Expertise includes adverse drug reactions; steroids; retinoids; prostaglandins; ocular drugs, pharmacology and toxicology; medicinal chemistry; patentability, patent infringement; drug discovery R and D; licensing contracts. Registered Patent Agent and Pharmacist. Dr. Wolff has been President and CEO of Intellepharm, Inc. since 1997, and is 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 Encysive Pharmaceuticals) he developed Thelin, an orally active, endothelin A-receptor antagonist marketed in Europe for pulmonary arterial hypertension. Prior to that he was Vice-President for Research at Allergan, Inc. where he developed three US marketed drugs: Alphagan and Lumigan for glaucoma and Tazorac for psoriasis. In earlier work for Smith, Kline and French he developed the anabolic steroid SKF 8048 which underwent clinical trial in the US.
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 serves 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 "ARTICLES" tab in this listing). He is a Registered Pharmacist and a Patent Agent registered to practice before the United States Patent and Trademark Office.
Background
Q: Please list your professional accreditations, degrees, licenses, and certificates granted:A: B.S., Pharmacy, Univ. of Calif., San Francisco (UCSF)
Ph.D., Medicinal Chemistry, Univ. of Calif. Berkeley
Postdoctoral Scholar, University of Virginia
Registered Patent Agent, United States Patent Office
Registered Pharmacist
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, 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.) Have also given 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. Have made many presentations to Venture Capital companies and at business meetings regarding technology of ImmunoPharmaceutics, Inc.
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: Seventeen
Q: For what area(s) of expertise have you been retained as an expert?
A: Adverse drug reactions, use of performance enhancing steroids, pharmacology, toxicology, calculated alcohol blood levels, drug metabolism, generic drug pricing expectations, pharmaceutical patent infringement, pharmaceutical patent invalidation, breach of research contract, pharmaceutical licensing agreement issues, steroid abuse, steroid pharmacology, steroid chemistry, prostaglandin chemistry, prostaglandin pharmacology, 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.
Q: In what percentage of your cases were you retained by the plaintiff?
A: Approximately 60%.
Q: In what percentage of your cases were you retained by the defendant?
A: Approximately 40%.
Q: On how many occasions have you had your deposition taken?
A: Six.
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: Six times.
Q: On how many occasions have you testified as an expert in court or before an arbitrator?
A: Five times.
Q: For how many years have you worked with the legal industry as an expert?
A: Mostly during the past five years, although occasionally prior to that.
Q: What services do you offer? (E.g.: consulting, testing, reports, site inspections etc.)
A: Pharmaceutical Licensing, patent preparation, SBIR preparation, consulting regarding drug discovery projects, R&D strategic planning.
Q: What is your hourly rate to consult with an attorney?
A: $335
Q: What is your hourly rate to review documents?
A: $335
Q: What is your hourly rate to provide deposition testimony?
A: $485 per hour (2 hr. minimum)
Q: What is your hourly rate to provide testimony at trial?
A: $1340 per half day or less (morning or afternoon); $2680 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: Research, technology evaluation, review of records and documents,preparation of reports,and travel time (one way): $335 per hour. Travel expenses, research expenses, secretarial expenses: Billed at cost
References
Available on request.Publications
- Articles, Books, and Patents
- 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
