Drug Discovery and Development Expert

This drug discovery and development expert is an experienced expert witness, having testified in deposition and in several Congressional hearings. He holds a Ph.D., an MD, and an MA. He is the president of a biotech and pharmaceutical consulting firm where consults on drug development, regulatory approval, and safety issues. He has held executive positions in drug discovery and development for several biotech and pharmaceutical companies and a contract research organization. His expertise includes drug discovery and development, clinical pharmacology, clinical trial methodologies, investigational new drugs (INDs), new drug application (NDA) approvals, drug safety, and drug regulation.

• Worked on patent infringement and liability related litigations
• Testified in deposition and in several Congressional hearings

• Over 10 years experience working in-house within the pharmaceutical industry
• Expertise includes drug discovery and development, clinical pharmacology, clinical trial methodologies, INDs, NDA approvals, drug safety and drug regulation
• Published papers and books on drug discovery and development, regulation, safety, and use
• Experienced in clinical research, clinical investigations, drug safety, regulatory affairs, project management, strategic product development planning
• Prior to working in the pharmaceutical industry, worked as a professor of medicine and an associate professor of pharmacology and toxicology
• Member, American Society for Clinical Pharmacology and Therapeutics (ASCPT)

• Ph.D., Pharmacology
• MD
• MA, Physiology and Biochemistry

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