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Meet the Program Commitee for 2024!

Program Committee

  • Venkatraman  Balasubramanian, PhD, MBA
    Venkatraman Balasubramanian, PhD, MBA SVP and Global Head, Industry Solutions - Healthcare and Life Sciences
    Orion Innovation, United States
  • Greg  Ball, PhD
    Greg Ball, PhD Safety Data Scientist
    ASAPprocess, United States
  • Sanghita  Bhattacharya, PhD
    Sanghita Bhattacharya, PhD Associate 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 Services and Solutions, OBI, OSP, CDER
    FDA, 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 Clinical Pharmacologist, OSI, OC, CDER
    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, Principal Biostatistician
    Tigermed, 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 Head, Diversity and Patient Inclusion, Clinical Development Solutions
    AbbVie, 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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