CLINICAL TRIALS/MEDICAL MONITORING / CARDIOLOGY
- Board-certified cardiologist with 17 years of experience in clinical development, and more than 10 years on the faculty of a major medical school with clinical, clinical research, teaching, and administrative duties.
Clinical Development, Clinical Trials Design / Plan (Phases 1-4), Medical Monitoring, Investigator Meetings and Site Interactions, CRO Management, Documents, Review / Synthesis of Trial Results, FDA Interactions (all phases of development), Due Diligence, In-licensing / Out-licensing, Partnering Initiatives, Presentations, and Leadership. Therapeutic Areas: Cardiovascular, Rare Disease, Gastroenterology, and Hematology.
Authored/co-authored more than 40 peer-reviewed manuscripts, book chapters, and reviews; principle/co-investigator on 40 different industry and NIH-funded research trials.
MD, Medical College of PA (Drexel); MS, Pharmacology, Emory University; BA, Chemistry, Cornell University.
Principal Consultant, Mittleman Consulting, LLC
Consults on clinical development for pharmaceutical and medical devices.
Senior Medical Director, Ironwood Pharmaceuticals
As Medical Lead, proposed a Phase 2 study for the evaluation of a novel sGC stimulator for the treatment of heart failure; developed the full protocol, led an Advisory Board, and executed the trial. Medical Lead for a Phase 2 study for the treatment of pGERD for study execution and interpretation and presentation of results to senior management and partner KOLs. Proposed Phase 3 trial design and led an Advisory Board and FDA interactions at end-of-Phase 2. Filed an IND for a different sGC stimulator, including design, conduct, and interpretation of two Phase 1 studies, and design for Phase 2 studies in two indications targeting rare diseases (sickle cell disease and achalasia). Participated in due diligence teams for the evaluation of multiple drugs for potential in-licensing and partnering opportunities, as well as for potential out-licensing/partnering for an investigational drug with multiple potential indications.
Senior Medical Director, Genzyme, (a Sanofi Company)
Medical Lead for clinical development of a form of small interfering RNA (si RNA) to treat familial amyloid cardiomyopathy, including the development of a Phase 3 protocol and interaction with European and US regulatory agencies, resulting in an approved clinical trial design. Collaborated to refine global development plan. Participated in due diligence team evaluating a large collaborative agreement between Genzyme and Alnylam, including review of multiple drugs in preclinical and clinical development, culminating in an investment of over $500 million and resulting in multiple new development projects for Genzyme. Medical Lead for execution and development of multiple clinical protocols supporting the EMA/NDA/sNDA process for a novel anti-sense lipid-lowering medication, including protocol development, interaction with KOLs, presentations for senior management, preparation of study documents, and review and interpretation of data.
Senior Medical Director, I3Global/I3Research (a division of United Health Group)
Led cardiovascular/scientific input to large (>$100 million) proposals to pharmaceutical companies for Phase 2/3/4 research studies. Part of proposal team for a large multinational study resulting in award of a $30,000,000 contract; served as therapeutic advisor for project, with multiple protocol-related responsibilities. Performed medical monitoring activities and developed and executed cardiovascular therapeutic area training for Medical & Scientific Affairs, operational, and other staff.
Associate Medical Director, Bristol-Meyers Squibb Medical Imaging
Medical/scientific leadership for clinical development program for a pharmacologic stress agent involving nine separate Phase 1-3 clinical trials, including Phase 3 trials, a pharmacokinetics study, and a special population study. Medical monitor for two large studies for the leading cardiac nuclear imaging agent (Cardiolite). Collaborated on a clinical development plan for a new cardiac imaging agent, including writing a protocol for a first-in-man study.