Commercial Considerations For Cell And Gene Therapies: Viewpoints From The 2016 ARM Meeting

The Alliance for Regenerative Medicine held its annual Cell & Gene Meeting on the Mesa in La Jolla, CA, in early October. Over the course of the three-day partnering meeting and scientific symposium, several important issues affecting the cell and gene therapy industries were discussed, including commercial considerations.

From a regulatory standpoint, the cell and gene therapy field is growing rapidly. Celia Witten, MD, PhD, the deputy director of the FDA's Center for Biologics Evaluation and Research, reported that there has been an explosion of investigational new drug (IND) applications submitted to the Office of Cellular, Tissue and Gene Therapies (OCTGT) over the last couple of years, including over 200 submissions in both 2014 and 2015. Furthermore, the dealmaking climate for cell and gene therapies has encouraged investment and more innovation