Innovative Medicines Initiative

Transcription

1 Innovative Medicines Initiative in Medicon Valley / Scandinavia Stina Gestrelius Medicon Valley Alliance Madrid, October 10th 2007

2 12 universities bioscientists 300 bio enterprises- 40,000 employees 2

3 Block busters from Medicon Valley NovoPen (insulin) Novo Nordisk Cipramil (antidepressive) Lundbeck Turbuhaler (powder inhalator) Astra Zeneca 3

4 New start-up companies Total New new companies every year 4

5 Clinical testing of new medicines Phase I Phase II Phase III Total 5

6 Drug candidates in the clinic About 100 Phase I-III trials from 40 SMEs Tissue restoration Other Metabolic disease Infectious disease Allergy Autoimmunity Wound healing/ dermatology Cancer CNS disease Cardiovascular 6

7 Prioritised disease areas Brain disorders Metabolic diseases (diabetes) Inflammation Cancer 7

8 Universities Lund University in Lund and Malmö (Sweden) University of Copenhagen, with faculties of pharmacy and life science after mergers 2007 (Denmark) Are the two largest universities in Scandinavia, each with 40-45,000 students About 50% of the research is within life science/biotechnology 8

9 New Biocenters: Lund Malmö - Copenhagen BioMedical Center Lund. Stem Cell Center Inflammation Neurology Cancer Research Part D 2006/2007 Clinical Research Center Malmö Blood and Defence Coagulation Diabetes Public Health Inaugurated Aug Copenhagen Biocenter with BRIC Cancer Research, Bioinformatics, Proteomics Crystallography Inaugurated Sep

10 Brain Disorders RESEARCH CENTERS & CLUSTERS NeuroLund (mechanisms of neurodegeneration in vivo/vitro) NeuroFortis (brain damage and repair, incl. Stem cells) Copenhagen NeuroCluster PHARMA & SME Lundbeck Acadia Enkam Exini Diagnostics Dandrit Neurosearch NS Gene Neuropharma Pharmexa SchizoDetect Z Gene 10

11 Metabolic Diseases (Diabetes) RESEARCH CENTERS & CLUSTERS Steno Diabetes Center (Novo + Capital Region Copenhagen) Hagedorn Research Institute (independent, owned by NN) Lund University Diabetes Center The Antidiabetic Food Center, Lund (New 2007) PHARMA & SME Novo Nordisk Zealand Pharma 7TM Pharma Rheoscience NETWORK Oresund Diabetes Academy (run by MVA) 11

12 Inflammation, allergy and autoimmune diseases RESEARCH CENTERS AND CLUSTERS Copenhagen Cluster of Immunology Institute for Inflammation Research in Copenhagen Blood and Defence, Malmö Chronic Inflammation Program, Lund PHARMA & SME Astra Zeneca ALK-Abelló Ferring Active Biotech, Alsensa AnaMar, Astion Pharma Atonomics, BioInvent Cartela, Chemotechnique Diagnostics Curalogic, EuroDiagnostica Genmab, Reflab Valderm 12

13 Infectious Diseases (resistent or new) RESEARCH CENTERS & CLUSTERS CISU (International Health Research, Copenhagen) Immunological Bioinformatics (Danish Technical University) Malmö University Hospital (WHO center) PHARMA & SME SSI, Statens Serum Institut Dermagen LICA Therapeutics Maxygen NatImmune Neobiotics Virogates 13

14 Cancer RESEARCH CENTERS & CLUSTERS Danish Cancer Society BRIC (Copenhagen Biocenter) Create Health (BMC, Lund) Clinical Research Centre (Malmö) PHARMA & SME Active Biotech BioInvent DAKO Genmab Meabco Nordic Vaccine Pharmexa Santaris Pharma Symphogen Topo Target 14

15 Strategic Center: CREATE Health Clinic CREATE Health Centre Clinic Sample handling Technology development & application Diagnostics/Treatment Sample collection Sample storage & tracking Sample processning Sample analysis Data analysis & mining Clinical transfer Diagnostic validation Treatment validation Technology development Strategic center for translational cancer research Public/private board of directors 7 research groups from 3 faculties Clinical preclinical collaboration to develop cancer biomarkers Each patient has a biomarker fingerprint Biomedical Center, Lund University 15

16 Medicon Valley Academy / Alliance Danish-Swedish Non profit, member based Started 1997 Today: 260 members 12 ft employees IMI project since 2005 Universities Industry Triple helix Hospitals 16

17 Scandinavian reasons for IMI participation Private industry with interest in the selected disease areas e.g. Astra Zeneca, Lundbeck, NovoNordisk + SMEs Public interest in biotech/ pharma- Prioritised areas Databases and biobanks in public healthcare Epidemiology and long follow up of patient cohorts Follow up of novel therapeutics after registration Regulatory agencies frequent EMEA rapporteurs Diagnostics companies/ SMEs Imaging Molecular markers 17

18 ScanBalt metaregion Inititiated by MVA and Nordic Innovation Center in 2002 Medicon Valley 11 countries 85 million people 18

19 IMI Forum in Medicon Valley /Baltic Sea Area Denmark IMI National Contact (DFU) Danish Pharma Consortium (Cph U, DTU) Danish Pharma Industries Association (Lif) Novo Nordisk Lundbeck Invest in Denmark, Øresundskomitéen Patient Forum Sweden IMI National Contact (VINNOVA) Lund University Karolinska Institutet Region Skåne & Sveriges kommuner & landsting Swedish Pharma Industries Association (LIF) MedCoast Scandinavia/ScanBalt Patient umbrella organisation ( HSO) Finland Finnish Pharma Industries Assoc. (PIF) Tekes Norway MedCoast Scandinavia Iceland IMI National Contact (decode) Estonia Estonian BIO Latvia P.Stradins Clinical University HospitaL Poland Medical University of Gdansk Germany BioCon Valley Norgenta 19

20 IMI Stakeholder meetings in Medicon Valley Four Disease Areas Oct-05 Bottleneck: Patient Recruitment & Diagnostics Jan-06 Bottleneck: Biomarkers Aug-06 Bottleneck: Predictive Toxicology Sep-06 Open Innovation Platforms Nov-06 Education &Training EMRA Dec-06 Knowledge Management Dec-06 Specific meetings arround expected calls (2007) Sponsored by NICe, VTU, Lif (DK) and LIF (SE) 20

21 IMI preparation activities Mapping (to database) Centers of Excellence Collaborative projects- partners SME Proposing / facilitating Public Private Partnerships 21

22 The PredTox Consortium (FP6) Companies (15) Universities Small and Medium-size Enterprise (SME) Altana Bayer Boehringer-Ingelheim Johnson & Johnson Lilly (B) Merck KGaG Novartis Novo-Nordisk Organon Roche Sanofi-Aventis (D) Sanofi-Aventis (F) Schering Serono Servier University of Wuerzburg Univ. College Dublin University Hacettepe Genedata Ciphergen 22

23 Example from PredTox Omics integrated with classical tox Toxicogenomics Conventional Endpoints Toxicoproteomics Metabonomics In silico Tools 23

24 In vitro alternative (liver toxicity) Toxicity testing using multicellular and organotypic cultures and systems such as functional liver cells derived from human stem cells Badly needed since liver damage is one of the biggest show stoppers in pharmaceutical development, and sometimes at very late stages, even postmarketing. 24

25 Knowledge Management New systems for Knowledge Management to store the large quantities of data to analyse the data to distribute data & results to safeguard sensitive information UNIVERSITIES CBS, Danish Technical University Safety & Efficacy Projects Data and requirements from S&E projects Translational Input and support to S&E calls HOSPITAL REGIONS Bio / IT COMPANIES S&E projects needs Results from S&E and KM projects Platform 25

26 Education & Training European Medicines Research Academy (EMRA) Educational and PhD programmes for 1. Integrated medicines development 2. Patient organisations and ethics committees 3. Safety science 4. Scientists within pharma R&D 5. Pharmaceutical medicine 6. Regulatory affairs 7. Biostatisticians 8. Bioinformaticians 26

27 Drug Research Academy Public-Private-Partnership PhD education since industries and government agencies Concepts Co-financed PhD grants Supervisors from both academia and industry Min. 3 month research in an industrial environment 2-3 mandatory courses Courses 72 projects in total, 17 completed 58 co-financed, 8 affiliated PhD study 85% spend time outside university 75% foreign censors Drug Research Academy, Copenhagen 27

28 Medicines Research Academy (MRA) A research academy for E&T in medicines research and development Participants represent (at this moment) Lund University Faculty of Medicine Faculty of Science Faculty of Technology Uppsala University Faculty of Pharmaceutical Sciences University of Copenhagen Faculty of Health Sciences Faculty of Life Sciences Faculty of Science Faculty of Pharmaceutical Sciences Technical University of Denmark Objective: to educate PhDs within the whole life cycle of medicine and offer training at postgraduate level, enabling pan-european public private collaborations PhD course catalogue established 28

29 First IMI calls? Asthma & COLD Brain disorders Diabetes Education & Training Pharmacovigilance Safety incl. Predtox continued Consortia will be initiated as soon as the draft calls are known. For collaboration contact or