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Program Committee

  • Jonathan Raymond Andrus, MS
    Jonathan Raymond Andrus, MS Chief Business Officer
    Clinical Ink, United States
  • Matt  Baldwin, MS
    Matt Baldwin, MS Senior Biostatistician
    Advance Research Associates, Inc (ARA), United States
  • David  Bowers, PharmD
    David Bowers, PharmD Director, Medical Communications
    PPD, United States
  • Philip (P.J.)  Brooks, PhD
    Philip (P.J.) Brooks, PhD Program Director, Office of Rare Diseases Research
    National Center for Advancing Translational Sciences (NCATS), NIH, United States
  • Jennifer  Burgess, MBA, MPH
    Jennifer Burgess, MBA, MPH Executive Director of Engagement
    TransCelerate BioPharma Inc., United States
  • Bill  Byrom, PhD
    Bill Byrom, PhD Vice President, Product Strategy and Innovation
    Signant Health , United Kingdom
  • Susan  Callery-D'Amico, BSN
    Susan Callery-D'Amico, BSN Vice President, R&D Quality Assurance
    AbbVie, Inc., United States
  • Dannis  Chang, PharmD
    Dannis Chang, PharmD Senior Director, Global Medical Information and Scientific Communications
    Halozyme Therapeutics Inc., United States
  • Yeh-Fong  Chen, PhD
    Yeh-Fong Chen, PhD Mathematical Statistician, Office of Translational Sciences, CDER
    FDA, United States
  • Karla  Childers, MS
    Karla Childers, MS Senior Director, Strategic Projects, Office of the Chief Medical Officer
    Johnson & Johnson, United States
  • Deborah E. Collyar
    Deborah E. Collyar President
    Patient Advocates In Research (PAIR), United States
  • Sonya L. Eremenco, MA
    Sonya L. Eremenco, MA Associate Director, PRO Consortium, and Acting Director, ePRO Consortium
    Critical Path Institute, United States
  • Ron D. Fitzmartin, PhD, MBA
    Ron D. Fitzmartin, PhD, MBA Sr. Informatics Advisor
    FDA, United States
  • David William Fryrear, MS
    David William Fryrear, MS Senior Vice President and Head of Clinical & Research QA, Medical and Dev
    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 Worldwide Medical and Safety
    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 (EMA), Netherlands
  • Jennifer  Helfer, PhD
    Jennifer Helfer, PhD Patient Advocacy
    bluebird bio, Inc., United States
  • Nita  Ichhpurani, PMP
    Nita Ichhpurani, PMP Consultant
    Phase One Forward, Canada
  • Jeremy  Jokinen, PhD, MS
    Jeremy Jokinen, PhD, MS Senior Director, Decision Sciences
    AbbVie, Inc., United States
  • Nadina  Jose, MD
    Nadina Jose, MD Assistant Professor, Clinical Trial Sciences, BioPharma Educational Initiative
    Rutgers, The State University of New Jersey, United States
  • Sean Y. Kassim, PhD
    Sean Y. Kassim, PhD Director, Office of Study Integrity and Surveillance, OTS, CDER
    FDA, United States
  • Sean D.  Kennedy, MPH
    Sean D. Kennedy, MPH Clinical Operations Lead, Clinical Trial Strategy and Operations, GCO
    Bristol-Myers Squibb, United States
  • Agnes Victoria Klein, MD
    Agnes Victoria Klein, MD Senior Medical Advisor
    Health Canada, Canada
  • Darryl Zachary L'Heureux, PhD, MPharm, MSc
    Darryl Zachary L'Heureux, PhD, MPharm, MSc Global Strategic and Regulatory Documentation
    Bristol-Myers Squibb, United States
  • Erik  Laughner
    Erik Laughner Project Manager, Business Operations Staff, BOS, OD, CBER
    FDA, United States
  • Rebecca  Lipsitz, PhD
    Rebecca Lipsitz, PhD Associate Director
    Janssen, United States
  • Chris  Matheus, MBA
    Chris Matheus, MBA President
    Matheus BD Connections, 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 Vice President, Global Head, Quality Assurance
    IQVIA, 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
  • Jean M. Mulinde, MD
    Jean M. Mulinde, MD Medical Officer, Senior Policy Advisor, OSI, OC, CDER
    FDA, United States
  • Nobumasa  Nakashima, PhD
    Nobumasa Nakashima, PhD Senior Director for International Programs
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Michael  Neidl, MBA, MS
    Michael Neidl, MBA, MS Senior Clinical Research Executive
    Clinical Research Consultant, LLC, United States
  • David  Olaleye, PhD
    David Olaleye, PhD Senior Manager and Principal Research Statistician
    SAS Institute Inc., United States
  • David  Pepperl, PhD
    David 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 and Head, Regulatory Policy, North American Regulatory Affairs
    Bayer, United States
  • Giuseppe  Randazzo, MS
    Giuseppe Randazzo, MS Director, Office of New Drug Products, OPQ, CDER
    FDA, United States
  • Margaret  Richards, PhD
    Margaret Richards, PhD Executive Director, Scientific Affairs, Real-World Solutions
    PRA Health Sciences, United States
  • Amanda Marie Roache, MS
    Amanda Marie Roache, MS Operations Research Analyst, OCD, CDER
    FDA, United States
  • Steven L. Roberds, PhD
    Steven L. Roberds, PhD Chief Scientific Officer
    Tuberous Sclerosis Alliance, United States
  • Khyati  Roberts, PharmD, RPh
    Khyati Roberts, PharmD, RPh Head US/Canada, Regulatory Policy and Intelligence
    AbbVie, Inc., United States
  • Khushboo  Sharma, MBA
    Khushboo Sharma, MBA Deputy Director for Operations, Office of New Drugs, CDER
    FDA, United States
  • Leigh  Shultz, PhD, PMP
    Leigh Shultz, PhD, PMP Associate Vice President, Global Project and Alliance Management
    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
    Nancy Pire Smerkanich, DrSc Assistant Professor, Department of Regulatory & Quality Sciences, USC School of
    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, MS
    Elizabeth Somers, MS Executive Director of Infectious Disease, Global Project and Alliance Management
    Merck & Co., Inc., United States
  • Jeffrey N. Stuart, PhD
    Jeffrey N. Stuart, PhD Executive Director, Global Regulatory Affairs
    Merck & Co., Inc., United States
  • Ling  Su, PhD
    Ling Su, PhD Professor
    Shenyang Pharmaceutical University, China
  • Rachel SW Turow, JD, MPH
    Rachel SW Turow, JD, MPH Executive Counsel, Regulatory Law
    Teva Pharmaceutical Industries Ltd., United States
  • Kristin  Voorhees, MA
    Kristin Voorhees, MA Senior Manager, Patient Advocacy
    Ultragenyx Pharmaceutical, United States
  • Robin  Whitsell
    Robin Whitsell President
    Whitsell Innovations, Inc., United States
  • Amy  Xia, PhD
    Amy Xia, PhD Vice President, Biostatistics, Design & Innovation
    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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