ATMP 2015 - Issues and challenges from bench to bedside


 (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
From manufacturing clinical trial samples towards producing commercial quantities: challenges, tools and perspectives
C. 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
Oncolytic virus vaccine: An emerging class of ATMPs
D. 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


C. Kasper, BOKU - University of Natural Resources and Life Sciences, Vienna/A


Optimizing performance and quality of mesenchymal progenitors for better regeneration
M. Dominici, University of Modena and Reggio Emilia, Modena/I

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
Pre-clinical requirements for (gene) cell therapies
U. 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
Quality of raw materials for the production of ATMPs: Ph Eur  recommendations
J. 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

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

Is 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
Quality 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
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