Pharmaceutical Excipient Formulation in Various Medicinal Applications

Technical Consultant #2017


Expertise

  • Pharmaceutical formulation science
  • Drug delivery
  • Pharmaceutical excipients
  • Pharmaceutical quality by design
  • Pharmaceutical preformulation
  • Scale-up
  • Technical transfer
  • Solid oral dosage forms
  • Liquid dosage forms
  • Semisolid dosage forms
  • Poorly soluble drugs
  • Chemistry, manufacturing and controls documentation
  • Chemistry, manufacturing and controls project management
  • Training

Expert Witness Experience

Patent infringement, controlled release oral solid dosage form.

  • Product liability, injection formulation.
  • Penalty phase litigation oral solid dosage form.
  • Patent infringement, injection formulation.
  • Patent infringement, oral solid dosage form.
  • Expert Witness in patent litigation in Canada and the United Kingdom.

Experience

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.

Honors & Publications

Credentials

  • Qualified in the EU (U.K.)
  • Chartered Scientist, U.K.

Languages

  • Swedish; professional terminology, writing, reading
  • French; professional terminology, writing, reading

Academic and Professional Affiliations

  • Visiting Tutor, School of Pharmacy, University of Manchester, U.K.
  • Member of the Royal Pharmaceutical Society of Great Britain
  • Diploma Member of the Institute of Packaging, UK
  • Member American Association of Pharmaceutical Scientists
  • Member of the American Chemical Society
  • Member of the American Association for the Advancement of Science
  • Member of the International Society of Pharmaceutical Engineers
  • Member European Federation of Pharmaceutical Scientists
  • Member Academy of Pharmaceutical Sciences of Great Britain
  • Member Royal Society of Chemistry
  • Member Parenteral Drug Association

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).

Education

  • Ph.D. Pharmaceutics, University of Wales College of Cardiff, Cardiff, U.K.
  • M.S. Pharmaceutical Analysis, University of Strathclyde, Glasgow, U.K.
  • BPharm Pharmacy, University of Nottingham, Nottingham, U.K.
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