- 15 years of proven executive performance in research and development, medical affairs, regulatory affairs, and quality operations in small company settings to support initiation of clinical development programs and product commercialization, and 25 years as a physician.
Executive Leadership / Governance in Preclinical and Clinical Pharmaceutical / Medical Device Research and Development (protocols, clinical development plans and studies, target product profiles, investigator brochures, safety review/data monitoring committee charters, and regulatory meetings and submissions/institutional review board documents); Medical Affairs; Regulatory Strategy / Affairs; Quality and Clinical Operations; Strategic Growth / Business Development / Corporate Financing; Medical Monitoring; Due Diligence; Intellectual Property Assessment / Management; Product Commercialization; and Marketing / Market Access.
Therapeutic Areas: Pediatrics, Pulmonary/Respiratory, Asthma, Cystic Fibrosis, Critical Care, Dermatology, Metabolic Disease, Gastrointestinal Disease, Orphan Populations / Rare Diseases, Oncology, Ophthalmology, Nutrition, Cardiovascular, Hypertension/Renal, Neurology, Urology, Bone, and Osteoporosis. Doctor of Osteopathic Medicine (DO), Philadelphia College of Osteopathic Medicine. Board certification: Pediatrics and Pediatric Pulmonology (American Academy of Pediatrics).
Consultant, Aeremedea, LLC
Provide consulting services to support development and commercialization of therapeutic products, including translational and clinical research, regulatory affairs, medical affairs, and management/operations to primarily start-up and small companies developing pharmaceuticals, biologics, or medical devices and/or CROs pursuing therapies for rare diseases, primarily in infants/children. Perform asset evaluation and due diligence on behalf of companies and investment groups.
Chief Medical Officer, Alcresta Therapeutics, Inc.
Executive responsibility for clinical research and medical affairs: led and supervised all clinical research and medical affairs activities; provided guidance on regulatory strategies and activities; and served as lead scientific/medical spokesperson, supporting commercialization and market access, business development, and corporate financings of $50M.
Senior Vice President/Vice President: Research and Development, Regulatory Affairs, Preclinical Research & Development, Academic and Medical Affairs, Worldwide Research and Development, and Medical Affairs, Discovery Laboratories, Inc.
Executive responsibility for research and development, regulatory affairs, medical device development, and medical affairs. Provided leadership, oversight, strategic direction, and key expertise for all research and development activities, including regulatory strategies and medical affairs/pharmacovigilance. Was lead scientific/medical spokesperson, supporting business development projects and corporate financings. Designed, orchestrated, and led research and development, quality, and regulatory activities leading to successful NDA resubmission. Provided strategic vision and led tactical execution of investigational device design and development, successful filing of complex IND for drug/device combination, and initiation of clinical program. Built comprehensive medical affairs function to support drug and medical device product launches. Led attaining orphan drug designations for product, CE marking for medical device, and key patents. Restructured quality operations to meet increased throughput demands. Revitalized clinical development functions to initiate clinical program. Orchestrated key clarification meetings with FDA and coordinated important submissions to advance potential product approval. Designed and implemented cohesive preclinical research plan in support of developing drug and drug/device products. Successfully defended US Method of Use patent for product. Directly supported business development activities and several 10 to 20+ million-dollar financings.
Regional Medical Director of Medical and Scientific Affairs; Director-Regulatory Liaison of Regulatory Affairs International, Merck and Co., Inc.
Provided high level medical and scientific support to Cardiovascular, Hypertension/Renal, Metabolic, Neurology, Oncology, Urology, and Respiratory franchises in US Southeast region, with nationwide support of the Respiratory franchise. Achieved Medicaid Tier 2 formulary acceptance with or in place of leading competitors’ products for all franchises in eight state, and in 15 states for the Respiratory franchise. Built a network of academic leaders in Cardiovascular, Metabolic, Bone, Hypertension/Renal, and Respiratory therapeutic areas. Collaborated with the North Carolina Department of Health to support the design and implementation of disease management programs for asthma and osteoporosis. Supported active maintenance of Hypertension/Renal franchise products in 37 countries. Developed and executed strategy for additional indication, based on Phase 4 research, in worldwide product circular and marketing activities. Key activities include: successful approval of combination Hypertension/Renal franchise product in United States and worldwide, and successful initiation of Phase 1 trial of Neurology franchise compound.