Sage Therapeutics Alzheimer’s drug likely to progress: regulatory roundup – Clinical Trials Arena

Innovation Fund Denmark (IFD) is a public grant agency that part funds entrepreneurs, students and companies to make new products and solutions that better the lives of Danish people.

The agency currently has over a million euros in active investments. In 2020 alone IFD funded 1002 projects, with 90+ funded projects aimed at improving the health of the population.

For 2021 the agency has been allocated DKK180m (24.2m) for health investment through the Grand Solutions Program, which focuses on challenge-driven research and innovation projects that create new solutions, technologies and valuable new knowledge in life science, health, welfare and clinical research.

DKK 63.3m (8.5m) of that is exclusively for clinical research that focuses on optimising the quality of patient treatment, disease prevention, health technology, and the health services organisation.

The grants are competitive and only the most innovative solutions are successful. As well as innovation, prospective projects are evaluated on social welfare improvements, increased societal wealth, jobs, reduction of CO2 emissions and more.

Clinical Trials Arena sat down with Innovation Fund Denmark investment officer Steen Bennike Mortensen, who recently spoke at this years Outsourcing in Clinical Trials & Clinical Trial Supply Nordics conference, to find out what the grant agency looks for when choosing projects to fund, the flurry of decentralised clinical trial applications in the wake of Covid-19 and some of the exciting innovations in healthcare that have been funded this year.

Steen Bennike Mortensen: We see a lot of research within diseases associated with an ageing population. It could be Alzheimers or other diseases related to ageing where we try to help make the symptoms better. We have seen a lot of new inventions within the daily care sector such as virtual reality to make people feel less alone and like they are participating with other people in daily life because they cannot get out of the house.

We see a lot of incentives within general practices because we have a lot of data in Denmark we monitor everything that happens from birth to death so you can link all that data to test a medication. This data is very difficult to get in other countries because of data security and you do not normally have this kind of data in one place like in Denmark.

We see a move towards decentralised trials and home health. In doing these clinical trials, of course, theres all the legislation around privacy and GDPR thats a really important item to solve in order to be successful here. Especially in Denmark and the Nordic countries, where we have information about all patients.

SBM: I think some of the important projects we have funded are within the area of decentralised clinical trials because its simply a new concept and it makes life so much easier not only for patients but also for the [research] companies. They are much cheaper. For example, you can reach out to patients by using social media. Its much easier to recruit them and make the agreements and the general population is much more interested in using technology now.

SBM: It was started before the pandemic actually but Covid-19 seemed to increase the number of applications because we had a specific call where we [provided grants] in relation to the pandemic. That brought a lot of very interesting applications and it was a very hectic time. Hopefully, for those that succeeded, we will see more mature products in the coming years.

SBM: Sometimes in trials, you need to get samples from people, like blood samples. I think thats where the most critical need is. There needs to be some innovation on how we do sampling closer to or in peoples homes. Right now we are picking the low-hanging fruits with diseases that do not need so much one-to-one interaction with a healthcare professional.

We foresee that in the future, we will start to train more relatives to have these direct actions with their family members involved in a trial. So, you might ask how do we make it fun to be part of these kinds of trials?

SBM: One is Novo Nordisks smart insulin pen for patients with Type 2 diabetes, which is both a glucose monitor and insulin doser at the same time. It can be done already, but its young people hacking themselves. Its something that needs to be very tightly regulated, and thats why you need a clinical trial to test that it actually works. Thats something we have funded as its very expensive to involve patients.

We funded a virtual trial platform that uses mobile phones to check skin conditions like psoriasis and we also funded a project from the University of Copenhagen called FluoGuide, which makes cancer cells fluorescent, enabling surgeons or robots to remove the cancer without damaging healthy tissue.

SBM: First of all, it needs to be a really good idea, with an element of innovation. It needs to be different from all the rest. For example, within clinical trials even the idea of getting the data handling correct is innovative. How can you get the data without violating GDPR regulations? How do you make the app? How do you actually get the app to the patients? A lot of innovations are very practical. It could be a really small problem that when solved would be really beneficial for everybody.

Hopefully, you would have done some initial experiments that show that what you are trying to do can actually be done. You have to set up a team that we believe would actually be able to deliver. You need to have the right partners, have the right competencies and you need to be realistic about your budget, so its not under or over-financed.

You have to describe how you would do it and we need to know that you have actually talked with the people you plan to enrol in the project. Finally, we need to see what you plan to do afterwards whats the next step? It could be plans for a Phase II trial or plans to attract additional funding from private investors.

SBM: We will set up the new call in December and it will be similar to last year. One minor change is that Innovation Fund Denmark would get a little less funding for trials but more funding will be available through the Independent Research Fund. Instead, IFD has got more money for digitalisation, which would involve the decentralised trials aspect.

To access more upcoming clinical trial events, visit the Arena International website.

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28 Aug 2020

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Sage Therapeutics Alzheimer's drug likely to progress: regulatory roundup - Clinical Trials Arena