Highlights of Project Management Experience and Accomplishments

Executed both internal and external program/project budget related to development of R&D feasibility, non-clinical, CMC, clinical, and regulatory activities on both NCE and Non-NCE.

Selected different CMO/CRO and secured the appropriate legal documents (CDAs, MTAs, and contractual agreements).

Managed, executed and accounted for the development of different pharmaceutical dosage forms*(Parenteral, Ocular, Oral, and Topical) from laboratory scale to pilot scale to commercial scale.

Coordinated the compilation of eCTD modules for IND, NDAs, sNDAs submissions (both paper and electronic).

Organized PAI team and interacted with FDA and MCA investigators and inspectors, respectively during PAI.

Addressed the CMC related questions such as the selection of a method of sterilization (Terminal vs. Aseptic), process validation requirements and product specifications at the EOP2 and Pre-NDA meetings.

Addressed and worked with API suppliers to control exposure to potential genotoxic impurities (NMT 1.5 μg/person/day) to meet the FDA guidance document on genotoxic impurity.

Secured internal and external budgets for the project/program development activities at different CMOs and CROs.

Screened and selected a CMO for the synthesis of a small molecule (NCE) and secured appropriate legal and/or contractual agreements.

Sourced suitable starting materials, produced and supplied Test Articles (TA) and Clinical Trial Material (CTM) of NCEs for a non-GLP, GLP, and First In Human (FIH) clinical trials.

Transferred the manufacturing process of various Roche/Syntex products to different domestic and international pharmaceutical manufacturing sites and manufactured ICH registration and validation batches.

Education: Ph.D. (Pharmaceutical Sciences, University of Rhode Island)

Experience: Please see the attached CV for details.

References: Available upon request.

* Please refer to the attachment.

EXPERIENCE:

DURECT CORPORATION, Cupertino, CA APR 2006 – MAR 2017

Executive Director, Program and Product Development/CMC

Established and managed both internal and external program/project development related to R&D feasibility, non-clinical, CMC, clinical, and regulatory activities on both NCE and Non-NCE.

Secured internal and external budgets for the CMC development activities of a sterile product (i.e., manufacturing process development, tech transfer, scale-up, registration/validation, extractables, leachables, toxicology risk assessment on the extractables/leachabels, and stability) at different CMOs and CROs.

Collected toxicology assessments on extractables and leachables and established limits on the leachables based on the dose.

Addressed and worked with API suppliers to control exposure to potential genotoxic impurities (NMT 1.5 μg/person/day) to meet the FDA guidance document on genotoxic impurity.

Participated in the EOP2 and Pre-NDA meetings to address the CMC related questions such as the selection of a method of sterilization (Terminal vs. Aseptic), process validation requirements and product specifications.

Initiated and secured Manufacturing and Supply Chain Agreements with different CMOs and CROs for the CMC development activities.

Nektar Therapeutics, San Francisco, CA

Director, Product Development 2004 –2006

Outsourced development and evaluation of Oral Dosage Forms (Tablets and Capsules) and appointed qualified QA person for overseeing the manufacturing activities of clinical trial materials (CTM) for Proof Of Concept (POC) studies in INDIA.

Executed (i.e., resources, deliverables, and budget of ~ $50M) a Partner’s program which is development and supply of a room temperature stable, portable dry powder product that uses Suspension PulmoSphere and T-326 proprietary technology.

SUGEN, Inc., South San Francisco, CA (PHARMACIA/Pfizer) 2000 - 2004

Director, Product Development

Conducted CMC meetings to discuss, drug discovery interactions (to produce pharmacologically active compounds while retaining pharmaceutical properties) and project management for diverse cross-functional teams (for instance, API, Formulation Development, Analytical Methods/Specifications, Quality Assurance and Regulatory Affairs) for new drug product development.

Worked with project management to refine the project timeline by addressing and resolving issues related to deliverables, international project team discussions (Italy and Japan).

Produced and delivered high quality Clinical Trial Materials (CTMs) such as Powder In Bottles, Capsules, Tablets, and Injectable for Phase I and II/III clinical trials by working with PHA manufacturing sites such as Nerviano (Italy) and Morpeth (U.K.).

Interacted with Pharmacia global supply group selected a commercial drug product-manufacturing site for SUGEN compounds and completed the technology transfer activities and final reports.

Oread, Inc., Palo Alto, CA 1998 – 2000

Director, Process Development/Tech Transfer

Developed technology transfer protocols related to process development, scale-up and validation. Prepared pharmaceutical development reports for CMC section of the NDAs, sNDA, and ANDAs. Responded to CMC issues related to PAI and questions from the DEA on controlled substance.

Interacted with both Big Pharma and virtual companies to discuss projects on technical and regulatory issues. Negotiated technical scope of the contracts with clients and advised cost efficient ways to complete their projects on time and within budget.

Coordinated background package for end of phase (EOP) 2 meeting with the FDA and participated in the FDA meeting along with client to address the Phase 3 clinical supply and NDA registration/stability batches manufacturing plans.

Otsuka, Rockville, MD 1995 – 1998

Manager, Pharmaceuticals Manufacturing

Executed contract manufacturers and packagers in the USA and Canada. Successfully transferred both sterile (IV) and solid dosage form products from Otsuka Japan to US and Canadian contract manufacturing and packaging companies.

Obtained an sNDA approval for a sterile drug product (Ocupress ) after successful negotiation and productive dialogue with consultants and the FDA.

Syntex/Roche, Palo Alto, CA 1986 – 1995

Sr. Project Engineer/Process Engineer

Planned, coordinated and executed several Registration, Scale-up and Tech Transfer Batches of solid dosage form products at both Syntex, Palo Alto and International Syntex Production Units (Puerto Rico, Canada, and Mexico).

Prepared CMC regulatory documents for NDA submissions. Provided responses to questions raised from different regulatory agencies both FDA (US) and MCA (EU) relating to manufacturing issues.

Designed and executed validation protocols for the manufacturing processes of solids (5 products), semi-solids, liquids (3 products), and sterile dosage forms (one product at two different sites) in Palo Alto, Puerto Rico, Mexico and Canada facilities.

Successfully interacted with Syntex regulatory divisions, local and international production and QA units, contract manufacturing divisions and project team leaders to resolve equipment, process development and validation issues to meet cGMP requirements.

EDUCATION: Ph.D. (Pharmaceutical Sciences)

University of Rhode Island 1981 – 1985

Studies of the interaction of beta-cyclodextrin with ampicillin, phenobarbitone and phenytoin

PRESENTATIONS, PUBLICATIONS, and ACHIEVEMENTS:

Invited Keynote Speaker: “Pharmaceutical Process Scale-up and Validation” presented to the Otsuka International Managers Meeting in Japan (1996).

Presentation: “Use of Microwave Drying for Pharmaceuticals” presented to the International Society for Pharmaceutical Engineers (1990).

Studies of the powder flow using a recording powder flow meter and measurement of the dynamic angle of repose. J. Pharm., Sci., 74, 1, 11-15 (1985).

Preparation of a phenytoin beta-cyclodextrin complex and evaluation of suspension and tablet dosage forms prepared from the complex. Pharm. Acta. Helv., 60, 2, 53-57 (1985).

Studies of the interaction of beta-cyclodextrin with ampicillin, phenobarbitone, and phenytoin. Drug Development and Ind. Pharm., 10 (4) 601-611 (1984).

Syntex management award for excellence in performance for lead projects.

Completed a Postgraduate Industrial Course on Parenteral Medications at University of Tennessee.

Completed a Course on Sterile Products – Qualifications/Validation of Pharmaceutical Processes and Systems.

ATTACHMENT

Product Name

Route of Administration

Company

Regulatory Submission Type

Comments

POSIMIR

Parenteral

DURECT

NDA

505(b)(2) Application

(manufacturing site change)

NDA submission is underway

DUR-928

Oral

DURECT

IND

Submitted

SUTENT

Oral

Sugen/

Pharmacia/

Pfizer

Approved product

Ocupress

Ophthalmic

Otsuka

sNDA

(manufacturing site Change)

Approved product

Toradol (IM)

Cytovene (IV)

Parenteral

Syntex/

Roche/

Genentech

Approved product

CellCept

Toradol

Trivora

Oral

Syntex/

Roche/

Genentech

Approved product

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