„The Product is the Process – Is it?“
Manufacturing and Translation of ATMPs and Tissue- & Cell-based products - save the date: 20-11-2025!
Nov. 2025|09:00 - 17:00 h
GSCN, bbb e.V., Paul Ehrlich Institut (PEI), the German ZLG, Health Capital - Cluster Healthcare Industries Berlin Brandenburg &
Berlin Partner
40 - 240 € (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)“)
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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 in the focus of interest.
Several products have achieved marketing approval and some ATMPs even reached broad clinical application. In addition, a 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.
Program:
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. Prof. Dr. Prof. Dr. Caspar Franzen, Krystal Biotech, Inc., Pittsburgh, USA
"Beremagene geperpavec: First approved topical gene therapy for dystrophic epidermolysis bullosa"
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"
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"
Stefan Gärtner, Labor L&S, Bad Bocklet, Germany
"Solutions for rapid bioburden, sterility and endotoxin testing: Update and general requirements"
Dr. Thorsten Ulf 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"
All speakers and presentation titles are confirmed, changes possible if necessary.
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