Steve Rabin Iovance Biotherapeutics

Steve has more than 25 years experience in the pharmaceutical industry, starting with the drug delivery company ALZA Corporation in Palo Alto and Mountain View. When ALZA was acquired by Johnson and Johnson, he remained with J&J, ultimately serving in product development of a drug/device combination product. He then transitioned to CMC Regulatory Affairs at J&J for 5 years, leading the submission and approval of prostate cancer drug in 120 countries. He then moved to Iovance, a cell therapy company where he started the CMC Regulatory Affairs group 7 years ago. Iovance recently had its first product approved, Amtagvi, the first cell therapy product using the patient’s own natural tumor fighting T-cells, for metastatic melanoma. A portion of the patient’s tumor is harvested, the T-cells extracted and grown out in vitro, and then returned to the patient Comparability has proven to be an important topic for cell and gene therapies. Analytical comparability is often insufficient to demonstrate changes in the manufacturing process, which may force companies to perform additional clinical trials. Many discussions have taken place between industrial representatives and the FDA, however, it is still a topic in its infancy.