RARE DISEASE AND INNOVATIVE SPECIALTY MEDICINES,
STRATEGIC GLOBAL DRUG DEVELOPMENT
- Strategic, results-oriented physician with 25 years of global drug development and medical affairs experience in biotech, pharma, and CRO settings across development phases and molecule types.
Global Drug Development, CMO/Clinical Leadership, Translational Medicine, Clinical Research Strategies and Execution, Development Plans, Clinical Studies, Risk Assessment/Mitigation, Pipeline Advancement (proof-of-concept to registration to lifecycle management), Regulatory (FDA advisory committees, BLA/NDA teams, EU and MAA filings), IND/CTA Filings, Drug Safety/REMS/RMPs, and Leadership. Specialties: Rare Diseases, Immunology, Diverse Therapeutic Areas, Biologics, Small Molecules, Drug/Device Combinations, Microbiome, and Gene Therapy.
MD from University of Pennsylvania.
Principal, Drug Development Consultant, Jeffrey Gelb, MD, LLC
Provide drug development, medical affairs, and clinical research strategies and execution support to biotech companies and pharma industry organizations to advance medicines through development, licensing, and commercialization.
Vice President, R&D Program Leadership, NPS Pharmaceuticals (acquired by Shire)
Established and led cross-functional global strategic development teams for company drug development rare/orphan disease assets. Built teams and processes for development plans, risk assessments/mitigation, goal-setting, and decision-making to advance pipeline through proof-of-concept, registration, and lifecycle management. Part of FDA advisory committee and BLA team for Natpara for hypoparathyroidism, resulting in FDA approval; oversaw global team strategies for EU MAA filing, pediatrics development, and formulation/device development. Led Gattex/Revestive Global Program Team for short bowel syndrome program; pursued global filings in Japan, Canada, and Switzerland; shaped strategy for pediatrics program to extend patent exclusivity in US and EU; and created comprehensive lifecycle management strategy. Led NPSP795 (SHP635) Global Program Team for autosomal dominant hypocalcemia, completed proof-of-mechanism study and preclinical translational studies, and created development strategy and business case to advance program development further.
Global Vice President, Molecule Development Group, Covance
Built and led global drug development function to strategically design and manage outsourced drug development programs. Consulted and partnered with biotech companies globally across therapeutic areas and phases to advance medicines through development milestones. Designed and managed multiple investigational drug development programs through IND/CTA filings, and transitions into Phase 1 first-in-human studies, through proof-of-concept and Phases 2b/3. Launched and operationalized translational medicine service and next generation molecule capabilities.
Vice President, Global Development Lead, Belatacept , Bristol-Myers Squibb, Pharmaceutical R&D
Partnered with commercial co-lead to guide Nulojix (belatacept) full development team for solid organ transplantation for immunology biologic product development and commercialization. Successfully filed and defended BLA in US and MAA in Europe, resulting in US, EU, and other approvals, and led FDA advisory committee team to a positive vote. Defined belatacept risk management strategy to address lymphoma and PML safety findings, and incorporated strategy into European RMP and company’s first REMS. Built cross-functional development plans for multiple indications, and defined product profile for regulatory filings, medical communications, thought leader engagement, brand positioning, and payer access.
Medical Director, Global Clinical Research Immunology, Bristol-Myers Squibb, Pharmaceutical R&D
Led subcutaneous drug-device development programs for Orencia and belatacept (Phases 1, 2, and 3). Developed and executed plan to address FDA concerns about immunogenicity for subcutaneous Orencia; gained FDA endorsement of plan, enabling program to advance toward US and EU approvals. Part of EU team securing initial intravenous Orencia market authorization. Defined subcutaneous belatacept clinical development strategy and gained FDA agreement. Leveraged innovative biomarker program and created dosing plan. Chaired Immunology Protocol Review Committee (IPRC) to review immunology studies for global clinical research, global medical affairs, and clinical discovery.
Director, Global Clinical Research and Health Economics, Bristol-Myers Squibb, ConvaTec Division
Led global clinical research team to create and execute clinical development and lifecycle programs for wound therapeutics and gastrointestinal medical devices. Managed global staff in trial operations, biostatistics, programming, data management, health economics, and scientific publications.