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Accelerating Development of Biopharmaceutical Workshop 2015

Speakers
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Speakers

TBC

Moderator

Diane Seimetz

Biopharma Excellence

Diane

Dr. Seimetz has over 16 years of global drug development, regulatory affairs and partnering experience in the biopharmaceutical industry.

She is co-founder of Biopharma Excellence, a consulting company specialized in drug development, regulatory affairs and partnering strategies.

She is the former Executive Vice President and Chief Scientific Officer of Fresenius Biotech. In this function she was responsible for Regulatory Affairs, Medical Affairs, Preclinical and Clinical Development as well as Program Management. Together with her team she developed on an international level the first bispecific, trifunctional antibody catumaxomab. After successful approval in the EU, this antibody was awarded the “Prix Galien” which honors outstanding research and innovative drug development.

She was involved in numerous due diligence projects for both, in-licensing and out-licensing strategies.

Dr. Seimetz looks back on a large number of meetings with EMA, national European agencies, FDA, Health Canada, and TGA as well as other jurisdictions. She has dealt with these regulators during (parallel) scientific advice, pre-submission, submission and post-authorization phases of projects as well as GMP and GCP inspections.

She planned and implemented product life cycle strategies including post marketing studies and publications to increase product value.

Her product portfolio knowledge covers mono- and polyclonal antibodies, antibody-drug conjugates, recombinant proteins, complex peptides, advanced therapy medicinal products as well as medical devices. She has in-depth experience with the development and approval of new products and biosimilars.

Dr. Seimetz received her degree in pharmaceutical science from the University of the Saarland and completed her PhD at the University of Heidelberg. Her research work related to glycotargeting in oncology was conducted at the German Cancer Research Center and the Johns Hopkins University in Baltimore, USA. Dr. Seimetz has a Master’s Degree in Drug Regulatory Affairs. In her thesis she assessed the EU and US environment for early market access and the essential requirements within a pharmaceutical company.

Topic lectured:

Seminar 4.2:

  • From scientific advice to successful marketing authorization – experience with the European authorization of the bispecific monoclonal antibody Removab

Be successful in biopharmaceutical partnering: Due diligence as the essential element