During this Ph.D's graduate education, he worked under the direction of Dr. Robert F. Furchgott, Ph.D., a Nobel laureate in Pharmacology and Medicine ( Dr. Furchgott's Nobel Prize was for the discovery of nitric oxide as an important endogenous vasodilator agent.  His first years as an industry practitioner involved areas of specialization focused on the discovery and development of pharmaceutical products for cardiovascular disease.  Following his industrial experience, he joined the Food and Drug Administration where his last position was Deputy Director of the Division of Cardiorenal Drugs responsible for the approval of new drugs and blood substitutes, including TPA.

His skills span the areas of drug research and regulation.  He spent ten years consulting with companies whose major objectives were the submission of successful INDs, NDAs, 510( k )s, and PMAs, not only in the cardiovascular area but in the other disciplines regulated by FDA.  His current clients are being assisted in the following drug areas: AIDS, antidepressants, cardiovascular, endocrine, biotechnology products, wound healing, and anticancer drugs, among others.  He has extensive experience with generic drugs, ANDAs for topical and systemic use, and OTC drug evaluation.  He has close ties to FDA personnel and visits FDA on a regular basis to keep up to date with the latest information that would be valuable to clients.  His marriage of industrial and regulatory know-how is unique and clients are using his services not only to preclude FDA issues but also to solve tough scientific / clinical / regulatory issues which arise post-submission.

• Cardiovascular Drug Development
• Education in Pharmaceuticals and their Applications
• FDA Drug Approval Process
• FDA Regulation
• Medical Devices
• New Drug Evaluation
• Pharmaceutical Product Development
• Pre-Clinical Toxicology

• Post-doctoral Fellow, Pharmacology
• Ph.D., Pharmacology
• M.S., Pharmacology
• B.S., Biochemistry

Expert Witness Experience;

• Technical Consultant