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Program Committee

  • Sandra L. Kweder, MD, FACP
    Sandra L. Kweder, MD, FACP Deputy Director, Office of New Drugs, CDER
    FDA, United States
  • Freda  Lewis-Hall, MD, FAPA
    Freda Lewis-Hall, MD, FAPA Executive Vice President and Chief Medical Officer; PCORI Board of Governors
    Pfizer Inc, United States
  • J. Lynn  Bass, PharmD, RPh
    J. Lynn Bass, PharmD, RPh Director, Medical Affairs
    Jazz Pharmaceuticals, United States
  • Larry A. Blankstein, PhD
    Larry A. Blankstein, PhD Consultant, Clinical Development
    Blankstein Consulting Group, United States
  • Linda F. Bowen, MS, RAC
    Linda F. Bowen, MS, RAC Head, US Regulatory Policy and Intelligence
    Sanofi, United States
  • Jonca C. Bull, MD
    Jonca C. Bull, MD Assistant Commissioner for Minority Health, Office of the Commissioner
    FDA, 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
  • Nancy A. Dreyer, PhD, MPH, FISPE
    Nancy A. Dreyer, PhD, MPH, FISPE Global Chief of Scientific Affairs, SVP
    Quintiles Real-World & Late Phase Research, 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, Data Standards Program, 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
  • Elizabeth E. Garrard, PharmD
    Elizabeth E. Garrard, PharmD Founder and CEO
    Garrard Safety Solutions, United States
  • Jonathan  Haddad, MPH, MT
    Jonathan Haddad, MPH, MT Director, Clinical Statistics
    GlaxoSmithKline, United States
  • Susan  Hagen
    Susan Hagen Patient Saves Director
    National Ataxia Foundation, United States
  • Martin  Harvey Allchurch, LLM
    Martin Harvey Allchurch, LLM Principal International Affairs Officer
    European Medicines Agency, European Union , United Kingdom
  • Deborah J. Henderson, MSN
    Deborah J. Henderson, MSN Executive Director, Global Regulatory Policy
    Merck & Co., Inc., United States
  • Alan M. Hochberg
    Alan M. Hochberg Senior Process Development Leader
    F. Hoffmann-La Roche Ltd., Switzerland
  • Christopher J. Hoyle, MBA
    Christopher J. Hoyle, MBA Executive Director
    Elite Research Network, United States
  • Rima  Izem, PhD
    Rima Izem, PhD Lead Mathematical Statistician, Office of Translational Science, CDER
    FDA, 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, United States
  • Janet  Jenkins-Showalter
    Janet Jenkins-Showalter Head, US Regulatory Policy
    Genentech, A Member of the Roche Group, United States
  • John  Kamp, JD, PhD
    John Kamp, JD, PhD Attorney at Law; Executive Director
    Wiley Rein LLP; Coalition For Healthcare Communication, United States
  • Agnes V. Klein, DrPH, MD
    Agnes V. Klein, DrPH, MD Director, Evaluation of Radiopharmaceuticals and Biotherapeutic Products
    Health Canada, Canada
  • Mark A. Kryah, PMP
    Mark A. Kryah, PMP Senior Advisor/COO, Pharmaceutical Project Management
    Eli Lilly and Company, United States
  • Tatsuo  Kurokawa, PhD
    Tatsuo Kurokawa, PhD Professor, Div. of Drug Development and Regulatory Sciences, Faculty of Pharmacy
    Keio University, Japan
  • Mary Jo  Lamberti, PhD, MA
    Mary Jo Lamberti, PhD, MA Senior Research Fellow
    Tufts Center for the Study of Drug Development, 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 Outcomes Liaison
    Eli Lilly and Company, United States
  • Philomena  McArthur, JD
    Philomena McArthur, JD Senior Director, Regulatory Advertising and Promotion and Healthcare Compliance
    Johnson & Johnson International, United States
  • Ann  Meeker-O'Connell, MS
    Ann Meeker-O'Connell, MS Head, Risk Management and External Engagement, Bioresearch Quality & Compliance
    Johnson & Johnson, 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
  • Christine M. V. Moore, PhD
    Christine M. V. Moore, PhD Acting Director, Office of Process and Facilities, OPQ, CDER
    FDA, United States
  • Bob  Muzerall
    Bob Muzerall Vice President, Sales and Sales Training
    ForeignExchange Translations, United States
  • Nancy Bradish Myers, JD
    Nancy Bradish Myers, JD President
    Catalyst Healthcare Consulting, Inc, United States
  • Shaghig  Palanjian
    Shaghig Palanjian Head of Research and Development Quality Assurance and Compliance
    Shire Pharmaceuticals, 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
  • Julia  Petses, PharmD
    Julia Petses, PharmD Director, Medical Information Services, Oncology
    Sanofi, United States
  • Kim M. Quaintance-Lunn
    Kim M. Quaintance-Lunn Head, US Regulatory Policy
    Bayer HealthCare Pharmaceuticals, United States
  • Badri  Rengarajan, MD
    Badri Rengarajan, MD Study Physician, Medical Affairs
    Actelion, 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, Biostatistics and Clinical Informatics
    Synageva Biopharma, United States
  • Suzanne  Sensabaugh, MBA, MS
    Suzanne Sensabaugh, MBA, MS President and Principal Consultant
    HartmannWillner LLC, United States
  • Leigh  Shultz, PhD, PMP
    Leigh Shultz, PhD, PMP Executive Director, Global Project Management
    Merck & Co., Inc., United States
  • Maureen  Smith, MEd
    Maureen Smith, MEd Patient Advocate / Secretary
    Canadian Organization For Rare Disorders (CORD), Canada
  • Ling  Su, PhD
    Ling Su, PhD Strategic Advisor, Life Sciences
    Sidley Austin LLP, China
  • Sameer  Thapar, PharmD
    Sameer Thapar, PharmD Professor and Advisor, Biopharma Educational Initiative, Drug Safety and PV
    Rutgers, The State University of New Jersey, United States
  • 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, PhD
    Toshiyoshi Tominaga, PhD Associate Executive Director for International Programs
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Jurgen  Venitz, MD, PhD
    Jurgen Venitz, MD, PhD Professor, Pharmaceutics
    Virginia Commonwealth University, United States
  • Keith W. Wenzel
    Keith W. Wenzel Senior Director
    Perceptive Partner Program, 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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