Gregory Glass graduated with a Juris Doctor from Vanderbilt Law School and an MBA from Duke University. He began working in the pharmaceutical industry in 1995 and has worked in a variety of areas including market and business research, legal, and product strategy for both brand and generic companies.
Given his business and legal background, he naturally gravitated towards the end-of-brand/beginning-of-generic life cycle part of the pharmaceutical business. This range of time in the product life cycle covers the intersection of law and business.
He is the founder of ParagraphFour.com and FDAPetitions.com. ParagraphFour.com researches the universe of PIV patent infringement cases since 2000 brought under the Hatch-Waxman Act. The data cover ANDA filings and the generic entry into the market. The site also covers the parallel proceedings of Inter Partes Reviews which can affect the PIV case and product life cycle. All pharmaceutical-based citizen petitions filed since 2004 are covered in FDAPetitions.com.
Cited in such business publications as The Wall Street Journal, Mr. Glass has also written and published extensively in the area of pharmaceutical life cycle management and the Paragraph IV Market, much of it based on the data collected in ParagraphFour.com and FDAPetitions.com. These publications and journals include Nature Reviews Drug Discovery, Journal of Generic Medicines, American Corporate Counsel Docket, Food & Drug Law Institute Update, and Pharmaceutical Executive.
The research philosophy is simple and direct, similar to the reliable research found in the pharmaceutical industry: data driven. Data are compiled from the universe of active PIV court cases, Inter Partes Reviews, citizens petitions, and biosimilar BPCIA cases which are followed from start to finish. Once assembled, the data are presented in an unbiased, factual, and balanced manner which focuses on pharmaceutical products. There is no guessing. There is no speculation. It does not try to predict an outcome of a court case as it is impossible to guess what a judge will do, and the essential rule applies: no guessing.
Mr. Glass is often asked to provide further assistance for clients dealing with end-of-brand/beginning-of-generic life cycle issues. Gregory Glass Associates LLC offers bespoke project engagements of any size.