- Drug Development consultant: 20+ years as successful C-level biopharma executive, including Chief Medical
Officer and board member, specializing in drug development (Phases 1-4), translational medicine, and commercial strategy. Strong track record in clinical trials, regulatory strategy, medical governance, and risk management. Proven expertise in FDA strategy/meetings submission, entrepreneurship, business development/venture capital, and strategic partnerships.
- President, CMO, and Board Member of Furiex Pharmaceuticals (acquired by Actavis/Allergan).
- Chief Operating Officer, CMO, and Strategic Advisor of Innovate BioPharmaceuticals.
- Public, private biotech and venture philanthropy board experience (see below).
- Vice President, Clinical Safety/Risk Management at GSK. Member: senior medical governance and labeling boards.
- GSK-led development of pioneering systems to minimize drug development risk, now industry/regulator standards.
- Value creation for small companies: integrating clinical development, science, commercial, and regulatory expertise.
- MD, PhD. Icahn (Mt. Sinai) School of Medicine; Residency/Fellowship, Stanford University; Board-certified, Fellow of the American College of Physicians; more than 50 publications and 20+ invited presentations; 15 years of academic medical and research experience in internal medicine, infectious diseases, molecular biology, and pharmacology, and 10 years of clinical practice.
Preclinical/Clinical Development and Translational Medicine, Clinical Trials (Phases 1-4), Medical Governance, Clinical Safety-Risk Management, Regulatory and Commercial Strategy, Submissions, Product Labeling, Data Mining/Signal Detection, FDA Sponsor Meetings and Advisory Committees, KOL Expert Panels, Medical Affairs, Business Development/Investor Outreach, Scientific Licensing, Investment Due Diligence, and Venture Capital.
Therapeutic Areas: Gastroenterology, Infectious Diseases, Microbiome, Immuno-inflammation/Oncology, Rare Diseases, Neuro/CNS, Regenerative Medicine, General Medicine, Metabolic, Respiratory, Ophthalmology, and Dermatology.
Independent Biopharma Consultant, Board Director (2014-current)
- Chief Operating Officer/CMO of Innovate BioPharma (celiac and GI immune-inflammatory diseases): led Phase 3 strategy, including FDA negotiation, and served as investor/KOL interface (2018)
- Executive Chair [currently Board member] of RDD Pharma (an Orbimed gastroenterology/neuro company): fundraising, clinical development/regulatory, and corporate strategy (2015-current)
- Independent Director of TiGenix (regenerative medicine, stem cells, GI/immuno-inflammation): acquired for $630M
- Independent Director of BrainStorm Cell Therapeutics: neuro/regenerative cell therapies (2017-current)
- Investment Advisory Board of Harrington Discovery Institute, University Hospitals Health System, OH (2015-current)
- Member 2019-Drug Safety Research Unit, International Working Group
- Consultant with Flagship Ventures (Kaleido Biosciences, a microbiome company), RedHill Biopharma (anti-infective, immuno-inflammation, oncology), and Frequency Therapeutics (hearing/neuro-regeneration)
- Executive-in-Residence of Hatteras Venture Partners (2015)
- Consulting (Adjunct) Professor of Medicine, Duke University (2012-current)
President, Principal Executive Officer, and Chief Medical Officer, Furiex Pharmaceuticals (2010-2014)
Responsible for strategic, scientific/medical, and financial/fundraising goals of publicly-traded development-stage pharmaceutical company. Company valuation increased tenfold during 4+-year tenure and was acquired by Actavis (now Allergan) for $1.2B. Oversaw Phases 2/3, NDA filing of Viberzi™ (novel molecule for IBS-d that gained US/EU approval), and successful Phase 2 proof-of-concept trials for novel antibiotic awarded FDA fast track. Led commercial financing deal for Prilogy, and raised $60M in debt financing for Phase 3 trials.
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). Secured FDA/EU approvals for several products. As Director/Senior Director, established and led Pharmacovigilance Risk Management Group, chaired a PhRMA-FDA working group, worked in scientific licensing, and managed global clinical safety teams. Served on CIOMS VI committee (international working group on Signal Detection).