Bill Wardell, MD,PhD, is a Board-certified Clinical Pharmacologist, & internationally respected consultant & expert witness on the devt, safety, approval & postmarket of drugs & medical devices (toxicity, product liability, label, clinical trials).

He has provided expert opinion to law firms, investment firms, and large and small pharmaceutical, biotech, and medical-device firms on such subjects as Clinical Pharmacology, Adverse Reactions, Alternative Medicine, Drug and Device Safety, Allergic Reactions, Experimental Treatment, FDA Review and Approval, Post-market Pharmacovigilance and Safety, Herbal Medicines, Toxicology, Patent Infringement, and Product Liability.

Dr. Wardell has served in the Pharma, CRO, and Biotech industries, and has also practiced, taught medicine, and done research on 3 continents. He has been engaged as an Expert Witness for the defendant in pharmaceutical adverse event cases, including writing Depositions. He has also advised law firms in-house on how to proceed in similar cases. He has been a candidate for FDA Commissioner and has testified as an expert in Drug Development in several Congressional hearings.

In addition to drug and device development, his interests include clinical pharmacology, clinical trial methodology, drug safety, regulation, biotechnology, pharmacogenomics, and botanicals and alternative medicine -- topics on which he has published over one hundred scientific papers and four books.

No fee for initial consultation.

Background

Q: Please list your professional accreditations, degrees, licenses, and certificates granted:
A: MD Medicine, PhD Pharmacology, MA Physiology & Biochemistry: all from Oxford University, England

Medical Licensure: New York State [+ formerly New Zealand and UK]

Board Certification: American Board of Clinical Pharmacology

Honors:

1994 Henry Elliott Award for Distinguished Service, American Society for

Clinical Pharmacology and Therapeutics

Founding Director, Center for the Study of Drug Development

Merck International Fellowship in Clinical Pharmacology

University of Oxford: Commonwealth Medical Scholarship

University of Oxford: Christopher Welch Scholarship in Biology

University of Oxford: Radcliffe Prize for Research in Medical Science

Otago University Medical School: John Malcolm Memorial Prize in Physiology



Q: Please list your affiliations or memberships in any professional and/or industry organizations:
A: American Society for Clinical Pharmacology and Therapeutics (ASCPT): Vice President, Board of Directors. Committees: Government Affairs, Long-Range Planning, Certification in Clinical Pharmacology, Clinical Trials Methodology (Chairman), Publications (Vice Chairman), Membership.

PhRMA: Member, Medical Section Steering Committee; International Committee on Harmonization (ICH): Member of US Delegation and Speaker, ICH-1; Chairman, Subcommittee on ICH-2 (Efficacy Expert Working Group; Dose-Response Panel).
American Medical Association - ASCPT Section Council on Clinical Pharmacology and Therapeutics (Chairman).

American Society of Pharmacology and Experimental Therapeutics (ASPET).

American Board of Clinical Pharmacology (Board Member).

American Association of Pharmaceutical Physicians.

Australasian Society of Clinical and Experimental Pharmacology (ASCEP).

Merck Fellow in Clinical Pharmacology


Q: Please list any teaching or speaking experience you have had, including subject matter:
A: Clinical Pharmacology and Toxicology; Drug Development, Approval, and Safety:
At both the University of Rochester, where he founded the Center for the Study of Drug Development (now at Tufts), and at Covance and professional societies, he has organized Annual Courses and given probably 100-200 presentations and seminars.
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. He has published more than 100 papers and 4 books.

Academic and Professional Appointments:

University of Connecticut Health Sciences Center Clinical Professor of Medicine

Adjunct Professor of Pharmacology and Therapeutics, Tufts University Medical School
Lecturer, Tufts Univ. Annual Postgraduate Course in Clinical Pharmacol, Drug Development, and Regulation

Faculty, Pharmaceutical Development, Drexel University MBA Program in
Pharmaceutical Management

Founder/Director, Boehringer Ingelheim Fellowship Program in Clinical Pharmacology

University of Rochester Medical Center, Rochester, NY, Strong Memorial Hospital Associate Professor of Pharmacology and Toxicology (tenured); Assistant Professor of Medicine; Associate Physician, Strong Memorial Hospital (Clinical Pharmacology Service); Director (Co-founder), Center for the Study of Drug Development now at
Tufts); Merck International Fellow in Clinical Pharmacology and Medicine

Otago University Medical School, Dunedin, New Zealand: Dunedin Hospital; Lecturer -Pharmacology and Clinical Pharmacology (Pharmacology Dept, Medical School); Clinical Assistant, Dunedin Hospital; Medical Research Officer, NZ-MRC Clinical Pharmacology & Toxicology Research Unit; Staff Physician, National Adverse Drug Reaction Center & National Poisons Center

Q: Have any of your accreditations ever been investigated, suspended or removed? (if yes, explain)
A: No.

Q: On how many occasions have you been retained as an expert?
A: Many times as a consultant to drug, biotech, device firms, investment firms -- estimated 30 times.
By law firms about 6 times.
Testified as an expert before Congress several times on drug development and FDA reform.

Q: For what area(s) of expertise have you been retained as an expert?
A: Drug product development, Drug and device safety, Adverse reactions, Drug combinations, Toxicology, Biomedical innovation and health policy, FDA Review and Approval Process, Patent infringement.

Q: In what percentage of your cases were you retained by the plaintiff?
A: 20%

Q: In what percentage of your cases were you retained by the defendant?
A: 80%

Q: On how many occasions have you had your deposition taken?
A: Three times.

Q: When was the last time you had your deposition taken?
A: December 2008.

Q: On how many occasions have you been qualified by a court to give expert testimony?
A: -

Q: On how many occasions have you testified as an expert in court or before an arbitrator?
A: -

Q: For how many years have you worked with the legal industry as an expert?
A: About 6 times.

Q: What services do you offer? (E.g.: consulting, testing, reports, site inspections etc.)
A: Consulting, Medical & Regulatory Due Diligence for Company and Product Acquisitions, Product Evaluation, Strategy, Development Plans, and Operations, Product Development, Medical Writing, Regulatory Submissions, FDA Review/Approval Process, Medical Marketing, Adverse Reaction Problems: Strategy, Management, and Operations, Corporate Pharmacovigilance Systems, Risk Management, Interim Corporate Management(Medical, Safety, Clinical, Regulatory, Postmarket,) Corporate Board and Scientific Advisory Board Membership, Expert Opinion: Pharmaceutical and Device Litigation, Lectures and Presentations, In-house Training Courses, Biomedical Innovation and Health Policy: Government & Industry, U.S. and International, Patent Infringement

Q: What is your hourly rate to consult with an attorney?
A: $400/hour; $500/hour for depositions and testifying

Q: What is your hourly rate to review documents?
A: $400/hr

Q: What is your hourly rate to provide deposition testimony?
A: $500/hr

Q: What is your hourly rate to provide testimony at trial?
A: $500/hr

Q: Please list any fees other than those stated above (E.g.: travel expenses, copy fees, etc.)
A: Travel expenses, copy fees.

References

Kristen Allen, Esquire
Kirkland and Ellis
200 East Randolph Drive
Chicago, IL 60601
(312) 861-2175

Thomas B.K. Ringe, Esquire
Duane Morris
30 South 17th St
Philadelphia, PA, 19103-4196
(215) 979-1576

Joseph Cohen, Esquire
Porter & Hedges
1000 Main, 36th Floor
Houston, TX 77002-6336
(713) 226-6628

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