Expertise: adverse drug reactions; drug patentability and patent infringement; DUI; performance enhancing drugs; IV drug injury; steroids; retinoids; prostaglandins; ophthalmic drugs; nucleosides; pharmacology, psychopharmacology, and toxicology; medicinal chemistry; Registered Patent Agent and Pharmacist. Dr. Wolff has been President and CEO of Intellepharm, Inc. since 1997, and involved in biotechnology licensing, expert witness services and testimony, and intellectual property services. Prior to that, as Senior Vice-President for Research and Development at ImmunoPharmaceutics, Inc. (now Pfizer) he developed Thelin, an orally active, endothelin A-receptor antagonist sold to Pfizer and marketed in Europe for pulmonary arterial hypertension. Prior to that he was Vice-President for Research at Allergan, Inc. where he developed five drugs marketed in the EU and US: Alphagan P, Combigan, Ganfort, and Lumigan for glaucoma; and Tazorac for psoriasis. In earlier work for Smith, Kline and French Dr. Wolff developed the anabolic steroid SKF 8048 which underwent clinical trial in the US, and was registered in Canada.
Dr. Wolff was Professor and Chairman, Department of Pharmaceutical Chemistry, UCSF for twelve years. He is an elected Fellow of the American Association of Pharmaceutical Scientists, and an elected Fellow of the American Association for the Advancement of Science. Dr. Wolff was Adjunct Professor of Medicinal Chemistry at the University of Southern California (1982-2002), and was on the faculty of the Drew University (NJ) Residential School of Medicinal Chemistry (1998-2008) where he annually lectured on drug discovery and pharmaceutical patents to more than 150 young researchers from the pharmaceutical industry. As a member of the USP Committee of Revision (1990-2010), Dr. Wolff served on the Reference Standards Committee, which sets the legal standards for US drugs. He is the author of more than 100 scientific papers, patents and books (samples may be found under the "ARTICLES" tab in this listing). Dr. Wolff is a frequent contributor of book reviews for the Journal of Medicinal Chemistry (the most recent may be found under the "PUBLICATIONS" tab in this listing). He is a Registered Pharmacist and a Patent Agent registered to practice before the United States Patent and Trademark Office.
BackgroundQ: Please list your professional accreditations, degrees, licenses, and certificates granted:
A: B.S., Pharmacy, Univ. of Calif., Berkeley and San Francisco Medical Center
Ph.D., Medicinal Chemistry, Univ. of Calif. Berkeley
Postdoctoral Scholar, University of Virginia, Department of Chemistry, Prof. Alfred Burger
Registered Patent Agent No. 43,282, United States Patent Office
Certificate in Drug Development, Tufts University
Elected Fellow, American Association of Pharmaceutical Scientists (AAPS)
Elected Fellow, American Association for the Advancement of Science (AAAS)
Q: Please list your affiliations or memberships in any professional and/or industry organizations:
A: Member, American Chemical Society
Member, American Association of Pharmaceutical Scientists
Q: Please list any teaching or speaking experience you have had, including subject matter:
A: As Professor, Department of Pharmaceutical Chemistry, during my 22 years at the University of California, San Francisco, I gave courses on steroids, prostaglandins, drug design and medicinal chemistry. During 1998-2008, I lectured annually to 150-200 young medicinal chemists from major pharmaceutical industry at the Drew University Residential School in Medicinal Chemistry on Drug Discovery and Pharmaceutical Patents. Lectures included "Strategic Issues in Drug Discovery" and "Pharmaceutical Patents" (the class handout for the latter may be found in my publications on this site.) I've also presented invited lectures to scientific groups in US, UK, France, Germany, Switzerland, Czech Republic, Italy, Australia, China and Japan in the general areaa of medicinal chemistry, the pharmaceutical sciences, and pharmaceutical patents. I've made many presentations to venture capital companies and at business meetings regarding technology of Allergan, Inc. (1982-8, and ImmunoPharmaceutics, Inc. (1989-1996). Most recently I was the Invited Lecturer (2012) at the University of Missouri (Kansas City) on "Recent Developments in Pharmaceutical Patents" for the Graduate Student Program in Medicinal Chemistry.
Q: Have any of your accreditations ever been investigated, suspended or removed? (if yes, explain)
Q: On how many occasions have you been retained as an expert?
Q: For what area(s) of expertise have you been retained as an expert?
A: Adverse drug reactions, performance enhancing steroids, pharmacology, toxicology, blood alcohol levels, drug metabolism, generic drug pricing, pharmaceutical patent invalidation, drug discovery research contract breach, pharmaceutical licensing agreement issues, steroid chemistry and pharmacology, prostaglandin chemistry, pharmacology, and patent validity; ophthalmological drugs, antimicrobial drug patents, proton pump inhibitor patents, glaucoma drug patents, anti-HIV drug research contract, antipsychotic drug patents, drug receptor mechanisms, medicinal chemistry; DUI for alcohol and drugs; drug blood level methods; drug assisted sexual assault; IV drug infiltration and extravasation damage; drug assisted suicide.
Q: In what percentage of your cases were you retained by the plaintiff?
A: Approximately 45%.
Q: In what percentage of your cases were you retained by the defendant?
A: Approximately 55%.
Q: On how many occasions have you had your deposition taken?
Q: When was the last time you had your deposition taken?
A: November, 2014.
Q: On how many occasions have you been qualified by a court to give expert testimony?
A: Twelve times.
Q: On how many occasions have you testified as an expert in court or before an arbitrator?
A: 12 times.
Q: For how many years have you worked with the legal industry as an expert?
A: Mostly during the past 15 years, although occasionally prior to that.
Q: What services do you offer? (E.g.: consulting, testing, reports, site inspections etc.)
A: Pharmaceutical litigation related consulting re: medicinal chemistry, drug patents, pharmacology, toxicology, drug metabolism. Pharmaceutical R&D related consulting re: pharmaceutical Licensing, patent preparation. R&D related consulting re: drug discovery projects, and R&D strategic planning.
Q: What is your hourly rate to consult with an attorney?
A: $385 per hour.
Q: What is your hourly rate to review documents?
A: Internet and library literature research, technology evaluation, review of records and documents,and preparation of reports. $385 per hour.
Q: What is your hourly rate to provide deposition testimony?
A: $600 per hour (2 hr. minimum).
Q: What is your hourly rate to provide testimony at trial?
A: $2400 per half day or less (morning or afternoon); $4800 per between one half day and a full day.
Q: Please list any fees other than those stated above (E.g.: travel expenses, copy fees, etc.)
A: Roundtrip portal to portal travel time: $190 per hour. Travel expenses, research expenses, secretarial and notary expenses: Billed at cost.
ReferencesAvailable on request.
- Tramadol Toxicology and Road Traffic Crashes: A Case Report
- BOOK REVIEWS BY MANFRED E. WOLFF
- Articles, Books, and Patents
- The Chemist's Companion Guide to Patent Law
- RealWorld DrugDiscovery. A Chemist’s Guide to Biotech and Pharmaceutical Research
- Example of my book reviews.
- Dispelling Discovery Myths
- Photoaffinity site-specific covalent labeling of human cortisosteriod-binding gobulin
- Glu-96 of Basic Fibroblast Growth Factor Is Essential for High Affinity Receptor Binding
- Exclusivity and Patent Invalidation: What the Medicinal Chemist Should Know