Expert Details
Pharmaceutical Formulation, Drug Delivery, CMC, NDA, and Formulation Patents
ID: 730122
California, USA
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
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 2004 | Degree: MBA | Subject: General Management and Strategy | Institution: The Wharton School; University of Pennsylvania |
| Year: 1996 | Degree: PhD | Subject: Pharmaceutical Sciences | Institution: The University of Maryland |
| Year: 1992 | Degree: MS | Subject: Industrial Pharmacy | Institution: The University of Toledo |
| Year: 1988 | Degree: B. Pharm | Subject: Pharmacy | Institution: Birla Institute of Technology and Sciences |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2011 to Present | Employer: Undisclosed | Title: Principal | Department: |
Responsibilities:Provide consultation services to pharmaceutical companies, venture capitalists, patent law firms. |
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| Years | Employer | Title | Department |
| Years: 2006 to 2011 | Employer: Transcept Pharmaceuticals Inc. | Title: Vice President, Pharmaceutical Sciences | Department: |
Responsibilities:He was responsible for technical pharmaceutical development of new products. He led various technical functions including Formulation Design and Development, Process Development, Analytical Sciences, Laboratory Management, Contract Management, Supply Chain, packaging, CMC Regulatory, and Manufacturing. |
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| Years | Employer | Title | Department |
| Years: 2005 to 2006 | Employer: ALZA Corporation | Title: Senior Director | Department: Program Management |
Responsibilities:He led a 70-member multidisciplinary team including Clinical, Regulatory, CMC, and Project Management for the approval of OROS hydromorphone in the EU. |
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| Years | Employer | Title | Department |
| Years: 2004 to 2004 | Employer: ALZA Corporation | Title: Director | Department: Clinical Pharmacology |
Responsibilities:He was responsible for the identification of new drug device opportunities within ALZA. |
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| Years | Employer | Title | Department |
| Years: 1996 to 2004 | Employer: ALZA Corporation | Title: Research Fellow/Product Development Manager | Department: Oral Products Development |
Responsibilities:He led the formulation and process development of several new products including Invega (OROS paliperidone). |
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Career Accomplishments
| Associations / Societies |
|---|
| American Association of Pharmaceutical Scientist, American College of Clinical Pharmacology |
| Publications and Patents Summary |
|---|
| 11 issued and published patents and 20 publications and book chapters related to formulation, drug delivery, technology transfer, and lifecycle management of drug products |
Fields of Expertise
dosage form, drug formulation, drug stability, formulation, pharmaceutical product formulation, pharmaceutical research and development, pharmaceutical scale-up, drug development, drug product approval, new drug application, pharmaceutical product development, Chemistry, Manufacturing and Controls, patent interpretation, pharmaceutical life cycle management, technology evaluation, pharmaceutical patent, pre-approval inspection, pharmaceutical technology, pharmaceutical liquid, dry lubricant, pharmaceutical manufacturer, Current Good Manufacturing Practice, coating technology, drug degradation, pharmaceutical manufacturing facility auditing, drug processing, adhesive application process, pharmaceutical research, pharmaceutical engineering, technology transfer, new drug, coating material, patent, coating