Program Committee
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Sandy Milligan, JD, MD Board of Director Member, Gossamer Bio; Principal
Innovex Strategies, United States -
J. Lynn Bass, PharmD, RPh Senior Director, Medical Science Liaisons
BridgeBio, United States -
Annetta C. Beauregard, MBA, MPH, MS Head of Global Regulatory Policy and Intelligence (GRPI)
Janssen , United States -
Larry Blankstein, PhD Head of Clinical Operations
Synlogic, United States -
Linda Bowen, MSc, RAC Chief of Staff, Oncology Regulatory Strategy
Pfizer, United States -
Joan Buenconsejo, PhD, MPH Head of Cardiovascular and Neuroscience Biostatistics
Bristol Myers Squibb, United States -
Jonca Bull, MD Vice President, Regulatory Consulting
PPD, United States -
Thomas M. Casola, MBA Head, Global Regulatory Affairs, Advertising and Promotion
Shire Specialty Pharmaceuticals, United States -
Nancie E. Celini, DrPH Chief Health Technology Advisor and Educator
CAB Inc., United States -
Leah Christl, PhD Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
Amgen, United States -
Anne Cropp, PharmD Chief Scientific Officer
Early Access Care LLC, United States -
Nancy A Dreyer, PhD, MPH, FISPE Founder
Dreyer Strategies LLC, United States -
Charles Drucker, MBA Director of Operations and Project Management
Quest Diagnostics, United States -
Lauren Edelstein Henry Senior Principal Operational Specialist
Janssen Pharmaceutical Companies of Johnson & Johnson, United States -
Kathleen Findlen Head of Clinical Operations and Project Management
Piramal Life Sciences, United States -
Ron Fitzmartin, PhD, MBA Senior Informatics Advisor, Office of Regulatory Operations, CBER
FDA, United States -
Michael Folkendt, MS Associate Director for Regulatory Affairs, OPRO, OPQ, CDER
FDA, United States -
Stacey Fung, PharmD Head, Global Medical Information
Gilead Sciences, United States -
Jonathan Haddad, MPH HIV Disease Area Head, Clinical Statistics
GlaxoSmithKline, United States -
Martin Harvey Allchurch, LLM Head of International Affairs
European Medicines Agency, Netherlands -
Alan Hochberg Principal Scientific Enablement Director, Scientific Enablement and Processes
Genentech, A Member of the Roche Group, United States -
Mark Hope Chief Development and Regulatory Officer
Leal Tx, United States -
Chris Hoyle, MBA CEO
Elite Research Network, United States -
David Jacobson-Kram, PhD Associate Director for Pharmacology and Toxicology, Office of New Drugs, CDER
FDA, United States -
Nirdosh Jagota, PhD Managing Partner
GRQ Biotech Advisors LLC, United States -
Janet Jenkins-Showalter Head, US Regulatory Policy
Genentech, A Member of the Roche Group, United States -
Agnes Klein, MD Senior Medical Advisor
Health Canada, Canada -
Tatsuo Kurokawa, DIAFellow, PhD Director General
The Japan Biosimilar Association, Japan -
Sheila Lapping Senior Director, Outsourcing Management
Takeda Global Research & Development Center Inc., United States -
Jeffrey Litwin, MD, FACC Chief Operating Officer
WIRB-Copernicus Group (WCG), United States -
Barry Mangum, PharmD Chief Executive Officer
Paidion Research, Inc., United States -
JeanMarie Markham Chief Executive Officer
Clinlogix, United States -
Christopher Marrone, PharmD, RPh Outcomes Liaison Advisor – National Accounts, Value, Evidence and Outcomes (VEO)
Eli Lilly and Company, United States -
Munish Mehra, PhD, MS, MSc Senior Principal Biostatistician and Executive Director Biometrics
Tigermed, United States -
Jon Meyer, MBA, MSc Co-Founder and Managing Member
Life Science Strategy Group, LLC, United States -
C. Latham Mitchell, MD Managing Principal
Erudita Biotechnical LLC, United States -
Christine Moore, PhD Executive Director, Global External Advocacy and Standards
Organon & Co., United States -
Patrick C. O'Brien, JD, PharmD General Counsel
Arrowhead Research Corporation, United States -
Shaghig Palanjian, MBA Vice President, Global Head, R&D QA and Compliance
Shire, United States -
James L. Parmentier, PhD Professor
Retired, United States -
Pradip Paul, MD, MS Consultant
Strategic Pharmacovigilance and Risk Management, United States -
Kirsten H. Paulson, MS, RAC
Pfizer, Inc., United States -
Kim Quaintance-Lunn Vice President, Regulatory Affairs Americas
Bayer AG, United States -
Badri Rengarajan, MD Life Sciences
Jazz Pharmaceuticals, United States -
Margaret Richards, PhD, MPH Executive Director, Solutions
Panalgo, United States -
Lucy Rose, MBA President
Lucy Rose and Associates, United States -
Abdul J. Sankoh, PhD, MA, MS Vice President, Data Science
Sage Therapeutics, Inc. , United States -
Gregg Schneider Director, R&D Financial Management
Otsuka Pharmaceutical Development & Commercialization, Inc., United States -
Suzanne Sensabaugh, MBA, MS President and Principal Consultant
HartmannWillner LLC, United States -
Leigh Shultz, PhD, PMP Executive Director, Human Health Commercial Operations
Merck & Co., Inc., United States -
Ling Su, PhD Research Fellow
Shenyang Pharmaceutical University, Yeehong Business School, China -
Patrick J. Thomas, MS Senior Director, Global Regulatory Lead
Pfizer Inc, United States -
Carolynn Thomas-Jones
The Ohio State University, United States -
Toshiyoshi Tominaga, PhD Project Professor
Keio University Hospital, Japan -
Jurgen Venitz, MD, PhD Professor, Dept of Pharmaceutics, Pharmacotherapy & Outcomes Sci, Dir PK/PD Lab
Virginia Commonwealth University, United States -
Keith Wenzel Volunteer
DIA Study Endpoints Community, United States -
Albert I. Wertheimer, PharmD, PhD, MBA Professor of Pharmacy Administration, School of Pharmacy
Temple University, United States -
Linda Fossati Wood President
MedWrite, Inc., United States
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