Faculty Fellow, Center for Law, Science & Innovation, Sandra Day O'Connor College of Law, Arizona State University
Dr. Klein is a Faculty Fellow at the Center for Law, Science & Innovation at the Sandra Day O'Connor College of Law at Arizona State University. He is also Principal at Roger D. Klein, MD JD Consulting and Klein & Klein Co., L.P.A. He was formerly Chief Medical Officer at OmniSeq, an oncology focused genomic profiling company that was recently acquired by LabCorp. Previously, Roger was the Medical Director at the Molecular Oncology division at the Cleveland Clinic. He was also the Chair of the Professional Relations Committee at the Association for Molecular Pathology. Prior to joining the Cleveland Clinic, he served as Medical Director of Molecular Oncology at the BloodCenter of Wisconsin where he led the center’s Diagnostic Laboratories’ initiative focused on DNA- and RNA-based testing for evaluation of cancer patients.
Dr. Klein has been an advisor to the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and the Centers for Disease Control and Prevention (CDC). He has participated in and assumed leadership roles in many professional society committees and corporate advisory boards and is a policy advisor to the Heartland Institute.
Dr. Klein is licensed to practice medicine in Ohio, Florida, and Wisconsin. Additionally, he is licensed to practice law in the District of Columbia and Ohio. Roger obtained his Molecular Genetic Pathology certification at Mayo Medical School following completion of his M.D. Yale University School of Medicine. He obtained his J.D. from Yale Law School.
Andrew A. Hufford is an Intellectual Property attorney with Brinks Gilson & Lione. His practice emphasizes US and global patent prosecution in biopharma, chemistry, and plant genetics. He also has significant experience in patent and trade secret litigation, inter-partes review, and patent due diligence. Mr. Hufford is the Vice Chair of the Utah State Bar Intellectual Property Section; a founding member of the David K. Winder IP Inns of Court; and an active member of the American Bar Association’s IP Law Section.
Mr. Hufford was a Professor of Biology before practicing law. He holds a Bachelor of Science (Cum Laude, Phi Beta Kappa) and Master of Science in Biochemistry, and spent several years conducting clinical pharmacology research. He earned his J.D. from the University of Houston, where he was an Articles Editor with the Houston Journal of Health Law and Policy and a member of the Moot Court and Mock Trial teams.
Andrew A. Hufford is an Intellectual Property attorney with Brinks Gilson & Lione. His practice emphasizes US and global patent prosecution in biopharma, chemistry, and plant genetics. He also has significant experience in patent and trade secret litigation, inter-partes review, and patent due diligence. Mr. Hufford is the Vice Chair of the Utah State Bar Intellectual Property Section; a founding member of the David K. Winder IP Inns of Court; and an active member of the American Bar Association’s IP Law Section.
Mr. Hufford was a Professor of Biology before practicing law. He holds a Bachelor of Science (Cum Laude, Phi Beta Kappa) and Master of Science in Biochemistry, and spent several years conducting clinical pharmacology research. He earned his J.D. from the University of Houston, where he was an Articles Editor with the Houston Journal of Health Law and Policy and a member of the Moot Court and Mock Trial teams.
Explainer Episode 53 - Biologics, Biosimilars, and the Two-fold U.S. Approval Framework’s Possible Impact on Prices
Roger D. Klein
Biosimilars, a category of biologic (medicine derived from a living organism), require approval, at least...
Courthouse Steps: Amgen, Inc. v. Sandoz, Inc. - Podcast
Andrew A. Hufford
The Biologics Price Competition and Innovation Act of 2010 (42 U.S.C. § 262) created an...
Courthouse Steps: Amgen, Inc. v. Sandoz, Inc.
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