Menu Back to Committee

Meet the Program Commitee for 2023!

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 Owner and Consultant
    ASAP Process Consulting, United States
  • Amy  Bertha
    Amy Bertha Executive Director, Regulatory Policy
    Bayer, United States
  • Claire  Blanchette, PMP
    Claire Blanchette, PMP Vice President, Compound Development Team Leader
    Genmab, United States
  • Susan  Callery-D'Amico, BSN
    Susan Callery-D'Amico, BSN Vice President, R&D Quality Assurance
    AbbVie, Inc., United States
  • Brooke  Casselberry, MS, RAC
    Brooke Casselberry, MS, RAC Associate Vice President
    NNIT, United States
  • Meghana  Chalasani, MHA
    Meghana Chalasani, MHA Clinical Analyst, Special Projects Staff, Office of New Drugs, CDER
    FDA, United States
  • Andrew  Chang, PhD
    Andrew Chang, PhD Vice President, Quality and Regulatory Compliance
    Novo Nordisk, Inc., United States
  • Wendy  Charles, PhD
    Wendy Charles, PhD Chief Scientific Officer; Adjunct Faculty
    BurstIQ; Health Admin Program, CU Denver Business School, 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
  • Leah  Christl, PhD
    Leah Christl, PhD Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
    Amgen, 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 Pharmaceutical Inc., United States
  • Julie  Dietrich, MS
    Julie Dietrich, MS Vice President, Clinical Development
    GENFIT Corp., United States
  • Andrew  Emmett, MPH
    Andrew Emmett, MPH FDA Liaison | Global Regulatory Policy and Intelligence
    Pfizer Inc, United States
  • Jennifer  Farmer, MS
    Jennifer Farmer, MS Chief Executive Officer
    Friedreich`S Ataxia Research Alliance (FARA), United States
  • Maureen  Feeney, PharmD, MBA, RPh
    Maureen Feeney, PharmD, MBA, RPh Vice President Scientific and Medical Communications
    Takeda, United States
  • Ron  Fitzmartin, PhD, MBA
    Ron Fitzmartin, PhD, MBA Senior Informatics Advisor, Office of Regulatory Operations, CBER
    FDA, United States
  • David  Fryrear, MS
    David Fryrear, MS Executive Vice President and Head of Quality Assurance
    Astellas, United States
  • M. Scott  Furness, PhD
    M. Scott Furness, PhD Deputy Director, Office of New Drug Products, OPQ, CDER
    FDA, 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
  • Sabine  Haubenreisser, PhD, MSc
    Sabine Haubenreisser, PhD, MSc Principal Scientific Administrator, Stakeholders and Communication Division
    European Medicines Agency, Netherlands
  • Alan  Hochberg
    Alan Hochberg Principal Scientific Enablement Director, Scientific Enablement and Processes
    Genentech, A Member of the Roche Group, United States
  • Michelle  Hoiseth
    Michelle Hoiseth General Manager
    United States
  • Cammilla  Horta Gomes, MA, MPharm
    Cammilla Horta Gomes, MA, MPharm Latam Regulatory Policy Lead
    Roche, Brazil
  • Xianghong (Emily)  Jing
    Xianghong (Emily) Jing Associate Director for Scientific Coordination, OBP, OPQ, CDER
    FDA, United States
  • Jeremy  Jokinen, PhD, MS
    Jeremy Jokinen, PhD, MS Vice President and Head, Global Risk Management & International Patient Safety
    Bristol Myers Squibb Company, United States
  • Cathryn C Lee, MSN
    Cathryn C Lee, MSN Director, Office of Program Operations, PDIMS, OND, CDER
    FDA, United States
  • Demetra  Macheras, MBA
    Demetra Macheras, MBA Director, Regulatory Policy and Intelligence - Regulatory Affairs
    AbbVie, Inc., United States
  • Nicole  Mahoney, PhD
    Nicole Mahoney, PhD Executive Director, Regulatory Affairs, GDD
    Novartis Pharmaceuticals Corporation, United States
  • Sheila  Mahoney Jewels, MBA
    Sheila Mahoney Jewels, MBA Drug Development Multi-Functionalist
    LifeSciHub , United States
  • Ingrid  Markovic, PhD
    Ingrid Markovic, PhD Senior Science Advisor for CMC, Office of the Center Director, CBER
    FDA, 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, Inc., United States
  • David  Meats
    David Meats Director, Regulatory Services Management
    Certara Synchrogenix, United States
  • Munish  Mehra, PhD, MS, MSc
    Munish Mehra, PhD, MS, MSc Managing Director, Tigermed India
    Tigermed, United States
  • Timothe  Menard, PharmD, MSc
    Timothe Menard, PharmD, MSc Head Quality Data Science and Bioethics Coach, PDQ
    F. Hoffmann-La Roche, Switzerland
  • Alexis  Miller, JD
    Alexis Miller, JD US Lead, Global Regulatory Policy
    Merck Sharp & Dohme LLC , United States
  • Martha  Monser
    Martha Monser Consumer Safety Officer, Office of Regulatory Operations, CBER
    FDA, United States
  • Christine  Moore, PhD
    Christine Moore, PhD Executive Director, External Advocacy and Standards
    Organon & Co., United States
  • Erin  Mulrooney, MSc, PMP
    Erin Mulrooney, MSc, PMP Director, Discovery Project and Portfolio Management
    Merck Sharp & Dohme LLC , United States
  • Nobumasa  Nakashima, PhD
    Nobumasa Nakashima, PhD Associate Executive Director for International Programs
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Sissi  Pham, PharmD
    Sissi Pham, PharmD Chief Executive Officer
    AESARA, 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
    FDA, United States
  • Leslie  Sam
    Leslie Sam President
    Leslie Sam and Associates, 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 of Infectious Disease, Global Project and Alliance Management
    Merck Sharp & Dohme LLC, United States
  • Mat  Soukup, PhD
    Mat Soukup, PhD Deputy Director, Division of Biometrics VII, OB, OTS CDER
    FDA, United States
  • Shannon  Sparklin, MS
    Shannon Sparklin, MS Operations Research Analyst, PFDD, OCD, CDER
    FDA, United States
  • Ling  Su, PhD
    Ling Su, PhD Research Fellow
    Shenyang Pharmaceutical University Yeehong Business School, China
  • Linda  Sullivan, MBA
    Linda Sullivan, MBA
    Consultant, United States
  • Phil  Tregunno
    Phil Tregunno Deputy Director - Patient Safety Monitoring
    Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
  • Pujita  Vaidya, MPH
    Pujita Vaidya, MPH Director, Global Regulatory and R&D Policy, Patient Centricity, Pediatrics, ROD
    Amgen, United States
  • Paula  Walker, MA
    Paula Walker, MA Quality Policy Chapter Lead, Product Development Quality Global Leadership
    Roche Products Ltd., United Kingdom
  • Susan  Wang, PhD
    Susan Wang, PhD Global Head of Biostatistics and Data Sciences Inflammation
    Boehringer Ingelheim Pharmaceuticals Inc., United States
  • Nancy  Watanabe, MS, PMP
    Nancy Watanabe, MS, PMP Consultant
    Self-Employed, United States
  • Keith  Wenzel
    Keith Wenzel Senior Director, Scientific Data Organization
    Parexel International, United States
  • Jennifer  Whitely, PhD, MSc
    Jennifer Whitely, PhD, MSc Head of OMNI Evidence for Access
    Genentech, A Member of the Roche Group, United States
  • Robin  Whitsell
    Robin Whitsell President
    Whitsell Innovations, Inc., United States
  • Judith  Zander, MD
    Judith Zander, MD Director, Office of Pharmacovigilance and Epidemiology, OSE, CDER
    FDA , United States
  • Martine  Zimmermann, PharmD
    Martine Zimmermann, PharmD Senior Vice President, Head of Global Regulatory Affairs, R&D Quality
    Ipsen Innovation, France
Load More