Pharmaceutical Excipient Formulation in Various Medicinal Applications

Technical Consultant #2017

Expert Witness Experience

Patent infringement, controlled release oral solid dosage form.

Undisclosed Company, Partner, 2007 - Present

Provide consulting services and advice to pharmaceutical companies (mostly small molecule and peptide drugs) on preformulation, formulation design and development, scale-up, technical transfer and analytical method development for solid, liquid and semisolid dosage forms for oral, vaginal, rectal, topical, transdermal and parenteral administration for immediate or modified release.
Provide consulting services and advice to excipient companies on regulatory, GMP, analytical testing and technical development for new and existing excipients.
Act as an expert witness in patent and product liability litigation.
Provide training on excipients, preformulation and pharmaceutical formulation design and development.

Idenix Pharmaceuticals, Inc., Cambridge, MA, 2002 - 2007

Vice President, Pharmaceutical Sciences

Directed and coordinated all preformulation and formulation activities, and the development of the associated analytical methods.
Directed and coordinated the manufacture of preclinical and clinical supplies.
Provided pharmaceutics input to the drug discovery teams.
Prepared and/or reviewed CMC reports and documents relating to pharmaceutical product development activities for regulatory submissions for both INDs and an NDA.

Independent Consultant, Toronto, Ontario, Canada, Consultant, 2002 - 2002

Provided consulting/advisory services to contract manufacturer and excipient, manufacturer.
Acted as an expert witness in a patent litigation.

Genpharm, Inc., Toronto, Ontario, Canada Vice President, Research and Development, 2001 - 2002

Oversaw all formulation, analytical and validation actives.
Managed a staff of ca. 50 with an operating budget of ca. CA$ 5 million and a project budget of ca. CA$ 20 million.
Prepared and, or reviewed CMC reports and documents relating to pharmaceutical product development activities for regulatory submissions for ANDAs.

Penwest Pharmaceuticals, Inc., 1992 - 2001

Served several positions: Senior Director of Technical Operations, Director of Quality Assurance-Quality Control and Technical Services Manager at site in Patterson, NY.
At the United Kingdom site, served as Technical Services Manager with combined responsibilities as listed:
Oversaw QA, QC and regulatory affairs for both Penwest excipients and Timerx businesses, and later research and development, technical support to manufacturing and technical service to customers for the excipients business.
Worked as an internal technical consultant on the Timerx drug delivery projects.
Oversaw QA, QC and regulatory affairs activities for the Penwest Excipients business.
Provided technical support to U..S customers on non-cellulosic excipients.
Provided technical service and support to customers and agents in Europe and then the U.S.

Additional Professional Experience

ACO Lkemedel AB, Tablet Section Manager, Solna, Sweden, 1984 - 1986

Managed the Tablet Section in the (R&D Department) which comprised two groups; formulation design and scale-up, working on tablets (plain, film coated, solution and effervescent) and capsules for branded generics and OTC products sold through Swedish pharmacies, and including packaging evaluations.
Helped design new laboratories and a pilot manufacturing area for the department.

Sterling Winthrop Research Center, Alnwick, UK , Department Manager, 1981 - 1984

Managed Solids Section dealing with tablets, hard gelatin capsules and powder sachets.
Manufacture clinical trials supplies for European clinical trials programme, to scale up formulations of development candidates, to formulate product line extensions and to reformulate existing products.
Design and commission the new pharmaceutical laboratories.

Pfizer Central Research, Sandwich, U.K., Senior Research Assistant, 1973 - 1980

Undertook variously preformulation studies, formulation design, scale-up and clinical trials supplies manufacture for a range of different types of medicinal product, including tablets (plain and coated and including controlled release), hard and soft gelatin capsules, small volume parenterals (design and development only), creams, transdermal gels, suppositories and self-emulsifying agricultural sprays.
Member of team on enteric coating project.
Planning and executing the expansion of the range of equipment available in the department for use in scale-up of solid dosage forms.

Credentials

Languages

Academic and Professional Affiliations

Publications

Author and Co-Author of peer-reviewed papers, book chapters, (over 80 publications), including, conference presentations and posters, (over 60), presentations at universities and training courses (over 130).