According to Vinnova’s Vision-driven Health programme, Sweden shall be a leader in the field of advanced therapies by 2030, i.e. medicines based on gene, cell and tissue therapy products. The five-year initiative aimed at achieving this goal commenced at the end of 2019 and has made good progress towards some of the sub-goals.
Advanced Therapy Medicinal Products (ATMPs) are a completely new type of medicine in which the active substances are genes, cells, and tissue. Some ATMPs are already on the market and research is well-underway in several areas. The medicines are both difficult to develop and expensive to make, and there are considerable logistical challenges when it comes to storing and transporting medicines based on living cells.
Vinnova funds and supports long-term, visionary innovation environments that engage operators across society to jointly make a difference for the health of inhabitants. One of these innovation environments is focused on advanced therapies. The work involved to make Sweden a leader in the field of advanced therapies by 2030 is not run as a normal project, but is more of a collaboration where researchers, companies, healthcare, government agencies and politicians work together to solve a number of challenges with the goal of realising the vision. The work is coordinated by a core team of seven people from different organisations, including associate professor Jukka Lausmaa and researcher and biomedical student Jim Lund at RISE. Both consider it self-evident that the vision will become a reality.
“– By 2030, all processes and infrastructure will be in place, it will be attractive to develop these medicines in Sweden and they will be available to patients,” says Jukka Lausmaa.
Barely a year after getting off the ground, 18 partners are involved in the work, including large and small research companies, the Swedish Medical Products Agency, the Swedish Association of Local Authorities and Regions (SALAR), universities, patient representatives and the pharmaceutical industry’s trade association - all of which have different perspectives and driving forces. Together they work towards achieving a number of sub-goals.
“– One sub-goal involves mobilisation efforts; looking at what already exists in the country and identifying synergies. We also need to network and collaborate internationally,” says Lausmaa and adds:
“– So far we have carried out a survey of the landscape in Sweden and compared ourselves to eight other European countries. The results show that Sweden has research of a very high quality - we are actually second best taking into account the size of the country.”
In the long term, there must also be a new type of logistics chain in healthcare
About twenty companies in Sweden
The survey has also shown that there are currently around 20 companies in Sweden doing research in the field of ATMPs, and that they are very successful at obtaining funding from the EU.
Another sub-goal focuses on necessary infrastructure for commercialising the new medicines.
“– Development at process level is required along with capabilities to produce the medicines according to applicable regulations and criteria,” says Jim Lund. “In the long term, there must also be a new type of logistics chain in healthcare.”
RISE has brought together a number of small innovation companies in an independent council in order to identify infrastructure needs, both now and further down the line. Based on the needs, different concepts that already exist in other countries are examined.
“– We have concluded that infrastructure must be invested in nationally and not just regionally,” says Lund. “We have also found that process development and production should preferably be under the same roof and in the same organisation to ensure an efficient transition to production.”
Given the rapid pace at which international developments in the field of ATMPs are moving, Sweden needs to have efficient infrastructure in place as soon as possible. Lund hopes that work to start implementing this will get underway as early as 2021. However, it is imperative that both the State and other actors are willing to invest.
“– To achieve the greatest possible efficiency, we believe that a brand-new, independent entity needs to be created,” asserts Lausmaa. “It must not be incorporated into an existing organisation and it must definitely be highly specialised. This will help create value and jobs in Sweden.”
He adds that several of the country’s university hospitals have already built up some capacity in this area, but that that infrastructure is not intended for commercialisation as it is tailored to the needs of hospitals to, for example, carry out clinical studies with ATMPs.
A third sub-goal is geared towards healthcare. It focuses on organisation, expertise, and infrastructure, as well as health economics. The advanced therapies are very expensive but can also be very effective and are able to, for instance, cure a chronic disease with a single treatment.
“– The way health economists perform calculations is based on current medicines and their efficacy,” explains Lausmaa. “There is a major challenge in getting health economics assessments and the healthcare payment system to function together.”
Network of hospital pharmacies
The initiative has, thus far, established a network for the country’s hospital pharmacies, set up a team of healthcare lawyers to discuss agreements and similar, and arranged various educational courses.
Education constitutes another one of the sub-goals. It is already difficult for the Swedish companies to find the necessary skills within the country’s borders, but the fact remains that securing skills for the future is important.
“As the area grows, the need for people with specialist skills in the field of ATMPs will increase,” says Lausmaa. “There is no academic programme on ATMPs in Sweden at present. One of our goals is to establish a national research academy in the field and we will try to get the Swedish Research Council and universities involved in this.”
“Decision-makers, the general public and patients also need to be informed of the opportunities and challenges posed by these medicines,” says Lund. “For example, some believe that ATMPs are the same as precision medicine. That’s not true. Precision medicine is a concept that largely involves individual patient diagnosis. ATMPs can be used in precision medicine, such as by making specific changes to the genome based on genetic or other diagnostic analyses of a patient. But the two concepts are not equal.”
Lausmaa and Lund both emphasise that ATMPs constitute an incredibly important future area in healthcare, and they underscore that Sweden must invest in the field to keep up with rapidly moving developments.
“We cannot solely invest in research – we also need to build infrastructure and review processes and laws so that research investments are able to create value effectively and benefit patients and society as a whole,” says Lund. “But I’m an optimist, we will reach our goal by 2030. Failure is simply not an option.”