“The Product is the Process – Is it?” Manufacturing and Translation of ATMP and Tissue-& Cell-based products
Whether in regenerative medicine, cell or gene therapy – driven by remarkable research and clinical success, innovative therapy and product concepts for advanced therapy medicinal products (ATMPs) are increasingly in the focus of interest.
Several products have meanwhile achieved marketing approval and some ATMPs even reached broad clinical application. In addition, another multitude of 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 can be translated to safe and effective medicines for patients, the intensive exchange of expertise between involved stakeholders in research, clinical, industrial as well as 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 technical solutions is an important way of making information and expectations transparent and counteracting erroneous trends. This symposium offers a forum for information and intensive exchange of current developments, experiences and requirements including authority representatives.
The symposium 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 be English, while for individual questions or topic discussions a switch to german is possible.
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20 November 2025, 9.00 -17.00 h, Investitionsbank des Landes Brandenburg (ILB), Potsdam
Programme and Speakers
Dr. Ralf Sanzenbacher, Paul-Ehrlich-Institut, Langen, Germany
„Welcome address“
Prof. Dr. Heiko Lickert, Helmholtz Zentrum Munich and Technical University Munich, Germany
„Beta cell replacement therapies for Diabetes: Where do we stand?“
Prof. Dr. Caspar Franzen, Krystal Biotech, Pittsburgh, USA
„Beremagene geperpavec: First approved topical gene therapy for dystrophic epidermolysis bullosa“
Discussion
Coffee Break
Janina Hahnloser / Dr. Irina Bosman, German Ministry of Health, Berlin, Germany
„SoHO and Implementation in Germany: Update and Perspective“
Dr. Bernd Schröder, Miltenyi Biotec B.V. & Co. KG, Bergisch-Gladbach, Germany
„Decentralized ATMP manufacturing: Opportunities and challenges“
Discussion
Lunch Break
Prof. Dr. Markus Mäurer, Champalimaud Foundation and Botton-Champalimaud Pancreatic Cancer Center, Lisboa Portugal / Johannes Gutenberg University of Mainz
„TIL-based cancer therapy and state of the art manufacturing of TILs“
Dr. Hans-Georg Eckert, Valicare GmbH, Frankfurt/Main, Germany
GMP Manufacturing of Cell and Gene Therapy Drugs at Point of Care – Suitable Facility „Concepts and Scalable Solutions“
Discussion
Coffee Break
Stefan Gärtner, Labor L&S, Bad Bocklet, Germany
„Solutions for rapid bioburden, sterility and endotoxin testing: Update and general requirements“
Dr. Thorsten Meyer, Granzer Regulatory Consulting & Services GmbH, Munich, Germany
„Comparison of interactions and submission pathways for ATMP in the US and EU: From pre-IND to marketing application“
Discussion
Résumé and End of Symposium
All speakers and presentation titles are confirmed.
Speakers, presentation titles and speaker sequence are final, nevertheless may be subject to change if necessary.
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Participation fee: 240,00 €
A reduced participation fee of 50% applies to representatives of authorities. Please indicate your authority under „Remarks (Anmerkungen)“.
Student participation fee: 40,00 €. Please indicate your matriculation number under „Remarks (Anmerkungen)“.