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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 Consulting Physician
    Austrian Association of Social Security Bodies, Austria
  • 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 Associate Director
    Boston Scientific Corporation, United States
  • J. Lynn  Bass, PharmD, RPh
    J. Lynn Bass, PharmD, RPh Senior Director, Medical Science Liaisons
    BridgeBio, United States
  • Kimberly  Belsky, MS
    Kimberly Belsky, MS Reg Policy & Intell and AdPromo, Regulatory Affairs
    Independent, United States
  • Larry  Blankstein, PhD
    Larry 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 Assistant Adjunct Temple University
    Temple University Pharmacy School, United States
  • Bill  Byrom, PhD
    Bill Byrom, PhD Vice President, Product Intelligence and Positioning; 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 Head, Bioethics-Based Science and Technology Policy
    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 Associate Vice President, Statistics
    Eli Lilly and Company, United States
  • Sara  Doshi, PharmD
    Sara Doshi, PharmD Senior Director, Decentralized Clinical Trials
    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 Advisor, Office of Regulatory Operations, 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 Senior Lecturer, Faculty, & Program Coordinator,
    Johns Hopkins University, 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
  • Ginny  Hussong
    Ginny Hussong Branch Chief, Data Standards, CBER
    FDA, United States
  • Rima  Izem, PhD
    Rima Izem, PhD Associate Director Statistical Methodology
    Novartis, Switzerland
  • John  Kamp
    John Kamp Washington Counsel
    Coalition For Healthcare Communication (CHC), United States
  • Ellen  Kelso
    Ellen Kelso Head, Knowledge Strategy
    KSE Ltd., United States
  • Lynn  King, MHA
    Lynn King, MHA Chief Operating Officer
    M3 Wake Research, Inc, United States
  • Agnes  Klein, MD
    Agnes 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, Program and Portfolio Management
    Ultragenyx Pharmaceutical Inc., 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, Office of Clinical Policy and Programs, OC
    FDA, United States
  • Mary  Murray, MBA, MS
    Mary Murray, MBA, MS Family Caregiver
    Independent Consultant, 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 CEO and Founder
    Catalyst Healthcare Consulting, Inc, United States
  • Jane Elizabeth Myles, MSc
    Jane Elizabeth Myles, MSc Program Director
    Decentralized Trials and Research Alliance (DTRA), United States
  • Roger  Nosal, PhD
    Roger Nosal, PhD Vice President, Head of Global CMC
    Pfizer Inc, United States
  • Lisa  Palladino-Kim, MS
    Lisa Palladino-Kim, MS Program Director / Lecturer
    Rutgers School of Health Professions Clin Research Mgmt, 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 Executive Director, CMC Regulatory Affairs
    Gilead Sciences, United States
  • Kim  Quaintance-Lunn
    Kim Quaintance-Lunn Vice President, Head of Regulatory Science and Execution
    Alexion, United States
  • Badri  Rengarajan, MD
    Badri Rengarajan, MD Life Sciences
    Jazz Pharmaceuticals, United States
  • Margaret  Richards, PhD, MPH
    Margaret Richards, PhD, MPH Executive Director, Solutions
    Panalgo, United States
  • Matthew D. Rotelli, PhD, MS
    Matthew D. Rotelli, PhD, MS Vice President, Bioethics
    Eli Lilly and Company, United States
  • Leslie  Sam
    Leslie Sam President
    Leslie Sam and Associates, LLC, United States
  • Leigh  Shultz, PhD, PMP
    Leigh Shultz, PhD, PMP Executive Director, Human Health Commercial Operations
    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, LLC , 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
  • Sameer  Thapar, PharmD, RPh
    Sameer Thapar, PharmD, RPh Global Pharmacovigilance Director
    Oracle Health Sciences, United States
  • Toshiyoshi  Tominaga, PhD
    Toshiyoshi Tominaga, PhD Project Professor
    Keio University Hospital, Japan
  • Annette S. Williams, MBA, RPh
    Annette S. Williams, MBA, RPh Vice President, Pharmacovigilance
    IQVIA, United States
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