The LIFE (Learn about Industry From Experts) seminar series presents:

‘Biogenerics:   The Next Big Money Battleground between Pharmaceutical Companies and the Generics Industry’ by

Paul Salo, Ph.D.
Technical Advisor, Merchant & Gould, LLC

When: Tuesday, April 21st, 4pm-5pm
Where: IBB Seminar Room (#1128 IBB)

Food and drink will be provided!!

Paul is a Technical Advisor in the Atlanta office of Merchant & Gould, and assists in the preparation and prosecution of patent applications and provides technical expertise in support of freedom to operate and invalidity opinions.  He graduated from Georgia Tech in 2007 with a Ph.D. in Biochemistry and was in the TI:GER (Technological Innovation: Generating Economic Results) Program. In 2003, Paul earned a M.S. in Paper Science and Engineering from the Institute of Paper Science and Technology at Georgia Tech.

During the past several years, there has been increasing interest in the development of follow-on biologic products in light of advances in manufacturing technology, process control, and protein characterization.  The term biogenerics, or follow-on biologic products, generally refers to proteins and peptides that are intended to be sufficiently similar to a product already approved under the Federal Food, Drug, and Cosmetic Act, or licensed under the Public Health Service Act, to permit the applicant to rely on certain existing scientific knowledge about the safety and effectiveness of the approved biologic product.  Biogeneric products may be produced through biotechnology or derived from natural sources.  The FDA has been considering the circumstances in which review and approval of biogeneric products may be appropriate.  In addition, biogenerics legislation is currently pending in Congress and will likely pass this year.  This presentation will examine the legal, regulatory, and scientific issues surrounding biogenerics.

Thanks!

BBUGS Industry Committee

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