Bethesda, Md., April 21, 2014 – The Parenteral Drug Association (PDA) announced today that it has confirmed the participation of four experts from the U.S. FDA in the upcoming 2014 PDA/FDA Virus and TSE Safety Conference, June 12-13, 2014, at the Hyatt Regency Hotel, Bethesda, Maryland.
The four U.S. FDA experts represent the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER):
- Kurt Brorson, PhD, Staff Scientist, CBER
- Luisa Gregori, PhD, Biologist, CBER
- Arifa Khan, PhD, Sr. Investigator, CBER
- Scott Lute, Biologist, CDER
“PDA has partnered with the U.S. FDA for nearly a decade to hold conferences and workshops on this critical topic for manufacturers of biotech drug products,” said PDA President Richard Johnson. “This year’s conference will extensively cover risk mitigation strategies to avoid contamination in biomanufacturing.”
FDA’s interest in the subject is exemplified by Kurt Brorson’s participation not only as a speaker, but as a Co-Chair of the Program Planning Committee. He will provide the U.S. regulatory position on virus and TSE safety during the opening plenary session and another talk on the different regulatory expectations at the clinical and commercial development phases.
Dr. Gregori will discuss reference materials for CJD and vCJD infectivity. Dr. Khan, who also serves on the program planning committee, will discuss advanced virus detection technologies for the evaluation of cell substrates. CDER’s Lute will discuss the risks of virus breakthrough in filters and mitigation strategies.
For more information, including press registration, go to www.pda.org.