Codex4SMEs - Companion Diagnostics expedited for SMEs


Project Summary

Codex4SMEs - the support programme for diagnostics manufacturers

With the mission of "the right drug, at the right dose, at the right time, to the right patient“, the Interreg North-West Europe Codex4SMEs project funds the development of innovative diagnostics for improved personalised healthcare in Europe. The funding programme aims to support small and medium-sized (SME) companies in the life sciences and medical technology sectors engaged in the development of diagnostics.  For the development of improved diagnostics, nine partners from six EU countries have launched a strong Fast Track Programme offering SMEs a wide range of services along the entire value chain.

Who is eligible to receive services?

SMEs from the life sciences or medical technology sector with headquarters located in a North-West Europe country are eligible to apply for a service (more details via SME self-assessment). The costs for services are covered by the EU-funded Interreg NWE Codex4SMEs project. Therefore, SMEs have to submit an application together with a self-declaration of state aid received by the company under the de-minimis rule over the past three-year period.

Open Calls

 Codex4SMEs Services

Opening date

Deadline

Application Form

Translational Assessment

1 April 2022

continuously open

Apply Now

Partner Search

1 September 2022

continuously open

Apply Now

Modular Biomarker Validation Services

1 September 2022

17 October 2022

Apply Now

Tailored consultancy services on specific biomarker topics

1 September 2022

continuously open

Apply Now

Interactive online seminars on biomarker validation topics

1 September 2022 17 October 2022 Appy Now


More Services for SMEs

Project events & news

Events

Online Coaching - IP Strategy Support is underway!

13-09-2022 - 31-12-2022, Online

Are you a Pharma/Medtech/Companion Diagnostic SME or a company with Diagnostic products? Are you in need of IP strategy insights or do you have questions concerning patent protecti... Read more

View more

News

Break into the MedTech industry with Meet&Match.Dx!

Posted on 15-06-2022

Are you interested in collaborating with leading MedTech companies to tackle diagnostic challenges and open the path for partnership exploration? Join the Meet & Match.Dx, a challe... Read more

Metabrain and IBBL successfully cooperated in developing new CDx supported by Codex4SMEs

Posted on 22-08-2022

Sophie Raynal (Metabrain Research SA, France) presented the entrepreneurial perspective on translation in practice – developing and bringing a PM product to the market. Read more

View more

Project Partners

  • 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

  • EIT Health Germany GmbH, DE

    116 Sandhofer Strasse
    Mannheim
    68305
    Germany

    View partner details

  • European Research Infrastructure for Translational Medicine, NL

    1118 De Boelelaan
    Amsterdam
    1081 HZ
    Netherlands

    View partner details

  • FlandersBio, BE

    13 Jean Baptiste de Ghellincklaan
    Ghent
    9051
    Belgium

    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
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 Yaniss Hamiche yhamiche@medicen.org France
Integrated BioBank of Luxembourg, LU Monica Marchese Codex4SMEs@ibbl.lu Luxembourg
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 Katrien Lorré katrien.lorre@flanders.bio Belgium

We offer targeted support to our SMEs through our Fast-Track Programme

Our Fast-Track-Programme includes a range of services provided by our project partners. You can find detailed descriptions of our services in the Codex4SMEs Service Catalogue at the end of the page and in the respective sections below.

Who can participate?

Our services are in general open to SMEs from all over NWE with preference given to SMEs from one of the participating partner regions (see table of partners) for the services offered. Individual criteria are applicable for the different services. If you have questions about individual service, please feel free to get in touch with the respective contact person in the full service description or ask the lead partner from your region.

What services are available?

Codex4SMEs offers a range of support services for SMEs. Our services are designed to help SMEs expedite their development of products in the field of diagnostics (Dx). Our key aim is to establish a sustainable network of all key actors along the value chain of Dx development. 

How to apply for services?

  • Check your eligibility:
    • Does your company meets the SME definition of the EU?
    • Did your SME receive more than a total of €200.000 of de Minimis state aid between 2020 and 2022? For more information about de-minimis aid. You can find helpful information via these links  de minimis rule and state aid.
  • Browse the Codex4SMEs Service Catalogue
  • Select a service you want to apply for (Note: An SME can apply for several different services, however cannot apply for the same service more than once.)
  • Complete application form
  • Submit your application and your de minimis self-declaration

 

Tailored Advice for accelerating your business growth in Diagnostics Sector

You can find various diagnostics experts on this platform to help you accelerate the growth of your business: Investment, Intellectual Property, Market Access, Regulation, Reimbursement.

Access to investor-ready planning and business support for SMEs

The experts from the partner regions, are service providers and researchers specialised in the diagnostics sector. SMEs can receive a voucher for a service as part of the Fast-Track Programme.

Announcement for workshops on IP Strategy Support is underway! run by NLO.

Detailed information can be found via the following links.


The Business Growth Programme provides tailored support for SMEs

Read full Business Growth service description and apply

Apart from Business Growth service, the project partners help SMEs to get in contact with experts in the field. Please send us your request via this e-mail.

Eunan Cunningham ecunningham@westbic.ie

 

Investment & Funding

 Organisation  Expertise  Country
AdBio partners AdBio Partners invest in and develop the most innovative early-stage startups in life sciences in Europe France
Capricorn Partners The Capricorn Health-tech Fund focuses on non-digital technologies that help prevent, diagnose and treat diseases (while the Capricorn Digital Growth Fund focuses on digital health technologies). The human healthcare technology sector comprises a diverse range of products and services in sub-sectors such as biopharmaceutical and pharmaceutical drugs, vaccines, medical devices, medical imaging, diagnostics, research equipment and nutraceuticals.  Belgium
CS Ventures CS Ventures is the corporate venture fund initiative of Canterbury Scientific Ltd., a leading OEM developer and supplier of high quality in vitro diagnostic controls and calibrators for diabetic and haemoglobinopathy applications worldwide. CS Ventures was established in 2019 to invest in promising IVD opportunities that align with Canterbury Scientific’s existing capabilities and to diversify into applications beyond diabetes mellitus.  The Netherlands
Go Capital GO CAPITAL, an independent management company, brings together the best assets to strengthen the regional economic landscape and support emerging technology companies France
Grey Bird Ventures GreyBird Ventures invests in and helps to build companies that solve critical diagnostic problems in precision medicine. Our unique and singular focus allows us to partner with entrepreneurs that meet our stringent criteria from the hundreds of new technologies coming to us from around the world. USA
HBAN | Halo Business Angel Network Halo Business Angel Network

is responsible for the development of business angel activity and angel syndicates on the island of Ireland. HBAN provides qualified deal flow to investors who want to be part of the journey in creating great Irish companies, scaling globally and making returns to their shareholders.
Ireland
IQVIA IQVIA MedTech Solutions provides support to Life Science/MedTech companies from market entry and assessment through reimbursement and distribution so they have the data, analytics and expertise to navigate this environment and optimize their business strategy. France
Karista Karista is an early-stage venture capital firm created in 2001, which funded 90+ companies over the past two decades and supports tomorrow’s game changers in the field of Health, Digital, Tech, and NewSpace. France
Kurma Partners Funding in healthcare and biotechnology in Europe.
Kumar Partners invest at various states of mturity, from comapny creation to capitalexpansion.
France
Novalis Biotech Acceleration Novalis Biotech is an early stage venture capital investor in life sciences.
Focus areas are: innovative research and manufacturing tools, bioinformatics, genomics, diagnostics and digital health. 
Belgium
Thermo Scientific Business Development in Life Sciences.
Thermo Fisher Scientific  is dedicated to the development and implementation of new strategies in the life sciences. One major topic area is diagnostics. For this, new business opportunities and innovations for health are continuously identified.
France
Wellington Partners Since 1998, Wellington Partners has been a leading European Venture Capital firm investing in early- and growth-stage Life Science companies, active in the fields of Therapeutics, Medical Technology, Diagnostics, Digital Health and Industrial Biotechnology Germany
XAnge XAnge believes that major paradigm shifts, such as the inception of mobile telephony and the Internet, trace their origins to scientific and technological innovations that were as highly disruptive as those that paved the way for microprocessors.

XAnge invests in start-ups that are ready to meet such great challenges, staffed by visionary teams bent on expanding the capabilities of technology without losing sight of the product/market fit.
France
Intellectual Property

Organisation Expertise Country
Regimbeau  REGIMBEAU provides value-adding advice for all legal and technical problems related to Industrial Property.

The PATENT Attorneys team at REGIMBEAU consists of over seventy lawyers and scientists. 
France
Ruff, Wilhelm, Beier, Dauster & Partner mbB Ruff, Wilhelm, Beier, Dauster & Partner mbB provide extensive legal counsel and representation for clients in the fields of medical technology, medicinal chemistry, pharmaceuticals, organic chemistry, polymer chemistry, biochemistry, molecular biology, genetic and bio engineering, life sciences as well as textile technology.
Conducting patent litigation proceedings in and out of court, including infringement and nullity proceedings in Germany and abroad, when necessary together with colleagues from an international network of attorneys.
Germany
VOELKER & Partner mbB Certified Specialist Attorney in International Business Law
Certified Specialist Attorney in Intellectual Property Law
Germany

 

Market Access

Organisation Expertise Country
Seijgraaf BV Seijgraaf BV offers consultancy on market access for pharmaceuticals and medical devices. For the Dutch market, but also for other markets.  IHC Switzerland does international market access in cooperation with MARS.  Maxinsight makes it easy to get market access advice for Germany, Austria and Switzerland. Alpscapes provides consulting for the Austrian market.

The partner BioPortUSA provides market access in the USA.
The Netherlands
Emergo  Energo offers comprehensive service at every point in the product life cycle
  • Market Access
  • Privacy & Security Services
  • Business Process Services
  • Human Factors Research & Design
  • Clinical Research
  • Digital Applications: RAMS
The Netherlands

 

Regulation | MDR & IVDR

 Organisation  Expertise  Country
AIBILI AIBILI is a private non-profit Research Technology Organisation, established in 1989, dedicated to clinical research and development of new diagnostic and therapeutic strategies. As an Interface Centre by the Portuguese Ministry of Economy, AIBILI supports translational research and technology transfer in the health sector, acting as a facilitating partner between scientific institutions, healthcare providers and industry in order to bring novel products to the market.  Portugal
Digitorc DigiTorc.com is an international privacy consultancy company, focusing on digital business Ireland
Lean Entries Lean Entries Ltd was found and hired by OuluHealth due to their intuitive digital solution (Entries) to solve the early stage regulatory challenge and their mission to empower health tech startups. Finland
Med-Di-Dia Limited Med-Di-Dia is a regulatory and quality compliance consultancy firm supporting Medical Device, In-Vitro Diagnostics and Digital Health companies from our base in Galway, Ireland. Med-Di-Dia offers a range of services including:
  • EU Authorised Representative
  • Regulatory Strategy for US, EU and Rest of World
  • Assessments against new EU Medical Device / IVD regulations (2017) to assist with transition to new requirements
  • Device classification & predicate device searches (US)
  • US FDA Regulatory Submissions
  • Clinical evaluations
  • Quality Management Systems
  • Advice, guidance and implementation of all mandatory standards, such as ISO 13485:2016 (Quality Management Systems)
  • Technical file compilation
Ireland
Novineon novineon CRO structures technical documentation of the performance evaluation of in vitro diagnostic medical devices for its clients: from the review of the risk analysis and instructions for use to the preparation of the plan and report of the performance evaluation and post-market surveillance Germany
ProPharma Group From early concept development through each clinical phase, product launch, and commercialization, ProPharma partners with pharmaceutical, biotechnology, and medical device clients to tackle complex challenges. ProPharma helps to ensure regulatory expectations are met, business goals are achieved, and patient health and safety is improved. The Netherlands
Venn Life Sciences 
Venn Life Sciences is an Integrated Drug Development partner offering a unique combination of drug development consultancy, clinical trial design and execution.
The Netherlands
Voisin consulting VCLS experts in Europe and the US work within a project matrix team to provide their clients with coherent regulatory strategies and operational support that cover the full range of activities from early preclinical development to marketing authorization and product lifecycle management,  by navigating through the FDA and EU agencies interactions. France
Zwiers consultancy BV Medicinal products and Medical devices/In vitro diagnostics

Zwiers Regulatory Consultancy provides companies with quality support, throughout the entire drug lifecycle. From initial clinical trial application to post-marketing compliance.
The Netherlands

 

Reimbursement

Organisation Expertise Country
Justin Stindt Consulting Justin Stindt Consulting is a consulting firm specializing in Strategy & Market Access advisory services for the pharmaceutical, biotech and medical device industry.
Justin Stindt Consulting delivers specific and actionable insight on payer resonating evidence including endpoints, how to operationalize them and the required effect size.
UK
Health Systems - Innovative Care | University Hospital Tübingen Reimbursement: German healthcare system; Noval care structures: structural analysis, conception and evaluation of new forms of care; Health services research: methodological advice; international comparative projectsteaching Germany

 

Research

Organisation Expertise Country
CAPGEMINI ENGINEERING  Capgemini supports transformation and optimization of compliance processes, through a tailored & agile approach for healthcare & life sciences companies France
Center for Personalised Medicine (ZPM) | University of Tübingen The Center for Personalised Medicine (ZPM) was founded in the context of the Excellence Initiative of the Eberhard Karls University of Tübingen. The ZPM connects the diverse aspects of data production, data analysis, functional imaging, development of new therapies and their clinical trials to transfer the concept into clinical care. Germany
Dianox Dianox is developing a biotechnology platform for non-invasive diagnostics to make a sustainable impact on global health. Denmark
Metabolomic Diagnostics Ltd Metabolomic Diagnostics is a deep-tech company specialized in the development of novel biomarker-based diagnostic solutions for complex diseases. The company has developed an effective pipeline to firstly identify diagnostic biomarker panels and then translate these panels into clinical assays ready for application in the clinical laboratory. Ireland
NMI | Tumor Biology In cooperation with customers and partners from industry as well as academic and clinical research, the Tumor Biology working group develops novel, patient-derived cellular model systems for preclinical efficiency testing and validation of pharmacological agents as well as for the analysis of biomarkers for diagnostics and monitoring of therapeutic success. Germany
Signatope GmbH
SIGNATOPE´s testing service is offered to the pharmaceutical industry and CROs in 3 areas:
Kidney & Liver Toxicity Drug Safety
CYP450 & Transporter Protein Induction
Tailored Assay & Antibody Development
Germany
Comprehensive Cancer Center Tübingen-Stuttgart |University Hospital Tübingen Research at the CCC Tübingen-Stuttgart:

The CCC is looking for new ways to predict the appropriate, individual therapy. The focus is on the following three main research areas:
Functional target identification and molecular tumor therapies.
Immunotherapies
Molecular and functional multiparametric imaging
Germany
Heidelberg University Hospital | Klaus-Tschira-Institute for Computational Cardiology The Klaus Tschira Institute for Integrative Cardiology is active in three thematic areas
RNA maturation and processing
Systems cardiology research for in vitro and in vivo models of heart failure
 Clinical data science: Open source software tools for the scientific community 
Germany
National Center for Tumor Diseases (NCT) Heidelberg, German Cancer Research Center (DKFZ) „Interdisciplinary research, preventing and treating cancer, to benefit patients“. This is the aim at the National Centre for Tumor Diseases (NCT) in Heidelberg. With this unifying approach, the NCT was the first German Cancer Center to set new standards. The NCT is an internationally renowned Center of Excellence and receives intensive support from its supporting organizations. Germany
Precision Diagnostics Group | IBM Research Europe (Zurich) In the precision diagnostics project, the Precision Diagnostics Group at IBM Research Europe is creating enabling technologies for healthcare and life sciences using multidisciplinary research and a problem-oriented agenda.
Point-of-care diagnostics
Capillary-driven microfluidics
Mobile health
Switzerland

 

News


Innovation for Health – Codex4SMEs break-out session

Posted on

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 ground breaking ideas, energy, perseverance and a relentless belief in the added value represented by collaborations. You could find these kind of people at the Innovation for health congress in Rotterdam. On February 13th in the framework of the congress, the Codex4SMEs break-out session took place. Read More

TRANSMED Academy - virtual learning environment by EATRIS

Posted on

Our associated partner EATRIS (European Infrastructure for Translational Medicine) is offering support via their new developed virtual learning platform 'TRANSMED academy': To support biomedical researchers to gain better understanding of translational research and medicines development, EATRIS has developed a learning platform, offering access to several online activities, free of charge. Online training modules are a great way to provide high quality, accessible, interactive training at all levels. Read More

Partners from across Europe to host event in Galway to support companion diagnostics SMEs

Posted on

WestBIC, CÚRAM, the Science Foundation Ireland Research Centre for Medical Devices at NUI Galway, and their European partners in Codex4SMEs Information and Networking Event are to host the Interreg North-West Europe project Codex4SMEs (Companion Diagnostics Expedited for Small and Medium-sized Enterprises) on Wednesday, 18 September, at Hotel Meyrick, Galway. Read More

Atriva Therapeutics Receives EU Award for Biomarker Validation

Posted on

Atriva Therapeutics GmbH, a biopharmaceutical company pioneering the development of host-targeting antiviral therapies, today announced that they have received the Biomarker Validation Award as part of the European Interreg Project Codex4SME. A total of four award winners will receive a grant of approximately 100,000 Euros each, in the form of laboratory services by the Integrated Biobank of Luxembourg. Read More

Exclusive access to biobank service

Posted on

Four companies from Germany, France and the Netherlands have been presented with the Biomarker Validation Award as part of Codex4SMEs. The European project aims to establish a transnational network to accelerate the development of companion diagnostics along the entire value chain of small and medium-sized enterprises. The award is endowed with approximately EUR 100,000, which is handed over in the form of laboratory services. The chosen companies can now have their respective biomarkers validated by the Integrated Biobank of Luxembourg – in other words, have them tested to assess their reliability with regard to their relevant indication. Read More

Presentation of the web seminar with Tom Miller

Posted on

Finding capital to fund your (companion) diagnostics SME: The Venture Capital perspective. On 28 May, a web seminar with Tom Miller in the frame of the Interreg NWE project 'Codex4SMEs' took place. Tom Miller is founder of Greybird Ventures and is dedicated to invest in companies that can help to eliminate "trial and error" medicine with high-specifity diagnostics and generate value for patients, providers, developers of therapies, and those who pay for healthcare. Read More


Networking in Codex4SMEs

Codex4SMEs is one of the largest diagnostics networks in North-West-Europe.

Be part of the Codex4SMEs network

Post your competencies on our map to raise your visibility in the diagnostics community. Download the form, fill in and send it to codex4smes@bioregio-stern.de

 

Find new cooperation partners via the Information and Networking Platform

For Matchmaking opportunities with other key players in the diagnostics sector, you are invited to take advantage of the online networking platform, which will run until September 2023. Here you will find key players in the field of personalised medicine, biomarker development, and diagnostics.


Sign up here for the matchmaking

Matchmaking Platform

Meet our wider network

Codex4SMEs teams up with initiatives in the field of diagnostics and personalised medicine. Through our wider network of related projects and synergistic biobanks we can offer additional support to diagnostics SMEs. We invite you to profit from the support measures of other project's activities and have access to even more stakeholders and key players in Europe! 

 

Related projects

Looking for specific support not provided within the Codex4SMEs Fast-Track Programme? Then browse the repository of related projects to find the right support for your business.

BIC Project

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.

Visit the BIC Project Website now!

Boost4Health

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.

 

Visit the Boost4Health website now!

BY-COVID

The BeYond-COVID project aims to make COVID-19 data accessible to scientists in laboratories but also to anyone who can use it, such as medical staff in hospitals or government officials. Going beyond SARS-CoV-2 data, the project will provide a framework for making data from other infectious diseases open and accessible to everyone.

BY-COVID CORE ACTIVITIES

Mobilising data: Ensuring data from around the world can easily be submitted to core data hubs.

Connecting data: Linking infectious disease data. For instance, clinical data with viral data.

Standardising data: Providing recommended data management best practices and standards for describing data.

Exposing and analysing data: Providing data analysis methods and protocols.

 

Visit the BY-COVID website now!

CELIS - Cluster Excellence in Life Sciences

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

  • Twinning, networking, and joint collaboration activities to support SMEs (EventXchange) in the field of digitalisation, biomarkers, nano-electronics and multi-omics in the life sciences [more]
  • Financial support for short-term exchanges within Europe: ClusterXchange. The ClusterXchange programme is a new pilot programme to financially support short-term exchanges to better connect Europe’s industrial ecosystems. [more]
  • Cluster management skill development to boost excellence in delivering SME support

 

Visit the CELIS website now!

DIGI-B-CUBE

DIGI-B-CUBE

Lead by Oslo Cancer Cluster, the DIGI-B-CUBE project aims to unlock the cross-sectoral collaborative potential of SMEs by combining Artificial Intelligence (AI), Cognitive Computing Digital Technologies (CCDT) with the Bioimaging-Biosensing-Biobanking (B-CUBE) industries to deliver market sensitive disruptive technologies and generating innovative solutions that enhance patient-centred diagnostic work-flows, delivered through the improved algorithms for Medical Diagnostics’ efficiency and accuracy.

Visit the DIGI-B-CUBE website now!

MATMED

Developing cross-border partnerships to boost innovation in advanced MATerials for MEDical applications

Are you a health SME, looking to accelerate your innovation within the fields of Advanced Materials and Medical Devices? MATMED is your project!

MATMED supports SME innovations through different services:

  • Online platform to match with a MATMED partner or a service provider, that can help develop your innovation.
  • Acceleration Programme:
    • €12,500 vouchers to reach TRL 4-5;
    • €25,000 vouchers to reach TRL 6-7.
  • Private investment - Matchmaking events to connect you with specialised investors.
  • Regulatory workshops, to adapt your company to the new EU Medical Device Regulations (2017/745 and 2017/746).

 

Interested? You can register for free at www.matmed.eu!  

SAPHIRe – Securing the Adoption of Personalised Health in Regions

SAPHIRe

SAPHIRe is a 3.5-year project (2019-2022) managed by a consortium consisting of the department of Economy, Science and Innovation of the Flemish Government, the Public Health Agency of Northern Ireland, EIT Health/InnoStars and EuroBioForum Foundation. It aims to structure the application of personalised health at regional level which will drive the transition towards sustainable healthcare and personalised health. To realise this goal the consortium mapped personalised medicine and health policies in European regions, to understand barriers, gaps and to identify good practices. There was also a special emphasis on remote and sparsely populated regions and regions with limited resources, innovation and/or absorption capacity to ensure access to advanced developments in this field for all.

Visit the SAPHIRe website now!

 

Vanguard Initiative Smart Health

Vanguard Initiative Smart Health

The Vanguard Initiative (VI) is an initiative of European regions seeking to influence the European political agenda. The initiative’s vision is that inter-regional collaboration to develop new, innovative value chains is essential to accelerate the uptake of innovative technologies and thereby provide solutions to the societal challenges facing European regions. VI has developed a methodology (learn – connect – demonstrate – commercialize) to facilitate and accelerate this type of collaboration. In 2021 the VI Smart Health pilot was launched. This pilot will bring the agenda to implement personalised medicine to the next level while transforming the connected European industrial value chains. The partner regions already established solid ecosystems combining biomedical, technological and data-driven expertise. By bringing these ecosystems together, a higher added value will be reached and boost the implementation of personalised medicine. It will realise an innovative approach for health and care in Europe.

 

Visit the Vanguard Initiative Smart Health website now!

Synergistic biobanks

Discover specific patient samples for the development of new diagnostics thanks to our synergistic biobanks. We are ready to help you submit or specify your request to the biobanks or search for scarcely available samples. 

Biobank Graz

Biobank Graz

Biobank Graz is one of the largest and most well-known clinical biobanks in the world. Around 20 million individual specimens of body fluids and human tissue are stored here. Biobank Graz allows access to these specimens and associated data for scientific research purposes. The common goal is to develop approaches to diagnosing and treating disease.

Biobank Graz is a central service institution of the Medical University of Graz that supports biomedical research by collecting, processing and storing high-quality biological specimens and associated data. Biobank Graz works closely with academic and industrial research partners while building up specific cohorts, operating basic collections and making the specimens along with associated anonymized/pseudonymized data available for research projects. See full specimen collection.

Please find their homepage here.

BBMRI-ERIC

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.
BBMRI.be

BBMRI.be is the Belgian National Node of the European biobank infrastructure BBMRI-ERIC.

The BBMRI.be network connects 18 Belgian biobanks that are linked to public institutions such as hospitals, universities and research centers. The BBMRI.be network offers not only samples and data but also expertise on several biobank topics including ethical-legal, quality and IT issues. More information about the network can be found on the homepage: https://www.bbmri.be/

  • Samples and/or data needed? The collections of the BBMRI.be biobanks can be consulted in the online Directory: https://directory.bbmri.be/ . Due to the link with the Negotiator of BBMRI-ERIC, researchers looking for samples can also easily negotiate with our different biobanks about sample/data requests.
  • Expertise needed? Do you have a question about the Belgian biobank Law, the notification of your biobank, the new biobank ISO standard (ISO 20387) or other biobank related questions, don’t hesitate to contact us at BBMRIbe@kankerregister.org.
  • Looking for collaboration? BBMRI.be welcomes all Belgian biobanks with translational research potential  as well as biobank users that are seeking structural research collaborations with the BBMRI.be network to join the BBMRI.be network. 
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.

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

What Codex4SMEs has been doing?

Codex4SMEs has been supporting SMEs in Companion diagnostics (Cdx) in expediting their innovations since 2018. Since the beginning of the project, we have successfully completed a range of services. Learn here about our previous services and how they have helped our SMEs.

Free Sample Access Service

Biobank Graz is one of the largest and most renowned clinical biobanks in the world. It stores around 20 million individual samples of body fluids and human tissue. Biobank Graz provides access to these samples and the associated data for scientific research purposes. The overall goal is to develop novel diagnostic and treatment approaches for diseases. More than 40 SMEs applied for the sample access offer of Biobank Graz. A sample screening was carried out at 25 SMEs to verify whether the desired samples were available. In total, more than 10 SMEs received patient samples.

The biggest advantage is the capacity of Codex4SMEs to provide access to patient’s samples to facilitate the validation of early concept in the area of cancer research.”

Life&Soft, France

Pitch Trainings

Financing the cost-intensive research and development of innovative diagnostics is particularly difficult for small and medium-sised companies. For the young companies, the pitch training in preparation for the Pitch & Win Session and the MeetMyInvestor roundtable with investors are more than welcome.

“The pitch training was very well organised with initial brief and to the point webinars and subsequently two personal web based sessions and it finished with F2F practicing. Especially the direct feedback on the content of the presentation, but also how it was presented was very useful and really helped to shape the message towards investors."

Han van 't Klooster, CEO of PharmaCytics

Pitch Sessions

Access to large pharmaceutical companies and investors is one of the main pillars for successful entry into the highly regulated healthcare market. The Codex4SMEs partnership has paved the way for SMEs to facilitate access to large pharmaceutical companies and investors.

Since companion diagnostics are associated with a specific molecule or treatment rather than their global therapeutic target, it is mandatory to collaborate with the pharmaceutical industry and present a joint product to get closer to the market. Diagnostic companies looking to enter or get closer to the market received pitching support and were invited to attend a dedicated pitch session. During the MeetMyPharma session, SMEs presented their technology to the pharmaceutical company Sanofi. 

"The online round table gave insight in the needs and interests in companion diagnostics for oncology of a big pharmaceutical company (Sanofi). The event also provided the opportunity to learn about the activities of other SMEs in the North-West Interregion in the field of precision medicine for cancer.”

Guido Zaman, Ph.D. Managing Director & Head of Biology NTRC

 

“I already had some responses to the pitch and requests already to share the deck. So the session for me was definitely successful.”

Omnigen BV, The Netherlands

Information & Networking Events

With the aim making it possible for all players in the field of diagnostics and personalised medicine to exchange the latest trends, to gain insight into the development of diagnostics and to establish valuable contacts for future collaborations, 10 information and networking events were successfully organised. More than 300 stakeholders participated in the events and/or benefited from the opportunity to establish new contacts.

“We are delighted to host this information and networking event in Galway. It provides an excellent opportunity for SMEs working in the Companion Diagnostics field to hear the latest information from experts in diagnostics, regulation, investment and other topics. There is a formal networking session incorporated into the event where attendees can meet up with other attendees and discuss collaborative projects and possibilities.”

WestBIC, Ireland

Roadshows

Five roadshows were organised in the cities of Paris, Galway, Leicester, Leiden and Stuttgart to highlight the market potential for companion diagnostics and medical devices in personalised medicine in the partner regions. Outstanding key opinion leaders from large enterprises, research institutions and hospitals presented their technologies, competences and/or medical needs to bring new diagnostics to healthcare market in collaboration with innovative diagnostics developing SMEs. The roadshows at dedicated events offered the opportunity to strengthen the business of the SMEs and initiating long-term partnerships and deals.

Biomarker Validation Award

Within the framework of Codex4SMEs, four companies from Germany, France and the Netherlands have been granted the Biomarker Validation Award. The winners of the Biomarker Validation Award - for which companies from North-Western European countries could apply - benefited from the opportunity to have their selected biomarkers validated by an internationally renowned biobank. The four companies took advantage of this service, which was provided by Integrated Biobank Luxembourg - a service valued at approximately 100,000 euros. The service provides a solid proof of concept for the biomarkers of the awarded SMEs, resulting in a potential 'new product' for the company with the opportunity to bring their product one step closer to the market.

“The best advantage of the project was to receive independent and objective data and evidence regarding our project development.

Mediagnost GmbH, Germany

"Metabrain Research SA intends to develop further therapeutics in conjunction with CDx and can build on the knowledge gained in Codex4SMEs for these projects for which it intends to set up new collaborative R&D partnerships following its PRO approach." (read more)

Metabrain Research SA, France

Knowledge Transfer

Biobank Graz is not only one of the largest biobanks in the world, but also offers a wide range of training courses on sample collection, processing, storage, shipping and quality management of samples. From this knowledge transfer, 21 SMEs could benefit, who participated in trainings on the following topics:

  • Influx of Data,
  • Single Cell Analysis,
  • Automation of Biobanking Processes
  • The Biobank sample collection at a glance,
  • Finding Samples and Data with the BBMRI-ERIC Directory & Negotiator
  • Biobanking of Placental Tissues,
  • Biological Samples in Biobanks,
  • Quality of Biomarkers and Testing Cycle
  • How to build a biobank – interactive 3-days course

Guide platform for regulatory and reimbursement issues

One critical hurdle for developers of 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 diagnostics a list of information that compiles all relevant links on this topic published by public authorities, agencies, institutes, associations or initiatives.

European Union | European Commission & EMA

Institution Description Type
European database on medical devices (EUDAMED) registration system, a collaborative system, a notification system, a dissemination system Regulatory
European Medical Agency (EMA) Scientific evaluation, supervision and safety monitoring of medicines in the EU 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 Device Regulation (MDR) REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 Regulatory
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
Guidance MEDDEVs MEDDEV documents summarize the consensus of various working groups that were proposed later to the EU Commission. The contents are guidelines that are developed for the application of the EU directives for medical devices and are revised on a regular basis. The MEDDEV documents support manufacturers by providing further details on the regulatory requirements, in particular those of the directives. MEDDEV is derived from MEDical DEVices. Regulatory
MDCG endorsed documents and other guidance The Medical Device Coordination Group (MDCG) addresses important medical device issues, for example, supervision of Notified Bodies, standardization, market surveillance, international affairs, new technologies, or clinical trials.

Thirteen subgroups, organized by topic, provide advice and produce guidance on their areas of expertise.
 

 

France | National Alliances, Agencies & Institutes

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 |National Agencies & Institutes

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

Dokumente Medizinprodukte
Zentralstelle der Länder für Gesundheitsschutz
bei Arzneimitteln und Medizinprodukten (ZLG)

 

 Documents relevant to the ZLG's scope of work in the field of medical devices can be found on this page. These include the rules for the approval and notification of laboratories and bodies as well as the answers and resolutions drawn up in ZLG committees with interested parties. In addition, documents of the Medical Devices Working Group (AGMP) of the federal state authorities responsible for this area can be accessed here.  Regulatory

 

Ireland | Health Products Regulatory Authority

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 | National Agency

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

 

United Kingdom | National Agency

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

 

Associations & Initiatives | Market Access & Reimbursement

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
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
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
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 Society of Human Genetics (ESHG) ESHG promotes research in basic and applied human and medical genetics Healthcare R&D

 

The Biomarker Commercialization guideline is online! Provided by our partner project 'Biomarker Commercialization'

>> BIC - guide

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.

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