www.crp-sante.lu luxembourg biohealth initiatives dr. jean-claude schmit, md, phd ceo, centre de...

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www.crp- sante.lu Luxembourg BioHealth Initiatives Dr. Jean-Claude Schmit, MD, PhD CEO, Centre de Recherche Public de la Santé (CRP-Santé) President, Integrated BioBank of Luxembourg (IBBL) Prague, RDI Day, 19 October 2009

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www.crp-sante.lu

Luxembourg BioHealth Initiatives

Dr. Jean-Claude Schmit, MD, PhDCEO, Centre de Recherche Public de la Santé (CRP-Santé)President, Integrated BioBank of Luxembourg (IBBL)

Prague, RDI Day, 19 October 2009

www.crp-sante.lu

Luxembourg Public Research Landscapein BioHealth

CRP-Santé(250)

Laboratory researchPublic health

Clinical research

Santec (Tudor)(25)

IT & health

EVA (Lippmann)Environment

Life sciences (uni.lu)

(80)

IBBL(5→70)

BiobankingCryopreservation

LCSB(2→250)

First wave (before 1990) Second wave(2003)

Third wave (now)

LNS/NHL

HospitalsPPM Lung cancer

www.crp-sante.lu

How did we get there? Why the third wave ?

• Biotech SWOT analysis 2005/2006• Health expenditures average 9% of GDP in OECD

countries• Health technologies action plan (2007):

- leverage existing core competences (research and industrial)

- capitalize on Luxembourg’s competitive advantages (central location, international setting,

rewarding fiscal environment, dense research network in greater region)

• Particular focus on medical devices

www.crp-sante.lu

Challenges

• Companies need to cooperate with research institutions in order to fuel the innovation cycle

• Start-ups or companies that relocate need access to specific incubation spaces

• Access to financing via dedicated VC funds is crucial:

Need to strengthen both volume and quality of research efforts, and link these to economic development

Need to concentrate in some core areas of excellence (OECD review of Luxembourg’s innovation system, 2006)

www.crp-sante.lu

Process agreed upon by Government

• Targeted search for potential strategic partnerships in the United States in the focus area of molecular diagnostics

• Vision:– To establish a research enterprise in the health sciences and

technologies and make it grow– To attract talents– To connect research with healthcare– To improve the quality and the efficiency of the health care

system– To spin off and retain for-profit companies– And therewith to also create employment and foster economic

diversification

www.crp-sante.lu

Underlying change of paradigm: the shift from traditional to « personalised medicine »

• Today: trial-and-error method!

• Tomorrow: The right drug, for the right person, at the right moment, at a right dosis

• Personalized medicine is based on molecular diagnostics and requires access to high-quality biological samples (tissue, blood, sputum, etc.)

www.crp-sante.lu

Three complementary projects

• Creation of a Luxembourg Biobank (with TGen, Phoenix Arizona), as an engine to attract and fuel research initiatives

• Strategic research partnership between the University of Luxembourg and the Institute for Systems Biology (Seattle)

• Lung cancer research project of CRP-Santé with the « Partnership for Personalized Medicine - PPM» (Phoenix)

www.crp-sante.lu

IBBL a key infrastructure

Sample collectionAnd analysis R&D New commercialization

Health Careapplications

ISB (L. Hood) Discovery Project

PPM (L. Hartwell) Demonstration Project

CROs

Luxembourg research teamsEuropean / international research teams

Commercial ventures

HospitalsCRP Santé &

Local research capabilitiesCommercial ventures

Integrated BioBank of Luxembourg

Sample (patient / non-patient) collection and processing Sample tracking and distribution Information collection and analysis

Patient

www.crp-sante.lu

Integrated Biobank of Luxembourg

INTEGRATED BIOBANK

OF LUXEMBOURG (IBBL)

BIOREPOSITORY

INFORMATION

MANAGEMENT CENTER

· Biospecimen Reciept

· Biospecimen Storage

· Biospecimen Redistribution

BIOREFINERY(Sample Processing: DNA, RNA, Proteins)

· Analyte Production· Tissue Microarray· Protein Extraction

IBBL / TGEN TECHNOLOGY

CENTER (ITTC)(Mature Technologies)

DNA

RNA

· DNA Sequencing· Copy Number· SNP Profiling

· Gene Expression· Microarray

Distributed Technology Resource in Luxembourg

DNA

Protein

RNA

· Copy Number· SNP Profiling· Sequencing

· Gene Expression· Epigenomics· siRNA

· Proteomics· TMAs

LNS: Pathology

LuxembourgResearch Centers

LuxembourgUniversity

Biospecimens

DataData

Clinical Information

DNA,RNA,Protein

Biospecimens

Patient

Samples

1. Compliance2. Consent3. Archived Resources4. Prospective Cohorts5. Standards of

Procedure / QC6. Outreach & Education

OFFICE FORREGULATORY COMPLIANCE

AND ADMINISTRATION

InternationalHealthcare Providers

LuxembourgHealthcare System

ISB Project 2 with University and CRPs G.

Lippmann and H. Tudor

International Research& Collaborations

PPM Project with Dr. Hartwell, Dr.

Berchem and CRP Santé

ISB Project 1 with University and CRPs

Santé and H. Tudor

www.crp-sante.lu

– Is a nation-wide project, supported by Luxembourg research

institutions, hospitals and foreign scientists– Is an independent entity financed by government (60 Mio Euros

over 5 years)– Will be built in partnership with international recognised

scientists and cover specific research targets– Will support basic-/clinical research and facilitate links to

downstream commercial applications• access to samples/data by public and private research (as

consented by donor)• clear IP regulations to facilitate cooperation

IBBL is not a “stand-alone” project. It will integrate specific requests of present and future research projects.

IBBL’s unique features

www.crp-sante.lu

Leading scientist shaping the Biobank project

• Dr. Jeffrey M. Trent, PhD• President and Scientific Director of T-Gen (Translational Genomics Research Institute)• Dr. Trent has worked during 10 years within the National Institutes of Health where he has founded and managed the laboratory charged to coordinate and finalize the Human Genome Project• Before his tenure at the NIH, Dr. Trent has been professor at the University of Michigan, where he was the head of the “comprehensive cancer center”

www.crp-sante.lu

Possible collaborations ?

• IBBL has European / international ambitions

• IBBL is looking for partners for sample collection (+ is open for customised collections based on specific needs)

• IBBL is looking for partners for biopreservation research (sample collection/storage, biorefinery, next generation analysis technology)

• IBBL is a sample provider for public and private research institutions, this includes pharma and biotech companies (selection criteria = scientific value of proposal)

www.crp-sante.lu

www.crp-sante.lu

III.Integrated Diagnostic Inc.

I.Personalized Genome

Project

II.Blood Organ Fingerprint

Project

Seattle Luxembourg

II.

I.

III.

Year 1 Year 2 Year 3 Year 4 Year 5

Luxembourg/ISB Strategic Partnership

www.crp-sante.lu

Systems Biology: 21st century science

Systems biology is the study of an organism, viewed as an integrated and interacting network (bioinformatics) of genes (genomics), proteins (proteomics) and biochemical reactions (metabolomics) which give rise to life. Instead of analyzing individual components or aspects of the organism, such as sugar metabolism or a cell nucleus, systems biologists focus on all the components and the interactions among them, all as part of one system. These interactions are ultimately responsible for an organism´s form and functions.

www.crp-sante.lu

ISB-University projects: Objectives

– Providing a focus and a vision for biological research in Luxembourg

– Ambitious research projects to drive innovation– Intensive training programs and knowledge transfer– Developing a systems biology framework for

personalized medicine– Creating the framework for new economic activity

by setting up the environment for biotechnological research

www.crp-sante.lu

Luxembourg Center for Systems BioMedicine(LCSB)

• Interdisciplinary Center (IC) of University– Overarching topic: systems biology of inflammation– Thematic focus: neurodegenerative diseases (others to come)– Bioinformatics and advanced mouse models (pre-clinical) to be developed

at LCSB• National collaborations

– Genomics (Microarray – CRP-Santé / Next generation sequencing - IBBL)

– Clinical Proteomics & Metabolomics (Joint unit CRP-Santé and University)– Clinical investigation center (CRP-Santé)

• International collaborations (ESFRI structures)– BBMRI (via IBBL), ECRIN (via CRP-Santé), EATRIS & ELIXIR (via LCSB)

www.crp-sante.lu

Dr Lee Hood - Biography• Work– National Cancer Institute National Institutes of Health 67-70 (Senior Investigator)– Caltech-Biology 70-92 (Professor 70-92 and Chairman--80-90)– Molecular Biotechnology-UW-92-2000 (Founder and Chairman)-first cross-

disciplinary biology department– Institute for Systems Biology--2000-present (Co-founder and President)-first systems

biology institute

• Founder and director– Founder and director Caltech Microchemical Facility 82-92– Founder and director NSF Science and Technology Center 89-2000– Founder and director Megabase DNA Sequencing Center 96-2003– Co-founder and co-director NanoSystems Biology Alliance (Caltech and UCLA) 2003

to present– Co-founder and director Systems Biology Center 2006-present

• Founder or co-founder-start up companies– Founded or co-founded 14 companies, including Amgen, Applied Biosystems Darwin,

Rosetta and the Accelerator

www.crp-sante.lu

Possible collaborations ?

• To be defined

• Diagnostic companies wishing to develop research results (mainly neurodegenerative diseases)

www.crp-sante.lu

Partnership for Personalized Medicine (PPM)Lung Cancer project

Rational behind PPM projects:

Define new diagnostics for a specific disease in a timeframe of 3-5 years with the goal of improving treatment and reduce costs

Define the disease conjointly with partners (demonstration projects)

Test locally the new diagnostic and prove its capacity to diagnose the disease

Supervise the patient’s evolution in order to prove the health-enhancing and costs reductions of the treatment

www.crp-sante.lu

Choice of Disease Focus

Lung Cancer Project:

– Approximately 180 deaths per year in Luxembourg– Approximately 200 newly diagnosed cases per year

40% exhibit metastasis that have a median survival time of 8 months 30% exhibit ganglial metastasis that have a median survival time of 18

months 30% are operable with an median survival time of 3 years Only 8%-15% of all lung cancer patients survive 5 years or more

– Lung Cancer is at present an almost incurable disease– Without a method for improved screening and early

detection, it will be difficult to improve lung cancer survival rates

www.crp-sante.lu

The PPM process

www.crp-sante.lu

Project Lung Cancer: Partnership

• US Institutions:

• Fred Hutchinson Cancer Research Center, Seattle

•The Biodesign Institute at Arizona State University, Phoenix

•The Translational Genomics Research Institute , Phoenix

•Luxembourg Institutions:

• CRP-Santé• The National Health Laboratory

• Social Security• Central Service for Statistics and Economic Studies (STATEC)

www.crp-sante.lu

Page 24

Dr. Lee Hartwell - Biography

• President and director, Fred Hutchinson Cancer Research Center, Seattle (2700 researchers)

• Professor of genome sciences and adjunct professor of medicine, University of Washington School of Medicine

• American Cancer Society Research Professor of Genetics

• Nobel Prize in 2001 in Medicine for his discoveries of the mechanisms of cells division.

www.crp-sante.lu

Possible collaborations ?

• Luxembourg aims at setting up, as a complement to the PPM Lung Cancer project, an international network of clinical trial sites for Lung Cancer (TGen has done a similar effort for Pancreatic Cancer)

www.crp-sante.lu

Expected ROIs for Luxembourg

Research Ability to attract top scientists and ramp

up existing research programs

Leverage existing competencies

Strong contributions to the education and health care systems.

Health care and research are mutually reinforcing.

Contain health-care costs upstream through personalized therapies and preventive medicine (diagnostics)

A cutting-edge research enterprise facilitates the recruitment of world-class physicians.

Health care

Education

Economy

Research and Education are key assets to attract foreing companies

Existing sectors (IT, logistics) can immediately benefit from the development of research activities

Business failures are less of an issue if the research environment can continuously generate spin-offs and “recycle” both personnel and IP

Provide a well-educated workforce to support both economic and research activities

Create new training / education programs to support research and health care.

www.crp-sante.lu

Why now and why Luxembourg?

• Personalized medicine is not a new concept, but the technological breakthroughs which make the vision possible are very recent:

First mover advantage for Luxembourg• Luxembourg’s research institutions are relatively young. They still lack critical mass and international visibility but in the meantime structures are less sclerotic:

Opportunity to implement innovative approaches (interdisciplinarity)

www.crp-sante.lu

Contacts

• CRP-Santé: [email protected]

• IBBL: [email protected]

• LCSB: [email protected]