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This profile was last updated on 11/19/13  and contains information from public web pages and contributions from the ZoomInfo community.

Dr. Peter Hans Kalinka PhD

Wrong Dr. Peter Hans Kalinka PhD?


Phone: (310) ***-****  HQ Phone
Katan Associates Inc
245 33rd Street
Hermosa Beach, California 90254
United States

Company Description: Katan also provides high-level advice to the government sector and industry based organizations. We help to connect these organizations with similar organizations...   more

Employment History

  • Ph.D. Chief Executive Officer
    Accelsiors Group International
  • Managing Director
    Accelsiors Group International
  • Vice President, Biopharmaceuticals
    Apotex Inc.
  • Head Biopharmaceuticals
    Apotex Inc.
  • Head of Pharmaceuticals
    Apotex Inc.
  • Partner
    Biopharma Excellence
  • Chief Executive Officer
  • Owner
  • Chief Executive Officer
    Meridian Biopharmaceuticals
  • Head Biochemie Biologics
    Sandoz Inc
  • Key Positions
    Sandoz Inc


  • Ph.D.
16 Total References
Web References
Welcome to Katan Associates, 19 Nov 2013 [cached]
Peter Hans Kalinka, Ph.D. CEO of the Accelsiors Group International
SPI 2012 | Sachs Associates, 22 May 2012 [cached]
Peter Kalinka,Vice President Biopharmaceuticals,Apotex
Peter Kalinka's profile will be online shortly.
home | Dr. Peter Kalinka | ..., 26 Sept 2011 [cached]
home | Dr. Peter Kalinka | consulting | virtual network | contact
Dr. Kalinka 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. He was also involved in the development of the second biosimilar hGH, Valtropin.
Dr. Kalinka 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. He 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. - About Us, 24 May 2012 [cached]
Dr. Peter Kalinka:Senior Consultant
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. He 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.
Dr Kalinka 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.
Dr. Kalinka has worked with the fully back-integrated development model as well as the virtual model. His 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, EMA 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.
Biosimilars by Biopharm Knowledge Publishing in Biosimilars, Generics Drugs, Regulation & Policy, 30 Oct 2012 [cached]
Dr Peter H Kalinka, CEO and Managing Director, Accelsiors Group International
Peter H Kalinka PhD CEO and Managing Director, Accelsiors Group International Instructor for Clinical Development of Pharmaceuticals and Biologics, Advanced Biotechnology Studies, Johns Hopkins
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