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Program Committee

  • Jonathan Raymond Andrus, PhD, MBA, MS
    Jonathan Raymond Andrus, PhD, MBA, MS Chief Business Officer
    Clinical Ink, United States
  • Matt  Baldwin, MS
    Matt Baldwin, MS Senior Biostatistician
    Advance Research Associates, Inc (ARA), United States
  • Amy  Bertha
    Amy Bertha Senior Director, Regulatory Policy
    Bayer, United States
  • Poonam A. Bordoloi, PharmD
    Poonam A. Bordoloi, PharmD Director, Medical Affairs Team Lead
    Merck & Co., Inc., 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 Vice President, Global Engagement and Communications
    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
  • Meghana  Chalasani, MHA
    Meghana Chalasani, MHA Senior Research Analyst, Office of the Center Director, CDER
    FDA, 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 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
  • Freda W. Cooner, PhD
    Freda W. Cooner, PhD Director, Statistical Innovation
    Amgen, United States
  • Stephanie Y. Crawford, PhD, MPH, MS
    Stephanie Y. Crawford, PhD, MPH, MS Professor, Pharmacy Systems, Outcomes and Policy
    University of Illinois at Chicago, 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  Fitzmartin, PhD, MBA
    Ron Fitzmartin, PhD, MBA Senior Informatics Advisor, Office of the Director, CBER
    FDA, United States
  • David William Fryrear, MS
    David William Fryrear, MS Senior Vice President and Head of Clinical and Research QA, Medical and Dev
    Astellas, United States
  • M. Scott  Furness, PhD
    M. Scott Furness, PhD Deputy Director
    FDA, 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
  • 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 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 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
  • Christopher M. Marrone, PharmD
    Christopher M. Marrone, PharmD Outcomes Liaison
    Eli Lilly and Company, United States
  • Chris  Matheus, MBA
    Chris Matheus, MBA President
    Matheus BD Connections LLC, 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, Integrated QMS/OMS
    Vertex Pharmaceuticals, United States
  • Christine M. V. Moore, PhD
    Christine M. V. Moore, PhD Executive Director
    Merck & Co., Inc, United States
  • Jean M. Mulinde, MD
    Jean M. Mulinde, MD Policy Advisor, Division of Clinical Compliance Evaluation, OSI, OC, CDER
    FDA, United States
  • Nobumasa  Nakashima, PhD
    Nobumasa Nakashima, PhD Associate Executive Director for International Programs and Asia Training Centre
    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
  • Anita  Nelsen
    Anita Nelsen Senior Vice President, Translational Medicine
    Parexel, 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
  • James E. Polli, PhD
    James E. Polli, PhD Prof, Ralph F Shangraw/Noxell Endowed Chair in Industrial Pharmacy/Pharmaceutic
    University of Maryland School of Pharmacy, United States
  • Margaret  Richards, PhD, MPH
    Margaret Richards, PhD, MPH Senior Research Leader, Real World Evidence
    Evidera by PPD, 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, RPh
    Khyati Roberts, 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
  • 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, Department of Regulatory and Quality Sciences
    University of Southern California, United States
  • Meredith  Smith, PhD, MPA
    Meredith Smith, PhD, MPA Director, Risk Management, Global Drug Safety, Research and Development
    Alexion Pharmaceuticals, Inc. , United States
  • Elizabeth  Somers, MS
    Elizabeth Somers, MS Executive Director of Infectious Disease, Global Project and Alliance Management
    Merck & Co., Inc., United States
  • Evelyn  Soo, PhD
    Evelyn Soo, PhD Director, Bureau of Gastroenterology, Infection and Viral Diseases, HPFD
    Health Canada, Canada
  • 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
  • Nancy  Watanabe, MS, PMP
    Nancy Watanabe, MS, PMP Senior Director, Program Management
    BeiGene, Inc., United States
  • Robin  Whitsell
    Robin Whitsell President
    Whitsell Innovations, Inc., United States
  • Judith  Zander, DrMed, MD
    Judith Zander, DrMed, MD Director, Office of Pharmacovigilance and Epidemiology, OSE, CDER
    FDA , United States
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