- 27 years of drug development experience in large and small pharma companies.
- 36 years in medical/research field.
Physician Scientist, Medical Executive, Translational Medicine, Academic Clinical Investigator, Clinical Pharmacology, Drug Development, Clinical Trials, Oncologics, Biologics, Chief Medical Officer, Global Management, Regulatory, Advisory Boards, Emerging Markets.
World authority on translational medicine and clinical pharmacology. Pioneer in field of antiviral chemotherapy and proof-of-concept trials. Deep experience and knowledge of drug development, from discovery to global registration including oncologics and biologics. Extensive expertise in executive management of global sites with broad teams and large budgets. Successful registrations include: Revlimed, Thalidomide, Retrovir, Indinavir, Exelon, Ganciclovir, Acyclovir, and Neoral (cyclosporine). NDA submissions include Ivacaptor.
MD from Temple University, Fellow in Clinical Pharmacology at Johns Hopkins Hospital, and Post-Doctoral Fellow in Molecular Virology at The Johns Hopkins University. Currently holds a number of adjunct academic appointments in the US and China. Authored or co-authored 75 publications and more than 200 abstracts and/or invited presentations.
- President and Founder, R2D Pharma Services LLC
- Head, Global Clinical Regulatory Strategy and Global Regulatory Affairs, Vertex Pharmaceuticals, Inc.
- Vice President, Early Drug Development and Executive Director of Non-Clinical Development and Experimental Medicine, Celgene Corporation
- Vice President, Clinical Research and Development, Kyowa Pharmaceutical, Inc.
- US Director and Site Head, Clinical Pharmacology, GlaxoWellcome
- Vice President/Worldwide Head/Executive Director and Head of Clinical Pharmacology, Director and Head, Human Pharmacology, Novartis Pharmaceutical Corporation (formerly Sandoz Research Institute)
- Director, Clinical Pharmacology, Merck & Co.
- Assistant Professor of Medicine and Pharmacology, Cornell University Medical College
Biomarker development, first-in-human and proof-of-concept trials, pharmacodynamics/pharmacokinetics trials, evaluation of QTc prolongation potential, and evaluation of new chemical entities and biologics for in-licensing or investment purposes. Participation on mock FDA panels, Scientific Advisory boards, and DSM Committees. Creation and implementation of efficient programs to advance a NCE from research candidate to POC in humans, tailored to compound and indication. Development activities in emerging markets.
Integrated global registration strategies and plans including regulatory documents and submission of IND, CTA, NDA, and MAA. Management and strategy for early drug development, early clinical development, clinical research and development, and clinical operations.