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New opportunities for SMEs in early drug testing

Pharmaceutical firms spend millions every year ensuring that new drugs have no adverse side effects. By combining stem cell, software and hardware expertise, an innovative SME-led project has developed a new method that enables drugs to be tested early on in their development for any negative effects on the human heart.

Demonstrating drug safety can be an expensive and frustrating process, especially if negative results follow years of patient R&D investment. Then it’s back to the drawing board to start again.

In order to address this challenge, CardioXpress, a recent collaborative project supported by EUREKA’s Eurostars programme, successfully developed a cost effective means of testing the cardiac safety of drugs early on. Commercialisation of this breakthrough is now ongoing.

Cost-effective testing

“Our goal was to develop a high throughput system to test human cardiac cell cultures,” explains Karl-Heinz Boven, CEO of project partner Multi Channel Systems (MCS), Germany. “The system works like this: Cells obtained from human skin cells are first transformed into cardiac muscle cells and cultured. Electrical signals are recorded and corresponding analyses carried out, enabling conclusions to be drawn about the effect or side-effects of new substances on the human heart.”

The CardioXpress system has proved its effectiveness, and has the potential to save pharmaceutical firms and medical research institutes millions in R&D costs. It also removes the need for animal testing. Now on the market, the system is being targeted at academic institutions in this initial phase of commercialisation.

“This has traditionally been our market,” explains Boven. “Also, there is strong competition in the pharmaceutical market, though feedback from the pharma sector has also been very promising.”

Tapping SME strengths

The CardioXpress project’s success also underlines the game-changing potential of SMEs when they combine their expertise towards a common goal. “A key challenge in this project was ensuring that the stem cell biologists, hardware experts and software developers involved in this project all spoke the same language as it were, and read off the same page” says Boven. “And as we are all SMEs, we had to make sure that we came up with something commercially viable that we could market.”

The project brought together Notocord Systems (France), Multi Channel Systems (Germany) and Pluriomics (Netherlands). Effective cooperation – achieved in part through regular one-on-one meetings between the different project partners – led to positive results early on. “Eurostars funding also enabled us to focus on this specific field,” says Boven. “Like many SMEs, our staff are often spread over several product fields, and without this focus, our work would undoubtedly have been delayed.”

Onwards and upwards

Thanks to CardioXpress, project leader Notocord Systems were able to increase their technological expertise dramatically: they started to use fast computing techniques, investigated new generation of database technologies, used a new environment of software development and improved their know-how in using adaptive signal processing technologies.

“As we are all SMEs, we had to make sure that we came up with something commercially viable”

The project is also part of the reason why project partner Multi Channel Systems has been able to expand its staff from 45 to 60 over the past three to four years, bringing in additional R&D specialists, software engineers and hardware experts. The next step will be to expand the CardioXpress system to enable the testing of more types of pharmaceutical drugs.

“We have received a lot of interest in the concept high throughput combined testing system,” says Boven. “But perhaps most significantly, we are currently sponsoring – along with other SMEs – a study into Induced Plurient Stem cell (IPS) testing systems, which could lead to an FDA regulation stipulating that such tests are mandatory. This is a huge opportunity that would benefit both pharmaceutical firms and providers like us. Results so far have been positive, and we expect the final study to be published towards the end of next year.”