Monrovia, CA, May 11, 2014 --(PR.com
)-- Barry Eisenstein, Senior Vice President, Scientific Affairs, Cubist Pharmaceuticals to Present on “The Evolution of the Regulatory Framework for Antibacterial Agents” at the 11th Anti-Infectives Partnering and Deal-Making Conference on July 10-11, 2014, in Boston, MA, by GTCBio.
Dr. Eisenstein will discuss how bringing new antibacterial agents to market is challenging due to the difficulty of discovering new agents, the traditional regulatory requirement for two large trials per indication, and the limited economic reward when use of new antibiotics is restricted. These challenges have resulted in a frighteningly thin antibiotic pipeline despite the rapid and continued growth in the need for new agents. Approaches that balance the quantity of data required for registration with the unmet medical need would encourage work in this area. To this end, a tiered regulatory framework that allows either disease- or pathogen-based label indications has been proposed, along with label wording that encourages the most appropriate use of new agents. Dr. Eisenstein will share a number of explicit benefits for new antibiotic development and use.
Barry I. Eisenstein, M.D., has served as Senior Vice President, Scientific Affairs, Cubist since July 2004. From January 2003 until July 2004 he served as Senior Vice President, Research and Development, where he helped lead the FDA approval team for CUBICIN. Dr. Eisenstein received his MD from Columbia University followed by training in Internal Medicine and Infectious Diseases at the University of North Carolina. He has spent his career in academia and industry, serving as chief of the ID division at the University of Texas Health Sciences Center, San Antonio then as Professor and Chair of the Department of Microbiology and Immunology at the University of Michigan. Following four years as VP, Lilly Research Labs, in charge of ID discovery and clinical development, he moved to Boston as VP of Science and Technology, Beth Israel Deaconess Medical Center and Professor of Medicine, Harvard Medical School. He is the author of more than 100 original papers, book chapters, and editorials, and has edited several books on infectious diseases and microbiology. A past editor of Infection and Immunity, he currently serves (since 2004) as an editor of Antimicrobial Agents and Chemotherapy. In 2008 he provided testimony before the US Senate on, “Emergence of the Superbug: Antimicrobial Resistance in the U.S.”, and in both 2010 and 2012 before the US Congress hearings on antibiotic resistance that led to the passage of the GAIN Act. He co-chaired a 2010 FDA Workshop panel on endpoints and non-inferiority margins for antibiotic development, and was a panelist at a 2011 joint Pew/IDSA/PhRMA workshop on antibiotic resistance. He was recently a member of the Research Committee and of the Research on Resistance Working Group of the IDSA and is presently a member of the FNIH Biomarkers Consortium on endpoints in bacterial infections, and of the Brookings Institution Council on Antibacterial Drug Development. He also chairs the PhRMA taskforce on “emerging pathogens”, a group that met twice in 2012 with FDA leadership to discuss ways to reduce ATB registration hurdles
GTCBio’s Anti-Infectives Partnering & Deal-Making is an infectious disease partnering and business development conference that gives global biotechnology and pharmaceutical companies an opportunity to network with high-level executives from top pharma and various biotech/pharmaceutical companies, explore potential collaborations, and learn about relevant anti-infective issues and deals that will affect the industry. The conference will discuss antibiotic valuation and reimbursements, pricing strategies, current trends and recent deals, investment and seed stage funding opportunities, government collaborations, non-dilutive funding, evolution of the regulatory framework and pathways for limited use. Participants include Yoav Golan, Tufts University School of Medicine; Michael N. Dudley, Rempex Pharmaceuticals/ The Medicines Company; Michael Eichberg, Achaogen; Barry Eisenstein, Cubist Pharmaceuticals; Mark Goldberger, Abbvie; Peter Hammann, Sanofi-Aventis Deutschland GmbH; Elizabeth Jungman, The Pew Charitable Trusts; Joseph Larsen, BARDA; Kevin Outterson, Boston University; Alex White, Roche; Barrett Thornhill, Antimicrobial Innovation Alliance; Benjamin Thorner, Merck Research Laboratories and many more.
This conference is also part of the Infectious Diseases World Summit 2014, which consists of this and two other conferences:
1) 12th Vaccines Research & Development: All Things Considered Conference
2) 3rd Annual Influenza Research and Development Conference
For more information, please visit www.gtcbio.com