Peter Hans Kalinka, Ph.D.
Dr. Kalinka has more that 18 years of experience in the development of therapeutically active proteins in Senior Positions with major Pharmaceutical and Biotech companies.
At Serono Headquarters in Geneva, he was deeply involved in the development and first commercialisation of REBIF (Interferon beta-1a). In this function, he was directly responsible for the setting up of Serono ETOMS trial in early Multiple Sclerosis.
Working for Novartis, he oversaw the development and filing of the first ?generic? Biopharmaceutical in history, Omnitrope. The product has since been approved by the EMEA and FDA. Dr. Kalinka then spearheaded the development and filing of several other Biopharmaceuticals one of which has also been approved by the EMEA.
As Head of Clinical Operations of a venture funded Biotech Company, he directed the simultaneous development of 9 Biopharmaceutical compounds. He planned and implemented the various Phase I through III clinical studies which were carried out concurrently.
Dr. Kalinka has held positions such as Senior New Product Manager, Head of Scientific Affairs, Head of Biologics Division and Head of Clinical Operations with companies such as Sandoz, Ares-Serono, Novartis, and BioPartners.
Dr. Kalinka co-founded an international CRO active in Central Eastern Europe specialized in difficult indications such as Multiple Sclerosis, Cystic Fibrosis, Hepatitis C and Acromegaly with a significant US and Canadian client base. He is a consultant to the Biotech and Pharmaceutical Industry in all phases of drug development working presently for clients in the USA, Canada Europe, India, and Taiwan.
Furthermore, Dr. Kalinka teaches Biopharmaceuticals Development at the University of California at Berkeley, CA and Clinical Development of Drugs and Biologics at Johns Hopkins University, MD.