Menu Back to Committee

Meet the Program Commitee for 2022!

Program Committee

  • Amy  Bertha
    Amy Bertha Executive Director, Regulatory Policy
    Bayer, United States
  • David  Bowers, PharmD
    David Bowers, PharmD Senior Director, Operations
    PPD, United States
  • Kristina  Bowyer
    Kristina Bowyer Vice President, Patient Advocacy & Engagement
    Ionis Pharmaceuticals, Inc., 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, US Life Sciences Advisory and Consulting
    NNIT, Inc., 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 Health Admin Program, CU Denver Business School; Chief Scientific Officer
    BurstIQ, United States
  • Ethan  Chen, MBA
    Ethan Chen, MBA Director, Division of Data Management Services and Solutions, OBI, OSP, CDER
    FDA, United States
  • Karla  Childers, MS
    Karla Childers, MS Bioethics & Strategic Projects Leader, Office of the Chief Medical Officer
    Johnson & Johnson, United States
  • Leah  Christl, PhD
    Leah Christl, PhD Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
    Amgen, United States
  • Freda  Cooner, PhD
    Freda Cooner, PhD Executive Director, Biostatistics
    Arcutis Biotherapeutics, Inc., 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
  • Ebony  Dashiell-Aje, PhD
    Ebony Dashiell-Aje, PhD Head and Senior Director, Patient Engagement and Outcomes Research
    BioMarin Pharmaceutical Inc., United States
  • Sameen  Desai, MBA, MS
    Sameen Desai, MBA, MS Executive Director, IT Worldwide Patient Safety
    Bristol-Myers Squibb Company, United States
  • Julie  Dietrich, MS
    Julie Dietrich, MS Vice President, Clinical Development
    GENFIT Corp., United States
  • Hetal  Doshi, MBA
    Hetal Doshi, MBA Director, Business Operations and Strategy
    AbbVie, 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
  • 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, FISPE
    Alicia Gilsenan, PhD, FISPE Vice President, Epidemiology
    RTI Health Solutions, 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 M Hochberg
    Alan M Hochberg Principal Scientific Enablement Director, Scientific Enablement and Processes
    F. Hoffmann-La Roche, United States
  • Michelle  Hoiseth
    Michelle Hoiseth General Manager
    Cytel, United States
  • Kenneth  Hu, PharmD, MBA
    Kenneth Hu, PharmD, MBA Senior Manager (US Reg Lead), Global Regulatory Strategy & Policy, Oncology
    Bristol-Myers Squibb Company, 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
  • Annie  Kennedy
    Annie Kennedy Chief of Policy, Advocacy, and Patient Engagement
    EveryLife Foundation for Rare Diseases, United States
  • Lisa  Kim, MS
    Lisa Kim, MS Program Director / Lecturer
    Rutgers School of Health Professions, United States
  • Cathryn C Lee, MSN
    Cathryn C Lee, MSN Director, Office of Program Operations, PDIMS, OND, CDER
    FDA, United States
  • Rebecca  Lipsitz, PhD
    Rebecca Lipsitz, PhD Senior Director, TA Regulatory Intelligence and Portfolio Policy, Late R&I RA
    AstraZeneca, United States
  • Sheila  Mahoney Jewels, MBA
    Sheila Mahoney Jewels, MBA Small Business Innovation and Aggregator Advocate
    LifeSciHub , United States
  • Ingrid  Markovic, PhD
    Ingrid Markovic, PhD Senior Science Advisor for CMC, Office of the Center Director, CBER
    FDA, United States
  • Christopher  Marrone, PharmD, RPh
    Christopher Marrone, PharmD, RPh Outcomes Liaison Advisor – National Accounts, Value, Evidence and Outcomes (VEO)
    Eli Lilly and Company, United States
  • Chris  Matheus, MBA
    Chris Matheus, MBA Chief Commercial and Networking Officer
    Global Life Sciences Alliance (GLSA), United States
  • Lindsay  McNair, MD, MPH, MS
    Lindsay McNair, MD, MPH, MS Chief Medical Officer
    WCG, 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 the Director, CBER
    FDA, United States
  • Christine  Moore, PhD
    Christine Moore, PhD Executive Director, External Advocacy and Standards
    Organon & Co., United States
  • Jean M. Mulinde, MD
    Jean M. Mulinde, MD Medical Officer, Policy Advisor, Division of Clinical Compliance Evaluation, OSI
    FDA, 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
  • Anita  Nelsen
    Anita Nelsen Executive Vice President, Translational Medicine
    Parexel, United States
  • David O Olaleye, PhD, MSc
    David O Olaleye, PhD, MSc Senior Manager and Principal Research Statistician
    SAS Institute Inc., United States
  • Sissi  Pham, PharmD
    Sissi Pham, PharmD Chief Executive Officer
    AESARA, United States
  • Paul  Phillips
    Paul Phillips Director, Office of Program Operations, OND, CDER
    FDA, United States
  • Margaret  Richards, PhD, MPH
    Margaret Richards, PhD, MPH Executive Director, Solutions
    Panalgo, 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
  • Meredith  Smith, PhD, MPA, FISPE
    Meredith Smith, PhD, MPA, FISPE Senior Director, Implementation Science Pillar Lead
    Evidera, Inc, United States
  • Evelyn  Soo, PhD, MS
    Evelyn Soo, PhD, MS Director, Bureau of Gastroenterology, Infection and Viral Diseases, HPFB
    Health Canada, Canada
  • Mat  Soukup, PhD
    Mat Soukup, PhD Deputy Director, Division of Biometrics VII, OB, OTS CDER
    FDA, United States
  • Jeffrey N. Stuart, PhD
    Jeffrey N. Stuart, PhD Associate Vice President, Global Regulatory Affairs
    Merck Sharp & Dohme LLC , United States
  • Ling  Su, PhD
    Ling Su, PhD Research Fellow
    Shenyang Pharmaceutical University Yeehong Business School, China
  • Linda  Sullivan, MBA
    Linda Sullivan, MBA Senior Advisor, Metrics and Performance Management
    WCG, United States
  • Melek  Sunay, PhD
    Melek Sunay, PhD Pharmacology and Toxicology Reviewer, DCEPT, OTAT, CBER
    FDA, United States
  • Ashley  Trieu, PharmD
    Ashley Trieu, PharmD Manager, Pharmacovigilance Scientist
    Kyowa Kirin, Inc, United States
  • Rachel  Turow, JD, MPH
    Rachel Turow, JD, MPH Associate General Counsel, Regulatory Law and Policy; Head, US Regulatory Policy
    Teva Pharmaceutical Industries Ltd., United States
  • Pujita  Vaidya, MPH
    Pujita Vaidya, MPH Director, Global Regulatory and R&D Policy, Patient Centricity, Pediatrics, ROD
    Amgen, United States
  • Casey  Walker, PharmD
    Casey Walker, PharmD Pharmacist
    Jushi Holdings, Inc, United States
  • Paula  Walker, MA
    Paula Walker, MA Quality Practice Lead, Product Devlopment 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 Executive Director, New Market Development Project Leadership
    BeiGene, Inc., United States
  • Keith  Wenzel
    Keith Wenzel Senior Director, Scientific Data Organization
    Parexel International, 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 and Commercial Qua
    Alexion, Astrazeneca Rare Disease, Switzerland
Load More