Speakers

Dr. Rümenapp is based in Wuppertal, Germany and working within the Product Supply Biotech organization of Bayer AG, where he is responsible for the transfer of Bayer’s pipeline candidates (antibodies and antibody-drug-conjugates) to external manufacturing partners and regulatory submission and launch preparations.

Prior to working in Development, Dr. Rümenapp was Head of Biotech Projects in Product Supply Biotech at Bayer, where he was responsible for contract manufacturing partnerships in the field of biotechnological drug substances and drug products and interdisciplinary project management with the goal to ensure market supply.

Before it was acquired by Bayer, Dr. Rümenapp hold a similar position at Schering AG, and before that, he worked in the Production & Logistics department of Schering, where he was responsible for production aspects of in- and out-licensing deals, due diligences, and product acquisitions of small molecule products and biologics.

Dr. Rümenapp studied chemistry and holds a Ph.D. in biosciences. He worked several years in academic research in the field of signal transduction and as an assistant teacher in the field of general pharmacology.

Today, Dr. Rümenapp area of expertise is the set-up and management of external relationships for the development and supply of bio-pharmaceutical products. He has more than 20 years of experience in the bio-pharmaceutical industry.

To correspond with Dr. Rümenapp, please contact him at [email protected].

Presentation Title: Biotherapeutics Development and Production at Outsourcing Partners – How to Best Manage the Partnerships

Abstract: Many smaller and big pharma/ biotech companies employ outsourcing of the CMC development and manufacturing of their biologics to CDMOs for various strategic reasons. Thus, outsourcing partnerships are of crucial importance. For their clinical and/ or commercial manufacture, the companies must decide between building internal capabilities or outsourcing. Especially for biologics, this needs thorough evaluation and decision-making due to the technical complexity. This presentation will review the pros and cons as well as risks and mitigations of outsourcing CMC development and bio-manufacturing. Best practices for partner selection, collaboration, and how to avoid pitfalls in contract making, will be shared. The right expertise and fruitful CDMO partnerships allow successful development without supply or quality issues, leading to timely launch readiness.

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