Intellex Acquires Expert by Big Village

We're thrilled to announce that Intellex has acquired Expert by Big Village, effective March 22, 2024. This strategic move enhances our capabilities and strengthens our commitment to delivering exceptional solutions to our customers.

Stay tuned for more updates on how this acquisition will benefit our clients and experts.

For inquiries or more information, please contact us at info@intellex.com.

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Expert Details

Pharmaceutical Formulation, Drug Delivery, CMC, NDA, and Formulation Patents

ID: 730122 California, USA

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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

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.
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.
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.
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.
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).

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

Additional Experience

Vendor Selection
He was responsible for the identification and selection of the contract manufacturers in the development of Intermezzo and follow on products for Transcept. These contract manufacturers were responsible for the development of formulations, providing clinical supplies, clinical and commercial packaging needs, the supply of the drug substance, and for the development of specialized excipients.
Marketing Experience
He has deep insights in the area of pharmaceutical product lifecycle management.

Language Skills

Language Proficiency
Hindi
Punjabi

Fields of Expertise

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