Results and benefits from clinical studies

50 researchers and representatives of supporting services to medical research attended a network meeting in Biomedical Network on May 29th. The meeting was dedicated to present results and benefits from clinical studies, and to discuss how planning and implementation of such studies can be facilitated and improved.

It is a political ambition that more clinical studies should be carried out in Norway. National authorities, university hospitals and medical companies seem to share this ambition. Biomedical Network has a commitment to support researchers, companies, study personnel and patients who would like to participate in such studies. To succeed in this, it is necessary with local and national support – and efforts from the institutions. We will bring together organizations who are playing important roles in supporting, financing or developing clinical studies.

A number of speakers presented experiences, challenges and highlighted results from clinical studies. Clinical researchers, pre-clinical groups, pharmaceutical and entrepreneurial companies talked about the topic.

You can find The BTO Annual report for 2016 here

How to succeed with clinical studies?

Dr. Med. Consultant Hans Eikesdal chaired the first session, which started with an overview of regulatory aspects. Jan Petter Akselsen from Statens Legemiddelverk (SLV, the Medicines Agency) talked about important regulatory demands, and he outlined some of the common questions from researchers seeking guidance from SLV. He focused on topics that researchers and start-up companies need to sort out in order to perform successful clinical studies, and referred to important websites where basic information are accessible.

Hans Eikesdal made a presentation with the title “Don Quijote and his fight against windmills”. His talk was based on experiences from a study established by a research group at the oncology department. Eikesdal described a demanding process for researchers who want to set up clinical trials involving patients. It seems clear that most researchers’ needs guidance and support from people with skills in setting up studies, since a substantial amount of regulations has to be taken into account and acted upon. This meeting showed us that research support is becoming more important because of more strict regulations form 2018. University hospitals that aim for more studies initiated by their own researchers will have to establish stronger support for the teams that are planning to set up such studies.

Advisor Vetle Syverud from Haukeland University Hospital presented some financing opportunities. He highlighted the EU Horizon 2020 and some of the grants established by Forskningsrådet, and mentioned KlinBeForsk – where two large grants were awarded research teams led by investigators at Haukeland University Hospital this year. The research department at the hospital has put special efforts into helping researchers to increase the number of projects granted by external funding.

Medical Advisor Eli Bergli from Astra Zeneca pointed out that medical companies are motivated to become partners for academic researchers and to contribute in clinical studies established by research centers. This is happening at a larger scale in several countries, and Bergli said that companies more often should be invited to join research teams when phase I studies are established in Norway. As pharma companies reduces their in-house basic research it will be vital for them to follow early stage testing of new substances at a number of academic institutions. Research centers, university hospitals, TTOs and others should be aware of the possibilities that this situation is opening for partnering and possible co-financing of studies. Bergli emphasized various ways that industry can be involved.

Sonoporation in treatment of inoperable cancer

Professor Odd Helge Gilja from University of Bergen, chaired the next session about experience from study on new techniques applied in treatment of inoperable cancer by the use of sonoporation. The MedViz Group in Bergen has initiated studies on pancreatic cancer treated with a combination of drugs, microbubbles and ultrasound. There has been a number researchers working together with this concept. We had interesting presentations from the group that specialize on physical aspects including bubbles and administration of drugs, a group working with in vitro studies and a group for clinical testing.

Researcher Spiros Kotopoulis from University of Bergen presented a number of results from experiments with microbubbles. There is a number of properties of interest, size is especially important as this decides whether the microbubbles will enter the tumor or not. Professor Emmet McCormack from University of Bergen showed us a number of results from the in vitro testing. Head of the Department of Medical Gastroenterology at Haukeland University Hospital, Georg Dimcevski, presented early findings from clinical testing which shows promising results.

An industrial perspective

Jens Reigstad, Bergen Teknologioverføring, chaired the last session, where the speakers presented from an industrial perspective. CEO Per Sontum from Phoenix Solutions talked about the history of their technology, pre-clinical Proof of Concept and plans for Phase 1 clinical trials at HUH. Phoenix Solutions are working closely with a group representing broad competence from basic to clinical research in an area, which can bring promising treatment in the future – as well as interesting business opportunities.

Our last speaker was project manager Berit Nikolaisen from Lytix Biopharma, a private R&D company established in Tromsø who presented experiences in performing Phase I clinical trials. Their strategy is to develop projects to end of Phase II and enter into partnership for late stage development and commercialization. She pointed out the importance of picking the best CRO and labs, and a study center that is competent and capable of enrolling appropriate patients. She shared the insights in the importance to allocate enough time in the set-up phase to ensure the scientific expertise built into the study, with all the design considerations thoroughly scrutinized to maximize the likelihood of a successful study. It is critical for a start-up company like this to choose clinical trial sites that are successful in recruitment and retention of patients. Every time they are aware that the investigator is meeting a new potential patient, they hold their breath, as phase 1 cancer patients are already heavily treated – and the inclusion and exclusion criteria’s are strict. Nikolaisen also talked about selecting good collaborators, as small- to mid-size biotech or pharmaceutical sponsors cannot have all the competence in-house.

Professor Bjørn Tore Gjertsen summed up the day and highlighted the importance of clinical studies, sharing experience and collaboration to perform high quality clinical studies. Gjertsen is very satisfied with the way that Biomedical Network evolves. He points at opportunities opened up for researchers to share knowledge and establish collaboration with competence within academic, clinical and industry about research and innovation.

Next meeting in Biomedical Network will be in late October. We wish all participants and partners of Biomedical Network a good summer.

About Biomedical Network

Biomedical Network is a network collaboration between Haukeland University Hospital, University of Bergen, Legemiddelindustriforeningen (LMI) and Bergen Teknologioverføring (BTO). The network aims to become a common platform for innovation and project development across academic and between public and private actors, supported by the Norwegian Research Council. Read more about Biomedical Network here.

You can find The BTO Annual report for 2016 here

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