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Program Committee

  • Sandra A. Milligan, JD, MD
    Sandra A. Milligan, JD, MD Senior Vice President, Head of Global Regulatory Affairs and Clinical Safety
    Merck Research Laboratories, United States
  • J. Lynn  Bass
    J. Lynn Bass Senior Director, Medical Science Liaison (MSL) Operations
    TriNet Pharma, United States
  • Annetta C. Beauregard, MBA, MS
    Annetta C. Beauregard, MBA, MS Vice President, US Regulatory Strategy
    EMD Serono, Inc., United States
  • Larry A. Blankstein, PhD
    Larry A. Blankstein, PhD Consultant, Clinical Development
    Blankstein Consulting Group, United States
  • Linda F. Bowen, MSc, RAC
    Linda F. Bowen, MSc, RAC US Regulatory Science and Policy
    Sanofi, United States
  • Joan  Buenconsejo
    Joan Buenconsejo Statistics Team Leader, Inflammation, Neuroscience & Respiratory TA, B&I Science
    AstraZeneca Pharmaceuticals LP, United States
  • Jonca C. Bull, MD
    Jonca C. Bull, MD Assistant Commissioner for Minority Health, Office of the Commissioner
    FDA, United States
  • Thomas M. Casola, MBA
    Thomas M. Casola, MBA Head, Global Regulatory Affairs, Advertising and Promotion
    Shire Specialty Pharmaceuticals, United States
  • Nancie E. Celini, DrPH
    Nancie E. Celini, DrPH Chief Health Technology Advisor and Educator
    CAB Inc., United States
  • Leah  Christl, PhD
    Leah Christl, PhD Associate Director for Therapeutic Biologics, TBBS, OND, CDER
    FDA, United States
  • Anne B. Cropp, PharmD
    Anne B. Cropp, PharmD Vice President
    Pfizer Inc, United States
  • Nancy A. Dreyer, PhD, MPH
    Nancy A. Dreyer, PhD, MPH SVP & Global Chief of Scientific Affairs, Real-World & Late-Phase Research
    Quintiles, United States
  • Charles  Drucker, MBA
    Charles Drucker, MBA Director of Operations and Project Management
    Quest Diagnostics, United States
  • Lauren  Edelstein Henry
    Lauren Edelstein Henry Senior Principal Operational Specialist
    Janssen Pharmaceutical Companies of Johnson & Johnson, United States
  • Kathleen  Findlen
    Kathleen Findlen Head of Clinical Operations and Project Management
    Piramal Life Sciences, United States
  • Ron D. Fitzmartin, PhD, MBA
    Ron D. Fitzmartin, PhD, MBA Senior Advisor, Office of Strategic Programs, CDER
    FDA, United States
  • Michael  Folkendt, MS
    Michael Folkendt, MS Associate Director, Office of Programs and Regulatory Operations, OPQ, CDER
    FDA, United States
  • Stacey M. Fung, PharmD
    Stacey M. Fung, PharmD Associate Director, Medical Communications
    Genentech, A Member of the Roche Group, United States
  • Jonathan  Haddad
    Jonathan Haddad Director, Clinical Statistics
    GlaxoSmithKline, United States
  • Martin  Harvey Allchurch, LLM
    Martin Harvey Allchurch, LLM Principal International Affairs Officer
    European Medicines Agency, European Union, United Kingdom
  • Alan M. Hochberg
    Alan M. Hochberg Scientific Enablement Leader
    F. Hoffmann-La Roche Ltd., Switzerland
  • Mark J. Hope
    Mark J. Hope Vice President, Global Head of Regulatory Affairs
    UCB SA, Switzerland
  • Christopher J. Hoyle, MBA
    Christopher J. Hoyle, MBA Executive Director
    Elite Research Network, United States
  • David  Jacobson-Kram, PhD
    David Jacobson-Kram, PhD Associate Director for Pharmacology and Toxicology, Office of New Drugs, CDER
    FDA, United States
  • Nirdosh  Jagota, PhD
    Nirdosh Jagota, PhD Vice President and Head, Regulatory CMC
    Merck & Co., Inc., United States
  • Janet  Jenkins-Showalter
    Janet Jenkins-Showalter Head, US Regulatory Policy
    Genentech, A Member of the Roche Group, United States
  • Agnes V. Klein, DrPH, MD
    Agnes V. Klein, DrPH, MD Director, Evaluation of Radiopharmaceuticals and Biotherapeutic Products
    Health Canada, Canada
  • Tatsuo  Kurokawa, PhD
    Tatsuo Kurokawa, PhD President
    Japan Self-Medication Industry, Japan
  • Sheila  Lapping
    Sheila Lapping Senior Director, Outsourcing Management
    Takeda Global Research & Development Center Inc., United States
  • Jeffrey  Litwin
    Jeffrey Litwin President
    Litwin Consulting, United States
  • Barry  Mangum, PharmD
    Barry Mangum, PharmD Chief Executive Officer
    Paidion Research, Inc., United States
  • JeanMarie  Markham
    JeanMarie Markham Chief Executive Officer
    Clinlogix LLC, United States
  • Christopher M. Marrone, PharmD
    Christopher M. Marrone, PharmD Real World Outcomes Liaison
    Eli Lilly and Company, United States
  • Munish  Mehra, PhD
    Munish Mehra, PhD Managing Director
    Quantum Biopharma, United States
  • Jon  Meyer, MBA, MSc
    Jon Meyer, MBA, MSc Co-Founder and Managing Member
    Life Science Strategy Group, LLC, United States
  • C. Latham  Mitchell, MD
    C. Latham Mitchell, MD Assistant Professor, Rutgers University; Managing Principal
    Erudita Biotechnical LLC, 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
  • Patrick C. O'Brien, JD, PharmD
    Patrick C. O'Brien, JD, PharmD General Counsel
    Arrowhead Research Corporation, United States
  • Shaghig  Palanjian, MBA
    Shaghig Palanjian, MBA Vice President, Global Head, R&D QA and Compliance
    Shire Pharmaceuticals, United States
  • James L. Parmentier, PhD
    James L. Parmentier, PhD Professor
    Retired, United States
  • Pradip  Paul, MD, MS
    Pradip Paul, MD, MS Consultant
    Strategic Pharmacovigilance and Risk Management, United States
  • Kirsten H. Paulson, MS, RAC
    Kirsten H. Paulson, MS, RAC Senior Director, Global CMC Medical Devices
    Pfizer Inc, United States
  • Kim M. Quaintance-Lunn
    Kim M. Quaintance-Lunn Head, US Regulatory Policy
    Bayer, United States
  • Badri  Rengarajan, MD
    Badri Rengarajan, MD Medical Affairs Lead, ASPIRE Unit
    Actelion, United States
  • Margaret S. Richards, PhD, MPH
    Margaret S. Richards, PhD, MPH Executive Director, Global Epidemiology, Real World Outcomes
    PPD, United States
  • Lucy  Rose, MBA
    Lucy Rose, MBA President
    Lucy Rose and Associates, LLC, United States
  • Abdul J. Sankoh, PhD, MA, MS
    Abdul J. Sankoh, PhD, MA, MS Vice President, Data Science
    Sage Therapeutics, Inc. , United States
  • Gregg  Schneider
    Gregg Schneider Director, R&D Financial Management
    Otsuka Pharmaceutical Development & Commercialization, Inc., United States
  • Suzanne  Sensabaugh, MBA, MS
    Suzanne Sensabaugh, MBA, MS President and Principal Consultant
    HartmannWillner LLC, United States
  • Leigh  Shultz
    Leigh Shultz Associate Vice President, Project Management
    Merck & Co., Inc., United States
  • Ling  Su, PhD
    Ling Su, PhD Venture Partner
    Lilly Asia Ventures, China
  • Patrick J. Thomas, MS
    Patrick J. Thomas, MS Director, US Group Lead - Adult & Travellers Vaccines
    GlaxoSmithKline, United States
  • Carolynn  Thomas-Jones
    Carolynn Thomas-Jones
    The Ohio State University, United States
  • Toshiyoshi  Tominaga
    Toshiyoshi Tominaga Associate Executive Director (for International Programs)
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Jurgen  Venitz, MD, PhD
    Jurgen Venitz, MD, PhD Professor, Dept of Pharmaceutics, Pharmacotherapy & Outcomes Sci, Dir PK/PD Lab
    Virginia Commonwealth University, United States
  • Keith W. Wenzel
    Keith W. Wenzel Senior Director
    PAREXEL, United States
  • Albert I. Wertheimer, PharmD, PhD, MBA
    Albert I. Wertheimer, PharmD, PhD, MBA Professor of Pharmacy Administration, School of Pharmacy
    Temple University, United States
  • Linda Fossati Wood, MPH, RN
    Linda Fossati Wood, MPH, RN President
    MedWrite, Inc., United States
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