• Senior staff from the FDA and NIH will discuss how to develop a new product and how to comply with NIH grant and FDA requirements for investigational new drugs and marketing applications
• Speakers will address the unique challenges faced by companies in the development of orphan products, and how to develop efficient clinical rare disease programs and avoid common pitfalls
• Learn how to work with federal agencies on grants and orphan designations

Featured Speakers Include

Keynote:

• Robert M. Califf, MD, MACC: Vice Chancellor for Clinical and Translational Medicine Director, Duke Translational Medicine Institute

Plenary:

• Christopher P. Austin, M.D.: Director, National Center for Advancing Translational Sciences, National Institutes of Health
• Danilo A. Tagle, PhD: Associate Director for Special Initiatives, National Center for Advancing Translational Sciences (NCATS), NIH
• Bonnie B. Dunn, PhD: Program Director, National Center for Advancing Translational Sciences, NIH

Lunch:

• Preston W. Campbell, III, M.D.: Executive Vice President for Medical Affairs, Cystic Fibrosis Foundation