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This profile was last updated on 7/23/14  and contains information from public web pages and contributions from the ZoomInfo community.

Dr. Peter Hans Kalinka PhD

Wrong Dr. Peter Hans Kalinka PhD?

Principal

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
Background

Employment History

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

Education

  • Ph.D.
18 Total References
Web References
Welcome to Katan Associates
www.katanassociates.com, 23 July 2014 [cached]
Peter Hans Kalinka, Ph.D. CEO of the Accelsiors Group International
SPI 2012 | Sachs Associates
www.sachsforum.com, 22 May 2012 [cached]
Peter Kalinka,Vice President Biopharmaceuticals,Apotex
Peter Kalinka's profile will be online shortly.
home | Dr. Peter Kalinka | ...
www.tiburonbioconsulting.com, 26 Sept 2011 [cached]
home | Dr. Peter Kalinka | consulting | virtual network | contact
Dr. Peter H. Kalinka, CEO of TIBURON BIO CONSULTING
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.
Peter ...
www.biopharma-excellence.com, 1 July 2013 [cached]
Peter Kalinka
...
Peter H. Kalinka
...
Dr. Peter Kalinka has worked in the biopharmaceutical industry for over 25 years. He possesses in-depth knowledge of drug development and has directed a large number of development projects (biologics, biobetters, biosimilars and NCEs). Several of these were approved by the EMA, FDA or both and other jurisdictions, many were managed by him from inception to submission. His knowledge in overall development spans the feasibility stage to cloning, process development to scale up, analytical development including bioassays, pre-clinical to first in man, clinical Phases I - III, to manufacturing and regulatory affairs.
Dr. Kalinka looks back on a large number of meetings with FDA, EMA, Health Canada as well as other jurisdictions and has dealt with these regulators during the scientific advice, pre-submission and submission phases of his development projects. He held key positions at companies such as Sandoz, Novartis, Serono, BioPartners and Apotex.
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, including monoclonal antibodies, bio-betters and novel biologics.
In July 2013, Dr. Kalinka's latest project, a biosimilar G-CSF, received positive opinion from the EMA.
Welcome to Katan Associates
www.katanassociates.com, 5 Jan 2011 [cached]
Peter Hans Kalinka, Ph.D. CEO of the Accelsiors Group International
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 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.
...
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.
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