Work stream 1: Biobanks for innovation and industry ...

transcript

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

Univ. i Oslo

Univ. i Tromsø

Helse Nord

Helse Midt-Norge

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

Thank you!For more information, please contact

Christian.jonasson@ntnu.no+4790936941

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

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

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

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

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

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

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 »

«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

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

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

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

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

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

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

Family

Species

Strains

16S amplicon analysis

Whole Genome/Shot-gun sequencing

Speed Resolution Precision

2 – 3 weeks Genus Medium

Several weeks Species/strain Medium

Family

Species

Strains

16S amplicon analysis

Whole Genome/Shot-gun sequencing

GutCheck™

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

Thank you!

Morten L. Isaksen PhD

Bio-Me AS

www.bio-me.no

m.isaksen@bio-me.no

+47 97 51 20 70

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