Drug Development, Drug Delivery and Quality Assurance Expert

Expertise

Expert in managing drug product development of new chemical entities, novel drug delivery systems (film coated tablets, chewable tablets, rapidly disintegrating tablets, effervescent tablets, controlled release tablets, liquids, suspensions, parenterals, etc.). Highly experienced in formulation development, quality assurance, PAIs, and authoring NDA/CMC documents.

Thoroughly familiar with GMP, GLP, and FDA expectations.

• Pharmaceutical Product R&D
• Drug Delivery
• Statistical Optimization of Pharmaceutical Formulations
• Pharmaceutical Technical Writing of Documents for FDA-IND/NDA
• Applications
• Quality Assurance
• Clinical Study Monitoring as per GPC/FDA/ICH Regulations

Experience

2004 - Present Consultant

1981 - 2004 Merck, Senior Research Fellow, Group Leader

1974 - 1979 Cibi-Geigy Corporation (Novartis), Research Scientist

1971 - 1973 Beechan Research Labs (UK), Scientist Officer

New Drug Development

• Actively managed top priority projects for Merck and Novartis, involving formulation development of antihypertensive ACE-Inhibitors: Vasotec and Prinivil; Cholesterol Reducing HMG Co-EnzymeA Reductase Inhibitors: Mevacor and Zocor; Histamine-2 Receptor Blocker for Duodenal Ulcer and Heartburn: Pepcid; Ivermectin for Headlice and Scabies; HIV-Reverse Transcriptase Inhibitors, and so on.

Drug Manufacturing

• Responsible for Process Transfer (Process Manual, Validation Protocol, Validation runs) of these products to the Manufacturing Division in USA/Europe: Germany, Holland, France, UK.
• Played a significant role in filing IND NDA documentation of many new products.
• Actively participated in FDA's Pre-Approval Inspections; invited by FDA to present a training seminar to new FDA inspectors.
• Experience in unique unit operations: Rotogranulation, roller compaction, column coating, pellet coating for controlled release, extrusion/spheronization, taste-masking, Film Coated, Chewable, Effervescent, Lyophillized tablets, and Pediatric Dosage Forms.

Validation

• Extensively involved in validation of several Merck transfer (research-to-production) products such as writing Process Manual, Validation Protocol and Validation Report.
• Extensively involved in validation/qualification of equipment/facility of a new parenteral pilot plant that included water-for-Injection, lyophilizer, autoclave, hot air drying oven and other unit operations.

Honors & Publications

• British Council Scholar at Univ. of Wales, U.K.
• Merck's Vice-President Award for development of Vasotec and Privivil.
• Published and Presented numerous papers and awarded Patents.
• Gave Lectures at international meetings.

Education

• Ph.D., Pharmaceutics, Rutgers College of Pharmacy
• M.Pharm. (Pharmaceutical Chemistry), University of Wales, U.K.