„The Product is the Process – Is it?“ Manufacturing and Translation of ATMPs and Tissue- & Cell-based products

Whether in the fields of regenerative medicine, cell or gene therapy – driven by remarkable research success, innovative therapy and product concepts for advanced therapy medicinal products (ATMPs) are increasingly in the focus of interest.

Several products have already reached marketing approval. In addition, a multitude product approaches are in the early development phase or in clinical trials. Concomitantly, a complex and dynamic regulatory environment has emerged in this modern biotechnological area. To facilitate that ideas and development approaches are translated to safe and effective medicines for patients, the intensive exchange of expertise between involved stakeholders in research, clinical, industrial and regulatory affairs is required. This also includes aspects of manufacturing and testing as essential part. Thus, discussing regulatory requirements together with entrepreneurial aspects, medical needs and possible solutions is an important way of making information and expectations transparent and counteracting erroneous trends. This event offers a forum for information and intensive exchange of current developments, experiences and requirements including authority representatives.

The workshop is organized in collaboration with the Paul Ehrlich Institut (PEI), the German ZLG (Central Authority of the States for Health Protection Regarding Medicinal Products and Medical Devices), the German Stem Cell Network (GSCN), Health Capital – the Healthcare Industries Cluster Berlin Brandenburg and Berlin Partner.

Important note: The event language will mainly be English, while for individual questions or topic discussions a switch to german is possible.

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Confirmed speakers:

Dr. Ralf Sanzenbacher, Paul-Ehrlich-Institut, Langen, Germany
Address of welcome

Prof. Steven A. Goldman, M.D., Ph.D., Professor of Neurology and Neuroscience and co-director of the University of Rochester Medical Center, USA
„Development of advanced therapies targeting neurodegenerative diseases –where do we stand?“

Prof. Dr. med. Wolfram-Hubertus Zimmermann, Institute of Pharmacology and Toxicology, University Medical Center Göttingen
„Induced Pluripotent Stem Cell (iPSC)-Derived tissue-engineered Human Myocardium for Heart Failure Repair“

Christopher A. Bravery, Ph.D, Advanced Biologicals Ltd, London

Prof. Christopher Baum, Chair of the Berlin Institute of Health Board of Directors, Chief Translational Research Officer Charité, Berlin
„ATMP Development in Germany – Shortfalls and Future Perspectives“

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Participation fee: 220,00 €
A reduced participation fee of 50% applies to representatives of authorities.
Student participation fee: 30,00 €.

Further information: https://biotech-verbund.de