3rd Quarter 2007

Covance Leads Panel on Vaccine Risk Management at DIA

By Myra Frick and Jeff Stoddard

Vaccine development is expected to be a high-growth area of pharmaceutical research in the next several years. At the 43rd Annual Drug Information Association (DIA) Meeting in June, Dr. Jeffrey Stoddard from Covance Periapproval Services chaired a session entitled “Risk Management for Vaccine Products.” Dr. Stoddard assembled an impressive panel of industry, academic, and government experts to address specific areas of vaccine risk management. Panelists presented best practices for developing a risk management strategy, including risk assessment and communication. These components are hallmarks of the FDA's risk management framework.

Dr. Stoddard set the stage for the session by discussing the unique attributes of vaccine safety considerations; in many cases, healthy individuals are receiving an agent that will prevent disease and contribute to public health. Dr. Adrian Dana, a senior director at Merck & Co, spoke on the development of risk management programs that impact various age groups. Dr. Steven Black, a respected researcher who conducted pivotal studies for many of the vaccines that are commonly used today, then discussed approaches to evaluate vaccine risk assessment. Finally, Allison Kennedy, an epidemiologist from the Centers for Disease Control and Prevention (CDC), presented strategies for effective risk communication in today's environment. Real-world case studies brought the presentations to life – many drawn from recent headlines, such as GARDASIL^® [Qaudrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine] for HPV in females, and Menactra™ [Meningococcal (Groups A, C, Y and W-135) Polysaccaride Diptheria Toxoid Conjugate Vaccine], developed for young adults to prevent meningitis.

As development of novel vaccines and delivery methods progress, risk management will likely be a significant factor in the equation. Affiliations with key stakeholders from industry and public health agencies will be necessary for the successful advancement of new vaccine products. For more information on risk management for vaccine products, please contact Covance at 1-888-COVANCE.