Work stream 1: Biobanks for innovation and industry research
collaborations
AGENDA
09:00 - 09:20 Welcome and introduction. Status and deliverables of the dedicated work-package for innovation and industry research collaborations in Biobank Norway (WP8), Christian Jonasson, Senior Researcher HUNT Research Center, NTNU
Session 1: How to reach the goal of increased innovation and industry collaboration based on Norwegian health data?
09:20-09:45 What is needed to drive innovation and increase industry utilization of Norwegian healthdata - concrete proposals from the report led by Biobank Norway workpackage 8. Ninia M. Johnsen, Director Innovation and Industry at the Norwegian Institute of Public Health
09:45-10:10 How to build an ecosystem that can unleash the full potential for innovation and industryresearch collaboration on Norwegian health data? Ketil Widerberg, CEO Oslo Cancer Cluster
10:10 - 10:30 Norwegian Biobank-Industry case study: HUNT and Bio-Me collaboration to analyze themicrobiome on 30,000 HUNT4 subjects, Morten Isaksen, CEO Bio-Me
10:30 - 10:50 Discussion, moderated by Christian Jonasson
10:50 - 11:10 Coffee break
Status and deliverables of the dedicated work-package on innovation and industry research collaborations in Biobank Norway (WP8)
Christian Jonasson, Ph.D.
Senior Researcher
HUNT Research Center
K. G. Jebsen Center for Genetic Epidemiology
Norwegian University of Science and Technology (NTNU)
Helse Sør-Øst
Kreftregisteret
FHI
Univ. i Oslo
Univ. i Tromsø
Helse Nord
Helse Midt-Norge
NTNU
Univ. i Bergen
Helse Vest
Biobank Norway (bbmri.no)A national research infrastructure for biobanks funded by the Norwegian Research Council
BN1: 2011-2015 (95 mNOK)BN2: 2016-2018 (85 mNOK)
Biobank Norway 2 (2016-18)
WP1: project management and investments
30,9mNOK
+3,08 mNOK
WP2: Prospective clinical biobanks
8,5 mNOK
WP3: Multicentrebiobanking
10,7 mNOK
WP4: IT/Biocomputing
9,0 mNOK
WP5: Communication with study participants/donors
4,0 mNOK
WP6: Biobank register
2,5 mNOK
+3,0 mNOK
WP7: National platform for sequencing studies
4,1 mNOK
WP8: Innovation and industrial research
collaboration
4,7 mNOK
CS1: Biobanking best practises
2,7 mNOK
CS2: ELSI (ethical, legal and social aspects)
2,9 mNOK
• Hindringer• Muligheter• Organisatoriske,
juridiske og tekniske anbefalinger
WP8 objective #1: Develop a sustainable, national and publicly driven model & infrastructure that facilitate and handle biobank industry research collaborations
At present, a work package in Biobank Norway
Future need: a sustainable nationalcoordination of biobankinnovation and industry
WP8 objective #2: Preparing 11 selected biobanks for innovation and industry research collaborations
Population based biobanks Hospital research biobanks
#participants Matrices
The Nord-Trøndelag Health Study (HUNT)
127,000 Serum, plasma, DNA, RNA, urine
The Tromsø study (TU) 45,000 Serum, plasma, DNA,
The Mother and Child cohort (MoBa)
284,000 Serum, plasma, DNA, urine
JANUS serumbank 318,000 Serum
#Patients Matrices
Norwegian PrimarySclerosing Cholangitis(NoPSC)
1600 Serum, plasma, DNA, RNA, bile, feces, urine, tissue
Prostate cancer biobank 3000 FFPE and FF tissue, serum, plasma, DNA
Breast cancer (OSBREAC) 9000 Blood, FFPE, FF tissue
Prospective Breast Cancer Biobanking (PBCB)
1000 Tissue and serialblood and urine
TOP (tematisk organisertpsykoseforskning)
2500 (SCZ, BPD), 800 (ASD), 4500 (AD)
Blood, DNA, RNA
Multiple sclerosis register and biobank
6000 DNA, serum, plasma CSF and tissue
Norwegian Multiple Myeloma biobank
3000 Blood, serum, plasma, bone marrow, cells
Consent?Samples?Data?Collaboration areas & models?
WP8 objective #3: Biobank Norway policydocumentfor innovation and industrialresearch collaborations
https://www.ntnu.no/documents/15070332/0/Biobank+Norges+policydokument+om+innovasjon+og+samarbeid+med+n%C3%A6ringslivet+28Nov17.pdf/71f7d840-c8a7-4f02-a3fd-190451a4b283
WP8 objective #4: common framework for agreements withindustry
• Common guiding principles for;• Intellectual Property Rights
• Publication policy
• Ownership of raw data
• Data sharing and principles for embargoes and exclusivity
• Pricing terms
• Roles and responsibilities
• A set of standard contract templates
• Framework is based on the Lambert Toolkit from the UK
Coming soonMay 2018….
New web-sitewith informationrelevant for industry
WP8 objective #5: increasevisibility of Norwegian Biobanks
AGENDA
09:00 - 09:20 Welcome and introduction. Status and deliverables of the dedicated work-package for innovation and industry research collaborations in Biobank Norway (WP8), Christian Jonasson, Senior Researcher HUNT Research Center, NTNU
Session 1: How to reach the goal of increased innovation and industry collaboration based on Norwegian health data?
09:20-09:45 What is needed to drive innovation and increase industry utilization of Norwegian healthdata - concrete proposals from the report led by Biobank Norway workpackage 8. Ninia M. Johnsen, Director Innovation and Industry at the Norwegian Institute of Public Health
09:45-10:10 How to build an ecosystem that can unleash the full potential for innovation and industryresearch collaboration on Norwegian health data? Ketil Widerberg, CEO Oslo Cancer Cluster
10:10 - 10:30 Norwegian Biobank-Industry case study: HUNT and Bio-Me collaboration to analyze themicrobiome on 30,000 HUNT4 subjects, Morten Isaksen, CEO Bio-Me
10:30 - 10:50 Discussion, moderated by Christian Jonasson
10:50 - 11:10 Coffee break
March 13th 2018
Ninia M. Johnsen, National Institute of Public Health
Director Innovation and Industrial Collaboration
Presentation of a report from Biobank Norway (WP8): Access to Norwegian health data – how to address the needs of industry and enhance innovation and industry development
Biobank conference
FHI -
Biobank Norway – WP8
• Innovation/industrial collaboration (WP8)
The objective is to develop a national
model and framework for systematic
management of innovation efforts and
industry collaboration, tapping into the
rich resources of Norwegian biobanks. This
also involves exploring possibilities for and
obstacles to commercially oriented
projects.
05.04.2018
Ap
ril 1
7
FHI -
Background - the report
05.04.2018
• Great health data• Difficult to get access
• Decision in Parliament in May 2016, where the Parliament asked the Government to evaluate models and an infrastructure for safe and ethical collaboration between Norwegian public biobanks, health registers and industry
FHI -
Background - the report
05.04.2018
• June 2016: The Health Data Commission (Helsedatautvalget – HDU) was appointed by the Ministry of Health and Care Services
• Aim: Examine how to get simpler access and better utilization of health data
FHI -
Background - the report• HDU - broad mandate, including how a new system for more
efficient use of health data also can contribute to innovation and industry development
• Asked Biobank Norway, WP8, to answer the following questions:
1. What specific needs does the industry have wrt access to health data
2. What kind of actions should be taken to meet the industry's needs wrt organizational, legal and
technical issues
3. Describe trends, market possibilities and good examples where access to health data can be
used to increase innovation and industry development
05.04.2018
FHI -
Background - the report• WP8 established a working group with people representing
different kinds of expertise (biotechnology, health data, innovation, industrial collaboration)
05.04.2018
Name Work place
Christian Jonasson NTNU/HUNT
Helle Thorsen Inven2
Ole Johan Borge Bioteknologirådet
Monica Larsen LMI
Tarje Bjørgum Abelia
Stephen McAdam DNV GL
Ninia M. Johnsen Folkehelseinstituttet
Dag Undlien OUS/UiO
FHI -
Background - the report
05.04.2018
June 2017: HDU submitted a report to the Ministry of Health and Care Services: «A new system for simpler and safer access to health data »
Ap
ril
20
17
«Access to Norwegian health data –how to address the needs of industry and enhance innovation and industry development»
FHI - 05.04.2018
Value creation
FHI - 05.04.2018
Health and biobank data in drug R&D– across the life cycle from target ID to RWE
FHI -
Obstacles for the industryThe industry meets the same obstacles as everyone else applying for data, but to a stronger degree
• Apply for data in several/different places
• Restrictions in consent
• No or limited metadata
05.04.2018
Culture
FHI -
Important conditionsState/publicly owned
Important to preserve people’s/participant’s trust
Should be able to work with companies from different parts of the life-science sectorWell integrated with the institutions and professional expertise that manage/administer health data
National model (with regional collaboration/contribution)
Should include all Norwegian health data and biobanks (at least in the end…)
Critical mass is important
Social benefit should be the key, not economic profit
Be part of an ecosystem for health industry development
Make Norwegian health data attractive and competitive
Same access for public and private applicants – and same priceContribute to national value creation
05.04.2018
FHI -
A new national «unit»Public unit at a national (state) level with
innovation and industry development based
on health data as primary objective
National model with regional collaboration,
i.e. close collaboration with institutions that
manage health data today in the different
regions (North, West, Mid, South-East)
Employees with research competence,
knowing the health data managers well
The unit shall contribute to establish
collaboration models to make sure that wealth
creation is national (i.e. avoid only «passive
delivery» of health data with value creation
abroad)
05.04.2018
FHI - 05.04.2018
FHI -
A new national «unit », but where?Work in parallel in The Norwegian Directorate of eHealth (NDE)
A new unit should be established as part of
the new organisation model NDE will
suggest in their work to obtain simpler and
safer access to health data
Work in the Health Data Program, and
particularly in the project Health Analysis
Platform – Helseanalyseplattformen (HAP) –
will influence how a “national unit” finally
will be organized
05.04.2018
FROM CANCER RESEARCH TO CURE
Dedicated to accelerating the development of new cancer treatment
TODAY: IMPRECISION MEDICINE
DATA WILL CHANGE MEDICINE
AMERICAN PRECLINICAL INITIATIVE
- GOAL 6 TO 1 YEAR
TIME FOR A CLINICAL INITIATIVE
- GOAL 10 TO 5 YEARS?
NOT EVERYTHING IS PERFECT
COMPETETIVE ADVANTAGES
● One health provider and lifetime individual ID numbers
● Little population mobility
● National clinical annotated biobanks
● Cancer register
The Nordics are positioned to be a global testbed for personalized medicine
SOURCES OF DATA MULTIPLY
DIGITAL HEALTH - HYPE OR HOPE?
AMBITIOUS HEALTH ANALYTICS PLATFORM
PUBLIC WEATHER DATA PROVEN VALUABLE
HEALTH DATA HAS HIGH POTENTIAL VALUE
HOW DO WE SECURE NATIONAL VALUE
CREATION?
Give away? Lock in?
Think differently?
CAN OUR HEALTH DATA BE SEEN AS WORK?
Personal Microbiome Analysis
The value of HUNT for a small start-upAnalysis of fecal samples from 30.000 HUNT 4 subjects to
build unique database
Morten Isaksen PhDCEO Bio-Me
Gut microbiome (bacteria) and health
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
200520062007200820092010201120122013201420152016
Scientific break-throughNumber of scientific publications
Diet/blood sugar level Allergy in infants ObesityIBD/IBS Colon cancer Effect of drugs
GutCheck™ from Bio-Me will be the first high resolution, rapid gut microbiome test
Some diseases where GutCheck™ could help in diagnosis and choice of treatments:
In the media
Team – collaborators - advisors
Morten L. Isaksen PhDCEO
Experienced entrepreneur
Monika Sekelja PhD Leading
bioinformatics expert
Lars Snipen PhD Associate Professor
Bioinformatics, NMBU
Ove Solesvik MScBusiness Development
Aleap
Tore SagstuenBig Data consultant,
Brillio
Warren Flood PhDSenior Scientist
Christian Jonasson NTNU/HUNT
Kristian HveemProfessor, HUNT
Kjetill Jakobsen PhDProfessor at CEES, UiO
Bill HarrisBusiness Development
Norway Health Tech
Proprietary to Bio-Me
Health registries
GutCheck™ Database+ = Predictive modeling
Population based Biobank
+ Databank
• 10 x Faster
• 20 x Resolution
• 100+ bacterial species
• Scalable
• Comprehensive
• Machine Learning
• 130 000 donors
• 6000+ health parameters
• 30 000 feces samples
• Drug use
• Cancer and other diseases
• Medical history (journals, etc.)
HUNT (NTNU)
National registries
The Bio-Me solution
Microbiome analysis
Order
Family
Genus
Species
Strains
16S amplicon analysis
Whole Genome/Shot-gun sequencing
R e
s o
l u
t i
o n
Speed Resolution Precision
2 – 3 weeks Genus Medium
Several weeks Species/strain Medium
Order
Family
Genus
Species
Strains
16S amplicon analysis
Whole Genome/Shot-gun sequencing
GutCheck™
R e
s o
l u
t i
o n
Microbiome analysis
Speed Resolution Precision
2 – 3 weeks Genus Medium
Several weeks Species/strain Medium
1 – 3 days Species/strain High
Why is species and strain level information
important?
• Up- or down-regulation of a genus in a sample may hide up- or down-regulation of individual species and strains
• Different functionalities of different species within a genus
• Possible to understand how bacteria contribute to health condition
• Possible to understand disease and new drug development
Contribution of microbiome analysis to
Precision Medicine
• Many drugs are metabolized by the gut bacteria – Digoxin (Chronic heart failure) – Eggerthella lenta
– Metformin (T2DM)
– Statins (CVD)
– Immune Check-point inhibitors – responders/non-responders
• Increasing number of known drug-microbiome interactions
• Microbiome amenable to modifications – Dietary interventions
– Probiotics
– Prebiotics
– Specific drugs (over 700 clinical trails)
Opportunities through HUNT 4
• Basic info (age, gender, BMI, etc.)
• Life-style questionnaire
• HUNT databank (health parameters/genetic information)
• Link to national health registries
• Population-wide study - large sub-populations – Example: drug use – responders/non-responders, side-effects, etc.
• Starting point - 30.000 samples– Follow-up in longitudinal studies
– Other Biobanks
– Research collaborations
– Combine with other multiomics technologies
Limitations HUNT 4
• Only Norway – only Nord-Trøndelag
• Only one time-point
• Compare/share with Biobanks/Research Groups in other countries?
• Regulatory approval (local REK) – case-by-case
• Storage of data – local or Cloud?
• Possible to perform “open” Machine Learning algorithms?
• Common national platform for access to health data – timeframe?
Proprietary to Bio-Me
Health registries
GutCheck™ Database+ = Predictive modeling
Population based Biobank
+ Databank
• 10 x Faster
• 20 x Resolution
• 100+ bacterial species
• Scalable
• Comprehensive
• Machine Learning
• 130 000 donors
• 6000+ health parameters
• 30 000 feces samples
CLINICAL RELEVANCE/VALUE:• More precise treatment
• Understanding mechanism of
action (MOA)
• New drug development
• Successful clinical trials
• Technology for the future
• Drug use
• Cancer and other diseases
• Medical history (journals, etc.)
HUNT (NTNU)
National registries
Lessons learnt so far…
• Biobanks very valuable for start-up companies
• Important to understand and communicate the potential
• Willing to adapt/think new
• Think global
• Think synergistically