Mike Radomsky, PhD
Dr. Radomsky received his PhD in chemical engineering in 1991 from The Johns Hopkins University and has a nearly 25 year uninterrupted career in the pharmaceutical industry. He has served in a number of technical roles at both big pharma and small startup pharmaceutical and biotech companies. He has held technical positions at Syntex/Roche, Orquest, Epicyte, Arc Engineering, Boehringer-Ingelheim and most recently had a role as a founder and Vice President of Technical Operations at Oncogenerix/DARA Biosciences. He provides expertise in the chemistry, manufacturing, and controls for a wide variety of pharmaceutical products and has led product approvals and manufacturing efforts at contract manufacturing organizations (CMOs) around the world. His expertise has led to demonstrated success in advancing generic and innovator product pipelines to product approval and launch, utilizing CMOs and CROs for virtual development and manufacturing, and leading large and small groups of cross functional scientists. Dr. Radomsky has established a broad based knowledge of the FDA regulations of pharmaceutical products and a strong history in the development of intellectual property including a number of formulation and drug delivery patents. He has been consulting on and off in the industry since 2001.