Kavita Mistry, PhD, has more than 20+years of experience in the pharma and biotech industry in CMC regulatory, quality, process development, and analytical research. She is Group Senior Director for Biologics Development, Pharma Technical Regulatory, at Genentech, leading a group responsible for global CMC regulatory strategies for biologics products from entry into human through clinical development and launch. She has held various leadership roles in CMC, including oversight of the regulatory programs for Genentech’s key marketed products and small molecule products in development, building a QC function, as well as serving as a Technical Development Team leader. Prior to Genentech, Kavita worked at Merck Research Labs of Merck & Co. in analytical research and development. She has also worked at Hoffmann-La Roche in Switzerland. She holds BS and MS degrees from Stevens Institute of Technology and a PhD in chemistry from Northeastern University.