- 14 years as a physician executive specializing in pharma and medical devices, preclinical through commercialization, and 11 years as physician and assistant professor.
Executive Leadership in Preclinical and Clinical Pharmaceutical and Medical Device Research and Development, Medical Affairs, Regulatory Strategy/Affairs, Quality and Clinical Operations, Strategic Growth, and Business Development/Corporate Financing; Due Diligence; Intellectual Property Assessment and Management; Product Commercialization; Marketing and Market Access; and Team-Building and Motivation. Therapeutic Areas: Pediatrics, Pulmonary/Respiratory, Asthma, Cystic Fibrosis, Critical Care, Metabolic Disease, Gastrointestinal Disease, Orphan Populations, Nutrition, Cardiovascular, Hypertension/Renal, Neurology, Urology, Bone, and Osteoporosis.
Chief Medical Officer, Alcresta Therapeutics, Inc.
Executive responsibility for all clinical research and medical affairs. Lead scientific and medical spokesperson for commercialization and market access, business development, and management of $50M in corporate financings. Led initiation and execution of clinical studies for FDA submission, as well as product launch, regulatory approval/interactions, and product commercialization. Established and chaired promotional review committee.
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, including preclinical research plans, investigational device design and development, successful filing of complex IND for drug/device combination, and initiation of clinical program. Developed and supervised execution of development and regulatory strategies, operations, and product safety. Coordinated FDA meetings and submissions, and NDA resubmission. Provided executive leadership for medical affairs/pharmacovigilance to support drug and medical device product launches. Lead scientific and medical spokesperson for company, supporting business development projects and corporate financings. Led attaining orphan drug designations for product, CE marking for medical device, and key patents. Supported business development activities for several $10-20M financings. Designed, built out, and executed all aspects of Academic and Medical Affairs, including post-marketing risk minimization and pharmacovigilance plans. Defined strategy and rebuilt capabilities for preclinical and clinical development of Phases 2 and 3 programs. Orchestrated symposia, publication strategies, and interactions with key opinion leaders, healthcare providers, regulatory agencies, investors, and business development partners. Reorganized cross-functional project management, and upgraded Medical Affairs activities. Successfully defended US Method of Use patent for product. Provided comprehensive staff training, academic network improvements, and streamlined programs.
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 and Mid-Atlantic regions, with nationwide support of the Respiratory franchise. Achieved Medicaid Tier 2 formulary acceptance for all franchises in eight states and six managed care entities, and in 15 states and 11 managed care entities 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 including Europe, Asia, Africa, Canada, and Latin America. Developed and executed strategy for additional indication, based on Phase 4 research, in worldwide product circular and marketing activities. Supported successful initiation of early clinical Phase 1 trial of Neurology franchise compound; advised Promotion Review Board for Hypertension/Renal franchise.
Attending Pulmonologist, Director of Asthma Program and Pulmonary Function Laboratory, and Associate Director of Cystic
Fibrosis Center and Exercise Physiology Laboratory, The Children’s Hospital of Philadelphia
Attending Pulmonologist and Director of Asthma Program, Respiratory Therapy Department, St. Christopher’s Hospital for Children
Assistant Professor of Pediatrics, Department of Pediatrics, University of Pennsylvania School of Medicine
Assistant Professor of Pediatrics, Department of Pediatrics, Allegheny University of the Health Sciences
Assistant Professor of Pediatrics, Department of Pediatrics, Temple University School of Medicine
Doctor of Osteopathic Medicine (DO), Philadelphia College of Osteopathic Medicine