Expert Details

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

Expert ID: 725066 Florida, USA

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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.

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.

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.

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.

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.

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.

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.

Expert may consult nationally and internationally, and is also local to the following cities: Jacksonville, Florida - Gainesville, Florida - Deltona, Florida - Daytona Beach, Florida

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Education

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

Work History

Years Employer Title Department Responsibilities
Years: 2000 to Present Employer: Undisclosed Title: President Department: Consultants Network Responsibilities: Manage Consulting Firm for Drugs & Device Development: (Medical - Regulatory - Safety, Pharmaceutical & Device Product Development, Approval, and Post-Marketing phases.
Years: 1996 to 2000 Employer: Covance, Inc Title: Senior VP; Senior Scientific Officer; & Exec. Director, Covance Inst. for Drug Development Sciences Department: Medical, Regulatory, Drug Development, Approval, & Safety Responsibilities: Head Medical and Regulatory Departments;
Head Consulting Activities.
Years: 1993 to 1995 Employer: Protein Engineering Corporation (Now Dyax). Title: President Department: Office of the President Responsibilities: Head of Medical and Regulatory Development programs; Medical & Product Development aspects of Business Development.
Years: 1991 to 1992 Employer: Parke-Davis Inc (now Pfizer) Title: Senior VP, Drug Development Department: Medical Product Development Responsibilities: Manage the Drug Development Process, including Project Management
Years: 1983 to 1990 Employer: Boehringer Ingelheim Corp Title: Senior VP, Medical & Regulatory Department: Medical, and Regulatory & Safety Responsibilities: Managed the Departments of Medical (pre- and post-marketing), Regulatory, and Safety; including Data Management & Statistics.
Years: 1971 to 1983 Employer: University of Rochester Medical Center Title: Associate Professor, Pharmacology & Toxicology Department: Dept of Pharmacology and Toxicology Responsibilities: 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.
Years: 1968 to 1970 Employer: Dunedin Hospital and the University of Otago Medical School, Dunedin, New Zealand Title: House Physician, and Lecturer in Clinical Pharmacology Department: Dunedin Hospital & the Otago University Medical School, Department of Pharmacology. Responsibilities: Hospital House Physician, and Teacher/Researcher at Medical School
Years: 1967 to 1967 Employer: Radcliffe Infirmary and Oxford University Medical School Title: House Physician Department: Dept of Medicine Responsibilities: Rotating internships in various fields of medicine

Government Experience

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

Career Accomplishments

Associations / Societies
He is a member of the Americal Society of Clinical Pharmacology and Therapeutics; the American College of Clinical Pharmacology; and the Americal Medical Association.
Licenses / Certifications
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)
Awards / Recognition
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
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.

Additional Experience

Expert Witness Experience
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.
Training / Seminars
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.
Vendor 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.
Marketing Experience
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.
Other Relevant Experience
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

Fields of Expertise

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