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Program Committee

  • Jonathan Raymond Andrus, MS
    Jonathan Raymond Andrus, MS Chief Strategy 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 Senior Director, Operations
    PPD, 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
  • Bill  Byrom, PhD
    Bill Byrom, PhD Principal, eCOA Science
    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 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
    FDA, United States
  • Karla  Childers, MS
    Karla Childers, MS Bioethics & Strategic Projects Leader, Office of the Chief Medical Officer
    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 Informatics Advisor, Office of the Director, CBER
    FDA, United States
  • David  Fryrear, MS
    David Fryrear, MS Executive Vice President and Head of Quality Assurance, Medical and Development
    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
    Encoded 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, Epidemiology, Safety Science, Capabilities and Innovation
    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 Victoria Klein, MD
    Agnes Victoria 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 & Networking Officer
    Global Life Sciences Alliance, 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, OCPP, OC
    FDA, United States
  • Christine  Moore, PhD
    Christine Moore, PhD Executive Director, External Advocacy and Quality
    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
  • Nobumasa  Nakashima, PhD
    Nobumasa Nakashima, PhD Associate Executive Director for International Programs
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Michael  Neidl, MBA, MS, MSc
    Michael Neidl, MBA, MS, MSc Senior Clinical Research Executive
    Clinical Research Consultant, LLC, 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 and Head, Regulatory Policy, Regulatory Affairs Americas
    Bayer, United States
  • Giuseppe  Randazzo, MS
    Giuseppe Randazzo, MS Director, Global Regulatory and Development Policy
    Novartis Pharmaceuticals Corporation, United States
  • Margaret  Richards, PhD, MPH
    Margaret Richards, PhD, MPH Senior Research Leader, Real World Evidence
    Evidera, United States
  • Amanda Marie Roache, MS
    Amanda Marie Roache, MS Senior Director, Science and Regulatory Advocacy
    Pharmaceutical Research and Manufacturers of America (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 Head US/Canada, Regulatory Policy and Intelligence
    AbbVie, Inc., United States
  • Khushboo  Sharma, MBA
    Khushboo Sharma, MBA Vice President, Science and Regulatory Affairs
    BIO, United States
  • Leigh  Shultz, PhD, PMP
    Leigh Shultz, PhD, PMP Head, Commercial Trade Channels
    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 Director, Risk Management, Global Drug Safety, Research and Development
    Alexion Pharmaceuticals, 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 Associate Vice President, Global Regulatory Affairs
    Merck & Co., Inc., United States
  • Ling  Su, PhD
    Ling Su, PhD Professor
    Shenyang Pharmaceutical University, China
  • Rachel  Turow, JD, MPH
    Rachel Turow, JD, MPH Associate General Counsel, Regulatory Law & Policy; Head, U.S. Regulatory Policy
    Teva Pharmaceutical Industries Ltd., United States
  • Kristin  Voorhees, MA
    Kristin Voorhees, MA Director, Patient Advocacy
    Ultragenyx Pharmaceutical, 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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