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Program Committee

  • Julie Louise Gerberding
    Julie Louise Gerberding Executive Vice President and Chief Patient Officer
    Merck & Co., Inc., 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 President and Chief Operating Officer
    Clinical Research IO (CRIO), United States
  • Kimberly  Belsky, MS
    Kimberly Belsky, MS Executive Director Reg Policy & Intell, AdPromo, RegOps, Regulatory Affairs
    Mallinckrodt Pharmaceuticals, United States
  • Larry A. Blankstein, PhD
    Larry A. Blankstein, PhD Head of Clinical Operations
    Synlogic, United States
  • Philip (P.J.)  Brooks, PhD
    Philip (P.J.) Brooks, PhD Deputy Director, Office of Rare Diseases Research
    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 Vice President, R&D Quality Assurance
    AbbVie, Inc., United States
  • Juan  Castano, MBA, PMP
    Juan Castano, MBA, PMP Associate Director, Asset Planner
    Pfizer Inc, United States
  • Dannis  Chang, PharmD
    Dannis Chang, PharmD Executive Director, Head of Medical Capabilities
    Mirati Therapeutics , 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 Bioethics & Strategic Projects Leader, Office of the Chief Medical Officer
    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 Director, Medical Information Strategy and Capabilities, GMI
    Eli Lilly and Company, United States
  • Ron  Fitzmartin, PhD, MBA
    Ron Fitzmartin, PhD, MBA Senior Informatics Advisor, Office of the Director, 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 CEO
    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
    Encoded Therapeutics Inc.., United States
  • Frank  Hubbard, PhD, MS
    Frank Hubbard, PhD, MS President
    Global Regulatory Writing Solutions Inc., United States
  • Virginia  Hussong
    Virginia Hussong Chief, Data Standards Program, 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
  • Lisa  Kim, MS
    Lisa Kim, MS Program Director / Lecturer
    Rutgers School of Health Professions, 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
    Ultragenyx, 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
    Global Life Sciences Alliance (GLSA), 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, External Advocacy and Standards
    Organon & Co., United States
  • Jean M. Mulinde, MD
    Jean M. Mulinde, MD Medical Officer, Policy Advisor, 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
  • 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, US Regulatory Lead, Regulatory Affairs Americas
    Bayer, United States
  • Margaret  Richards, PhD, MPH
    Margaret Richards, PhD, MPH Executive Director, Solutions
    Panalgo, United States
  • Peter  Richardson, PhD
    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 Head US/Canada, Regulatory Policy and Intelligence
    AbbVie, 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 of Infectious Disease, 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, Chapter Lead Global Patient Networks | PD Medical Affairs
    Hoffmann-La Roche Ltd., 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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