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Expert has developed multiple immediate release and modified release oral formulations at ALZA Corporation and at Transcept Pharmaceuticals. Many of these formulations have been commercialized including Invega (OROS paliperidone) and Exalgo (OROS hydromorphone). Recently, Expert was instrumental in developing a sublingual formulation of zolpidem for Transcept Pharmaceuticals. He is proficient in the design and development of oral controlled-release formulations. He has led large technical teams responsible formulation design and development, scale up, technology transfer, analytical sciences, supply chain, quality assurance, regulatory, and manufacturing. He has developed novel drug delivery technologies including a multi-layered pulsatile delivery and buffer-based sublingual delivery technology.

As the Vice President of Pharmaceutical Sciences at Transcept, Expert led the technical pharmaceutical development of sublingual zolpidem for the middle of the night insomnia. He led the design of the technical studies required for the registration of the product with the FDA. He met with the Office of the New Drug Quality Assessment to negotiate the product specifications and various stability requirement for the product. He was the author of the CMC sections of the NDA. At the end of the review cycle, there were no technical CMC issues raised by the regulatory agency.

Expert was the Compound Development Team Leader for the OROS hydromorphone program at Johnson and Johnson/ALZA. As the Program Leader, he led a 70-member multidisciplinary team including members from the Clinical, CMC, Regulatory, and Project Management functions. The team was successful for the approval of the product (Jurnista) in Germany.

Expert is named an author on 11 issued, published patents or patent applications in the field of oral drug delivery-based products and technologies. He has the design of several proprietary pharmaceutical formulations or drug delivery-based products. During the due diligence process, he was instrumental in the defense of Transcept's patent landscape to its commercial partner, Purdue Pharma. He has provided patent interpretation for several in-licensing opportunities for the Venture Capitalists. Also he has routinely participated in the new product planning efforts within ALZA and Transcept.

He is consulting with a small pharmaceutical company developing a drug device combination product for the management of post operative pain. As the company is gearing up for the Phase 3 clinical trial, Expert is helping them in the design of CMC studies (formulation, process scale up) required for the NDA. He is reviewing the technical reports with a view to write the Pharmaceutical Development portion of the NDA.He is consulting for an early stage pharmaceutical company developing novel, 'minimally absorbing' therapeutics. He is developing a strategy, designing technical studies that will provide support for shifting from one early dosage form to a commercially viable dosage form. The results of these studies will be required for (1) support the internal decision to move forward with the new formulation (2) support the regulatory documentation required for the formulation change