NRI-CONFERENCE 2017NORDIC MODEL FOR PERSONALIZED MEDICINE 19. May 2017 - Oslo Cancer Cluster Innovation Park, Norway

WELCOMEWe are pleased to welcome you to this year’s special NRI-Conference with focus on creating aNordic model for Personalized Medicine.

Why personalized medicine?This year we will focus on precision medicine, a. key approach in the creation of future medical advances.. It is vital that the Nordic region shares common goals, and works closely to reach them.

Precision medicine is changing the way we treat life-threatening diseases. Access to patient data and collaborative clinical studies across the Nordic region will allow researchers to develop better and safer treatments that are increasingly tailored to each individual patient, based on their biology and specific disease.

Our goal today is to gather representatives and leading stakeholders throughout the Nordic region in order to find concrete solutions and better ways to collaborate in the future.

Organizers The conference is a close collaboration between Oslo University Hospital, the University Hospital of Northern Norway, The Norwegian Biotechnology Advisory Board, Oslo Cancer Cluster, the Norwegian Cancer Genomics Consortium, NRI-Networks, and Nordic NECT. We are also fortunate to have valuable conference supporters: NordForsk, Nordic Trial Alliance, UiO: Life Science and The Research Council of Norway.

We hope you will enjoy this conference and gain new perspectives from our expert speakers, network with Nordic colleagues, and join the discussions during our parallel sessions.

Kind regardsThe organizers

PRACTICAL INFORMATION 4

SPEAKER PRESENTATION 6

MAIN SESSION PROGRAM 8

PARALLELL SESSION INFO 9

PARALLELL SESSION 1 - USER INVOLVEMENT 10

PARALLELL SESSION 2 - NORDIC CROSS BORDER PATIENTS 11

PARALLELL SESSION 3 - DATA SHARING, PRIVACY AND INNOVATION 12

PARALLELL SESSION 4 - NORDIC HEALTH SUMMIT 14

ORGANIZERS 16

TABL

E O

F CO

NTE

NT

PRACTICALINFORMATION

CONFERENCEVENUE

LUNCH

NETWORKING

PARALLELSESSIONS

SPONSORS

The conference is held at Oslo Cancer Cluster Innovation Park. Address: Ullernchausseen 64/66, 0379 Oslo.The main part of the conference will take place in Kaare Norum lecture hall.

Lunch is served 11:55 – 12:40 in The Research Building - the building to the right of Oslo Cancer Cluster Innovation Park. Please follow sign and direction from staff.

Coffee breaks and lunch will be served in an environment tailored for networking. Meeting Nordic collages is an important part of the conference.

Parallel sessions are hosted after lunch and will take place in the following venues:

Oslo Cancer Cluster Innovation ParkParallel session 1: User involvement will be held in Jónas Einarsson AuditoriumParallel session 2: Nordic cross border patients for Clinical Trials will be held in Kaare Norum Auditorium

Research BuildingParallel session 3: Data sharing, Privacy and Innovation will be held in AuditoriumParallel session 4: Nordic Health Summit will be held in Seminar room 2Parallel session 5: NORM Workshop will be held in Meeting room

The NRI-Conference is made possible by our financial supporters: NordForsk, Nordic Trial Alliance, UiO: Life Sciences and The Research Council of Norway”

MOREINFORMATION

CONTACTINFORMATION

You can find more information on our website: www.nordicnetworks.org

Please contact us for any questions you may have:Christina Laastad, Project Manager Mobile: +47 454 49 896 E-mail: info@nordicnetworks.org

HAV

E A

GRE

AT

CON

FERE

NCE BJØRN ERIKSTEIN CEO, Oslo University Hospital and Chairman, NRI-

Networks

KETIL WIDERBERG CEO, Oslo Cancer Cluster

OLA MYKLEBOST CEO, Norwegian Cancer Genomics Consortium

OLE JOHAN BORGE CEO, The Norwegian Biotechnology Advisory Board

SAMELINE GRIMSGAARD Vice Dean Research, University of Northern Norway

STEINAR AAMDAL Head of Department of Early Cancer Trials, Oslo University Hospital and Chairman, Nordic NECT

4 5

SPEAKERS SPEAKERSANNE GRETHE ERLANDSENState Secretary Ministry of Health and Care Services - NorwayAnne Grethe Erlandsen represents the Conservative Party. She currently serve as State Secretary for the Norwegian Ministry of Health and Care Services.

NOOMI O. GREGERSENProject Manager FarGen - Faroe islandsNoomi Oddmarsdóttir Gregersen holds a position as Project Manager at FarGen. FarGen is a project managed by the Genetic Biobank, which is an entity under the authority of the Faroese Ministry of Health and the Interior.

LOUISE LOCOCKAssociate Professor and Director of Applied Research University of Oxford - UKLocock is interested in projects using qualitative research methods to understand health and illness experiences, and the use of these experiences to develop more patient-centred policy and practice, including service improvement and commissioning decisions.

JANE KAYEDirector of the Centre for Health, Law and Emerging Technologies (HeLEX) University of Oxford - UKProf. Jane Kaye DPhil, LLB, Grad Dip Leg, BA is the Director of the Centre for Law, Health and Emerging Technologies (HeLEX) at the University of Oxford and a Wellcome Trust University Award holder.

CHARLOTTE VIDEBÆKConsultant Innovation Fund Denmark - DenmarkDr. Videbaek is supporting the Innovation Fund Denmark as a consultant. She has previously worked with personalized medicine and drug development in different roles. Dr. Videbaek has a background as MD from the University of Copenhagen with a board certification as Neurologist.

JARI PARTANENState Secretary The Minister of Family Affairs and Social Services - FinlandJari Partanen represents the Centre Party of Finland and currently holds the position as State Secretary to the Finnish Centre Party’s group of ministers, including Juha Rehula, the Minister of Family Affairs and Social Services.

KÁRI STEFÁNSSONCEO deCODE - IcelandDr. Stefansson is recognized as a leading figure in human genetics. He has shaped deCODE’s scientific approach and been actively engaged in leading its gene discovery work, serving as senior author on most of the company’s publications in major scientific journals.

SIR JOHN BURNProfessor of Clinical Genetics Newcastle University - UKSir John Burn is Professor of Clinical Genetics at Newcastle University. He is medical director and head of the Institute of Human Genetics, and lead clinician for the National Health Service North East.

MORTEN MAU-SØRENSENChief Physician I unit Department of Oncology, Rigshospitalet - DenmarkMorten Mau-Sørensen holds a position as Head of Phase I unit, Department of Oncology, Rigshospitalet, Copenhagen, Denmark.

SHAWN M. SWEENEYDirector of translational research AACR Project GENIE Coordinating Center - USAMr Sweeney is the associate director of translational research at the American Association for Cancer Research (AACR), he serves as liaison for the AACR’s Clinical and Translational Cancer Research Committee (CTCRC) and scientific working groups; project lead and content developer for the AACR Cancer Progress Report series; and internal scientific consultant.

MARK CAULFIELDChief Scientist and Board member Genomics England - UKProfessor Mark Caulfield is Chief Scientist and member of the board at Genomics England. Genomics England is a company set up and owned by the UK Department of Health to run the 100,000 Genomes Project, which aims to sequence 100,000 genomes from NHS patients with a rare disease and their families, and patients with cancer.

6 7

08:30 - 09:00 Registration

Main Session 1: Personal genomics - the future of healthcare?

09:00 - 09:15 WelcomeAnne Grethe Erlandsen & Jari Partanen

09:15 - 09:40 Decoding Personalized Medicine Kári Stefánsson

09:40 - 10:00 Personalized Cancer Medicine: Redefining Cancer and its TreatmentSir John Burn

10:00 - 10:20 Cross Boarder Patients, a Danish ExampleMorten Mau-Sørensen

10:20 - 10:35 Coffee Break

Main session 2: Innovation and user involvement in the Nordic Countries

10:35 - 10:45 Genomics England - UKs Biggest Investment intoPersonalized MedicineMark Caulfield

10:45 - 10:55 Whole-genome Sequencing Data in theFarGen-infrastructureNoomi O. Gregersen

10:55 - 11:15 Patient and Public InvolvementLouise Locock

11:15 - 11:35 Dynamic ConsentJane Kaye

11:35 - 11:55 Bringing Innovation to the MarketCharlotte Videbæk

11:55 - 12:40 Lunch

01User involvementThe workshop aims to summarize present experiences and discuss future challenges related to user involvement in research. Target groups are patient organizations, researchers, health care administrators and providers, funding bodies, stakeholders and industry in the Nordic region. (See page 8 for program)

03Data Sharing, Privacy and InnovationThe workshop will in the first session focus on data sharing and the related data protection questions. The second session consists of two main topics; return of results, and translation and innovation.( See page 10 for program)

02Nordic Cross Border Patients for Clinical TrialsThe workshop aims to create awareness of the collaboration potentials in the Nordics, identify hurdles preventing patients from participating in clinical trials cross border, addressing regulatory and legal requirements, as well as discussing the challenges regarding logistics, language differences etc. The workshop will address these cross border challenges with lectures from regulatory authorities, pharmaceutical industry, clinical trialists in oncology, lawyers and healthcare politicians. (See page 9 for program)

04Nordic Health SummitThe summit is a forum for Nordic health professionals at management level, Deans of Medical Faculties and Hospital Directors to meet and discuss common challenges and development opportunities. (See page 11 for program)

05NORM WorkshopNordic Monitoring Network (NORM) is for everyone working within the field of monitoring and quality assurance of academic clinical trials with medicinal products in the Nordic countries. Ongoing tasks of the network include mapping all monitoring units and organizing a system of coordinated monitoring of trials with medicinal products in the Nordic countries. (Program will be given at the workshop)

MAIN SESSION PARALLEL SESSIONS12:40 - 16:00

CHOOSE ONE

8 9

PARALLEL SESSIONS PARALLEL SESSIONS01 USER INVOLVEMENT WORKSHOP

NORDIC CROSS BORDER PATIENTS FOR CLINICAL TRIALS

02

Venue: Jónas Einarsson Auditorium, Oslo Cancer Cluster Innovation Park

12:40 - 12:55 FinlandTiina Altonen, Grappo

12:55 - 13:10 Sweden Oskar Jonsson, Lund University

13:10 - 13:25 DenmarkMogens Hørder, University of Southern Denmark

13:25 - 13:40 NorwayLilly Ann Elvestad, The Norwegian Federation of Organizations of Disabled People / Health&Care21

13:40 - 13:55 Nordic Cancer SocietiesOle-Alexander Opdalshei

13:55 - 14:10 Summary

14:10 - 14:30 Coffee Break

14:30 - 15:30 Workshop discussions

Venue: Kaare Norum Auditorium, Oslo Cancer Cluster Innovation Park

Moderator: Steinar Aamdal, Oslo University Hospital

12:40 - 12:50 Introduction

12:50 - 13:00 Why Nordic Collaboration? Maiken Engelstad, Norwegian Ministry of Health and Care Services

13:00 - 13:55 Sending Patients Cross Border for Clinical Trial Participation – What are the challenges in each country?

• DENMARK - Morten Mau-Sørensen, Department of Oncology, Rigshospitalet - Copenhagen University Hospital

• SWEDEN – Jeffrey Yachnin, Early Clinical Trail Unit at Karolinska University Hospital

• FINLAND – Katriina Peltola, Clinical Trial Unit at Helsinki University Hospital

• NORWAY – Steinar Aamdal, Early Cancer Trials and Research Support, Oslo University Hospital

13:55 - 14:10 The Pharma Industry – Nordic Trial CollaborationCharlotte Qwist, Novartis Healthcare, Denmark

14:10 - 14:30 Coffee Break

14:30 - 14:45 Potential Logistic ChallengesSteinar Aamdal, Oslo University Hospital

14:45 - 15:00 Potential Legal ChallengesHarald Platou, International Centre, Oslo University Hospital Trust

15:00 - 15:10 Potential Regulatory ChallengesIngvild Aaløkken, Norwegian Medicines Agency

15:10 - 15:30 Open Discussion, Summary and Next Step We need National or Nordic Procedures for Cross Border Patients in Clinical Trials!

1. What are our experiences on user involvement so far – what works and what does not work? What are the main challenges and barriers?

2. How can we create and improve a culture for user involvement among users and researches?

3. Education for users - what and how much is needed?

4. Different kinds of user involvement for different research areas? • Involvement• Participation • Engagement

10 11

03 03DATA SHARING, PRIVACY AND INNOVATION

DATA SHARING, PRIVACY AND INNOVATION

PARALLEL SESSIONS PARALLEL SESSIONS

Venue: Main Auditorium, The Research Building

Topic 1: Privacy and Data SharingModerator: Ola Myklebost, Norwegian Cancer GenomicsConsortium

12:40 - 13:00 DENTIST OLAF AASE AND WIFE’S MEMORIAL LECTUREPublication of Tumor Genome data – AACR Project GENIEShawn M. Sweeney, AACR Project GENIE Coordinating Center

13:00 - 13:15 Genomics England’s Data Access ProceduresMark Caulfield, Genomics England

13:15 - 13:25 Databases for Sharing of DNA Data in the NordicsEivind Hovig, University of Oslo and Oslo University Hospital

13:25 - 13:35 Legal Aspects of DNA Data Processing in International DatabasesHeidi Beate Bentzen, University of Oslo

13:35 - 13:45 Security Requirements Pursuant to the EU General Data Protection RegulationLee Andrew Bygrave, University of Oslo

13:45 - 14:10 Panel debate and discussion

14:10 - 14:30 Coffee Break

Venue: Main Auditorium, The Research Building

Topic 2: Return of resultModerator: Ketil Widerberg, Oslo Cancer Cluster

14:30 - 14:40 Return of Results: Ethical and Societal ConsiderationsOle Johan Borge, The Norwegian Biotechnology Advisory Board

14:40 - 14:50 Return of Results from Diagnostic Genomic Sequencing: The Laboratory PerspectiveDanya Vears, KU Leuven

14:50 - 15:10 Panel debate and discussion

Topic 3: Translation and InnovationModerator: Ole Johan Borge, The Norwegian Biotechnology Advisory Board

15:10 - 15:20 How do we go from Promising Laboratory Science to Clinical Utility in Increasingly Fragmented Patient Populations?Ola Myklebost, Norwegian Cancer Genomics Consortium

15:20 - 15:30 Public-Private PartnershipsKetil Widerberg, Oslo Cancer Cluster

15:30 - 15:40 Big Data, IPRs & Competition in Precision Medicine: Challenges, Risks & OpportunitiesTimo Minssen, University of Copenhagen

15:40 - 16:00 Panel debate and discussion

CONTINUES

12 13

04 04NORDIC HEALTH SUMMIT NORDIC HEALTH SUMMIT

PARALLEL SESSIONS PARALLEL SESSIONS

Venue: Seminar Room 2, The Research Building

12:40 - 12:45 WelcomeBjørn Erikstein, Oslo University Hospital

Topic 1: Antimicrobial ResistanceModerator: John Arne Røttingen, The Research Council of Norway

12:45 - 13:00 Project Report: Turning the Tide of Antimicrobial ResistanceTone Tønjum, Oslo University Hospital

13:00 - 13:15 Founding Research on Antimicrobial ResistanceStener Kvinnsland, Bergen Research Foundation

13:15 - 13:30 Discussion

Topic 2: Nordic Collaboration for PrecisionMedicineModerators: Bjørn Erikstein, Oslo University Hospital and Per Morten Sandset, South-Eastern Norway Regional Health Authority

13:30 - 13:45 Norwegian Strategy for Personalised Medicine in HealthcareJohan Torgersen, The Norwegian Directorate of Health

13:45 - 13:55 Education, Training and Competence Building InitiativesChristin Marsh Ormhaug, The Norwegian Directorate of Health

13:55 - 14:10 Introducing new subjects in higher educationsNina Waaler, Oslo and Akershus University College of Applied Sciences

14:10 - 14:30 Coffee Break

14:30 - 14:45 Genomics EnglandMark Caulfield, Genomics England

14:45 - 15:15 Discussion

Venue: Seminar Room 2, The Research Building

Topic 3: Nordic Cross Border Patients for Clinical TrialsModerator: Moderator Per Morten Sandset, South-Eastern Norway Regional Health Authority

15:15 - 15:35 How can the Nordic Countries Collaborate for Cross Border PatientsSteinar Aamdal, Oslo University Hospital and Nordic NECT

15:35 - 16:00 Discussion

16:00 - 16:15 Coffee Break

16:15 - 17:00 Workshop on information to patients and the publicHosted by the Norwegian Directorate of Health

CONTINUES

14 15

Nordic Health Research and Innovation Networks (NRI-Networks)is an independent, non-profit organisation working to promote health research and innovation in the Nordic region.

Oslo University Hospitalis a highly specialised hospital in charge of extensive regional and local hospital assignments and the provision of high quality services for the citizens of Oslo. The hospital also has a nationwide responsibility for a number of national and multi-regional assignments and has several national centres of competence.

Oslo Cancer Clusteris an oncology research and industry cluster dedicated to improving the lives of cancer patients by accelerating the development of new cancer diagnostics and medicines. We gather about 90 Norwegian and international members, representing the entire oncology value chain, from exploratory research to global marketing of therapeutics and diagnostics.

The Norwegian Biotechnology Advisory Boardis an independent body appointed by the Norwegian government. The main tasks of the Norwegian Biotechnology Advisory Board are to evaluate the social and ethical consequences of modern biotechnology, and to contribute to public dissemination and debate about its use.

The University Hospital of North Norway (UNN)is a part of Helse Nord. Our four primary tasks are treatment of patients, training of patients and next of kin, research, and education of health personnel. We have hospitals in Tromsø, Harstad, Narvik and Longyearbyen in Svalbard/Spitsbergen.

The Norwegian Genomics Consortium (NCGC)consists of clinical and basic cancer research groups from all health regions in Norway. The consortium aims to develop more targeted cancer treatments by mapping tumour genetic mutations.

Nordic Network for Early Cancer Trials (NECT)is a cooperation between phase I units in Denmark, Finland, Sweden and Norway. The network is designed to promote patient access to new investigational drugs and access to phase I and early phase II programs in the Nordic countries.

ORGANIZERS NOTES

16 17

CancerGen

omics.N

o

NordForsk

18 19

CONTACTChristina Laastad, Project Manager Mobile: +47 454 49 896 E-mail: info@nordicnetworks.org

www.nordicnetworks.org

Graphic design: Per M

arius Didriksen