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 Expert  725066

Expert in Drug & Device Clinical Development, Regulatory Approval, Adverse Reactions, Expert Witness

Available for your Consulting and Expert Witness Needs

Florida (FL)
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise:

Listed with other top experts in: 

Clinical Pharmacology is the scientific discipline that brings science to the process of drug development, particularly at the key stage where a molecule of interest becomes a drug candidate. From this point, through the rest of Development, the science of Clinical Pharmacology continues to guide the complex process of demonstrating enough effectiveness and safety for the drug candidate molecule to become a drug -- that is, to satisfy, the regulatory criteria in the US and other countries, and so merit approval and admission to the market. This is a challenging process, but very rewarding in many ways when it succeeds in getting the drug to the market and benefiting patients.

clinical pharmacology



A drug, in the sense of a therapeutic molecule that has passed the scientific, clinical and regulatory hurdles of proven effectiveness and safety to be accepted as a commercially available product, represents a huge accomplishment of biology, business, science, and medicine.

He's privileged to have a career in this area of specialization, and he enjoys planning and executing the programs that are necessary to turn a chemical or biological product into an approved drug. It's among the highest achievements of science and medicine, in his view, and he loves doing it.



Drug Development is the process of bringing all the necessary science, organization, resources, and management to bear on the task of getting a discovery or a molecule to the point of regulatory approval for marketing -- and of continuing that work to support the product on the market. He's been privileged to be in this field for most of his professional life, and he enjoys helping clients to get their molecules through the development process, onto the market, and selling well.

drug development

Expert believes that drug dosage forms, in addition to being extremely important (sometimes the most important factor) in getting a drug approved initially, can become the key to keeping a drug evolving after initial marketing (eg to address further indications) and thus keeping ahead of the competition. Even the greatest molecule in the world may never see the light of day if it is developed in a mediocre dose form.

He enjoys challenges to improve a drug's properties (or even make it viable in the first place) through improved dose forms and other available avenues of improvement.


drug dosage form development

An investigational drug has to be handled very carefully if it is to survive the harsh winnowing process of drug development. So it's very important that the decision to take a drug into development is made very carefully, and that all resources are made available to address the numerous pitfalls that can throw it off track.

Expert enjoys planning and executing the steps needed to get a new molecule from the discovery stage, through all the investigational drug phases, to become a successfully approved and marketed product.


investigational drug

Developing a new drug is one of the most creative yet challenging tasks in all of biomedicine. Expert enjoys overcoming these challenges because of the value to the company, as well as to patients, that is created when a truly new drug is successfully developed, approved and marketed.

new drug

A newly-approved prescription drug represents the pinnacle of scientific and industrial achievement. Expert has spent his professional life, to date, first in medical practice, academic medicine, and clinical pharmacology, and then in pharmaceutical and biotech drug development for both large companies and small. Now he very much enjoys helping clients succeed in this challenging, but very rewarding, endeavor.

prescription drug

Show Secondary and Basic Areas of Expertise
Expert may consult nationally and internationally, and is also local to the following cities: Jacksonville, Florida;  Gainesville, Florida;  Deltona, Florida;  and Daytona Beach, Florida.

Year   Degree   Subject   Institution  
1964   PhD   Pharmacology   University of Oxford  
1967   MD   Medicine & Surgery   University of Oxford  
1973   DM   Doctor of Medicine   University of Oxford  

Work History:
Years   Employer   Department   Title   Responsibilities

2000 to




Consultants Network




Manage Consulting Firm for Drugs & Device Development: (Medical - Regulatory - Safety, Pharmaceutical & Device Product Development, Approval, and Post-Marketing phases.

1996 to 2000


Covance, Inc


Medical, Regulatory, Drug Development, Approval, & Safety


Senior VP; Senior Scientific Officer; & Exec. Director, Covance Inst. for Drug Development Sciences


Head Medical and Regulatory Departments; Head Consulting Activities.

1993 to 1995


Protein Engineering Corporation (Now Dyax).


Office of the President




Head of Medical and Regulatory Development programs; Medical & Product Development aspects of Business Development.

1991 to 1992


Parke-Davis Inc (now Pfizer)


Medical Product Development


Senior VP, Drug Development


Manage the Drug Development Process, including Project Management

1983 to 1990


Boehringer Ingelheim Corp


Medical, and Regulatory & Safety


Senior VP, Medical & Regulatory


Managed the Departments of Medical (pre- and post-marketing), Regulatory, and Safety; including Data Management & Statistics.

1971 to 1983


University of Rochester Medical Center


Dept of Pharmacology and Toxicology


Associate Professor, Pharmacology & Toxicology


Research, Teaching, and Founder-Director of the Center for the Study of Drug Development (CSDD). (This Center is now at Tufts University). Physician on the Clinical Pharmacology Consultation Service, Strong Memorial Hospital.

1968 to 1970


Dunedin Hospital and the University of Otago Medical School, Dunedin, New Zealand


Dunedin Hospital & the Otago University Medical School, Department of Pharmacology.


House Physician, and Lecturer in Clinical Pharmacology


Hospital House Physician, and Teacher/Researcher at Medical School

1967 to 1967


Radcliffe Infirmary and Oxford University Medical School


Dept of Medicine


House Physician


Rotating internships in various fields of medicine

Career Accomplishments:

He is a member of the Americal Society of Clinical Pharmacology and Therapeutics; the American College of Clinical Pharmacology; and the Americal Medical Association.


He has current Medical Licenses in New York & Connecticut.

He had previous Medical Licences in England (where he graduated on a Commonwealth Medical Scholarship to Oxford) and New Zealand (where he returned to perform Medical-Surgical internships and start his University teaching career after Oxford). He came to the US in 1970 as a Merck Fellow in Clinical Pharmacology, and has medical licenses in the states of New York and Connecticut.

He is certified in Clinical Pharmacology by the American Board of Clinical Pharmacology.

Professional Appointments

He currently serves on the Boards, or Advisory Boards / Committees, of: OrthoLogic Inc; Connecticut Innovations BioSeed Advisory Committee; PhytoCeutica Inc; The Sid Martin BioIndustry Advisory Committee (Univ of Florida)


University of Oxford Christopher Welch Scholarship in Medicine Radcliffe Prize in Medical Science (for PhD Thesis), Merck Fellowship in Clinical Pharmacology.

Welch Schoarship in Medicine. Radcliffe Prize for Research in Medical Science.

Medical/Professional Internships

His medical training was initially in New Zealand, and in Oxford, England.

His graduate training and subsequent academic career was as a faculty member in Clinical Pharmacology as a Merck Fellow in Clinical Pharmacology at the University of Rochester Medical Center, where he became a faculty member in the departments of Pharmacology and Medicine.

Publications and Patents Summary

110 Published papers and 4 books, many of them on aspects of Clinical Pharmacology, Drug Development, the Pharmaceutical Industry, and the FDA and Society.

Selected Publications and Publishers  
 - Handbook of Pharmaceutical Public Policy, Pharmaceutical Products Press  
 - Textbook of Pharmaceutical Medicine  
 - National Neurovision Research Institute  
 - John Wiley & Sons  

Government Experience:
Years   Agency   Role   Description
1990 to 1990   Committee on the Approval Process for Drugs for Cancer & AIDS   Presentation to "the Lasagna Committee"   He represented ASCPT & presented a statement (which he wrote) at this committee of the Dept of Health & Human Services.

Consulting Services:
Selected Consulting Examples:
  • Analyzing the R&D portfolio (success probability, design of BLA programs -- clinical, regulatory, & market prospects) for a medium-sized Biotech company.
  • Evaluating small-company opportunities, specific compounds, and product portfolios for an Investment firm.
  • Serving as part-time Medical Director for a small Biotech and Device company with marketed products, to set up a Product Development Program and an International Clinical Safety System.
  • Evaluating development plan and protocols for a large multicenter program on a cardiovascular product for a large Device company.
  • Managing development of a cardiovascular drug for a virtual (4-person) company.
Recent Client Requests:
  • Expert in quality systems and auditing for FDA regulatory affairs.
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:
Expert Witness Experience Summary:
He has had several engagements as an Expert Witness for the defendant in pharmaceutical adverse event cases, including writing Depositions. One of these came to the stage of a video deposition. He's also advised law firms in-house on how to proceed in similar cases. Of possible relevance is that he's been a candidate for FDA Commissioner.
Recent Litigation Client Requests:
  • Antibiotics expert for consulting on Rapamycin and antibiotics issues.
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.

Market Research:
He has participated as a US Industry representative in the ICH (International Conferences on Harmonization) process.

He's participated and written extensively on the big-picture problems that the Pharma Industry and the FDA have, and implications for the future.

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:

At both the University of Rochester, where he founded the Center for the Study of Drug Development (now at Tufts), and at Covance, he has organized Annual Courses and given probably 100-200 presentations and seminars himself.

He manages (and writes, with 3 colleagues) 2 Chapters on the US Drug Development / Regulatory system for the Textbook of Pharmaceutical Medicine, now coming up to its 6th Edition.

Supplier and Vendor Location and Selection

He advises Companies on Vendor Selection and other aspects of Drug Development and Approval.

As a consultant, he frequently finds the most appropriate Vendors for his clients.

Other Skills and Services

Medical & Regulatory Due Diligence for Company & Product Acquisitions Product Evaluation, Strategy, Development Plans, & Operations Product Development Consulting & Medical Writing Regulatory Submissions, Review/Approval Process, & Medical-Marketing Adverse Reaction Problems: Strategy, Management, & Operations Corporate Pharmacovigilance Systems; Risk Management Interim Corporate Management ( Medical, Safety, Clinical, Regulatory, Postmarket) Corporate Board and Scientific Advisory Board Membership Expert Opinion: Pharmaceutical & Device Litigation Invited Outside Lectures & Presentations; In-house Training Courses Biomedical Innovation and Health Policy: Government & Industry, U.S. and International


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