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Synopsis
This toolkit is the go-to resource for scientists, sponsors, investors, and other pharmaceutical industry pros. A lifestyle management toolkit for pharmaceutical and biotechnology products provides users with a thorough, concise, and highly organized handbook detailing U.S. pharmaceutical lifestyle management's practical and regulatory facets. A valuable aid to identifying regulatory opportunities and achieving the maximum effective patent life, the accessible Lifecycle Management Toolkit covers the gamut of drugs and biologics. This invaluable resource includes accessible knowledge and insights on pharmaceutical development phases, FDA approval pathways, coordination of patent protection with product labeling, bioequivalence requirements, new chemical entity data protection, labeling carve-outs, patent infringement litigation, patent term restoration reference product exclusivity, interchangeability exclusivity, orphan drug exclusivity, and pediatric exclusivity.
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About the Author
Gregory J. Glover, MD JD
Principal, Pharmaceutical Law Group PC
Author Greg Glover, a registered patent attorney and non-practicing physician with Pharmaceutical Law Group, has experience in food and drug law, intellectual property law, and technology licensing.
Greg’s practice focuses on advising life sciences companies, trade associations, and investors on the strategic interaction of Food and Drug Administration (“FDA”) regulations, intellectual property law, and technology licensing. Greg represents the research-based pharmaceutical industry on market exclusivity strategies and domestic intellectual property issues, and he has particular expertise in the patent and non-patent market exclusivity provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 (“the Hatch-Waxman Act”).
Greg has testified on behalf of the Pharmaceutical Research and Manufacturers of America (PhRMA) before the Subcommittee on Health in the House Committee on Energy and Commerce, the Senate Committee on Health, Education, Labor and Pensions, and the Senate Committee on Commerce, Science and Transportation. Greg has made presentations on the Hatch-Waxman Act before the general counsel of the FDA, has testified in hearings on the intersection of intellectual property and antitrust in the pharmaceutical industry before the Federal Trade Commission (FTC) and the Department of Justice – Antitrust Division, and has participated in FTC workshops on antitrust issues in the health care industry.
Greg received an A.B., magna cum laude, in Biochemical Sciences from Harvard College in 1981 and a J.D., cum laude, from Harvard Law School in 1986. Following law school, he completed medical school at Duke University in 1987, and served as an intern in Internal Medicine at New England Deaconess Hospital in Boston.
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