Professional Summary: This expert witness has over 25 years of industry experience in the development, commercialization and regulatory requirements associated with bringing a new pharmaceutical through clinical trials to market. He is a uniquely inter-disciplined individual, melding comprehensive pharmaceutical industrial Research and Development, business development, Quality Assurance and Quality Control, and consultancy experiences with formal FDA-tenured regulatory credentials.
He is an industry practitioner and recognized professional with demonstrable successes in the guidance and preparation for final review of regulatory filings and the rendering of strategic advisories, bearing upon domestic and international regulatory and business affairs in the pharmaceutical industry. |
Additional Information:
- Master of International Business Administration
- M.S., Biochemistry
- B.S., Chemistry
- B.S., Biology
- Leadership-4 performance management: Charter Oak Consulting Group
- Communication and team building: Gatto Training Associates
- Positive power and influence: Situation Management Systems
- Biotechnology: Centers for Drug Evaluation and Research Staff College
- ISO 9000/Q90 documentation standards: Quality Alert Institute
- Educational development modules in pharmaceutics: University of Maryland
- Capsule Formulation, Filling and Manufacture; Dissolution and Bioavailability; Metered Dosage Inhalers; Creams, Ointments, and Lotions Formulation; Sustained Release Formulation; Parenterals; Packaging.
Expert Witness Experience:
- Deposition
- Expert Witness Reports
- Expert Witness Testimony
- Intellectual Property
- Patent Analysis
- Patent Litigation
- Technical Consultant
- Trial Testimony
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