Dr. Peter Kalinka
Dr. Peter Kalinka is a Pioneer in the Biosimilars Arena, being responsible for the development of Omnitrope, the very first Biosimilar to be approved in the EU, Australia and the US.
was then involved in the development of the second Biosimilar to be approved, Valtropin.
This was followed by many other Biosimilars, Bio-betters and novel Biologics.
In July of this year, Dr. Kalinka's
latest project, a biosimilar G-CSF, received positive opinion from the EMA
also boasts more than 25 years of clinical development expertise in the development of Biologics, Biosimilars and Biobetters.
In Multiple Sclerosis alone, he
planned, implemented and directed five Phase III studies with Interferon beta's and other compounds in early, relapsing remitting and secondary progressive MS. He
is experienced in many other indications such as oncology, immunology, haematology, auto-immune diseases and endocrinology.
has worked with the fully back-integrated development model as well as the virtual model.
latest projects were all run virtually with a relatively small number of in-house experts and the utilization of his
extensive, international network of external service providers and sub-contractors.
In the last 7 years Dr. Kalinka has planned, set up and directed a complete virtual Biopharmaceuticals Division for a major Generics company in North America from scratch.
Presently the Division has 6 ongoing Biosimilar development projects comprising 3 Therapeutic Proteins and 3 Monoclonal Antibodies.
The Unit consists of 20+ internal subject-matter experts grouped in specific departments: Product Development (Process Development - Up and Down Stream, Analytical, Bioanalytical, Manufacturing), Regulatory Affairs, Programme Management and Clinical (Phase I + III) & Preclinical Development.
Apart from directing the entire Division, Dr. Kalinka
also single-handedly ran all of the pre-clinical as well as clinical strategy and development.
In the course of his
career, Dr. Kalinka
was directly responsible or intimately involved in the development of more than 12 Biosimilars all for submission to FDA
as well as other regulated markets.
In addition he
has managed and/or consulted in the development of several Biobetters and novel Biologics.
Dr. Kalinka held key positions at companies such as Sandoz, Novartis, Serono, BioPartners, Apotex and has consulted for many others.