NOK 16 million to new RWE company

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.

 

 

Ny rapport: stort potensial for eksport av helseindustri

Helseindustrien er en av Norges største eksportnæringer, med nesten 26 milliarder kroner i eksportinntekter i 2020. Med riktige rammebetingelser kan helsenæringen bli en betydelig eksportnæring for Norge. ­Det viser en ny rapport.

Rapporten “Strategier for økt produksjon og eksport av norsk helseindustri” er klar i sine anbefalinger: Det er fire nøkkeltiltak som norske myndigheter og helseindustrien sammen må sette i verk for at flere selskaper skal kunne produsere i Norge og øke eksporten. Disse tiltakene er:

  1. Gjøre kliniske studier mer attraktive
  2. Styrke hjemmemarkedet
  3. Bedre tilgang på nødvendig kompetanse
  4. Avlaste risikoen ved å investere i produksjon

Her kan du lese den nye rapporten.

Rapporten ble lansert digitalt 19. mai 2021.

Opptak av lanseringen kan du se her.

Utvikler kunnskapsgrunnlag

Rapporten er et samarbeid mellom flere aktører som jobber for norske bedrifter og oppstartsselskaper.

 

Logosky som viser aktørene bak rapporten: Aleap, Eksportkreditt Norge, Innovasjon Norge, Inven2, Legemiddelindustrien (LMI), LO, NHO, Norway Health Tech, Norwegian Smart Care Cluster, Oslo Cancer Cluster, Siva og The Life Science Cluster.

Bak rapporten står Aleap, Eksportkreditt Norge, Innovasjon Norge, Inven2, Legemiddelindustrien (LMI), LO, NHO, Norway Health Tech, Norwegian Smart Care Cluster, Oslo Cancer Cluster, Siva og The Life Science Cluster.

 

– Sammen ønsker vi å utvikle et kunnskapsgrunnlag for å videreutvikle og skalere norsk helsenæring for økt eksport. Dette grunnlaget har vi samlet i seks år, gjennom rapporter om Helsenæringens verdi av Menon Economics, sier Ketil Widerberg, daglig leder i Oslo Cancer Cluster.

Tidligere artikler om rapporter i denne serien:

Eksportutfordringen

Norsk helseindustri hadde en samlet omsetning på 53,6 milliarder kroner i 2019. De siste ti årene har næringen hatt en vekst på over 90 prosent. Denne veksten er betydelig høyere enn for norsk privat næringsliv i samme periode.

Bransjene i helseindustrien er i rapporten delt inn i digital helse, legemidler og medisinsk utstyr. De møter liknende utfordringer i utlandet.

Bedriftene har svart på hva som begrenser mulighetene for å øke inntektene fra eksportmarkedene.

– Det oppsummerende svaret er markedsapparat – i form av representasjon  og et distribusjons- og salgsapparat i et internasjonalt marked, forklarte Erik Jakobsen fra Menon Economics under lanseringen.

Virkemidler for særegne behov

Rapporten viser at virkemiddelapparatets ordninger ikke er utformet og tilpasset helseindustriens behov.

Få virkemidler er tiltenkt skalering, som for eksempel støtte til investeringer i produksjonskapasitet, kompetanse eller markedsapparat. Rapporten viser også at virkemidlene for eksport er begrenset.

– Det vi vet, er at vi må snu virkemiddelapparatene våre og gjøre dem mer fokusert på ulike næringer som trenger ulikt virkemiddelapparat, sa Trine Skei Grande (V) under lanseringen av rapporten.

Skei Grande har jobbet med næringsspørsmål i Stortinget i en årrekke, og sitter nå i Utenrikskomiteen.

Fordeler og ulemper i Norge

Rapporten viser at norske bedrifter i helseindustrien med produksjon i Norge samlet sett har hatt en høyere omsetningsvekst de siste ti årene enn bedrifter som ikke har hatt produksjon i Norge.

God kvalitet og godt samarbeid med forskningsinstitusjoner er et viktig fortrinn som bedriftene med produksjon i Norge trekker fram. De viser også til klyngene som en fordel med å produsere i Norge.

– Klyngene sitter på kompetansen og nettverkene og bør brukes i større grad for å øke eksport, sa Erik Jakobsen.

Utfordringene ved å legge produksjon av helseindustri til Norge, er høyt kostnadsnivå, et svakt hjemmemarked og fravær av offentlige ordninger for å finansiere risikoavlastning ved utvikling og bygging av produksjonsanlegg.

– Å stimulere hjemmemarkedet styrker konkurransekraft i eksportmarkeder og øker tilgangen på risikokapital, sa Erik Jakobsen.

Rapporten foreslår hvordan flere selskaper skal kunne produsere i Norge og øke eksporten.

Ett av disse forslagene er å øke bevilgninger til Norsk katapult for å sikre nye utlysninger – og få minst ett helserelatert katapultsenter inn i ordningen.

Resten av forslagene i rapporten kan du lese her.

Bildet viser forsiden av rapporten om helseindustrien med medisinglassflasker i produksjon.

 

 

Three new board members of Oslo Cancer Cluster: Per Morten Sandset, Gunhild M. Maelandsmo and Cathrine Lofthus

New board members

We are happy to welcome three new members to the board of Oslo Cancer Cluster. Find out what they had to say about entering their new positions.

Per Morten Sandset

Per Morten Sandset

Per Morten Sandset is a Senior Consultant in hematology at the Oslo University Hospital and a professor in thrombosis research at the University of Oslo. He has previously been head of the Department of Hematology and Deputy Director of the Medical Division at Ullevål University Hospital and Director of Research, Innovation and Education of the southeastern Norway Health Region. He is currently Vice-Rector at the University of Oslo with responsibilities for research and innovation including the life sciences activities of the university. Sandset has published more than 315 original publications and supervised 30 PhD students.

Why did you join the board of Oslo Cancer Cluster?

“There are currently strong political expectations that the many scientific achievements in the life sciences can be utilized, commercialized and eventually form the basis for new industry.”

“Oslo Cancer Cluster has matured to become a major player of the research  and innovation ecosystem within the life science area in Oslo and also on a national level. This is why being on the board is so interesting and important.”

What do you hope to achieve in your new role?

“As a OCC board member, I want to strengthen and develop the collaboration across the sectors, i.e., between the hospitals and the university – and between academia and industry. On a larger scale, it is about establishing a regional ecosystem that take achievements of the basic sciences into the development of enterprises. Oslo Cancer Cluster should maintain its role as the major player in the cancer area.”

Gunhild M. Mælandsmo

Gunhild Mari Mælandsmo

Gunhild M. Mælandsmo is the head of Department of Tumor Biology, Institute for Cancer Research, Oslo University Hospital where she also is heading the “Metastasis Biology and Experimental Therapeutics” research group. She is a Professor at Faculty of Health Sciences, University of Tromsø.

Why did you join the board of Oslo Cancer Cluster?

“I think the concept of Oslo Cancer Cluster is very interesting, fostering a close collaboration between academia, health care providers and the health industry. 

“Focusing on translational research for many years, I think I can contribute in the board with valuable experience in several parts of the value chain; from basic science, from translational aspects and from my close collaboration with clinical partners as well as administrative experience.”

What do you hope to achieve in your new role?

“I hope I can contribute with valuable knowledge – both from cancer research and from my administrative experience from Oslo University Hospital. I also hope to see more products from small Norwegian companies reaching clinical testing and expanding the biotech industry. Finally, I hope to see the Norwegian health care system more active in providing precision cancer medicine (and to utilise the advantages we have when it comes to registries etc).”

Cathrine M. Lofthus

Cathrine M. Lofthus

Cathrine M. Lofthus is the CEO at the Norwegian South East Regional Health Authority (Helse Sør-Øst RHF). She has previously held several leading positions at Aker University Hospital and at Oslo University Hospital. Lofthus is a qualified doctor from the University of Oslo, where she also completed a PhD in endocrinology. She also holds qualifications in economy, administration and leadership, and has experience from the health sector as a clinician, researcher and leader. Lofthus also holds directorships in Norsk helsenett and KLP, in addition to being a member of the board of National e-Health.

 

We also wish to extend a special thank you to our previous board members:

  • Kirsten Haugland, Head of the Research and Prevention Department at the Norwegian Cancer Society.
  • Inger Sandlie, professor at the Department of Biosciences, University of Oslo and research group leader at the Department of Immunology, Oslo University Hospital.
  • Øyvind Bruland, professor of clinical oncology at the University of Oslo and consultant oncologist at The Norwegian Radium Hospital, Oslo University Hospital.

Creating One Cancer Vaccine Per Patient

Oslo Cancer Cluster member Vaccibody is making headway with their cancer vaccine technology. Now they are ready with clinical trials involving 40 patients in Germany, the first patient is already enrolled.

 

Neoantigens Reveals Cancer Cells
Cancer is famous for its ability to deceive, appearing to the immune system as normal tissue while wreaking havoc on the body. But what if cancer cells could be revealed with subtle but unmistakable characteristics that revealed their true nature?

This revealing clue exists and is called neoantigens, which are mutated (or changed/altered) proteins found only in cancer cells. This is the science behind what Vaccibody and Agnete Fredriksen is currently doing, working to develop vaccines that use neoantigens to help patients’ own immune systems recognize and fight cancer tumors.

— I dare to say that this is quite unique. Each vaccine is thoroughly customized for each individual cancer patient. One vaccine per patient! What we do is conduct biopsies and blood tests to reveal each patient’s unique set of neoantigens and with our technology we have the ability to create a potent individualized vaccine in a relatively short time at reasonable cost, says Agnete B. Fredriksen, President and Chief Scientific Officer at Vaccibody.

Extra Effective With Checkpoint Inhibition
The Vaccibody researchers analyze individual tumor genomes and the patients’ immune systems to select an optimal mix of neoantigens.

— We can do that in a few days because of modern technology. Then we monitor and record the changes we think the immune system will react to and include them in the personalized vaccine. The neoantigen technology is then combined with so called checkpoint inhibitor therapy, which stops tumors from suppressing immune-system activity — to make the vaccine extra effective.

With this personalized medicine approach, each patient receives a unique DNA vaccine, in combination with standard of care checkpoint inhibitor therapy.

Vaccibody has also reached the front page of VG! Read the story here. (In Norwegian)

Clinical Trials in Germany
In the upcoming German clinical trials the vaccine will be tested on patients with locally advanced or metastatic non-small cell lung cancer, melanoma, renal, bladder or head and neck cancer.

— Our technology is very flexible and it can record a number of different changes. The vaccine is therefore applicable as a treatment for many different kinds of cancers. The ones included in the trial are chosen because they contain a high number of mutations and changes creating a good basis to create a neoantigen vaccine.

During the trial Vaccibody will check if the vaccine is safe and without side effects.

— We really think it is based on previous experience with this platform! And we will of course check if the vaccine has the expected immune response and investigate signs of clinical efficacy, says Fredriksen.