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

An event held in cooperation with the Biotechnologieverbund Berlin-Brandenburg e.V., BBB; the Paul-Ehrlich-Institut; the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices, ZLG; the German Stem Cell Network, GSCN; HealthCapital - Healthcare Industries Cluster Berlin-Brandenburg; and Berlin Partner für Wirtschaft und Technologie GmbH

 

 

Begin

08.12.2022 09:00 AM

End

08.12.2022 05:00 PM

Location

Investitionsbank des Landes Brandenburg, Babelsberger Straße 21, 14473 Potsdam

Organiser

bbb e.V., Paul-Ehrlich-Institut, German ZLG, GSCN, HealthCapital

Summary

Whether in regenerative medicine, cell therapy or gene therapy, research success stories bring innovative therapy and product concepts involving advanced therapy medicinal products (ATMPs) into focus.

The first such products have already received pharmaceutical marketing authorisations and are in clinical use, and others are on their way to reaching the same status. A large number of other product initiatives are in the early stages of development or clinical trials.

A complex and dynamic regulatory environment has concurrently emerged in this modern technological field. The importance of advanced therapy medicinal products in the field of drug development continues to grow. The significance of ATMPs was demonstrated by the positive response received from more than 150 participants who travelled to Potsdam for the on-site event.

The event served as an information platform for experts and offered a forum for the in-depth exchange of current developments, experiences and requirements. The scientific presentations focused on cell-based therapies involving induced pluripotent stem cells, which are now entering clinical trials. Several speakers shared exciting examples of these therapies. One such example was presented by the University Medical Center Göttingen, where living heart muscle transplants produced by biotechnology and used for the treatment of myocardial infarction were investigated in an initial clinical trial approved by the Paul-Ehrlich-Institut. In addition, regulatory aspects in the ATMP field were addressed, including a presentation of the European Commission's recitals on the current draft regulation on the revision of blood, tissue and cell legislation.

The next occurrence of the now firmly established event is planned for the end of 2023.

 

 

from left to right: Dr Daniel Besser, Professor Steven A. Goldman, Professor Wolfram-Hubertus Zimmermann, Professor Christopher Baum, Craig Beasley, Dr Christopher Bravery, Dr Deidre Fehily, Dr Martin Rabel, Dr Ralf Sanzenbacher, Jasna Curak Source: Biotechnologieverbund Berlin-Brandenburg e.V.


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