DIA Conference to Feature Sessions on Drug Labeling, Pandemic Flu
The Drug Information Association's 45th Annual Meeting, taking place June 21-25 in San Diego, will be the latest installment in the biopharmaceutical industry's largest and longest running global, multidisciplinary conference featuring sessions and preconference tutorials on issues affecting drug discovery and development. Included in this year's lineup are two timely sessions reflecting the state of today's global biopharmaceutical environment.
On June 22, from 1:30-3 p.m., the public policy/law track will feature a special session titled "Labeling Risk: Practical Approaches after Wyeth v. Levine, which will explore practical approaches pharmaceutical companies should consider when disseminating risk information to minimize failure-to-warn liability and to maximize the possibility such liability is preempted. DIA notes that in March 2009, The Wall Street Journal reported that the Supreme Court ruling in Wyeth stated that pharmaceutical companies are not necessarily shielded from failure-to-warn product liability lawsuits in state courts when the U.S. FDA has determined that approved labeling appropriately explains risk information.
"We will delve deep into the legal benefits of preemptions, describe regulatory and documentation strategies that maximize the availability of preemption in failure-to-warn lawsuits, and identify effective risk communication strategies," says Session Chair Patrick C O'Brien, JD, PharmD, a partner at Burke O'Neil LLC. Speakers for this session will include John B Moriarty, JD, senior vice president of Elan Pharmaceuticals; Sandra A. Milligan, JD, M.D., executive director of Amgen Inc.; and Mary K. Pendergast, JD, LLM, president of Pendergast Consulting.
Another timely session of note at this year's conference, featured in the biotechnology track, is "Regulatory Methods to Facilitate the Approval of Biological Products to Address Pandemic Influenza," which will also take place June 22 from 1:30-3 p.m. Incorporating descriptions of novel regulatory mechanisms for vaccine approval with a discussion of successful applications for pandemic influenza, the session will focus on industry approaches toward interactions with FDA, and the latest biochemical methods for the development of vaccines. Chaired by Richard M Lewis, Ph.D., CEO of Access BIO, the session's speakers will include Jean L Hu-Primmer, MS, program manager of the USFDA's Pandemic and Emerging Threat Preparedness Division; John Purves, Ph.D., head of the European Medicines Agency's Quality of Medicines Sector; and Ozzie Berger, senior director and head of Influenza Vaccines at GlaxoSmithKline's U.S. Regulatory Affairs, Biologicals Division.
DIA serves more than 30,000 professionals involved in the biopharmaceutical industry and regulatory affairs worldwide. Through its domestic and international meetings, training courses, workshops, and webinars, the association provides a neutral global forum for the exchange of information critical to the advancement of the drug discovery and lifecycle management processes. Led by its volunteer-based board of directors and executive management team, DIA is headquartered in Horsham, Pa., and has offices in Basel, Switzerland; Tokyo, Japan; Mumbai, India; and Beijing, China. For more conference information and registration, visit www.diahome.org/ or the conference Web site.