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

NOK 16 million to new RWE company

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.

 

 

Biobank Norway coordinates Norwegian biobanks with the health industry to ensure that the valuable biosamples are used to develop new, breakthrough treatments.

How will biobanks accelerate cancer research?

Image of taking tests in the lab.

Biobanks ­– the powerful tools in cancer research you may have never heard of.

 

Biobank Norway is a national research infrastructure that comprises all public biobanks in Norway and represents one of the world’s largest existing resources within biobanking. They are also a member of Oslo Cancer Cluster, through NTNU, and represent an exciting initiative in the endeavour to develop precision medicine.

 

A biobank is a storage facility that keeps biological samples to be used for medical research. The samples come from population-based or clinical studies.

 

Christian Jonasson, seniorforsker ved NTNU.

Christian Jonasson, seniorforsker ved NTNU.

Christian Jonasson, the Industry Coordinator for Biobank Norway, connects businesses with Norwegian biobanks to accelerate medical research. He said that more biobanks now work with the health industry and benefit from added value in the process.

“It is the health industry that will ultimately bring new therapies to patients.”
Christian Jonasson

Biobank Norway has developed several strategic areas for Norwegian biobanks. They have built automated freezers for secure long-term storage, with advanced robotised systems that can retrieve barcoded biological samples. They have initiated new biobanks, established new IT systems and also developed policies for public-private collaborations. Also, they have contributed to strategic processes that promote increased utilization of Norwegian health data, including the national Health Data Program.

Ultimately, Biobank Norway aims to facilitate collaborations between the global health industry and Norwegian biobanks to accelerate innovation in the life sciences, disease prevention and treatment.

“Biobanks are one of the most important tools in precision medicine.” Christian Jonasson

 

Biosamples may be used for important, life-saving cancer research. For example, to develop new immunotherapies, such as T cell therapy. Photograph by Christopher Olssøn

Biosamples may be used for important, life-saving cancer research. For example, to develop new immunotherapies, such as T cell therapy. Photograph by Christopher Olssøn

 

A competitive edge

Norway has been collecting biological samples for the last 30-40 years. For example, one of the world’s largest birth cohort studies, the Mother and Child study (called MoBa) was initiated in 1999. It included 100 000 newborns with mother and father, which totalled over 285 000 participants over a ten-year period. There are numerous other Norwegian health studies, which have involved hundreds of thousands of people, such as the HUNT study and the Tromsø study.

Moreover, the Norwegian Radium Hospital have collected countless valuable samples from cancer patients over the years from both regular clinical care and from clinical research studies. Hospitals across Norway also continually collect and save diagnostic samples, which may be used for medical research at a later stage.

The number of biobanks and the rigorous collection of clinical data in health registers in Norway represent unique assets for medical researchers.

“Norway has a competitive edge on its health data infrastructure.” Christian Jonasson

 

Sharing the data

However, Jonasson also points out that the health registers in Norway are too fragmented. To combat the problem, Biobank Norway are helping the Norwegian Directorate of eHealth to develop a Health Data Program. The digital platform, called the Health Analytics Platform (HAP), will collate copies of relevant data from the various health registers, providing a single point of easy access for researchers.

Biobank Norway also has a long-term vision to collect all biobank data and health data in a common platform. This is a necessary step to unleash a larger national precision medicine initiative. First, they want to organise the data from the four largest population-based cohort studies in one place. In a couple of years, this database would hopefully include 400 000 people, which is a very attractive cohort for medical research.

“We need to attract leading actors from the international health industry and Norwegian start-ups in real collaborations with biobanks.” Christian Jonasson

Important medical research is already being conducted in biobanks across Norway. Jonasson said that there now needs to be a plan to market Norwegian health data and biobanks internationally to spur innovation further.

 

Image of DNA spiral.

Biosamples are also used for sequencing of the human genome, to develop more precise diagnosis and treatment of cancer.

 

The hidden key

To unlock the potential of biobanks, the biological samples need to be analysed and converted into meaningful data, which can be an expensive and laborious process.

Finland, for example, has begun to collect biological samples from 500 000 individuals. One single database holds all phenotypic data, such as diagnosis and treatment, and all genotypic data, which is the mapping of the human genome.

In the UK, there is the Genomics Project, which has already sequenced the DNA (the coded parts of the human genome) of 100 000 patients. The UK Biobank are aiming to sequence the DNA of half a million brits.

Jonasson hopes that such ambitious initiatives will be imported to Norway to build the biobank infrastructure further and provide meaningful data for medical research. He adds that public-private collaborations will be key to drive and fund such large scale initiatives.

Biobank Norway is currently in the process of extending into its third phase and aims to continue to improve the biobanks, the partner institutions and global research collaborations in the future.

 

  • Do you need help with your research and innovation project using biobanks in Norway?
    E-mail Christian Jonasson.
  • For more information, please visit the official website of BioBank Norway.

 

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Kronikk: Dine helsedata kan styrke helsenæringen

Ketil Widerberg, daglig leder i Oslo Cancer Cluster.

This opinion piece was first published on 9 May 2019 in Dagens Medisin, by Ketil Widerberg, General Manager at Oslo Cancer Cluster, and Christian Jonasson, Senior Adviser at NTNU. Both are also members of a work group for innovation and business development for the Health Data Program for the the Norwegian Directorate of eHealth. Please scroll to the end of this page for an English summary.

 

Vi får nye forretningsmodeller innen helse som er basert på digitalisering og persontilpasset medisin. Her kan Norge virkelig lede an!

Christian Jonasson, seniorforsker ved NTNU.

Christian Jonasson, seniorforsker ved NTNU.

Ketil Widerberg, daglig leder i Oslo Cancer Cluster.

Ketil Widerberg, daglig leder i Oslo Cancer Cluster.

HELSE BLIR digitalisert og medisin blir tilpasset den enkelte pasienten. Dette er to megatrender som vil endre forretningsmodellen for helseindustrien. Forrige uke kom Stortingsmeldingen om nettopp helsenæringen. Den åpner for store muligheter for Norge.

I bilindustrien erstatter gradvis digital mobilitet den tradisjonelle boksen på fire hjul. Et eksempel er at Tesla blir verdsatt høyere enn tradisjonelle bilprodusenter blant annet for sin evne til kontinuerlig datainnsamling fra bilene. I helsenæringen vil vi se det samme.

 

NYE MODELLER. Med digital persontilpasset medisin vil nye forretningsmodeller vokse frem. Vi ser eksemplene daglig: Roche, et globalt legemiddelselskap, har nylig kjøpt opp helsedataselskapet Flatiron. Oppkjøpet gjorde de for å kunne utvikle nye kreftbehandlinger raskere, for nettopp tid er viktig for kreftpasienter som kjemper mot klokka. Et annet legemiddelselskap, AstraZeneca, har ansatt toppleder fra NASA. Norske DNVGL, som tradisjonelt har jobbet med olje, gass og shipping, har nå helsedata som et satsingsområde.

Helsemyndigheter erkjenner også endringen mot mer datainnsamling. Legemidler blir mer målrettede og brukes på stadig mindre undergrupper av pasienter. Dette utfordrer hva som er nødvendig kunnskapsgrunnlag for å gi pasienter tilgang til ny behandling. Mens det i dag er kunnskap om gjennomsnitt for store pasientgrupper som ligger til grunn for beslutninger om nye behandlingsmetoder, er det med persontilpasset behandling nettopp viktig å ta mer hensyn til individer og små undergrupper. De amerikanske helsemyndighetene (FDA) har derfor lagt frem retningslinjer for hvordan helsedata kan brukes som beslutningsgrunnlag for nye legemidler.

 

NORSKE FORTRINN. Legemiddelverket i Norge gir uttrykk for at de også ønsker å være i front i denne utviklingen – for også de ser at helsedata gir bedre beslutningsgrunnlag.

Hvordan kan så Norge lede an? Norge har konkurransefortrinn knyttet til et sterkt offentlig helsevesen, landsdekkende person- og helseregister og biobanker som kan knyttes sammen gjennom våre unike fødselsnummer. Dette er få land forunt! Derfor kan vi utnytte dette konkurransefortrinnet for å ta en posisjon i den store omveltningen av helsesektoren og helsenæringen.

Nedenfor følger noen forslag som vi mener vil styrke Norges stilling.

 

PLATTFORM. Vi kan starte med å lage en norsk dataplattform. Selskap leter globalt etter helsedata av god kvalitet. La oss utvikle en dataplattform hvor helsedata er raskt og sikkert tilgjengelig for norske og utenlandske aktører. Et eksempel er helseanalyseplattformen. Her må data gjøres tilgjengelig for alle aktører og for alle legitime formål. Samarbeidsmodeller må utvikles som sikrer at verdiskapingen blir i Norge og pasientene får bedre behandling.

Vi kan utvikle bedre økosystemer. Verdiskapingspotensialet for helsedata ligger i skjæringspunktet mellom offentlig og privat. Dagens offentlige forvaltere av helsedata må derfor samarbeide tettere med norske oppstartsbedrifter og internasjonale aktører.

 

INNSYN. Vi kan bruke personvern som konkurransefortrinn. Hver og en av oss eier våre egne helsedata. Derfor er det viktig med digitale plattformer som gir oss innsyn i egne helsedata.

Hvordan vi kommer til å bruke helsedata om få år, er vanskelig å forutse, akkurat som det var vanskelig å forutse hva konsesjonsutlysningen for oljeutvinning i 1965 ville føre til. Historien viser imidlertid at slike avgjørelser kan ha stor betydning for fremtidens verdiskapning i Norge, og for pasienter i hele verden. La oss derfor ikke overlate til tilfeldighetene hva vi i Norge gjør med våre helsedata.

 

 

English summary:

Digitalisation and precision medicine are influencing emerging business models in the health industry. It is time for Norway to lead the way!

As precision medicine develops, data gathering becomes ever more important. Instead of relying on results from a big patient group, cancer researchers are using big data to find out how treatments can be customised for small patient groups and individual patients.

Norway has a competitive advantage on health data: thanks to its strong public health sector, national health registers and biobanks that can be connected to unique personal ID numbers.

We suggest creating a common platform for Norwegian data, where high quality data can be accessed securely by legitimate national and international companies. Through collaborative models, we can ensure that the medical breakthroughs stay in Norway and benefit the patients. We need to develop better ecosystems that inspire simple collaboration between international key players, Norwegian start ups and the public agencies that handle health data.

Data privacy can be used as an asset. If we ensure everyone has complete access and insight into their own personal health data, people can be empowered to share it for the common good.

The decisions we make today will have great ramifications for the future value creation in Norway and for cancer patients across the world. We should not leave it up to chance.

 

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Jeg vil gjerne legge lista høyt og foreslå en felles database for data fra kliniske studier, hvor både firmaer og myndigheter har tilgang til helsedata umiddelbart etter at hver pasient har fått sin behandling, skriver Ketil Widerberg.

Hvordan gjør vi våre mest intime data til gull?

Ketil Widerberg, general manager, OCC

The following opinion piece was written by Ketil Widerberg, General Manager at Oslo Cancer Cluster, and published in Aftenposten on 1 May 2019. It is a response to an opinion piece written by Nikolai Astrup, the Norwegian Minister of Digitalization, which was published on 22 April 2019. The texts are only available in Norwegian, but a short summary in English is available at the bottom of this page.

 

Helsedata er en voksende gullåre, men vi kan ikke grave i den uten videre.

 

I Aftenposten 17. april svarer digitaliseringsminister Nikolai Astrup (H) på en appell om våre verdifulle data.

Astrup påpeker at data ikke kan sammenlignes med olje, for det er ikke staten, men hver og en av oss, som eier våre egne personopplysninger.

Det gjelder i høyeste grad de mest intime av våre data: helsedata.

 

En gullåre av data

Helsedata er en voksende gullåre, men vi kan ikke grave i den uten videre.

Hadde vi ikke først bygd opp beskyttelse av norske data og kompetanse, ville ikke prosjekter som DoMore blitt til.

Forskerne i DoMore bruker avansert bildeanalyse for å gi mer presise kreftprognoser. Samtidig ville ikke prosjektet eksistert uten internasjonale data og kompetanse.

For næringen som jeg jobber i, helsenæringen, er spørsmålet hvordan vi skal unngå å falle i digitaliseringsfellen. Der har mediebransjen landet.

Facebook og Google får all verdens data gratis gjennom samtykke og tar dermed livsgrunnlaget fra tradisjonelle aktører.

 

Trenger god strategi for kunstig intelligens

For norsk helsenæring blir de to strategiene som digitaliseringsministeren snart lanserer, digitalisering i offentlig sektor og kunstig intelligens, svært viktige. I en strategi for offentlige data oppfordrer jeg derfor til at fremskritt innen presisjonsmedisin tas med.

Da Kreftregisteret ble etablert på 50-tallet, forsto ingen den fulle nytteverdien av et slikt register. I dag tiltrekkes forskere og bedrifter fra hele verden for å få bruke data derfra.

Det viser hvorfor vi også i dag bør samle inn mer helsedata enn vi kan dra nytte av umiddelbart.

Hvordan finner vi balansen mellom god bruk av helsedata for å skape næring og rå utnyttelse av store firmaer? Her trenger vi en god strategi også for kunstig intelligens, som tar inn over seg denne balansegangen i helsedata.

Kunstig intelligens gjør presisjonsmedisin mulig på et helt annet nivå enn vi er på i dag, med mye høyere presisjon i behandlingen.

 

Ressurs for pasienter

For fremtidens presisjonsbehandling er helsedata ressursen vi må samle på. Vi må samle inn helsedata som gjør behandlingen bedre for neste pasient. Og vi trenger en struktur av dataene der både firmaer og myndigheter har tilgang til dem.

Jeg vil gjerne legge lista høyt og foreslå en felles database for data fra kliniske studier, hvor både firmaer og myndigheter har tilgang til helsedata umiddelbart etter at hver pasient har fått sin behandling.

Dette kan bidra til raskere tilgang til ny behandling og bedre oppfølging av pasienter med sykdommer som kreft.

Data former kreftbehandling og skaper nye tilbud til pasienter. Hvordan sikrer vi verdien av dataene? Skal vi gi dem bort for å bygge forskning og industri, skal vi ta så mye penger som vi kan for dem, eller skal vi prøve å finne på noe midt imellom?

I arbeidet med de nye strategiene bør våre mest intime data bli diskutert – med sikte på å skape verdi og næring av dem.

 

 

Short summary in English:

The question Astrup raised in his opinion piece concerned how data sharing can be improved across the public sector in Norway.

Widerberg responds by highlighting how we can make use of our health data to create added value and a successful health industry, without allowing large multinational corporations exploit the data freely.

Artificial intelligence makes precision medicine possible on a much higher level than today. We need to collect health data in order to improve treatments for future patients.

Widerberg therefore proposes a database where health data from all clinical trials is made available to both private and public bodies. This would contribute to making better treatments available sooner and provide better follow-up to patients suffering from diseases, such as cancer.

 

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