Medical Products News

To address these and other issues involving follow-on biologics drug development, the New York Academy of Sciences and the Food and Drug Administration (FDA) - in collaboration with the National Institute of Standards and Technology - will present a three-day conference on December 12-14 entitled Follow-on Biologics Workshop: Scientific Issues in Assessing the Similarity of Follow-on Protein Products at the New York Marriott at the Brooklyn Bridge, 333 Adams Street, Brooklyn, New York.

The goal of this meeting is to address the issues associated with the characterization and demonstration of similarity of protein pharmaceutical products. An overview of currently available analytical methodologies and technologies, as well as perspectives on future technology, will be presented. The focus will be on the use of analytical techniques to characterize follow-on biologics, and on the role of the fermentation and purification processes in determining product quality attributes. The meeting will also address challenges to characterizing and comparing proteins in the absence of reference standards for the active pharmaceutical ingredient.

The conference will consist of five sessions covering the following topics:

Analytical Techniques to Examine Molecular heterogeneity of Active Ingredient: Comparisons, Strengths and Weaknesses
Effect of the Manufacturing Process on the Product
Impurities and Contaminants
Bioassays and Potency
Assessing the Similarity of Active Ingredients.

Over 30 speakers from the U.S. and Europe are expected to attend, including Janet Woodcock, FDA-OC. Speakers will include: Francois Baneyux, University of Washington; Erik Fernandez, University of Virginia; Thomas M. Laue, University of New Hampshire; Igor Kaltashov, University of Massachusetts; Nadine M. Ritter, The Biologics Consulting Group, LLC; Keith Webber, FDA; Timothy D. Veenstra, SAIC-Frederick, Inc.; Frederick P. Schwarz, CARB/NIST; Steve Cramer, Rensselaer Polytechnic Institute; Jonathan Amster, University of Georgia; David Bunk, NIST; Donald F. Hunt, University of Virginia; Daron Freedberg, FDA/CBER; Russ Middaugh, University of Kansas; Keith Oberg, MannKind, Inc., Curtis Meuse, NIST; Ewa Folta-Stogniew, Yale University; Roger E. Marchant, Case Western Reserve University; Lauren Little, Bioquality.

The meeting was organized by Kurt Brorson, CDER, FDA; David Bunk, NIST; Andrew Chang, CBER, FDA; Barry Cherney, CBER, FDA; Kathleen A. Clouse, CDER, FDA; Blair Fraser, CBER, FDA; Travis Gallagher, NIST; Marcia Holden, NIST; Christopher Joneckis, CBER, FDA; Curtis Meuse, NIST; Stephen Moore, CDER, FDA; Amy Rosenberg, CBER, FDA; Emily Shacter, CDER, FDA; Marjorie Shapiro, CBER, FDA; and Victoria R. Sutton, CBER, FDA.

Space is limited and advance email reservation required. For more information, please visit
http://www.nyas.org/events/eventDetail.asp?eventID=4883&date=12/12/2005

Established in 1817, the New York Academy of Sciences is a worldwide nonprofit membership organization dedicated to building communities and advancing science