Request Expert

Expert is a Pharmaceutical development leader with ~25 years drug development and manufacturing experience with large Pharma, large Biotech, and a highly successful small start-up. Managed large groups (from three different countries), teams and budgets. Played critical roles in several major products launches including Fosinopril, Taxol and Entecavir. He is one of the very rare scientists with certain attributes: experience with large molecules (biologics), and small molecules and specific role as director of outsourcing. Lately he has been providing independent scientific advisory and consulting services to a diverse array of Pharma companies in many areas including drug delivery, development (Chemical, pre-clinical/non-clinical), CMC components, API manufacturing, CRO services, Due diligence to investment firms, Life cycle management, and regulatory strategies.

Specifically,
At a pharmaceutical start-up, he served as VP-R&D / Chief Scientific Officer (CSO) and was responsible for building an R&D organization, leadership capabilities and providing strategy and direction for the company’s drug discovery and development programs including pre-clinical/non-clinical development, pipeline advancement, and API manufacturing and facilitating regulatory filings. While at the start up-firm, he filed a US IND and successfully completed a Phase I clinical study, and early stage manufacturing of two projects under his stewardship.

While at Abbott, Expert not only modernized the analytical labs with facility, but brought instrumentation (~1 million dollar annual capital budget) and technology to address diagnostic-life science reagent development issues, quality issues, FDA concerns, and sustained growth. He played a crucial role in the FDA-post-consent decree development of reagents for Abbott diagnostic products for a globally compliant product development quality management system including introducing reagents stability studies, analytical specifications, and performance and acceptance criteria.

Over the years at BMS, he was involved with a multitude of drug development projects. This involved the discovery and development of synthetic routes, demonstration of these routes in the lab followed by its implementation in the Kilo-lab and pilot plant to prepare APIs for pre-clinical and clinical studies leading to regulatory IND and NDA filings. They not only addressed all the API issues, but issues such as pre-formulation, Final Form, particle issue and characterization, analytical issues and all other CMC disciplines. His department was responsible on a routine basis to provide data regarding process, procedures, characterization and structural proof, impurity identification, specification setting, analytical standards etc. for INDs, NDA/SNDA (as required) and for regulatory updates.

At BMS, he was credited for shortening the development timelines from lead drug candidate identification to first dose in man by making the drug candidates (APIs) available with a sense of urgency and coordinating the activities of various developmental divisions. This brought prestige and recognition to BMS from Wall Street and from its peers in industry.

Expert was also director of outsourcing at BMS. A newly created department, he set the direction and strategy for the process R&D outsourcing. They had ~$15 million worth of annual outsourcing (at that time) including APIs, advanced intermediates and contract R&D.

Three of Expert's recent consulting activities were in the CMC-disciplines, development and manufacturing area. One was a NASDAQ listed small molecules Pharma, and the other two were due diligence for a major Wall Street investment firm in the M&A area involving multiple products including biologics projects. Again he was helping with the CMC package of development and manufacturing.Scientific advisor and a consultant to a drug delivery based pharma start-up