Expert in Biopharmaceutical Process and Product Development; Patents and Trade Secrets in the Biotechnology Industry; and Biosimilar Patent Infringement
Expert ID: 735168 Colorado, USA
Expert's experience covers all aspects of biopharmaceutical product development, with proven expertise in the commercialization of manufacturing and quality operations for biopharmaceuticals, as well as extensive experience with global regulatory filings at all stages of the product lifecycle. Expert’s development and commercialization experience covers both innovator (including first-in-class) therapeutics as well as multiple biosimilars.
As President of Employer, Expert has experience as an expert consultant for biopharmaceutical patent infringement and trade secrets litigation. He has written multiple declarations (U.S.) and Affidavits (Canada), largely around issues related to biosimilar patent infringement, leveraging his vast knowledge of the scientific literature and experience as a process development leader in both establishing intellectual property while designing ways around existing patents to enable unencumbered process and product development (where feasible).
Expert's consulting experience includes assisting biopharmaceutical companies with difficult product development issues, including matters related to formulation and downstream processing. He also has recently consulted on CMC-related matters such as specification setting for a commercial product.
|Year: 1983||Degree: Ph.D.||Subject: Biochemistry||Institution: Duke University|
|Year: 1976||Degree: B.S.||Subject: Chemistry||Institution: Haverford College|
|Years: 2015 to Present||Employer: Undisclosed||Title: President||Department:|
Responsibilities:Expert's consulting business focuses on both expert witness services for patent infringement in the biopharmaceutical space as well as providing experienced problem-solving for process and product development issues at biopharmaceutical companies.
|Years: 2003 to 2015||Employer: Amgen||Title: Director/Executive Director||Department: Process Development|
Responsibilities:Expert was functional head of analytical and formulation development. In this role, he assumed direct responsibility for analytical testing in support of process development, providing high performance methods for Quality Control, product characterization data for regulatory filings, and stable formulations for clinical and commercial use.
|Years: 1993 to 2003||Employer: Bayer||Title: Staff Scientist/Associate Director||Department: Process Sciences|
Responsibilities:Expert served as purification and analytical scientist in support of development of new biopharmaceuticals, including recombinant factor VIII; functional head in charge of analytical development in support of multiple pipeline candidates.
|Years: 1987 to 1991||Employer: Beckman Instruments||Title: Senior Scientist||Department: Applications|
Responsibilities:Expert was responsible for the support of HPLC instrument and column development.
|Expert Witness Experience|
|Expert has experience providing expert witness services for biopharmaceutical patent infringement cases. Recently, he prepared three declarations for matters relating to biosimilar patent litigation, and is currently working on a patent infringement case that is scheduled for federal litigation in 2019.|
|Training / Seminars|
|Expert was a senior executive at Amgen and has extensive business process and leadership training.|
Fields of Expertise
biopharmaceutical product development, patent infringement analysis, biopharmaceutical, biotechnology patent law, biological testing, biotechnology management, biologic (product), bioanalytical chemistry, biological oxidation, biomedical instrumentation, cancer biology, biological antioxidant, biotechnology quality assurance, biochemical research, bioavailability, biocompatibility, cell (biology), biological process, biotechnology