Dr. Diane Seimetz
Dr. Diane Seimetz is an experienced drug development and regulatory expert with proven track record bringing first in class products from idea to approval.
She has over 19 years of international drug development, partnering and managerial experience in the biopharmaceutical industry.
She was Chief Scientific Officer at the Fresenius Healthcare Group and member of the Fresenius Executive Group. Together with her team, she developed first-in-class biopharmaceutical products, such as the first bispecific, trifunctional antibody catumaxomab. This program was awarded the "Prix Galien" honoring outstanding research and innovative drug development.
In the early 2000's, she supported progressing one of the first genetically engineered cell based products to clinical stage.
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 her projects.
Selected products under her responsibility were granted fast track and orphan drug status.
She planned and implemented product life cycle strategies including post marketing studies and publications to increase product value. Advisory boards with international Key Opinion Leader were established by Dr. Seimetz to provide customer focused expertise on drug development and life cycle management.
She has been involved in numerous large-size due diligence projects, both from an inlicensing and outlicensing perspective. This includes assets with a value in the upper triple-digit million range.
Her product portfolio knowledge covers antibodies, cell and gene therapy including genome edited products as well as recombinant proteins and vaccines. She supported as member of pharmaceutical associations the creation of the EU regulatory framework for advanced therapy medicinal products (ATMPs). She also contributed to a BPI position paper on orphan drugs and compassionate use.
Dr. Seimetz has dealt with the development and certification of medical devices.
She is a frequently invited speaker to international conferences and author of drug development related articles. Dr. Seimetz is an invited lecturer to the Pharma MBA, Goethe Business School, University Frankfurt.
Dr. Seimetz holds a degree in pharmaceutical sciences and completed her PhD at the German Cancer Research Center and the Johns Hopkins University in Baltimore (USA). She holds a Master’s Degree in Drug Regulatory Affairs and is a certified coach.
Dr. Seimetz started her professional career in 1999 within the Fresenius group. After successful set up of the Regulatory Affairs Department she was promoted to Vice President and Head of Department. In 2008 she took over as Executive Vice President the Chief Scientific Officer role with responsibility for international drug development.
In 2013, together with her partner Dr. Gabriele Dallmann, she founded Biopharma Excellence, a consulting company specialized in development and approval of biopharmaceuticals and partnering strategies.
Since 2017 she is member of the Decision Board of the Helmholtz Validation Fund, a fund that has been implemented to bridge gaps between scientific findings and their commercial applications.