science and Engineering Consortium (RSEC) Seminar, University of Colorado at Denver and Health

Sciences Center, Denver, CO (April 2007)

16. Speaker, “Evaluating Physician Adoption of FDA Drug Warnings: How do we get the most out of

administrative claims data?” Department of Preventive Medicine Research Seminar, University of

Colorado at Denver and Health Sciences Center, Denver, CO (January 2007)

17. Guest Speaker, “How I use statistics in my job”, Bergen Valley Elementary School, Evergreen, CO

18. Speaker, “Lessons Learned from Consumer Product Research” Qualitative Research Methods

Forum, University of Colorado at Denver and Health Sciences Center, Aurora, CO (November 2006)

19. Speaker, “From MEPS to Medicaid: Outcomes Research Learning in Diabetes and Mental Health”

Fellowship Seminar, Department of Clinical Pharmacy Seminar Series, University of Colorado at

Denver and Health Sciences Center, Denver, CO (July 2006)

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20. Speaker, “Pharmaceutical Risk Management Evaluation”, Colorado Health Outcomes Methods and

Applications Seminar, University of Colorado at Denver and Health Sciences Center, Aurora, CO

(February 2006)

21. Guest Speaker, “Food nutrition and how to read and understand food labeling”. Bergen Valley

Elementary School, Evergreen, CO (Spring Semester, 2005 and 2006)

22. Speaker, “Ethical Issues in Drug Product Risk Assessment and Communication” Western Drug

Safety and Pharmacoepidemiology Conference. Napa, CA, October 2005.

23. Speaker, “Impact of Relabeling on Nefazodone (Serzone®) Prescribing: A Risk Minimization

Evaluation”, First Western Pharmacoeocnomics Conference. Salt Lake City, UT, March 2005.

TEACHING RECORD

AWARDS AND RECOGNITION

2013 Training the Next Generation of Leaders in Clinical Preventive Services: Profiles from

the AHRQ Research Centers for Excellence. November 2013. Agency for Healthcare

Research and Quality, Rockville, MD. http://www.ahrq.gov/professionals/prevention-

chronic-care/decision/research-centers/rce_profile_morrato.html

Also see: Achievements in Prevention: Training to Implement Clinical Preventive

Services at http://www.ahrq.gov/sites/default/files/wysiwyg/professionals/prevention-

chronic-care/decision/research-centers/training_professionals.pdf

2012 “Science Meets Writing: Health science instructors utilize Writing Center to develop student

skills” by Amy Vaerewyck. Spotlight Stories. University of Colorado Denver | Anschutz

Medical Campus. October 14, 2012.

http://www.ucdenver.edu/about/newsroom/spotlight/students/Pages/Public-Health-Writing.aspx

2012 President’s Excellence in Teaching Award, Colorado School of Public Health, University

of Colorado Anschutz Medical Campus, Aurora, CO

NATIONAL CURRICULA DEVELOPMENT AND EDUCATION

2017 Invited Adjunct Instructor, National Innovation-Corps (I-Corps™) Training Program,

National Science Foundation, Denver, CO, July 30 – September 15, 2017.

2017 Invited Participant, Training the Next Generation of Implementation Researchers for

Health Equity Workshop, Center for Translation Research and Implementation Science

(CTRIS), National Heart, Lung, and Blood Institute (NHLBI), National Institutes of

Health, Bethesda, MD, August 30-31, 2017.

2016-2017 Workshop Faculty, Pre-Conference Course: Introduction to Therapeutic Risk Management

33rd International Conference on Pharmacoepidemiology & Therapeutic Risk

Management (ICPE), Montreal Canada, August 26-29, 2017

32nd International Conference on Pharmacoepidemiology & Therapeutic Risk

Management (ICPE), Dublin, Ireland, August 25-28, 2016.

2015 Developed and Delivered Invited Workshop, “Introduction to Implementation Science”,

American Academy of Pediatrics, Chicago, IL, April 1, 2015.

2014 Invited Participant, Conference for Developing Curricula for Teaching Patient Centered

Comparative Effectiveness Research sponsored by the Agency for Healthcare Research

and Quality, the Patient Centered Outcomes Research Institute, Pew Charitable Trust, and

the PhRMA Foundation, Washington, D.C., January 28-29, 2014.

http://www.ahrq.gov/professionals/prevention-chronic-care/decision/research-centers/rce_profile_morrato.html

http://www.ahrq.gov/professionals/prevention-chronic-care/decision/research-centers/rce_profile_morrato.html

http://www.ahrq.gov/sites/default/files/wysiwyg/professionals/prevention-chronic-care/decision/research-centers/training_professionals.pdf

http://www.ahrq.gov/sites/default/files/wysiwyg/professionals/prevention-chronic-care/decision/research-centers/training_professionals.pdf

http://www.ucdenver.edu/about/newsroom/spotlight/students/Pages/Public-Health-Writing.aspx

Updated: Sep 2017

Elaine H. Morrato

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2013 Item Writer, Epidemiology and Health Policy & Management, for Board Certification in

Public Health, National Board of Public Health Examiners

2011 Invited training module, annotated bibliography, and self-assessment questions on

“Pharmacovigilance and FDA Drug Safety Policy”, Chronic Illnesses, Pharmacotherapy

Self-Assessment Program, Seventh Edition, for Board Certification in Clinical Pharmacy,

American College of Clinical Pharmacy

2006 Developed and Delivered Invited Workshop, “Pharmaceutical RiskMAP Evaluation”,

Merck & Co., Inc.

GRADUATE CURRICULA DEVELOPMENT (Colorado School of Public Health)

2014-2015 Program Director, Certificate of Professional Achievement in Health Industry Analytics Pilot

Program, Colorado School of Public Health, CU South Denver

2009-2010 Steering Committee, Doctor of Public Health Program, Colorado School of Public Health

GRADUATE COURSES TAUGHT AND DEVELOPED (Colorado School of Public Health)

2015, 2016 Introduction to Health Systems, Management and Policy (HSMP 6601). University of

Colorado (70-80 students) and Colorado State University (35 students).

2015 Data-Driven Quality Improvement (HSMP 6643) (8-10 students)

2013 - 2014 Introduction to Health Policy Analysis and Communication (HSMP 6616). (20 students)

2011-2014 Health Policy (HSMP 6605) (20-30 students).

2011 Co-Instructor, GIS for Public Health Research and Practice (EHOH 6621). (20 students)

2011 - Independent Study: Health Systems, Management and Policy (HSMP 6840)

Kelsey Ford (MPH candidate, Community Behavioral Health), 2016

Project: Innovation-Corps Customer Discovery for a Pediatric mHealth Intervention

Erin Seedorf (DrPH candidate, Community and Behavioral Health), 2012

Project: Methods for Evaluating Local Policy Development and Implementation

Michele Shikomura (M.P.H. candidate, Epidemiology), 2011

Publishable paper: Health Care Reform: Impact to Service Providers and a Vulnerable

Population of Adults Living with HIV. An analysis of the Ryan White CARE Act in the

Part A Denver Transitional Grant Area

GUEST LECTURES TAUGHT AND DEVELOPED (University of Colorado Anschutz Medical Campus)

2015-2017 Clinical Reasoning and Decision Making (PRDO 7800, iPharmD® program). Topic:

Clinical Decision Making Process: Government, Law, and Industry. Skaggs School of

Pharmacy and Pharmaceutical Sciences (25 students)

2015 Evidence Based Medicine (MPAS 6701) Topic: comparative effectiveness research.

Child Health Associate / Physician Assistant Program. School of Medicine. (75 students)

2015, 2017 Pharmacoepidemiology (PHSC 7615 / EPID 7615) Topics: FDA Drug Approval, Risk

2014-2016 Clinical Reasoning and Decision Making (PHRD 6965). Topic: Decision Making: Drug

Warnings. Skaggs School of Pharmacy and Pharmaceutical Sciences (125-150 students)

2014, 2016 Dissemination and Implementation Research in Health (CLSC 7653). Topics: The Field of

Healthcare Marketing: Implications for Dissemination and Implementation Practice and

Health Policy Implementation. Clinical Science Graduate Program (8-10 students)

Updated: Sep 2017

Elaine H. Morrato

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2012 - 2013 GIS Application in Health Policy. GIS for Public Health Research and Practice (EHOH

6621). Colorado School of Public Health (25 students)

2012 Research Methods using Secondary Datasets (EPID 7605). Topic: Secondary Datasets

Used in Health Services Research. Colorado School of Public Health (10 students)

2011 Transition to Residency and Beyond (ICC 8004). Topic: FDA Drug Regulation. School

of Medicine (est. 125 students)

2010, 2011 Health Services Research in Public Health and Health Policy Research (HSMP 6670).

Topic: Comparative Effectiveness Research in the U.S. Colorado School of Public

Health (5-10 students)

2009, 2011 Communication and Management. Skaggs School of Pharmacy and Pharmaceutical

Sciences and Colorado School of Public Health (8-10 students)

2009 Applied Database Research (PHSC 7622). Topic: Analyzing Medicaid Data. Skaggs

School of Pharmacy and Pharmaceutical Sciences (5 students)

2008 Special Topics in Outcomes Research (PHSC 7570). Topic: FDA, Risk Evaluation and

Mitigation Strategies (REMS), and Future Direction for Drug Safety Policy. Skaggs

School of Pharmacy and Pharmaceutical Sciences (3 students)

2008 Research Methods (PHSC 7621). Topic: Medicaid Databases. Skaggs School of


2007 Biostatistics (PHRD 4400). Topic: Study Designs in Clinical Research. Skaggs School

of Pharmacy and Pharmaceutical Sciences (est. 125 students)

2006-2008 Cost Effectiveness Analysis and Pharmacoeconomics (PHRD 5400). Topic: U.S. Drug

Advertising and Patient-Reported Outcomes. Skaggs School of Pharmacy and

Pharmaceutical Sciences (est. 125 students)

2005-2008 Health Care Systems (PRMD/HSMP 6603). Topic: Drug Development and the History

of FDA Regulation. School of Medicine (est. 40 students)

2005, 2006 Biostatistics (PHRD 4400). Topic: Categorical Data: Comparing Groups. Skaggs

School of Pharmacy and Pharmaceutical Sciences (est. 125 students)

2005 Biostatistics (PHRD 4400). Topic: Descriptive Statistics. Skaggs School of Pharmacy

and Pharmaceutical Sciences (125 students)

2004 Biostatistics (PHRD 4400). Topic: Hypothesis Testing and Power. Skaggs School of


OTHER GUEST LECTURES TAUGHT AND DEVELOPED

2007 Pharmacoepidemiology (340.617.11). Topic: Drug Safety & Risk Management. Epidemiology

and Biostatistics Summer Institute, Johns Hopkins Bloomberg School of Public Health

1992-1995 Qualitative Methods Instructor, corporate training course: “PRISM 101, Understanding

consumers and communicating with them”, The Procter & Gamble Company

1992, 1994 Instructor, Health Care Division Diversity program, The Procter & Gamble Company.

Updated: Sep 2017

Elaine H. Morrato

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RESEARCH WORKSHOPS DIRECTED (University of Colorado Anschutz Medical Campus)

2015 “Introduction to Pragmatic Trials”, Center for Research in Implementation Science and

Prevention (100 participants)

2013 “Introduction to Dissemination and Implementation Science Workshop”, Center for

Research in Implementation Science and Prevention (75 participants)

SEMINAR SERIES DIRECTED AND DEVELOPED (University of Colorado Anschutz Medical Campus)

2013-2015 Insights and Innovation in Improving Health Seminar Series, Colorado Research on

Implementation Science Program

2006-2007 Outcomes Research Methodology Series, Department of Pediatric Surgery, Children’s

Hospital Colorado

TEACHING ASSISTANT

2003 Biostatistical Analysis Workshops I and II (140.613 and140.614). Winter Institute, Johns

Hopkins Bloomberg School of Public Health

ADVISING & MENTORING

K-Award Mentees

2015-2020 Beth McManus, PT, MPH, ScD (primary mentor)

Associate Professor, Department of Health Systems, Management and Policy, Colorado

School of Public Health, University of Colorado Anschutz Medical Campus

Comprehensive Opportunities in Rehabilitation Research Training (CORRT), NIH K12

HD055931, Washington University, St. Louis

Project: Understanding and Improving Early Intervention Therapy Access, Service Use,

and Outcomes

2017-2020 James A. Feinstein, MD, MPH (drug safety content mentor)

Assistant Professor, Department of Pediatrics, University of Colorado Anschutz Medical Campus

Colorado Clinical and Translational Science Institute KL2 (K12) Research Scholar

Program, NIH/NCATS Colorado CTSA Grant Number KL2 TR001080

NIH/NICHD Mentored Patient-Oriented Research Career Development Award, K23

HD091295 (Pending, Scored: 10)

Project: Enhancing Medication Safety in Children with Polypharmacy using Parent-

Reported Symptom Assessments

2010-2015 Ginger E. Nicol, MD (health services research mentor)

Assistant Professor, Department of Psychiatry, Washington University in St. Louis

National Institute of Mental Health Mentored Patient-Oriented Research Career

Development Award (K23MH092435)

Project: Measurement of Cardiometabolic Risk in Antipsychotic-Treated Children

T32 Mentees and Other Post-Doctoral Fellows

2016-2018 Demetria McNeal, PhD MBA (primary mentor)

Post-Doctoral Fellow in Dissemination Science in Health

Adult and Child Consortium for Health Outcomes Research and Delivery Science

University of Colorado Anschutz Medical Campus

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2016-2018 Nicole Amoyal Pensak, PhD (implementation scientist mentor)

Institutional NRSA (T32) Palliative Care and Aging Research Training


Project: A Randomized Controlled Trial of Mobilized Psychoeducation and Skills Based

Intervention (PEP-PAL) for Caregivers of Patients with Advanced Illness

2014-2016 Katherine Sauder, PhD (implementation science mentor)

National Institute for Diabetes and Digestive and Kidney Diseases, Nutrition Training

Grant (T32 DK07658-27) and Center for American Indian and Alaska Native Diabetes

Translational Research (CAIANDTR), P30 DK092923


Project: Reducing Risk Factors for Type 2 Diabetes in American Indian Youth: Tribal

Turning Point

2012-2014 Lauren Garfield, PhD (health services research mentor)

National Heart, Lung, and Blood Institute (T32 HL007456-28)

Washington University in St. Louis

Project: Metabolic Screening Rates in Adults and Youth Receiving Antipsychotic Medication

Doctoral Dissertation Committees, Colorado School of Public Health

2016- Kimberly Lind, MS (committee member)

Ph.D. in Health Services Research

2013-2017 Erin Seedorf, MPH (committee member)

Dr.P.H. in Community and Behavioral Health

Dissertation: Assessing the Effects of Policy Networks on Local Public Health Tobacco

Control Policy Networks Initiatives

2010-2016 KaraAnn Clouse, MSPH (mentor)

Ph.D. in Health Services Research

Dissertation: The Effect of Medical Home Legislation on Colorado’s Pediatric Practices

and Health Services Use in Children

Doctoral Dissertation Committee, Arnold School of Public Health, University of South Carolina

2012-2014 Georges Nahhas (committee member)

Ph.D. in Epidemiology

Arnold School of Public Health, University of South Carolina

Dissertation: Periodontal Disease and Obesity among Youth with Type 2 Diabetes Mellitus

Masters Thesis

2008 Valerie A. Orlando, RDH (reader)

Masters in Clinical Education

University of New South Wales

Updated: Sep 2017

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RESEARCH RECORD: ACADEMIC

PI, SITE PI OR CENTER GRANT CORE LEADER

PENDING

Colorado Clinical and Translational Sciences Institute (CCTSI) 5/1/2018 – 4/30/2023

NIH / NCATS (PI: Sokol) Overall Impact Score : 13

Purpose: The Clinical and Translational Science Award supports Colorado’s institutional home for

research and training in clinical and translational sciences. This seeks continuation of the CCTSI.

Roles: PI, Optional Function: Partnering for Innovation, Value Optimization, and Accelerated

Translation (PIVOT) (15% effort)

Core Lead, Dissemination (20% effort)

ACTIVE

CTSA Accrual to Clinical Trials (ACT) 10/1/2016-5/31/2021

NIH / NCATS UL1 TR001857-S, Administrative Supplement (PI: Reis)

Purpose: This administrative supplement supports the national dissemination of an EHR-based

informatics solution to improve clinical trial cohort discovery and recruitment creating an ACT

research Network across 60+ academic medical research centers in the U.S.

Role: Site PI and Dissemination Lead (15% effort)

Amount: $10 MM (Total Costs 5 years)

Center for American Indian and Alaska Native Diabetes 8/1/16–7/31/2021

Translational Research (CAIANDTR) P30 DK092923, National Institute of Diabetes and Digestive and Kidney Diseases (PI: Manson)

Purpose: To develop strategies and processes for translational research within the context of American

Indian/Alaskan Native health disparities specific to the prevention and management of diabetes

Role: Core Lead, Dissemination (3% effort)

Amount: $5 million (Total Direct Costs 10 Years)

Patient Integrated Value and Organizational Transformation Center 3/1/2016-2/28/2021

University of Colorado Dean of Medicine Transformational Award (PIs: Ho/Kutner/Schilling/Kahn)

Purpose: To link research and clinical innovation to transform our health system and espouse the

principles of patient-centeredness, increased quality, and lower costs.

Role: Core Lead, Dissemination (10% effort, suspended when assumed Interim Dean appointment)

Amount: $20 MM (Total Costs 5 years)

I-Corps Train-the-Trainer Program 04/01/2017-3/31/2019

NIH / NCATS UL1TR001417-02S, Administrative Supplement (PI: Kimberly)

Purpose: This administrative supplement supports adaptation of the NSF (I-Corps™) program for

clinical and translational scientists and its dissemination across the CTSA consortium to

provide researchers the skills necessary for commercializing biomedical innovation.

Role: Site PI (5% effort)

Amount: $850,000 (Total Costs 2 years)

Updated: Sep 2017

Elaine H. Morrato

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State Tobacco Education and Prevention Partnership (STEPP) 5/1/2016-5/31/2018

Tobacco Training and Technical Assistance

16 FHLA 79830, Colorado Department of Public Health and Environment (PI: Morrato)

Purpose: To "provide funding for community-based and statewide tobacco education programs designed

to reduce initiation of tobacco use by children and youth, promote cessation of tobacco use

among youth and adults, and reduce exposure to secondhand smoke”.

Role: PI (5% effort)

Amount: $824,947 (annual direct costs)

Colorado Clinical and Translational Sciences Institute (CCTSI) UL1TR001082, TL1TR001081, KL2TR001080, NIH / NCATS (PI: Sokol) 10/1/2013 – 4/30/2018

Purpose: The Clinical and Translational Science Award supports Colorado’s institutional home for

research and training in clinical and translational sciences.

Roles: Core Lead, Pragmatic Trials and Dissemination/Implementation Research (20% effort)

Core Lead, Innovation-Corps (I-Corps) training program for commercialization (15% effort)

Amount: $51.7 MM (Total Costs 5 years)

COMPLETED

Implementation Research Agenda: Appropriate Use of Clinical Preventive Services

R13 HS23723-01, AHRQ (PI: Morrato) 11/15/2014–11/14/2016

Purpose: This small conference developed a national implementation science research agenda to address

issues of under-, over- and inequitable use of clinical preventive services in primary care.

Role: PI

Amount: $33,000 (conference costs)

Metabolic Screening: Prioritizing Implementation Strategies in Mental Health 12/1/2012–11/30/2015

R21 MH 097045, NIMH (PI: Morrato)

Purpose: This project investigated provider and practice factors affecting the implementation of diabetes

and dyslipidemia screening guidelines in persons with mental illness taking antipsychotics.


Amount: $275,000 (total direct costs)

Center for Research in Implementation Science and Prevention (CRISP) 10/1/2011 – 9/30/2015

1 P01 HS021138-01, AHRQ (PI: Kempe)

Purpose: This project brought together experts in primary care and public health delivery to conduct

research on ways to increase implementation of clinical preventive services within primary care.

Role: Collaborative Scientific Lead (co-PI equivalent) (20% effort)

Core Lead, Training and Education (10% effort)

Amount: $3,158,296 (direct costs)

Center for Native Oral Health Research (CNOHR). 6/1/2008 –5/31/2015

U54 DE019259-02, National Institute of Dental and Craniofacial Research, NIH (PI: Albino)

Purpose: This Center focused on reducing oral health disparities in American Indians and Alaskan

Natives through community-based interventions

Role: PI, “R21-equivalent” development project. Transferred project after receiving K12 award.

Amount: $10.7 million

Updated: Sep 2017

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Children’s Outcomes Research (COR) Program 1/1/2007 – 5/31/2015

The Children’s Hospital Research Institute (PI: Kempe)

Purpose: This center program conducted pediatric health outcomes research and mentored clinical faculty.

Role: Associate Director (2009-2013), Co-I (2013-2105)

Core Lead, Comparative Effectiveness Research Core (2010-2013)

Amount: $1.5 million (2007-2011); $2.6 million (2012-2015)

Scalable Architecture for Federated Therapeutic Inquiries Network (SAFTINet) 10/1/2010–9/30/2013

Agency for Healthcare Research and Quality (R01 HS019908-01) (PI: Schilling)

Purpose: This multi-state registry project combined clinical data with Medicaid claims to support patient-

centered comparative effectiveness research with safety-net populations and stakeholders.

Role: Core Lead, CER methods (transferred role when the K-12 award was funded)

Amount: $4.6 million (direct costs)

SocioWorks: Integrated web-platform for social network analysis 9/1/2010 – 8/31/2013

R44 AG038316, National Institute on Aging, NIH (PI: Tien)

Purpose: This SBIR project created a technologically and organizationally scalable web application

toolset for social network methods and their application to improving health and productivity.

Role: Site PI, Demonstration Lead: Policy Application (funded at 20% effort, converted to research

staff support when the K-12 award was funded)

Amount: $78,000 (direct costs for our site). Approx. $2.1 MM (total costs for the award)

Colorado CER and Safety Scholars Program: Mental Health, CVD, and Methods 7/1/2010–6/30/2013

K12 HS019464, AHRQ (PI: Libby)

Purpose: This K12 program in Comparative Effectiveness Research (CER) addressed research capacity

and improve the CER workforce and leadership pools of the future. My project was entitled

“Accelerating the Diffusion of CER Evidence into Clinical Practice”.

Role: CER K12 Scholar PI (75% effort)

Amount: $4.5 million (total direct costs)

Comparative effectiveness of paliperidone palmitate 7/31/2012 – 8/1/2013

when used in a real-world clinical setting

Janssen Pharmaceuticals, Inc. (PI: Morrato)

Purpose: This project disseminated scientific results from a comparative effectiveness research study of a

new long-acting antipsychotic medication in Missouri Medicaid compared

Role: PI (20% effort, converted to research staff support while funded by the K-12 award)


Comparative effectiveness of paliperidone palmitate 1/1/2011 – 12/31/2012

when used in a real-world clinical setting

Janssen Pharmaceuticals, Inc. (PI: Lenze)

Purpose: This project described the diffusion a new long-acting antipsychotic medication in Missouri

Medicaid and compare its clinical and costs effectiveness compared to oral medications.

Role: Site PI (20% effort, converted to research staff support when the K12 award was funded)


Updated: Sep 2017

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Prescriber Education Curriculum-Impact and Results (PEC-IR) Study 5/1/2011 – 4/30/2012

MedScape (PI: Parks)

Purpose: This project compared the effectiveness of three continuing education strategies on improving

metabolic screening in Missouri Community Mental Health Centers

Role: Site PI, health services data analysis

Amount: $11,000

Periodontal health in adolescents with Type 1 Diabetes Mellitus 91//2006 – 8/31/2010

MO1-RR00069, NCRR, NIH, Delta Dental Frontier Center, Procter & Gamble (unrestricted gift)

Purpose: This epidemiology study estimated the prevalence of peridontal disease in adolescents with Type

1 diabetes in relationship to oral health knowledge, oral hygiene behaviors and diabetes control



Evaluating the impact of FDA warnings and consensus recommendations 9/1/2006 –12/31/2008

on metabolic screening and monitoring for patients initiating atypical antipsychotic medication

Pfizer, Inc.

Purpose: To determine rates and determinants of metabolic testing among patients receiving antipsychotic

medication in 3 Medicaid programs and whether rates changed following drug warnings


Amount: $119,000

Drug risk communication: physician perceptions. 9/1/2005 –8/31/2006

Johns Hopkins Bloomberg School of Public Health, Dissertation Award

Purpose: To qualitatively explore drug safety perceptions and information sources among physicians

Role: PI

Amount: $5,000 (research supplies)

CO-INVESTIGATOR

ACTIVE

IMPlementation to Achieve Clinical Transformation (IMPACT): 09/01/2017-08/31/2022

The Colorado Training Program

1 K12 HL137862-01, NIH / NHLBI (Co-PI: Glasgow, Havranek) Impact Score: 29

Purpose: To develop “T4” (clinical translation to population) scholars through training in key

competencies for dissemination and implementation research and in-depth tailored mentorship.

Role: K12 Faculty (3-5% effort)

Amount: TBD

Reducing Risk Factors for Type 2 Diabetes in American Indian Youth: 9/01/2017-08/31/2022

Tribal Turning Point 1 R01 DK115434-01, NIH / NIDDK (Co-PI: Dabelea, Sauder) Impact Score: 10

Purpose: This RCT evaluates a behavioral intervention on diabetes risk factors in 7-10 year old

American Indian children across three communities, and explores factors related to participant

engagement, program implementation, and potential for dissemination and sustained delivery.

Role: Co-I, dissemination and implementation scientist (8% effort)

Amount: TBD

Updated: Sep 2017

Elaine H. Morrato

Page 23

Problem-Solving Skills Training for Clinicians 04/15/2015-03/31/2020

Providing Psychosocial Care in Pediatric Oncology

R25 CA183725, NCI/NIH (Co-PIs: Sahler, Noll)

Purpose: This project aims to disseminate via a national training program an evidence-based

psychosocial skills training intervention which identifies coping strategies that facilitate the

adjustment of caregivers learning their child had been diagnosed with cancer.

Role: Co-Investigator, dissemination and implementation scientist (15% effort Year 1; 5% effort

years 2, 3, 4; and 20% effort year 5)

Amount: $310,594 (annual direct-prime)

COMPLETED

Maximizing Care Management Effectiveness in Primary Care 08/01/14-01/31/17

1R18HS022690-01, AHRQ (PI: Holtrop)

Purpose: This study investigated factors affecting care management implementation in primary care in

order to maximize the benefit of this new service in community-based primary care.

Role: Co-Investigator, dissemination and implementation scientist (2% effort)

Amount: $750,000 (total costs)

Pediatric Obesity and Type 2 Diabetes (T2D) 8/1/2015-7/30/2016

in American Indian Youth (PI: Sauder)

Pilot award from the Center for American Indian and Alaska Native Diabetes Translational Research

P30DK092923, NIDDK/NIH (PI: Manson)

Purpose: To investigate sustainable implementation of a pediatric nutrition program within the Navajo

Nation and plan for a larger dissemination and implementation research study.

Role: Co-Investigator, dissemination and implementation scientist (2% effort)

Amount: $50,000 (total)

SAFTINet: Optimizing Value and Achieving Sustainability 09/30/2013 – 03/31/2015

R01 HS022956, AHRQ (PI: Schilling)

Purpose: To enhance the capabilities of an existing data network, the Scalable Architecture for

Federated Translational Inquiries Network (SAFTINet), by improving its ability to conduct

comparative effectiveness research and ensure its financial sustainability.

Role: Co-Investigator, dissemination and implementation scientist (funded at 15%)

Amount: $750,000 (total costs)

Pediatric National Surgical Quality Improvement Program 9/1/2006 – 8/31/2009

American College of Surgeons (Site PI: William Henderson)

Purpose: To provide statistical and epidemiological guidance on protocol development and pilot-testing of

the Pediatric National Surgical Quality Improvement Program (Pediatric NSQIP)

Role: Co-Investigator, statistical core (20% effort)

Amount: $1.03 million (total costs)

Updated: Sep 2017

Elaine H. Morrato

Page 24

An evaluation of the FDA warnings on antidepressants and suicidality 5/1/2006 – 11/30/2006

on patterns of care for depression in U.S. managed care enrollees.

Eli Lilly and Company. (PI: Robert Valuck)

Purpose: To investigate whether antidepressant drug warnings had an effect on depression diagnosis,

treatment, and monitoring in pediatric and adult populations

Role: Co-Investigator (20% effort)

Amount: $350,000

Atypical antipsychotic treatment patterns in a multi-state 9/1/2004 – 8/31/2006

Medicaid population. Janssen Pharmaceuticals. (PI: Robert Valuck)

Purpose: To estimate the prevalence, determinants, and costs of antipsychotic polypharmacy in 5 states

Role: Co-Investigator (60% effort equivalent as a component of my Fellowship)

Amount: $250,000

CONSULTANT

ACTIVE

Methods Training in Patient-Centered Cancer Outcomes Research 6/1/1014 – 5/31/2019

1 R25 HS 023214-01, AHRQ (PI: Suarez-Almazor)

Purpose: The overall goal of this training program is to increase the nation’s workforce for conducting

cancer-related comparative effectiveness research and patient-centered outcomes research

through an innovative, accessible curriculum tailored to the needs and skills of the participants.

Role: Scientific Advisory Committee

SMINET: Applying Evidence to Improve Care and Outcomes in 7/1/2014-6/30/2018

Severe Mental Illness

1R18HS023258-01, AHRQ (PI: Crystal)

Purpose: SMINET will build on an established multi-state consortium to increase uptake, on a broad

scale, of selected evidence-based practices in the care of persons with severe mental illness that

are particularly high-impact targets for improving long-term health outcomes.

Role: Scientific Advisory Committee

COMPLETED

Building Networks of Engaged Parents for Patient-Centered Pediatric Research 4/1/2015-3/31/2017

Contract 1300-UCD, PCORI (PI: O’Leary)

Purpose: This project engaged patients, parents, clinicians, and other stakeholders in the collaborative

development of research questions and patient-centered research relevant to child health in the

PBRN setting.

Role: Leadership Advisory Board

Updated: Sep 2017

Elaine H. Morrato

Page 25

RESEARCH RECORD: PHARMACEUTICAL INDUSTRY

THE PROCTER & GAMBLE COMPANY

2000-2002 Azimilide Phase III (Registration) clinical development research program (class III

antiarrhythmia drug).

Role: Global R&D Program Lead

1997-1999 Azimilide Phase IIIb (Commercialization) clinical development and pharmacoeconomic

and epidemiology research program (class III antiarrhythmia drug).

Role: Global R&D Program Lead

1996-1997 Helidac® (bismuth subsalicylate/metronidazole/tetracycline hydrochlorid) Phase IIIb

(Commercialization) consumer research program (stomach/intestinal ulcer antibiotics).

Role: U.S.R&D Launch Lead

1994-1995 Asacol® (Mesalamine Delayed-Release) 5-year clinical development and manufacturing

cost savings program (inflammatory bowel disease drug).

Role: North American Technical Brand Manager

1992-1994 Cholysyl consumer and market understanding research (U.S., Germany, Mexico, and

Japan) (cholesterol-lowering drug).

Role: Global Product Development Lead: market evaluation

1992-1994 Metamucil® (psyllium) consumer understanding research program

Role: U.S. Product Development Team Lead: consumer understanding research

1992 Sunrise Smooth Metamucil® (psyllium) Sugar-Free Regular Flavor national launch

leader (constipation and cholesterol-lowering drug).

Role: U.S. Product Development Launch Lead

1990-1991 FDA approval of cyanoacrylate adhesive for Actisite® (tetracycline HCl). (device used

in combination with periodontitis site-specific antibiotic treatment)

Role: U.S. Product Development Lead

1989-1991 Actisite® (tetracycline HCl) Phase III clinical study (periodontitis site-specific

antibiotic). Pivotal clinical data supporting first regulatory approval in the U.S. and

Europe of site-specific drug therapy for periodontitis

Role: U.S. Product Development Lead

1989 Trade-off (conjoint analysis) study of preferred product attributes for site-specific drugs

to treat periodontitis: Understanding the needs of dentists and periodontists.

Role: PI

1989 Qualitative research study to understand the product needs of dentists and periodontists

for site-specific treatment of periodontitis.

Role: PI

1988 Clinical validation of gingivitis diagnostic testing (leukocyte esterase) using different

sampling methods of gingival crevicular fluid.

Role: PI

Updated: Sep 2017

Elaine H. Morrato

Page 26

BIBLIOGRAPHY

PEER-REVIEWED JOURNAL ARTICLES – CATEGORIZED BY AREA OF SCHOLARSHIP

Google Scholar H-Index = 20

52 Published articles. 23 first author. 8 senior author. 9 with student/mentees.

ǂ Senior author

§ Manuscript published with students, mentees

* Manuscript had an accompanying press-release or editorial from the journal or received notice from

a secondary medical news outlet (see CV Appendix B)

Mental Health Services Research

1. Morrato EH, Campagna EJ, Brewer SE, Dickinson LM, Thomas DSK, Miller BF, Dearing J,

Druss BG, Lindrooth RC. Metabolic Testing for Adults in a State Medicaid Program taking

Antipsychotics: Remaining Barriers to Achieving Population Health Prevention Goals. JAMA

Psych 2016 May 11. doi: 10.1001/jamapsychiatry.2016.0538. [Epub ahead of print]

2. Morrato EH, Brewer, S, Campagna EJ, Dickinson, LM, Thomas, DSK, Druss BG, Miller B,

Newcomer JW, Lindrooth RC. Glucose Testing for Adults Receiving Antipsychotics: A

Population-Based Prescriber Survey on Behaviors, Attitudes and Barriers in Medicaid Psych Serv

2016 Apr 1:appips201500181. [Epub ahead of print]

3. ǂ § Nicol GN, Campagna EC, Garfield L, Parks JJ, Newcomer JN, Morrato EH. Clinical Setting

and Management Approach Matters: Metabolic Testing Rates in Antipsychotic-Treated Youth

and Adults Psych Serv 2015 1:appips201400428. [Epub ahead of print].

4. ǂ Root ED, Thomas DSK, Campagna EJ, Morrato EH. Adjusting for Geographic Variation in

Observational Comparative Effectiveness Studies: A Case Study of Antipsychotics Using State

Medicaid Data BMC Health Serv Res [2014] BMC Health Services Research. 2014, 14:355 DOI:

10.1186/1472-6963-14-355.

5. Morrato EH, Parks J, Campagna EJ, Muser E, Thomas DS, Fang H, Doshi D. Comparative

effectiveness of injectable paliperidone palmitate versus oral atypical antipsychotics: early

postmarketing evidence. J Comparative Effectiveness Research 2014. Sep 24:1-11. [Epub ahead

of print]

6. ǂ Campagna E, Muser E, Parks J, Morrato EH. Methodological considerations in estimating

adherence and persistence for a long-acting injectable medication. J Manag Care Pharm 2014.

Jul;20(7):756-66.

7. Morrato EH. An update on lipid profile screening in second generation antipsychotic users in

the United States Clinical Lipidology 2012; 7(5): 509-523.

8. Gohlke JM, Dhurandhar EJ, Correll CU, Morrato EH, Newcomer JW, Remington G, Nasrallah

HA, Crystal S, Nicol G, Adipogenic and Metabolic Effects of APDS Conference Speakers,

Allison DB. Frontiers in Psychiatry 2012;3:62. Epub 2012 Jun 28.

9. Druss BG, Zhao L, Von Esenwein S, Morrato EH, Marcus SC. Understanding Excess Mortality

in Persons With Mental Illness: 17-Year Follow Up of a Nationally Representative US Survey.

Medical Care 2011 Jun; 49(6):599-604.

10. Morrato EH, Druss B, Hartung DM, Valuck RJ, Thomas D, Allen RR, Campagna E, Newcomer

JW. Small Area Variation in Metabolic Risk Management for Patients Initiating Second-

Generation Antipsychotics. Pharmacoepidemiology and Drug Safety 2010; 20:66-75. 2010 Nov 15.

Updated: Sep 2017

Elaine H. Morrato

Page 27

11. *§ Morrato EH, Nicol G, Maahs D, Druss B, Hartung DM, Valuck RJ, Allen RR, Campagna E,

Newcomer JW. Metabolic risk monitoring in children receiving second-generation antipsychotic

drugs Arch Ped and Adolesc Med, 2010 Apr;164(4):344-51.

12. Morrato EH, Newcomer JW, Kamat S, Baser O, Harnett J, Cuffel B. Metabolic screening after

the ADA’s Statement on antipsychotic drugs and diabetes Diabetes Care 2009; 32(6): 1037-1042.

13. Banta JE, Morrato EH, Lee SW, Haviland MG. Retrospective Analysis of Diabetes Care in

California Medicaid Patients with Mental Illness Journal of General Internal Medicine.

Jul;24(7):802-8. Epub 2009 May 5.

14. Morrato EH, Cuffel B, Newcomer JW, Lombard I, Kamat S, Barron J. Metabolic risk status and

second-generation antipsychotic drug selection: A retrospective study of commercially insured

patients. Journal of Clinical Psychopharmacology; 2009; 29(1): 26-32.

15. Morrato EH, Newcomer JW, Allen RR, Valuck RJ. Prevalence of baseline serum glucose and

lipid testing in users of second-generation antipsychotic drugs: A retrospective, population based

study of Medicaid claims data. J Clin Psychiatry. 2008; 69(2):316-22.

16. Valuck RJ, Morrato EH, Dodd S, Oderda G, Haxby DG, Allen RR. How expensive is

antipsychotic polypharmacy? Experience from five state Medicaid programs. Current Medical

Research and Opinion. 2007: 23(10): 2567-2576.

17. Morrato EH, Dodd S, Oderda G, Haxby DG, Allen R, Valuck RJ. Prevalence, utilization

patterns and predictors of antipsychotic polypharmacy: experience from a Multi-State

Medicaid Population (1998-2003). Clinical Therapeutics. 2007. Jan;29(1):183-95.

FDA Regulatory Science – Drug Safety

1. Dew K, Gardner, J, Morrato EH, Norris P, Chamberlain K, Hodgetts D, Gabe J. Public

Engagement and the Role of the Media in Post-Marketing Drug Safety: The Case of Eltroxin®

(levothyroxine) in New Zealand. Critical Public Health 2017

doi:10.1080/09581596.2017.1329520 [online]

2. § Feinstein JA, Morrato EH, Feudtner C. Prioritizing Pediatric Drug Research Using Population-

Level Health Data. JAMA Pediatrics 2017 Jan 1;171(1):7-8. doi:10.1001/jamapediatrics.2016.3462

3. Radawski C, Morrato EH, Hornbuckle K, Bahri P, Smith MY, Juhaeri J, Mol P, Levitan B,

Huang H-Y, Coplan P, Li J on behalf of the BRACE Special Interest Group. Benefit-Risk

Assessment, Communication and Evaluation (BRACE) throughout the Life Cycle of Therapeutic

Products: Overall Perspective and Role of the Pharmacoepidemiologist Pharmacoepidem Oct 12.

doi: 10.1002/pds.3859. [Epub ahead of print]

4. Morrato EH, Smith MY. Integrating risk minimization planning throughout the clinical

development and commercialization lifecycle: an opinion on how drug development could be

improved. Ther Clin Risk Manag 2015 Feb 26;11:339-48. doi: 10.2147/TCRM.S78202.

5. ǂ Smith MY, Morrato EH. Advancing the field of pharmaceutical risk minimisation through

application of implementation science best practices Drug Safety 2014 Jul 9. [Epub ahead of

print]

6. Morrato EH, Allison DB, FDA Approval of Obesity Drugs-- A Difference in Risk-Benefit

Perceptions. JAMA 2012; online Sep 19; 308(11): 1097-1098.

7. § Morrato EH, Ling S. The FDA Drug Safety and Risk Management Advisory Committee: A

Case Study Evaluation of Meeting Frequency, Content and Outcomes Before and After FDAAA.

Medical Care 2012; 50 (11): 970–986.

Updated: Sep 2017

Elaine H. Morrato

Page 28

8. * Morrato EH, Druss, B, Hartung DM, Valuck RJ, Allen RR, Campagna E, Newcomer JW.

Metabolic testing rates in three state Medicaid programs after FDA Warnings and ADA/APA

Recommendations for Second-Generation Antipsychotic Drugs. Arch Gen Psych 2010;

67(1): 17-24.

9. Morrato EH, Curbow B, Crum R, Nowels C, Feinleib, M. Communicating drug risk to

physicians: challenges and opportunities. International J of Risk & Safety in Medicine 2008;

20(3): 143-154.

10. * Morrato EH, Libby AM, Orton HD, deGruy III, FV, Brent DA, Allen RR, Valuck RJ.

Frequency of provider contact after FDA warning on suicidal risk of antidepressants in children.

Am J Psychiatry. 2007; 10.1176/appi.ajp.2007.07010205.

11. * Libby AM, Brent DJ, Morrato EH, Orton HD, Allen R, Valuck RJ. Pediatric depression

treatment declines after FDA advisory on suicidality risk of SSRI antidepressants. Am J

Psychiatry. 2007: 164: 884-891.

12. Valuck RJ, Libby AM, Orton HD, Morrato EH, Allen RR, Baldessarini RJ. Spillover effects on

treatment of adult depression in primary care after FDA Advisory on risk of pediatric suicidality

with SSRIs. Am J Psychiatry. 2007 Aug; 164(8):1198-1205.

13. Morrato EH, Staffa JA. Effectiveness of risk management plans: a case study of pemoline

using pharmacy claims data. Pharmacoepidemiology and Drug Safety. 2007 16(1):104-12.;

doi 10.1002/pds.1279.

Dissemination and Implementation Science

1. Morrato EH, Rabin B, Proctor J, Cicutto LC, Battaglia CT, Lambert-Kerzner A, Leeman-Castillo

B, Prahl-Wretling M, Nuechterlein BM, Glasgow RE, Kempe A. Bringing it Home: Expanding

the Local Reach of Dissemination and Implementation Training via a University-Based Training

Workshop 2015 Implement Sci 2015 Jul 4;10:94. doi: 10.1186/s13012-015-0281-6.

3. Morrato EH, Concannon TW, Meissner P, Shah ND, Turner BJ. Dissemination and

Implementation of Comparative Effectiveness Evidence: Key Informant Interviews with Clinical

and Translational Science Award Institutions. J Comparative Effectiveness Research 2013; 2(2):

185-194, DOI 10.2217/cer.13.10.

4. § Nicol GE, Morrato EH, Johnson MC, Campagna E, Yingling MD, Pham V, Newcomer JW.

Best Practices: Implementation of a Glucose Screening Program Based on Diffusion of

Innovation Theory Methods. Psychiatr Serv. January 2011; 62(1):12-14.

5. *Concannon TW, Meissner P, Grunbaum JA, McElwee N, Guise J-M, Santa J, Conway PH,

Daudelin D, Morrato EH, Leslie, LK. A New Taxonomy for Stakeholder Engagement in

Patient-Centered Outcomes Research. Journal of General Internal Medicine. EPub 2012 Apr 13.

DOI: 10.1007/s11606-012-2037-1.

Health Services and Health Outcomes Research

1. ǂ Merchant, AT, Nahhas GJ, Wadwa RP, Zhang, J, Tang Y, Johnson LR, Maahs DM, Bishop F,

Teles R, Morrato EH. Periodontal microorganisms and cardiovascular risk markers in youth

with type 1 diabetes and no diabetes J Periodontology . 2016 Apr;87(4):376-84. doi:

10.1902/jop.2015.150531. Epub 2015 Nov 28.

2. *§ Sømme S, Bronsert M, Morrato EH, Ziegler, MM. Frequency and Variety of Inpatient

Pediatric Surgical Procedures in the United States. Pediatrics 2013 Dec;132(6):e1466-72. doi:

10.1542/peds.2013-1243. Epub 2013 Nov 25.

Updated: Sep 2017

Elaine H. Morrato

Page 29

3. Barnard J, Albright K, Morrato EH, Nowles CT, Benefield EM, Hadley-Miller NA, Kempe A,

Erickson MA. Pediatric Spinal Fusion Surgery and the Transition to Home-Based Care: Provider

Expectations and Caregiver Experiences Health & Social Care in the Community. 2013

Nov;21(6):634-43. doi: 10.1111/hsc.12049. Epub 2013 May 6.

4. Erickson MA, Morrato EH, Campagna E, Benefield E, Miller NH, Kempe A. Variability in

Spinal Surgery Outcomes among Children's Hospitals in the US. J Pediatr Orthop 2013;33:80–90.

5. ǂ* Victoroff MS, Drury B, Campagna ES, Morrato EH. Impact of Electronic Health Records on

Malpractice Claims in a Sample of Physician Offices in Colorado: A Retrospective Cohort Study.

Journal of General Internal Medicine 2012 doi: 10.1007/s11606-012-2283-2.

6. § Sømme S, Bronsert M, Kempe A, Morrato EH, Ziegler M. Alignment of the Training

Curriculum and Surgical Practice: Implications for Competency, Manpower, and Practice

Modeling. Eur Journal of Pediatric Surgery 2012 Feb; 22(1): 74-9 Epub 2012 Mar 20.

7. Merchant AT, Jethwani M, Choi Y-H, Morrato EH, Liese AD, Mayer-Davis E. Oral care

practices and A1C among youth with type 1 and type 2 diabetes. J Periodontology 2011 Dec 5

[Epub ahead of print]

8. § Fox D, Morrato EH, Campagna E, Rees D, Dickinson LM, Partrick D, Kempe A. Outcomes

of Laparoscopic Versus Open Fundoplication in Children's Hospitals: 2005-2008. Pediatrics

2011; 127:872-880; doi: 10.1542/peds.2010-1198.

9. *Merchant AT, Jethwani M, Choi Y-H, Morrato EH, Liese AD, Mayer-Davis E. Associations

between periodontal disease and selected risk factors of early complications among youth with

type 1 and type 2 diabetes: a pilot study. Pediatric Diabetes 2011; doi: 10.1111/j.1399-

5448.2010.00736.x

10. ǂ§ Orlando VA, Johnson LR, Wilson AR, Maahs DM, Wadwa RP, Bishop FK, Dong F, Morrato

EH. Oral Health Knowledge and Behaviors among Adolescents with Type 1 Diabetes. Int J

Dentistry, 2010; 2010:942124. Epub 2010 May 13.

11. Morrato EH, Dillon P, Ziegler MM. Surgical outcomes research: A progression from

performance audits, to assessment of administrative databases, to prospective risk-adjusted

analysis. How far have we come? Curr Opin Pediatr June 1, 2008; 20(3): 320-325.

12. Dillon P, Hammermeister K, Morrato EH, Kempe A, Oldham K, Moss L, Marchildon M,

Ziegler M, Steeger J, Rowell K, Shiloach M, Henderson W. Developing a NSQIP module to

measure outcomes in children’s surgical care: opportunity and challenge Semin in Pediatr Surg

May 1, 2008; 17(2): 131-140.

13. *Morrato EH, Hill JO, Wyatt HR, Ghushchyan V, Sullivan PW. Physical activity in U.S. adults

with diabetes and at-risk for developing diabetes, 2003. Diabetes Care. 2007 Feb;30(2):203-9.

14. Morrato EH, Elias M, Gericke, C. Population-based data for evidence-based health policy

decisions: lessons from three examples of setting and evaluating national health policy in

Australia, the UK, and USA. Journal of Public Health. 2007; doi:10.1093/pubmed/fdm065.

15. Morrato EH, Hill JO, Wyatt HR, Ghushchyan V, Sullivan PW. Are health care professionals

advising patients with diabetes or at-risk for developing diabetes to exercise more? Diabetes

Care. 2006 Mar; 29(3):543-8.

Updated: Sep 2017

Elaine H. Morrato

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16. McCollum M, Ellis SL, Morrato EH, Sullivan PW. Prevalence of multiple cardiovascular

risk factors in U.S. adults with diabetes. Current Medical Research and Opinion. 2006;

22(4): 1031-1034.

17. Sullivan PW, Morrato EH, Ghushchyan V, Wyatt HR, Hill JO. Obesity, inactivity and the

prevalence of diabetes and diabetes-related cardiovascular comorbidities in the U.S., 2000-2002.

Diabetes Care. 2005; 28(7): 1599-1603.

EDITORIALS AND COMMENTARIES

1. Morrato EH. The Case for Funding Our National Drug Safety Surveillance System. Medical

Care. 2017 Jun;55(6):543-544. doi: 10.1097/MLR.0000000000000742.

2. Morrato EH Capsule Commentary on Sabbatini et al., Controlling Health Costs: Physician

Responses to Patient Expectations for Medical Care. J Gen Intern Med. 2014 Sep;29(9):1272.

doi: 10.1007/s11606-014-2929-3

3. Experts call for improved FDA Risk Evaluation and Mitigation Strategy Program. Endocrine

Today. January 2014.

4. Morrato EH, Perspective appearing August 28, 2012 in Psychiatric Annals on “Obesity

phenotypes in midlife and cognition in early old age, The Whitehall II cohort study” by Singh-

Manoux A, et al., Neurology, 2012; 79:755-762.

5. Morrato EH, Hartung DM, Lipid profile screening in second-generation antipsychotic users: the

gap between policy and practice. Clin Lipidol 2010;5:299-303

INVITED BOOK CHAPTERS

1. Morrato EH, “Social Science Theory as a Framework for Designing and Evaluating

Pharmaceutical Risk Mitigation Dissemination and Implementation Strategies” in Risk

Management Principles for Devices and Pharmaceuticals: Global Perspectives on the

Benefit:Risk Assessment of Medicinal Products (2nd Edition), ed. W.K. Sietsema, J. M. Sprafka.,

eds. Rockville, MD: Regulatory Affairs Professionals Society (in press).

2. Morrato EH, “Comparative Effectiveness and Health Care Reform, Counterpoint Commentary:

Patient-Centered Outcomes Research: Putting the patient at the center of comparative

effectiveness research” in Debates on U.S. Health Care Reform. Kronenfeld J, Parmet W, Zezza

M, eds. Thousand Oaks, CA: SAGE, 2012. ISBN: 9781412996020.

3. Morrato EH, “Social Science Theory as a Framework for Designing and Evaluating

Pharmaceutical Risk Mitigation Dissemination and Implementation Strategies” in Risk

Management Principles for Devices and Pharmaceuticals: Global Perspectives on the

Benefit:Risk Assessment of Medicinal Products, ed. W.K. Sietsema, J. M. Sprafka., eds.

Rockville, MD: Regulatory Affairs Professionals Society, 2012. ISBN: 978-0-9829320-3-2.

E-BOOKS: IMPLEMENTATION SCIENCE

1. Morrato EH, Rabin B, Cameron C, Glasgow RE. “Users’ Guide to Dissemination and

Implementation in Health for Researchers and Practitioners”. Colorado Research in

Implementation Science Program (CRISP), University of Colorado Denver, Anschutz Medical

Campus. Published October 2014. www.CRISPebooks.org .

2. Morrato EH, Rabin B, Cameron C, Glasgow RE. “Introduction to Pragmatic Clinical Trials”.

Colorado Research in Implementation Science Program (CRISP), University of Colorado Denver,

Anschutz Medical Campus. Published July 2015. www.CRISPebooks.org .

http://www.crispebooks.org/

http://www.crispebooks.org/

Updated: Sep 2017

Elaine H. Morrato

Page 31

INVITED BOOK REVIEWS

1. Textbook of Pharmacoepidemiology Edited by Brian L. Strom and Stephen E. Kimmel EH

Morrato American Journal of Epidemiology 2007; doi: 10.1093/aje/kwm215

2. Wade Hampton Frost, Pioneer Epidemiologist 1880-1938: Up to the Mountain by Thomas M.

Daniel. American Journal of Epidemiology. EH Morrato 2005; 162(3): 290-291.

LETTERS TO THE EDITOR

1. Morrato EH, Campagna E, Druss BG, Newcomer JW. Authors’ response: How can we produce

relevant information for decision makers from small area variation studies?

Pharmacoepidemiology and Drug Safety. 2011; 20(7):782–783.

TESTIMONY

1. “Input on Issues and Challenges Associated with the Standardization of REMS” Submitted

September 13, 2013 to the Federal Register: FDA Notice of Public Hearing and Request for

Comments Standardizing and Evaluating REMS, Vol. 78, No. 99, May 22, 2013.

2. On behalf of the Benefit Risk Assessment, Communication, and Evaluation Special Interest Group.

“International Society for Pharmacoepidemiology Response to FDA Questions: Standardization and

Evaluation of Risk Evaluation and Mitigation Strategies (REMS) – Public Meeting on July 25-26,

2013”. Submitted March 2014 to the Federal Register: FDA Notice of Public Hearing and Request

for Comments Standardizing and Evaluating REMS, Vol. 78, No. 99, May 22, 2013.

See: http://www.regulations.gov/#!documentDetail;D=FDA-2013-N-0502-0042

TECHNICAL RESEARCH REPORTS

1. Morrato EH, Campagna E, Fang H, Root ED, Thomas D, Dibert E, Ferre, Stuve P, Parks J,

Newcomer JW. “Effectiveness of Invega Sustenna® in a Medicaid Population: Comparing the

effectiveness of a long-acting paliperidone palmitate versus oral second generation antipsychotics

when used by adult patients with schizophrenia in a real-world clinical environment” for Janssen

Scientific Affairs, LLC. May 14, 2012R21

2. Morrato EH, Allen RR, Kempe A. “Colorado Children’s Healthcare Access Program (CCHAP): 12-

Month Evaluation of the Program (July 1, 2007 – June 30, 2008)” for the Colorado Department of

Health Care Policy and Financing. March 19, 2009

3. Morrato EH, Allen RR, Kempe A. “Colorado Children’s Healthcare Access Program (CCHAP):

Preliminary Evaluation of the Program (July 1, 2007 – December 31, 2007)” for the Colorado

Department of Health Care Policy and Financing. October 31, 2008

4. Valuck RJ, Libby AM, Morrato EH, Orton H, Allen R. “An evaluation of the FDA warnings on

antidepressants and suicidality on patterns of care for depression in U.S. managed care enrollees” for

Eli Lilly and Company. November 28, 2006.

5. Valuck RJ, Morrato EH, Allen RR. “Atypical Antipsychotic Treatment Patterns in a Multi-State

Medicaid Population (1998-2003)” for Ortho-McNeil, Janssen. March 2006.

6. Valuck RJ, Morrato EH. “Escitalopram vs. citalopram: a comparison of dosing and titration in

community-based clinical practices” for Forest Laboratories. December 2004.

ACKNOWLEDGMENT

1. Newman MG, Kornman KS, Doherty FM. A 6-Month Multi-Center Evaluation of Adjunctive

Tetracycline Fiber Therapy Used in Conjunction with Scaling and Root Planning in Maintenance

Patients: Clinical Results. J Periodontol. 1994; 65(7):685-91.

http://www.regulations.gov/#!documentDetail;D=FDA-2013-N-0502-0042

Updated: Sep 2017

Elaine H. Morrato

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PUBLISHED AND PRESENTED RESEARCH ABSTRACTS

ǂ Senior author

§ Presentation by students, mentees

1. § ǂ McNeal DM, Sahler OJ, Noll R, Fairclough D, Voll M, Morrato EH. Improving institutional and

provider sustainability of an evidence-based psychosocial intervention in pediatric oncology. Oral

presentation at the 10th Annual Conference on the Science of Dissemination and Implementation in

Health, Arlington, VA, December 4-5, 2017.

2. ǂ Lennox L, Schuster A, Morrato EH. Designing for dissemination: Characteristics of CTSA hubs as

adopters of clinical and translational science innovation. Poster presentation at the 10th Annual

Conference on the Science of Dissemination and Implementation in Health, Arlington, VA, December

4-5, 2017.

3. § ǂ Johnson RK, Thomas DSK, Campagna EC, Morrato EH. Use of Geospatial Analysis to Examine

Heterogeneity of Diabetes Risk Management Integration into Routine Healthcare for Adults Taking

Antipsychotics. Poster presentation at the 32nd International Conference on Pharmacoepidemiology

& Therapeutic Risk Management (ICPE), Montreal, Canada, August 25-28, 2017.

4. § Lind KE, Hildreth K, Lindrooth RC, Crane L, Morrato EH, Perraillon M. The Impact of Medicare

Part D on Ethnoracial Disparities in Anti-Dementia Medication Utilization. AcademyHealth 2017

Annual Research Meeting, New Orleans, LA, June 25-27, 2017.

5. § Lind KE, Hildreth K, Lindrooth RC, Crane L, Morrato EH, Perraillon M. Ethnoracial Disparities

in Medicare Annual Wellness Visit Utilization: Evidence from a Nationally Representative Database.

AcademyHealth 2017 Annual Research Meeting, New Orleans, LA, June 25-27, 2017.

6. Wasko M, Conway B, Morrato EH, Love S, Hafer N, Kenyon N, Bahti P, Rajguru S, Zonie S, Faye

J. Toward Entrepreneurial Training for Clinical and Translational Investigators: Lessons Learned in

Team-Based Customer and Stakeholder Discovery. Association for Clinical and Translational

Science. Translational Science 2017. Washington, D.C., April 19-21, 2017.

7. § Mulvahill M, Morrato EH, Carlson N. Going to Scale: Disseminating Statistical Software and

Methods in Biomedical Research. Association for Clinical and Translational Science. Translational

Science 2017. Washington, D.C., April 19-21, 2017.

8. Morrato EH, Fairclough D, Noll R, Voll M, Sahler OJ. Strategies for Promoting National Adoption

of Psychosocial Evidence-Based Care in Pediatric Oncology Centers. Poster presentation at the 9th

Annual Conference on the Science of Dissemination and Implementation, Washington, D.C.,

December 14-15, 2016.

9. Holtrop JS, Ruland S, Diaz S, Morrato EH, Jones ES. Using Social Network Analysis as a Means to

Plan and Evaluate the Impact of Health Care Interventions on Communication Networks. Poster

presentation at the 9th Annual Conference on the Science of Dissemination and Implementation,

Washington, D.C., December 14-15, 2016.

10. Holtrop JS, Ruland S, Diaz S, Morrato EH, Jones ES. Using social network analysis to examine the

effect of care management program structure on chronic disease communication. Oral presentation at

the 44th North American Primary Care Group (NAPCG) Annual Meeting, Colorado Springs, CO,

November 12-16, 2016.

11. Morrato EH, Campagna EC, Brewer SE. Programmatic Efficiency of a Pharmaceutical Risk

Management Program: Outcomes from Diabetes Screening of Adults Receiving Antipsychotics.

Poster presentation at the 32nd International Conference on Pharmacoepidemiology & Therapeutic

Risk Management, Dublin, Ireland, August 25-28, 2016.

12. § ǂ Brewer SE, Campagna EC, Morrato EH. Regulatory Considerations for Knowledge, Attitude,

and Belief Surveys: A Systematic Review of Physician Survey Response. Poster presentation at the

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Elaine H. Morrato

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32nd International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE),

Dublin, Ireland, August 25-28, 2016.

13. Morrato EH, Sheridan S, Miller T. Implementation of Appropriate Use of Clinical Preventive

Services: Setting a National Research Agenda. Symposium presentation at the Oral presentation at the

2015 AHRQ Research Conference, Crystal City, VA. October 6–8, 2015.

14. Morrato EH, Campagna E, Brewer S, Dickinson LM, Thomas DSK, Lindrooth R. After a Decade of

Risk Communication on Diabetes Risks Associated with Antipsychotic Drugs: Where Do We Stand

on Prescriber Attitudes and Behaviors? Pharmacoepidemiol Drug Saf. 2015 Aug;24(S1: A760). Oral

presentation at the 31st International Conference on Pharmacoepidemiology & Therapeutic Risk

Management (ICPE), Boston, MA. August 22-26, 2015

15. Morrato EH, Campagna E, Brewer S, Dickinson LM, Thomas DSK, Lindrooth R. Diabetes Testing

for Adults Taking Antipsychotic Drugs: Where To Target Risk Minimization Interventions.

Pharmacoepidemiol Drug Saf. 2015 Aug;24(S1: A805). Selected “Best Poster” in the Spotlight Poster

Session-Benefit Risk Assessment, Communication and Evaluation (BRACE) at the 31st

International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE),

Boston, MA. August 22-26, 2015.

16. Morrato EH, Campagna EJ, Brewer S, Lindrooth RC, Thomas DSK, Dickinson LM, Dearing JW,

Driver R, Druss B, Miller B, Newcomer JW, Parks JJ. Prioritizing Implementation Strategies for

Population Health using Market Segmentation: Diabetes Screening for Adults taking Antipsychotics in

Missouri Medicaid. Poster presentation at the 7th Annual Conference on the Science of Dissemination

and Implementation, Bethesda, MD. December 8-9, 2014.

17. Morrato EH, Rabin B, Proctor J, Cicutto LC, Battaglia C, Lambert-Kerzner A, Leeman-Castillo B,

Prahl-Wretling M, Buckley B, Glasgow RE, Kempe A. Bringing it Home: Expanding the Reach and

Spread of Dissemination and Implementation (D&I) Training. Poster presentation at the 7th Annual

Conference on the Science of Dissemination and Implementation, Bethesda, MD. December 8-9, 2014.

18. Morrato EH, Campagna EJ, Dibert E, Parks J. Diabetes Screening of Adults Receiving

Antipsychotics: A U.S. State Survey of Prescribers. presentation at the 29th International Conference

on Pharmacoepidemiology and Therapeutic Risk Management, Montreal, Canada, August 25-28,

2013.

19. § ǂ Garfield LD, Campagna EJ, Nicol GE, Scherrer JF, Ganeshra N, Parks J, Morrato EH.

Metabolic Risk and Screening in CMHC Patients Starting SGAs in MO Medicaid. Poster presentation

at the 29th International Conference on Pharmacoepidemiology and Therapeutic Risk Management,

Montreal, Canada, August 25-28, 2013.

20. ǂ Wilson AW, Johnson L, Wadwa RP, Maahs D, Haustein V, Bishop F, Morrato EH. ”Early

Periodontal Disease in Adolescents with Type I Diabetes”. J Dent Res Vol 92 (Special Issue A):

abstract 340, 2013 (www.iadr.org).

21. ǂ Campagna E, Muser E, Newcomer JW, Parks J, Morrato EH. "Methodological Considerations in

Estimating Drug Adherence for a Long-Acting Injectable Medication". Poster presentation at the 28th

International Conference on Pharmacoepidemiology and Therapeutic Risk Management, Barcelona,

Spain, August 23-26, 2012.

22. ǂ Root ED, Thomas D, Campagna EJ, Newcomer JW, Parks J, Morrato EH. "Geospatial Variation

in Drug Utilization and the Potential for Confounding by Geography". Poster presentation at the 28th

International Conference on Pharmacoepidemiology and Therapeutic Risk Management, Barcelona,

Spain, August 23-26, 2012.

http://www.iadr.org/

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23. Merchant AT, Morrato EH, Wadwa RP, Maahs DM, Teles R, Johnson L, Bishop F, Zhang J.

“Periodontal Microorganisms in Youth With and Without Type 1 Diabetes”. Poster Presentation at

the American Diabetes Association’s 72nd Scientific Sessions, Philadelphia, PA, June 8-12, 2012.

24. Morrato EH, Campagna E, Parks J, Stuve P, Thomas D, Fang H, Dilbert, Muser E, Newcomer JW.

“Characteristics of Medicaid patients initiating paliperidone palmitate compared with oral atypical

antipsychotics”. Poster presentation at the American Psychiatric Association’s 165th Annual Meeting,

Philadelphia, PA, May 5-9, 2012.

25. ǂ Newcomer JW, Campagna E, Parks J, Stuve P, Thomas D, Fang H, Dilbert, Muser E , Morrato EH.

“Drug utilization patterns for paliperidone palmitate in Medicaid patients”. Poster presentation at the

American Psychiatric Association’s 165th Annual Meeting, Philadelphia, PA, May 5-9, 2012.

26. Morrato EH, Dibert E, Parks J, Jones EC, Green M, Tien A. “Linking Drug Prescriber Behaviors to

Peer Influence Networks”. Oral presentation at the International Network for Social Network

Conference (Sunbelt XXXII), Redondo Beach, CA, March 12-18, 2012.

27. Somme S, Bronsert M, Morrato EH, Ziegler MM. “U.S. Prevalence of Paediatric Surgical

Procedures”. Oral presentation at the 2011 British Association of Paediatric Surgeons (BAPS)

International Congress, Belfast, Ireland, July 19-22, 2011.

28. § Nicol GE, Morrato EH, Johnson MC, Campagna EC, Yingling MD, Pham V, Newcomer JW.

“Successful Implementation of a Glucose Monitoring Program in a Community Mental Health

Setting”. Poster presentation at the 2010 Institute on Psychiatric Services, Boston, MA, October 14-

17, 2010.

29. Morrato EH, Orlando VA, Johnson LR, Wilson AR, Maahs DM, Bishop FK, Dong F, Merchant A,

Wadwa RP. “Questions Concerning Periodontal Disease Prevalence in Adolescents with Type 1

Diabetes”. Poster presentation selected as one of the top 100 posters showcased in the Presidents

Poster Session and Reception at the 70th Scientific Sessions of the American Diabetes Association,

Orlando, FL June 25-29, 2010.

30. § ǂ Orlando VA, Johnson LR, Wilson AR, Maahs DM, Wadwa RP, Bishop FK, Dong F, Morrato

EH. “Oral Health Knowledge and Behaviors among Adolescents with Type 1 Diabetes”. Poster

presentation featured in the poster tour entitled “Pediatrics – Type 1 Diabetes – Care and Outcomes”

at the 70th Scientific Sessions of the American Diabetes Association, Orlando, FL June 25-29, 2010.

31. § Nicol GE, Morrato EH, Johnson MC, Campagna EC, Yingling MD, Pham V, Newcomer JW.

“Successful Implementation of a Glucose Monitoring Program in a Community Mental Health

Setting”. Poster presentation at the 2010 American Psychiatric Association Annual Meeting, New

Orleans, LA, May 22-26, 2010.

32. Erickson MA, Barnard JG, Morrato EH, Nowels CT, Benefield EM, Hadley-Miller NA, Kempe A.

“Management of Surgical Risk in High Risk pediatric Patients: Provider and Family Caregiver

Experiences of Spinal Fusion Surgery and Care Program” Poster presentation at the Annual Meeting

of the Pediatric Orthopaedic Society of North America, May 4-7, 2010, Waikoloa , HI.

33. Erickson MA, Barnard JG, Morrato EH, Nowels CT, Benefield EM, Hadley-Miller NA, Kempe A.

“Quality of Life for Children with Neuromuscular Scoliosis Two-Years after Spinal Fusion Surgery”

Poster presentation at the Annual Meeting of the Pediatric Orthopaedic Society of North America,

May 4-7, 2010, Waikoloa , HI.

34. Barnard JG, Morrato EH, Benefield EM, Hadley-Miller NA, Kempe A, Erickson MA. “Quality of

Life for Children with Neuromuscular Scoliosis", Poster presentation at the 2010 Pediatric Academic

Societies' Annual Meeting, May 1-4, 2010, Vancouver, BC, Canada.

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35. Barnard JG, Morrato EH, Benefield EM, Hadley-Miller NA, Kempe A, Erickson MA. Quality of

life for children with neuromuscular scoliosis. Poster presentation at the 2009 Annual Meeting of the

International Society for Quality of Life Research, New Orleans, LA, October 28-31, 2009.

36. Morrato EH, Druss B, Hartung DM, Valuck RJ, Thomas D, Allen RR, Campagna E, Newcomer JW.

Determinants of metabolic testing for patients treated with second-generation antipsychotics after the

FDA diabetes Warning. Oral presentation at the 25th Anniversary International Conference on

Pharmacoepidemiology and Therapeutic Risk Management, Providence, RI, August 16-19, 2009.

Pharmacoepidemiology and Drug Safety. 2009.

37. Morrato EH, Nicol G, Druss B, Hartung DM, Valuck RJ, Allen RR, Campagna E, Newcomer JW.

Metabolic risk mitigation in children receiving antipsychotics. Poster presentation at the 25th

Anniversary International Conference on Pharmacoepidemiology and Therapeutic Risk Management,

Providence, RI, August 16-19, 2009. Pharmacoepidemiology and Drug Safety. 2009.

38. Morrato EH, Druss, B, Hartung DM, Valuck RJ, Allen RR, Campagna E, Newcomer JW. Metabolic

testing rates in three state Medicaid programs after FDA Warnings on Antipsychotic Drugs and

Diabetes. Poster presentation at the 2009 American Psychiatric Association Annual Meeting, San

Francisco, CA, May 16-19, 2009.

39. Barnard JG, Erickson MA, Morrato EH, Hadley-Miller NA, Benefield EM, Nowels CT, Kempe A.

Managing Surgical Risk and Post-Discharge Needs in Special Needs Children with Neuromuscular

Scoliosis: The High-Risk Pathway. Poster presentation at the 2009 Pediatric Academic Societies’

Annual Meeting, Baltimore, MD, May 2-5, 2009.

40. Erickson MA, Miller N, Kempe A, Morrato EH, Benefield E. Benton K. Variability in Spinal

Surgery Outcomes among Children s Hospitals in the U.S. Oral presentation to be presented at the

2009 American Academy of Orthopedic Surgeons (AAOS) Annual Meeting, Las Vegas, NV, February

25-28, 2009.

41. § ǂ Flake C, Johnson L, Orlando V, Bishop F, Wadwa P, Wilson A, Maas, D, Morrato EH.

Periodontal health status of adolescents with type 1 diabetes. Poster presentation at the 25th Annual

Research Day at the School of Dental Medicine. February 18, 2009. University of Colorado Denver,

Aurora, CO.

42. Morrato EH, Newcomer JW, Kamat S, Baser O, Harnett J, Cuffel B. Metabolic testing after the

FDA warning on atypical antipsychotic drugs and diabetes risk. Oral presentation at the 24th

International Conference on Pharmacoepidemiology and Therapeutic Risk Management. August 17-

20, 2008. Copenhagen, Denmark. Pharmacoepidemiology and Drug Safety. 2008 17: S266.

43. Morrato EH, Partrick D, Sullivan PW, Ghushchyan V, Kempe A. Prevalence of reflux disorders and

antireflux medication in U.S. children. Poster to be presented at the 24th International Conference on

Pharmacoepidemiology and Therapeutic Risk Management. August 17-20, 2008. Copenhagen,

Denmark. Pharmacoepidemiology and Drug Safety. 2008 17: S204.

44. Morrato EH, Erickson M, Beaty B; Benton K; Benefield E, Kempe, A. Variability in surgical

outcomes for spinal fusion surgery in U.S. children’s hospitals. Oral presentation presented at the

Health Services Epidemiology Spotlight Session at the Society for Epidemiology Research

Conference, June 24-27, 2008, Chicago, IL. Am J Epidemol. 2008; 167(Suppl): S40.

45. Partrick DA, Morrato EH, Kempe A, Beaty B, Roach JP, Ziegler MM. National frequency of

antireflux procedures and gastrostomy. Analysis of hospital type, patient age, and presence of

neurologic impairment. Oral presentation at the Pacific Association of Pediatric Surgeons 41st

Annual Meeting. June 29-July 3, 2008, Jackson Hole, WY.

46. Morrato EH, Newcomer JW, Kamat S, Baser O, Harnett J, Cuffel B. Metabolic screening before and

after the ADA Consensus Statement on Antipsychotic Drugs and Risk of Diabetes and Dyslipidemia.

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Poster presented at the American Diabetes Association’s 68th Scientific Sessions. June 6-10, 2008,

San Francisco, CA. Diabetes. 2008; 57(Suppl 1): A279.

47. Morrato EH, Newcomer JW, Kamat S, Baser O, Harnett J, Cuffel B. Impact of the atypical

antipsychotic FDA Warning on risk of hyperglycemia and diabetes and metabolic monitoring

practices. Poster to be presented at the 48th Annual NCDEU Meeting, co-sponsored by the National

Institute of Mental Health (NIMH) and the American Society of Clinical Psychopharmacology

(ASCP). May 27-30, 2008, Phoenix Arizona.

48. Fox D, Morrato EH, Partrick D, Bruny J, Benton K, Kempe A. National trends regarding

fundoplication in neurologically impaired children. Poster presented at the Pediatric Academic

Societies’ & Asian Society for Pediatric Research Joint Meeting. Honolulu, HI, May 3-6, 2008.

49. Morrato EH, Newcomer JW, Kamat S, Baser O, Harnett J, Cuffel B. Trends in annual metabolic screening

for patients taking second-generation antipsychotic medications. Poster presented at the 161st Annual

Meeting of the American Psychiatric Association Annual Meeting. May 3-8, 2008, Washington, D.C.

50. ǂ Benefield E, Erickson MA, Morrato EH. Implementing a protocol for high risk children undergoing

surgery: How do you make it work? Poster presented at the 18th Annual Convention of the Society for

Pediatric Nurses. April 4-6, 2008, Denver, CO.

51. Partrick DA, Morrato EH, Roach JP, Ziegler, MM. The national frequency of gastrointestinal pediatric

surgery in hospitalized neonates. Oral presentation presented at the 3rd Annual Academic Surgical

Congress. February 13-15, 2008, Huntington Beach, CA.

52. Banta JE, Morrato EH, Lee SW. Diabetes care among Medicaid psychiatric patients. 135th Annual

Meeting of the American Public Health Association. November 3 – 7, 2007, Washington, D.C.

53. Morrato EH, Cuffel B, Newcomer JW, Lombardo I, Kamat S, Barron J. Effect of metabolic risk status on

atypical antipsychotic treatment choice. 160th Annual Meeting of the American Psychiatric Association.

May 19-24, 2007, San Diego, CA.

54. Morrato EH, Curbow B, Nowels C, Feinleib M. Physician sources and perceptions of drug risk

communication. Pharmacoepidemiology and Drug Safety. 2006;15 (Suppl 1): S189.

55. Morrato EH, Feinleib M, Valuck RJ. Changes in liver function testing following the nefazodone

boxed warning. Pharmacoepidemiology and Drug Safety. 2006;15 (Suppl 1): S139.

56. Morrato EH, Feinleib M, Valuck RJ. Characteristics of nefazodone patients receiving baseline liver

function testing. Pharmacoepidemiology and Drug Safety. 2006;15 (Suppl 1): S139.

57. Morrato EH, Newcomer JW, Allen RR, and Valuck RJ. Atypical antipsychotics and diabetes testing:

a four-state Medicaid study. Diabetes. 2006; 55 (Supplement 1).

58. Morrato EH, Newcomer JW, Allen RR, and Valuck RJ on behalf of the Medicaid Pharmacotherapy

Research Consortium. Atypical antipsychotics and metabolic screening: a four-state Medicaid study.

159th Annual Meeting of the American Psychiatric Association Annual Meeting. May 20-25, 2006.

Toronto, Canada.

59. RJ Valuck, EH Morrato, SL Dodd and RR Allen on behalf of the Medicaid Pharmacotherapy

Research Consortium. Antipsychotic utilization: a six-state Medicaid study. 159th Annual Meeting of

the American Psychiatric Association Annual Meeting. Toronto, Canada. May 20-25, 2006.

60. RJ Valuck, EH Morrato, SL Dodd and RR Allen on behalf of the Medicaid Pharmacotherapy

Research Consortium. Antipsychotic polypharmacy costs: a five-state Medicaid study. Value in

Health. 2006; 9(3):A70.

61. Valuck RJ, Libby AM, Morrato EH, Oquenda MA, Brown H, Gibbons RD. Antidepressant

treatment and risk of suicide attempt by adults with major depressive disorder: a propensity-adjusted

retrospective cohort study. Neuropsychopharmacology. 2005: 30 (Supplement 1): S242.

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62. McCollum M, Ellis SE, Morrato EH, Ghushchyan V, Sullivan PW. Prevalence of cardiovascular

risk factors among people with and without diabetes and CHD. American College of Clinical

Pharmacy Annual Meeting. San Francisco, CA. October 22-26, 2005.

63. Valuck RJ, Morrato EH, Allen R, Dodd S. Atypical antipsychotic treatment patterns in six Medicaid

fee-for-service populations. The 2005 National Medicaid Summit. Park City, UT. September 29-

October 1, 2005.

64. Morrato EH, Feinleib M, Valuck RJ. Impact of nefazodone relabeling: changes in prescriber mix

and prescribing volume. Pharmacoepidemiology and Drug Safety. 2005; 14 (Supplement 1).

65. Morrato EH, Sullivan PW, Ghushchyan V, Wyatt HR, Hill JO. Prevalence of diabetes with

increasing adiposity and inactivity in U.S. adults: the Medical Expenditure Panel Survey 2000-

2002. Diabetes. 2005; 54 (Supplement 1): A259.

66. Morrato EH, Sullivan PW, Ghushchyan V, Wyatt HR, Hill JO. Physical activity and diabetes in

U.S. adults: the Medical Expenditure Panel Survey 2000-2002. Diabetes. 2005; 54 (Supplement

1): A254 .

67. Morrato EH, Valuck RJ. Impact of relabeling on nefazodone prescribing: a risk minimization

evaluation. Value in Health. 2005; 8(3): 395.

68. Morrato EH, Staffa JA. Analysis of longitudinal claims data to examine first and second-line use

of pemoline (Cylert®). Value in Health. 2004; 7(3): 282.

69. Morrato EH. Pediatric Drug Labeling Policy: Characteristics of Drugs Granted Exclusivity.

University of Colorado Health Sciences 21st Annual Epidemiology Conference, February 2003.

70. Kerr, CR, Morrato, EH, Humphries, KH et al. Limitations to antiarrhythmic dug use in patients with

atrial fibrillation: Insights from the Canadian Registry of Atrial Fibrillation. North American Society

for Pacing and Electrophysiology Conference, May 2001.

71. Bhattacharyya SK, Tomondy P, Huber D, Morrato EH. Resource utilization for side-effects of

antiarrhythmic drugs. DIA 36th Annual Meeting, June 2000.

72. ǂ Bhattacharyya SK, Tomondy P, Huber D, Morrato EH. Outpatient resource utilization of patients

with atrial fibrillation or flutter related to recurrence and maintenance of normal sinus rhythm. DIA

36th Annual Meeting, June 2000.

73. ǂ Bhattacharyya SK, Morrato EH. Costs of the treatment of side effects of antiarrhythmic drugs in

the USA. International Society for Pharmacoeconomic and Outcomes Research 5th Annual

International Meeting, May, 2000.

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Appendix A. U.S. Food and Drug Administrative Advisory Service

FDA advisory committees are established to contribute scientific expertise which supports the FDA's mission of

protecting and promoting the public health. Since 2008, I have been invited to contribute my expertise in drug

safety and risk management implementation on 51 advisory committees and 7 expert panels and workshops.

I served for four years as a standing member of the Drug Safety and Risk Management Advisory Committee

(2009-2013) during the critical implementation period of the 2007 Food and Drug Administration Amendments

Act (FDAAA) which expanded FDA’s drug safety regulatory authority and oversight of Risk Evaluation and

Mitigation Strategies (REMS). I was subsequently invited to serve a second advisory term as a standing

committee member for the Pulmonary-Allergy Drugs Advisory Committee (2014-2018) and in 2017 was invited

to serve as the Chair of the Committee.

PULMONARY-ALLERGY DRUGS ADVISORY COMMITTEE

The Committee reviews and evaluates data concerning the safety and effectiveness of marketed and

investigational human drug products for use in the treatment of pulmonary disease and diseases with allergic

and/or immunologic mechanisms and makes recommendations to the Commissioner of Food and Drugs.

2017-2018 Chair

2014-2018 Standing Committee Member

Summary of Meeting Topics

1. Review of supplemental new drug application for ivacaflor oral tablets for the treatment of cystic fibrosis

in patients 6 years and older with an R117H mutation in the cystic fibrosis transmembrane conductance

regulator (CFTR) gene. (Oct 2014)

2. Review of supplemental new drug application for fluticasone furoate and vilanterol for the once daily

maintenance treatment of asthma in patients 12 years of age and older. (Mar 2015)

3. Review of new drug application lumacaftor/ivacaftor oral tablets for the treatment of cystic fibrosis in

patients age 12 years and older who are homozygous for the F508del mutation in the cystic fibrosis

transmembrane conductance regulator (CFTR) gene. (May 2015)

4. Review biologics license application for mepolizumab as add-on maintenance treatment in patients 12

years and older with severe eosinophilic asthma. (June 2015)

5. Review biologics license application for reslizumab for injection as add-on maintenance treatment in

patients 12 years and older with severe eosinophilic asthma. (December 2015)

6. Review of the safety of codeine in children 18 years of age and younger. (December 2015)

DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE

The Committee advises the Commissioner of Food and Drugs on risk management, risk communication, and

quantitative evaluation of spontaneous reports for drugs for human use and for any other product for which the

Food and Drug Administration has regulatory responsibility. The Committee also advises the Commissioner of

Food and Drugs regarding the scientific and medical evaluation of all information gathered by the Department of

Health and Human Services and the Department of Justice with regard to safety, efficacy, and abuse potential of

Updated: Sep 2017

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drugs or other substances, and recommends actions to be taken by the Department of Health and Human Services

with regard to the marketing, investigation, and control of such drugs or other substances.

2011-2013 Standing Committee Member


1. How to address the public health problem of liver injury related to the use of acetaminophen in over-the-

counter and prescription products (Jun 2009)

2. Review of EXALGO, a modified-release hydromorphone drug product (Sep 2009)

3. Review of OXYCONTIN, a re-formulated oxycodone controlled-release drug product designed to reduce

misuse and abuse (Sep 2009)

4. Review of AMAYA, a new drug product to improve walking ability in individuals with multiple sclerosis

(Oct 2009)

5. Review of everolimus, a new drug product for patients with kidney transplants to prevent rejection of the

transplanted kidney (Dec 2009)

6. Review of post-marketing safety related to FDA approved gadolinium-based contrast agents used with

magnetic resonance imaging scans (Dec 2009)

7. Review of belatacept injectable, a new biologics product to be used in patients with kidney transplants to

prevent rejection of the transplanted kidney (Mar 2010)

8. Design of medical research studies to evaluate serious asthma outcomes (such as hospitalizations,

intubation, or death) with the use of the class of asthma medications known as long acting beta-2

adrenergic agonists (LABAs) (Mar 2010)

9. Review of ACUROX (oxycodone/niacin), a new combination drug product designed to reduce misuse

and abuse (Apr 2010)

10. Cardiovascular safety of AVANDIA (rosiglitazone) for blood glucose control in adults with type 2

diabetes mellitus and whether it should remain on the market. (Jul 2010)

11. Review of QNEXA (phentermine/topiramate), a new combination drug product for the treatment of

obesity and weight management (Jul 2010)

12. Risk Evaluation and Mitigation Strategies (REMS) for the therapeutic class of extended-release and long-

acting opioid analgesics (Jul 2010)

13. Review of CYMBALTA (duloxetine) for the treatment of chronic pain (Aug 2010)

14. Review of abuse potential of dextromethorphan, the public health benefits and risks of dextromethorphan

use as a cough suppressant in prescription and non-prescription drugs, and whether it should be a

scheduled narcotic (Sep 2010)

15. Postmarketing studies of OxyContin and Embeda to assess whether product-specific properties intended

to discourage misuse and abuse result in a decrease in risks and consequences (Oct 2010)

16. Review of CONTRAVE (naltrexone/bupropion), a new combination drug product for the treatment of

obesity and weight management (Dec 2010)

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17. Safety considerations of ultrasound contrast agents, including the results of required post-marketing

safety studies and data from post-marketing surveillance (May 2011)

18. Drug development of an investigational gastroenterology drug, closed to the public to permit the

discussion and review of trade secret and/or confidential commercial information (Jul 2011)

19. Benefits and risks of long-term bisphosphonate use for the treatment and prevention of osteoporosis in

light of the emergence of the safety concerns of osteonecrosis of the jaw and atypical femur fractures that

may be associated with the long-term use of bisphosphonates (Sep 2011)

20. REMS program for isotretinoin (iPLEDGE) as an example of a REMS that has Elements to Assure Safe

Use (ETASU) and general issues related to the impact of REMS with ETASU on the healthcare system

and patient access, such as how programs with ETASU can be better integrated into existing health

systems. (Dec 2011)

21. Benefits and risks of drospirenone-containing oral contraceptives in light of the emerging safety concern

that the risk of venous thromboembolism because it may be higher compared to oral contraceptives that

contain the progestin, levonorgestrel (Dec 2011)

22. Benefits and risks of ORTHO EVRA (norelgestromin/ethinyl estradiol transdermal system) for the

prevention of pregnancy. Specifically, the possibly increased risk of thrombotic and thromboembolic

events compared to women who use commonly prescribed birth control pills, as suggested by

postmarketing studies. (Dec 2011)

23. Safety and efficacy of new drug application ADASUVE (loxapine) inhalation powder for the acute

treatment of agitation associated with schizophrenia or bipolar I disorder in adults. (Dec 2011)

24. Safety and efficacy of new drug application (NDA) 22-580, proposed trade name QNEXA

(phentermine/topiramate), as an adjunct to diet and exercise for weight management (Feb 2012)

25. To determine whether reports of joint destruction represent a safety signal related to the anti-nerve growth

factor (Anti-NGF) class of drugs, and whether the risk benefit balance for these drugs favors continued

development of the drugs as analgesics. (Mar 2012)

26. Advice on types of consumer studies needed to assess proper use of a MedKit containing doxycycline to

be taken in the event of anthrax exposure. (Apr 2012)

27. Efficacy supplement for TRUVADA (emtricitabine/tenofovir disoproxil fumarate), for an indication for

pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection (May 2012)

28. Safety and efficacy for safety and efficacy NDA 203441, GATTEX (teduglutide), for the treatment of

adult patients with short bowel syndrome. (October 2012)

29. Risk management of teratogens, some of which have Risk Evaluation and Mitigation Strategies with

Elements to Ensure Safe Use (ETASU) (December 2012)

30. Public health benefits and risks (including the potential for abuse of drugs containing hydrocodone) and

the impact of rescheduling these hydrocodone products from Controlled Substance Schedule III to

Schedule II narcotics (January 2013)

31. Efficacy and safety of Aveed (testosterone undecanoate, intramuscular injection) (April 2013)

Updated: Sep 2017

Elaine H. Morrato

Page 41

OTHER FDA ADVISORY COMMITTEES

Invited to contribute expertise on drug safety, risk communication and risk management implementation

2008 - Temporary Voting Committee Member


1. Review of the results of an independent re-adjudication of the RECORD (Rosiglitazone Evaluated for

Cardiovascular Outcomes and Regulation of Glycemia in Diabetes) trial, (June 2013)

2. Review of the Lotronex (alosteron hydrochloride) Risk Evaluation and Mitigation Strategies program (Jul

2013)

3. Review of tolvaptan tablets slowing kidney disease in adults at risk of rapidly progressing autosomal

dominant polycystic kidney disease (Aug 2013)

4. Review of vedolizumab for ulcerative colitis and Crohn’s disease (Dec 2013)

5. Review of safety data concerning serious neuropsychiatric adverse events with CHANTIX (varenicline)

for smoking cessation (Oct 2014)

6. Review of a new drug application, oxycodone immediate-release tablets, and abuse-deterrent properties

(Sep 2015)

7. Review of new drug application, oxycodone extended-release capsules, and abuse-deterrent properties

(Sep 2015)

8. Review results from assessments of the extended-release and long-acting (ER/LA) Opioid Analgesics

REMS. (May 2016)

9. Review new drug application, benzhydrocodone/acetaminophen, and its abuse-deterrent properties (May

2016)

10. Review new drug application, hydrocodone bitartrate extended-release, and abuse-deterrent properties

(June 2016)

11. Review new drug application, oxycodone hydrochloride and naltrexone hydrochloride extended-release

capsules, and abuse-deterrent properties (June 2016)

12. Review of biologics license application for brodalumab injection, a human monoclonal antibody for the

treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy

or phototherapy (July 2016)

13. Review of postmarketing-requirement randomized, placebo-controlled trial of the neuropsychiatric effects

of CHANTIX (varenicline), ZYBAN (buproprion), and nicotine replacement therapy and observational

studies to determine whether the findings support removal of the boxed warning or other changes to

product labeling (September 2016)

14. Review new drug application, oxycodone hydrochloride immediate-release tablets, and abuse-deterrent

properties (April 2017)

Updated: Sep 2017

Elaine H. Morrato

Page 42

Appendix B. Reach of Scientific Contributions

SELECTED EXAMPLES: INCORPORATION OF RESEARCH FINDINGS INTO SYSTEMATIC REVIEWS AND

CLINICAL RECOMMENDATIONS

Cervesi C, Park SY, Galling B, Molteni S, Masi G, Gerhard T, Olfson M, Correll CU. Extent, Time Course, and

Moderators of Antipsychotic Treatment in Youth With Mood Disorders: Results of a Meta-Analysis and Meta-

Regression Analyses. J Clin Psychiatry. 2017 Mar;78(3):347-357. doi: 10.4088/JCP.15r10435.

Dusetzina SB, Higashi AS, Dorsey ER, Conti R, Huskamp HA, Zhu S, Garfield CF, Alexander GC. Impact of

FDA drug risk communications on health care utilization and health behaviors: a systematic review. Med Care.

2012 Jun;50(6):466-78. doi: 10.1097/MLR.0b013e318245a160.

The Concannon et al. taxonomy for stakeholder engagement was referenced at the Patient-Centered Outcomes

Research Institute’s (PCORI) May Board of Governors meeting as a possible framework to guide PCORI’s

stakeholder engagement efforts. Cited in Avalere EBM Insights, June 4, 2012.

M. De Hert, D., Vancampfort, C.U. Correll, V. Mercken, J. Peuskens, K. Sweers, R. van Winkel, A. J. Mitchell.

“Guidelines for screening and monitoring of cardiometabolic risk in schizophrenia: systematic evaluation” The

British Journal of Psychiatry. 2011; 199: 99-105.

Agency for Healthcare Research and Quality (AHRQ) Effective Health Care Program. “Review of Off-Label Use

of Atypical Antipsychotics – Update.” March 21, 2011.

Clinical Context article cited in the Continuing Medical Education (CME) program “New Guidelines for Exercise

in Type 2 Diabetes from Medscape Education Clinical Briefs,” December 16, 2010

(http://www.medscape.org/viewarticle/734359). This CME activity reviews “Exercise and Type 2 Diabetes:

American College of Sports Medicine and the American Diabetes Association: Joint Position Statement”.

Medicine and Science in Sports and Exercise. 2010; 42(12):2282-2303.

Treatment in Psychiatry. Benedetto Vittiello and Jane L. Pearson. “A Depressed Adolescent at High Risk of

Suicidal Behavior”. Am J Psychiatry. 2008; 165(3); 323-328.

SELECTED EXAMPLES: MEDIA COVERAGE OF RESEARCH FINDINGS

Story. “Antipsychotic-Related Metabolic Testing Falls Far Short” MedScape. May 26, 2016.

Guest Appearance. Emmy Award-winning show The Doctors! Episode: Underage Habits That Turn Into Over-

Age Health Dilemmas! Story: New, FDA-Approved Weight Loss Drugs. Air date: October 16, 2012.

Feature Story. “Metabolic syndrome risk in patients prescribed atypical antipsychotics.” Psychiatric Annals.

2011; 41(7): 347-349.

Research Highlights. “Diabetes mellitus and periodontal disease in youth”. Nature Reviews Endocrinology.

2011; 7:7.

Cover Story. “Antipsychotic drug warnings indicate need for better communication between endocrinologists,

psychiatrists.” EndocrineToday. 2010; 8(6): 1, 10-12.

Story. “Are FDA Warnings on Antipsychotics Heeded?” Psychiatric Times. 2010; Vol 27, No. 4, April 7, 2010.

Medical News and Perspectives. “Questionable Antipsychotic Prescribing Remains Common, Despite Serious

Risks” JAMA. 2010; 303(16); 1582-1584.

http://www.medscape.org/viewarticle/734359

Updated: Sep 2017

Elaine H. Morrato

Page 43

Medical News and Perspectives. “Studies Shed Light on Risks and Trends in Pediatric Antipsychotic

Prescribing” JAMA. 2010; 303(19); 1901-1903.

Editorial. Graham J. Emslie. “Improving Outcome in Pediatric Depression”. Am J Psychiatry. 2008; 165(1):1-3.

“Study looks at possible connection between periodontal disease and type 1 diabetes in children”, Practice

update, The Children’s Hospital (Denver, CO) Spring 2008; 8-9.

Story. “Medical Monitoring Often Missing from Care of Patients on SGAs”. Psychiatric News. 2008;

43(21): 2, 25.

Chase Squires (The Associated Press) “Study: Most Diabetics Don’t Exercise” appeared in The Washington Post.

USAToday. msnbc.com and other national news outlets. January 26, 2007.

Jorge Cruise. FitSmart Highlight. “Losing weight decreases diabetes risk”. USA Weekend. June 22-24, 2007.

Editorial. Cynthia R. Pfeffer. “The FDA Pediatric Advisories and Changes in Diagnosis and Treatment of

Pediatric Depression”. Am J Psychiatry. 2007; 164 (6); 843-846.

Tony Dokoupil. “Trouble in a ‘Black Box’ – Did an effort to reduce teen suicides backfire?” Newsweek.

July 16, 2007.

SELECTED PRESS COVERAGE: QUOTED CONTRIBUTIONS FROM FDA ADVISORY COMMITTEE HEARINGS

FDA Panel Backs Abuse-Deterrent Immediate-Release Opiod. MedPage Today-Apr 5, 2017.

Nix Box Warning on Smoking Cessation Drug, FDA Panel Says. Medscape-Sep 16, 2016

FDA Panel Splits on Softening Chantix Warning. MedPage Today-Sep 15, 2016

FDA Panel Backs Approval of Psoriasis Drug Broadalumab. Medscape-Jul 20, 2016

Psoriasis Drug Siliq Supported by FDA Panel Despite Suicide Risk. Psoriasis news Today-Jul 21, 2016

FDA Panel: Physician Opioid Training Should be Mandatory. Medscape-May 6, 2016

Novel Opioid Not Abuse-Deterrent, FDA Panel Says. MedPage Today-May 6, 2016

Cystic Fibrosis Drug Wins Approval of FDA Advisory Panel. New York Times-May 12, 2015

Cover Story. “Experts call for improved FDA Risk Evaluation and Mitigation Strategy Program”

EndocrineToday. 2014; 1

FDA Panel Split on Safety of Long-Acting Testosterone. Medscape-Apr 18, 2013

FDA panel backs obesity pill Qnexa: What happens next? CBS News-Feb 23, 2012

Qnexa Gains FDA Panel Backing: Facts on and Side Effects of the Newest Weight-Loss Drug. International

Business Times-Feb 23, 2012

Drospirenone Contraceptives Worth the Risk: FDA Panel – Medscape-Dec 9, 2011

FDA Panel Votes to Restrict Avandia. New York Times (blog)-Jul 14, 2010

Documents

UNIVERSITY OF COLORADO ANSCHUTZ MEDICAL …...2013-2015 Faculty-member-at-large, Executive Council 2012, 15-16 Member, Departmental Appointments, Promotions, and Tenure Committee (DAPTCO)