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2014-01-18T00:00:00.000Z

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Wrong Peter Kalinka?

Dr. Peter Kalinka Hans

Partner

Biopharma Excellence GbR

Direct Phone: (647) ***-****       

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Biopharma Excellence GbR

Agnes-Pockels-Bogen 1

Munich, Bavaria 80992

Germany

Company Description

Biopharma excellence designs for your biopharmaceutical development products a well thought through regulatory strategy always with a view on how to accelerate and optimize your development programs. Should your biological be a borderline product, i.e. no ... more

Find other employees at this company (6)

Background Information

Employment History

Chief Executive Officer and Managing Director

Accelsiors

Head Biochemie Biologics

Sandoz Inc

Key Positions

Apotex Inc.

Key Positions

BioPartners Inc

Key Positions

Serono S.A.

Key Positions

Novartis AG

Instructor for Clinical Development of Pharmaceuticals and Biologics, Advanced Biotechnology Studies

Johns Hopkins University

Chief Executive Officer

me.com Inc

Education

Universities of Vienna

Doctorate

Biology

University of Innsbruck

Web References (25 Total References)


Peter ...

www.biopharma-excellence.com [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). MORE


Peter ...

www.biopharma-excellence.com [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.


healthcare-economics-llc.com - About Us

www.healthcare-economics-llc.com [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.


healthcare-economics-llc.com - About Us

www.healthcare-economics-llc.com [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.


healthcare-economics-llc.com - About Us

www.healthcare-economics-llc.com [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.

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