DIA 2018
June 24-28, 2018
Boston
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Program Committee

  • Julie Louise Gerberding
    Julie Louise Gerberding • Executive Vice President and Chief Patient Officer
    Merck & Co., Inc., United States
  • Tatsuya Kondo, MD, PhD
    Tatsuya Kondo, MD, PhD • Honorary Chief Executive
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Teresa Ancukiewicz, MA
    Teresa Ancukiewicz, MA • Senior Manager, Clinical Data Management
    Boston Scientific Corporation, United States
  • Jonathan Raymond Andrus, MS
    Jonathan Raymond Andrus, MS • Chief Business Officer
    Clinical Ink, United States
  • Kimberly Belsky, MS
    Kimberly Belsky, MS • Head of Regulatory Policy & Intelligence, Regulatory Affairs
    Mallinckrodt Pharmaceuticals, United States
  • Larry A. Blankstein, PhD
    Larry A. Blankstein, PhD • Head of Clinical Operations
    Synlogic, 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
  • Susan Callery-D'Amico, BSN
    Susan 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 • 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
  • Leah Christl, PhD
    Leah Christl, PhD • Executive Director, Global Regulatory and R&D Policy
    Amgen, 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, PhD, MBA
    Ron D. Fitzmartin, PhD, MBA • Data Standards Staff, Office of the Director, CBER
    FDA, 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
  • Jennifer Graff, PharmD
    Jennifer Graff, PharmD • Vice President, Comparative Effectiveness Research
    National Pharmaceutical Council (NPC), 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
  • Frank Hubbard, PhD
    Frank Hubbard, PhD • President
    Global Regulatory Writing Solutions Inc., United States
  • Virginia Hussong
    Virginia Hussong • Chief, Data Standards Program, CBER
    FDA, United States
  • Nita Ichhpurani, PMP
    Nita Ichhpurani, PMP • Consultant
    Phase One Forward, Canada
  • 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
  • Lisa Palladino Kim, MS
    Lisa Palladino Kim, MS • Director of Capstone / Lecturer
    Rutgers School of Health Professions, United States
  • Agnes Victoria Klein, MD
    Agnes Victoria Klein, MD • Senior Medical Advisor
    Health Canada, Canada
  • Mark Kryah, PMP
    Mark Kryah, PMP • Senior Advisor/COO, Bio-Medicines Business Unit
    Eli Lilly and Company, United States
  • Vicky Martin
    Vicky Martin • Sr Director US Business Development
    IDDI Inc., United States
  • Chris Matheus, MBA
    Chris Matheus, MBA • President
    Matheus BD Connections, 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
  • Michael Neidl, MBA, MS
    Michael Neidl, MBA, MS • Senior Clinical Research Executive
    Clinical Research Consultant, LLC, United States
  • David J. Pepperl, PhD
    David J. Pepperl, PhD • Senior Consultant and Nonclinical Group Leader
    Biologics Consulting, United States
  • Kim Quaintance-Lunn
    Kim Quaintance-Lunn • Vice President and Head, Regulatory Policy, North American Regulatory Affairs
    Bayer, United States
  • Margaret Richards, PhD
    Margaret Richards, PhD • Executive Director, Scientific Affairs, Real-World Solutions
    PRA Health Sciences, United States
  • Peter Richardson, PhD
    Peter Richardson, PhD • Head of Quality, Specialised Scientific Disciplines Department
    European Medicines Agency (EMA), United Kingdom
  • 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
  • Mitra Rocca, MSc
    Mitra Rocca, MSc • Associate Director, Medical Informatics, Office of Translational Science, CDER
    FDA, United States
  • David H. Schubert
    David H. Schubert • Vice President of Regulatory and Quality
    Stealth BioTherapeutics, United States
  • Leigh Shultz, PhD, PMP
    Leigh Shultz, PhD, PMP • Associate Vice President, Project Management
    Merck & Co., 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
  • Veronica Todaro, MPH
    Veronica Todaro, MPH • Chief Operating Officer
    Parkinson's Foundation, United States
  • Toshiyoshi Tominaga, PhD
    Toshiyoshi Tominaga, PhD • Senior Advisor
    Japan Self-Medication Industry, Japan
  • Rebecca A. Vermeulen, RPh
    Rebecca A. Vermeulen, RPh • Head, Customer Strategy and Patient Partnership Global Medical Affairs
    Hoffmann-La Roche Ltd., United States
  • Kristin Voorhees, MA
    Kristin Voorhees, MA • Senior Manager, Patient Advocacy
    Ultragenyx Pharmaceutical, United States
  • Karen D. Weiss, MD
    Karen D. Weiss, MD • Vice President, Global Regulatory Affairs
    Janssen Pharmaceutical Companies of Johnson & Johnson, United States
  • Robin Whitsell
    Robin Whitsell • President
    Whitsell Innovations, Inc., United States
  • Annette S. Williams
    Annette S. Williams • Vice Presdient, Pharmacovigilance
    IQVIA, United States
  • Michael Williams
    Michael Williams • Managing Partner
    Facio Consulting Group and Associates, 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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