Program Co-Chairs & Committee
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 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
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Hans-Georg Eichler, MD, MSc
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Consulting Physician
Austrian Association of Social Security Bodies, Austria -
Gigi Hirsch, MD
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Executive Director
Massachusetts Institute of Technology (MIT) Center for Biomedical Innovation, United States -
Teresa Ancukiewicz, MA
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Associate Director
Boston Scientific Corporation, United States -
J. Lynn Bass, PharmD, RPh
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Senior Director, Medical Science Liaisons
BridgeBio, United States -
Kimberly Belsky, MS
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Reg Policy & Intell and AdPromo, Regulatory Affairs
Independent, United States -
Larry Blankstein, PhD
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Head of Clinical Operations
Synlogic, United States -
Daniel Bollag, PhD
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Chief Strategy Officer
Ocular Therapeutics, United States -
Linda Bowen, MSc, RAC
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Assistant Adjunct Temple University
Temple University Pharmacy School, United States -
Bill Byrom, PhD
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Vice President, Product Intelligence and Positioning; Principal, eCOA Science
Signant Health , United Kingdom -
Joy A. Cavagnaro, PhD
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President
Access BIO, United States -
Karla Childers, MS
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Head, Bioethics-Based Science and Technology Policy
Johnson & Johnson, United States -
Leah Christl, PhD
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Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
Amgen, United States -
Brenda Crowe, PhD
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Associate Vice President, Statistics
Eli Lilly and Company, United States -
Sara Doshi, PharmD
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Senior Director, Decentralized Clinical Trials
Eli Lilly and Company, United States -
Betsy Fallen, RN
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Consultant
BAFallen Consulting LLC, United States -
Ron Fitzmartin, PhD, MBA
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Senior Advisor, Office of Regulatory Operations, CBER
FDA, United States -
Elizabeth E. Garrard, PharmD
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Executive Vice President, Global Safety Operations
Clinipace Worldwide, United States -
Jonathan Haddad, MPH
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HIV Disease Area Head, Clinical Statistics
GlaxoSmithKline, United States -
Martin Harvey Allchurch, LLM
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Head of International Affairs
European Medicines Agency, Netherlands -
Jonathan Solomon Helfgott, MS
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Senior Lecturer, Faculty, & Program Coordinator,
Johns Hopkins University, United States -
Deborah J. Henderson, MSN
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Head, Global Regulatory Policy
Merck & Co., Inc., United States -
Frank Hubbard, PhD, MS
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President
Global Regulatory Writing Solutions Inc., United States -
Ginny Hussong
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Branch Chief, Data Standards, CBER
FDA, United States -
Rima Izem, PhD
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Associate Director Statistical Methodology
Novartis, Switzerland -
John Kamp
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Washington Counsel
Coalition For Healthcare Communication (CHC), United States -
Ellen Kelso
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Head, Knowledge Strategy
KSE Ltd., United States -
Lynn King, MHA
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Chief Operating Officer
M3 Wake Research, Inc, United States -
Agnes Klein, MD
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Senior Medical Advisor
Health Canada, Canada -
Stephen Knowles, MD, MRCP
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Chief Medical Officer
Halozyme Therapeutics, United States -
Mark Kryah, PMP
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Executive Director, Program Team Leader, Program and Portfolio Management
Ultragenyx Pharmaceutical Inc., United States -
Andrea C. Masciale, JD
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Vice President, Regulatory Policy and Global Analytics
Johnson & Johnson, United States -
Philomena McArthur, JD
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VP, Global Policies, Procedures & Training, Health Care Compliance & Privacy
Johnson & Johnson International, United States -
Ann Meeker-O'Connell, MS
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Director, Office of Clinical Policy, Office of Clinical Policy and Programs, OC
FDA, United States -
Mary Murray, MBA, MS
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Family Caregiver
Independent Consultant, United States -
Bob Muzerall
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Vice President, Sales & Sales Training
AMPLEXOR Life Sciences, LLC, United States -
Nancy Bradish Myers, JD
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CEO and Founder
Catalyst Healthcare Consulting, Inc, United States -
Jane Elizabeth Myles, MSc
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Program Director
Decentralized Trials and Research Alliance, United States -
Roger Nosal, PhD
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Vice President, Head of Global CMC
Pfizer Inc, United States -
Lisa Palladino-Kim, MS
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Program Director / Lecturer
Rutgers School of Health Professions Clin Research Mgmt, United States -
Julia Petses, PharmD
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Global Head, Medical Information Excellence and SEC Established and Rare Franchi
Novartis, United States -
Christine Pierre, RN
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President
Society for Clinical Research Sites, United States -
Sarah Pope Miksinski, PhD
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Executive Director, CMC Regulatory Affairs
Gilead Sciences, United States -
Kim Quaintance-Lunn
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Vice President, Head of Regulatory Science and Execution
Alexion, United States -
Badri Rengarajan, MD
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Life Sciences
Jazz Pharmaceuticals, United States -
Margaret Richards, PhD, MPH
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Executive Director, Solutions
Panalgo, United States -
Matthew D. Rotelli, PhD, MS
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Vice President, Bioethics
Eli Lilly and Company, United States -
Leslie Sam
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President
Leslie Sam and Associates, LLC, United States -
Leigh Shultz, PhD, PMP
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Executive Director, Human Health Commercial Operations
Merck & Co., Inc., United States -
Ashley F. Slagle, PhD, MS
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Principal, Scientific and Regulatory Consulting
Aspen Consulting, LLC, United States -
Nancy Pire Smerkanich, DrSc, MS
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Assistant Professor Regulatory & Quality Sciences
University of Southern California School of Pharmacy, United States -
Maureen Smith, MEd
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Member
Clinical Trials Ontario College of Lived Experience, Canada -
William B. Smith, MD
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CEO
Alliance for Multispecialty Research, LLC , United States -
Jeffrey N. Stuart, PhD
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Associate Vice President, Global Regulatory Affairs
Merck Sharp & Dohme LLC , United States -
Ling Su, PhD
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Research Fellow
Shenyang Pharmaceutical University, Yeehong Business School, China -
Sameer Thapar, PharmD, RPh
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Global Pharmacovigilance Director
Oracle Health Sciences, United States -
Toshiyoshi Tominaga, PhD
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Project Professor
Keio University Hospital, Japan -
Annette S. Williams, MBA, RPh
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Vice President, Pharmacovigilance
IQVIA, United States