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Program Committee

  • Jonathan Andrus, MS
    Jonathan Andrus, MS • Past Chair/Current Treasurer
    Society For Clinical Data Management, United States
  • Matt Baldwin, MS
    Matt Baldwin, MS • Biomedical Data Stewardship Senior Manager
    Amgen, United States
  • David Bowers, PharmD
    David Bowers, PharmD • Senior Director, Operations
    PPD, United States
  • Philip (P.J.) Brooks, PhD
    Philip (P.J.) Brooks, PhD • Deputy Director, Division of Rare Diseases Research Innovation
    National Center for Advancing Translational Sciences (NCATS), NIH, United States
  • Jennifer Burgess, MBA, MPH
    Jennifer Burgess, MBA, MPH • Vice President, Global Engagement and Communications
    TransCelerate Biopharma Inc., United States
  • Bill Byrom, PhD
    Bill Byrom, PhD • Vice President, Product Intelligence and Positioning; Principal, eCOA Science
    Signant Health , United Kingdom
  • Susan Callery-D'Amico, BSN
    Susan Callery-D'Amico, BSN • Retired, Vice President, R&D Quality Assurance, AbbVie
    United States
  • Dannis Chang, PharmD
    Dannis Chang, PharmD • Director, Hematology Medical Information Team Lead
    Genentech, Inc., United States
  • Yeh-Fong Chen, PhD
    Yeh-Fong Chen, PhD • Mathematical Statistician (Team Lead), Office of Translational Sciences, CDER
    United States
  • Karla Childers, MS
    Karla Childers, MS • Head, Bioethics-Based Science and Technology Policy
    Johnson & Johnson, United States
  • Deborah Collyar
    Deborah Collyar • President
    Patient Advocates In Research (PAIR), United States
  • Sonya Eremenco, MA
    Sonya Eremenco, MA • Executive Director, PRO Consortium
    Critical Path Institute, 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
  • Barbara Gladson, PhD, MS
    Barbara Gladson, PhD, MS • Director of Biopharma Initiative; Interim Chair, Health Informatics
    Rutgers School of Health Professions, United States
  • Richard Gliklich, MD
    Richard Gliklich, MD • Chief Executive Officer
    OM1, United States
  • William Gregory, PhD
    William Gregory, PhD • Senior Director, Safety and Risk Management
    Pfizer Inc, United States
  • Marianne Hamilton Lopez, PhD, MPA
    Marianne Hamilton Lopez, PhD, MPA • Research Director, Value-Based Payment Reform
    Duke-Margolis Center For Health Policy, United States
  • Sabine Haubenreisser, PhD, MSc
    Sabine Haubenreisser, PhD, MSc • Principal Scientific Administrator, Stakeholders and Communication Division
    European Medicines Agency, Netherlands
  • Jennifer Helfer, PhD
    Jennifer Helfer, PhD • Senior Director, Patient Advocacy and Engagement, Corporate Affairs
    Viridian Therapeutics, Inc., United States
  • Nita Ichhpurani, PMP
    Nita Ichhpurani, PMP • Consultant To Daiichi Sankyo, Inc.
    Phase One Forward, Consultant, Canada
  • Jeremy Jokinen, PhD, MS
    Jeremy Jokinen, PhD, MS • Vice President and Head, Safety Evidence and Sciences
    Bristol-Myers Squibb Company, United States
  • Nadina Jose, MD
    Nadina Jose, MD • Assistant Professor, School of Health Professions, MS Clinical Research Program
    Rutgers, The State University of New Jersey, United States
  • Sean Kassim, PhD
    Sean Kassim, PhD • Director, Office of Study Integrity and Surveillance, OTS, CDER
    FDA, United States
  • Sean D. Kennedy, MPH
    Sean D. Kennedy, MPH • Global Head, Real World Evidence
    ICON plc, United States
  • Agnes Klein, MD
    Agnes Klein, MD • Senior Medical Advisor
    Health Canada, Canada
  • Darryl L'Heureux, PhD, MPharm, MSc
    Darryl L'Heureux, PhD, MPharm, MSc • Director, Clinical Science, Medical Writing, and Publications
    Ambrx, Inc, United States
  • Erik Laughner
    Erik Laughner • Project Manager, Business Operations Staff, OD, CBER
    FDA, United States
  • Rebecca Lipsitz, PhD
    Rebecca Lipsitz, PhD • Senior Director, TA Regulatory Intelligence and Portfolio Policy, Late R&I RA
    AstraZeneca, United States
  • Chris Matheus, MBA
    Chris Matheus, MBA • Chief Commercial and Networking Officer
    Global Life Sciences Alliance (GLSA), United States
  • K. Kimberly McCleary
    K. Kimberly McCleary • Founder and Chief Executive Officer
    The Kith Collective, LLC, United States
  • Ann Meeker-O'Connell, MS
    Ann Meeker-O'Connell, MS • Director, Office of Clinical Policy, Office of Clinical Policy and Programs, OC
    FDA, United States
  • Christine Moore, PhD
    Christine Moore, PhD • Executive Director, Global External Advocacy and Standards
    Organon & Co., United States
  • Jean M. Mulinde, MD
    Jean M. Mulinde, MD • Associate Director, Division of Clinical Compliance Evaluation, OSI
    FDA, United States
  • Nobumasa Nakashima
    Nobumasa Nakashima • Health Policy Director, National Healthcare Policy Secretariat
    Cabinet Office, Japan
  • Michael Neidl, MBA, MS, MSc
    Michael Neidl, MBA, MS, MSc • Senior Consultant
    Clinical Research Quality Consultant, United States
  • David O Olaleye, PhD, MSc
    David O Olaleye, PhD, MSc • Senior Manager and Principal Research Statistician
    SAS Institute Inc., United States
  • David J Pepperl, PhD
    David J Pepperl, PhD • Senior Consultant and Nonclinical Group Leader
    Biologics Consulting, United States
  • Sissi Pham, PharmD
    Sissi Pham, PharmD • Chief Executive Officer
    AESARA, United States
  • Kim Quaintance-Lunn
    Kim Quaintance-Lunn • Vice President, Head of Regulatory Science and Execution
    Alexion, United States
  • Giuseppe Randazzo, MS
    Giuseppe Randazzo, MS • Vice President, Sciences and Regulatory Affairs
    Association for Accessible Medicines, United States
  • Margaret Richards, PhD, MPH
    Margaret Richards, PhD, MPH • Executive Director, Solutions
    Panalgo, United States
  • Amanda Marie Roache, MS
    Amanda Marie Roache, MS • Senior Director, Science and Regulatory Advocacy
    Phrma, United States
  • Steven L. Roberds, PhD
    Steven L. Roberds, PhD • Chief Scientific Officer
    Tuberous Sclerosis Alliance, United States
  • Khyati Roberts, RPh
    Khyati Roberts, RPh • Retired
    Retired, United States
  • Khushboo Sharma, MBA
    Khushboo Sharma, MBA • Chief Regulatory Innovation Officer
    Accumulus Synergy, United States
  • Leigh Shultz, PhD, PMP
    Leigh Shultz, PhD, PMP • Executive Director, Human Health Commercial Operations
    Merck & Co., Inc., United States
  • Nancy Slater, MBA, PMP
    Nancy Slater, MBA, PMP • Senior Director, Portfolio Program Management Therapeutic Area Head
    AbbVie, Inc., United States
  • Nancy Pire Smerkanich, DrSc, MS
    Nancy Pire Smerkanich, DrSc, MS • Assistant Professor Regulatory & Quality Sciences
    University of Southern California School of Pharmacy, United States
  • Meredith Smith, PhD, MPA, FISPE
    Meredith Smith, PhD, MPA, FISPE • Senior Director, Implementation Science Pillar Lead
    Evidera, Inc, United States
  • Elizabeth Somers, MS
    Elizabeth Somers, MS • Executive Director, Global Project and Alliance Management
    Merck Sharp & Dohme LLC, United States
  • Jeffrey N. Stuart, PhD
    Jeffrey N. Stuart, PhD • Associate Vice President, Global Regulatory Affairs
    Merck Sharp & Dohme LLC , United States
  • Ling Su, PhD
    Ling Su, PhD • Research Fellow
    Shenyang Pharmaceutical University, Yeehong Business School, China
  • Rachel Turow, JD, MPH
    Rachel Turow, JD, MPH • Managing Counsel, FDA Regulatory
    Walmart, Inc., United States
  • Kristin Voorhees, MA
    Kristin Voorhees, MA • Director, Patient Advocacy
    Ultragenyx, United States
  • Robin Whitsell
    Robin Whitsell • President
    Whitsell Innovations, Inc., United States
  • Amy Xia, PhD
    Amy Xia, PhD • Vice President, Center for Design and Analysis
    Amgen Inc., United States
  • Judith Zander, MD
    Judith Zander, MD • Director, Office of Pharmacovigilance and Epidemiology, OSE, CDER
    FDA , United States
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