DIA 2019
June 23-27, 2019
San Diego, CA
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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 • 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
  • Dannis Chang, PharmD
    Dannis Chang, PharmD • Senior Director, Medical Communications & Operations
    Myovant Sciences, 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
  • Sonya Eremenco, MA
    Sonya 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
  • 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 • 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 • 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 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 • 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 • Clinical Scientist, Global Strategic and Regulatory Documentation
    Bristol-Myers Squibb Company, United States
  • Erik Laughner
    Erik Laughner • Project Manager, Business Operations Staff, OD, CBER
    FDA, United States
  • Rebecca Lipsitz, PhD
    Rebecca Lipsitz, PhD • Director, Regulatory Policy
    Janssen, 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 and Global Head, CMC Policy
    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
  • 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 & Head, Regulatory Policy, Regulatory Affairs Americas
    Bayer U.S. LLC, 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 • 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, MS
    Nancy Pire Smerkanich, DrSc, MS • Assistant Professor Regulatory & Quality Sciences
    University of Southern California School of Pharmacy, United States
  • Meredith Smith, DrPH, PhD, MPA
    Meredith Smith, DrPH, 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
  • 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 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 • 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, DrMed, MD
    Judith Zander, DrMed, MD • Director, Office of Pharmacovigilance and Epidemiology, OSE, CDER
    FDA , United States
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