Expert Details

Expert in Biopharmaceutical Process and Product Development; Patents and Trade Secrets in the Biotechnology Industry; and Biosimilar Patent Infringement

Expert ID: 735168 Colorado, USA

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Expert is a classically trained biochemist with 30 years of experience in the biopharmaceutical industry as both a hands-on scientist and scientific leader in process, analytical, and formulation development, product commercialization, and product quality assessment. During his long tenures at Bayer and Amgen, he had the privilege of participating in the development, registration and/or lifecycle management of 15 biological drugs (9 BLAs), including Epogen, Neupogen, Aranesp, Neulasta, Prolia, Kogenate (Factor VIII), and Vectibix. Expert has deep experience in the development of biologicals for oncology and immune disorders, including Imlygic, the first licensed oncolytic virus for melanoma, and Blincyto, the first licensed immunotherapy (for leukemia) using a bifunctional ("BITE") antibody.

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 Colorado Biotechnology Consultants, 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.

Expert may consult nationally and internationally, and is also local to the following cities: Denver, Colorado - Colorado Springs, Colorado - Aurora, Colorado - Fort Collins, Colorado - Arvada, Colorado - Westminster, Colorado - Boulder, Colorado - Greeley, Colorado - Longmont, Colorado - Cheyenne, Wyoming

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Education

Year Degree Subject Institution
Year: 1983 Degree: Ph.D. Subject: Biochemistry Institution: Duke University
Year: 1976 Degree: B.S. Subject: Chemistry Institution: Haverford College

Work History

Years Employer Title Department Responsibilities
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.

Additional Experience

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

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