(subject to change)
Wednesday, 4 November 2015 | |
|---|---|
| from 12:00 | Participant Registration |
| 13:00 | Welcome Address Director of the Evangelische Akademie Tutzing |
| 13:15 | Welcome Address U. Bethke, Miltenyi Biotec GmbH, Bergisch Gladbach/D |
Challenges and perspectives of ATMP manufacturing | |
| Chair: | K. Kohler, University Hospital Tübingen/D |
| 13:20 |
KeynoteFrom manufacturing clinical trial samples towards producing commercial quantities: challenges, tools and perspectivesC. van den Bos, Mares Ltd., Greven/D |
| 14:05 | Next generation cell therapy manufacturing - Applying scalable bioreactor platforms to meet demand and quality E. Abraham, M. Mahdavi, E. McAfee, S. Jung, S. Gupta, Lonza AG, Walkersville/USA |
| 14:30 | Fully automated expansion and activation of clinical grade natural killer cells for adoptive immunotherapy M. Granzin, S. Soltenborn, S. Müller, J. Kollet, Miltenyi Biotec GmbH, Bergisch Gladbach/D; M. Berg, National Heart, Lung and Blood Institute, Bethesda/USA; A. Cerwenka, German Cancer Research Center, Heidelberg/D; R. W. Childs, National Heart, Lung and Blood Institute, Bethesda/USA; V. Huppert, Miltenyi Biotec GmbH, Bergisch Gladbach/D |
| 14:55 | CAR expressing natural killer cells for cancer retargeting R. Esser, S. Kloess, Hannover Medical School/D; W.S. Wels, Georg-Speyer-Haus, Frankfurt am Main/D; M. Morgan, J.D. Suerth, Hannover Medical School/D; M. Grez, Georg-Speyer-Haus, Frankfurt am Main/D; T. Tonn, DRK Blutspendedienst Nord-Ost, Dresden/D; W. Glienke, C. Priesner, L. Arseniev, A. Schambach, U. Köhl, Hannover Medical School/D |
| 15:20 | Coffee Break |
Gene therapeutics | |
| Chair: | R. Wagner, Rentschler Biotechnologie GmbH, Laupheim/D |
| 15:50 |
KeynoteOncolytic virus vaccine: An emerging class of ATMPsD. Holm-von Laer, Innsbruck Medical University/A |
| 16:35 | Translation of cell-based gene therapy product into clinical phase II trial U. Verzetnitsch, C. Günther, Apceth GmbH & Co. KG, Ottobrunn/D |
| 17:00 | Pre-clinical biodistribution studies for RNA therapeutics: Why, how and when? Insights from a GLP-certified service provider A. Schreieck, C. Hock, IMGM Laboratories GmbH, Martinsried/D |
Performance and monitoring of stem cells - 1 | |
| Chair: |
C. Kasper, BOKU - University of Natural Resources and Life Sciences, Vienna/A |
| 17:25 |
KeynoteOptimizing performance and quality of mesenchymal progenitors for better regeneration |
| 18:10 | End of Lecture Programme of Day 1 |
| 18:15-19:30 | Dinner |
| 19:30-20:00 | Guided Tour |
| 20:00-22.00 | Get Together |
Thursday, 5 November 2015 | |
Regulatory environment and demands - 1 | |
| Chair: | U. Bethke, Miltenyi Biotec GmbH, Bergisch Gladbach/D |
| 09:00 |
KeynotePre-clinical requirements for (gene) cell therapiesU. Kalinke, Hannover Medical School / TWINCORE GmbH, Hannover/D |
| 09:45 | Can hospital exemptions pave the way to clinic for tissue engineered products developed in university research institutions? J. Frese, RWTH Aachen University/D; M. Haubrock, Hochschule Osnbarück/D; S. Gatzer, S. Jockenhövel, RWTH Aachen University/D |
| 10:10 | Navigator - market access for individualized medicine H. Schneiderheinze, K. .J. Preuß, University of Applied Sciences Hamburg/D |
| 10:35 | Coffee Break |
Quality of raw materials - recommendations and quality assurance | |
| Chair: | A. Karau, Evonik Industries AG, Hanau/D |
| 11:15 |
KeynoteQuality of raw materials for the production of ATMPs: Ph Eur recommendationsJ. Vesterinen, Finnish Medicines Agency Fimea, Helsinki/FI |
| 12:00 | Raw materials in the manufacture of advanced therapies medicinal products: quality attributes and quality assurance B. Leistler, CellGenix GmbH, Freiburg/D |
| 12:25 | Lunch |
Regulatory environment and demands - 2 | |
| Chair: | B. Schröder, Miltenyi Biotec GmbH, Teterow/D |
| 13:45 | Environmental risk assessment for gene and cell therapy: Tips and tricks for clinical trial and market authorization applications U. Jenal, Jenal & Partners Biosafety Consulting, Rheinfelden/CH |
| 14:10 | Patterns and paradigms of EU ATMP approval and reimbursement K. Engelke, Bremen University/D and Dierks+Bohle Rechtsanwälte, Berlin/D |
| 14:35 |
Regulatory framework of lentiviral vector for CAR-T-cell transduction C. Schröder, Hochschule Albstadt-Sigmaringen/D |
| 15:00-16:45 | Coffee Break / Poster Session / Exhibition |
Issues and challenges from bench to bedsite | |
| Chair: | R. Pörtner, Hamburg University of Technology/D |
| 16:45 |
KeynoteIs the academic model for Bench-to-Bedside fit for purpose for the world of ATMPs? M.W. Lowdell, Royal Free London NHS FT & University College London/UK |
| 17:30 | End of Lecture Programme of Day 2 |
| 18:00 | Dinner |
| 19:00-20:00 | Members Assembly DECHEMA Sections Cell Culture Technology and Medical Bioechnology |
Friday, 6 November 2015 | |
Quality controls, safety studies and cell signature | |
| Chair: | U. Köhl, Hannover Medical School/D |
| 09:00 |
KeynoteQuality controls for ATMP-products in the regulatory framework: what is mandatory?I. Slaper-Cortenbach, University Medical Center Utrecht/NL |
| 09:45 | Preclinical good laboratory practice-compliant safety study to evaluate biodistribution and tumorigenicity of a cartilage therapeutic J. Lehmann, R. Schulz, Fraunhofer IZI, Leipzig/D |
| 10:10 | Cell signature for tracking of autologous transplanted stem cells K. von der Haar, A. Lavrentieva, F. Stahl, T. Scheper, Universität Hannover/D; S. Immenschuh, K. Reimers, B. Weyand, Hannover Medical School/D; C. Blume, Universität Hannover/D |
| 10:35 | Coffee Break |
Performance and monitoring of stem cells - 2 | |
| Chair: | C. Kasper, BOKU - University of Natural Resources and Life Sciences, Vienna/A |
| 11:05 | Monitoring osteogenic differentiation of MSC under dynamic culture conditions D. Egger, Universität für Bodenkultur, Wien/A; S. Nebel, K. Radl, FH Technikum, Wien/A; J. Hansmann, H. Walles, Universitätsklinikum Würzburg/D; C. Kasper, Universität für Bodenkultur, Wien/A |
| 11:30 | Raman spectroscopy as novel marker for sensitive stem cell identification in 2D and 3D cultures K. Schütze, CellTool GmbH, Bernried/D; D. Marino, S. Meyer, University Children's Hospital, Zürich/CH; H. Kremling, CellTool GmbH, Bernried/D |
| 11:55 | Closing remarks |
| 12:00 | Lunch and End of the Conference |