2000 to

(Undisclosed Consulting Company)

Principal Consultant

Expert is responsible for all consulting projects spanning life-cycle development of pharmaceutical drugs and devices from pre-clinical to market.

1996 to 1999

Protodigm Limited

Director, Clinical Development

He was the global leader of virtual drug development projects inlcuding CMC, non-clinical, clinical and regulatory activities.

1994 to 1996

Wyeth Laboratories

Medical Affairs

Senior Medical Adviser

Expert was responsible for clinical development of female healthcare and CNS products in Phases II-IV. He provided medical input to product launch and marketing teams.

1992 to 1994

SmithKline Beecham

Clinical Research

Senior Medical Adviser

He worked on Phase I-IV development of vaccines and anti-virals. He was a member of the International Vaccine Group. He provided medical input to product launch and marketing teams.

1990 to 1992

Ortho-Cilag

Medical Affairs

Manager

Expert set up the company's medical affairs department. He was responsible for pharmacovigilance, Phase IV clinical trials, and medico-marketing input to a range of products.

1988 to 1990

Simbec Research Limited

Clinical Pharmacology

Senior Research Physician

He had management responsibility for a 44-bed research unit. He performed protocol design, implementation, medical monitoring, PK and statistical analysis, and reporting of various Phase I studies.

1999 to 2005

Health Decisions Limited

Director

Expert was a Board Director for the European operations of a U.S.-based Contract Research Organization.

1985 to

(Undisclosed)

Various

At first, he was a junior doctor specializing in obstetrics and gynaecology, then general practice. Currently, he is a part-time non-principal general practitioner in the Buckinghamshire Health Authority.

• A medium-sized pharmaceutical company required external advice in taking a novel drug from non-clinical to clinical development. Expert desgined the clinical and regulatory plan including Phase I-III clinical trials and assisted in obtaining the U.S. IND, Fast Track Designation, and Orphan Drug Status.
• An Israel-based company was considering in-licensing of an oncology product. Expert assembled a team of experts from his partnership network and conducted a due diligence assessment of the product. As follow-up, Expert managed the pre-IND meeting process with the FDA.
• A U.S.-based biotechnology company had a platform technology producing a product at the pre-manufacturing stage. Following an inital assessment of the product and the marketplace, a life-cycle development plan spanning CMC, toxicology, clinical pharmacology, clinical trials, and regulatory strategy was constructed and is now being implemented.
• The U.K. affiliate of a multinational pharmaceutical company wanted to reorganize their marketing and medical departments to increase productivity. Following on-site interactions with staff of both departments, Expert proposed a new business model based on empowered therapeutic area teams that ensured shared vision and day-day working efficiencies.
• The U.K. affiliate of a multinational pharmaceutical company wanted to increase the rate of market penetration of its newly launched drug. Expert designed a post-marketing clinical trial strategy involving the use of academic trialists. This helped contribute to the product now having the second largest market share despite being fifth onto the market.

• QC expert for consulting on BLA for vaccine development.