Illustration of health data used to make a heat map of the world. Photo: Clay Banks / Unsplash

NOK 16 million to new RWE company

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Picture of computer screen with red dots in a heat map of the worldClay Banks / Unsplash

The Research Council of Norway recently awarded grants to several innovation projects in the industrial sector. One of the lucky companies was the newcomer NordicRWE.

NordicRWE was granted 16 million NOK for their research and development (R&D) project that will focus on applying Real-World Evidence (RWE) in different steps in the drug development process.

Let us pause for a moment at the term RWE. What is it? According to the U.S. Food and Drug Administration (FDE), real-world data are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Real-world evidence is the clinical evidence of the usage and potential benefits or risks of a medical product derived from analysis of real-world data.

Addressing a mismatch

“Nordic and Norwegian health data are among the best in the world, but we can use them much better than how it is done today. This is especially true for drug development and follow-up of patient care. However, advanced research and quality assurance are needed”, said Ketil Widerberg, chairman of the board in Nordic RWE.

Ketil Widerberg is also the general manager of Oslo Cancer Cluster.

The vision of NordicRWE is to develop a research-based system for RWE that supports drug development in accordance with high regulatory demands. Observational data, epidemiologic methods of research, and the use of artificial intelligence and machine learning are all part of the research base.

The funded R&D project will construct external control arms for oncology clinical trials and combine machine learning with pharmacoepidemiology for drug signal detection. Pharmacoepidemiology is the study of the utilization and effects of drugs in large numbers of people. It provides an estimate of the probability of beneficial effects of a drug in a population and the probability of adverse effects.

“There is a mismatch between the need to document effect and the availability and tools to analyse health data. This is what we aim to address,” said Steinar Thoresen, project leader NordicRWE.

Well known in the Norwegian health industry, Thoresen has worked for more than twenty years at The Cancer Registry of Norway and published more than a hundred international papers on cancer-epidemiology. He has held leading roles in the pharma industry since 2006, and he has seen many of the hurdles and opportunities to succeed with innovative clinical trials. Thoresen will join the company in October in a half-time position while keeping a separate consultancy role.

Private initiatives are needed

“This is a once-in-a-lifetime opportunity,” said Christian Jonasson, project leader NordicRWE.

Jonasson will join the company full time in October from the position of Specialist Director Health Data at the Norwegian Institute of Public Health. He brings 25 years of diverse experience from R&D roles in pharma, academia, and the governmental sector.

“The need for high-quality health data is increasing exponentially and private initiatives are needed to complement government programs. Cooperation based on public-private partnerships is our goal,” said Jonasson.

The funded R&D project will focus on external control arms for oncology clinical trials and machine learning methods combined with pharmacoepidemiology for drug signal detection, which represents innovative applications of RWE in drug development.

Joining forces for RWE

Professor Arnoldo Frigessi, Director at the Oslo Centre for Biostatistics and Epidemiology at the University of Oslo, and Lena Nymo Helli, CEO of Norway Health Tech, have both joined the board as non-executive directors.

“Technologically, we are at a crossroad. The ability modern machine learning and statistics give for understanding and being able to deliver better healthcare is transformative, NordicRWE comes at the right time,” said Professor Frigessi.

He has supervised more than forty Ph.D. students and published more than 150 peer-reviewed papers in the field.

“We see real-world data change the dynamics in consultancy companies, technology companies, and medical technology companies. However, we believe now is the time for a dedicated effort to enable Nordic health data to be transformative. This is what NordicRWE is about,” said Lena Nymo Helli.

With more than 25 years of experience in the international pharmaceutical industry, she has worked in many phases of the product life cycle from R&D to sales and marketing.

The timing is now

In the project description to the Research Council, NordicRWE stresses that the timing is now for RWE, mainly because of precision medicine, implying advanced treatments for smaller patient groups, making health data a natural part of drug development, and evaluation of patient care.

To succeed with the research project, NordicRWE has partnered with the AI drug development division in NEC Corporation, The Cancer Registry of Norway, and the University of Oslo. The company is currently looking for new employees.

For more information about Nordic RWE, see the company webpage.

 

 

During Arendalsuka, Thomas Axelsen talked about the political ambitions and compared them with the realities of using new cancer treatments in hospitals. Photo: Media Service video streaming

The Future of Cancer Treatment

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What is the The Future of Cancer Treatment all about?

The seminar series The Future of Cancer Treatment (Fremtidens kreftbehandling in Norwegian) usually has two yearly events, always about new possibilities in cancer treatments, and how Norway can be better equipped to keep up with the rapid developments in precision medicine.

It started as a political meeting in 2015, during a political festival in the southern Norwegian town Arendal. The last seminar was also held in Arendal, 18 August 2021.

You can watch the latest Arendal-event on our YouTube channel: 

A collective effort

The series is a collaboration between Oslo Cancer Cluster, Association of the Pharmaceutical Industry in Norway (LMI), the Norwegian Cancer Society (Kreftforeningen), and the three pharmaceutical companies MSD, AstraZeneca, and Janssen.

Why have the same six partners worked together on the same subject for six years? Part of the answer is the collaboration itself.

The collective effort of hosting these seminars has value to everyone involved. For Oslo Cancer Cluster, facilitating collaborations between members is one of our main functions as a research and industry cluster. In addition, we have a role as a changemaker, in which we aim to improve the framework conditions for cancer innovations in the Norwegian health industry and raising expertise. The Future of Cancer Treatment allows the cluster to act as a changemaker and bring members with common goals together.

At the forefront of cancer care

Behind each seminar, there is of course a great deal of planning. Mattis Dahl Åmotsbakken, Associate Director Policy and Communications at MSD Norway, is one of the permanent members of the planning group, together with the other voices quoted in this article.

“The collaboration between this truly cross-functional team ensures innovative ideas that always are at the forefront of cancer care, constructive exchange and learning for everyone involved, as well as a solid output that both attracts and generates interest among a broad variety of stakeholders,” said Åmotsbakken.

He added that a mature cluster is a well-fitted frame for these kinds of collaborations.

“The fact that Oslo Cancer Cluster is a well-established and experienced cluster ensures efficiency, continuous and profound insights into healthcare policies and a solid perception among stakeholders that output from Oslo Cancer Cluster’s collaborative activities is of high quality and solution minded. The cluster’s accumulated experience and position in the cancer care domain coupled with the continuous generation of innovative ideas make the cluster a unique arena for collaboration and development of actionable solutions to further ameliorate the Norwegian health care system,” said Åmotsbakken.

The common interest

Hege Edvardsen, Senior Advisor at LMI, underlines the variety of audiences the seminars are designed to reach.

“This meeting series is arranged by partners deeply invested in bringing the future of cancer therapies to Norwegian patients, specifically through clinical studies, but also in general. The collaboration ensures that we are looking at this issue from all perspectives, since the meetings are targeted to researchers, clinicians, politicians and government bodies, and also to patients and their next of kin,” said Edvardsen, and added:

“The partnership behind this meeting series is in itself an example of how private-public partnerships can help us challenge each other, build culture and collaboration and together press forward a topic of common interest.”

Astra Zeneca is the second industry partner in the series, and Line Walen, Head of Governmental Affairs at AstraZeneca Norway, has been part of the meeting series planning group for a couple of years.

“The group has a common interest in making effective treatments available for patients and to put focus on obstacles, and suggestions for solutions. It is great to come together among patient organisations, clusters and companies to work towards a common goal on important topics. We hope this seminar series will continue in the years to come, and that this will be a good contribution to the debate on how to make new and effective treatments accessible for the patients who need them,” said Line Walen.

Cancer on the political agenda

The third and final pharmaceutical company involved in the series is Janssen Norway. Marthe Brovold Løberg, Communication and Public Affairs Manager at Janssen, has been part of the planning group since the start in 2015. She said:

“Janssen is very proud to be a collaboration partner in this well-established political meeting series that has highlighted important issues since 2015. We all have a common goal; to secure the best possible cancer treatment, now and in the future, and our focus is to enable fast and equal access to innovative treatment in Norway. Janssen wishes to be a part of the solution for cancer patients. To achieve this, collaboration is key,” said Marthe Brovold Løberg.

Thomas Axelsen, head of the political department at The Norwegian Cancer Society, also part of the planning group, added that cross sectoral collaboration is important for a patient organisation.

“This meeting series has been a great arena for the Norwegian Cancer Society to find common ground and raise important issues together with other actors in a field that is of enormous importance to cancer patients. Even though we sometimes have different perspectives and incentives, most of the time we share a common end goal – and finding together across sectors is both important and necessary for us to succeed at creating better cancer care,” said Thomas Axelsen, and added:

“The most important thing we want to achieve is putting cancer on the political agenda and creating a meeting place where different sectors can come together and offer solutions to existing problems. We want the politicians who attend our meetings to leave with more knowledge, and new input that can lead to needed political action. To some extent I think we have succeeded at this so far.”

Why Arendal

Arendalsuka, the political festival in the southern Norwegian town Arendal, taking place in August, has become an important arena for those who want to improve aspects of Norwegian society and politics. Oslo Cancer Cluster has participated several years to meet key players and accelerate the development of cancer treatments.

There was a natural pandemic pause in Arendalsuka in 2020 but in 2021 the town was once again the hub of politics and organisations for a week in mid-August, and The Future of Cancer Treatment hosted an open breakfast seminar about health data – from politics to clinics.

 

About Cluster Collaborations

In an article series called Cluster Collaborations, we want to highlight the fruitful collaborations in the cluster, underlining the very essence of what Oslo Cancer Cluster is all about, from cancer research to cure.

 

Dr. Bjørn Atle Bjørnbeth is CEO Oslo University Hospital (OUH).

Bjørn Atle Bjørnbeth joins the board

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Man with glasses looking into camera, outdoorsOUS

Dr. Bjørn Atle Bjørnbeth was welcomed into the board of Oslo Cancer Cluster during the annual general meeting on Thursday 26 August.

The Board of Oslo Cancer Cluster is made up of nine highly skilled and experienced member representatives who reflect the oncology value chain from basic research to globally marketed products.

Dedicated to good health services

Dr. Bjørn Atle Bjørnbeth (59) is CEO Oslo University Hospital (OUH). He is a trained gastro surgeon and was formerly head of the gastro and pediatric surgery department at OUH. As a hospital leader, he is concerned with change management, the work environment, and professional development.

Bjørnbeth is dedicated to good health services for the patients at OUH and to manage the resources in the best possible way. His emphasis is on collaborations with the city of Oslo and the University of Oslo, and other important partners, to develop the research and the extensive activity in education and training which the hospital is in charge of.

An overview of all the board members and their background is found on this page: The board of Oslo Cancer Cluster.

En forsker undersøker celler fra en kreftsvulst. Illustrasjonsfoto: AstraZeneca

Nye kreftbehandlinger krever nye samarbeidsformer

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En forsker undersøker et celler fra en kreftsvulst. Illustrasjonsfoto: AstraZeneca

I et debattinnlegg i Aftenposten beskriver Sigbjørn Smeland, Steinar Thoresen og Ketil Widerberg hvordan Norge er i en internasjonal særstilling for godt samarbeid i helsesektoren.

This opinion piece was originally printed in the daily newspaper Aftenposten and is only available in Norwegian. / Debattinnlegget sto først på trykk i Aftenposten mandag 9. august, og kan også leses på aftenposten.no.

 

Innføring av nye legemidler for små pasientgrupper tar unødvendig lang tid. Noen blir ikke tatt i bruk i Norge i det hele tatt. Det er en utfordring.

Direktørene i helseforetakene mener hovedgrunnen er at legemiddelprisene er for høye i forhold til nytten for pasientene. Legemiddelindustrien (LMI) mener at store utviklingskostnader gjør at medisinene er dyre. Pasientorganisasjonene påpeker at byråkrati og prestisje går foran alvorlig syke.

Alle har rett. Likevel er ikke løsningen å argumentere videre i hver sin retning. Det trengs et nytt samarbeid mellom industri, myndigheter og pasientorganisasjoner.

Et nasjonalt samarbeid

Hoveddelen av nye legemidler innføres innen kreft. Her er det nylig etablert et nasjonalt samarbeid som heter Connect. Det skal nettopp forbinde alle oss som jobber med kreft, som legemiddelfirmaer, regulerende myndigheter, Kreftforeningen og sykehusleger.

Målet er å finne løsninger for å få tilgjengelig ny medisin til små pasientgrupper. Det kalles presisjonsmedisin. Connect omfatter både avansert diagnostikk og nye behandlingsmetoder. Det har som ambisjon å løfte frem nye prinsipper for finansiering av nye legemidler.

Innføring av presisjonsmedisin er på mange måter et puslespill. Vårt mål er å sette brikkene sammen til et helhetlig bilde som både er bra for pasientene, men som også skaper innovasjon og er innenfor rammene og prioriteringene vi har i Helse-Norge.

Presisjonsmedisin for små pasientgrupper innebærer at utviklingskostnadene deles på færre pasienter. Dette driver kostnadene oppover.

Dagens gullstandard ved innføring av nye medikamenter er randomiserte kliniske studier. Randomisering innebærer at behandlingene vi sammenligner i en studie, blir tildelt deltagerne helt tilfeldig. Det krever store pasientgrupper og er derfor ikke egnet som eneste grunnlag ved innføring av presisjonsmedisin.

Det illustrerer også en fordel med presisjonsmedisin: Kun et utvalg av pasientene vil bli tilbudt behandlingen, basert på analyser av kreftsvulsten. Det hindrer overbehandling, som vi ser i utstrakt grad i dag.

Lære fra hver pasient

Det er derfor nødvendig med felles utvikling av nye løsninger. Det betyr ikke at firmaer får automatisk godkjenning, eller at klinikere får alt de ønsker til pasientene. Regulerende myndigheter får nok heller ikke jobbe på den samme trygge måten som før. Dette blir et krevende samarbeid for alle parter.

Innføring av presisjonsmedisin i helsevesenet er en utfordring de fleste land sliter med. Samtidig er det en enorm mulighet for kostnadsbesparelser og forbedret omsorg. Et stikkord er «midlertidig godkjenning» under forutsetning av fortsatt kunnskapsgenerering.

For vi må lære fra hver eneste pasient. I Norge gjør vi fremskritt, for eksempel gjennom samarbeid om helsedata, tidlig innføring og ny nasjonal handlingsplan for kliniske studier. Myndigheter og industri finner i økende grad løsninger sammen.

Norge i en særstilling

I Norge kan vi etter samtykke samle informasjon fra blodprøver og overskuddsvev. Dette kan kobles opp mot helseopplysninger fra våre unike kvalitetsregistre. Ett eksempel er Kreftregisteret.

Her er vi internasjonalt i en særstilling. Det kan gi oss interesse fra legemiddelfirmaer og bidra til at flere kliniske studier kommer til Norge.

Men det vil kreve en satsing fra våre politikere. I dag mangler infrastruktur i storskala, og da spesielt drift av biobanker. Dette må på plass. Først da kan vi hevde at vi oppfyller målsetningen om at vi skal lære av hver eneste pasient.

Samarbeid mellom offentlig og privat sektor kan gjøre Norge mer interessant for klinisk utprøvning. Det kan igjen gjøre flere legemidler tidlig tilgjengelig for norske pasienter.

Alene redder det ikke liv. Alene skaper det heller ikke en ledende helsenæring i Norge. Men det hjelper betydelig på veien.

 

Artikkelforfattere:

Sigbjørn Smeland, Klinikkleder ved Oslo universitetssykehus, styreleder i Connect

Steinar Thoresen, Leder av Oncology I Norden og Baltikum i Merck, styremedlem i Connect

Ketil Widerberg, Leder av Oslo Cancer Cluster, styremedlem i Connect