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Program Committee

  • Teresa  Ancukiewicz, MA
    Teresa Ancukiewicz, MA Senior Manager, Clinical Data Management
    Boston Scientific Corporation, United States
  • Jonathan  Andrus, MS
    Jonathan Andrus, MS Chief Operations and Data Officer
    Clinical Ink, Inc., United States
  • Kimberly  Belsky, MS
    Kimberly Belsky, MS Senior Director, Regulatory Affairs, Regulatory Policy and Intelligence
    Mallinckrodt Pharmaceuticals, United States
  • Larry A. Blankstein, PhD
    Larry A. Blankstein, PhD Head of Clinical Operations
    Synlogic, United States
  • Philip  Brooks, PhD
    Philip Brooks, PhD Program Director, Office of Rare Diseases Research & Div of Clinical Innovation
    NIH, National Center for Advancing Translational Sciences (NCATS), United States
  • Jennifer  Burgess
    Jennifer Burgess Senior Director of Communications and Engagement
    TransCelerate BioPharma Inc., United States
  • Susan V. Callery-D'Amico, BSN
    Susan V. 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 Strategic Program Lead, Medical Affairs, Business Systems Design
    Genentech, A Member of the Roche Group, United States
  • Representative Invited
    Representative Invited FDA, United States
  • Karla  Childers, MS
    Karla Childers, MS Senior Director, Strategic Projects, Office of the Chief Medical Officer
    Johnson & Johnson, United States
  • Representative Invited
    Representative Invited FDA, United States
  • Deborah E. Collyar
    Deborah E. Collyar President
    Patient Advocates In Research (PAIR), United States
  • Brenda  Crowe, PhD
    Brenda Crowe, PhD Senior Research Advisor, Global Statistical Sciences
    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 D. Fitzmartin, DIAFellow, PhD, MBA
    Ron D. Fitzmartin, DIAFellow, PhD, MBA Senior Advisor, Office of Strategic Programs, CDER
    FDA, United States
  • Barbara  Gladson, PhD, MS
    Barbara Gladson, PhD, MS Director of Biopharma Initiative; Interim Chair, Health Infomatics
    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 Vice President, Comparative Effectiveness Research
    National Pharmaceutical Council (NPC), United States
  • William  Gregory, PhD
    William Gregory, PhD 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-Robert J. Margolis, MD, Center For Health Policy, United States
  • Sabine  Haubenreisser, PhD, MSc
    Sabine Haubenreisser, PhD, MSc Principal Scientific Administrator, International Affairs
    European Medicines Agency (EMA), United Kingdom
  • Jennifer  Helfer, PhD, MA
    Jennifer Helfer, PhD, MA Patient Advocacy
    bluebird bio, Inc., United States
  • Frank  Hubbard, PhD
    Frank Hubbard, PhD President
    Global Regulatory Writing Solutions, Inc., United States
  • Representative Invited
    Representative Invited FDA, United States
  • Nita  Ichhpurani, PMP
    Nita Ichhpurani, PMP Senior Director, Global Clinical Development
    Celerion, Canada
  • Nadina  Jose, MD
    Nadina Jose, MD Assistant Professor, Clinical Trial Sciences, BioPharma Educational Initiative
    Rutgers, The State University of New Jersey, United States
  • Representative Invited
    Representative Invited FDA, United States
  • Sean D. Kennedy, MPH
    Sean D. Kennedy, MPH Principal, Real World Evidence, Late Stage, Clinical Division
    inVentiv Health, United States
  • Lisa  Kim, MS
    Lisa Kim, MS Director of Capstone / Lecturer
    Rutgers School of Health Professions, United States
  • Agnes V. Klein, MD
    Agnes V. Klein, MD Director, Evaluation of Radiopharmaceuticals and Biotherapeutic Products
    Health Canada, Canada
  • Mark A. Kryah, PMP
    Mark A. Kryah, PMP Senior Advisor/COO, Bio-Medicines Business Unit
    Eli Lilly and Company, United States
  • Ann  Meeker-O'Connell, MS
    Ann Meeker-O'Connell, MS Senior Director/ Head, BioResearch Quality and Compliance, Consumer Products
    Johnson & Johnson, United States
  • Christine M. V. Moore, PhD
    Christine M. V. Moore, PhD Global Head and Executive Director, GRACS CMC - Policy
    Merck Research Laboratories, United States
  • Representative Invited
    Representative Invited FDA, United States
  • Michael J. Neidl, MBA, MS
    Michael J. Neidl, MBA, MS Senior Clinical Research Executive
    Clinical Research Consultant, LLC, United States
  • David  Pepperl, PhD
    David Pepperl, PhD Senior Consultant and Nonclinical Group Leader
    Biologics Consulting Group, Inc., United States
  • Kim M. Quaintance-Lunn
    Kim M. Quaintance-Lunn Vice President and Head, US Regulatory Policy
    Bayer, United States
  • Margaret S. Richards, PhD, MPH
    Margaret S. Richards, PhD, MPH Vice President, Data Analytics and Epidemiology, RW Strategy and Analytics
    Mapi, United States
  • Peter  Richardson, PhD
    Peter Richardson, PhD Head of Quality, Specialised Scientific Disciplines Department
    European Medicines Agency (EMA), United Kingdom
  • Steven L. Roberds
    Steven L. Roberds Chief Scientific Officer
    Tuberous Sclerosis Alliance, United States
  • Khyati  Roberts, RPh
    Khyati Roberts, RPh Head US/Canada, Regulatory Policy and Intelligence
    AbbVie, United States
  • Representative Invited
    Representative Invited FDA, United States
  • David H. Schubert
    David H. Schubert Vice President of Regulatory and Quality
    Stealth BioTherapeutics, United States
  • Leigh  Shultz, PhD
    Leigh Shultz, PhD Associate Vice President, Project Management
    Merck & Co., Inc., United States
  • Nancy Pire Smerkanich, DrSc, MS
    Nancy Pire Smerkanich, DrSc, MS Assistant Professor, Clinical Pharmacy; Educational Liaison & Instructor, ICRS
    University of Southern California, United States
  • Meredith Y. Smith, PhD, MPA
    Meredith Y. Smith, PhD, MPA Global Risk Management Officer, Global Patient Safety
    Amgen Inc., United States
  • Elizabeth  Somers, MSc, PMP
    Elizabeth Somers, MSc, PMP Executive Director of Infectious Diseases the Global Project and Alliance Manage
    Merck & Co., Inc., United States
  • Jeffrey N. Stuart, PhD, RAC
    Jeffrey N. Stuart, PhD, RAC Global Regulatory Director, Oncology, Immunology, and InVitro Diagnostics
    Merck & Co., Inc., United States
  • Ling  Su, DIAFellow, PhD
    Ling Su, DIAFellow, PhD Professor
    Shenyang Pharmaceutical Univeristy, China
  • Veronica L. Todaro, MPH
    Veronica L. Todaro, MPH Vice President, National Programs
    Parkinson's Foundation, United States
  • Rebecca A. Vermeulen, RPh
    Rebecca A. Vermeulen, RPh Head, Customer Strategy Global Medical Affairs
    Hoffmann-La Roche Ltd., Switzerland
  • Kristin  Voorhees, MA
    Kristin Voorhees, MA Senior Manager, Patient Advocacy
    Ultragenyx Pharmaceutical, United States
  • Karen D. Weiss, MD, MPH
    Karen D. Weiss, MD, MPH Vice President, Global Regulatory Affairs
    Janssen Pharmaceutical Companies of Johnson & Johnson, United States
  • Annette S. Williams, MBA, RPh
    Annette S. Williams, MBA, RPh Vice President, Lifecycle Safety
    IQVIA, United States
  • Amy  Xia, PhD
    Amy Xia, PhD Executive Director, Biostatistics
    Amgen, Inc., United States
  • Representative Invited
    Representative Invited FDA , United States
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