The Berlin-Leipzig Model

Transcription

1 The Berlin-Leipzig Model

2 Regenerative Medicine Germany In 2006, the German Ministry of Research and Education (BMBF) has established two Centres charged with the translation of RegMed Therapies. Lübeck Rostock Each Centre has an attracted a budget of 40 Mio for 2007 to 2010 and manages and grants own awards for investigator initiated therapy concepts and for young investigators. Münster Düsseldorf Köln Bonn Aachen Hannover Gatersleben Leipzig Halle Berlin Dresden Frankfurt Berlin is charged with clinical research, Leipzig with pre-clinical translation and technology and model development Mainz Straßburg Würzburg Stuttgart Ulm Regensburg Krems

3 BCRT Research Areas

4 TRM-Leipzig Research Areas TEMAT Tissue engineering and materials science CELLT Cell therapies for repair and replacement REMOD Regulatory molecules and delivery systems implants bioreactors immunology cell therapy drug delivery systems molecule design surface modification transplantation endogenous regeneration gene expression REPLACE REPAIR RENEW IMONIT Imaging, modelling and monitoring of regeneration modelling biosensor molecular imaging RECONNAISSANCE

5 The Centres Challenges Translation of basic discoveries into clinical applications including scientific validation of experimental results Researchers with the mindset and skills necessary for translational medicine Overcoming the translational gap Institutional partnership and common strategies for translation Long term sustainable funding & business development

6 The Translational Gap Anna Krassows, European Stem Cell and RegMed Congress, London, May 2007

7 The Translational Gap Challenge already addressed for Germany by the BMBF in establishing and funding the two Translational Centres BMBF DFG

8 Berlin - Leipzig Model Ethical & legal implications Reimbursment issues & Business Development BCRT TRM Funding of innovative high risk Therapy Concepts GxP Staff Development Programmes Funding of Investigator Initiated Clinical Studies GCP Applied Cell Biology GMP facility Model development and pre-clinical studies (QM, GLP, TOX, ISO9001, ISO ) Approx. 2 Mio p.a. Therapy Commercialisation Conceptual Pre-clinical Clinical Services offered to biotech and academic partners

9 Steps to go Practical steps for translation from discovery to the clinic Quality of experimental data Define, control and validat e Animal models Toxicology Tumour development Bio-distribution provide strong proof of concept pathology of animal models is key major safety concern Imaging of who - where - when?

10 Key EU proposal on the translation of (stem) cell products

11 Key FDA guidance on translation of (stem) cell products

12 The Fona L2L Health Economics POSTER Potential of Regenerative Therapies for Sustainable Health Care Integration of Health Economic Analysis in Pre-clinical and Clinical Research Tobias Mahn Interpretation of the ICER: The lower the ICER the more efficient the treatment A in comparison to the treatment B

13 The Fona L2L Staff Development POSTER Education and Staff Development (ESD) Programme - The Principle of Interdisciplinary Transfer of Knowledge in Translational Research Doreen Karl The main defect of the German university system is that it is top heavy. Full professors are endowed with veritable kingdoms of power and privilege, whereas most young researchers and PhD students suffer ridiculously subordinate and dependent conditions the exceptions only prove the rule. Young scientists who struggle through the system, usually on half-time contracts but expected to act as workhorses, risk ending up at 40 knocking on closed doors where, all too often,the academic appointment plans set up by state officials, not by the universities make no provision to employ them. Editorial, Nature 427(2004): p.271 Meet your typical German Scientist: PhD with 29, junior group leader with 34, professor with 42 MSc PhD PostDoc Independent Research Group or Junior Professor a b RSA TRT JRT a. average age; b. years after doctorate; Data obtained from the German Ministry of Education and Research, BMBF (2004) First Professorship

14 The Fona Implementing Diversity POSTER Equity & Diversity in a New Translational Research Centre Institutional concepts and policies in a research environment Audrey Braun male 60.40% female 39.60% Addressing Elements of Work-Life-Balance Potential Barriers TRM-Leipzig Approach n = 101 Hours & Location Often work hours in conflict with operating hours of child care facilities Timing of research does not coincide with regular business hours Location and distance of child care providers to research facility can impact schedules Culture Lack of diversity in scientific discipline High level of drop out rates of female scientist programs Institutional Support Lack of diversity awareness, career opportunities, child care, and psycho-social support Prolonged family leave Hours & Location Extended operating hours and evening, weekend, and overnight care for children in child care centre that is partnered with the TRM-Leipzig Emergency child care support Child care facility is located near the central facilities of the Centre Flexible working hours and for events planned outside of normal operating hours, additional child care can be provided Culture Implementation of diversity programmes (gender mainstreaming, gender competency, targeted recruiting) Annual reporting and monitoring of diversity plan Institutional Support Gender awareness, professional training, networking, job search, mentoring Access to Career counselling and external career advancement programs (ELiSA, Arbeitsamt) Maintenance of communication while on family leave

15 October 2007 Leipzig

16 Thank You Sonya Faber, RegMedNet Leipzig - Halle Joeri Borstlap, B-CRT Berlin - Brandenburg Jan Matthias Braun, TRM-Leipzig