- Ph.D. biochemist / molecular biologist, patent attorney, and M.B.A.
- Completed postdoctoral research fellowships at Harvard Medical School / NIH (Alzheimer's disease, tau gene, genomic cloning). Johnson & Johnson (skin diseases, homeobox transcription factors), and Memorial Sloan-Kettering Cancer Center (immunology, MHC class I genes, NF- kB).
- Broad scientific training and experience (especially neurology Alzheimer's disease, epilepsy, immunology, and transcription) and have published widely, both scientifically and legally. Author of papers and reviews, member of several journal editorial boards, and continue to publish under own identity.
- Currently consulting for several start-ups / development stage companies and biotech-focused venture capital funds - doing primarily patent work.
- Strong experience in clinical trial work, site contracts, safety committee documents, informed consents.
Independent Intellectual Property Consultant and Advisor, 2005 - Present
- Provide various companies and clients with legal, patent and portfolio support.
- Consultant, Intellectual Property (VaxDesign was acquired by Sanofi).
- Responsible for IP strategy, management of outside counsel, patent drafting and prosecution.
Nordic Biotech, Copenhagen, Denmark, Advisor, Intellectual Property, 2005 - Present
- Responsible for IP due diligence: Validity, infringement, and freedom-to-operate issues.
Resverlogix Corp., Calgary, Canada, Consultant, Intellectual Property, 2006 - Present
- Responsible for IP strategy, patent management, contract and agreement review.
- Served as a scientific, patent and legal consultant to investment banks in connection with financing deals for biotech, medical device, diagnostics, and drug delivery companies with projects listed below:
- Consultant to Kleinwort Benson in connection with the acquisition of Divysio, a Canadian cardiovascular stent company by BioCompatibles, a British biotech company.
- Consultant to Fahnestock & Co, Inc., for scientific/patent review and evaluation of several companies' technologies.
- Intellectual Property Consultant to various pharmaceutical and biotechnology companies.
Paddock Laboratories, Inc., Minneapolis, MN, Director, Corporate Development
- Responsible for patent and scientific due diligence, patent design; in-licensing, deal prospecting, freedom-to-operate analyses, management of outside counsel, litigation management and paragraph IV ANDA strategy.
Nutrition 21, Inc., Purchase, NY, Scientific and IP Consultant
- Business plan analysis, scientific writing, editing, deal prospecting, freedom-to-operate, patent strategy, IP due diligence.
Pharmasset, Inc, Atlanta, GA, Senior Director, Legal Affairs and Company Secretary
- Responsible for all legal issues, especially management of patent portfolio, patent licensing (in and out), clinical trial contracts, general contract review and negotiation, liability and insurance issues, confidentiality and materials transfer agreements, research and manufacturing / supply agreements employment agreements, trademark filings.
- Prepared documents for proposed funding round. Supervised outside counsel.
Restoragen, Inc., Lincoln, NE, General Counsel, Vice President
- Responsible for all legal issues and competitive intelligence efforts.
- Managed patent portfolio, trademark filings and freedom-to-operate opinions.
- Employment agreements, clinical trial contracts, general contract review and negotiation, insurance issues, collaborator and consultant agreements, materials transfer and confidentiality agreements. Participated in preparation of a private placement memorandum and documents for a proposed funding round. Supervised outside counsel.
Taro Pharmaceuticals,/B., Hawthorne, NY, Patent Counsel
- Analyzed patents and prepared internal opinions on patents susceptible to paragraph IV ANDA challenge.
- Member of the Research and Development and New Product committees.
- Managed patent portfolio, trademark filings. Supervised outside counsel.
- Domain name management.
Kaye Scholer, llp., New York, NY, Associate
- Represented major pharmaceutical companies in Hatch-Waxman paragraph IV lawsuits against generic drug companies.
- Represented major pharmaceutical company in biotech patent infringement lawsuit.
- Expert witness and consultant work. Document review and analysis.
Whitman Breed Abbott & Morgan, llp., New York, NY, Scientific Consultant
- Pharmaceutical products liability litigation. Represented pharmaceutical company in suits over an anti-epileptic drug.
- Expert witness work, medical record analysis, NDA review.
Sills Cummis & Gross, pc., Newark, NJ, Scientific Consultant
- Medical devices products liability litigation. Finding, and preparing potential expert witnesses. Daubert challenges to the plaintiffs' medical and expert witnesses. Scientific literature review, analysis.
Honors & Publications
- Regulatory Affairs Certified (R.A.C.)
- Chartered Scientist (C.Sci.)
- European Chemist (EurChem)
- European Professional Biologist (EurProBiol.)
- Fellow of the Royal Society of Chemistry (C.Chem., F.R.S.C.)
- The Society for Biology (C.Biol., F.S.B.)
- Methods in cell and molecular biology, European Molecular Biology Laboratory, Germany.
- Computers in protein biochemistry and molecular biology, Maxwell Institute, U.K.
- Advanced methodologies for the analysis of proteins, Autonomous University of Barcelona, Spain.
- Solid phase methods in DNA sequencing, cloning and protein purification, Royal Institute of Technology, Sweden.
- Development of the central nervous system, NATO Advanced Study Institute.
Academic and Professional Affiliations
- Member of the New York Academy of Sciences.
- Otto L. Walter Distinguished Legal Writing Award.
- New York Law School Law Review Member - Articles Editor and Certificate of Merit recipient.
- Irving Mariash Scholar, New York Law School.
- Woodrow Wilson Award for Constitutional Law.
- G.A. Kerkut Prize for Biochemistry.
- British Association for the Advancement of Science Award.
Publications and Patents
- Author of three books, peer reviewed journals (and academia journals), editor of many scientific and medical manuscripts, and author of more than 75 scientific and legal publications.
- Over 80 patent applications filed (U.S., Europe and World patents).
- J.D. Honors (magna cum laude) New York Law School, NY
- M.B.A. Management, Fairleigh Dickinson University, U.K.
- Ph.D. Molecular Biology/Biochemistry, University of Southampton, U.K.
- B.Sc. Honors (summa cum laude) Biochemistry/Chemistry, University of Southampton, U.K.