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Meet the Program Commitee for 2023!

Comité del programa

  • Venkatraman Balasubramanian, PhD, MBA
    Venkatraman Balasubramanian, PhD, MBA • Healthcare and Life Sciences Strategic Advisor
    VB Insights, LLC, United States
  • Greg Ball, PhD
    Greg Ball, PhD • Safety Data Scientist
    ASAPprocess, United States
  • Amy Bertha
    Amy Bertha • Executive Director, Regulatory Policy and Science
    Bayer, United States
  • Claire Blanchette, PMP
    Claire Blanchette, PMP • Executive Drug Development Program Leader
    Consultant, United States
  • Susan Callery-D'Amico, BSN
    Susan Callery-D'Amico, BSN • Retired, Vice President, R&D Quality Assurance, AbbVie
    United States
  • Brooke Casselberry, MS, RAC
    Brooke Casselberry, MS, RAC • Vice President, Advisory and Delivery
    Epista Life Sciences, United States
  • Meghana Chalasani, MHA
    Meghana Chalasani, MHA • Associate Director for Clinical Trial Innovation, Office of New Drugs, CDER
    FDA, United States
  • Andrew Chang, PhD
    Andrew Chang, PhD • Vice President, Quality and Regulatory Compliance
    Novo Nordisk, United States
  • Wendy Charles, PhD
    Wendy Charles, PhD • Chief Ethics and Compliance Officer; Adjunct Faculty
    Equideum Health, United States
  • Ethan Chen, MBA, MS, PMP
    Ethan Chen, MBA, MS, PMP • Director, Division of Data Management
    FDA CDER, United States
  • Leah Christl, PhD
    Leah Christl, PhD • Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
    Amgen, United States
  • Mary Ellen Cosenza, PhD, MS, RAC
    Mary Ellen Cosenza, PhD, MS, RAC • President
    MEC Regulatory & Toxicology Consulting, LLC, United States
  • Stephanie Y. Crawford, PhD, MPH, MS
    Stephanie Y. Crawford, PhD, MPH, MS • Professor, Pharmacy Systems, Outcomes and Policy
    University of Illinois at Chicago, United States
  • Alysha Croker, PhD
    Alysha Croker, PhD • Director, Centre for Policy, Pediatrics and International Collaboration, BRDD
    Health Canada, Canada
  • Ebony Dashiell-Aje, PhD
    Ebony Dashiell-Aje, PhD • Executive Director and Head, Patient Centered Outcomes Science
    BioMarin, United States
  • Julie Dietrich, MS
    Julie Dietrich, MS • Vice President, Clinical Development
    GENFIT, United States
  • Andrew Emmett, MPH
    Andrew Emmett, MPH • FDA Liaison | US Regulatory Policy and Global Intelligence
    Pfizer Inc, United States
  • Jennifer Farmer, MS
    Jennifer Farmer, MS • Chief Executive Officer
    Friedreich's Ataxia Research Alliance (FARA), United States
  • Maureen Feeney, PharmD, MBA, RPh
    Maureen Feeney, PharmD, MBA, RPh • Vice President Scientific Communications and Strategic Alliances
    Takeda, United States
  • Ron Fitzmartin, PhD, MBA
    Ron Fitzmartin, PhD, MBA • Senior Advisor, Office of Regulatory Operations, CBER
    FDA, United States
  • David Fryrear, MS
    David Fryrear, MS • Executive Vice President and Head of Quality Assurance
    Astellas, United States
  • M. Scott Furness, PhD
    M. Scott Furness, PhD • Deputy Director, Office of New Drug Products, OPQ, CDER
    FDA, United States
  • Alicia Gilsenan, PhD, MS, RPh, FISPE
    Alicia Gilsenan, PhD, MS, RPh, FISPE • Vice President, Epidemiology
    RTI Health Solutions, United States
  • Cheryl Grandinetti, PharmD
    Cheryl Grandinetti, PharmD • Associate Director for Clinical Policy, CDER/OC/OSI/DCCE
    FDA, United States
  • Renmeet Grewal, PharmD, MS
    Renmeet Grewal, PharmD, MS • Division Director, Office of Regulatory Operations (DRO-II), OND, CDER
    FDA, United States
  • Sabine Haubenreisser, PhD, MSc
    Sabine Haubenreisser, PhD, MSc • Principal Scientific Administrator, Stakeholders and Communication Division
    European Medicines Agency, Netherlands
  • Alan Hochberg
    Alan Hochberg • Principal Scientific Enablement Director, Scientific Enablement and Processes
    Genentech, A Member of the Roche Group, United States
  • Michelle Hoiseth
    Michelle Hoiseth • General Manager, Project-Based Services
    Cytel, United States
  • Cammilla Horta Gomes, MA, MPharm
    Cammilla Horta Gomes, MA, MPharm • Latam Regulatory Policy Lead
    Roche, Brazil
  • Emily (Xianghong) Jing, PhD
    Emily (Xianghong) Jing, PhD • Associate Director for Scientific Coordination, OBP, OPQ, CDER
    FDA, United States
  • Jeremy Jokinen, PhD, MS
    Jeremy Jokinen, PhD, MS • Vice President and Head, Safety Evidence and Sciences
    Bristol-Myers Squibb Company, United States
  • Cathryn C Lee, MSN
    Cathryn C Lee, MSN • Director, Office of Program Operations, PDIMS, OND, CDER
    FDA, United States
  • Demetra Macheras, MBA
    Demetra Macheras, MBA • Director, Regulatory Policy and Intelligence - Regulatory Affairs
    AbbVie, United States
  • Nicole Mahoney, PhD
    Nicole Mahoney, PhD • Executive Director US Regulatory Policy & Intelligence
    Novartis Pharmaceuticals Corporation, United States
  • Sheila Mahoney Jewels, MBA
    Sheila Mahoney Jewels, MBA • Drug Development Multi-Functionalist
    LifeSciHub , United States
  • Ingrid Markovic, PhD
    Ingrid Markovic, PhD • Senior Science Advisor for CMC, Office of the Center Director, CBER
    FDA, United States
  • Lindsay McNair, MD, MPH, MS
    Lindsay McNair, MD, MPH, MS • Principal Consultant
    Equipoise Consulting, United States
  • Melodi J McNeil, MS, RPh
    Melodi J McNeil, MS, RPh • Director, Regulatory Policy and Intelligence
    AbbVie, United States
  • David Meats
    David Meats • Director, Regulatory Services Management
    Certara, United States
  • Munish Mehra, PhD, MS, MSc
    Munish Mehra, PhD, MS, MSc • Managing Director and Sr. Principal Biostatistician
    Quantum Biopharma, United States
  • Timothe Menard, PharmD, MSc
    Timothe Menard, PharmD, MSc • Global Head, Quality Excellence Digital | Bioethics Coach (Data Ethics)
    F. Hoffmann-La Roche Ltd, Switzerland
  • Alexis Miller, JD
    Alexis Miller, JD • Acting Global Lead, Global Regulatory Policy and Intelligence
    Merck & Co., Inc., United States
  • Martha Monser
    Martha Monser • Consumer Safety Officer, Office of Regulatory Operations, CBER
    FDA, United States
  • Christine Moore, PhD
    Christine Moore, PhD • Executive Director, Global External Advocacy and Standards
    Organon & Co., United States
  • Erin Mulrooney, MSc, PMP
    Erin Mulrooney, MSc, PMP • Director, Portfolio Management
    Daiichi Sankyo, Inc, United States
  • Sissi Pham, PharmD
    Sissi Pham, PharmD • Chief Executive Officer
    AESARA, United States
  • Margaret Richards, PhD, MPH
    Margaret Richards, PhD, MPH • Executive Director, Solutions
    Panalgo, United States
  • Cynthia Rothblum-Oviatt
    Cynthia Rothblum-Oviatt • Science Policy Analyst, Rare Disease Team, OND, CDER
    FDA, United States
  • Leslie Sam
    Leslie Sam • President
    Leslie Sam and Associates, LLC, United States
  • Earl Seltzer, MBA
    Earl Seltzer, MBA • Senior Director, Partnerships and Innovation
    CTI, United States
  • Anjali Shah, PharmD
    Anjali Shah, PharmD • Executive Director, Business Capabilities and Innovation, WWPS
    Bristol-Myers Squibb Company, United States
  • Elizabeth Somers, MS
    Elizabeth Somers, MS • Executive Director, Global Project and Alliance Management
    Merck Sharp & Dohme LLC, United States
  • Mat Soukup, PhD
    Mat Soukup, PhD • Deputy Director, Division of Biometrics VII, OB, OTS CDER
    FDA, United States
  • Shannon Sparklin, MS
    Shannon Sparklin, MS • Project Manager, OPPD, OMP, CDER
    FDA, United States
  • Ling Su, PhD
    Ling Su, PhD • Research Fellow
    Shenyang Pharmaceutical University, Yeehong Business School, China
  • Linda B Sullivan, MBA
    Linda B Sullivan, MBA • Senior Fellow
    Tufts Center For the Study of Drug Development, United States
  • Phil Tregunno
    Phil Tregunno • Deputy Director - Patient Safety Monitoring
    Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
  • Pujita Vaidya, MPH
    Pujita Vaidya, MPH • North America Lead, Regulatory Science and Policy
    Sanofi, United States
  • Paula Walker, MA
    Paula Walker, MA • Global Head of Risk Based Quality Management
    Roche Products Ltd., United Kingdom
  • Susan Wang, PhD
    Susan Wang, PhD • Global Head of Biostatistics and Data Sciences Inflammation
    Boehringer Ingelheim, United States
  • Nancy Watanabe, MS, PMP
    Nancy Watanabe, MS, PMP • Independent Consultant
    Independent Consultant, United States
  • Keith Wenzel
    Keith Wenzel • Volunteer
    DIA Study Endpoints Community, United States
  • Jennifer Whiteley, PhD, MSc
    Jennifer Whiteley, PhD, MSc • Executive Director, Head OMNI Evidence for Access
    Genentech, A Member of the Roche Group, United States
  • Robin Whitsell
    Robin Whitsell • President
    Whitsell Innovations, Inc., United States
  • Judith Zander, MD
    Judith Zander, MD • Director, Office of Pharmacovigilance and Epidemiology, OSE, CDER
    FDA , United States
  • Martine Zimmermann, PharmD
    Martine Zimmermann, PharmD • Senior Vice President, Head of Global Regulatory Affairs
    Ipsen , France
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