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THE FORUM FOR THE INDUSTRY EXECUTIVE July/August 2014 PUBLICATION www.pharmavoice.com SPECIAL ISSUE 100 of the Most Inspiring People Inaugural RED JACKET AWARD

THE FORUM FOR THE INDUSTRY EXECUTIVE 100 - Sciformix · THE FORUM FOR THE INDUSTRY EXECUTIVE July/August 2014 PUBLICATION SPECIAL ISSUE 100 of the Most Inspiring People InauguralDr

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Page 1: THE FORUM FOR THE INDUSTRY EXECUTIVE 100 - Sciformix · THE FORUM FOR THE INDUSTRY EXECUTIVE July/August 2014 PUBLICATION SPECIAL ISSUE 100 of the Most Inspiring People InauguralDr

THE FORUM FORTHE INDUSTRY EXECUTIVE

July/August 2014

P U B L I C AT I O N

www.pharmavoice.com

SPECIAL ISSUE

100of the Most

Inspiring PeopleInaugural

RED JACKET AWARD

Page 2: THE FORUM FOR THE INDUSTRY EXECUTIVE 100 - Sciformix · THE FORUM FOR THE INDUSTRY EXECUTIVE July/August 2014 PUBLICATION SPECIAL ISSUE 100 of the Most Inspiring People InauguralDr

Dr. Ann AertsNovartis

Susan SeroskieAdvanced Clinical

Dan GoldsmithVeeva Systems

2 July/August 2014 � PharmaVOICE

Index by Section

Tara FitzgeraldINC Research

Reid ConnollyEvoke Health

Tina FascettiPulseCX

David Cunningham

TrialCard

Dr. Rob KotinVoyager Therapeutics

John GlasspoolBaxter Healthcare Corp.

Dr. Chitra Lele Sciformix Corp.

Who’s on the List — 2014 Indexed by Section

THE ACADEMICSDr. Molly Carnes ............University of Wisconsin-MadisonDr. Yvonne Paterson..............................................University of

Pennsylvania / Advaxis Inc.

THE CLINICAL SPECIALISTSMichael Brooks ........................................................................PPDDr. Susan Dallabrida....................................................PHT Corp.Tara Fitzgerald ........................................................INC ResearchJulie Ross................................................Advanced Clinical LLCKen Shore..............................Blue Chip Patient RecruitmentBadhri Srinivasan ..........................................................Quintiles

THE COMMANDERS & CHIEFSReid Connolly ........................................................Evoke HealthJim Curtis ..............................................Remedy Health MediaDr. Stephan de la Motte ....................................SynteractHCRMichael du Toit ............................Digitas Health LifeBrands,

Publicis LifeBrands, Medicus International and Publicis Healthcare

Dr. Deborah Dunsire ......................Forum PharmaceuticalsRobert Forrester....................................................Verastem Inc.Tracy Foster ................................................................Lash GroupTim Frank ..............................Triple Threat CommunicationsDr. Richard Gams ..............................................Novella ClinicalNeil Gleghorn ................................................................Kallik Ltd.Alex Gorsky ................................................Johnson & JohnsonShannon Hartley ..............................................................RosettaMichelle Keefe ..........................................Publicis Touchpoint

Solutions Inc.Dr. Freda Lewis-Hall..............................................................PfizerBrian Loew ............................................................................InspireIbraheem Mahmood....................................................DrugDevTonya Mallory ..............Health Diagnostic Laboratory Inc.Matt McNally ........................................Publicis Health MediaCiaran Murray..........................................................................ICONJan Nielsen..........................................................Sonexus HealthJames Powers ..................................................HemoShear LLCRobert Previdi ..............................................................PSKW LLCAnna Protopapas ....................................................Millennium:

The Takeda Oncology CompanyKen Ribotsky ....................................................Brandkarma LLCDuane Roth ......................................................................ConnectSydney Rubin ............................................inVentiv Health Inc.Dr. Nancy Ruiz ....................................Meda PharmaceuticalsRaman Singh........................................................MundipharmaDr. Jean-Pierre Wery ..........................Crown Bioscience Inc.Mark Wheeldon ............................................................FormedixCorbin Wood..................................................Snow CompaniesMeryl Zausner ..................Novartis Pharmaceuticals Corp.

THE CREATIVESTina Fascetti ......................................................................PulseCXPaul Harrington Jr. ................................................Palio+Ignite,

an inVentiv companyDiane Iler-Smith ......................................Ogilvy Healthworld,

part of Ogilvy CommonHealth WorldwideJonathan Isaacs......................................................Evoke Health

THE ENTREPRENEURSDr. Jeffrey Adelglass ....................Research Across AmericaArif Butt ....................................................................SelectScienceBob Chandler..........................Chandler Chicco CompaniesDavid Cunningham ......................................................TrialCardDr. Jonathan de Pass ............................................Evaluate Ltd.Daniel Ghinn ............................................Creation Healthcare

Kathy Giusti..........................................The Multiple Myeloma Research Foundation

Fabio Gratton ......................................Sonic Health, Vocalize, Alchemy Factory

Jean Hendrickson ..................Catalyst Clinical ResourcingDr. Iya Khalil ........................................................GNS HealthcareMark Laabs....................Rare Cancer Research FoundationDr. Chitra Lele......................................................Sciformix Corp.Dr. Jules Mitchel............................................Target Health Inc.Miranda Pothiawala ..........................................Samarind Ltd.Dr. George Savage..............................Proteus Digital HealthAlex Sefanov ..........................................................Perficient Inc.Leerom Segal ..................................................................Klick Inc.Chris Trizna ................................................................................CSSiKenneth VanLuvanee ..Virtual Regulatory Solutions Inc.Dr. Graham Wylie..............The Medical Research Network

THE MARKETERSDr. Jeffrey Berg ....................................................AbelsonTaylorMatt Brown......................................................................ICC Lowe

THE MENTORSJohn White, R.Ph. ................The Medical Affairs Company

THE PATIENT ADVOCATESAaron Fleishman ..............................................BBK WorldwideJohn Glasspool ................................Baxter Healthcare Corp.Regina Holliday ..........The Walking Gallery of HealthcareDr. Alessandro Riva..................................................Novartis AGRachel Sexton ....................VPR Patient Outreach Program

THE RESEARCHERS & SCIENTISTSDr. Kate Dawson ......................................................Biogen IdecDr. Nancy Dreyer ............................................................QuintilesDr. Rob Kotin..........................................Voyager TherapeuticsDr. Boaz Mendzelevski ......................................BioClinica Inc.Krista Payne........................................United BioSource Corp. Dr. Dinah Sah ........................................Voyager TherapeuticsDr. Pablo Umaña..........................................Roche GlycArt AG

THE STRATEGISTSLisa Adler ..........................................Takeda Pharmaceuticals

International Cos.Dr. Ann Aerts..............................................................Novartis AGMark Cunningham..................................Janssen Research &

Development LLCMatthew D'Ambrosio ....Sunovion Pharmaceuticals Inc.Joe Doyle ....................................................................HCB HealthJennie Fischette ..................Concentric Health ExperienceHeather Gervais ........Epocrates, an athenahealth serviceEugene Lee ..............................Communications Media Inc.Susan Perlbachs ..............................................GSW WorldwideDr. Michelle Rohrer ..................................................GenentechKaren Roy ..........................................................Phlexglobal Ltd.Susan Seroskie..............................................Advanced ClinicalNicolette Sherman..............................................................SanofiTodd Skrinar ..................................................................................EYDr. Judy Swilley ......................................................INC ResearchAngela Tenuta ..............................................Intouch Solutions

THE TECHNOLOGISTSWill Cheung..................................Comprehend Systems Inc.Dan Goldsmith....................................................Veeva SystemsMichelle Marlborough ..........................Medidata SolutionsAndrea McGonigle ......................................................MicrosoftDonald Soong........Cegedim Relationship Management

Page 3: THE FORUM FOR THE INDUSTRY EXECUTIVE 100 - Sciformix · THE FORUM FOR THE INDUSTRY EXECUTIVE July/August 2014 PUBLICATION SPECIAL ISSUE 100 of the Most Inspiring People InauguralDr

pany, but started the operations with a newproject in hand. This was one of her biggestprofessional challenges to date, she says.

“To start a pharmacovigilance project whenthe company is just being established and hav-ing to meet SLAs with the majority of theteam being domain-naive, while also simulta-neously creating the organizational frameworkand trying to grow the business was a tremen-dous challenge,” she says.

Before Sciformix, Dr. Lele worked for Pfizeras executive director of India operations ofglobal R&D and head/director of biometrics.In this role, she led India’s first biometrics cen-ter, growing it to more than 400 staff in clini-cal data management, clinical programming,medical writing, and clinical statistics. Duringher almost 10 years at Pfizer, Dr. Lele was alsoinstrumental in developing an outsourcingstrategy for clinical data management in India,strategizing and implementing a new modelfor partnering with contract research organiza-tions.

The result of these initiatives was increasedcapacity building in the Indian CRO industry,leading to large-scale offshoring of biometricsand medical writing in a functional serviceprovider model from cost-effective locations,with several pharma companies taking advan-tage of the new talent pool.

“It was challenging to build a group at atime when the skill set wasn’t available in thegeography and the culture of offshoring suchservices was new for the pharma industry,” Dr.Lele says.

However, challenges don’t slow her downmuch, and colleagues say they are continuallyamazed at her ability to add one more thing toher to-do list and take on more work, as wellas her roll-up-her-sleeves attitude to makingsure projects are executed effectively.

Dr. Lele’s plans for the future include creat-ing new cross-functional innovative technol-ogy offerings to fill the unmet need in today’senvironment of new operating and partnershipmodels emerging across product developmentand life-cycle maintenance.

As a mentor, Dr. Lele has instructed the

Entrepreneurs

pioneer in operationalizing a globallydistributed model to support design,analysis, and reporting of clinical tri-

als, Dr. Chitra Lele has been blazing trails inthis arena for 20 years. Her contributions, par-ticularly in the offshoring of biometrics andmedical writing, have created a shift in howthe industry now sources clinical trial relatedservices.

In 2007, she co-founded Sciformix Corp.,with business partner Ajit Nagral, to establisha knowledge-process outsourcing companythat could provide specialized science-basedservices to pharmaceutical organizations. Dr.Lele has displayed a strong entrepreneurialspirit in continuing the growth and success ofSciformix by focusing on capabilities and op-portunities across industry segments, geogra-phies, and partnership models, along withconceptualizing new solutions and offerings.

Colleagues credit Dr. Lele with creating asolid foundation for Sciformix in all respects,from the management of operations and deliv-ery, to strategizing the organizational path andtrajectory. Sciformix partners with clientsthrough the entire drug development cycle toprovide a full range of services from study de-sign to postmarketing surveillance and com-mercialization support.

Dr. Lele didn’t just help establish the com-

Dr. Chitra LELE

Dr. Chitra Lele is driven to innovate by the urge to dosomething better and different every day.

next generation of scientists through her workas a visiting faculty member at the Universityof Pune, teaching statistics courses and super-vising Ph.D. students. She has also worked asa faculty member at the School of Statistics atthe University of Minnesota, and IIT, Bombay.She was instrumental in setting up the Acad-emy for Clinical Excellence at the BombayCollege of Pharmacy. She is one of the found-ing members of the Indian Association for Sta-tistics in Clinical Trials.

Dr. Lele is also always happy to mentor hercolleagues.

“Since I have been part of an emerging areaof business, I have always worked with col-leagues who were relatively less exposed to thearea and who were making the switch to a newand emerging area,” she says. “Hence several ofthem were in need of coaching and mentoring,which I gladly provided since it was my re-sponsibility to help them shape their careers.”

Dr. Lele supports several charitable causes,but her passion is education for the underpriv-ileged, and especially for women.

“Education has helped me become what Iam today,” she says. “I would like to help pro-vide educational opportunities to girls in ruralareas and also to handicapped girls.”

She also strives to support those who do notreceive adequate healthcare due to their finan-cial status.

“Everyone is aware of the skyrocketingcosts of specialized healthcare that preventsthose in need from getting treated,” Dr. Lelesays. “I support an initiative, which is an ex-cellent public-professional partnership aimedat providing affordable/subsidized qualityhealthcare to the less fortunate sections of soci-ety.”

It is her hope in the healthcare world of thefuture that safer medicines become more avail-able to a larger section of the population.

Seemingly mild mannered, Dr. Lele has anadventurous side: she enjoys roller coasterrides, Alfred Hitchcock movies, and AgathaChristie mysteries. PV

Forging New Models in ClinicalOutsourcing

FAIR. ETHICAL.

Driven to innovAte by

IMPROVEMENT

TITLE: Chief Scientific Officer

COMPANY: Sciformix Corp.

EDUCATION: Ph.D., Stanford University; M.Sc., Indian Institute Technology-Bombay; B.Sc., Bombay University

FAMILY: Husband

HOBBIES: Reading fiction and nonfiction; traveling; listening to music; watching plays and movies; cooking; exercising; watching Olympics, tennis, basketball

BUCKET LIST: Travel to all continents; visit UNESCOWorld Heritage Sites and Wonders of the World — ancient and modern

ASSOCIATIONS: The Academy for Clinical Excellence; The Indian Association for Statistics in Clinical Trials;Drug Information Association (DIA); Society of Actuaries USA

Getting to Know...

Chitra Lele, Ph.D.

A

3PharmaVOICE � July/August 2014