„The Product is the Process – Is it?“ Manufacturing and Translation of ATMPs and Tissue- & Cell-based products
Whether in the fields of regenerative medicine, cell or gene therapy – driven by remarkable research success, innovative therapy and product concepts for advanced therapy medicinal products (ATMPs) are increasingly in the focus of interest.
Several products have already reached marketing approval. In addition, a multitude 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 are translated to safe and effective medicines for patients, the intensive exchange of expertise between involved stakeholders in research, clinical, industrial and 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 solutions is an important way of making information and expectations transparent and counteracting erroneous trends. This event 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.
Dr. Ralf Sanzenbacher (Paul-Ehrlich-Institut, Langen, Germany)
Address of welcome
Prof. Steven A. Goldman (University of Rochester Medical Center, USA)
„Development of advanced therapies targeting neurodegenerative diseases –where do we stand?“
Prof. Wolfram-Hubertus Zimmermann (Institute of Pharmacology and Toxicology, University Medical Center Göttingen, Germany)
„Induced Pluripotent Stem Cell (iPSC)-derived tissue-engineered human myocardium for heart failure repair“
Craig Beasley, Bluerock Therapeutics, Cambridge, USA
„Key Aspects on CMC development, qualification and life cycle management of stem cell banking systems in a GMP context“
Dr. Martin Rabel (Precision NanoSystems Inc, Vancouver Canada)
„Formulation of ATMPs: Lipid Nanoparticles and nano-based drug delivery systems“
Deirdre Fehily PhD (DG Santé, European Commission, Brussels, Belgium)
„EC Revision of the EU legislation on blood, tissues and cells“
Prof. Christopher Baum (Berlin Institute of Health/ Charité, Berlin, Germany)
„ATMP Development in Germany – Shortfalls and Future Perspectives“
Jasna Curak (Hoffmann-La Roche Ltd., Mississauga, Canada)
„CMC requirements: Comparison of EMA, US-FDA and PIC/S ATMP guidance from a global stakeholder´s perspective“
Dr. Christopher Bravery (Advanced Biologics Ltd,, London, United Kingdom)
„Quality control of ATMP: Potency assays revisited“
Participation fee: 220,00 €
A reduced participation fee of 50% applies to representatives of authorities. Please indicate your authority under „Remarks (Anmerkungen)“.
Student participation fee: 30,00 €. Please indicate your matriculation number under „Remarks (Anmerkungen)“.
Download Program: ATMP_Flyer_web