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
12-10-2021 – online
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15 Goirlese Weg
Tilburg
5026
Netherlands
Galway Technology Centre Mervue Business Park
Galway
H91 E2W5
Ireland
32 Prinses Margrietplantsoen
Den Haag
2595
Netherlands
3-5 Impasse Reille
Paris
75014
France
6 Rue Nicolas Ernest Barblé
Luxembourg
L-1210
Luxembourg
2 Auenbruggerplatz
Graz
A-8036
Austria
116 Sandhofer Strasse
Mannheim
68305
Germany
1118 De Boelelaan
Amsterdam
1081 HZ
Netherlands
13 Jean Baptiste de Ghellincklaan
Ghent
9051
Belgium
10 Friedrichstrasse
Stuttgart
70174
Germany
Lead partner
| Organisation | Address | Website | |
|---|---|---|---|
| BioRegio STERN Managment GmbH, DE |
10 Friedrichstrasse Stuttgart 70174 Germany |
jehle@bioregio-stern.de | www.bioregio-stern.de |
| Name | Contact Name | Country | |
|---|---|---|---|
| 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 | Pablo Zardoya Laguardia | codex4smes@medunigraz.at | Austria |
| EIT Health Germany GmbH, DE | Katharina Ladewig | katharina.ladewig@eithealth.eu | Germany |
| European Research Infrastructure for Translational Medicine, NL | Emanuela Oldoni | emanuelaoldoni@eatris.eu | Netherlands |
| FlandersBio, BE | Willem Dhooge | willem.dhooge@flanders.bio | Belgium |
Lyonbiopôle is co-organizing, with our partner cluster Mabdesign, the 5th edition of the Immunotherapies & Innovations for Infectious Diseases Congress (I4ID2021), that will be held in Lyon, France on November 15-16, 2021.
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‘Diagnostics-4-Future Conference‘ is the international meeting-place for users and providers from industry and science.
Based on questions in medical care, clinics and laboratories, innovative solutions for new diagnostics are discussed including research and development. The focus is also on solutions for rural areas (point-of-care). Organizer is the international health network BioLAGO. The conference emerged from the DiagNET project.
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An appealing framework programme was created with subject matter expects ranging from regulatory affairs to market access by the Enterprise Europe Network (EEN) and the Interreg NWE project Codex4SMEs, with special thanks to project partner Daniela Onofri from Medicen as event coordinator. Participants learned about opportunities to work with global medtech companies in programmes such as Horizon Europe Health and the Innovative Health Initiative. Read More
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On July 6th 2021 the online event „Biomarkers from Research to Market“ took place as part of the Interreg NWE project Codex4SMEs. Find here a recording of the session as well as the slides of the speakers Read More
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To give small and medium-sized companies the chance to quickly launch new products on the market, the Interreg NWE project Codex4SMEs supports SMEs to pitch to investors through the online event MeetMyInvestor. Read More
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An online seminar on the European In-Vitro Diagnostics Regulation (IVDR) took place on May 11, 2021. Almost 50 participants received an introduction to the most important points of the IVDR. There were also instructions for the Biomarker Commercialization Guide (BIC Guide) and the IVDR Regulatory Guide. With this IVDR online seminar, the two networks Interreg North-West Europe Codex4SMEs and Interreg Baltic Sea BiC offered extensive tips and tools for getting started on the current topic. Read More
The Commission is mobilising €123 million from Horizon Europe, the new EU research and innovation programme, for urgent research into coronavirus variants. This first emergency funding under Horizon Europe adds to a range of EU-funded research and innovation actions to fight the coronavirus and contributes to the Commission's overall action to prevent, mitigate and respond to the impact of coronavirus variants, in line with the new European bio-defence preparedness plan HERA Incubator. Read More
On March 12th, 2021, an online round table with Sanofi took place in the context of the project Codex4SMEs. Nine companies from the Netherlands, Ireland, France and Germany had the opportunity to pitch in front of the French pharmaceutical company. Read More
On March 9th, 2021, our project partner the Biobank of Graz gave an online seminar about the role of Biobanks managing biospecimens to improve biomarker development. Please find here a recording of the online seminar. Read More
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:
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:
For evaluation of the application forms and professional recommendations to the Codex4SMEs-consortium, an independent expert group was integrated.
The members were:
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!
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:
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.
For Matchmaking opportunities with other key players of the diagnostics' sector, we establsihed a platform which will run until September 2021.
Benefit from the Codex4SMEs projekt and get tailored support depending on your product TRL level. Furthermore you get access to:
In the field of companion diagnostics, and even broader: in the field of Lifesciences and Medical Technology, timelines of research to market are very long. To create a therapy for a disease, it takes 10 to 15 years.
A lot of SME’s working on these kind of developments need external money to proceed with their businesses. However in the venture capital world return on investment timelines are much shorter: around 5 to 7 years. The SME has no time to work on their product in the way they want to do it. Capacity is lacking for research and business development, because it goes towards financing, keeping stakeholders happy, and going from one investment round to another.
In an ideal world an investor has patience and waits for actual results of the company. Environmental impact should be of much more added value than ROI’s. And when there is patience, the SME will come up with much better results, because they have the time to invest in their product. Current numbers of SME-successes with external investment, can raise from 10% to 60%.
To realize this change, a change of attitude is necessary. It is a slow process because assumptions how the venture capital works, have to be refuted. With this animation we want to plant a seed, and food for thought. So in the long term hopefully things can and will change. For more information contact: rhein@bom.nl
Please note: costs for samples and/or other activities from other than the Biobank of Graz cannot be covered by the project.
Fingenious is a
Feasibility and access costs (FINBB)
Please find their homepage here.
For further questions: please feel welcome to contact Marieke Huis in 't Veld: mhuisintveld@bom.nl
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.
| 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 |
| 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 |
| 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 |
| Overview of European regulatory framework for medical devices and in vitro diagnostic medical devices. | Regulatory |
| 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 |
| 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 |
| 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 |
| Institution | Description | Type |
| Health and Youth Care Inspectorate | Registration and deregistration of medical devices or IVD's | Regulatory |
| 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 |
The BIC Guide supports academic researchers and SMEs when developing an in-vitro diagnostic biomarker invention to a commercial product. It provides guidance through the technology readiness levels (TRL) and covers the clinical, regulatory, and business aspects of the commercialization process. The tasks are described and partially supported by useful, downloadable documents. The guide supports the potential commercialization and guides you through dialogue with industrial partners.
Your contact person:
Aalborg University Hospital
Valérie Daussin Laurent
+4597666 297
Planning to commercialize your biomarker invention?
Thousands of candidate biomarkers are being discovered and the number of publications has exploded in recent years, but the discovery of a candidate biomarker is just the beginning of a long road to a commercial product.
Few findings enter to the specific assay development phase, pass the evaluation of analytical and clinical performance characteristics, and are eventually transformed into IVD assays, as biomarker development and commercialization is complicated, time consuming and expensive.
To support and help the commercialization process of new in vitro diagnostics (IVD)-applicable biomarkers, a set of tools and useful information was made available free of charge. The tools give structure and validation to biomarker research. They guide researchers and product developers through the technology readiness levels and remind about the clinical, regulatory, and business aspects of the innovation process.
The tools are only intended as guidance. They have been compiled to the best of our knowledge from a wide variety of sources, but cannot claim to be complete. Each new discovery or development is individual, therefore all information and mentioned standards have to be considered for the concrete individual case. As soon as possible, think of establishing a dialogue with specialists and experts in the field.
The tools are intended for researchers, SMEs and technology transfer offices and are available to all free of charge.
Choose a tool to get started:
an Interreg North-West-Europe - project
Your contact person:
Noord-Brabant Development Agency (BOM)
Ria Hein
+31 6 52 607 187
Connect to your clients in North-West Europe!
Looking for new contacts and clients in North-West Europe? Make sure that you are in the online database of Boost4Health!
Within Boost4Health we aim to connect SMEs and service providers, to help SMEs making the next step. SMEs out of the Boost4Health regions have access to vouchers. Vouchers to spend in North-West Europe, maybe at your organisation! Make sure you are visible now for those SMEs! They are looking for service providers in the field of Lifesciences and Medical Devices. The vouchers can be used for specific expertises in the field of e.g. market insight. Make use of this business opportunity and connect through Boost4Health and the database.
CELIS is funded by the European Union’s COSME programme
Your contact person:
BioRN Cluster Management GmbH
Annalisa Zuccotti
az@biorn.org
CELIS is one of 13 European Strategic Cluster Partnerships for Excellence (ESCP-4x) selected under the European Cluster Excellence Programme as part of the European Commission’s COSME programme.
CELIS combines some of the world-class life science ecosystems in Europe: BioRN Life Science Cluster Rhine Neckar (Germany), Smart Hub Flemish-Brabant (Belgium), Biopeople: Denmark's Life Science Cluster (Denmark) and Tartu Biotechnology Park (Estonia).
The project helps clusters, networks and business and innovation support organisations to maximize opportunities linked to cross-sectoral and inter-regional cooperation and internationalisation. It offers them and their members unique opportunities to expand their relationships and to enhance public-private partnerships.
CELIS CORE ACTIVITIES
