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Project to Spur on Companion Diagnostics Development Launches in Europe

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NEW YORK (360Dx) – A new European project commenced this week to accelerate the development and adoption of companion diagnostics by small and medium-sized enterprises.

The "Companion diagnostics expedited for small and medium-sized businesses" (Codex4SMEs) project has a budget of 3.1 million ($3.7 million) and is slated to run for the next three years. It involves partners from seven European countries and has been funded through the European Union's Interreg North-West Europe program, which aims to increase cooperation in Europe's northwest.

Margot Jehle, a project manager at BioRegio STERN, a Stuttgart, Germany-based company that supports the region's life sciences industry, is leading the new project, which aims to build a transnational network for supporting companion diagnostics made up of a variety of players.

"The combination of regional economic development organizations and biobanks creates the ideal conditions to provide companies with direct access to specific expertise such as the verification of biomarkers," Jehle said.

Other institutions contributing to Codex4SMEs are the EU Business and Innovation Center for Ireland's Border, Midlands and Western Regions (WestBIC); CÚRAM, the Science Foundation Ireland Center for Research in Medical Devices; the University of Leicester in the UK; Medicen Paris Region cluster in France; Dutch technology funding body BOM Holding; the Integrated BioBank of Luxembourg (IBBL); and Biobank Graz at the Medical University of Graz in Austria.

"Our core services will be knowledge transfer in regards to biomarkers and biobanking, sample access, and a biomarker validation service that will be provided by both biobanks," Jehle noted.

According to Jehle, currently just 1 percent of therapies in Germany are accompanied by companion diagnostics. One of the premises of Codex4SMEs is that smaller firms are best poised to take advantage of that deficit. By creating a network involving resources in countries throughout the region, Codex4SMEs aims to support such businesses along the entire companion diagnostics value chain. The project held an initial meeting this week in Stuttgart, and invited representatives from a number of interested companies.

Alexander Wittmann, who is responsible for marketing and project management at GPS Grosch Pharma Service, a Waiblingen, Germany-based firm that offers marketing and sales services for the healthcare industry, attended the initial Codex4SMEs meeting. He said it allowed him to network with SMEs that are about to enter the German market and explore joint business opportunities. It was "an opportunity to gain more insights on some of the current challenges in the biotech-branch and to perform some valuable networking," Wittmann said.

According to Jehle, one issue facing European SMEs developing companion diagnostics is a perceived lag behind the US. "Northwest Europe is not competitive with the US in the implementation of companion diagnostics," she said. She provided several reasons for the delay, including the lack of a regulatory framework in Europe to support the clearance of companion tests.

Europe is currently in the process of adopting a new directive covering in vitro diagnostics that is set to come into force by 2020.  

Another reason that European SMEs have not been as successful as their US counterparts in developing companion diagnostics is high development costs, which she estimated to be greater than 5 million, as well as a lengthy development time of over five years. "The US is far ahead of Europe in creating a commercially attractive regulatory and market structure," Jehle said.

The Codex4SMEs project aims to remedy that by supporting partners in three phases: incubation, acceleration, and growth. It is an aim of the project to involve around 200 SMEs in the field of companion diagnostics, Jehle noted, roughly a quarter of which should increase their technology readiness level by at least one phase by accessing the network's expertise in knowledge transfer, sample access, and biomarker validation.

Jehle added that Codex4SMEs hopes to collect at least 100 letters of intent from members and sponsors to sustain the network and provide services beyond the three-year window of the project.

One of the institutions taking part in Codex4SMEs is CÚRAM, Science Foundation Ireland's Center for Research in Medical Devices, which is based at National University of Ireland, Galway. SFI established CÚRAM in 2015 to combine existing hubs of expertise in regenerative medicine, biomaterials, glycoscience, drug delivery, and device design.

Abhay Pandit, CÚRAM's scientific director, said that the Codex4SMEs project is aligned with CÚRAM’s aims to improve quality of life for patients with chronic illnesses and to reduce costs in public healthcare, of which companion diagnostics play a role.

According to Pandhit, CÚRAM's current clinical targets include cardiovascular, musculoskeletal, soft tissue, renal, respiratory, and neural diseases, which will be its focus in the new project. The center will also work with other participants to exchange experience and knowledge "with the long-term aim of having significant economic and social benefits for the region," he said.

Ireland is home to numerous biotechs and pharmaceutical companies that already liaise with CÚRAM, Pandhit noted, from startups to SMEs to multinational corporations. Pandhit said the center supports industry from the basic research level through clinical development and into commercialization readiness. All of these partners stand to benefit from Codex4SMEs, he said.

"This model is particularly attractive for SMEs and the development of indigenous industry," said Pandhit. "The companion diagnostics market is expanding in number and application into other disease areas, such as infectious or widespread diseases as diabetes or cardiovascular diseases," he continued. "Therefore, the project will involve as many SMEs as possible to achieve added value through the territorial cooperation of the eight partner regions."

The project should also make Ireland more competitive Pandhit noted, as the shared infrastructure created via Codex4SMEs should "reduce disparities" between "innovation leader" countries in the region, such as Germany, and "innovation follower territories," which he named as the UK, Ireland, Netherlands, France, and Luxembourg.

Arnaud D'Agostini, head of marketing and communications at IBBL, said the institution will contribute to Codex4SMEs by offering biomarker validation services for biomarker candidates from members of partner clusters. "Partners benefiting from IBBL service will receive an objective evaluation of the potential clinical application of their biomarker," D'Agostini said.

Under this scheme, different participating SMEs will propose biomarkers to be validated and IBBL will then screen the markers and recommend which markers to further validate. D'Agostini said that IBBL will work closely with Biobank Graz, which will be responsible for providing the samples necessary for validation.

"The deliverables for this activity are the recommendation report, the list of biomarkers selected for validation, and a biomarker validation report for each selected biomarker," D'Agostini said.

He added that as part of Codex4SMEs, IBBL will aim to boost SMEs' time to market, and to connect pharmas and clinics with SMEs, contract research organizations, and R&D centers that can assist them. The biobank will also work to establish more collaboration between SMEs and clinical networks that support clinical trials, he said.