Proximity to their customer base means SMEs can fine-tune their products and spot new applications for them. It also helps with the regulatory process
They’re reactive to changing and challenging environments and often headed up by entrepreneurial types who aren’t afraid to take risks. Small- and medium-sized enterprises (SMEs) are powerhouses of the economy, and they drive industrial growth and job creation in Europe.
What's in it for SMEs?
IMI brings SMEs into our projects to bridge the gap between universities and pharma giants on the hunt for innovations that will keep them competitive. For an SME, the attraction is not just about funding; being part of a consortium grants them unparalleled access to a network that includes their target market. The consortia are made up of an SME’s potential customer base, and ‘access’ doesn’t just mean catching up on the side-lines of events and conferences. Small businesses get to work on a regular basis alongside the pharma companies that might be interested in their products or services, and for the multi-year duration of the project lifespan, they can have regular, in-depth conversations about what works, what doesn't work, and which product features their pharma partners would like to see. Unlike brief business meetings in which an SME makes a pitch, the objective of these encounters is not a sale. The objective is to find out how to make their product better.
What kind of SME does IMI attract?
IMI is best placed to help SMEs grow once they’ve become viable, but that are perhaps looking to develop their technology further, change direction or diversify. SMEs might join a project simply to offer a service that the consortium needs, or they might want to explore ways in which their technology, developed for one particular use, might be applied in another way. A good example is the Ebola project FILODIAG, whose lead partner Gna Biosolutions, a German SME, expanded their molecular test platform to create an ultra-fast Ebola diagnostic test, and is now being adapted for rapid COVID-19 testing. Many SMEs are focussed on a narrow area, and IMI projects can help them see their product or service from a new perspective.
Some IMI projects have even resulted in new commercial entities that were conceived in response to an unmet need that was identified during the course of the project, such as ITTM (Information Technology for Translational Medicine, S.A.), a Luxembourg company that grew out of the eTRIKS project. While working on eTRIKS, the researchers realised there was a real demand in the pharmaceutical sector for data integration and standardisation services. These services are now provided by spin-out company created by the Luxembourg partners. Other examples include Phenaris, who provide in-silico toxicology services, and Keapstone, which is developing next generation drugs for Parkinson’s Disease based on the results of the European Lead Factory.
Most SMEs that have joined the ranks of IMI projects so far have been applying an existing technology rather than developing a new one. IMI and our pharma partners are unlikely to take a risk on a prototype, but an SME that comes with a working product can use their time in the consortium to tweak their technology, perhaps by adding an extra feature and experimenting with it, all while allowing the project to generate whatever data it needs. A good example of this is the Israeli SME ImmunArray, whose technology, originally developed for diagnosis and monitoring of immune-related disorders, was used in the BIOVACSAFE project for detecting and monitoring possible adverse effects of vaccination.
A prototype, on the other hand, might need months or years before it’s ready to use. However, the pharma industry increasingly recognises that an SME that comes with a prototype can really tailor the product to their end users. If the consortium moves fast, and spends the first six months or a year of a four-year project developing a tailored product, maybe it’s not such a bad bet after all.
Health and the regulatory landscape
The other massive draw for SMEs is the direct route to the regulator. Health is a hugely complex regulatory landscape, and getting the official stamp of approval from the authorities can be tricky. IMI encourages consortium members to talk to the regulators (both national bodies and the European Medicines Agency) as early in the project as possible.
Academics tend not to be familiar with the process, whereas pharma companies often have whole departments dedicated to it. SMEs are usually aware of requirements, but often don’t know how to go about communicating with regulators. Within an IMI project, the pharma companies start getting the message across to both the academic and the small business partners that if they want to have an impact, they need to start engaging regulators from the very beginning.
This is how they can ensure that whatever is generated as part of the project is actually suitable to be used in the drug development process. If the data gathered for an application for regulatory approval is done without first finding out what the regulator wants, it’s possible that an SME will find that the data doesn’t meet the requirements and they might have to start their clinical study all over again.
They need to talk to the regulators up front and ask them what kind of data is needed. The same applies for getting approval from HTAs (Health Technology Assessment) bodies, who determine whether a new drug or technology should be reimbursed by national healthcare systems. An SME might have regulatory authorisation declaring that their drug is safe and efficacious, but the payers will determine whether it’s worth what the company wants to charge for it. IMI encourages all project partners to develop relationships with HTAs from the get-go.
The new partnership
IMI is expanding beyond traditional pharmaceutical based drug discovery research and bringing imaging, diagnostics and medical device-making partners into the fold. This will also involve using more innovative ways of gathering data using wearables and other new technologies. There’s much more space for SMEs and others to get engaged there. Even in the final years of IMI2, the calls have been more technology-driven. Whereas IMI1 projects tended to envision final products that would come 10-15 years after the end of the project, those funded in the later stages of IMI2 tended to expect more immediate results. If we're going in the direction of fast-moving technology, we will find that SMEs are going to be much more interested in joining our projects.