Biotechnology Innovation Services
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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 restructuring. He also ran shareholder discussions and maneuvered the development of a complex cancer vaccine.