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Program Co-Chairs & Committee

Hans Georg EichlerHans-Georg Eichler, MD, MSc
Senior Medical Officer
European Medicines Agency, European Union    

Hans-Georg Eichler, MD, MSc, is the Senior Medical Officer at the European Medicines Agency in London, United Kingdom, where he is responsible for coordinating activities between the Agency’s scientific committees and giving advice on scientific and public health issues.
Prior to joining the European Medicines Agency, Dr. Eichler was at the Medical University of Vienna in Austria for 15 years. He was vice-rector for Research and International Relations since 2003, and professor and chair of the Department of Clinical Pharmacology since 1992. His other previous positions include president of the Vienna School of Clinical Research and co-chair of the Committee on Reimbursement of Drugs of the Austrian Social Security Association. His industry experience includes time spent at Ciba-Geigy Research Labs, U.K., and Outcomes Research at Merck & Co., in New Jersey. In 2011, Dr. Eichler was the Robert E. Wilhelm fellow at the Massachusetts Institute of Technology’s Center for International Studies, participating in a joint research project under the MIT’s NEWDIGS initiative.
Dr. Eichler graduated with an MD from Vienna University Medical School and a Master of Science degree in Toxicology from the University of Surrey in Guildford, U.K. He trained in internal medicine and clinical pharmacology at the Vienna University Hospital as well as at Stanford University.

Gigi HirschGigi Hirsch, MD
Executive Director
Massachusetts Institute of Technology (MIT) Center for Biomedical Innovation        

Dr. Hirsch is the Executive Director of the MIT Center for Biomedical Innovation (CBI), which focuses on improving global health by overcoming challenges to the development, diffusion and adoption of biomedical innovations.

Her current efforts at CBI center on leading the New Drug Development Paradigms initiative (NEWDIGS), a “think and do tank” that is re-engineering pharmaceutical innovation to deliver new, better, affordable therapeutics to the right patients, faster.  Within the broad strategic framework of “Adaptive Biomedical Innovation (ABI),” NEWDIGS’ flagship project focused on aligning stakeholders around more adaptive, patient-centered approaches to the management of risk and uncertainty across the life span of new medicines.  This project helped inspire the Adaptive Pathways pilot program launched by the European Medicines Agency (EMA) in March 2014.

Under Dr. Hirsch’s leadership, NEWDIGS continues to channel multi-stakeholder thought leadership to advance other critical enablers of ABI such as adaptive financing and reimbursement models; real world evidence standards; and simulation methods/tools for collaborative innovation.

Dr. Hirsch has held a number of leadership roles that leverage her broad clinical background (Internal Medicine, Emergency Medicine, and Psychiatry) along with her passion for innovation, entrepreneurship, and improving patient outcomes.   Prior to joining CBI, she served as Director of Academic and Professional Relations at Millennium Pharmaceuticals, and was founder and CEO of a boutique entrepreneurial venture (MD IntelliNet), funded by Boston’s Beth Israel Hospital.  She has held faculty appointments at the medical schools of Harvard, Brown, and Tufts after receiving her medical degree at the University of Cincinnati.

Program Committee

  • Hans-Georg  Eichler, MD, MSc
    Hans-Georg Eichler, MD, MSc Senior Medical Officer
    European Medicines Agency, Netherlands
  • Gigi  Hirsch, MD
    Gigi Hirsch, MD Executive Director
    Massachusetts Institute of Technology (MIT) Center for Biomedical Innovation, United States
  • Teresa  Ancukiewicz, MA
    Teresa Ancukiewicz, MA Senior Manager, Clinical Data Management
    Boston Scientific Corporation, United States
  • J. Lynn  Bass, PharmD, RPh
    J. Lynn Bass, PharmD, RPh Senior Director, Medical Sciences
    Medexus Pharma, United States
  • Kimberly  Belsky, MS
    Kimberly Belsky, MS Executive Director Reg Policy & Intelligence and AdPromo Regulatory Affairs
    Mallinckrodt Pharmaceuticals, United States
  • Larry A. Blankstein, PhD
    Larry A. Blankstein, PhD Head of Clinical Operations
    Synlogic, United States
  • Daniel  Bollag, PhD
    Daniel Bollag, PhD Chief Strategy Officer
    Ocular Therapeutics, United States
  • Linda  Bowen, MSc, RAC
    Linda Bowen, MSc, RAC Head of Regulatory Policy and Intelligence
    Seagen, United States
  • Bill  Byrom, PhD
    Bill Byrom, PhD Principal, eCOA Science
    Signant Health , United Kingdom
  • Joy A. Cavagnaro, PhD
    Joy A. Cavagnaro, PhD President
    Access BIO, 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
  • Brenda  Crowe, PhD
    Brenda Crowe, PhD Senior Research Advisor, Global Statistical Sciences
    Eli Lilly and Company, United States
  • Sara  Doshi, PharmD
    Sara Doshi, PharmD Director, Medical Information Strategy and Capabilities, GMI
    Eli Lilly and Company, United States
  • Betsy  Fallen, RN
    Betsy Fallen, RN Consultant
    BAFallen Consulting LLC, United States
  • Ron  Fitzmartin, PhD, MBA
    Ron Fitzmartin, PhD, MBA Senior Informatics Advisor, Office of the Director, CBER
    FDA, United States
  • Elizabeth E. Garrard, PharmD
    Elizabeth E. Garrard, PharmD Executive Vice President, Global Safety Operations
    Clinipace Worldwide, United States
  • Jonathan  Haddad, MPH
    Jonathan Haddad, MPH HIV Disease Area Head, Clinical Statistics
    GlaxoSmithKline, United States
  • Martin  Harvey Allchurch, LLM
    Martin Harvey Allchurch, LLM Head of International Affairs
    European Medicines Agency, Netherlands
  • Jonathan Solomon Helfgott, MS
    Jonathan Solomon Helfgott, MS Executive Director, Global Regulatory/Clinical Affairs
    Stage 2 Innovations, United States
  • Deborah J. Henderson, MSN
    Deborah J. Henderson, MSN Head, Global Regulatory Policy
    Merck & Co., Inc., United States
  • Frank  Hubbard, PhD, MS
    Frank Hubbard, PhD, MS President
    Global Regulatory Writing Solutions Inc., United States
  • Virginia  Hussong
    Virginia Hussong Chief, Data Standards Program, CBER
    FDA, United States
  • Rima  Izem, PhD
    Rima Izem, PhD Associate Director, Statistical Methods and Consulting
    Novartis, United States
  • John  Kamp
    John Kamp Washington Counsel
    Coalition For Healthcare Communication (CHC), United States
  • Ellen  Kelso
    Ellen Kelso Head, Knowledge Strategy
    KSE Ltd., United States
  • Lisa Palladino Kim, MS
    Lisa Palladino Kim, MS Director of Capstone / Lecturer
    Rutgers School of Health Professions, United States
  • Lynn  King, MHA
    Lynn King, MHA Executive Director, Clinical Management
    PPD , United States
  • Agnes Victoria Klein, MD
    Agnes Victoria Klein, MD Senior Medical Advisor
    Health Canada, Canada
  • Stephen  Knowles, MD, MRCP
    Stephen Knowles, MD, MRCP Chief Medical Officer
    Halozyme Therapeutics, United States
  • Mark  Kryah, PMP
    Mark Kryah, PMP Executive Director/Program Team Leader
    Ultragenyx Pharmaceutical, United States
  • Andrea C. Masciale, JD
    Andrea C. Masciale, JD Vice President, Regulatory Policy and Global Analytics
    Johnson & Johnson, United States
  • Philomena  McArthur, JD
    Philomena McArthur, JD VP, Global Policies, Procedures & Training, Health Care Compliance & Privacy
    Johnson & Johnson International, United States
  • Ann  Meeker-O'Connell, MS
    Ann Meeker-O'Connell, MS Director, Office of Clinical Policy, OCPP, OC
    FDA, United States
  • Mary  Murray, MBA, MS
    Mary Murray, MBA, MS Vice President, Collaborative Action Networks
    National Minority Quality Forum, United States
  • Bob  Muzerall
    Bob Muzerall Vice President, Sales & Sales Training
    AMPLEXOR Life Sciences, LLC, United States
  • Nancy Bradish Myers, JD
    Nancy Bradish Myers, JD President and Founder
    Catalyst Healthcare Consulting, Inc, United States
  • Jane Elizabeth Myles, MS
    Jane Elizabeth Myles, MS Vice President, Clinical Trial Innovation
    Curebase, United States
  • Roger  Nosal, PhD
    Roger Nosal, PhD Vice President, Head of Global CMC
    Pfizer Inc, United States
  • Julia  Petses, PharmD
    Julia Petses, PharmD Global Head, Medical Information Excellence and SEC Established and Rare Franchi
    Novartis, United States
  • Christine  Pierre, RN
    Christine Pierre, RN President
    Society for Clinical Research Sites, United States
  • Sarah  Pope Miksinski, PhD
    Sarah Pope Miksinski, PhD Senior Director
    AstraZeneca, United States
  • Kim  Quaintance-Lunn
    Kim Quaintance-Lunn Vice President and Head, Regulatory Policy, Regulatory Affairs Americas
    Bayer, United States
  • Badri  Rengarajan, MD
    Badri Rengarajan, MD Life Sciences
    Industry Consultant, United States
  • Margaret  Richards, PhD, MPH
    Margaret Richards, PhD, MPH Senior Research Leader, Real World Evidence
    Evidera, United States
  • Matthew D. Rotelli, PhD
    Matthew D. Rotelli, PhD Senior Advisor, Bioethics
    Eli Lilly and Company, United States
  • Leslie  Sam
    Leslie Sam Principal Consultant
    Leslie Sam and Associates, United States
  • Leigh  Shultz, PhD, PMP
    Leigh Shultz, PhD, PMP Head, Commercial Trade Channels
    Merck & Co., Inc., United States
  • Ashley F. Slagle, PhD, MS
    Ashley F. Slagle, PhD, MS Principal, Scientific and Regulatory Consulting
    Aspen Consulting, LLC, 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
  • Maureen  Smith
    Maureen Smith Patient Advocate / Secretary
    Canadian Organization For Rare Disorders (CORD), Canada
  • William B. Smith, MD
    William B. Smith, MD CEO
    Alliance for Multispecialty Research (AMR), 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
  • Sameer  Thapar, PharmD, RPh
    Sameer Thapar, PharmD, RPh Global Pharmacovigilance Director
    Oracle Health Sciences, United States
  • Toshiyoshi  Tominaga, PhD
    Toshiyoshi Tominaga, PhD Senior Advisor
    Japan Self-Medication Industry, Japan
  • Annette S. Williams, MBA, RPh
    Annette S. Williams, MBA, RPh Vice President, Pharmacovigilance
    IQVIA, United States
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