Generic and Biosimilar Drug Development Regulatory Expert

Expertise

• 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.

Experience

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

Languages

• 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

Publications

• Author of numerous publications and reports

Education

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