Pharmaceutical Product Development, Drug & Medical Device Safety, Regulatory Affairs
ID: 722270 United Kingdom
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.
Additional Pharmaceutical Industry Experience:
-Many consultancy projects covering marketing campaigns, promotional materials, sales training materials, writing EU and FDA regulatory documents including clinical expert reports and patient information leaflets
-Preparation for and attendance at multiple regulatory agency meetings, notably in Europe and North America
-Speaker on topics concerning clinical development and use of technology in clinical trials
-Past Editorial Board member, 3D International
-Past Executive Board Member of the Contract Clinical Research Association
-Author of numerous Clinical Expert Reports and Statements covering the risk-benefit of medicinal products and devices.
-Assisting clients with preparation and participation in Competent Authority pharmacovigilance inspections.
List of projects personally managed to date:
- Expert statement on POM-P switching of several products in Israel
- Expert statement on the co-prescribing of statins and fibrates
- Licensing due diligence reports for new drugs in oncology, cardiovascular disease, pain, neruology
- Due diligence on the potential acquisition of an EU biopharmaceutical company and four corporate acquisitions
- General business set-up and life-cycle product development planning for a spin-out company (RNA interference)
- Clinical and regulatory consulting for:
B2 antagonist in traumatic brain injury
New drugs (3) in Alzheimer's disease
New metabolic drug
Peptide for hereditary angioedema
Novel immune therapy in multiple sclerosis and inflammatory bowel disease
Multiple new oncology agents
New therapeutic option for Sickle Cell disease
Implantable medical device
New therapeutic option for reduction of body fat
Human thrombin/fibrinogen for surgical use
Anti-CD19 monoclonal antibody for IgG4- Related Disease
- Interim CMO for a small oncology company with lead product in phase I
- Preparation of CTD Clinical Overview and Summaries for multiple products including those indicated for hereditary angioedema, Type 2 Diabetes Mellitus, PDE5 inhibitor for erectile dysfunction, surgical haemostasis
- Interim VP, Clinical Development for an EU biopharmaceutical company
- Preparation of PSURs and DSURs for multiple clients and prudcts
- Preparation of multiple Eu Pediatric Investigatory Plans, including regulatory strategy and clinical trial designs
- EU Qualified Person for Pharmacovigilance for small-medium pharma companies in the USA, Canada, Germany, and the UK, including subsidiaries of top 10 pharma companies
- Design and implementation of the pharmacovigilance systems for a German biopharmaceutical company and a Canadian specialty pharmaceutical company
- Day-to-day ICSR handling for multiple investigatory and approved medicinal products and Class II-III medical devices, including MedDRA coding, case assessment and reporting, medical review and narrative generation, and liaison with regulatory agencies on safety issues.
- Routine for-cause and pre-inspection audits of pharmacovigilance systems on behalf of numerous clients
- Successful defense of products cited for withdrawal under EU Article 20 and Article 31 procedures.
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.
|Year: 1985||Degree: M.B. Ch.B.||Subject: Medicine||Institution: Liverpool University|
|Year: 1990||Degree: Diploma in Pharmaceutical Medicine||Subject: Pharmaceuticals||Institution: Royal College of Physicians|
|Year: 1992||Degree: Member of the Faculty of Pharmaceutical Medicine||Subject: Pharmaceutical Medicine||Institution: Royal College of Physicians|
|Year: 1993||Degree: Diplomate of Faculty of Family Planning||Subject: Reproductive Healthcare||Institution: Royal College of Obstetricians and Gynaecologists|
|Year: 2006||Degree: Fellow of the Faculty of Pharmaceutical Medicine||Subject: Pharmaceutical Medicine||Institution: Royal College of Physicians|
|Years: 2000 to Present||Employer: Undisclosed||Title: Principal Consultant||Department:|
Responsibilities:Responsible for all consulting projects spanning life-cycle development of pharmaceutical drugs and devices from pre-clinical to market.
|Years: 1996 to 1999||Employer: Protodigm Limited||Title: Director, Clinical Development||Department:|
Responsibilities:He was the global leader of virtual drug development projects inlcuding CMC, non-clinical, clinical and regulatory activities.
|Years: 1994 to 1996||Employer: Wyeth Laboratories, UK||Title: Senior Medical Adviser||Department:|
Responsibilities:Responsible for clinical development of female healthcare and CNS products in Phases II-IV. He provided medical input to product launch and marketing teams.
|Years: 1992 to 1994||Employer: SmithKline Beecham Pharmaceuticals, UK||Title: Senior Medical Adviser||Department: Anti-Infection and Vaccine Research and Development|
Responsibilities: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.
|Years: 1990 to 1992||Employer: Ortho-Cilag, UK||Title: Manager||Department:|
Responsibilities: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.
|Years: 1988 to 1990||Employer: Simbec Research Ltd, South Wales||Title: Senior Research Physician||Department: Clinical Pharmacology|
Responsibilities: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.
|Years: 1999 to 2005||Employer: Health Decisions Limited||Title: Director||Department:|
Responsibilities:Board Director for the European operations of a U.S.-based Contract Research Organization.
|Years: 1985 to Present||Employer: Undisclosed||Title: Various||Department:|
Responsibilities: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.
|Years||Country / Region||Summary|
|Years: 2001 to Present||Country / Region: U.S.A.||Summary: 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.|
|Years: 2001 to Present||Country / Region: Europe||Summary: He has managed National Authority and EMEA meetings and communications. He has prepared CTx/trials approvals, and briefing documents.|
|Years: 2001 to Present||Country / Region: Global||Summary: 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.|
|Years: 2001 to Present||Country / Region: U.K.||Summary: Expert has performed an evaluation of commercial markets, line extension opportunities, and reimbursement.|
|Associations / Societies|
|Expert is a member of the British Medical Association.|
|He is a Board Director of Health Decisions Limited. He is also a member of the editorial board of 3-D International.
JCC Family Planning Certificate
Diploma in Pharmaceutical Medicine
Associate of the Faculty of Pharmaceutical Medicine
Member of the Faculty of Pharmaceutical Medicine
Diplomat of the Faculty of Family Planning & Reproductive Health Care
Registered Non-Principal in General Practice, Bucks Health Authority
Fellow of the Faculty of Pharmaceutical Medicine
|Medical / Professional|
|He is a non-principal general practitioner with the Buckinghamshire Health Authority.|
|Publications and Patents Summary|
| Expert is a regular invited contributor of articles on drug development; he has 11 recent publications.
27 publications in total to date.
|Training / Seminars|
|Expert has trained pharmaceutical sales representatives on therapeutic areas, indications, and drug profiles.|
|He is knowledgeable of a global network of suppliers and partnerships based on general experience and having managed virtual drug development projects.|
|Expert has been a member of marketing teams for products in biotechnology, female healthcare, CNS, oncology, gastroenterology, and nutrition.|
Fields of Expertise
clinical medicine, Current Procedural Terminology, drug clinical trial, drug development, drug regulation, Food and Drug Administration drug registration, strategic planning, Chemistry, Manufacturing and Controls, family medicine, regulatory affairs, pharmaceutical life cycle management, pharmacovigilance, pain medication, medical reimbursement, pharmaceutical launch, drug sales, business management, drug allergy, biologic (product), drug product approval, competitive intelligence, organization redesigning, transdermal patch, over-the-counter drug regulation, governmental registration process, pharmaceutical research, corporate strategic planning, gynecologic drug development, pharmaceutical industry, drug-drug interaction, antihypertensive drug, Food and Drug Administration, pharmaceutical drug, clinical pharmacology, vaccine, drug, pharmacokinetics, over-the-counter drug, oral contraceptive drug, FDA medical device regulation, investigational drug, hormone, gastrointestinal drug, drug therapy, drug screening, drug metabolism, antihistamine, anticonvulsant drug, antibiotic, anti-inflammatory drug