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Generic and Biosimilar Drug Development Regulatory Expert

Technical Consultant #2346


  • Generic pharmaceutical strategic product and portfolio management for generic pharmaceuticals.
  • Biosimilar drug development, intellectual property, regulatory and licensing.
  • Generic commercial issues and legal strategies for developing generic medicines.
  • Commercial aspects of generic industry with extensive international experience at senior level.
  • European marketing and business development in the generic pharmaceutical industry.
  • Consultant to non-European companies, obtaining insight into the Europe generics industry.
  • Experience of in and out pharmaceutical licensing.
  • Branded pharmaceutical companies advisor-support and defense strategies.


Undisclosed Company, Consultant, Proprietor, 1993 - Present

  • Running independent pharmaceutical consultancy company providing advice to small and medium sized companies in various European countries and Asia on international marketing strategies.
  • Advisor for branded pharmaceutical companies on generic defense strategies.
  • Advised on business development for generic companies.
  • Developed defensive strategies for branded companies against generic erosion.
  • Negotiated out licensing of generic products to Europe and European markets.
  • Provided competitive intelligence for both generic and branded companies.
  • Operating workshops and training sessions on a variety of generic and biosimilar topics.

Rambaxy Ltd., London, England, UK General Manager, 1996 - 1997

  • Developed a strategic plan for expansion of Ranbaxy's sales in the UK generic market.
  • Created the innovative and attractive new Product packaging design.
  • Re-introduction of the entire Rima Pharmaceuticals generic range under new label.
  • Set up warehousing, distribution and invoicing arrangements using external logistics organization.
  • Produced price lists, customer mailing lists, advertising materials and promotional concepts.
  • Recruited a National Sales Manager and fulfilled other roles: Salesmen, Product Manager, and Regulatory Officer.
  • Negotiated contract manufacturing business with other generic companies in the UK.
  • Successfully launched generic Cefaclor (=Eli Lilly=s DISTACLOR) which represented the first ever launch of an Indian pharmaceutical product onto the UK market.

H.N.Norton(Ivax), Harlow , Essex, England, European Sales and Marketing Manager, 1989 - 1993

  • Developed a strategic plan for expansion of Norton's generic sales in both Western and Eastern Europe and set up Norton Poland.
  • Liaised with Regulatory department to develop priorities for product registration on a country-by-country basis.
  • Selected companies to act as distributors in the specific countries.
  • Negotiated contracts with distributors, licensees and licensors.
  • Maintained commercial contacts with selected distributors and other agents.
  • Arranged marketing and promotional support, developed promotional materials for distributors.
  • Liaised with Product Development Departments for Inhalation and solid-dose formulations.
  • Acted as Trademarks Manager, building, computerizing and maintained a Trademarks database.

Honors & Publications


  • French - Fluent
  • German - Fluent
  • Spanish - Good conversation, and reading
  • Italian - Moderate writing and reading

Academic and Professional Affilations

  • Chairman of Health Networks Europe Biosimilar Drug Development
  • Chairman of Global Generic Strategy Summit
  • Chairman - The Generics Marketplace, Management Forum symposium
  • Chairman of Independent Ethics Committee for Shandon Clinic

Conferences and Workshops

Domestic and International

  • Moderator of workshop - Strategic Product & Portfolio Management for Generics
  • Discussion panel member at Virtue Insight's Biosimilars Congregation
  • Speaker and roundtable discussion moderator at Health Networks World Generic Medicines
  • Presenter of workshop-Biosimilars - Regulatory and Commercial Issues (SMi)
  • Speaker at Biosimilars & Biobetters (SMi)
  • Presenter of workshop-IP and the Generics Industry (Management Forum)
  • Speaker at EBCG- Pharma PPM Toolbox
  • Presenter of workshop-IP and the Generics Industry
  • Presenter of workshop-Biosimilars - Regulation and Reality
  • Presenter of workshop-Biosimilars - Regulatory and Commercial Issues (SMi)
  • Speaker at SMi Generics, Supergenerics and Patent Strategies
  • Presenter-Generic Medicine, IP and Legal and Regulatory Issues
  • Presenter of workshops for SMi on Intellectual Property and Generics (SMi)
  • Presenter-Generic Medicine, IP, Legal and Regulatory Issues (Management Forum)
  • Co-Presenter workshop-Generic Strategic Business Models
  • Speaker at Global Generic Medicines Summit
  • Speaker of topic in Creating a Generic Biodrug Company
  • Presenter of seminar-Pharmaceutical Patents and their effects on Generics
  • Speaker-Legal Strategies for Developing Generic Medicines
  • Presenter (symposium) Intellectual Property and its effects on generic markets
  • Speaker-New Trends in Generic Medicine
  • Speaker-Generic Portfolio Management
  • Speaker-Global Generic Strategy symposium
  • Presenter of workshop-Accelerating the Regulatory Process
  • Speaker-The Generics Marketplace (Management Forum) symposium
  • Speaker-Impact of generics on branded industry, symposium


  • Author of numerous publications and reports


  • B.Sc. Chemistry, (With Honors) UMIST- University Of Manchester Institute, Manchester, UK
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