Ingvild Hagen, Area Owner of Personalized Healthcare at Roche Norway, hopes this will motivate other companies to join the effort of bringing precision medicine to cancer patients. Photo: Roche

First pharma company joins IMPRESS-Norway

Roche is the first pharmaceutical company included in the national clinical study in cancer precision medicine called IMPRESS-Norway.

IMPRESS-Norway is a national clinical trial in precision oncology. Approved drugs will be used to treat new cancer indications (“off label”) based on the molecular profile of the patient’s tumour. The success of IMPRESS-Norway is dependent on molecularly targeted drugs contributed by pharmaceutical companies. Roche is the first company to officially join IMPRESS-Norway. The company will contribute eight different medicines and provide a diagnostic gene test through its subsidiary Foundation Medicine.

“Positive and important news that Roche wishes to contribute their resources. Now, this will be a joint investment in both diagnostics and treatment, so that precision medicine for advanced cancer disease can be offered at all hospitals in Norway. We are very happy that Roche wishes to participate in this initiative,” commented Egil Støre Blix, oncologist at the Cancer Department at the University Hospital of North Norway and member of the Trial Management Committee at IMPRESS-Norway.

IMPRESS-Norway is in dialogue with several other pharmaceutical companies about contributing cancer medicines. These companies have also joined CONNECT, the newly established public-private partnership initiated to accelerate the implementation of precision medicine for cancer patients in Norway (see the fact box below for a complete list of CONNECT Founding Partners).

“The CONNECT partnership and IMPRESS-Norway are important milestones in the implementation of personalised medicine and will drive the development of a more personalised health service,” commented Ingvild Hagen, Area Owner for Personalized Healthcare in Roche. “We hope that in signing the IMPRESS agreement, we are motivating other companies to do the same. To realise the potential of this project, we are dependent on as many partners as possible. We are definitely stronger together!”

Oslo Cancer Cluster has played an active role in setting up the initiatives IMPRESS-Norway, CONNECT, InPreD and INSIGHT, to gather the Norwegian oncology community with the common goal of getting cancer precision medicine faster to Norwegian patients.

Ketil Widerberg, General Manager at Oslo Cancer Cluster. Photo: Stig Jarnes/Oslo Cancer Cluster

Ketil Widerberg, General Manager at Oslo Cancer Cluster. Photo: Stig Jarnes/Oslo Cancer Cluster

“Cancer is a genetic disease. However, we often treat according to where in the body the cancer is discovered and not based on the genetic profile. This changes now when technology and medicine are merging in precision medicine. Roche is one of the companies that has come furthest in this development. Their involvement in IMPRESS and CONNECT is highly appreciated. This is an important milestone, and we look forward to more companies following their example,” commented Ketil Widerberg, General Manager, Oslo Cancer Cluster.

Precision medicine is about providing the right treatment for the right patient at the right time. There are many cancer therapies today that can be targeted towards specific molecular changes in the cancer cells. Patient access to molecular diagnostics is one of the prerequisites for the successful implementation of precision medicine.

Randi Hovland, Head of Section for Clinical Genetics at Haukeland University Hospital and member of Trial Management Committee in IMPRESS-Norway. Photo: Mathilde Oseberg

Randi Hovland, Head of Section for Clinical Genetics at Haukeland University Hospital and member of Trial Management Committee in IMPRESS-Norway. Photo: Mathilde Oseberg

“The establishment of broad genetic testing is essential to offer patients our treatments in clinical studies and IMPRESS drives the implementation of this in Norway. For patients whose tumour tissue isn’t available, the contribution from Roche through Foundation Medicine is of great importance to examine whether blood can replace tissue when identifying relevant biomarkers,” commented Randi Hovland, Head of Section for Clinical Genetics at Haukeland University Hospital and member of Trial Management Committee in IMPRESS-Norway.

IMPRESS is based on the DRUP (Drug Rediscovery Protocol) trial in the Netherlands, a precision medicine trial evaluating the effects of a broad portfolio of precision treatments based on the molecular profile of the patient’s tumour. The benefits of this study were highlighted by Emile Voest, Medical Director of The Netherlands Cancer Institute, at the recent Cancer Crosslinks. The  learnings from IMPRESS and related trials will be discussed in CONNECT and are important to develop novel implementation models for cancer precision medicine.

Read more about CONNECT, InPred and INSIGHT here: Landmark public-private agreement for precision cancer medicine

 

CONNECT Founding Partners:

  • Akershus universitetssykehus HF
  • Helse Bergen HF
  • Helse Stavanger HF
  • Olavs hospital HF
  • Universitetssykehuset Nord-Norge HF
  • Oslo Universitetssykehus med Kreftregisteret og OUH Comprehensive Cancer Center
  • Folkehelseinstituttet
  • Oslo Cancer Cluster SA
  • Kreftforeningen
  • Legemiddelindustrien
  • Roche Norge AS
  • Bristol-Myers Squibb Norway Ltd NUF
  • Novartis Norge AS
  • Merck AB NUF
  • Takeda AS
  • Amgen AB Norge NUF
  • AstraZeneca AS
  • AbbVie AS
  • Bayer AS
  • PubGene AS
  • Pfizer Norge AS
  • NEC Corporation

 

Please get in touch with Jutta Heix, Head of International Affairs at Oslo Cancer Cluster, to learn more about our initiatives in precision medicine and how to join CONNECT.

Eivind Lysheim at Ullern Upper Secondary School during the summer 2020 when he returned to complete a summer job with Kongsberg Beam Technology. Photo: Sofia Lindén / Oslo Cancer Cluster.

From pupil to full-time employee

Eivind Lysheim

This article was first published in Norwegian on our school collaboration website. Read it here.

Through the collaboration between Oslo Cancer Cluster and Ullern Upper Secondary School, former Ullern-student Eivind Lysheim has found his way in life – both academically and professionally. “I am very thankful for this,” said Eivind.

“I want to thank you for helping me find a summer job with Kongsberg Beam Technology (KBT). I appreciate that you took the time to help, despite problems caused by the pandemic.

“I worked for KBT last summer and felt right at home. I have since then worked a few hours every week with the company, next to my studies. A couple of days ago, I signed a permanent contract with KBT and I will begin to work in the company’s prospective office at Oslo Cancer Cluster Incubator from the summer 2021.”

This is the e-mail that Eivind Lysheim sent to Bente Prestegård in Oslo Cancer Cluster at the end of November 2020.

A guiding placement

Eivind Lysheim has half a year left of his degree at the Norwegian University for Science and Technology (NTNU), where he is working intensely to finalise his master’s in Medical Physics.

Eivind chose this degree after participating in a one-week placement at the Department for Medical Physics at the Radium Hospital in March 2016. The placement is an annual option for students at Ullern Upper Secondary School, as a part of the opportunities the students receive through the collaboration between Oslo Cancer Cluster and Ullern Upper Secondary School.

Eivind attended Ullern between 2013 and 2016 and specialised in different science subjects.

“I did not know exactly what do to after graduation. I liked science but didn’t know what I could do with it. When I participated in the placement, everything fell into place and I changed my first choice from Economics to Medical Physics at NTNU,” said Eivind.

Eivind said that choosing his degree was a direct consequence of the placement.

The physicist Taran Hellebust Paulsen explains to Kristian Novsett Borgen, Aurora Opheim Sauar, Edvard Dybevold Hesle, Alexander Lu, Trym Overrein Lunde and Tuva Askman Nærby about the use of radiation in cancer therapy. Photo: Elisabeth Kirkeng Andersen

The physicist Taran Hellebust Paulsen explains to Kristian Novsett Borgen, Aurora Opheim Sauar, Edvard Dybevold Hesle, Alexander Lu, Trym Overrein Lunde and Tuva Askman Nærby about the use of radiation in cancer therapy. Photo: Elisabeth Kirkeng Andersen

“It was an incredibly exciting placement and I was very fascinated by the researchers and clinicians that use radiation to treat cancer, even though radiation is deadly. This duality awakened something in me,” said Eivind.

He also found the people responsible for the placement genuinely enthusiastic about teaching their subjects to him and his co-students. They took time out of their busy schedules and were excellent communicators.

Summer job in a relevant company

Half a year after the placement, Eivind was in Trondheim at NTNU studying Medical Physics. This was the same degree that Taran Paulsen Hellebust, associate professor at the Department for Medical Physics and responsible for the placement that Eivind participated in, had studied.

In January 2020, Eivind sent an e-mail to Bente Prestegård. Bente is project manager for the collaboration between Oslo Cancer Cluster and Ullern Upper Secondary School.

“Eivind sent me a very nice e-mail, in which he told me he was a former student at Ullern and that he had participated in the placement with Taran. He wondered if I knew of any relevant summer jobs,” said Bente.

Bente asked around in her network among start-up companies in Oslo Cancer Cluster Incubator: were there any companies that needed Eivind’s skill set?

“Bjørn Klem, the manager of the Incubator, suggested the company Kongsberg Beam Technology that he was actively advising. I connected Per Håvard Kleven, the general manager at the time, with Eivind and, as a result, he got a summer job there during 2020,” said Bente.

Eivind and his co-students from Ullern at a placement at the Department for Radiobiology at the Radium Hospital in 2016. Photo: Elisabeth Kirkeng Andersen

Eivind and his co-students from Ullern at a placement at the Department for Radiobiology at the Radium Hospital in 2016. Photo: Elisabeth Kirkeng Andersen

Only positive references

Kongsberg Beam Technology is a member of Oslo Cancer Cluster Incubator and develops technologies to improve the accuracy of proton therapy machines.

“The core of the project is to achieve industrial precision in cancer radiation therapy, to avoid damaging healthy tissue. By achieving higher precision, the cancer cells can be radiated with more powerful doses than today,” said Per Håvard Kleven, founder of Kongsberg Beam Technology.

Per Håvard Kleven, founder of Kongsberg Beam Technology

Per Håvard Kleven, serial entrepreneur and founder of Kongsberg Beam Technology. Photo: Oslo Cancer Cluster.

Per Håvard is a serial entrepreneur and started the project that Kongsberg Beam Technology has spun out from in 2016. The company was officially founded in 2018.

In the summer of 2020, Eivind worked with different types of research for the company and it went so well that he continued in a 20 per cent position next to his studies during the fall. In November, Eivind was offered a permanent job beginning in August 2021.

“I am thrilled about this job. The assignments are exciting, and the colleagues are nice, so I am very happy and thankful for the opportunity. It was a good match with Kongsberg Beam Technology, and I feel that I am also contributing to a relevant part of the project. It is fun,” said Eivind.

Per Håvard only has words of praise for the new employee.

“Eivind is endlessly interested in the project and what we do. He receives tasks from a project manager. Many of the assignments are about researching different things. I receive great feedback on his work and efforts,” said Per Håvard.

New offices in the incubator

Kongsberg Beam Technology is in a research and development phase, the goal is to develop finished control systems for proton machines during the next years, in order to transition to a commercial phase by 2025. That is when Kongsberg Beam Technology will sell the systems globally.

“If we succeed with this, it will mean a revolution in radiation treatment of cancer patients.”

“We are in the lucky position that no one else globally is doing exactly what we are doing. If everything goes according to plan, we will be in a unique position on the market in only a few years,” said Per Håvard.

Per Håvard has recently hired Kerstin Jakobsson as new CEO of the company. She has long experience from radiobiology in Sweden, where this is an established commercial field, which it hasn’t become in Norway – yet.

“From the fall of 2021, Kerstin and Eivind will be in Oslo Cancer Cluster Incubator, while I will be leading the Kongsberg-side of things in the Incubator Kongsberg Innovation,” said Per Håvard.

He is very impressed by the collaboration between Oslo Cancer Cluster and Ullern Upper Secondary School and says this is important to secure the recruitment of highly competent employees to a knowledge-intensive industry in Norway.

“It is very smart and positive that they have managed to build a collaboration between the school, the hospital, Oslo Cancer Cluster and the Incubator, where there is such a clear common goal on many levels,” said Per Håvard.

A unique network

Eivind says that the degree he chose was because of the placement. Now, the permanent position he has secured before finishing his master is very important to him.

“I realised in Trondheim that I had a network through Oslo Cancer Cluster that opened doors for me.”

“This made it easier for me, compared to my fellow students, to find a relevant summer job. I knew who to turn to,” said Eivind.

Bente is extremely happy to hear that Eivind, starting this fall, will be one of the many employees that share a workplace with her in Oslo Cancer Cluster Incubator.

Bente Prestegård, Project Manager, Oslo Cancer Cluster

Bente is project manager in Oslo Cancer Cluster and responsible for the collaboration with the school on behalf of the cluster. Photo: Gunnar Kopperud

“This is a really nice story that fully shows what we wish to achieve with the school collaboration. It should inspire further education and we wish to recruit for our members, both the companies and academic institutions,” said Bente.

“This fall, corona is hopefully under control so that I can meet Eivind in the incubator. It is really a cross-disciplinary environment, which is truly inspiring to work in. It will be fun to have him here,” said Bente.

  • Eivind was interviewed by Oslo Cancer Cluster in August 2020 about his summer job with Kongsberg Beam Technology – read the interview here.

 

About Kongsberg Beam Technology

  • Founded and led by serial entrepreneur Per Håvard Kleven, who has had a long career in the Kongsberg industry
  • Owned by Oslo Cancer Cluster Incubator, Kongsberg Innovation, VIS Innovation and 18 private owners. Partner with Semcon Norway on development.
  • Kongsberg Beam Technology will, by using precision technology from industrial control systems, make proton therapy to treat cancer tumours more precise and with fewer side effects.
  • Have developed a system for this called MAMA-K, which is short for Multi-Array Multi-Axis Cancer Combat Machine.
  • In 2020, the company received NOK 22,7 million in support from the Norwegian Research Council to develop the system.
  • The plan is to work with the development of the technology until 2025 and then transition to patient treatment.
  • The company has received support from Oslo Cancer Cluster Incubator for business development and obtaining capital.

 

Read articles about the company

 

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Photo: Handlingsplan for kliniske studier, regjeringen.no

New political paper: Action Plan for Clinical Studies

illustrasjon av handlingsplan for kliniske studier

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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Jutta Heix, Head of International Affairs at Oslo Cancer Cluster and Project Manager of the new initiative CONNECT, which 22 public and private partners have joined to accelerate the implementation of precision medicine for Norwegian patients. Photo: Stig Jarnes/Oslo Cancer Cluster

Landmark public-private agreement for precision cancer medicine

Scroll down to read the press release in Norwegian.

While more than 30 000 Norwegians are diagnosed with cancer every year and the incidence is still increasing, more precise treatments can save lives. CONNECT is a new initiative aiming to ensure that precision medicine reaches the patients.

“A serious cancer disease is an existential challenge for the individual. Cancer research gives hope. The pharmaceutical industry and the public health sector, clinicians and executive authorities, have to collaborate to offer new treatments, balancing the latest research with hospital operations,” says Åsmund Flobak, Oncologist at St Olav’s Hospital, Trondheim University Hospital.

The new initiative, called CONNECT (Norwegian Precision Cancer Medicine Implementation Consortium), is a direct response to Health Minister Bent Høie’s political guidance to accelerate the implementation of precision medicine for Norwegian patients. It also responds to the Health Minister’s ambition to increase research and collaboration between public and private actors, including hospitals, other public stakeholders, the Norwegian Cancer Society, and the pharmaceutical industry.

CONNECT is one of four interconnected initiatives that will ensure infrastructure and collaboration on diagnostics, clinical trials, implementation of advanced precision medicine and use of health data e.g. for health economics analysis. This could eventually affect how Nye Metoder (The National System for Managed Introduction of New Health Technologies within the Specialist Health Service in Norway) is adapted for personalized medicine and treatments for small patient groups in cancer.

See the fact boxes about the different initiatives at the bottom of this page.

Precision medicine for the future

Precision medicine, or personalised medicine, is a type of treatment tailored to the individual patient based on individual diagnostic and clinical information. In simple words, it is about giving the right treatment to the right patient at the right time.

“The research front is continuously moving forward. With modern technology, today’s clinicians can analyse specific changes in the cancer of each patient. There are individual changes in a patient’s tumour that can be treated with targeted therapies tailored to every individual patient,” says Bjørn Tore Gjertsen, Director of Research at Haukeland University Hospital, Helse Bergen Health Trust.

“Precision medicine changes healthcare. The implementation of precision medicine requires new types of interactions and partnerships among patients, clinicians, companies, regulators, and payors. CONNECT is a new public-private partnership allowing all stakeholders to jointly address key obstacles and piloting novel solutions,“ says Jutta Heix, Project Manager for CONNECT and Head of International Affairs at Oslo Cancer Cluster.

A nationwide effort towards a common goal

CONNECT is a unique national partnership where the central players join forces to accelerate the implementation of precision medicine.

All six university hospitals in Norway are partners in CONNECT. More than ten leading pharmaceutical companies have joined the initiative so far. As representative for patients, the Norwegian Cancer Society will play a central role.

“We are also having a good dialogue with the Norwegian Directorate of Health, the Norwegian Institute of Public Health and the Norwegian Medicines Agency about participating in CONNECT and contributing with their competency. The Institute of Public Health joins as an observer from the start and the Directorate of Health has expressed an intention to join as an observer as well,” says Kjetil Tasken, Head and Director of the Institute for Cancer Research at Oslo University Hospital.

Karen Marie Ulshagen, Area Director at the Norwegian Medicines Agency, says in a comment that the Medicines Agency supports the project and intends to engage.

“A culture for public-private collaboration is not created through strategic plans, political ambitions or celebratory speeches, but through actions and behaviours that set a new standard. CONNECT is not about money or donating pharmaceuticals. It is the combined expertise of the different players and agencies that will increase the competency essential to ensure the implementation of precision medicine. Novartis is happy to participate, and I think that is true for the other industry players too,” says Lars Petter Strand, Head of Medical, Novartis Oncology Norway. He has worked closely together with representatives from Roche, BMS and Merck in the working group for CONNECT.

CONNECT and the associated public initiatives work towards common goals: giving patients access to medicines they otherwise wouldn’t receive, increasing the precision medicine experience of clinicians and researchers nationwide, generating data and insights important for analysing the outcomes and adopting health technology assessments for these new treatment concepts. Via CONNECT a structured dialogue, information sharing and planning for national precision medicine and diagnostics will be established, with Oslo Cancer Cluster having the coordinating role.

Unique public-private partnership

CONNECT will be an arena for all partners and stakeholders to address important issues and will ensure a balanced, broad, and informed approach and debate.

“This is a concrete and important milestone for public-private collaborations in the health sector and builds on the ambitions from, among other things, HelseOmsorg21. This is a completely new way to work in Norway and I hope it paves the way for more collaborative projects and pilots between private and public players in healthcare,” says Karita Bekkemellem, CEO of Legemiddelindustrien (LMI).

 

Press release in Norwegian:

Inngåelse av historisk offentlig-privat kreftsamarbeid

Mer enn 30 000 nordmenn diagnostiseres med kreft hvert år og antall krefttilfeller øker, mer presis behandling vil kunne redde liv. CONNECT er et nytt initiativ med mål å sørge for at presisjonsmedisin når pasientene.

– Alvorlig kreftsykdom er en eksistensiell utfordring for den enkelte. Kreftforskning er håp. Privat legemiddelindustri og offentlig helsevesen, både behandlere og overordnet byråkrati, må samarbeide for å kunne tilby ny behandling i grenseflaten mellom forskningsfront og sykehusdrift, sier Åsmund Flobak, lege ved Kreftklinikken St Olavs hospital.

Det nye initiativet, som kalles CONNECT, er en direkte respons til helseminister Bent Høies ønske om å akselerere implementering av presisjonsmedisin for norske pasienter. Det svarer også helseministerens ønske om mer forskning, og aktivt samarbeid mellom offentlige og private aktører som blant annet sykehus, andre offentlige interessehavere, Kreftforeningen og legemiddelindustrien.

Avtalen er en del av flere initiativ som vil sikre en infrastruktur og samarbeid for diagnostikk, kliniske studier, implementering av avansert presisjonsmedisin og bruk av helsedata til blant annet helseøkonomiske analyser. Dette vil etter hvert kunne påvirke hvordan systemet for Nye Metoder tilpasses persontilpasset medisin og behandlinger til små pasientgrupper innen kreftområdet.

Se faktaboks om de ulike initiativene nederst i saken.

Presisjonsmedisin for fremtiden

Presisjonsmedisin, eller persontilpasset behandling, er en form for kreftbehandling som er tilpasset spesielt den enkelte pasient. Kort fortalt handler dette om å gi riktig medisin til riktig pasient og til riktig tid.

– Forskningsfronten flytter seg stadig fremover, og med moderne teknologi kan leger i dag undersøke detaljerte forandringer i kreftsvulster hos hver enkelt pasient. Det finnes individuelle forandringer i arvestoffet som kan behandles med målrettede behandlinger som er tilpasset hvert enkelt individs behov sier Bjørn Tore Gjertsen, forskningssjef, Helse Bergen

– Presisjonsmedisin forandrer hele helsetjenesten og krever nye typer samarbeid og partnerskap mellom pasienter, klinikere, selskaper, regulatoriske myndigheter og betalere. CONNECT er et helt nytt offentlig-privat samarbeid som vil gi alle parter felles muligheter for å adressere utfordringer og prøve nye løsninger, sier Jutta Heix, prosjektleder for CONNECT og leder for internasjonal kontakt i Oslo Cancer Cluster.

Samler hele Norge for felles mål

CONNECT er et unikt partnerskap der alle de sentrale aktørene er samlet for å akselerere innføringen av presisjonsmedisin.

Alle seks universitetssykehus i Norge er med som partnere. Over ti ledende legemiddelselskaper har også gått med i initiativet. Som representant for pasientperspektivet er Kreftforeningen sentral.

– Vi har også hatt en god dialog med Helsedirektoratet, Folkehelseinstituttet og Legemiddelverket om å delta i CONNECT og bidra med sin kompetanse. Folkehelseinstituttet kommer inn som observatør fra starten, Helsedirektoratet har uttrykt en intensjon om å være med som observatør i CONNECT, sier Kjetil Tasken, leder for Institutt for Kreftforskning ved Oslo Universitetssykehus.

Karen Marie Ulshagen, Områdedirektør, SLV sier i en kommentar at Legemiddelverket støtter prosjektet og har en intensjon om en nærmere tilknytning dersom det er mulig.

– Kultur for offentlig-privat samhandling skapes ikke ved strategiske planer, politiske ambisjoner eller festtaler, kun gjennom handling og adferd som setter en ny standard. CONNECT handler ikke om penger eller donasjon av legemidler, det er den faglige ekspertisen fra de ulike aktører og instanser som utgjør kompetanseløftet som er essensielt for å sikre innføring av presisjonsmedisin. Novartis er glad for å kunne ta del i dette, og det tror jeg gjelder de andre industriaktørene også, sier Lars Petter Strand, Medisinsk Direktør i Novartis. Han har arbeidet tett sammen med representantene fra firmaene Roche, BMS, Merck i arbeidsgruppen for CONNECT.

Målet er at CONNECT og de underliggende initiativene sammen kan bidra til å gi pasienter tilgang til medisiner som de ikke ellers ville fått, helsepersonell og forskere får unik erfaring med denne type medisiner og diagnostikk, og helsevesenet vil få data og erfaring fra hvordan presisjonsmedisin fungerer og påvirker måten vi i dag regner helseøkonomi. Gjennom CONNECT skal det etableres strukturert dialog, kunnskapsutveksling og planlegging for persontilpasset medisin og diagnostikk hvor Oslo Cancer Cluster vil ha den koordinerende rollen.

Unikt offentlig-privat samarbeid

Alle medlemmer og interessenter vil kunne ta opp saker som er viktige for dem, da målet er at CONNECT blir en arena som sikrer en bred, balansert og informert debatt.

Dette er et konkret og viktig løft for offentlig-privat samarbeid på helsefeltet og bygger videre på ambisjonene fra blant annet HelseOmsorg21-rådet. Det er en helt ny måte å jobbe på i Norge og jeg håper det baner vei for flere samarbeidsprosjekter og piloter mellom private og offentlige helseaktører, sier Karita Bekkemellem, Administrerende direktør i Legemiddelindustrien (LMI).

 

Fact boxes:

InPreD (Infrastructure for Precision Diagnostics) is a national infrastructure for advanced molecular diagnostics that will secure a robust, interactive structure facilitating clinical cancer trials on a national level by providing equal access for patients to advanced diagnostics, state-of-the art competence and technology.
IMPRESS-Norway (Improving public cancer care by implementing Precision medicine in Norway) is a prospective, non-randomized clinical trial evaluating efficacy of commercially available, anti-cancer drugs prescribed for patients with advanced cancer diagnosed with potentially actionable alterations as revealed by standardized molecular diagnostics. IMPRESS-Norway is a nation-wide study and all hospitals with an oncology and / or hematology department will be invited to participate in the study. As of December 2020, 17 Norwegian Hospitals have agreed to join IMPRESs. The study will use a combined umbrella and basket design and a Simon two-stage model of expanding cohorts to follow up potentially effective combinations of biomarker and drug on specific indications. Sampling of biological material will be performed at presentation, during treatment and upon progression. Additional biomarker and translational analyses including whole genome sequencing (WGS) on tumour material and liquid biopsies, identifying mechanisms underlying drug sensitivity versus resistance will be performed.
INSIGHT (Regulatory framework for implementing precision medicine into the Norwegian health care system) will develop an analytic framework for using synthetic control data for evaluating effects of small-scale one-armed clinical trials, as in IMPRESS-Norway. INSIGHT will use the developed control arms and data from IMPRESS-Norway and InPreD to evaluate cost-effectiveness of the PCM-model and suggest new reimbursement scheme that reflects the uncertainty in PCM. Concrete ethical and legal challenges when integrating clinical research as part of standard-of-care e.g. the need for informed consent, access and data sharing, storage of molecular data as part of diagnostic pipeline will also be addressed. Taken together, the project will deliver fundamental knowledge and suggest regulatory changes/models necessary for implementation of PCM.

 

CONNECT Founding Partners:

  • Akershus universitetssykehus HF
  • Helse Bergen HF
  • Helse Stavanger HF
  • Olavs hospital HF
  • Universitetssykehuset Nord-Norge HF
  • Oslo Universitetssykehus med Kreftregisteret og OUH Comprehensive Cancer Center
  • Folkehelseinstituttet
  • Oslo Cancer Cluster SA
  • Kreftforeningen
  • Legemiddelindustrien
  • Roche Norge AS
  • Bristol-Myers Squibb Norway Ltd NUF
  • Novartis Norge AS
  • Merck AB NUF
  • Takeda AS
  • Amgen AB Norge NUF
  • AstraZeneca AS
  • AbbVie AS
  • Bayer AS
  • PubGene AS
  • Pfizer Norge AS
  • NEC Corporation