“The Product is the Process – Is it?” Manufacturing and Translation of ATMP and Tissue-& Cell-based products
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 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. Dr. Dr. Ulrike Köhl (Fraunhofer Institute for Cell Therapy and Immunology Leipzig & University Leipzig, Institute for Clinical Immunology, Germany)
CAR effector cells: Pushing the boundaries in cancer treatment and beyond
Prof. Dr. Sergio A. Quezada (Achilles Therapeutics UK Ltd and University College London, United Kingdom)
TIL immunotherapy and key targets: Where do we stand? (tbc)
Dr. Jan Spanholtz (Glycostem, Oss, The Netherlands)
Recent Advances and Challenges of NK cell therapy (tbc)
Dr. Ilona Reischl (Austrian Medicines and Medical Devices Agency (AGES MEA), EMA-CAT, Amsterdam, The Netherlands)
15 years EMA CAT: Experiences, news and trends for ATMPs
Dr. Sergio Fracchia (Cell and Gene Therapy Division Novartis, Switzerland)
CAR-T manufacturing and QC: Lessons learned and optimization opportunities
Dr. Ruth Offergeld (Robert-Koch-Institut Berlin, Germany)
Dr. Silvia Vogl (Paul-Ehrlich-Institut, Langen, Germany)
ATMP and Companion Diagnostics – Regulatory background and first experiences
Dr. Helmut Lerch (Minaris GmbH, Munich, Germany)
GMP for ATMPs – Opportunities and Challenges (tbc)
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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)“.
More information and registration please visit the event website and see the Event Flyer:
