NewswireToday - /newswire/ -
Monrovia, CA, United States, 2011/08/01 - Erik Henchal, Associate Director, Management and Scientific Affairs, Office of Vaccine Research and Review, Food and Drug Administration, to deliver featured speech at 9th Annual Vaccines Discovery and Development - GTCbio.com.
Dr. Erik Henchal, to deliver featured speech at “9th Annual Vaccines Discovery and Development: All Things Considered” conference, to be held on Nov. 7-8, 2011 in Boston, MA by GTC.
Dr. Erik Henchal will talk about the challenges and opportunities for clinical development and licensure presented by vaccines against emerging infectious diseases and bioterrorism threats. Vaccine safety is evaluated in all phases of clinical development, and additional studies may be required after licensure. In addition to the traditional licensure pathway, other approaches available to the U.S. FDA to facilitate the availability of vaccines include licensure based on Accelerated Approval, use of the product under an Investigation New Drug Application, or Emergency Use Authorization (EUA). In circumstances where efficacy studies in humans cannot be conducted and field trials have not been feasible, the “animal rule” provides a regulatory path to approval of certain new drug and biological products based on animal data.
Prior to joining the FDA, Dr. Henchal served over 25 years in the U.S. Army Medical Research and Materiel Command developing medical countermeasures and diagnostics to protect the health of soldiers, sailors, airmen and marines. Dr. Henchal has served on national panels and research review committees for the Defense Advanced Research Projects Agency, the National Institutes of Health, the Centers for Disease Control and Prevention, and the American Academy of Microbiology. He has appeared as a speaker and consultant at numerous medical, professional and government conferences, and has published extensively on the development of diagnostic and detection approaches for disease-causing agents and biological threats of military and civilian concern.
The 9th Vaccine Discovery and Development: All Things Considered conference annually brings together experts in vaccines from big and small pharmaceutical companies, academia, and government. The intimate setting of the conference enables networking and the opportunity to meet speakers and delegates. This year’s conference will appropriately take place in Boston, MA, the hub of research and development.
The purpose of the event is to generate dialogue and to introduce novel advances in the field of vaccines. It is part of a two-track meeting that will take place at the Omni Parker House. Delegates at this event will have a chance to meet the attendees of the concurrent 8th Anti-Infectives Partnering and Deal-Making conference.
The sessions for this conference are:
• Vaccines for Infectious Diseases;
• Therapeutic Vaccines;
• Regulatory and Government Policy;
• New Technologies in Vaccine Development;
• Future Trends in Vaccine Discovery and New Vaccines.