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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, European Union, United Kingdom
  • 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
    J. Lynn Bass, PharmD Director, Medical Science Liaisons, Americas
    Santen, Inc., United States
  • Kimberly  Belsky, MS
    Kimberly Belsky, MS Senior Director, Regulatory Affairs, Regulatory Policy and Intelligence
    Mallinckrodt Pharmaceuticals, United States
  • Larry A. Blankstein, PhD
    Larry A. Blankstein, PhD Head of Clinical Operations
    Synlogic, United States
  • Daniel M. Bollag, PhD
    Daniel M. Bollag, PhD Senior Vice President, Pharmacovigilance and Quality
    Ocular Therapeutics, United States
  • Linda F. Bowen, MSc, RAC
    Linda F. Bowen, MSc, RAC Senior Director, Global Regulatory Science and Policy
    Sanofi, United States
  • Bill  Byrom, PhD
    Bill Byrom, PhD Senior Director of Product Innovation, and Vice Director of ePRO Consortium
    ICON, plc., United Kingdom
  • Joy A. Cavagnaro
    Joy A. Cavagnaro President
    Access BIO, United States
  • Karla  Childers, MS
    Karla Childers, MS Senior Director, Strategic Projects, Office of the Chief Medical Officer
    Johnson & Johnson, United States
  • Leah  Christl, PhD
    Leah Christl, PhD Associate Director for Therapeutic Biologics, TBBS, OND, CDER
    FDA, 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 D. Fitzmartin, PhD, MBA
    Ron D. Fitzmartin, PhD, MBA Senior Advisor, Office of Strategic Programs, CDER
    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 Director, Clinical Statistics
    GlaxoSmithKline, United States
  • Martin  Harvey Allchurch, LLM
    Martin Harvey Allchurch, LLM Principal International Affairs Officer
    European Medicines Agency, European Union, United Kingdom
  • Jonathan Solomon Helfgott, MS
    Jonathan Solomon Helfgott, MS Coordinator for Regulatory Science Program
    Johns Hopkins University, United States
  • Deborah J. Henderson, MSN
    Deborah J. Henderson, MSN Executive Director, Global Regulatory Policy
    Merck & Co., Inc., United States
  • Frank  Hubbard, PhD
    Frank Hubbard, PhD President
    Global Regulatory Writing Solutions, Inc., United States
  • Virginia  Hussong
    Virginia Hussong Data Standards Program Manager, OD, BSS, CBER
    FDA, United States
  • Rima  Izem, PhD
    Rima Izem, PhD Lead Mathematical Statistician, Office of Translational Science, CDER
    FDA, United States
  • John  Kamp
    John Kamp Executive Director
    Coalition For Healthcare Communication, United States
  • Ellen  Kelso
    Ellen Kelso Head, Knowledge Strategy
    KSE Ltd., United States
  • Lisa  Kim, MS
    Lisa 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 V. Klein, MD
    Agnes V. Klein, MD Director, Evaluation of Radiopharmaceuticals and Biotherapeutic Products
    Health Canada, Canada
  • Stephen  Knowles, MD, MRCP
    Stephen Knowles, MD, MRCP Senior Director, Global Patient Safety, Medical and Benefit Risk Management
    Eli Lilly and Company, United States
  • Mark A. Kryah, PMP
    Mark A. Kryah, PMP Senior Advisor/COO, Bio-Medicines Business Unit
    Eli Lilly and Company, 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 Senior Director/ Head, BioResearch Quality and Compliance, Consumer Products
    Johnson & Johnson, United States
  • Mary Stober Murray, MBA
    Mary Stober Murray, MBA Associate Director, Diversity and Patient Engagement
    Bristol-Myers Squibb, 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 E. Myles, MS
    Jane E. Myles, MS Head, Operational Intelligence and Innovation
    Genentech, A Member of the Roche Group, United States
  • Roger  Nosal
    Roger Nosal Vice President and Head, Global CMC
    Pfizer Inc., United States
  • Julia  Petses, PharmD
    Julia Petses, PharmD Director, Medical Information Services, Diabetes
    Sanofi US, United States
  • Christine  Pierre, RN
    Christine Pierre, RN President
    Society for Clinical Research Sites, United States
  • Sarah  Pope Miksinski, PhD
    Sarah Pope Miksinski, PhD Dir., Off. of New Drug Products; Dir. (Acting), Off. of Surveillance, OPQ, CDER
    FDA, United States
  • Kim M. Quaintance-Lunn
    Kim M. Quaintance-Lunn Vice President and Head, US Regulatory Policy
    Bayer, United States
  • Badri  Rengarajan, MD
    Badri Rengarajan, MD Medical Affairs Lead, ASPIRE Unit
    Actelion, United States
  • Margaret S. Richards, PhD, MPH
    Margaret S. Richards, PhD, MPH Vice President, Data Analytics and Epidemiology, RW Strategy and Analytics
    Mapi, United States
  • Matthew D. Rotelli, PhD
    Matthew D. Rotelli, PhD Director, Global PK/PD and Pharmacometrics
    Eli Lilly and Company, United States
  • Leslie  Sam
    Leslie Sam Experienced Quality Professional
    Leslie Sam, United States
  • Leigh  Shultz, PhD
    Leigh Shultz, PhD Associate Vice President, Project Management
    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, Clinical Pharmacy; Educational Liaison & Instructor, ICRS
    University of Southern California, United States
  • Maureen  Smith
    Maureen Smith Patient Advocate / Secretary
    Canadian Organization For Rare Disorders (CORD), Canada
  • William B. Smith, MD
    William B. Smith, MD President
    VRG/NOCCR, An AMR Company, United States
  • Jeffrey N. Stuart, PhD, RAC
    Jeffrey N. Stuart, PhD, RAC Global Regulatory Director, Oncology, Immunology, and InVitro Diagnostics
    Merck & Co., Inc., United States
  • Ling  Su, PhD
    Ling Su, PhD Professor
    Shenyang Pharmaceutical Univeristy, China
  • Sameer  Thapar, PharmD, RPh
    Sameer Thapar, PharmD, RPh Global Pharmacovigilance Director
    Oracle, United States
  • Toshiyoshi  Tominaga, PhD
    Toshiyoshi Tominaga, PhD Associate Executive Director (for International Programs)
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Annette S. Williams, MBA, RPh
    Annette S. Williams, MBA, RPh Vice President, Lifecycle Safety
    IQVIA, United States
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