Steven Pikulin

Is the of President of TechReg Services, Inc. (TRSI). Dr. Pikulin, through TRSI, is directing manufacturing and CMC/formulation development of TP508 (Chrysalin®) for FDA-IND submission and to move Chrysalin® into human clinical trials and beyond. He has prepared over 100 NDA CMC sections, as well as numerous INDs, DMFs, BLAs, 510(k)s, for a wide variety of therapeutic indications in the US, EU and other regions. He has over 30 years of experience in CMC, Quality Assurance, and Drug Development and has held positions with Dow Chemical Company, Hoechst-Roussel (currently Aventis), Janssen Pharmaceutical (Assistant /Director, Technical Regulatory Affairs), Ohmeda Pharmaceutical Products now Baxter Healthcare (Director, Worldwide CMC Regulatory Affairs), and Schering-Plough Research Institute (Group Manager, Pharmaceutical Documentation and Compliance).