Development Management

Vincent H. Li, PhD

***** ********** ***** ( Mechanicsville, VA 23116 ( (C) 804-***-**** (

*********@*****.***

Qualifications Summary

SENIOR PHARMACEUTICAL PROFESSIONAL LEVERAGING HANDS-ON RESEARCH AND

MANAGEMENT EXPERIENCE IN PRESCRIPTION AND OVER-THE-COUNTER PRODUCT

DEVELOPMENT AND PROVEN STRENGTHS IN DRUG CANDIDATE DEVELOPMENT, PRE-

FORMULATION / FORMULATION DEVELOPMENT, AND PROCESS OPTIMIZATION. PROVEN

TRACK RECORD OF MANAGING CMC PRODUCT DEVELOPMENT ACTIVITIES FROM IDEATION

TO SUPPORTING COMMERCIAL LAUNCH.

Small Molecules & Biologics Product Scale-up/Validation & Technology

CMC Dosage Form Development Transfer

Lifecycle Management & Product Innovation

CMC Expertise - IND, NDA, MAA Using Drug Delivery Technologies

CRO & Start-up Alliance Management

Dossier Preparation & Review Biopharmaceutics of Dosage Form Performance

CMC Regulations & Staff Leadership & Development

Requirements

Project Management

Professional Experience

Eisai, Inc. - Research Triangle Park, NC 2007 to 2009

Director, Drug Delivery Technology

Identified and applied drug delivery technologies to address unmet patient

needs, supervising a senior manager and working with Marketing and Global

Formulation Technology Committee. Managed CMC (chemistry, manufacturing,

and controls) activities at 4 CRO/external drug delivery companies. Gained

knowledge of unmet patient/medical needs in the area of primary care,

neurology, oncology and institutional care to define lifecycle management

opportunities for marketed products.

. Completed CMC development activities (scale-up, technology transfer, and

process validation) and regulatory dossier submission of a product using

an external drug delivery technology, with MAA dossiers submitted in

March, 2009.

. Prepared a CMC MAA/NDA eCTD dossier for one lyophilized product.

. Served a member of the senior management committee of Pharmaceutical and

Analytical Development to monitor progress of product development and

reviewed CMC-related documents (pre-NDA meeting, annual report, IND

amendment) for 7 parenteral injectable products.

. Resolved several development issues of an on-going project at a CRO to

allow the project to proceed to process validation.

. Submitted 4 drug delivery proposals to Global Formulation Technology

Committee, resulting in 3 gaining approval to proceed to feasibility

studies.

. Chaired a 5-member task force that designed and implemented a drug

delivery technology selection process, resulting in the approval of 5

product ideas using this process.

. Defined lifecycle management strategies for marketed products (primary

care, neurology, oncology and institutional care) to identify and focus

resources on high-ROI opportunities.

. Assessed implant, vaccine and liposomal delivery systems for cancer drug

delivery.

Wyeth Consumer Healthcare - Richmond, VA 1996 to 2007

Research Fellow (Associate Director II), Technology Development (2006 to

2007)

Associate Director, Technology Development (2002 to 2005)

Assistant Director, Technology Development (1996 to 2001)

Led a group of 3 scientists (including 2 PhDs) to work with Marketing and

Global Business Development to apply and develop drug delivery

technologies to enhance marketed products. Provided technical (CMC &

biopharmaceutical) assessments on a wide range of drug delivery

technologies.

. Developed several technologies (mucoadhesive gel, orally-disintegrating

tablet, sustained released tablet, taste-masking technologies, and topical

products) and product concepts - resulted in 4 issued patents and 7

pending patent applications.

. Developed a new product design to increase appeal to teenagers and

children and took the idea all the way to process validation.

. Played a key role in the identification and licensing of an external drug

delivery technology for a major marketed product with more than $500

million in annual sales based on a good understanding of the

physicochemical and physiological constraints placed on the oral

absorption of the drug and pharmacokinetic simulation of expected in vivo

performance.

. Spearheaded an effort to out-license a technology platform developed by

my group to an outside drug delivery company.

. Completed a high-level assessment of the implications of nanotechnology

to Wyeth to guide the company's nanotechnology-related business

development strategy.

. Served as a member of scientific landscape team and opportunity

evaluation team to identify and review new product opportunities,

resulting in several licensing deals.

. Served as a core member of pharmaceutical R&D reengineering project team

to redesign the product development processes from ideation to launch with

Andersen Consulting. Led a sub-team to produce a product development

manual - efforts resulted in a shorter and more predictable new product

development cycle due to a better defined targeted product profile and

risk management.

. Served as interim Head of Experimental Packaging Department for 5 months

after the departure of all the managers and supervisors during the

relocation from Hammonton, NJ to Richmond, VA in 7/1998. Rebuilt the

department and provided on time delivery of all clinical test materials

and stability study materials.

. Gained in-depth knowledge of a variety of drug delivery systems,

including transdermal patch, liposome, metered dose inhaler, dry powder

inhaler, nasal pump, nanoparticles, thin strip, and orally-disintegrating

tablet methods, and diagnostics.

Schering-Plough Inc. - Kenilworth, NJ 1989 to 1996

Associate Principal Scientist/Senior Scientist, Formulation Development

Directed CMC development and product support of small and biotechnology-

derived (interleukins, monoclonal antibodies) molecules. Performed pre-

formulation and developed analytical methods to screen prototypes. Prepared

CMC document for regulatory submissions. Supported multiple clinical

manufacturing campaigns for toxicological and clinical studies.

. Completed IND formulation development of a biologic injectable

formulation in less than 6 months.

. Implemented several testing methodologies for metered-dose inhalers and

topical products to provide more efficient screening of prototype

formulations.

. Gained hands-on formulation experiences of a variety of dosage forms,

including topical, inhalation (MDI), oral and parenteral formulations

(liquid & lyophilized).

Allergan Inc. - Irvine, CA 1987 to 1989

Research Scientist, Product Development

Directed CMC development of ophthalmic products.

. Conducted feasibility evaluation of multi-particulate system and thermo-

sensitive gel for ocular drug delivery.

. Conducted reformulation of an ocular product to remove potential safety

concerns.

. Successfully conducted experiments and completed response to FDA

questions on a commercial product with no further questions from FDA after

the submission of the response.

Education & Training

PhD in Pharmaceutics (1987)

MS in Pharmaceutics (1984)

University of Wisconsin - Madison, WI

Thesis: "Gastric Emptying of Non-Digestible Solids in Fasted Dogs" (Thesis

Advisor: Dr. Joseph Robinson)

BS in Chemistry (1980)

Hamilton College - Clinton, NY

Selected Professional Development

. Optimization of Drug Formulations using In-Vitro/in Vivo Modeling with

Stella

. Assessment of Value & Applications of In-vitro Testing of Topical

Dermatological Drug Products AAPS Workshop

. Statistics: Methods as Applied to the Pharmacokinetic / Biopharmaceutics

and Clinical Drug Development

. Winnonlin Hands-on

. Stage-Gate Innovation: Accelerating NPD Productivity from Idea-to-

Launch,

. Disruptive Innovation

Awards & Honors

. Exceptional Work Achievement Award, PR&D, Eisai, 2008

. Panelist of the session "Integrate enhanced delivery options to carve a

unique place for your consumer & OTC products" at 11th Annual Drug

Delivery partnership Meeting at Las Vegas, NV, Jan. 2007.

. Moderator of the Optimization of Oral Drug Delivery Section of the 1999

Asian Conference and Exhibition of Controlled Release.

. Moderator of the Oral Drug Delivery Section in the 1990 Controlled

Release Meeting at Reno.

. Oscar Rennebohm Awards for outstanding teaching at University of

Wisconsin-Madison, 1981-82.

Publications

Joseph R. Robinson and Vincent H.K. Li, "Ocular Disposition and

Bioavailability of Pilocarpine from Piloplex and Other Sustained Release

Drug Delivery System", in Recent Advances in Glaucoma, U. Ticho and R.

David (ed.), Elsevier Publishers B.V., pp.231-236 (1984).

Ray W. Wood, Vincent H.K. Li, Jorg Kreuter and Joseph R. Robinson, "Ocular

Disposition of Poly-Hexyl-2-Cyano-3-14C. Acrylate Nanoparticles",

International Journal of Pharmaceutics, 23:175-183 (1985).

Vincent H.K. Li, Ray W. Wood, Jorg Kreuter, T. Harmia and Joseph R.

Robinson, "Ocular Delivery of Progesterone Using Nanoparticles", Journal of

Microencapsulation, 3:213-218 (1986).

Vincent H.K. Li, Vincent H.L. Lee and Joseph R. Robinson, "Influence of

Drug Properties and Routes of Administration on the Design of Sustained and

Controlled Release Systems" in Controlled Drug Delivery: Fundamentals and

Applications, 2/e Edited by Joseph R. Robinson and Vincent H.L. Lee, Marcel

Dekker, pp1-94 (1987).

Peter Gruber, Abraham Rubinstein, Vincent H.K. Li, Paul Bass, Joseph R.

Robinson, "Gastric Emptying of Nondigestible Solids in the Fasted Dog",

Journal of Pharmaceutical Sciences, 76:117-122 (1987).

A. Rubinstein, Vincent H.K. Li, Peter Gruber and Joseph R. Robinson,

"Gastrointestinal-Physiological Variables Affecting the Performance of Oral

Sustained Release Dosage Forms", in Oral Sustained Release Formulation:

Design and Evaluation, Edited by Abraham Yacobi and Eva Halperin-Walega,

Pergamon Press, New York, pp 125-156 (1987).

A. Rubinstein, Vincent H.K. Li, Peter Gruber and Joseph R. Robinson,

"Improved Intestinal Cannula for Drug Delivery Studies in the Dog", Journal

of Pharmacological Methods, 19:213-217 (1988).

Vincent H.L. Lee and Vincent H.K. Li, "Prodrugs for Improved Ocular

Delivery"' Advanced Drug Delivery Reviews, 3:1-38 (1989).

Vincent H.K. Li and Joseph R. Robinson, "The Influence of Solution

Viscosity on Ocular Disposition of Cromolyn Sodium", International Journal

of Pharmaceutics, 53:219-225 (1989).

Khawla Abu-Izza, Vincent H. Li, Graham Parr, "OTC Drugs & Lifestyle Drugs",

in Burger's Medicinal Chemistry & Drug Discovery, 6/e, Vol. 3, D. Abraham

(ed.), John Wiley & Sons. (2003).

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