Hear from the FDA, National Institute of Health and More at PDA Freeze Drying Workshop 19 October, 2010

Bethesda, Md. – The Parenteral Drug Association (PDA) is proud to announce the confirmation of expert regulatory and industry speakers at this year’s Pharmaceutical Freeze Drying Workshop.

“The application of lyophilization to preserve health care products continues to expand, with new and innovative products being introduced at a growing pace. Novel formulations and delivery systems for administration and use present new challenges,” remarks Ed Trappler, President, Lyophilization Technology, Inc. and Chair, 2010 PDA Pharmaceutical Freeze Drying Workshop Program Planning Committee, “A goal of this workshop is to bring together professionals from the diagnostics and therapeutics industry involved with lyophilization in order to further develop skills and knowledge of the wide range of activities required to develop a lyophilized product,” he added.

Confirmed speakers include:

• Enrico Corona, Formulation and Process Development Manager, Patheon Italia S.p.A.
• David Doleski, Team Leader, CBER, DMPQ, FDA
• Fred Lim, PhD, Principal Engineer, Genentech, Inc.
• Shanker Gupta, PhD, Program Director, Pharmaceutical Resources Branch, NCI, National Institute of Health
• Edward Trappler, President, Lyophilization Technology, Inc.
• Sharon Thoma, PharmD, National Expert Pharmaceutical Investigator, FDA

The PDA workshop and exhibition is scheduled for November 17-18 at the Sheraton San Diego Hotel Marina in San Diego, California. There is a pre-workshop course, Fundamentals of Lyophilization scheduled for November 15-16 at the same location.

The agenda includes sessions on advances in lyophilized health care products, product and formulation design, aspects of process development, industrialization of lyophilized products, quality of lyophilized products and current regulatory expectations.

For more information, visit www.pda.org/freezedry2010. Press inquiries about registration should be directed to PDA’s Adrienne Fierro, fierro@pda.org.