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Program Committee

  • Julie Louise Gerberding
    Julie Louise Gerberding • Chief Executive Officer
    Foundation for the National Institutes of Health (FNIH), United States
  • Tatsuya Kondo, MD, PhD
    Tatsuya Kondo, MD, PhD • President
    SH Medical Excellence JAPAN, Japan
  • Teresa Ancukiewicz, MA
    Teresa Ancukiewicz, MA • Associate Director
    Boston Scientific Corporation, United States
  • Jonathan Andrus, MS
    Jonathan Andrus, MS • Past Chair/Current Treasurer
    Society For Clinical Data Management, United States
  • Kimberly Belsky, MS
    Kimberly Belsky, MS • Reg Policy & Intell and AdPromo, Regulatory Affairs
    Independent, United States
  • Larry Blankstein, PhD
    Larry Blankstein, PhD • Head of Clinical Operations
    Synlogic, 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
  • Susan Callery-D'Amico, BSN
    Susan Callery-D'Amico, BSN • Retired, Vice President, R&D Quality Assurance, AbbVie
    United States
  • Juan Castano, MBA, PMP
    Juan Castano, MBA, PMP • Associate Director, Asset Planner
    Pfizer Inc, 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
  • Leah Christl, PhD
    Leah Christl, PhD • Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
    Amgen, United States
  • Deborah Collyar
    Deborah Collyar • President
    Patient Advocates In Research (PAIR), United States
  • Brenda Crowe, PhD
    Brenda Crowe, PhD • Associate Vice President, Statistics
    Eli Lilly and Company, United States
  • Sara Doshi, PharmD
    Sara Doshi, PharmD • Senior Director, Decentralized Clinical Trials
    Eli Lilly and Company, United States
  • Ron Fitzmartin, PhD, MBA
    Ron Fitzmartin, PhD, MBA • Senior Advisor, Office of Regulatory Operations, CBER
    FDA, 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
  • Jennifer Graff, PharmD
    Jennifer Graff, PharmD • Senior Director, Professional Affairs
    Academy of Managed Care Pharmacy (AMCP), 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
  • Frank Hubbard, PhD, MS
    Frank Hubbard, PhD, MS • President
    Global Regulatory Writing Solutions Inc., United States
  • Ginny Hussong
    Ginny Hussong • Branch Chief, Data Standards, CBER
    FDA, United States
  • Nita Ichhpurani, PMP
    Nita Ichhpurani, PMP • Consultant To Daiichi Sankyo, Inc.
    Phase One Forward, Consultant, Canada
  • 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
  • Mark Kryah, PMP
    Mark Kryah, PMP • Executive Director, Program Team Leader, Program and Portfolio Management
    Ultragenyx Pharmaceutical Inc., United States
  • Vicky Martin
    Vicky Martin • Sr Director Business Development USA
    IDDI, United States
  • Chris Matheus, MBA
    Chris Matheus, MBA • Chief Commercial and Networking Officer
    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
  • Michael Neidl, MBA, MS, MSc
    Michael Neidl, MBA, MS, MSc • Senior Consultant
    Clinical Research Quality Consultant, United States
  • Lisa Palladino-Kim, MS
    Lisa Palladino-Kim, MS • Program Director / Lecturer
    Rutgers School of Health Professions Clin Research Mgmt, United States
  • David J Pepperl, PhD
    David J Pepperl, PhD • Senior Consultant and Nonclinical Group Leader
    Biologics Consulting, United States
  • Kim Quaintance-Lunn
    Kim Quaintance-Lunn • Vice President, Head of Regulatory Science and Execution
    Alexion, United States
  • Margaret Richards, PhD, MPH
    Margaret Richards, PhD, MPH • Executive Director, Solutions
    Panalgo, United States
  • Dr. Peter Richardson, PhD
    Dr. Peter Richardson, PhD • Head of Quality, Specialised Scientific Disciplines Department
    European Medicines Agency, Netherlands
  • 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
  • Mitra Rocca, MSc
    Mitra Rocca, MSc • Associate Director, Medical Informatics, Office of Translational Science, CDER
    FDA, United States
  • David H. Schubert
    David H. Schubert •
    DH Schubert Regulatory Solutions LLC, United States
  • Leigh Shultz, PhD, PMP
    Leigh Shultz, PhD, PMP • Executive Director, Human Health Commercial Operations
    Merck & Co., 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
  • Veronica Todaro, MPH
    Veronica Todaro, MPH • Chief Operating Officer
    Parkinson's Foundation, United States
  • Toshiyoshi Tominaga, PhD
    Toshiyoshi Tominaga, PhD • Project Professor
    Keio University Hospital, Japan
  • Rebecca A. Vermeulen, RPh
    Rebecca A. Vermeulen, RPh • Vice President, Global Patient Networks | PD Medical Affairs
    Genentech, A Member of the Roche Group, United States
  • Kristin Voorhees, MA
    Kristin Voorhees, MA • Director, Patient Advocacy
    Ultragenyx, United States
  • Karen D. Weiss, MD
    Karen D. Weiss, MD • Vice President, Global Regulatory Affairs
    Janssen Pharmaceutical Companies of Johnson & Johnson, United States
  • Robin Whitsell
    Robin Whitsell • President
    Whitsell Innovations, Inc., United States
  • Annette S. Williams, MBA, RPh
    Annette S. Williams, MBA, RPh • Vice President, Pharmacovigilance
    IQVIA, United States
  • Michael Williams
    Michael Williams • Managing Partner
    Facio Consulting Group and Associates, 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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