IMI: What was the main outcome of the project and how will it benefit patients in the future?
Michael Merz: We have generated a lot of data on new biomarkers – molecules that we can measure in the blood or urine – that allow us to detect drug side-effects earlier and more accurately than has been feasible in the past. In addition to helping detect drug-related injuries, these biomarkers will also help improve diagnosis and monitoring in chronic disease patients. They will help clinicians make better decisions on specific treatment alternatives and other things, such as when to stop treatment.
So yes, I think there will be lots of benefits to patients across a large variety of different diseases. However, there is still a lot of work to be done in the next couple of years: the same kind of data we generated within SAFE-T for drug development purposes, we now need to generate for chronic and acute disease populations. For example, our biomarkers may be of value when it comes to transplant rejection, but there is still a lot of work to be done. That’s why we’re now planning follow-up projects and initiatives.
IMI: Some of the biomarkers generated within your project recently received letters of support from the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). What does this mean for the project?
Michael Merz: It means that the two leading regulatory agencies in the world said: this stuff is good and interesting, go and use it, and generate more data so we can understand these biomarkers in more depth. Thus we still need more data before we can ‘qualify’ these biomarkers for use in clinical trials.
IMI: Which project accomplishment are you most proud of?
Michael Merz: The fact that we achieved six out of eight major objectives is something we’re all proud of. There were times during the project when it looked like we would not achieve what we have achieved, yet we still did. We’re also proud of ourselves a team – it is not always easy to maintain team spirit and enthusiasm over such a long period, but this team did it and it helped us a lot to achieve our objectives. Keeping people motivated is really crucial to complete such a complex qualification programme.
IMI: There were several SMEs participating in the project. Did you note any SME success stories during the course of the project?
Thomas Joos: Indeed, we did. For example, a French biotechnology SME, Firalis, was an early start-up when they joined our project. Participating in SAFE-T allowed them to hire additional employees: they went from 5 to 70 people in 7 years. It also allowed them to get additional infrastructure and acquire two innovative biotechnology companies in France, building a dedicated French network. Now, after 7 years, they’re really seeing a return on their investment. Participating in this IMI project helped them a lot to get to where they are now.
SAFE-T also led to creation of a spin-out. Based on the SAFE-T activities at the Natural and Medical Institute at the University of Tübingen (NMI), we set up a new biotech company SIGNATOPE which is benefitting a lot from the interaction with the Critical Path Institute in the US, one of the collaborators in the project.
IMI: Could you tell us a bit more about this spin-out?
Thomas Joos: SAFE-T inspired a great business opportunity. The spin-out company is dedicated to immune assay technology, more specifically to cross-species immune assays. For example, we developed kidney assays to measure kidney injury in dogs, cats, rats, and monkeys, which is important for the pre-clinical trial phase of drug development. It took quite a while to develop the assays, but now we already have a couple of projects with some of the industry members of the SAFE-T consortium.
In the short-term, we have a five-year commitment of the NMI to host the company in their incubator. When it grows to more than 15 members, the company will have to move out. It should be solid, organic growth – it is a service company with the potential to make €30 million revenue in the next 7 years and become a leading company in this field.
IMI: What was the main value of this project for the academic community?
Thomas Joos: Prior to the project, the academics were on a different knowledge level in this field. Yes, we had scientific expertise, but the complicated and cumbersome biomarker qualification process took much more time than anticipated. Our tests required appropriate validation prior to getting acceptance by the regulatory agencies. And the collection of high quality sample needed much more time. We had great support for some aspects of the project, for other aspects it was a bit more difficult, but at the end of the day we achieved our goals.
IMI: How did the public-private nature of this IMI project contribute to all the achievements? Would it have been possible without IMI?
Michael Merz: No, it wouldn’t have been possible. The key was to have this framework that IMI has set up, bringing public and private partners together, bringing the SMEs into the collaboration, and establishing the contact with regulators. This framework and concept was the driving tool which helped us bring everything together.
IMI: Michael, what was the biggest lesson you learned as a project coordinator? If you could give a tip to someone who is about to become an IMI project coordinator, what would be the number one advice you would give them?
Michael Merz: Put as much time and energy as possible into discussions with other people during the planning phase. Really invest as much time as possible in the planning of the project and have your initial plans re-checked and re-evaluated by other people. These are complicated programmes and you really need to make sure that you have all the nuts and bolts in place in your project plan, so you’re not forgetting anything. Also, try to get critical and constructive feedback from experts outside the consortium. Make sure that key experts, relevant to the area of research you’re engaging in, have a critical look at your project plan.
IMI: Anything else you would like to add?
Thomas Joos: It is really commendable that more than a year after the end of the project, a lot of people are still contributing a lot of energy to our project. And things are exciting - we received letters of support from the FDA for our liver, kidney and vascular system biomarkers, and from EMA for our liver biomarkers. We’re confident that other letters from EMA will be coming as well. The initial feedback we’re receiving seems positive.