illustrasjon av handlingsplan for kliniske studier

New political paper: Action Plan for Clinical Studies

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The Norwegian government wants to double the number of clinical studies by 2025, but is this goal ambitious enough?

The highly anticipated political paper “Action Plan for Clinical Studies (2021-2025)” was released in Norway by the Ministry of Health and Care Services this week. The government’s vision is to make clinical studies an integrated part of patient care.

A clinical study is a type of research study that tests how well new medical approaches, such as screening, prevention, diagnosis, or treatments, work in people.

The action plan is the first of its kind and has been requested by researchers, clinicians, the health industry and patient organisations for several years.

The number of clinical studies in Norway is on a negative, spiralling trend. This is especially alarming for cancer patients, who are eager to receive novel treatments.

The Norwegian Health Minister Bent Høie now sets the goal to double the number of clinical studies in Norway and include 5% of all patients in the specialist health services before 2025.

“The action plan includes many important points, we believe the bar should be raised higher,” commented Ketil Widerberg, general manager of Oslo Cancer Cluster.

“Our goal should be to make clinical studies available for all cancer patients in Norway – not just a small fraction.”

The government also announced in the State Budget proposal in October 2020 that NOK 30 million will be allocated through the NorTrials scheme. The funds will be used to employ study nurses and improve competency in clinical research.

The Norwegian Health Minister also calls for a change in work culture, in order to make clinical trials an integrated part of patient treatment.

Another major obstacle is the difficulty to recruit patients quickly. The regional health authorities are now tasked with developing a best practice for patient recruitment.

Oslo Cancer Cluster contributed input to the development of this political paper in September 2019. Our major suggestions included:

  • the need for financial incentives to improve patient recruitment,
  • establishing Norway and the Nordic countries as an international testbed for innovative medicine,
  • authorities to collaborate with industry on guidelines on how to approve precision medicine treatments and the documentation requirements.

Read our entire input here (in Norwegian): Innspill Kliniske Studier til Helse- og omsorgsdepartementet (September 2019) fra Oslo Cancer Cluster

 

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statsbudsjett 2021

State budget: 61,3 million to personalized medicine

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Funds for personalized medicine, clinical trials, mature clusters, and digitalisation – these are some of the main points for cancer innovation in the newly released state budget.

In this week’s state budget, the Norwegian government increases the funding for personalized medicine with NOK 30 million to a total of NOK 61,3 million.

NOK 25 million will be used to establish precision diagnostics with advanced molecular profiling in the hospitals, which will give cancer patients a more precise diagnosis. This is also an important requirement for cancer patients to participate in clinical trials.

“The infrastructure for precision diagnostics will improve Norway’s ability to attract clinical studies internationally, it will give more cancer patients the opportunity to participate in clinical trials and it will provide valuable data for further research,” said Ketil Widerberg, general manager of Oslo Cancer Cluster.

The remaining funds for personalized medicine will be used to build competences and begin to establish a national genome centre.

More funding for clinical trials

The Norwegian government announces NOK 75 million to health innovation and clinical studies. The establishment of NorTrials, which will be a partnership between industry and hospitals on clinical studies, will receive NOK 30 million. NorTrials will offer a one-stop-shop for small- and medium-sized enterprises in the health industry and for public institutions that want to conduct clinical trials in Norway.

“Oslo Cancer Cluster has long worked for the establishment of a partnership model for clinical studies between industry and public actors. It is great to see this important aspect addressed in the state budget,” said Widerberg.

More information about NorTrials and the infrastructure for precision diagnostics will be announced in the Action Plan for Clinical Studies, to be presented in December 2020.

As a follow-up to The White Paper on the Health Industry, the Norwegian government also proposes to establish a scheme to improve collaboration between industry and public institutions on health innovation, called Pilot Helse (Pilot Health). This scheme will receive NOK 20 million in funding.

100 million for Norwegian export

A total of NOK 100 million will be used for strategic investments in export opportunities. Most of these funds, NOK 75 million, will go directly to the new unit Business Norway. Another NOK 20 million will strengthen the Norwegian mature clusters through Innovation Norway’s cluster programme. The remaining NOK 5 million will support Norwegian cultural export.

“The mature clusters can assume a central role in creating export opportunities for Norwegian industry abroad. The aim for Oslo Cancer Cluster is to put Norwegian health industry on the agenda internationally, and develop a leading European cancer innovation centre,” said Widerberg.

Greenlight for Horizon Europe

In 2021, an impressive NOK 40,9 billion will be used for research and development, which is 1,1 per cent of Norway’s total BNP.

The government also announced that Norway will participate in the EU programme Horizon Europe. The programme will replace Horizon 2020 and covers the period 2021-2027. It has a total budget of 75,9 billion euro over the entire period.

“It is important for Norwegian industry to participate in Horizon Europe, it brings access to novel knowledge and capital, and encourages cross-disciplinary collaboration, which is essential for cancer innovation,” Widerberg commented.

A new data factory

The budget for digitalisation will be doubled next year: NOK 1,5 billion is set aside. NOK 56,2 million will be used for Norwegian participation in the Digital Europe Programme, which will give Norwegian businesses access to skills and resources in the areas of artificial intelligence, supercomputers, IT security and advanced digital competency.

Another NOK 16 million goes to the creation of a “Data Factory”, which will be set up by The Agency for Digitalisation in cooperation with Digital Norway. The Data Factory will provide services that will help small companies to develop business ideas and create value from data.

At the same time, the newly established Health Analysis Platform, which will make it easier for scientists to conduct research on health data, gains another NOK 35 million.

“There is a massive unleashed potential in Norwegian health data, to create value for both industry and patients. Important hurdles and opportunities are addressed; however, we see the need for even more efforts to understand and treat illnesses like cancer better in the future. With the help of digital tools, we can develop new cancer medicines in 5 instead of 10 years,” Widerberg commented.

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Ketil Widerberg and Bjørn Klem

The new frontier in cancer innovation

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This column was originally published in the Nordic Life Science magazine (September 2020 Issue).

Oslo Cancer Cluster (OCC) Innovation Park and Incubator plans to expand by 5o ooo m² in the coming years. The goal is to create an international innovation hub in cancer. Why? Because personalized medicine is changing cancer innovation.

The Norwegian Prime Minister Erna Solberg had great expectations when she opened OCC Innovation Park in July 2015, including a 5 000 m² Incubator, situated next to the Oslo University Hospital. The goal was to accelerate the development of new cancer treatments.

With world-class researchers in-house, Jónas Einarsson, CEO of Radforsk, investing in cancer biotechs, and one thousand noisy high school students in the same building, what could go wrong? Possibly everything.

At the time of opening, lab inventory and equipment were missing and only a few lease agreements were signed. More importantly, would scientists, investors and students be viewed as weird outcasts or would an attrac­tive innovation platform be created?

The idea is simple; the OCC Incubator helps entrepreneurs to quality check research ideas, to recruit competent people to board and management roles, and to fund projects. One example is Ultimovacs that started working back-to-back with academics in the OCC Incubator lab to develop cancer vaccines. The company is today listed on the Oslo Stock Exchange with an estimated value of NOK 1.3 billion.

Siva, the governmental infrastruc­ture for innovation, has been essential in making this a success. Their long­term commitment as owner and their support for start-up services has helped start-ups reach the next phase. Kongs­berg Beam Technology, for example, recently attracted NOK 27 million from the Norwegian Research Council and private investors to develop real-time cancer radiation steering systems.

The OCC Incubator was awarded the Siva Innovation Prize in 2017 and is frequently listed among the top 20 innovation hubs in Europe. The start-ups in the OCC Incubator have raised more than NOK 5 bil­lion in equity and treated hundreds of patients since its opening.

The Norwegian Prime Minister’s expectations on both job creation and cancer care are certainly being fulfilled.

So why strive for more? Because precision medicine is changing the world and digital oncology is the new frontier.

From personalized vaccines to cell therapy, medicines are increasingly developed for smaller patient groups. However, government systems for approvals and sharing of data go painfully slow, while global technology companies’ efforts in health fail repeatedly. The recent corona pan­demic has proven the importance of both international collaboration and regional sustainability, from develop­ment of tests to treatments.

It is time to join forces in the Nordics!

Real-world data and artificial intelligence will shorten develop­ment times and reduce costs for new cancer treatments. The OCC Incubator will provide labs and infrastructure next to patients, clinicians and researchers to help achieve this.

Our goal is to reduce the develop­ment of new cancer treatments from 10 to 5 years.

 

Written by: Ketil Widerberg, general manager of Oslo Cancer Cluster, and Bjørn Klem, general manager of Oslo Cancer Cluster Incubator

 

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Ministers meet at Oslo Cancer Cluster

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The corona pandemic and international trade were on the top of the agenda when the Foreign Minister of Denmark Jeppe Kofod met with the Minister for Trade, Industry and Fisheries of Norway Iselin Nybø at Oslo Cancer Cluster Innovation Park.

Norway and Denmark are close friends and allies, and the current corona situation has made conversations between Nordic colleagues more valuable than ever.

Export, international trade and investments will be crucial to overcoming the challenges the corona pandemic has brought to Nordic economies.

These pressing issues were discussed when the two ministers from Denmark and Norway met at Oslo Cancer Cluster Innovation Park on 13 August 2020.

Ministers Nybø and Kofod

Ministers Nybø and Kofod discussed how to increase export from and attract international investments to the Nordic countries. Photo: The Embassy of Denmark in Norway

The starting point of the meeting was how many companies in the health industry need access to international markets and value chains to grow.

The Norwegian government are preparing an Export Action Plan. It will include several measures to help Norwegian industry come through the corona crisis.

“In the development of the Export Action Plan, the government is collaborating with both industry and financial organisations. We want to gain as much knowledge as possible about where the challenges lie and evaluate which measures are most effective,” Nybø said in a press release from the Department of Trade, Industry and Fisheries.

The Embassy of Denmark in Norway released the following statement after the meeting:

“It is important to attract foreign investments and there is a big potential in Nordic collaboration within the life science sector, since Denmark and Norway have complementary competencies in this field.”

Ketil Widerberg, general manager at Oslo Cancer Cluster, was happy to facilitate the visit and to give input to the ministers on how international collaboration helps the development of cancer treatments:

“Denmark and Norway collaborate on important research areas, including cancer. Our countries have national health data that attract international recognition. Our countries also collaborate on purchasing of developed drugs.

“The opportunity now is the collaboration on how to use our health data and collaborative efforts to better and faster approve new innovative treatments.

“This could reduce development time from 10 to 5 years, and make the Nordics a destination for health innovation.”

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