Ketil Widerberg, daglig leder i Oslo Cancer Cluster, var med i høring digitalt i Finanskomiteen 22.3.2021. Video: Stortinget

Innspill til Perspektivmeldingen

Oslo Cancer Cluster har uttalt seg om Perspektivmeldingen 2021. Vårt hovedpoeng er at helsenæring må være en større del av regjeringens strategi for norsk økonomi.

Hvert fjerde år legger Finansdepartementet fram en Stortingsmelding om utfordringer i norsk økonomi de neste førti årene, og regjeringens strategier for dem. Denne kalles Perspektivmeldingen.

Oslo Cancer Cluster deltok i høringen av denne meldingen i Stortingets Finanskomité 22. mars 2021. Flere andre aktører innen kreft og helse deltok også i høringen, blant annet Kreftforeningen, Norway Health Tech, Legeforeningen og Pårørendealliansen.

Helsenæringens potensial for norsk økonomi var et gjennomgangstema.

Helsenæringens aspekter

Perspektivmeldingen poengterer hvor viktig det blir med offentlig-privat samarbeid og investeringer i helsenæring fremover. Videre nevner meldingen at ny teknologi i helse bidrar til økt ressursbruk og økt levealder med flere funksjonsdyktige leveår. Dermed fører ny teknologi også til et økt skattegrunnlag for finansiering av offentlige velferdsordninger.

– Det er gode elementer som er med. Samtidig er det flere aspekter ved helsenæring som Oslo Cancer Cluster savner, og som vi ønsker å trekke frem, sa Ketil Widerberg, daglig leder i Oslo Cancer Cluster, under høringen.

Se Ketil Widerbergs innspill på video:

 

Det første aspektet som Oslo Cancer Cluster savner i Perspektivmeldingen, er at både uventede og forventede hendelser i helse gir store kostnader.

Uventede hendelser, som Covid19, har store budsjettkonsekvenser. I tillegg til kostnadene med nedstengte samfunn, er det store kostnader forbundet med innkjøp av teknologi til sporing, testing, behandling og vaksinering.

Forventede hendelser er for eksempel antallet nordmenn som får kreft og antallet som overlever kreftsykdom. Før fylte 75 år har nå én av tre nordmenn fått minst en kreftdiagnose, og dette tallet øker, ifølge Kreftregisteret. Det er også flere og flere som overlever og må leve med følgene av kreftsykdom. En slik prognose vil påvirke Norges finanser, og ved å utvikle norsk helsenæring blir ikke Norge stående kun på kjøpersiden, men vil også få inntekter fra et av verdens største og økende markeder.

Det andre aspektet er de økonomiske mulighetene. Slik ressursbruken i helse kan bidra til et økt skattegrunnlag, vil også store kostnader i helse representere store økonomiske muligheter for norsk helsenæring.

Norge har så langt bidratt til milliardeventyr i helse med blant annet Ugelstadkuler fra Dynal, som er sentrale i Covid19-testing, og med kreftmedisin fra Algeta og Vaccibody. Sistnevnte utvider nå sin vaksineplattform fra kreft til neste generasjons Covid 19-vaksiner.

– Dersom vi i Norge tilrettelegger godt for innovasjon innen helse og konkret følger opp Stortingsmeldingen om Helsenæringen, vil den voksende utgiftssiden også bli en voksende inntektsstrøm. Det er gode perspektiver, sa Ketil Widerberg under høringen.

Det tredje aspektet er økt samarbeid mellom det offentlige og privat næringsliv gjennom modne helseklynger.

– De norske klyngene er en etablert arena for samhandling mellom offentlig og privat sektor. Vi er også pådrivere for internasjonalt samarbeid og kunnskapssamarbeid. I tillegg legger vi til rette for kommersialisering av samfunnsnyttige, forskningsbaserte innovasjoner, og vi jobber med å koble bedrifter som søker finansiering med investorer og prosjekter. Dermed er vi med på å sikre nye selskaper viktig tilgang til kapital. Dette gir bedre kanalisering av tilgjengelig kapital, og er nettopp det Kapitaltilgangsutvalget ønsker mer av, sa Widerberg.

Spørsmål fra politikere

Oslo Cancer Cluster fikk spørsmål fra stortingsrepresentantene Sigbjørn Gjelsvik (Senterpartiet) og Ola Elvestuen (Venstre) under høringen. Spørsmålene var:

  • Hvilken rolle mener dere at det offentlige skal ha i et offentlig-privat samarbeid i helse?
  • Kan dere si noe mer om samarbeidet med helseforetakene om næringsutvikling og teknologiutvikling?

I denne videoen svarer Ketil Widerberg på spørsmålene:

 

Flere vil sikre helseklyngene

Kreftforeningen talte for at alle nå må gjøre alvor av satsingen på helsenæringen, blant annet gjennom å sikre finansiering av helseklyngene.

– Det er på tide å gjøre alvor av satsingen på helsenæringen. Vi må lykkes med å styrke samarbeidet mellom det offentlige, det private, akademia og ideell sektor. Et viktig ledd i denne satsingen må være å sikre finansieringen av klyngene på helseområdet, sa Thomas Axelsen, leder for samfunnspolitisk seksjon i Kreftforeningen, og viste til klyngene som deltok i høringen.

Axelsen understreket også behovet for umiddelbar handling:

– Vi må investere i teknologi og innovasjon i dag mens vi har et handlingsrom for å gjøre det, og sørge for at vi får på plass gode avtaler mellom det offentlige, det private og ideell sektor, slik at vi står klare neste gang vi trenger det.

Se videoen av Kreftforeningens innspill her.

Les mer: 

 

Ketil Widerberg, general manager of Oslo Cancer Cluster, represented Norway in one of the panel sessions during Global Health Security Demo Day at SXSW2021.

Norwegian life science @ SXSW2021

We put global health security on the agenda at the influential technology conference SXSW.

Oslo Cancer Cluster and the other Norwegian health clusters Norway Health Tech and The Life Science Cluster participated in the conference South by South West (SXSW) for the first time ever last week.

The conference usually takes place in Austin (Texas), but due to current corona restrictions it was made available through an online platform.

The full-day event Global Security Demo Day, arranged by The Texas Global Health Security Innovation Consortium (TEXGHS), attracted many big names in health and life science from across the globe on Wednesday 17 March.

“It is clear that there is a silver lining of accelerated development, new innovations and increased public-private partnership in health emerging from the current Covid-crisis,” said Ketil Widerberg, general manager of Oslo Cancer Cluster.

The Norwegian life science environment was also represented at this event, by keynote speaker Bent Høie, Minister of Health and Care Services, several representatives from private companies and the heads of the Norwegian health clusters Oslo Cancer Cluster, Norway Health Tech and The Life Science Cluster.

“It is great that Bent Høie, the Norwegian Minister of Health, supports innovative health companies at one of the world’s largest technology conferences in Texas,” said Ketil Widerberg.

View the panel sessions

Watch the video above for the panel session The race to a vaccine with Ketil Widerberg, general manager of Oslo Cancer Cluster and Trent Munro, Professor at Australian Institute for Bio-Engineering and Nanotechnology, moderated by Janet Walkow Executive Director and CTO, Drug Dynamics Institute, UT Austin.

The event was organised by TEXGHS, Austin Technology Incubator at the University of Texas at Austin, Australian Trade and Investment Commission (Austrade), Consulate General of Denmark in Houston, The Royal Norwegian Consulate General in Houston and European Network of Research and Innovation Centres and Hubs, USA (ENRICH).

Cancer researchers Åslaug Helland, Simone Mester, Sigrid Skånland and Else Marit Inderberg talk about equality on International Women's Day.

Talking about cancer research and equality

International Women’s Day: three Norwegian researchers share their personal stories of being women in the cancer field.

Every year, International Women’s Day is marked on the 8th of March to put gender equality on the agenda. We wish to use this opportunity to celebrate women dedicated to developing new cancer treatments. It is important for us to highlight researchers that perform important research, who can also be role models.

We have reached out to cancer researchers across Norway, both in the public and the private sector. As a result, three accomplished Norwegian researchers share their personal perspectives. They are at different stages in their careers and focusing on different areas of research.

 


Åslaug Helland. Photo: Oslo University Hospital

Åslaug Helland. Photo: Oslo University Hospital

Combining family life and research

Åslaug Helland is a Group leader at the Institute for Cancer Research at the Norwegian Radium Hospital in Oslo and Senior Oncologist at the Department of Oncology at Oslo University Hospital. Helland’s research group focuses on translational studies on solid tumours, with a special interest in pancreatic cancers, lung cancers, ovary cancers and colorectal cancers.

“First of all, being involved in cancer research has been extremely rewarding. I started when still at med-school, in 1991, and since then we have learned a lot. Today we see that the insights gained some years ago benefit patients!

“When I started working in cancer research, there was a male dominance, which is not as obvious today. I started in Anne-Lise Børresen-Dale’s group at the Norwegian Radium Hospital. She was a world leading researcher in cancer molecular genetics and working with her was very inspiring.

“The regulations in Norway have made it possible for both men and women to combine family life and research.

“My family and I have lived abroad twice for research stays, first at Stanford University and thereafter at Peter MacCallum Cancer Centre in Melbourne, Australia, and my experience is that Norway is one of the most advanced countries in gender balance and equal opportunities.”

 


 

Sigrid Skånland. Photo: Private.

Sigrid Skånland. Photo: Private.

Let me hold the door for you

Sigrid S. Skånland is a PhD, Project group leader, lab leader and researcher at the Institute for Cancer Research at Oslo University Hospital. Skånland has established her own research group, focusing on functional precision medicine in haematological cancers, in particular the B-cell malignancy chronic lymphocytic leukemia.

“When I talk about gender equality, I do it for my daughters. Their future. When they show bold confidence, I think ‘You go, girl!’

I want them to feel that they can claim their space, even as girls. I want them to see that it is possible to be smart, strong and successful, even as a single mom. I want them to be valued equally to men, also when they become women.

“As a biologist, most of my fellow students were female, and most of my colleagues during my graduate and post-graduate studies were women. As I have become more senior, my perspective has changed. Most students and trainees are still women. But. When I go to conferences, I see that most of the speakers are men. When I apply for research funding, I see that most of the grants are awarded to men. And when I establish new collaborations, I see that most of the higher positions are filled by men. I want everyone to see this.

“My daughter sat with me through a virtual conference. She pointed to the screen and said: ‘Are there only men?’ At the age of five, she already sees it.

“As a woman, I need women in leading positions to look up to. And I greatly appreciate the men who also see the value of acknowledging and promoting excellent female scientists. After 40 years, the first female members were elected to the international workshop on chronic lymphocytic leukaemia in 2019. This could not have happened without the support from the men on the board. Together, we can raise awareness on gender equality and make the gender gap smaller.

“I hope that I can inspire other women. Kamala Harris said it nicely: ‘It’s on those of us leading the way to leave the door more open than it was when we walked in.’”

 


 

Simone Mester. Photo: University of Oslo

Simone Mester. Photo: University of Oslo

Follow your dreams!

Simone Mester is a PhD student at The Laboratory of Adaptive Immunity and Homeostasis, which is part of both the Medical Faculty at the University of Oslo and Department for Immunology and Transfusion Medicine at Oslo University Hospital. Her research focus is on development of new biomedical technologies that may make cancer treatments more precise and effective. Her ambition is to start a biotechnology company in Norway.

Mester attended Ullern Upper Secondary School, which has an active collaboration with Oslo Cancer Cluster to inspire students to pursue careers in science and entrepreneurship. She was also the youngest researcher to be selected to SPARK, the University of Oslo’s two-year innovation programme. When she won the SPARK “pitch challenge”, she was awarded a six-month stay in ShareLab, where she now is exploring the commercial potential of her research results together with her colleague Torleif Tollefsrud Gjølberg, also a PhD student in the same laboratory.

“Early in my career, I have experienced great opportunities and lot of support. I strongly feel that the life science ecosystem is supporting me and would like to see me succeed. This is very motivating!

“For me, it is important to be part of a dynamic research environment that allows me to explore and develop as a researcher.

“I would like to encourage students and young researchers to be brave, ambitious and to follow their dreams!”

 


Else Marit Inderberg. Photo: Oslo University Hospital

Else Marit Inderberg. Photo: Oslo University Hospital

Calling for clear career paths

Else-Marit Inderberg is a Senior Researcher and Group leader at the Department of Cellular Therapy at Oslo University Hospital-The Norwegian Radium Hospital. The focus of her research is immunomonitoring in clinical studies and the development of cell therapies in cancer treatments. Inderberg’s research group uses the offices and facilities in Oslo Cancer Cluster Incubator.

“My experience as a woman in cancer research in Norway is very good and my supervisors and mentors were always very supportive.

“I was always given opportunities to take on responsibility and to be independent and it was up to me to decide if I wanted or could grab them or not.

One of the key things to change to keep future generations motivated to do cancer research is to have clear career paths for researchers, both female and male.

 


 

The students of entrepreneurship at Ullern Upper Secondary School listened to Øyvind Kongstun Arnesen, former CEO of Ultimovacs, give advice about fundraising. Photo: Elisabeth Kirkeng Andersen

Fundraising on the school curriculum

This article was first published in Norwegian on our School Collaboration website.

To set up a company, you need financing. In February, fundraising was a topic on the schedule for the students of entrepreneurship at Ullern Upper Secondary School. The lecturer was Øyvind Kongstun Arnesen who – as former CEO for Ultimovacs – has been through several fundraising rounds.

“Today, I will share my experiences with you and you can interrupt or ask questions as much as you like,” Øyvind Kongstun Arnesen began his lecture.

Kongstun Arnesen has 10 years of experience as CEO for Ultimovacs, a company that develops a universal cancer vaccine and has been through many rounds of raising funds.

Kongstun Arnesen shared his experiences with the students about what things companies need to organise before actively seeking financing.

“It is very important to have solid patents, which is the basis for any pharmaceutical or biotech company,” said Kongstun Arnesen.

He also stressed the importance of creating good investor presentations based on what kind of information the potential investors need.

Then, the former CEO explained the different stages of fundraising that the company had been through.

Kongstun Arnesen talks to the students of entrepreneurship at Ullern Upper Secondary School.

Kongstun Arnesen talks to the students of entrepreneurship at Ullern Upper Secondary School. Photo: Elisabeth Kirkeng Andersen

From flying start to stock market

“In the beginning, we were lucky, because one of Norway’s wealthiest men, Bjørn Rune Gjelsten, invested in the company and was also involved in the management. The reason for this was that his father was diagnosed with prostate cancer and he wished to contribute to something more than a donation to the Radium Hospital,” said Kongstun Arnesen.

Kongstun Arnesen continued to explain that having Gjelsten on the team was important for the next time the company needed to raise funds.

“Gjelsten contacted his network and we got large owners onboard, such as Canica led by Stein-Erik Hagen and others. It went surprisingly well,” said Kongstun Arnesen.

Then the company needed to go on the financial market to raise funds. The financial market consists of companies that are set up to earn money from investments. The only thing they have in common is that the companies are different and invest in differing ways.

“It is about collecting so called venture capital and going to ‘family offices’. In other words, family-owned businesses that invest funds in order to manage families’ fortunes in the best way,” said Kongstun Arnesen.

During the next round, Ultimovacs was set to raise NOK 130 million.

“That is when you need to reach the big and heavy players, for example different types of retirement funds, banks and other types of investment funds,” said Kongstun Arnesen.

Finally, was the biggest ask. The company wanted to raise NOK 450 million.

“To raise such a big sum, you need to be listed on the stock market. Everyone can invest on the stock market and it demands a lot of a company to get listed and raise money. We still managed it. At that milestone, we had the funds we needed to show that the vaccine worked. That is when it was time for me to step down as CEO,” said Kongstun Arnesen.

 

LEGEN OG PASIENTEN: Fra venstre møteleder Siri Lill Mannes, kreftpasient Kjetil og lege Andreas Stensvold.

Evaluerer Nye metoder: – Tar arbeidet på største alvor

LEGEN OG PASIENTEN: Fra venstre møteleder Siri Lill Mannes, kreftpasient Kjetil og lege Andreas Stensvold.

– Evalueringen av Nye metoder er viktig for så mange, og det handler om liv og helse. Så vi går til dette arbeidet med stort alvor, sier Jens Plathe, prosjektleder i Proba samfunnsanalyse.

Jens Plahte, Proba Samfunnsanalyse

Jens Plahte, Proba Samfunnsanalyse

– Vi må velge ut noen enkeltsaker som dels kan belyse når systemet fungerer etter hensikten, og saker som kan belyse hvordan systemet fungerer når det settes under stress. Vi har fått mange innspill fra referansegruppen, og fortsetter å samle inn data frem til sommeren. Innen utgangen av oktober skal vi levere sluttrapporten, sa Plathe.

Han var invitert til å fortelle om prosjektet på årets første møte i møteserien Fremtidens kreftbehandling, der temaet var nettopp evalueringen av Nye metoder. Møteserien er i flere år blitt arrangert av Kreftforeningen, Oslo Cancer Cluster og LMI, i samarbeid med Janssen, MSD og AstraZeneca.

Her kan du se hele møtet

Kreftpasient Kjetil betalte gentesten selv

Evalueringen av systemet, som så mange er enige om at må forbedres, har vakt stor interesse, og det digitale møtet samlet rundt 370 deltakere rundt i hele landet. Vi fikk også høre historien til Kjetil, som har prostatakreft, og hvordan han sammen med legen sin, Andreas Stensvold, har funnet stadig nye måter å teste ut nye medisiner på – også delvis på tross av systemet – slik at han fortsatt er i live i dag. Historien hans sier noe om hvordan systemet, slik det er rigget i dag, har fått konsekvenser for pasientene og deres – til tider – kronglete vei til riktig behandling.

– Jeg har kjent Kjetil i mange år, og han har gjennomgått alt av standardbehandling, både cellegift og godkjente medisiner. Men disse virket veldig dårlig.  Det var tydelig at Kjetil ikke var en standardpasient, så vi måtte tenke på en annen måte, og gjøre flere undersøkelser – blant annet genanalyser. Men han disse måtte han betale for selv, forteller Stensvold.

Blant annet ville de finne ut om Kjetil hadde en genprofil som tilsa at han trengte en medisin som var beregnet på brystkreft, ikke prostatakreft. For Kjetil var det ikke vanskelig å ta valget om å betale for gentesten selv.

– Det var ikke noe annet alternativ enn å finne de pengene. Det begynte å se mørkt ut, så det var min eneste mulighet, sier han.

Da resultatene fra gentesten kom fra USA, satte Kjetil seg i bilen og kjørte hjem til legen sin for å levere resultatene.

– Vi endte med en off label-behandling, det vil si at Kjetil fikk en medisin som er godkjent i Norge, men til en annen kreftform. Og dette var ikke en avgjørelse jeg tok alene, den ble tatt etter en grundig juridisk og etisk vurdering. Det var også et kostnadsaspekt her, for hvis vi hadde sagt nei til off label-behandlingen måtte Kjetil ha betalt medisinen av egen lomme, sier Stensvold.

Behandlingen, som er en kombinasjonsbehandling med to immunterapier, startet de med i oktover 2020, og i løpet av få uker merket Kjetil at klumpene ved kragebeinet var borte. I desember var PSA-verdiene så lave at de ikke var målbare. Kreftlege Stensvold er rørt.

– Jeg har utsatt Kjetil for bivirkninger og nerveskader med de tidligere behandlingene. Men ingenting er likevel hyggeligere enn å se at nå har kreftsvulstene forsvunnet. Det er første gang siden 2014 at vi ikke ser noen metastaser hos ham, nesten alle kreftsvulster har forsvunnet. Det er veldig gøy, og man blir litt rørt selv, sier legen.

Men han etterlyser et bedre system, med mulighet for genanalyser og persontilpasset behandling. Noe er allerede på vei, men det er på overtid.

– Vi tilbyr behandlinger som ikke har effekt, fordi ny behandling er for dyr eller av andre grunner får nei i Nye metoder. Jeg syns danskene har et godt system der fagpersoner er dypt involvert, og der er det åpenhet og transparens om beslutningene, sier Stensvold.

Evalueringen skal besvare to hovedspørsmål

Prioriteringssystemet Nye metoder ble etablert i 2013, og har hatt noen «startproblemer» som etter 7 år ikke lenger kan kalles startproblemer. Myndighetene har derfor bestemt at systemet skal evalueres, og Helse og omsorgsdepartementet ga Proba evalueringsoppdraget. Proba har knyttet til seg Institutet för Hälso- och Sjukvårdsekonomi (IHE) i Lund i Sverige, samt flere uavhengige forskere: professor Kristin Bakke Lysdahl ved Universitetet i Sørøst-Norge, professor emeritus Ivar Sønbø Kristiansen og professor emeritus Aslak Syse. Professor Olav Helge ved Universitetet i Tromsø og førsteamanuensis Anne Kjersti Befring fra Universitetet i Oslo er eksterne kvalitetssikrere. I tillegg har Proba opprettet en rådgivende referansegruppe med 14 medlemmer som representerer pasientene, industrien, sykehusene, myndighetene og andre aktører.

Sluttrapporten Proba skal levere, skal besvare to hovedspørsmål.

Er dagens organisering og saksbehandlings¬proses¬ser i sys¬temet hensiktsmessig utformet og egnet til å oppnå de fastsatte målene?

Og er sys¬temet rustet til å møte fremtidens medisinsk-teknologiske utvikling, herunder utvikling av persontilpas¬set medisin?

Stor enighet om utfordringene

Hva er utfordringene med Nye metoder? Det er stor enighet om at tiden det tar, mangelen på åpenhet og hvordan usikre data i studier med presisjonsmedisin skal håndteres, er blant de viktigste. Også behovet for alternative prisløsninger går igjen i ønskene. Nederst i saken kan du se videoer der alle møtearrangørene fremhever de tre viktigste sakene de mener evalueringen av Nye metoder bør ta for seg.

Revolusjonen de siste årene, med immunterapier, målrettede behandlinger og genterapier, gjør at behandlingsmulighetene overstiger tilgjengelige ressurser, og særlig innen kreftbehandling. Flere av de nye kreftbehandlingene er så lovende at enkelte kreftformer går fra å være dødelige til å kunne leves godt med, og kanskje til og med bli kurert. Men hvordan skal helsetjenesten, som betalere, og legemiddelindustrien, som leverandører, bli enige om verdien av disse behandlingene når usikkerheten om effektene er så store? Hvordan kan de ulike aktørene bidra til at systemet blir mer rigget for fremtidens kreftbehandling?

Tid og nye dokumentasjonspakker

For Legemiddelverket, som gjør metodevurderingene som ligger til grunn for beslutningene i Nye metoder, gjør de nye avanserte terapiene hverdagen mer utfordrende. Enhetsleder Einar Andreassen sier at deres oppgave er å følge det som står i Prioriteringsmeldingen.

– Vi må vurdere hvilken nytte behandlingen har for pasienten, hvor alvorlig sykdommen er og hvor mye behandlingen koster eller hvor mye vi sparer. Dette vurdere vi hver for seg, og Beslutningsforum veier disse opp mot hverandre. Mest krevende nå er at vi får en dokumentasjonspakke fra firmaene, som viser effektdokumentasjonen, og den opplever vi blir mer sparsom med de nye teknologiene. Det kan det være fornuftige grunner til, andre ganger er det vanskelig å si hvorfor disse er vanskelige å vurdere for oss, sier han.

Færre pasienter i studiene kan være én grunn, men også etiske årsaker, sier han.

– Det vi også opplever er at disse studiene får midlertidig godkjenning i EMA. De godkjenner medisinene på bakgrunn av studier som er gjort på tidligere fase enn før, de fungerer godt i forhold til bivirkningene. Da vil den dokumentasjonen sendes videre til oss, som skal gjøre metodevurdering, og det er da utfordringene kommer. Ikke fordi kvaliteten er dårlig, men fordi den ikke sier like mye som vi er vant til fra før, sier Andreassen.

Han bekrefter at tid er en utfordring.

– Vi bruker de 180 dagene vi har på oss, og vel så det, og det jobber vi for å få ned. Men det handler om vår ressurskapasitet. Det handler også om tiden det tar for industrien å sende inn sin dokumentasjon.

Han sier at Legemiddelverket bør bli bedre til å velge ut hvilke saker de skal bruke tid på, slik at de kan behandle disse enklere og raskere. Her kan europeisk samarbeid, og nordisk samarbeid, gjøre at man kan dele på arbeidsbyrden og ikke gjøre unødvendig dobbeltarbeid.

Styrke testkapasiteten og finne nye betalingsløsninger

Jan Frich, viseadministrerende direktør i Helse Sør-Øst, mener en styrking av kapasiteten innen diagnostikk blir viktig fremover, med tanke på persontilpasset medisin. Han påpekte at det jobbes med å ruste opp dette i sykehusene nå. Han sier at det i mangelen på dokumentasjon i ny behandling blir en glidende grense mellom etablert behandling og utprøvende behandling, og viste i likhet med Karita Bekkemellem (i videoen) til IMPRESS-studien.

– Jeg hørte legemiddelindustrien nevne IMPRESS, som er en stor plattform for å prøve ut utprøvende behandling og samle dokumentasjon. Det er positivt å høre at industrien er med på dette, og vil bidra. Det har vi ønsket oss, at vi kan stå sammen for å bli bedre, sa Frich.

Også Frich mener industrien må levere dokumentasjon raskere.

– Jeg er enig i at vi skal prøve alt vi kan for å få saksbehandlingstiden ned, men noen ganger er det vårt system som er årsaken, men en god del ganger er det også industrien som ikke sender dokumentasjon. Så vi venter og venter på dokumentasjon, som kanskje ikke finnes. I noen av disse studiene er det kanskje 10-15 pasienter, sier Frich.

På spørsmål fra ordstyrer Siri Lill Mannes svarte han også på behovet for nye pris- og betalingsløsninger.

– Ja vi må lage forutsigbare finansieringsløsninger, slik at industrien blir mer på en løsning. Der må vi lage en ny modell for finansiering. Det blir en viktig nyskaping.

Politisk enighet

Tuva Moflag fra Arbeiderpartiet og Marianne Synnes fra Høyre var enige om det meste da de diskuterte temaene i en paneldebatt mot slutten av møtet. Blant annet er de helt enige om at de må se på det jurist Marianne Hammer tok opp, nemlig at pasienter i praksis har fått redusert sin rett til individuell vurdering fordi lovverket er så vanskelig å forstå.

– Vi må vurdere å endre lovteksten på det som går på pasientrettigheter. Dette er interessant for oss å se videre på, vi som tross alt er lovgivere, sa Moflag.

Hun mener evalueringen av Nye metoder og Beslutningsforum kommer sent, men godt.

– I fjor ble Beslutningsforum lovfesta. Vi ønsket at Beslutningsforum skulle evalueres før det ble lovfestet. De legger blant annet i for stor grad vekt på gruppetenkning. Hvis en kvinne på 30 år får en kreftform som vanligvis rammer menn over 75, blir den i systemet ikke funnet kostnadseffektiv. Og vi får stadig flere tilbakemeldinger om det med pris, at den delen vektes for tungt. Det gjelder ikke bare kreftpasienter. Innen MS er standardbehandlingen en gammel kreftmedisin. Det er helt fint hvis det fungerer, men problemet er at vi ikke vil betale for ny medisin til de som ikke har nytte av den gamle medisinen. Da har det gått for langt. Det handler om samspillet mellom pris og individuell vurdering, og det handler om at vi gjør prioriteringer ut fra hvordan dette påvirker sykehusbudsjettene. Hun som ikke får MS-behandlingen må nå få hjemmetjeneste og kan ikke lenger jobbe, sier Moflag, som mener dette bør tas med i det store regnestykket.

Marianne Synnes i Høyre er enig.

– Med evalueringen av Nye metoder kan vi se på nye ting som gjør at vi får til et bedre system likevel. Off label-behandling, at ikke alle vurderinger gjøres på gruppenivå,  og at vi skal implementere persontilpassa medisin. Det kommer til å bli krevende, men det må vi politikere også ta innover oss. Og så syns jeg det var et godt forslag fra Tuva om å se hele samfunnsregnskapet når man tar disse avgjørelsene.

Hege Edvardsen, seniorrådgiver i LMI, er fornøyd med møtet og alle innspillene som kom.

– Både vi i industrien og det offentlige må ta ansvar for å samarbeide bedre, og komme opp med gode løsninger som gjør at pasientene får raskere og bedre tilgang til de innovative medisinene som utvikles av industrien. En innovasjon som ikke tas i bruk er av liten verdi både for pasientene, samfunnet og for industrien, vi må derfor sammen finne løsninger som ivaretar både et bærekraftig helsevesen og næringsinteressene til en av de næringene Norge skal bygge sin fremtid på. Tilgang handler om mer enn bare pris, og industrien ønsker å være en samarbeidspartner både innen kliniske studier, pasienters tilgang til compassionate use og ved innføring av legemidler i standard pasientbehandling, sier Edvardsen.

 

 

Ketil Widerberg, daglig leder, Oslo Cancer Cluster. Foto: Stig Jarnes/Oslo Cancer Cluster

Mer presis behandling kan redde liv

Ketil Widerberg, general manager of Oslo Cancer Cluster

Originally published in Dagbladet on 4 February 2021.

Verdens kreftdag markeres 4. februar hvert år for å styrke den globale innsatsen mot kreft. Vi har kommet langt – både i forebygging, tidlig behandling og bedre livskvalitet for mange pasienter. Vi er imidlertid langt ifra ferdige …

Vi har sett store fremskritt de siste 20 årene. Forskning innen immunologi har ledet til utviklingen av nye terapier som gjør at vi kan behandle pasienter mer effektivt, gir færre bivirkninger så de kan leve bedre og lengre liv. I dag kan behandlingen og kombinasjoner av behandlinger i økende grad målrettes til den enkelte pasienten og den spesifikke krefttypen, noe som kalles persontilpasset medisin eller presisjonsmedisin.

Norge har verdensledende miljøer som har bidratt i utviklingen av disse behandlingene som forlenger og redder liv. Dette har skapt fremgangsrike bedrifter, gitt oss arbeidsplasser og tiltrukket internasjonale investeringer til en helsenæring i vekst.

Legemiddelindustrien spiller en viktig rolle for å utvikle nye medisiner. Kliniker jobber hardt for å tilby beste behandling til sine pasienter. Ledere i helseforetakene kjemper med å prioritere kost og nytte for å godkjenne nye medikamenter fortest mulig.

I dag står vi overfor en stor utfordring.

Vi lever lengre. Vi har en voksende eldre befolkning. De nye kreftbehandlingene er dyrere og setter økt press på velferdsstaten Norge. For å lykkes i å gi god behandling til alle kreftpasienter må alle samarbeide. Politikerne må gi klar beskjed om hvordan pengesekken skal brukes. Helseforetak må snakke sammen med industrien for å finne nye måter å dokumentere og godkjenne medisiner raskere. Kliniker og pasienter må bli hørt gjennom hele prosessen.

CONNECT er et nytt offentlig-privat samarbeid som samler alle universitetssykehusene i Norge, ledende legemiddelselskaper, Kreftforeningen og offentlige instanser rundt et bord. Til sammen skal de diskutere problemstillinger og hindringer, samt pilotere nye løsninger for å ta i bruk presisjonsmedisin raskere. Oslo Cancer Cluster har en koordinerende rolle for å sikre en bred, balansert og informert tilnærming og debatt. Målet er at vi gjennom initiativet får fart på innføring av presisjonsmedisin.

Koronakrisen har vist oss att om vi jobber sammen er det mulig å utvikle vaksiner på mindre enn et år. Nå må vi gjøre det samme med kreft.

Vårt mål er at nye kreftbehandlinger i samarbeid skal utvikles på 5 istedenfor 10 år.

 

Ketil Widerberg

Daglig leder, Oslo Cancer Cluster

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