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In Vitro Diagnostics in Finland

Jouko Haapalahti , M.D.PhD.(hc.), eMBA Assistant Vice President, R&D, Orion Diagnostica Oy Program Director , Intelligent Monitoring, SalWe Oy Chairman, Finnish In Vitro Diagnostics Industry Cluster, FIVDIC Board Member , Finnish Bioindustries , FIB

Helsinki 10.05.2012 1

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Directive IVDD 98/79/EC “Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the determination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological ,pathological state or a congenital abnormality, to determine the safety and compatibility with potential recipients and to monitor therapeutic measures “

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Global In Vitro Diagnostics (IVD) Revenues 2007 43 bUSD* “Diagnostic tests account for only less than 2 % of government healthcare expenditures worldwide, yet their finding influence 60-70% of healthcare decisions” Clinica 2008

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35 30 25

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20 Europe Japan USA

20 15 10 5 0 IVD €/capita

Clinical chemistry Immunochemistry Bacteriology Molecular Biology Hematology Hemostasis

38% 36% 9% 7% 5% 5%

Diabetes Infectious diseases Oncology Cardiology Hematology Other clinical chemistry

24% 23% 8% 6% 5% 13%

Centralized lab testing Decentralized glucose Other Point-of-Care

63% 22% 15%

Source: FIVDIC, Espicom 2006, BioMerieux 2006, Yole Development 2007, Kalorama 2008*

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7 Technology trends and drivers of IVD-diagnostics

Technology trends • • • • •

Molecular diagnostics (nucleic acid testing and genetic testing) Point-of-Care testing (POCT) Microarrays and lab-on-a-chip technologies Laboratory automation Wireless communications and web-based data management

Key drivers of growth in the global IVD market • • • • • • •

Aging of the population > increased demand for healthcare services Personalized medicine > diagnostic testing to optimize treatment of individual patients Continued expansion of POC including self-testing Expansion of test menus as new disease markers are discovered and put into practice Pharmacogenetic testing and new types of genetic disease screening tests Replacement of manual labor with automation Pressure to control healthcare costs > preventive health care is an opportunity 7

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Diagnostics Technology Road Map Technology convergence is creating new product innovations .Need to continue to invest in new broad technology platforms

Optics

Printing

-Micro optical components -Signal transmission etc. -Printing

-Chemicals -Biomolecules -Microfluidics

Microelectronics

-Microfluidics -Micromolds, printing -L-O-C’s etc.

-Computers -Lasers -Detectors etc.

Industrial Design -User interface -New functional design -Printing

Diagnostics Systems

Nanotechnology -Nanoparticles -Quantum Dots -CNT’s etc.

Micromachining

Mathematics

-Novel Measuring Algorithms -Sophisticated programming

Materials Science Biomolecular Recognition

-Novel materials for devices -Functional materials -Nanomaterials

-DNA, RNA - -RecAbs,peptides etc.

Diagnostics is the cross-road of advanced technologies

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EU FP7 Workshop on Trends in Detection, Diagnosis and Monitoring Views of Molecular Diagnostics Task Force • • • • • • • • • • • •

Molecular Testing not available for many diseases Lack of technology for detection of emerging biomarkers Taking molecular testing closer to patient High throughput screening of markers Multi Modality testing for different classes of markers will enhance diagnostics Analysis of mechanisms within the cell

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High Throughput Screening devices to screen biomarkers Versatile diagnostic platforms to deal w/ variety samples/analytes Easy to handle – cheap screening devices for diagnostics Low cost devices for non-developed countries Smart new combination of existing technology Taking basic technology (e.g. biosensors) to a level as being used in diagnostic devices

• Qualification and selection of samples critical for development and validation • Sample handling, preservation & purification technology critical for comparable results • Too many not well characterized markers • High Cost for clinical validation of markers of unknown quality • Pre-selection of most relevant candidates from a wide range of available markers • Joint projects for marker characterization of different classes

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Multiplex Multi Modality testing Detection of signatures consisting of different classes of markers Validation of detected marker signatures Screening of population for marker(s) In depth analysis of (additional) markers after positive screening result Therapy monitoring

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General Requirements for In Vitro Diagnostic Products TECHNICAL REQUIREMENTS • Predictive and/or Diagnostic / Responds to unmet needs • Precise, Accurate, Sensitive, Specific, Reproducible • Low cost – High value , Least Invasive or Non-invasive • Widely adoptable , Easy-to-use, Rapid, Robust • HIS/LIS Connectivity COMMERCIAL REQUIREMENTS • Sufficient market potential (disease incidence / prevalence) • Produces actionable health information > affects treatment • Helps to reduce total cost of health care • Helps to differentiate from competition • Regulatory clear, Clear indication / intended use • Reimbursable , Freedom-to-Operate

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350 million €

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Finnish landscape aiming at Next Generation Diagnostics Public Research Projects

Consortia & Company Projects

Biobanks Diagnostics alliances ? USA / India / China ?

FiDiPros IVD–Graduate School DIA-NET

Strategic Center for Health & Well-being (CSTI/SHOK) Program for Intelligent Monitoring of Health and Well-being

University reform

HealthBIO cluster program 2007-2013 (Biomolecular Recognition thematic group )

Biotechnology strategy Innovation strategy

Diagnostics Microsystems ? EU FP-7 and other broad programs

SalWe Oy FIVDIC

FIB

National Tekes Technology programs Regional Centres of BioExcellence & local cluster activities

Academy of Finland

Bio Meets Nano & IT Biocenter Finland

Institute of Molec Med FIMM

Universities & Technical Univ

Other inst THL, TTL Clin Research

VTT Techn Res Cntr

Diagnostics Companies

Basic and Applied Research supporting diagnostics applications Source: modified 2011 from Next Gen Diagnostics seminar 11/2007

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www.fivdic.net [email protected]

FIVDIC Task Force: J.Haapalahti, I.Råman, T.Ståhlberg, M.Parviainen FIVDIC-members also are members of FIB, FiHTA or SaiLab associatiotions

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Towards low-cost biomolecular recognition Advanced manufacturing methods

Roll-to-Roll Printing

Antibody engineering

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Sensor design Coupling grating integrated in doped waveguide

Integration and demonstration

Waveguide Sensitive material Mach-Zender type sensor

Detectors

Integrated light sources Doped sensitive waveguides

Wireless communications

Modeling of micro/nanostructure s

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Hybrid and new materials Antibody engineering Printing technology Modelling and design Optical measurements Integration Applications

¤ Point-of-care ¤ Environmental ¤ Process contr

BioOulu & BioDet1-2 Programs, Tekes projects : Welfare1-2, BioGel, BioAct1-2, BioFace, LCD/QB3,

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IVD-related interests, views of Finnish IVD-experts (n=48)

Source: Future Diagnostics Finland, Query 2009

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Some key words from the Strategic Research Agenda of the “Health and Well-being SHOK “ > SalWe IMO Program • • • • • • • •

Aims: To develop products, services and practices to prevent and treat diseases with major public health and economic impact Focus areas: i) Microbial infections and inflammation; ii) Metabolic syndrome; iii) Neurodegenerative diseases and iv) Malignant diseases, especially solid tumors Global trends: An individual becoming a more knowledgeable and demanding consumer of health and social care services. Customer shift: People are willing and capable of taking more responsibility of monitoring their health and actively contributing to it Drivers: The P4 medicine (personalized, preventive, predictive and participatory) , high demands to handle increasing magnitude of data Background: Long pioneer positions, traditions and innovations in the technology platforms for diagnostic applications Finland: Uniform health care structure enabling new solutions to be studied for efficiency in selected “test-beds” Health issues: costs are increasing, population is aging rapidly, increasing service needs

IMO Program 2010-2013 18 (24,7 M€, 209 FTE) Sari Tikanoja Thermo

Juhani Luotola Orion

Jukka Kirjavainen Tieto

Gösta Ehnholm Philips

WP201 65 FTE 7,3 M€

WP202 66 FTE 7,5 M€

WP203 34 FTE 3,6 M€

Companies :What to Do ?

Multimodal Image Processing & Archiving

Citizen-Professional Collaboration

Intelligent Printable Monitoring

Intelligent Platform Integration

Intelligent Biomarker Combinations

Over-arching themes of the IMO-program Prostate Cancer Inflammations /Infections

Tools for individuals´ use

Tools for professional use Biobanks, Biocomputing

Affordable, Intelligent, Easy-to-Use Tools for Monitoring of Health & Well-being

Intelligent monitoring of infections, inflammations , metabolic syndrome (CVD,T2D), neurodegenerative diseases, and cancer

Jaana Mättö FRCBS

WP204 WP205 19 FTE 26 FTE 2,5M€ 3,8 M€

Companies & Research org together : How to Do It ?

Strategic Centre for Health and Well-being (SHOK) Research Program of Intelligent Monitoring of Health and Well-being (IMO)

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Intelligent Monitoring (IMO) “Affordable, Intelligent, Easy-to-Use Tools for Monitoring of Health & Well-being” WP 201 Intelligent Biomarker Combinations WP 202 Intelligent Technology Platforms WP 203 Intelligent Printable Monitoring WP 204 Citizen-Professional Collaboration WP 205 Multimodal Image Processing & Archiving Duration: 1.6.2010 – 31.12.2013 Total volume: about 25 M€ 20 partners: 13 companies and 7 universities, research institutions Program Director: Jouko Haapalahti, Orion Diagnostica Oy [email protected]

Strategic Centre for Health and Well-being (SHOK)

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Affordable, intelligent and easy-to-use tools for monitoring health and well-being by citizens and health professionals

WP 205 Targets:

I I I n a h h h

Reliable image segmentation for clinical use (brain imaging, therapy targeting means of fusion of multimodal images, practical methods of image archiving

Strategic Centre for Health and Well-being (SHOK) Research Program of Intelligent Monitoring of Health and Well-being (IMO)

IMO Program 2010-2013 Work Packages and Tasks 21 WP201 : Intelligent Biomarker Combinations Task WP201.1 ; Inflammatory Biomarkers for Intestinal disorders Task WP201.2 ; COPD / Asthma Biomarkers Task WP201.3 ; Prostate Cancer Biomarkers Task WP201.4 ; Stem Cell Biomarkers WP202 : Intelligent Platform Integrations Task WP202.1 ; New optical measurement techniques Task WP202.2 ; Multi-electrode Platforms Task WP202.3 ; Multianalysis Platforms Task WP202.4 ; Automated Sample Pretreatment WP203 : Intelligent Printable Monitoring Task WP203.1 ; Sampling and Sample treatment Task WP203.2 ; Substrate Materials Task WP203.3 ; Biological Materials Task WP203.4 ; Ink Formulations Task WP203.5 ; Channeling Structures / Unit Operations Task WP203.6 ; Detection methods / demos Task WP203.7 ; Design and Facilitation WP204 : Citizen – Professional Collaboration Task WP204.1 ; Screening of New Services and Technologies Task WP204.2 ; Modeling and Description of New Services Task WP204.3 ; Impact of Services WP205: Multimodal Image Processing & Archiving Task WP205.1 ; Methods of Image Segmentation Task WP205.2 ; User Interfaces for Data Handling Task WP205.3 ; Formats of Input and Output Data

Strategic Centre for Health and Well-being (SHOK) Research Program of Intelligent Monitoring of Health and Well-being (IMO)

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WP 201: Intelligent Biomarker Combinations

WP 202: Intelligent Platform Integration

WP 203: Intelligent Printable Monitoring

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Preliminary23Results of the IMO Program at the 1 year milestone COPD underdiagnosed killer Analysis of multiplex biomarkers

SHOK Summit Hyde Park

SHOK Summit posters

Printable biosensing

Biomarkers of chronic airway diseases Biomarkers of intestinal inflammations Multiplex analysis of prostate cancer biomarkers Affordable monitoring by printing technology Image segmentation for therapy targeting

SHOK Evaluation

Review of Interim Results at 1 year milestone of the IMO Work packages and Tasks

Strategic Centre for Health and Well-being (SHOK) Research Program of Intelligent Monitoring of Health and Well-being (IMO)

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“Network of networks” has been built for the 24 enhanced development of Intelligent Monitoring of Health and Well-being Tekes projects

FiDiPro program

Networks of IMO partners

Centres of Excellence programs

Partners

Biobanks Cohorts

120+ Identified partners ´ international collaborations

of Intelligent Monitoring

FinPro

Academy

Program

FinnNode India

of Finland

IMO

projects

Canada

FIVDIC FIB industries

DIA-NET

AKASHOK projects

IVD GS

Strategic Centre for Health and Well-being (SHOK) Research Program of Intelligent Monitoring of Health and Well-being (IMO)

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www.fivdic.net [email protected]

FIVDIC Task Force: J.Haapalahti, I.Råman, T.Ståhlberg, M.Parviainen FIVDIC-members also are members of FIB, FiHTA or SaiLab associatiotions

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Several diagnostics platforms of Finnish origin

Source: FIVDIC and web-sites of companies

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