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• Created a new Product Development Department at (then) Glaxo Pharmaceuticals and pioneered a new Clinical Supplies Unit at (then) Hoechst Marion Roussel.

• Successfully directed teams responsible for bringing significant pharmaceutical products to market e.g Sectral (Aventis), Zantac 300 (gsk), Ventadisk (gsk) and Lasoride (Aventis).

• Published a chapter of a book on ‘Discovering New Medicines: Careers in Pharmaceutical R&D’.

• Established regular lecture modules on pharmacokinetics and stability testing for the MSc Pharmaceutical Medicine course at the University of Surrey.

• Opened up new research areas in drug delivery by inhalation and mucoadhesion.

• Founded own pharmaceutical consultancy business, specialising in CMC.

CAREER PROGRESSION

• R5 Pharmaceuticals Limited – Chief Scientific Officer (2006-2009)

Responsible for the corporate scientific affairs of this new start-up contract research organisation, based at the BioCity biotechnology cluster in Nottingham. Specialisms focus on sterile and non-sterile clinical manufacturing, supported by formulation design, analytical method development and stability testing. Specific activities surround the scientific content of all client projects, representing the company’s scientific image externally and acquiring suitable novel technologies, possibly including IP considerations.

• White Rose Consulting Limited - Founder and Director (2004 – 2006)

Based on a successful track-record in the pharmaceutical industry, formed a new limited company to offer international consultancy services in CMC issues such as (a) formulation and analytical development, especially matching drug delivery to the desired pharmacokinetic profile, (b) project outsourcing and management, (c) interim management services, (d) contract business development and (e) search & selection for senior recruitment positions.

• Quintiles Limited - Director of Business Development (1998 - 2004)

Responsible for the expansion of human ethical/OTC pharmaceutical and veterinary business into Quintiles Limited as individual projects or integrated programmes with other divisions.
Created strategic scientific alliances with external, specialist technology groups e.g. in materials characterisation, oral, inhalation, transdermal, and colonic drug delivery.

• Hoechst Marion Roussel Ltd - Head of Pharmaceutical Development (1985 - 1998)

Created new development team (50 staff), following two company mergers, covering all aspects of CMC activities. Executed international and local project responsibilities. Instituted and controlled a ‘business unit’ culture, leading to total recovery of operating costs. Established and utilised formal collaborations with external specialist research organisations targeted to long-term product development objectives. Supervised research students in recognised centres of excellence and exploited the resulting intellectual properties. Co-ordinated the compilation of regulatory information for dossier submission.

• Glaxo Pharmaceuticals Ltd - Product Development Manager (1982 -1985)

Created and headed a group of scientific staff directed at innovative product improvement and the development of range extension products, including creative (functional) package development and evaluation, including inhalation device design.
Approved technical information for use in regulatory submissions.

SUMMARY OF DRUG DEVELOPMENT EXPERIENCE

• Intra-articular liposomal injection of sodium aurothiomalate, for chronic rheumatoid arthritis (Boots)

• Inhalable cross-linked gelatin microspheres containing salbutamol, for chronic asthma (Glaxo)
Development of the Diskhaler/Ventodisk dry-powder inhaler for salbutamol and beclomethasone (Glaxo)

• Semi-solid matrices filled as thixotropic liquids into capsules, for the purposes of oral controlled-release of oxazepam and glibenclamide (Hoechst and Liverpool School of Pharmacy)

•Using mucoadhesives (e.g. polycarbophil, DEAE dextran), to control gastric and intestinal transit times (Nottingham University)

• Veterinary anthelmintic bolus for cattle, adopting a novel electropotential difference between materials concept, to controllably erode the device over 6-months (Hoechst Vet.)

• Electrostatic film-coating, for precision drug dosing and oral controlled-release, using xylitol, PEGs, poloxamer188 and polycaprolactone (Hoechst Roussel)

• Use of electrical stimulation, to evoke on-demand and reproducible drug release from microemulsion systems, based on microcrystalline cellulose and silicone oil (Hoechst Roussel)

• Intra-vaginal ‘rings’, for hormone replacement therapy and contraception e.g. using norethisterone and ethinyl oestradiol (Hoechst Marion Roussel)

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