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Meet the Program Commitee for 2021!

Program Committee

  • Matt  Baldwin, MS
    Matt Baldwin, MS Senior Biostatistician
    Advance Research Associates, Inc (ARA), United States
  • Amy  Bertha
    Amy Bertha Executive Director, Regulatory Policy
    Bayer, United States
  • Poonam  Bordoloi, PharmD
    Poonam Bordoloi, PharmD Executive Director, Head of Global Medical Affairs Capabilities
    Organon & Co., United States
  • David  Bowers, PharmD
    David Bowers, PharmD Senior Director, Operations
    PPD, United States
  • Kristina  Bowyer
    Kristina Bowyer Vice President, Patient Centric Drug Development
    Ionis, United States
  • Philip (P.J.)  Brooks, PhD
    Philip (P.J.) Brooks, PhD Deputy Director, Office of Rare Diseases Research
    National Center for Advancing Translational Sciences (NCATS), NIH, United States
  • Bill  Byrom, PhD
    Bill Byrom, PhD Principal, eCOA Science
    Signant Health , United Kingdom
  • Meghana  Chalasani, MHA
    Meghana Chalasani, MHA Lead, Science Strategies, 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
  • 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 Director, Global Biostatistics
    Amgen, 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
  • Julie  Dietrich, MS
    Julie Dietrich, MS Vice President, Clinical Development
    GENFIT Corp., United States
  • Sonya  Eremenco, MA
    Sonya Eremenco, MA Executive Director, PRO Consortium
    Critical Path Institute, United States
  • Jennifer  Farmer, MS
    Jennifer Farmer, MS Chief Executive Officer
    Friedreich's Ataxia Research Alliance (FARA), United States
  • Ron  Fitzmartin, PhD, MBA
    Ron Fitzmartin, PhD, MBA Senior Informatics Advisor, Office of the Director, CBER
    FDA, United States
  • David  Fryrear, MS
    David Fryrear, MS Executive Vice President and Head of Quality Assurance, Medical and Development
    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, 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
    F. Hoffmann-La Roche, Switzerland
  • Michelle  Hoiseth
    Michelle Hoiseth Chief Data Officer
    Parexel, 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, Epidemiology, Safety Science, Capabilities and Innovation
    Bristol-Myers Squibb Company, United States
  • Darryl  L'Heureux, PhD, MPharm, MSc
    Darryl L'Heureux, PhD, MPharm, MSc Director, Clinical Science, Medical Writing, and Publications
    Ambrx, Inc, United States
  • Erik  Laughner
    Erik Laughner Project Manager, Business Operations Staff, OD, CBER
    FDA, United States
  • Cathryn C Lee, MSN
    Cathryn C Lee, MSN Senior Regulatory Project Manager, OPO, 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 Independent Workforce 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
    Eli Lilly and Company, United States
  • Chris  Matheus, MBA
    Chris Matheus, MBA Chief Commercial & Networking Officer
    Global Life Sciences Alliance, United States
  • K. Kimberly  McCleary
    K. Kimberly McCleary Founder and Chief Executive Officer
    The Kith Collective, LLC, United States
  • Lindsay  McNair, MD, MPH, MS
    Lindsay McNair, MD, MPH, MS Chief Medical Officer
    WCG, United States
  • Ann  Meeker-O'Connell, MS
    Ann Meeker-O'Connell, MS Director, Office of Clinical Policy, OCPP, OC
    FDA, United States
  • Christine  Moore, PhD
    Christine Moore, PhD Executive Director, External Advocacy and Quality
    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 Management
    Merck & Co., Inc., 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 (Acting), Office of Program Operations, OND, CDER
    FDA, United States
  • Margaret  Richards, PhD, MPH
    Margaret Richards, PhD, MPH Senior Research Leader, Real World Evidence
    Evidera, United States
  • Steven L. Roberds, PhD
    Steven L. Roberds, PhD Chief Scientific Officer
    Tuberous Sclerosis Alliance, United States
  • Earl  Seltzer, MBA
    Earl Seltzer, MBA Senior Director, Feasibility and Site Selection
    Labcorp Drug Development, United States
  • Nancy  Slater, MBA, PMP
    Nancy Slater, MBA, PMP Senior Director, Portfolio Program Management Therapeutic Area Head
    AbbVie, Inc., 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
  • Meredith  Smith, PhD, MPA, FISPE
    Meredith Smith, PhD, MPA, FISPE Director, Risk Management, Global Drug Safety, Research and Development
    Alexion Pharmaceuticals, United States
  • Evelyn  Soo, PhD
    Evelyn Soo, PhD Director, Bureau of Gastroenterology, Infection and Viral Diseases, HPFD
    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 & Co., Inc., United States
  • Ling  Su, PhD
    Ling Su, PhD Professor
    Shenyang Pharmaceutical University, China
  • Rachel  Turow, JD, MPH
    Rachel Turow, JD, MPH Associate General Counsel, Regulatory Law & Policy; Head, U.S. Regulatory Policy
    Teva Pharmaceutical Industries Ltd., United States
  • Daniel  Urban, PhD
    Daniel Urban, PhD Pharmacology/Toxicology Reviewer, OTAT, CBER
    FDA, United States
  • Paula  Walker, MA
    Paula Walker, MA Deputy Head of Inspectorate, Inspection, Enforcement & Standards Division
    Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
  • 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
  • Judith  Zander, MD
    Judith Zander, MD Director, Office of Pharmacovigilance and Epidemiology, OSE, CDER
    FDA , United States
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