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BioRN Network e.V.

Im Neuenheimer Feld 582

D-69120 Heidelberg

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INFORMATION

BioRN is the science and industry cluster of the Rhine-Main-Neckar region around Heidelberg, one of Germany’s strongest biotech hubs. It is a non-profit network fostering health innovations, supporting a rich translational ecosystem and promoting, representing and connecting the regional innovation stakeholders.

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"We make Life Science matter...

...and Innovation happen!"

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Pathways to Pre-Clinical Development Success

Focus on Biologics and ATMPs

This event introduced technical and regulatory strategies for pre-clinical development, with a focus on biologicals and advanced therapy medicinal products (ATMPs). The sessions are designed to provide attendees with a regulatory scientific approach for successful translation of biologicals and ATMPs into the clinic. We aim to provide an understanding of pre-clinical development pathways and requirements for biologicals and ATMPs leading to the most expedited regulatory strategy in Europe, the US and beyond. Potential challenges in the development and registration of these products will also be discussed, to provide practical advice as well as highlight key aspects determining successful regulatory submissions.

Agenda