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

30.11.2023 | 09:00 - 17:00
Investitionsbank des Landes Brandenburg (ILB), Potsdam, Babelsberger Str. 21, 14473 Potsdam
bbb e.V., Paul Ehrlich Institut (PEI), the German ZLG, the German Stem Cell Network (GSCN), HealthCapital - Cluster Healthcare Industries Berlin Brandenburg & Berlin Partner
40 - 230 €

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 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.



Confirmed speakers:

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

Prof. Dr. Marina Cavazzana (Necker-Enfants Malades Hospital/Institut Imagine, Paris, France)
Cell and gene therapy for inherited and acquired disease of the hematopoietic system

Prof. Dr. Roland Meisel (Universitätsklinikum Düsseldorf, Germany)
Current results with first-in-class stem cell genome editing for treatment of hemoglobinopathies

Dr. Matthias Renner (Paul-Ehrlich-Institut, Langen, Germany)
Regulatory trends and news in gene therapy

Dr. Martin Schleef (Plasmid Factory, Bielefeld, Germany)
High grade Plasmid and Minicircle DNA for gene therapy: Key manufacturing and control settings

Dr. Matthias Wilken (Federal Association of the Pharmaceutical Industry e.V., Berlin, Germany)
EU Pharm Revision and impact on ATMPs

Prof. Dr. Heiko von der Leyen (Orgenesesis Inc, USA)
Decentralized Manufacturing: New POCare Strategies for ATMPs

PD Dr. Sabine Hünecke (Universitätsklinikum Frankfurt/Main, Germany)
Flow cytometry-based QC of cell-based products: Development and validation of assays

Dr. Liam Childs (Paul-Ehrlich-Institut, Langen, Germany)
How AI will impact regulatory processes


Participation fee: 230,00 €
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)“.