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The biomedical sector is full of giants, but it’s the start-ups that connect the dots

IMI has enticed over 300 SMEs to join our research efforts, despite legitimate concerns about IP and consortia size

By Pierre Meulien, IMI Executive Director

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Joining an IMI consortium is one way for SMEs to work with experienced partners ​​and to get to know their potential clients' needs, as well as the expectations of regulating authorities. Image by RAEng_Publications/Pixabay

 

European universities generate impressive results, but to boost industrial growth, their discoveries need to be connected to the needs of industry. That’s where SMEs can come in. IMI brings start-ups together with pharma industry giants in a mutually beneficial partnership that helps the EU pharma sector compete on the world stage, one of IMI’s principal objectives.

SMEs are where early-stage innovation happens, and IMI is attractive because we can fund this early part of the research without diluting a start-up’s capital or impeding their growth strategy. It can be difficult for small players in the biotech industry to raise the funding necessary to conduct large-scale clinical trials, for example, and joining an IMI consortium is one way to work on an asset with experienced partners and get it to the later stages of drug discovery.

Is IMI the best funding fit?

However, IMI consortia are large and complex, and participation requires considerable time and effort. Small businesses often don’t have the resources to dedicate to the task, and may look to other (simpler) funding instruments either within the European research funding family of instruments, or indeed those offered by their national research bodies where the bureaucracy is comparatively lower and the admin is in their own language.

SMEs that develop products (as opposed to services and assays), are more likely to worry about protecting their intellectual property. As a result, IMI tends to attract SMEs that build things like computer models, chemical libraries or screening platforms because they’re a better fit for the IMI model.

 

IMI has had to work to overcome these challenges, which are very sector-specific, to attract more SMEs to our projects. Other public-private partnerships don’t have these problems because they are often in new industries that are being built from the ground up (like hydrogen and bio-based industries), and whose ecosystem today is largely made up of SMEs.

For a start, we've done a lot of education on intellectual property rules. If an SME comes on board an IMI project, they need to know that the IP they have established is protected so that if a pharma company is interested in their technology, there'll be a licensing agreement. The reassurance that nobody will walk away with their technology has been vital in attracting SMEs.

Making the SME opportunities more obvious

The other thing we have worked a lot on is the topic texts that make up the IMI calls for proposals: one of the reasons IMI had disappointing numbers of SME applicants in the early years was that it just wasn’t obvious from the topics in the calls where an SME might fit in. We did a lot of work to write the topics in a way that made it more obvious why SMEs should get involved. Later topics bringing in novel technologies attracted more SMEs, such as those concerning patient remote monitoring (see IDEA-FAST, MOBILISE-D, Trials@Home). SMEs specialised in artificial intelligence have joined MELLODDY to help create a machine-learning platform to learn from multiple pharma partners’ datasets while respecting their confidentiality, a sticking point for the industry.

The European Lead Factory was set up to help SMEs translate their innovative design ideas into industry‐standard compound libraries and give them free access to industrial screening capabilities without cost. We have other great examples of SMEs that have been hugely successful in IMI projects because of the nature of what they do, and they are not confined to one disease area. There are 15 SMEs involved in the antimicrobial resistance project ENABLE, and they are benefitting from access to top AMR drug discovery expertise brought in by other partners. Meanwhile, RADAR-AD’s SME experts are helping combine smart devices with data analytics to work on remote health monitoring for patients with Alzheimer’s disease.

Real-world (and regulatory) experience 

IMI projects offer a great opportunity for SMEs that want to test their technology in real world situations and gather evidence that they can later use to support their regulatory applications. The biggest advantage for SMEs, however, in joining a consortium is that they end up with direct access to their potential market. It’s win-win, because pharma companies can learn about innovative but mature technologies, and the SME can potentially benefit from a licensing deal that can perhaps help them invest internally on other innovations. An SME could be asking for a million euro (from IMI) to allow them to develop an asset up to advanced preclinical phase, and this financing is unencumbered. We don’t ask for any part in their company in exchange for the funding, which is what any other investor would do. In this case, the investor is European citizens, and the return is to European citizens, too, in the form of faster access to new medical innovations.

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