Iridium Biosciences
Cornelius Sobel, Ph.D. - Affiliate Consultant LinkedIn Profile
Cornelius.Sobel@gmail.com
Dr Cornelius Sobel established SPC GmbH in 2009
With more than 20
years of experience in the pharmaceutical industry and extensive expertise in
the areas of production, clinical development, regulatory and intellectual
property, Dr Sobel decided to share his expertise with worldwide clients.
Dr Sobel has spent more than 10 years working in the emerging field of
biosimilars. As CSO of BioPartners, he led and managed the submission of two
biosimilar applications to the EMEA, one of which was the first biosimilar ever
filed. The second biosimilar product, human growth hormone, resulted in
successful marketing authorization.
For more than a decade, he has
engaged in extensive consultation with national agencies, the EMEA and the FDA
with a view to anticipating developments in the regulatory framework that would
be applied to the approval processes for biotechnology derived products. Based
on these discussions, he developed programs for drug substance manufacturing and
testing, plus a cost effective strategy for clinical development programs. His
product expertise includes key therapeutic protein products including cytokines
and hormones. In addition he has experience in the area of monoclonal antibodies
and fusion proteins through his work at Merck KGaA
As CSO of
BioPartners, a "virtual" pharmaceutical company, Dr. Sobel worked with issues,
large or small, and accomplished tasks independently. In addition, he is fully
familiar with in-licensing/out-licensing negotiations and due diligence work
with potential partners, developing forecast sales models, setting up and
overseeing budgets. Most importantly, Dr. Sobel is adept at managing
relationships with venture capitalists and analysts.
As the former
CEO of LipoNova, Dr. Sobel identified the strengths of the company through
re-structuring. He also ran shareholder discussions and maneuvered the
development of a complex cancer vaccine.
