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 Expert  722270

Expert in Pharmaceutical Product Development, Drug & Medical Device Safety, Regulatory Affairs


Available for your Consulting and Expert Witness Needs

Berkshire
United Kingdom
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise:

Listed with other top experts in: 

Expert is active in U.K. General Practice with wide therapeutic area knowledge and practical patient prescribing. He has a good understanding of the U.K. health system, formulary adoption, N.I.C.E., and reimbursement.

Expert has 15 years of experience in the design, conduct, analysis, and reporting of Phase I-IV clinical trials. His practical experience spans Europe, Eastern Europe, Russia, the U.S., Canada, South Africa, Australia, and Japan. He has been involved in clinical trials with over 30 different investigational drugs in early phase development and with over 20 drugs in later phase development.

Expert has over seven years' experience as a global project leader in various drug development projects. He is exceptionally experienced in the virtual development of drugs using complete outsourcing to a global network of suppliers spanning manufacturing, pharmacology, toxicology, clinical pharmacology, clinical trials, regulatory, and post-marketing surveillance.

Expert is conversant with the preparation of NDAs, BLAs, IDEs, and particularly with integrated summaries of safety and efficacy. He regularly organizes, prepares, and attends FDA meetings on behalf of clients.

Expert has renowned expertise in the design of life-cycle development plans for new products from CMC through non-clinical and clinical testing to regulatory approval. Currently, two clients are implementing life-cycle plans that he has designed.

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clinical medicine

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Current Procedural Terminology

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drug clinical trial

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drug development

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drug regulation

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Food and Drug Administration drug registration

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strategic planning

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Chemistry, Manufacturing and Controls

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family medicine


Show Secondary and Basic Areas of Expertise

Education:
Year   Degree   Subject   Institution  
1985   M.B. Ch.B.   Medicine   Liverpool University  
1990   Diploma in Pharmaceutical Medicine   Pharmaceuticals   Royal College of Physicians  
1992   Member of the Faculty of Pharmaceutical Medicine   Pharmaceutical Medicine   Royal College of Physicians  
1993   Diplomate of Faculty of Family Planning   Reproductive Healthcare   Royal College of Obstetricians and Gynaecologists  
2006   Fellow of the Faculty of Pharmaceutical Medicine   Pharmaceutical Medicine   Royal College of Physicians  

Work History:
Years   Employer   Department   Title   Responsibilities

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.


Career Accomplishments:
Associations/Societies

Expert is a member of the British Medical Association.

Professional Appointments

He is a Board Director of Health Decisions Limited. Expert is also a member of the editorial board of 3-D International.

Medical/Professional Internships

He is a non-principal general practitioner with the Buckinghamshire Health Authority.


Publications:
Publications and Patents Summary

Expert is a regular invited contributor of articles on drug development; he has 11 recent publications.

Selected Publications and Publishers  
 - International Conf. Pharm. Med.  
 - Primary Care Psychiatry  
 - Eur. Pharm. Cont.  
 - 3D Directory  

Consulting Services:
Selected Consulting Examples:
  • 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.
Recent Client Requests:
  • QC expert for consulting on BLA for vaccine development.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

International Experience:
Country / Region   Summary
U.S.A.   Expert has prepared regulatory briefing documents, IND submissions, annual reports, and NDA and IDE submissions. He has also worked on regulatory interactions and meeting preparation.
Europe   He has managed National Authority and EMEA meetings and communications. He has prepared CTx/trials approvals, and briefing documents.
Global   Expert has designed and executed Phase I-IV clinical trials in Western and Eastern Europe, North America, South Africa, Australia and the Far East. He has conducted patient recruitment feasibility and trial logistics assessments.
U.K.   Expert has performed an evaluation of commercial markets, line extension opportunities, and reimbursement.

Market Research:
Expert has been a member of marketing teams for products in biotechnology, female healthcare, CNS, oncology, gastroenterology, and nutrition.

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:
Training/Seminars

Expert has trained pharmaceutical sales representatives on therapeutic areas, indications, and drug profiles.

Supplier and Vendor Location and Selection

He is knowledgeable of a global network of suppliers and partnerships based on general experience and having managed virtual drug development projects.


 

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