Center for Translational Molecular Medicine

Transcription

1 Center for Translational Molecular Medicine A Dutch Partnership Innovating Healthcare Hans Hofstraat Acting Director CTMM 1 - Business Plan

2 Translational Molecular Medicine 2 -

3 Molecular Medicine Supported by a growing Clinical Research program Molecular imaging, diagnostics & therapy will transform clinical practices and improve patient outcomes through earlier detection, and personalized treatment 3-24

4 Could we find the disease real early? Organ level Tissue level Cellular level Molecular level Detection, Tumor burden Angiogenesis Growth kinetics Drug delivery Tumor markers Drug targeting From symptomatic to preventive medicine Genetic mutations Biomarker testing Gene therapy 4 -

5 Diagnostic Imaging: Today now Diagnose past what happened Molecular Imaging: Tomorrow now Predict future what will happen and prevent 5 -

6 Molecular Medicine: Earlier diagnosis More effective, less-invasive, personalized, therapy Tailored after-care Based on high-tech technology platforms Translational Molecular Medicine: Generating fundamental know-how and translating it into clinical applications 6 - Bench-to-Bedside

7 Translational Medicine: From Bench to Bedside Realizing the Care Cycle through Open Innovation The Care Cycle: Focus on Disease Diagnostics Information & Decision Support Treatment Follow Up Translation: From principle to clinical proof of concept, First in Man 7 -

8 Translational Medicine: From Bench to Bedside Realizing the Care Cycle through Open Innovation The Care Cycle: Focus on Disease Information & Decision Support Treatment Diagnostics Follow Up Innovation throughout the Care Cycle requires Technology developed hand in hand with clinicians Technology developed in partnership between medical technology, pharma, chemistry and IT companies A multidisciplinary approach: from science, engineering, industrialization, regulatory activities and clinical tests, to healthcare economics, reimbursement, 8 -

9 From the Business Plan What is the CTMM? 9 -

10 Ambition of CTMM Technology Medicine The CTMM strives to become a leading European scientific, technological and clinical institute, within the area of Molecular Medicine CTMM Objectives Become a leading European Molecular Diagnostics & Imaging Center Establish and maintain scientific, technological and clinical excellence With an ambition to exist beyond 5 years (15-20 years) With clear visibility With active participation of private partners (also in kind ) Driving entrepreneurial activities Boasting cost-effective healthcare 10 -

11 How to realize these ambitions? By bringing together excellent partners from public and private organizations in multidisciplinary projects, with a clear translational drive By concentration and focusing, e.g. at the University Medical Centers for clinical research, at technology centers for medical technology research, providing IT infrastructure to be shared by all projects, etc., With excellent partners, sharing the vision! 11 -

12 Benefits of CTMM Society & Healthcare Higher lifetime expectancy Increased quality of life, Less side effects in therapy Cost containment Economy Large opportunities for Dutch-based existing and new industry Attraction of foreign companies and investors Global impact Knowledge Infrastructure Critical mass and infrastructure for research in exciting field Focus and drive to stimulate world-class research Strengthening of education for research and application Innovation Policy Providing an excellent position for the Netherlands in a future-proof knowledge-intensive application area 12 -

13 The Consortium: Comprehensive and of High Quality Public partners Excellent, world-renowned research groups in (translational) medicine, in fundamental biology and in technology Private partners Global top-players in medical technology and instrumentation Leading and ambitious companies in pharma, materials, IT Enthusiastic and promising SME s in molecular medicine Patient groups National organizations in all major disease area s (cardiovascular, oncology, neurodegenerative) ensure commitment of and links to the patient groups Insurers The leading national health insurance company will participate, and make sure that solutions can be implemented with the government (e.g., Medical Technology Assessments ) ~45 parties have signed LoI s or LoS s 13 -

14 EUR 25 m < EUR 15 m Growing Public & Private Support! Public Partners Academic Medical Centers (Technical) Universities Research Institutes < EUR 5 m Private Partners Medical Technology Pharma Chemistry Diagnostics Instrumentation IT CRO s Food Patient Organizations 14 -

15 From the Business Plan Status and Organization 15 -

16 CTMM working group prof. dr. F.P.T. Baaijens Technische Universiteit Eindhoven prof. dr. P.J.E.H.M. Kitslaar Academisch Ziekenhuis Maastricht drs. H. van den Berg Organon prof. dr. A.J.M. Berns Nederlands Kankerinstituut prof. dr. M.J.A.P. Daemen Universiteit Maastricht dr. R.H.J. Fastenau FEI Company prof. dr. J.W. Hofstraat Philips prof. dr. B. Löwenberg Erasmus Medisch Centrum prof. dr. H.M. Pinedo Vrije Universiteit Medisch Centrum prof. dr. Ph. Scheltens Vrije Universiteit Medisch Centrum dr. E.G.J. Staring DSM prof. dr. E.G.E. de Vries Universitair Medisch Centrum Groningen 16 -

17 CTMM working group Executive Board a.i. prof. dr. F.P.T. Baaijens Technische Universiteit Eindhoven prof. dr. P.J.E.H.M. Kitslaar Academisch Ziekenhuis Maastricht drs. H. van den Berg Organon prof. dr. A.J.M. Berns Nederlands Kankerinstituut prof. dr. M.J.A.P. Daemen Universiteit Maastricht dr. R.H.J. Fastenau FEI Company prof. dr. J.W. Hofstraat Philips prof. dr. B. Löwenberg Erasmus Medisch Centrum prof. dr. H.M. Pinedo Vrije Universiteit Medisch Centrum prof. dr. Ph. Scheltens Vrije Universiteit Medisch Centrum dr. E.G.J. Staring DSM prof. dr. E.G.E. de Vries Universitair Medisch Centrum Groningen 17 -

18 From the Dutch budget 18 - Centre for Translational Molecular Medicine Het Centre for Translational Molecular Medicine heeft als doel om (inter)nationaal een leidende rol te spelen in de ontwikkeling van molecular diagnostics en molecular imaging technologieën. Deze ontwikkelingen dienen predispositie, vroegtijdige diagnose en gepersonaliseerde behandeling van patiënten mogelijk te maken. Van de 150 mln bijdrage wordt 75 mln gereserveerd op het artikel Projecten in voorbereiding. Om deze reservering vrij te maken zal het penvoerende departement (EZ) vóór 1 januari 2008 aan de CWTI inzicht moeten bieden of het voorstel na aanvang goed uit de startblokken is gekomen en wat de omvang van benodigde extra middelen is. Per 1 januari 2009 zal opnieuw de balans worden opgemaakt. Bij een gunstige uitkomst ligt een aanvullende bijdrage tot het gevraagde bedrag uit het Fes ( 200 mln.) in de rede.

19 Initial tasks for CTMM organization Preparation of information for the Government (acting through Ministry of Economic Affairs), to establish formal organization Within the framework of IOP-TTI (Technological Top Institute) Preparation of CTMM program: preliminary call for proposals Establishing Foundation CTMM: structure and organization 19 -

20 CTMM Headquarters at High Tech Campus Eindhoven RF T&M lab Thin Film Microsystems Materials Analysis Life Sciences Facilities + HQ CTMM Photonics lab Reliability Centre Prototyping & Asssembly lab Part of CTMM (& Philips Healthcare Research) 20 - part of Philips Research & involved in Healthcare research

21 Communication Website with actual information Direct Mail Newsletters Communication plan in preparation Please make sure your contact information is available!!! 21 -

22 Organization and Governance Professional organization 22 -

23 Status IP Starting Point IP regulations TI Pharma Evaluation by IP Working Group Suitability for CTMM? IP Working Group prepares proposal, to be discussed with authorized representatives of CTMM partners 23 -

24 Status IP Starting Point IP regulations TI Pharma Evaluation by IP Working Group Suitability for CTMM? Participants: Maaike van Velzen (Philips) Chair Bob Smailes, Raoul Linschoten NFU representation Joop van Helvoort (Flexgen) Gerard Verschuren (TU/e) IP Working Group prepares proposal, to be discussed with authorized representatives of CTMM partners: Representatives NFU, VSNU Representatives large companies Representatives SME s Representatives institutes Observer SenterNovem 24 -

25 Intellectual Property Rights (Business Plan) IP ownership and access rights tailored to each project, to be arranged between the participating parties within a basic framework Basic framework Universities and research institutes will have a license under all foreground IP for internal research and education Industrial partners that participate in a project will have options to obtain exclusive access to foreground IP Industrial partners will compensate the other contributors to a project for commercial use of foreground IP Background IP may be licensed on a non-exclusive basis in return for compensation 25 -

26 Knowledge Transfer (Business Plan) Public and private partners will mutually contribute to the projects Active participation of industry in the projects ensures effective commercialization and clinical application of the results Exchange of researchers between industrial R&D laboratories, academic research departments and clinical sites will be actively encouraged All knowledge generated will be shared with peers outside the consortium as quickly as possible Academic compliance (e.g., publication of negative results) will be secured 26 -

27 From the Business Plan Research program 27 - Business Plan

28 The Research Program: Key concepts of Molecular Medicine 28 -

29 The Research Program: Focus on disease and translation Technology is enabler: technology platforms 29 -

30 The Research Program: How are we going to achieve these goals? Program will be defined by a portfolio of projects 30 -

31 Projects: Defining the Program Program will be defined by portfolio of projects Projects will be carefully selected, in an open tender procedure, and comprise public and private partners External, international, peer reviewers will be used Criteria: top-quality of research (verified through external peer review); fit within one of the four programs; technology-platform based; translational character: bench-to-bedside; clinical and economic value creating potential; complementarity to ongoing projects; quid-pro-quo funding by academia and industry; expected to be cost-effective ( MTA ). 31 -

32 Participation of non-dutch companies CTMM is an initiative supported by the Dutch Government, with an ambition to strengthen the Dutch knowledge infrastructure and the Dutch economy Therefore: CTMM will support public and private research carried out in the Netherlands CTMM will build Molecular Medicine infrastructure in the Netherlands CTMM will strive to have a positive impact on the Dutch economy Eligible for support are: Dutch academia and research institutes Dutch companies Non-Dutch companies with research activities in the Netherlands Exception may be made for (minor) participation of non-dutch public or private partners to CTMM projects, provided that their participation is essential for the project and supports the overall ambitions of CTMM 32 -

33 MTA: Key to Assess the (Cost) Effectiveness! From the Business Plan: 33 -

34 Execution of selected projects Agreements will be made between parties participating in the projects, maximizing translation and exploitation potential Project teams will be given autonomy to organize themselves within the boundaries of the project proposals agreed upon, and within the project agreements Progress will be monitored by Program Committees against pre-defined and agreed milestones Progress will be annually reviewed by the Executive Board A mid-term review will be organized for every project; an external expert may be involved Projects may be terminated as a result of the reviews, e.g., if they have moved outside the scope of CTMM, or if quality or progress is poor 34 -

35 Financial considerations High risk research, impact foreseen ~10 years from now Pre-competitive projects, starting with early, fundamental-stage research Big research expenses follow after proof-of-concept Aim of CTMM is to provide the proof, prepare for a successful follow-up financed by private partners (industry/start-up s) Have infrastructure available to create optimal conditions for this follow-up in the Netherlands Dutch healthcare system profits directly from developments (projected cost saving EUR 1 b/yr in ~2016) Truly P-P-P model and financial structure ( 1:1:2 ) CTMM profits from other investments in infrastructure, e.g. Through NGI (e.g., Proteomics Center) At UMC s (e.g., high-field MRI) By Philips at High Tech Campus and will invest in infrastructure as well (e.g., IT) 35 -

36 Preliminary Call for Proposals: Goal and Contents Goal: Inventory of project ideas Improving/focusing the research program Advising the proposers Getting insight into infrastructure needs NO PRE-SELECTION 36 - Contents: Survey of relevant information refering to the Business Plan Considering the 8 criteria ALL important! Partnership Scientific excellence, Companies/SME, Technology Budget range 8-20 M Euro TTI rules, will be published on the CTMM Website Max 6 A4

37 Preliminary Call for Proposals: Timeline Preliminary Call distributed 22-12, in consultation with EZ/SenterNovem Networking meeting 31 January 2007 Deadline 28 February 2007 Feedback to proposers end of March 2007 Call for Proposals: April 2007 (if approved by EZ) Evaluation September/October 2007 Start November

38 Preliminary Call for Proposals: Support actions Contact to the field January 31, 2007 Aims: Give information on status and progress Increase involvement of: SME, other companies University groups (particularly technological!) Answer questions Get feedback/suggestions 38 -

39 Conclusions 39 -

40 Center for Translational Molecular Medicine Bridging the knowledge gap Molecular Medicine: A paradigm shift in healthcare Enabled by science and technology Driven by clinical applications A public-private partnership initiative, bringing together excellent researchers throughout the Netherlands Universities and University Medical Centers Medical Technology, Pharma, Chemical & IT companies, Instrumentation, Molecular Diagnostics ventures Matched by the Dutch government with upto 200 MEuro Involvement of patient organizations, government, insurers,. With global connections & ambitions 40 -

41 Executive Board a.i. Distribution of Tasks prof. dr. F.P.T. Baaijens Technische Universiteit Eindhoven Technologies Organization C.P. van der Plasse, MBA Dr P.J. van der Zaag drs. H. van den Berg Organon prof. dr. M.J.A.P. Daemen Universiteit Maastricht prof. dr. J.W. Hofstraat Philips prof. dr. B. Löwenberg Erasmus Medisch Centrum Pharma/Chemistry Cardiovascular Diseases General information/technology Oncological Diseases prof. dr. Ph. Scheltens Vrije Universiteit Medisch Centrum Neurodegenerative Diseases 41 -

42 Center for Translational Molecular Medicine AGENDA 13:30 Welcome & Introduction 14:00 Networking Market 17:00 Drinks 18:00 Close 15:00 Tour of LifeSciences Facilities 42 - HTC Eindhoven January 31, 2007 Business Plan

43 Floor plan: Where do you find what Cardiovascular COMPANIES I+A Oncology Current position 43 - CTMM networking day

44 CTMM will strive to make efficient use of existing infrastructure at partners e.g.: Life Science HTC Eindhoven: A unique > 2000m 2 flexible infrastructure for R&D programs in the area of Molecular Medicine, 44 -