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Meet the Program Commitee for 2025!

Comité del programa

  • Linda Akunne, MPH
    Linda Akunne, MPH • Chief, Project Management Staff, ORO, OND, CDER
    FDA, United States
  • 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
  • Amy Bertha
    Amy Bertha • Executive Director, Regulatory Policy and Science
    Bayer, United States
  • Sanghita Bhattacharya, PhD
    Sanghita Bhattacharya, PhD • Director Data Science Global Function
    Johnson & Johnson Innovative Medicine, United States
  • Asia Blackwell
    Asia Blackwell • Consumer Safety Officer
    FDA, United States
  • Claire Blanchette, PMP
    Claire Blanchette, PMP • Executive Drug Development Program Leader
    Daiichi Sankyo, United States
  • Tywnia Brewton
    Tywnia Brewton • Executive Director, Human Resources
    Astellas , United States
  • James Buchanan, PharmD
    James Buchanan, PharmD • President
    Covilance LLC, United States
  • Mandy Kaur Budwal-Jagait, MSc
    Mandy Kaur Budwal-Jagait, MSc • Head of GCP
    Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
  • Meghana Chalasani, MHA
    Meghana Chalasani, MHA • Associate Director for Clinical Trial Innovation, Office of New Drugs, CDER
    FDA, United States
  • Joan Chambers
    Joan Chambers • Senior Consultant
    Tufts CSDD, United States
  • Rachel Chasse, MS
    Rachel Chasse, MS • Associate Director, Digital Science Strategy
    AbbVie, United States
  • Christine Colvis, PhD
    Christine Colvis, PhD • Director, Drug Development Partnership Programs
    National Center for Advancing Translational Sciences (NCATS), United States
  • Karen Correa, PhD
    Karen Correa, PhD • Vice President, Clinical Development Operations
    Boehringer Ingelheim, United States
  • Solange Corriol-Rohou, DrMed, MD, PhD
    Solange Corriol-Rohou, DrMed, MD, PhD • Senior Director, Global Regulatory Affairs & Policy, R&D, Europe
    AstraZeneca , France
  • 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 of the Centre for Policy, Pediatrics and International Collaboration
    Health Canada, Canada
  • Victoria DiBiaso, BSN, MPH, RN
    Victoria DiBiaso, BSN, MPH, RN • Global Head, Patient Informed Development and Health Value Translation
    Sanofi, France
  • Megan Doyle, JD, MPH
    Megan Doyle, JD, MPH • Associate Vice President, Assistant General Counsel - Diagnostics
    Eli Lilly & Company, United States
  • Nancy Dreyer, PhD, MPH, FISPE
    Nancy Dreyer, PhD, MPH, FISPE • Founder
    Dreyer Strategies LLC, United States
  • Joseph Dustin
    Joseph Dustin • Founder and Principal
    Dauntless Eclinical Strategies, 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
    Celeste Frankenfeld Lamm • 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 • Chief Quality Officer
    Astellas, United States
  • Cheryl Grandinetti, PharmD
    Cheryl Grandinetti, PharmD • Associate Director for Clinical Policy, CDER/OC/OSI/DCCE
    FDA, United States
  • Courtney Granville, PhD, MPH
    Courtney Granville, PhD, MPH • Chief Scientific Officer
    GO2 For Lung Cancer, United States
  • Lani Hashimoto
    Lani Hashimoto • Consultant, Patient Experience
    Hashimoto Consulting Services, 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
  • Huong Huynh, PhD
    Huong Huynh, PhD • Director of Regulatory Science
    Critical Path Institute, 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
  • 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 Affairs (Global Regulatory Lead, Oncology Early Development
    AbbVie, United States
  • David Meats
    David Meats • Director, Regulatory Services & Medical Affairs Management
    Certara, 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
  • Pallavi Mishra-Kalyani, PhD, MS
    Pallavi Mishra-Kalyani, PhD, MS • Deputy Division Director, DBV, OB, CDER
    FDA, United States
  • May F Mo, MBA, MS
    May F Mo, MBA, MS • Executive Director, Biostatistics
    Amgen, United States
  • Monica Munoz, PharmD, PhD
    Monica Munoz, PharmD, PhD • Division Director, Division of Pharmacovigilance-I, OSE, CDER
    FDA, United States
  • Lauren Oliva, PharmD, RPh
    Lauren Oliva, PharmD, RPh • US Lead, Global Regulatory Policy
    Biogen, United States
  • Y. Veronica Pei, MD, MEd, MPH
    Y. Veronica Pei, MD, MEd, MPH • Acting Associate Director, Biomedical Informatics and Regulatory Review Science
    FDA, United States
  • Vada A. Perkins, DrSc, MSc
    Vada A. Perkins, DrSc, MSc • Vice President, Global Head of Regulatory Intelligence & Policy
    Boehringer Ingelheim, United States
  • Ranjini Prithviraj, PhD, PMP
    Ranjini Prithviraj, PhD, PMP • Director, Global Medical Affairs, Publication Management
    Regeneron, United States
  • Kim Ribeiro, MS
    Kim Ribeiro, MS • Chief Client Officer
    Inside Edge Consulting Group, United States
  • Margaret Richards, PhD, MPH
    Margaret Richards, PhD, MPH • Executive Director, Solutions
    Panalgo, United States
  • Elizabeth Rosenkrands-Lange, MPH, MS
    Elizabeth Rosenkrands-Lange, MPH, MS • Senior Director/ Head of US Regulatory Scientific Policy
    EMD Serono, Part of Merck KGaA, Darmstadt, Germany, United States
  • Cynthia Rothblum-Oviatt, PhD
    Cynthia Rothblum-Oviatt, PhD • 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
  • Nancy Pire Smerkanich, DrSc, MS
    Nancy Pire Smerkanich, DrSc, MS • Assistant Professor Regulatory & Quality Sciences
    University of Southern California School of Pharmacy, United States
  • Elizabeth Somers, MS
    Elizabeth Somers, MS • Executive Director, Global Project and Alliance Management
    Merck Sharp & Dohme LLC, United States
  • Benjamin Stevens, PhD, MPH
    Benjamin Stevens, PhD, MPH • Director CMC Policy and Advocacy
    GlaxoSmithKline, 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
  • Alec Thompson, PharmD, MS
    Alec Thompson, PharmD, MS • Senior Product Manager, Oncology
    Gilead Sciences, United States
  • Michael Torok, PhD
    Michael Torok, PhD • Vice President, Global Head of Quality Assurance Programs
    Genentech, A Member of the Roche Group, United States
  • Phil Tregunno
    Phil Tregunno • Deputy Director - Patient Safety Monitoring
    Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
  • Yoshiaki Uyama, PhD, MS, RPh
    Yoshiaki Uyama, PhD, MS, RPh • Associate Executive Director
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • 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
  • Robin Whitsell
    Robin Whitsell • President
    Whitsell Innovations, Inc., United States
  • Amira Deia Younes
    Amira Deia Younes • Director, Eastern Europe, Middle East & Africa (EEMEA) Global Regulatory Policy
    MSD, United Arab Emirates
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