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Meet the Program Commitee for 2024!

Comité del programa

  • Venkatraman Balasubramanian, PhD, MBA
    Venkatraman Balasubramanian, PhD, MBA • Healthcare and Life Sciences Strategic Advisor
    VB Insights, LLC, United States
  • Greg Ball, PhD
    Greg Ball, PhD • Safety Data Scientist
    ASAPprocess, United States
  • Sanghita Bhattacharya, PhD
    Sanghita Bhattacharya, PhD • Director Data Science , Feasibility and Analytics, Clinical Operations
    Johnson & Johnson Innovative Medicine, United States
  • Claire Blanchette, PMP
    Claire Blanchette, PMP • Executive Drug Development Program Leader
    Consultant, United States
  • Tywnia Brewton
    Tywnia Brewton • Executive Director, Human Resources
    Astellas , United States
  • Susan Callery-D'Amico, BSN
    Susan Callery-D'Amico, BSN • Retired, Vice President, R&D Quality Assurance, AbbVie
    United States
  • Brooke Casselberry, MS, RAC
    Brooke Casselberry, MS, RAC • Vice President, Advisory and Delivery
    Epista Life Sciences, United States
  • Meghana Chalasani, MHA
    Meghana Chalasani, MHA • Associate Director for Clinical Trial Innovation, Office of New Drugs, CDER
    FDA, United States
  • Wendy Charles, PhD
    Wendy Charles, PhD • Chief Ethics and Compliance Officer; Adjunct Faculty
    Equideum Health, United States
  • Ethan Chen, MBA, MS, PMP
    Ethan Chen, MBA, MS, PMP • Director, Division of Data Management
    FDA CDER, United States
  • Mary Ellen Cosenza, PhD, MS, RAC
    Mary Ellen Cosenza, PhD, MS, RAC • President
    MEC Regulatory & Toxicology Consulting, LLC, United States
  • Stephanie Y. Crawford, PhD, MPH, MS
    Stephanie Y. Crawford, PhD, MPH, MS • Professor, Pharmacy Systems, Outcomes and Policy
    University of Illinois at Chicago, United States
  • Alysha Croker, PhD
    Alysha Croker, PhD • Director, Centre for Policy, Pediatrics and International Collaboration, BRDD
    Health Canada, Canada
  • Ebony Dashiell-Aje, PhD
    Ebony Dashiell-Aje, PhD • Executive Director and Head, Patient Centered Outcomes Science
    BioMarin, United States
  • Megan Doyle, JD, MPH
    Megan Doyle, JD, MPH • Associate Vice President, Assistant General Counsel - Diagnostics
    Eli Lilly & Company, United States
  • Nancy A Dreyer, PhD, MPH, FISPE
    Nancy A Dreyer, PhD, MPH, FISPE • Founder
    Dreyer Strategies LLC, United States
  • Jennifer Emerson, PhD, MPH, RN, PMP
    Jennifer Emerson, PhD, MPH, RN, PMP • Head Quality Analytics & Risk Management
    Boehringer Ingelheim, Germany
  • Andrew Emmett, MPH
    Andrew Emmett, MPH • FDA Liaison | US Regulatory Policy and Global Intelligence
    Pfizer Inc, United States
  • Ron Fitzmartin, PhD, MBA
    Ron Fitzmartin, PhD, MBA • Senior Advisor, Office of Regulatory Operations, CBER
    FDA, United States
  • Celeste Frankenfeld Lamm, PhD
    Celeste Frankenfeld Lamm, PhD • Senior Director, Global Regulatory Affairs – CMC
    Merck Sharp & Dohme LLC , United States
  • Danielle Friend Economo, PhD
    Danielle Friend Economo, PhD • Senior Director, US Head Regulatory Policy and Intelligence
    Johnson & Johnson Innovative Medicine, United States
  • David Fryrear, MS
    David Fryrear, MS • Executive Vice President and Head of Quality Assurance
    Astellas, United States
  • Alicia Gilsenan, PhD, MS, RPh, FISPE
    Alicia Gilsenan, PhD, MS, RPh, FISPE • Vice President, Epidemiology
    RTI Health Solutions, United States
  • Cheryl Grandinetti, PharmD
    Cheryl Grandinetti, PharmD • Associate Director for Clinical Policy, CDER/OC/OSI/DCCE
    FDA, United States
  • Renmeet Grewal, PharmD, MS
    Renmeet Grewal, PharmD, MS • Division Director, Office of Regulatory Operations (DRO-II), OND, CDER
    FDA, United States
  • Lani Hashimoto
    Lani Hashimoto • Associate Director, Patient Engagement
    Novartis Pharmaceuticals Corporation, United States
  • Sabine Haubenreisser, PhD, MSc
    Sabine Haubenreisser, PhD, MSc • Principal Scientific Administrator, Stakeholders and Communication Division
    European Medicines Agency, Netherlands
  • Cammilla Horta Gomes, MA, MPharm
    Cammilla Horta Gomes, MA, MPharm • Latam Regulatory Policy Lead
    Roche, Brazil
  • Stacy Hurt, MBA, MHA
    Stacy Hurt, MBA, MHA • Chief Patient Officer
    Parexel , United States
  • Emily (Xianghong) Jing, PhD
    Emily (Xianghong) Jing, PhD • Associate Director for Scientific Coordination, OBP, OPQ, CDER
    FDA, United States
  • Jeremy Jokinen, PhD, MS
    Jeremy Jokinen, PhD, MS • Vice President and Head, Safety Evidence and Sciences
    Bristol-Myers Squibb Company, United States
  • Mark Kryah, PMP
    Mark Kryah, PMP • Executive Director, Program Team Leader, Program and Portfolio Management
    Ultragenyx Pharmaceutical Inc., United States
  • Dominique Lagrave, PharmD
    Dominique Lagrave, PharmD • Senior Vice President of Regulatory Innovation
    Accumulus Synergy, United States
  • Cathryn C Lee, MSN
    Cathryn C Lee, MSN • Director, Office of Program Operations, PDIMS, OND, CDER
    FDA, United States
  • Jingyu (Julia) Luan, PhD
    Jingyu (Julia) Luan, PhD • Executive Regulatory Science Director, BioPharmaceuticals R&D
    AstraZeneca, United States
  • Demetra Macheras, MBA
    Demetra Macheras, MBA • Director, Regulatory Policy and Intelligence - Regulatory Affairs
    AbbVie, United States
  • Nicole Mahoney, PhD
    Nicole Mahoney, PhD • Executive Director US Regulatory Policy & Intelligence
    Novartis Pharmaceuticals Corporation, United States
  • Lindsay McNair, MD, MPH, MS
    Lindsay McNair, MD, MPH, MS • Principal Consultant
    Equipoise Consulting, United States
  • Melodi J McNeil, MS, RPh
    Melodi J McNeil, MS, RPh • Director, Regulatory Policy and Intelligence
    AbbVie, United States
  • David Meats
    David Meats • Director, Regulatory Services Management
    Certara, United States
  • Munish Mehra, PhD, MS, MSc
    Munish Mehra, PhD, MS, MSc • Managing Director and Sr. Principal Biostatistician
    Quantum Biopharma, United States
  • Timothe Menard, PharmD, MSc
    Timothe Menard, PharmD, MSc • Global Head, Quality Excellence Digital | Bioethics Coach (Data Ethics)
    F. Hoffmann-La Roche Ltd, Switzerland
  • Alexis Miller, JD
    Alexis Miller, JD • Acting Global Lead, Global Regulatory Policy and Intelligence
    Merck & Co., Inc., United States
  • Pallavi Mishra-Kalyani, PhD, MS
    Pallavi Mishra-Kalyani, PhD, MS • Deputy Division Director, DBV, OB, CDER
    FDA, United States
  • Martha Monser
    Martha Monser • Consumer Safety Officer, Office of Regulatory Operations, CBER
    FDA, United States
  • Monica Munoz, PharmD, PhD
    Monica Munoz, PharmD, PhD • Division Director, Division of Pharmacovigilance-I, OSE, CDER
    FDA, United States
  • Ana Padua, MSc, RPh
    Ana Padua, MSc, RPh • Director EU Global Regulatory and Scientific Policy
    EMD Serono, Switzerland
  • Kim Ribeiro, MS
    Kim Ribeiro, MS •
    United States
  • Margaret Richards, PhD, MPH
    Margaret Richards, PhD, MPH • Executive Director, Solutions
    Panalgo, United States
  • Cynthia Rothblum-Oviatt
    Cynthia Rothblum-Oviatt • Science Policy Analyst, Rare Disease Team, OND, CDER
    FDA, United States
  • Leslie Sam
    Leslie Sam • President
    Leslie Sam and Associates, LLC, United States
  • Earl Seltzer, MBA
    Earl Seltzer, MBA • Senior Director, Partnerships and Innovation
    CTI, United States
  • Anjali Shah, PharmD
    Anjali Shah, PharmD • Executive Director, Business Capabilities and Innovation, WWPS
    Bristol-Myers Squibb Company, United States
  • Elizabeth Somers, MS
    Elizabeth Somers, MS • Executive Director, Global Project and Alliance Management
    Merck Sharp & Dohme LLC, United States
  • Nancy Linda Styple
    Nancy Linda Styple • Project Management Leader
    Bayer AG, United States
  • Ling Su, PhD
    Ling Su, PhD • Research Fellow
    Shenyang Pharmaceutical University, Yeehong Business School, China
  • Linda B Sullivan, MBA
    Linda B Sullivan, MBA • Senior Fellow
    Tufts Center For the Study of Drug Development, United States
  • Alec Thompson, PharmD, MS
    Alec Thompson, PharmD, MS • Senior Product Manager, Oncology
    Gilead Sciences, United States
  • Phil Tregunno
    Phil Tregunno • Deputy Director - Patient Safety Monitoring
    Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
  • Rachel Turow, JD, MPH
    Rachel Turow, JD, MPH • Managing Counsel, FDA Regulatory
    Walmart, Inc., United States
  • Yoshiaki Uyama, PhD, RPh
    Yoshiaki Uyama, PhD, RPh • Associate Executive Director
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Pujita Vaidya, MPH
    Pujita Vaidya, MPH • North America Lead, Regulatory Science and Policy
    Sanofi, United States
  • James Valentine, JD, MHS
    James Valentine, JD, MHS • Director
    Hyman, Phelps & McNamara, PC, United States
  • James Wabby, MHS
    James Wabby, MHS • Global Head, Regulatory Affairs, Emerging Technologies and Combination Products
    AbbVie, United States
  • Paula Walker, MA
    Paula Walker, MA • Global Head of Risk Based Quality Management
    Roche Products Ltd., United Kingdom
  • Susan Wang, PhD
    Susan Wang, PhD • Global Head of Biostatistics and Data Sciences Inflammation
    Boehringer Ingelheim, United States
  • Robin Whitsell
    Robin Whitsell • President
    Whitsell Innovations, Inc., United States
  • Representative Invited
    Representative Invited • DIA, United States
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