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.

 

 

Rapportens forsidebilde illustrerer produksjon. Foto: Menon Economics

Ny rapport: stort potensial for eksport av helseindustri

Close-up of brown glass bottle filling at production line.Foto: Menon Economics

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.

 

 

Torbjørn Furuseth is the Chief Financial Officer of Targovax, a Norwegian company developing oncolytic viruses against cancer. Photo: Targovax

Targovax releases 12-month clinical data

Our member Targovax has released 12-month data from the company’s clinical study of the oncolytic virus ONCOS-102 in patients with malignant pleural mesothelioma.

Targovax is a member of Oslo Cancer Cluster that develops oncolytic viruses to treat solid cancer tumours. The company’s lead product is called ONCOS-102 and has been engineered to selectively infect cancer cells and activate the immune system to fight cancer.

An oncolytic virus is a virus that preferentially infects and kills cancer cells.

The oncolytic virus ONCOS-102 is currently being tested in a phase I/II clinical trial with the aim to establish its safety and efficacy. ONCOS-102 is tested in combination with the standard-of-care chemotherapy on patients with mesothelioma.

The company released 12-month data from the clinical trial this week, which powerfully demonstrate a broad immune activation linked to clinical benefit.

Watch the presentation with Magnus Jäderberg, Chief Medical Officer at Targovax:

What is mesothelioma?

Malignant mesothelioma is a type of cancer that occurs in the thin layer of tissue that covers the majority of your internal organs (mesothelium). Mesothelioma is an aggressive and deadly form of cancer.

Mesothelioma is a difficult cancer disease to diagnose and treat. Only 10% of all patients are eligible for surgery. Many of the remaining patients receive chemotherapy. Radiotherapy may be used in some cases for palliative reasons. There have been no new break-through treatments with any significant impact during the last 15 years.

Immunotherapy has started to make an inroad on the disease. There are a couple of checkpoint inhibitor trials for patients with second-line disease. For patients with first-line disease, there are currently no immunotherapy options.

Checkpoint inhibitor therapy is a form of cancer immunotherapy, a type of therapy that uses substances to stimulate or suppress the immune system to help the body fight cancer.

The 12-month data

Targovax has presented data from the company’s phase I/II trial focusing on safety on combining ONCOS-102 with chemotherapy. They have looked at both first-line and second-line patients being treated with standard-of-care chemotherapy in combination with ONCOS-12.

The study includes a control group of 11 patients who have received chemotherapy only and an experimental group of 14 patients who received the combination of chemotherapy and ONCOS-102.

The 12-month results show that ONCOS-102 drives broad and powerful immune activation across key parameters, including innate immune responses, adaptive immune responses and remodelling of the tumour microenvironment.

The tumor microenvironment has profound impacts on cancer progression and remodelling of the tumour microenvironment has emerged as a strategy to facilitate cancer therapy.

The analysed genes show that there is a clear difference in ONCOS-102-induced immune activation compared to chemotherapy only. The genes also show there is a clear association between the powerful immune activation and improved clinical outcome.

The data shows that ONCOS-102 drives the infiltration of CD8+ T cells into the tumour, which is associated with better outcomes.

Targovax now plans to continue the clinical study for first-line patients. The company sees a strong rationale for combining ONCOS-102 with checkpoint inhibitor and standard-of-care chemotherapy.

On Tuesday, Targovax also revealed they will collaborate with our member pharmaceutical company MSD (known as Merck in the US) to evaluate the immunotherapy drug Keytruda in combination with ONCOS-102.

Find out more …

Thermo Fisher Scientific Norway was one of many stops during the guided tours through Oslo Cancer Cluster Innovation Park for students of Ullern Upper Secondary School.

A peak into the cancer research world

ThermoFisher Scientific Norway lectures students at Ullern

Ullern Upper Secondary School is unique, because it shares its building with world-class cancer researchers. Last month, all new Ullern students got to experience this first-hand.

This year’s School Collaboration Days in Oslo Cancer Cluster Innovation Park were held right before the autumn holiday. All the first-year classes at Ullern Upper Secondary School were given a guided tour around the Innovation Park to get to know the companies that they share their everyday lives with.

The purpose of the School Collaboration Days is to give the first-year students at Ullern Upper Secondary School an understanding of what the different companies in the Innovation Park and departments of Oslo University Hospital do.

The common denominator for all of them is cancer and many are developing new cancer treatments. While the Cancer Registry of Norway are collecting statistics and doing cancer research, Sykehusapotekene (Southern and Eastern Norway Pharmaceutical Trust) produce chemotherapy and antibodies for patients that are admitted to The Norwegian Radium Hospital and the Department of Pathology (Oslo University Hospital) gives the cancer patients their diagnoses.

 

IN PICTURES

The student guided tours of Oslo Cancer Cluster Innovation Park

Jonas Einarsson lecturing to students at Ullern

True to tradition, Jónas Einarsson, CEO of the evergreen fund Radforsk, opened the School Collaboration Days in Kaare Norum auditorium with a common lecture. In this image, Einarsson is talking about the development of the Montebello area, which Oslo Cancer Cluster Innovation Park is a part of. The first Radium Hospital was opened in 1932 and the following year Ullern School was moved from Bestum to the same place that houses Oslo Cancer Cluster Innovation Park today.

 

Kreftregisteret lecturing to students at Ullern.

Elisabeth Jakobsen, Head of Communications of the Cancer Registry of Norway, tells the first year students about what they do and the risk factors for developing cancer. Also, she asked the students several questions about how to regulate the sales of tobacco, e-cigarettes and many other things.

 

Thor Audun Saga is the CEO of Syklotronsenteret (“the Norwegian medical cyclotron centre”). He told the students about what they do, what a cyclotron is and how they use cyclotrons to develop cancer diagnostics.

 

ThermoFisher Scientific Norway lectures students at Ullern

The management of Thermo Fisher Scientific Norway are also housed in the Oslo Cancer Cluster Innovation Park. They told the students about the Norwegian invention called “Ugelstadkulene”. This is both the starting point for million of diagnostic tests across the world and revolutionary (CAR T) cancer treatments, 45 years after they were invented.

 

Students guided through the Oslo Cancer Cluster Incubator Laboratory

The tour was ended with a walk through the laboratory of the Oslo Cancer Cluster Incubator. The students were given an inside look at the work done and instruments used by the cancer researchers in the lab. This area is only one or two floors above their regular class rooms. The student could see first-hand the opportunities there are in pursuing a career in research, entrepreneurship and innovation.