Codex4SMEs - Companion Diagnostics expedited for SMEs


Project Summary

The Interreg project Codex4SMEs (Companion diagnostics expedited for small and medium-sized businesses) project plans to improve healthcare by enhanced adoption of Personalized Medicine in North-West Europe. The objective is to establish a network, which supports SMEs along the value chain of Companion diagnostics (Cdx) development.

Companion diagnostics (Cdx) are an indispensable tool for optimum application of Personalized Medicine: they allow tests to determine the molecular causes of a disease before treatment has started. However, thus far the development of companion diagnostics has been highly time-consuming and costly, so at present it is only used in the context of very few treatments.

Codex4SMEs will establish a transnational network of nine partners and two sub-partners from seven countries and expedite the development of the SMEs’ products in the field of Cdx. There is a need to improve SMEs‘ innovative capabilities and raise both international competitiveness and the impact of North-West Europe SMEs in this global market as the USA are far ahead - Codex4SMEs will directly address this challenge.

 

Benefits for SMEs

  • Access to:
    • Sample access service
    • biomarker validation service
    • knowledge transfer service of biomarker/biobanking
    • ecosystems from 11 partners
    • transnational roadshow to venture and large pharma companies
    • business model and expert access service for business growth and scaling
  • Tailored support dependent from the product TRL levels of the SMEs

 

 

Project events & news

Events

Webinar: Launching the Support Tool for Biomarker Commercialization

22-09-2020 – online

Get to know the Biomarker Commercialization (BIC) - Guide, a web-based tool that supports academic researchers and SMEs when developing an in-vitro diagnostic biomarker invention ... Read more

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News

Recording and slides of the web seminar 'Digital Health Data in Personalized Medicine'

Posted on 13-05-2020

On May 11th, 2020, the Codex4SMEs-project organized an online event highlighting "Digital Health Data in Personalized Medicine". Please find the audio of the event and the slides o... Read more

Innovation for Health – Codex4SMEs break-out session

Posted on 25-02-2020

A healthy future with good and affordable healthcare demands smart solutions. But those types of solutions don´t just appear out of thin air. To realise this, you need people with ... Read more

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Project Partners

  • University of Leicester, UK

    1 University Road
    Leicester
    LE1 7RH
    United Kingdom

    View partner details

  • BOM Holding BV, NL

    15 Goirlese Weg
    Tilburg
    5026
    Netherlands

    View partner details

  • Innovation and Management Centre Limited T/A WestBIC, IE

    Galway Technology Centre Mervue Business Park
    Galway
    H91 E2W5
    Ireland

    View partner details

  • InnovationQuarter, NL

    32 Prinses Margrietplantsoen
    Den Haag
    2595
    Netherlands

    View partner details

  • Medicen Paris Region, FR

    3-5 Impasse Reille
    Paris
    75014
    France

    View partner details

  • Integrated BioBank of Luxembourg, LU

    6 Rue Nicolas Ernest Barblé
    Luxembourg
    L-1210
    Luxembourg

    View partner details

  • Biobank Graz @ Medizinische Universität Graz, AT

    2 Auenbruggerplatz
    Graz
    A-8036
    Austria

    View partner details

  • CÚRAM Centre for Research in Medical Devices, IE

    Biomedical Sciences National University of Ireland Galway
    Galway
    H91 TK33
    Ireland

    View partner details

  • BioRegio STERN Managment GmbH, DE

    10 Friedrichstrasse
    Stuttgart
    70174
    Germany

    View partner details

Lead partner

Organisation Address Email Website
BioRegio STERN Managment GmbH, DE 10 Friedrichstrasse
Stuttgart
70174
Germany
jehle@bioregio-stern.de www.bioregio-stern.de
Name Contact Name Email Country
University of Leicester, UK Carl M Edwards ce133@le.ac.uk United Kingdom
BOM Holding BV, NL Maria Hein rhein@bom.nl Netherlands
Innovation and Management Centre Limited T/A WestBIC, IE Eunan Cunningham ecunningham@westbic.ie Ireland
InnovationQuarter, NL Lonneke Baas Lonneke.baas@innovationquarter.nl Netherlands
Medicen Paris Region, FR Daniela Onofri donofri@medicen.org France
Integrated BioBank of Luxembourg, LU Monica Marchese Codex4SMEs@ibbl.lu Luxembourg
Biobank Graz @ Medizinische Universität Graz, AT Sarah Frajuk codex4smes@medunigraz.at Austria
CÚRAM Centre for Research in Medical Devices, IE John Cunningham jcunningham@nuigalway.ie Ireland

Events



News



The Codex4SMEs project offers a tailored support scheme programme.

Services provided by the biobank project partners will be covered 100 % of the costs by the project.

 

Following services are still available within the project:

  • Knowledge Transfer Services (in biomarker & biobanking topics) provided by the Biobank Graz
  • Sample Access Service provided by the Biobank Graz

          Look into specific collections & cohorts here

          Samples for pilot projects

                 - to test or establish a new method

                - clinical samples from a maximum number of 5 patients

                - no ethics vote required

                - Results must not be published

          Samples for  research projects

                - sample access for research projects/biomarker research

               - clinical samples from a maximum number of 20 patients

               - valid ethics vote mandatory

 

Sample Access and Knowledge Transfer services will be available continously.

Please note: there is a limited number of services available and will be revised following a 'fist come first serve basis'.

For interested SMEs the guidelines and the application documents are available for download below.

Do not hesitate to get in contact with your local Codex4SMEs-partner and/or the Biobank of Graz directly (codex4smes@medunigraz.at).

 

 

 

Earlier in the project, the Integrated Biobank of Luxembourg (IBBL) offered a Biomarker validation serivce for the Codex4SMEs-community. Five SMEs were awarded with the service during two call periods:

  • First call period: Oktober 15th, 2018 till December 14th, 2018
  • Second call period: February 18th, 2019 until April 19th, 2019

 

For evaluation of the application forms and professional recommendations to the Codex4SMEs-consortium, an independent expert group was integrated.

The members were:

  • Marie Souleau, European Patent Attorney
  • Patrice Debre, Pitié- Salpêtrière Hospital, INSERM

The Codex4SMEs-consortium would like to thank the expert group for their support, their time for revising the applications and helping us selecting the winners!

Find out more about the award and the winners:

The Advisory Board acts as an observing body. They provide insights and recommendations on different topics in the framework of Cdx to support the project.

These are the members:

  • Andreas Baur, BioLAGO e.V.
  • Dr. Michael Steinwand, BioLAGO e.V.
  • Sylvain Lehmann, French society of Clinical Biology
  • Philippe Manivet, French society of Clinical Biology
  • Prof. Dr. Kurt Zatloukal, Medical University of Graz
  • Prof. Dr. Berthold Huppertz, Medical University of Graz
  • Florence Bietrix, EATRIS- ERIC
  • Eric Steinfelder, BBMRI- ERIC
  • Diarmuid Cahalan, Metabolomic Diagnostics
  • Dave Mead, PhD, Medilink East Midlands
  • Ida Haisma, Leiden Bio Science Park
  • Eefje Dekkers, InnovationQuarter

The map gives an overview of companies which are active in the field of companion diagnostics in the partner regions. When you klick at one selected company, further information like the main activities or the contact datails are mentioned.

Be part of the Codex4SMEs network, contact your regional partner and get an entry on the map.

 

Benefit from the Codex4SMEs projekt and get tailored support depending on your product TRL level. Furthermore you get access to:

  • Sample access service
  • biomarker validation service
  • knowledge transfer service of biomarker/biobanking
  • ecosystems from 11 partners
  • transnational roadshow to venture and large pharma companies
  • business model and expert access service for business growth and scaling

The Codex4SMEs-partners have good contacts to other biobanks.

 

Please feel free to contact us, the Codex4SMEs-partners are happy to help you in facilitating your individual biobank service, such as follows:

  • Need for a higher amount of samples (>20 samples)
  • Need for specific sample requests not available via Biobank Graz and the related free sample access service
  • Need for additional support in clinical trial/study planning (not covered within free sample access service)

Please note: costs for samples and/or other activities from other than the Biobank of Graz cannot be covered by the project.

 

BBMRI-ERIC

Biobanking and Biomolecular Resources Research Infrastructure – European Research Infrastructure Consortium, the pan-European infrastructure of national biobank networks (Homepage).

  • European research infrastructure for biobanking
  • Bringing together all the main players from the biobanking field – researchers, biobankers, industry, and patients to boost medical research.
  • Quality management services
  • Support with ethical, legal and societal issues
  • IT services:
    • Directory
      • Intended for all different types of users, providing aggregate information about biobanks and their sample/data collections.
    • Negotiator
      • Facilitating communication between researchers searching for samples/data and biobanks allowing refinmenet of their queries and once the search is done, to request samples
    • Locator
      • A tool for researchers looking for samples/data, enabling them to query available samples/data sets on the level of individual samples and/or data items, under development.
      • NOT a search tool for individual samples.
Finnish Biobank Cooperative (FINBB)

FINBB, as a member of BBMRI-ERIC, is a one-accessshop for effortless access to Finnish biobank materials and biodata:

Fingenious is a

  • Digital gateway to Finnish biobanks and biomedical research
  • Built to serve academic and industry researchers and to advance medical research globally
  • Provides a view of and access to biospecimens and data from all public biobanks in Finland, through a single point of contact

Feasibility and access costs (FINBB)

  • Initial feasibility service is free of charge.
  • Providing cost-estimation for the feasibility report if compiling the feasibility report requires exceptional effort and a significant amount of time
  • Submitting access requests through Fingenious is also free of charge. Questioner will receive a cost estimation of your biobank project during the feasibility and access request

Please find their homepage here.

Commercial Biobanks

In.vent Diagnostica GmbH

In.vent Diagnostica GmbH

  • Partner of all diagnostic Stakeholders for the procurement of biologic material of human origin (e.g., innovations, research, development, clinical studies, production, controls, standardisation, ...)
  • Active in the field of diagnostics
  • Targeted procurement of human biomaterials:
    • Standards & controls – high volumes possible
    • Quality control panels
    • Clinically defined samples
      • Highly specific parameters possible
      • Samples suitable for Clinical Performance Studies
      • Extensive global network of physicians and hospitals
  • Company owned study centre:
    • on demand blood donations
    • control over all steps of pre-analytics
  • Clinical services: Planning, Ethics, Samples, Performance Studies, Statistics, Reports (PER), Submission at NB

Reliable sources of information on the SARS-CoV-2:

The Market Analysis Service offered in the Codex4SMEs-project is based on information derived from widely accepted professional sources.

Here are two examples on information that an SME developing diagnostics will receive:

  • Example 1: A diagnostics company would like to know the trial status of pharmaceuticals for blood cancer treatment in order to identify and develop a biomarker for companion diagnostics in parallel.
    • The company will receive a comprehensive report of current trial status including pharmaceuticals from different types of organisations (private, public), market size, pipeline products, competitors and a forecast of the next five years.

 

  • Example 2: A company would like to receive information on Companion Diagnostic Tests in Oncology including a Global Analysis and Market Forecasts. 
    • The Market Analysis Service offered in the Codex4SMEs project will provide a comprehensive report on Market Volume, number of Companion Diagnostic Tests performed, Market Revenue, number of Pipeline Products and relevant Companies, and Competitive Assessment.

 

Please feel welcome to contact us personally if you are interested in our new market analysis service.

Your contact person is Marieke Huis in 't Veld: mhuisintveld@bom.nl

Please find a recording of the introductory webinar here.

 

Guide platform for regulatory and reimbursement issues


One critical hurdle for developers of (companion) diagnostics  is obtaining the right information on regulatory and reimbursement issues. In order to facilitate the access to such information, the Codex4SMEs project  provides SMEs from the field of (companion) diagnostics a list of information that compiles all relevant links on this topic.

Global

Institution Description Type
Foundation for the National Institutes of Health (FNIH) The Biomarkers Consortium Biomarker R&D
Health and environmental sciences institute (HESI) Health and environmental sciences institute  Healthcare R&D
ISPOR France Medical Device - Global Health Technology Assessment Road Map Reimbursement and Regulatory
Personalized Medicine Coalition (PMC) Personalized Medicine in the Clinic Advocacy Group
Personalized Medicine Coalition (PMC) Advancing Access to Personalized Medicine: A Comparative Assessment of European Reimbursement Systems Advocacy Group
Personalized Medicine Coalition (PMC) Personalized Medicine at FDA: an annual research report Advocacy Group
Personalized Medicine Coalition (PMC) Personalized Medicine Coalition Advocacy Group
Europe

Institution Description Type
European Molecular Quality Network (EMQN) Not-for-profit community interest company (CIC) promoting quality in genetic testing by establishing, harmonising and disseminating best practice Best Practice
MTR Consulting Innovative payment schemes for medical technologies and in vitro diagnostic tests in Europe Reimbursement
MTR Consulting Challenges of the European market access function in a medical device company Market Access
MTR Consulting Key trends in European market access for medical technologies Market Access
European Union

Institution Description Type
Competent Authorities for Medical Devices (CAMD) CAMD Implementation Taskforce: Medical Devices Regulation/In-vitro Diagnostics Regulation (MDR/IVDR) Roadmap Regulatory
EuroGentest Harmonisation of genetic
testing across Europe 
Regulatory
European database on medical devices (EUDAMED) registration system, a collaborative system, a notification system, a dissemination system Regulatory
European In vitro diagnostic Regulation (IVDR) EGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 Regulatory
European Medical Agency (EMC) Scientific evaluation, supervision and safety monitoring of medicines in the EU Regulatory
European Medical Device Regulation (MDR) REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 Regulatory
European Society of Human Genetics (ESHG) ESHG promotes research in basic and applied human and medical genetics Healthcare R&D
List of Notified Bodies Notified bodies responsible for the certification of IVD according to Regulation (EU) 2017/746 on in vitro diagnostic medical devices Regulatory

European Commission:

Medical Devices - Sector

Overview of European regulatory framework for medical devices and in vitro diagnostic medical devices. Regulatory

 

France

Institution Description Type
Alliance Aviesan et à ses membres, né des investissements d’Avenir (AVIESAN) BMK Tools for biomarker developers Biomarker R&D
Alliance nationale pour les sciences de la vie et de la santé (AVIESAN) French National Alliance for Life Sciences and Health: Coordination of national research policies Biomarker R&D
Haute Autorité de Santé (HAS) Recommendations that aid public authorities in reimbursement and pricing decision-making with regards to the French national health fund Reimbursement
Institut National du Cancer (INCA) French National Cancer Institute: health and science agency in charge of cancer control in France Regulatory
Agence nationale de sécurité du médicament et des produits de santé (ANSM)  National Agency for Medicines and Health Products Safety (France) Regulatory

 

Germany

Institution Description Type
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) General information on the regulation of deployment of medical apps in Germany: Digitale-Versorgung-Gesetz  Regulatory
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) Legal text of Digitale-Versorgung-Gesetz–DVG (Regulation of medical apps in Germany) Regulatory
DEKRA Notified Body responsible for IVD certification Regulatory
German Institute of Medical Documentation and Information (DIMDI) Notifications Medical Devices and In vitro Diagnostics Regulatory
Gemeinsame Bundesausschuss The federal joint Committee (G-BA) The federal joint Committee (G-BA): Reimbursement of Medical Devices and Drugs in Germany Reimbursement
Instituts für Qualität und Wirtschaftlichkeit im
Gesundheitswesen (IQWiG).
Institute for Quality and Efficiency in Health Care (IQWiG): IQWiG examines the advantages and disadvantages of medicine services - in certain cases also theirs costs, Reimbursement and Regulatory

 

Ireland

Institution Description Type
Health Products Regulatory Authority (HPRA) Guide for Manufacturers of General Class In-Vitro Diagnostic Medical Devices  Regulatory
Health Products Regulatory Authority (HPRA) New EU Device Legislation Information Pack Regulatory
Health Products Regulatory Authority (HPRA) Key aspects specific to the in-vitro Diagnostics Regulation (IVDR) Regulatory

 

The Netherlands

Institution Description Type
Health and Youth Care Inspectorate Registration and deregistration of medical devices or IVD's Regulatory
United Kingdom

Institution Description Type
Medicines and Healthcare products Regulatory Agency (MHRA) In vitro diagnostic medical devices: guidance on legislation  Regulatory
Medicines and Healthcare products Regulatory Agency (MHRA) Medical devices: how to comply with the legal requirements. Placement of a medical device in the UK market. Regulatory

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