Ken Phelps founded Camargo Pharmaceutical Services to provide one-stop drug development services to emerging, virtual to small pharmaceutical companies. These companies desire to maximize their use of capital by outsourcing the drug development services. Camargo specializes in using the 505(b)(2) submission mechanism. This regulatory route is particularly attractive to small pharma because it has more certain outcomes with less cost, shorter timeframes and controlled risks compared to traditional NDA development. Camargo also uses its expertise to assist in 505(b)(1) projects as well as ANDA’s that have difficult bioequivalence problems, such as clinical endpoints needed for topical drug products.
Ken has more than 33 years experience in the pharmaceutical industry. He holds a B.S. degree in Chemistry from the University of Nebraska. Big pharma experience comes from multiple assignments at Marion Merrell Dow and predecessor companies. Small pharma experience comes from many positions at Duramed Pharmaceuticals which became Barr Laboratories. International experience comes from a 3-year assignment based in Milan Italy where he had responsibility for quality and process technology at 29 facilities world-wide.