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Dr. Peter H. Kalinka, CEO of TIBURON BIO CONSULTING
has more that 20 years of experience in the development of therapeutically active proteins having held 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
was also involved in the development of the second biosimilar hGH, Valtropin.
since spearheaded the development and filing of several other biopharmaceuticals such as interferon alpha, EPO, hGH, interferon beta, monoclonal antibodies etc.
As Head of Clinical Operations of a venture funded Biotech Company, he directed the simultaneous development of 9 biopharmaceutical compounds.
planed 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.
Furthermore, Dr. Kalinka
is faculty of Johns Hopkins University
, MD, teaching Clinical Development of Drugs and Biologics.