- 20 years in pharma/biotech: Successful C-level biopharma executive/Chief Medical Officer and biopharma
board member, specializing in drug development, translational medicine, medical governance, risk management, and commercial strategy, with extensive regulatory experience. Effective track record of business and operational execution, fundraising/business development, entrepreneurship, venture capital, and strategic partnerships.
- President/CMO of small biopharma company (Furiex Pharmaceuticals) acquired by Actavis for $1.2B.
Company’s lead asset received FDA and EU approval.
- Senior medical/risk management leadership at GSK: oversaw numerous successful NDA/sNDA submissions. Served on global labeling and senior governance committees. Led global programs on safety signal detection/management. Chaired Pharma-FDA committee and served on CIOMS VIII editorial Board.
- Track record of value creation for small companies through integration of science, medicine, commercialization, and regulatory knowledge.
- 15 years of academic medical and research experience in internal medicine, infectious diseases, molecular biology, and pharmacology, and 10 years of clinical practice; 52 publications and 20+ invited presentations.
- MD, PhD Icahn (Mt. Sinai) School of Medicine; Residency/Fellowship, Stanford University; Board-certified,
Fellow of the American College of Physicians.
Hands-on Experience: Clinical Development and Translational Medicine, Clinical Trials (Phases 1-4), Medical Governance, Clinical Safety-Risk Management, Regulatory and Commercial Strategy, Regulatory Submissions, Product Labeling, Data Mining/Signal Detection, FDA-Sponsor Meetings and FDA Advisory Committees, Key Opinion Leader Expert Panels, Medical Affairs, Business Development/Investor Outreach, Scientific Licensing (buy and sell side), Investment Due Diligence, and Deal-Structuring.
Therapeutic Knowledge and Experience: Gastroenterology, Infectious Diseases, Microbiome, Immuno-inflammation/Oncology, General Medicine, Metabolic, Respiratory, Regenerative Medicine, Neuroscience, Ophthalmology, and Dermatology.
Board Director, Independent Biopharma Consultant (ongoing)
- Executive Chair, Board of RDD Pharma, an Orbimed gastroenterology/neuro company: role involves fund- raising, clinical development/regulatory, and corporate strategy
- Independent Director, TiGenix (TIG: Nasdaq): regenerative medicine, stem cells, GI/immuno-inflammation
- Independent Director, Ohr Pharmaceutical (OHRP: Nasdaq): ophthalmology therapeutics
- Consultant: Flagship Ventures (Kaleido Biosciences, a microbiome company), RedHill Biopharma (anti-infective, immuno-inflammation, oncology), and Frequency Therapeutics (hearing/neuro-regeneration)
- Investment Advisory Board, Harrington Discovery Institute, University Hospitals Health System, Cleveland
- Founding Board Member, Valanbio – Duke University spinoff (novel antibiotics)
- Executive-in-Residence, Hatteras Venture Partners (2015-16)
- Consulting (Adjunct) Professor of Medicine, Duke University
President, Principal Executive Officer and Chief Medical Officer, Furiex Pharmaceuticals (2010-2014)
Responsible for all strategic, scientific/medical, and financial/fundraising goals of publicly-traded $1B+ market-cap development-stage pharmaceutical company. Company valuation increased tenfold during four-and-a-half-year tenure and was acquired by Actavis (now Allergan). Oversaw Phases 2/3, NDA filing of Viberzi™ (novel molecule for IBS-d, now approved in US and EU), as well as several other Phase 1/2 programs in diverse therapeutic areas.
Vice President of Clinical Safety, Head of Global Signal Management, GSK (2005-2010)
Provided medical/scientific leadership, management oversight, benefit-risk management, R&D due diligence, and global regulatory submissions (including NDA, sNDA, labeling) for >30 products, as well as clinical trials (Phases 1-4).
Secondment, GSK Worldwide Business Development (2008-2009):Directed scientific licensing/deal diligences.