The potential of novel cell and gene therapies is now becoming realized with the U.S. FDA’s first approval of an immunotherapy for treatment in human patients. As clinical trials for this new class of drugs continues and more knowledge is gained, additional therapies for difficult-to-treat diseases show increasing promise. Follow us:               However, there are unique challenges when developing cell and gene products. For example, regulatory pathways, manufacturing processes, and analytics are not well defined. Also, comparability studies and regulatory filing strategies, considered routine for conventional biologics, demand a closer look when developing these biologically complex products.   At the 2017 PDA Cell and Gene Therapy Conference, hear pioneering academic researchers and industry experts, who have helped to drive these novel treatments forward, speak about how the unique regulatory and manufacturing challenges of these innovative products can be managed.   Explore ways to redefine the approach for the development of a process control strategy that will ensure consistency of process performance and deliver products that meet quality requirements. In addition, discover the unique process and facility design needs for cell and gene therapy products. Learn how to speed the development of cell and gene therapy products from the benchtop to the clinic. Understand more about this exciting and rapidly growing field and what you need to do to keep pace with the latest developments.     Book your hotel room by Nov. 6 to receive the Conference rate! Call the Manchester Grand Hyatt San Diego at +1 (619) 232-1237 and ask for the PDA Conference rate or make your reservation online.     Parenteral Drug Association (PDA) 4350 East West Highway, Suite 600 Bethesda, MD 20814 USA Tel: +1 (301) 656-5900 Fax: +1 (301) 986-1093 www.pda.org