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Using healthcare data
for biomedical research
MAY 27, 2016
Kees van Bochove, CEO & Founder, The Hyve
Open Source
u  Source code openly accessible and reusable for everyone
u  Enables pre-competitive collaboration: both academics and
industry can use and enhance it
u  Transparency: verification (scientific as well as IT security) can be
done by anyone, no ‘black box’
3
The Hyve
u  Professional	support	for	open	source	so*ware	for	bioinforma1cs	and	transla1onal	
research	so5ware,	such	as	tranSMART,	cBioPortal,	i2b2,	Galaxy,	ADAM	and	OHDSI	
	
	
	
	
	
	
Mission	
Enable	pre-compe11ve	
collabora1on	
in	life	science	R&D	
by	leveraging		
open	source	so*ware	
Core	values	
Share		
	
	
Reuse	
	
	
Specialize	
Office	Loca5ons	
Utrecht,	Netherlands	
Cambridge,	MA,	United	States	
Services	
So5ware	development	
Data	science	services	
Consultancy	
Hos1ng	/	SLAs	
Fast-growing	
Started	in	2012	
35	people	by	now
Interdisciplinary team
so5ware	 engineers,	 data	 scien1sts,	 project	 managers	 &	 staff;	 exper1se	 in	
bioinforma1cs,	medical	informa1cs,	so5ware	engineering,	biosta1s1cs	etc.		
4
YoungCB meeting @ The Hyve
5
New The Hyve offices being built at the Arthur van Schendellaan
in Utrecht, The Netherlands
6
7
3 Health Data Areas The Hyve is active in
u  Translational Research Data
(‘Clinical & bioinformatics data’)
u  Population Health Data
(‘Real world data’)
u  Personal Health Data
(‘Wearable sensors data’)
Example project:
1.
TRANSLATIONAL RESEARCH DATA
8
9
Center for Translational Molecular Medicine (CTMM)
u  Public-private consortium
u  Dedicated to the development of Molecular
Diagnostics and Molecular Imaging technologies
u  Focusing on the translational aspects of molecular
medicine.
u  120 partners
u  universities, academic medical centers, medical
technology enterprises and chemical and
pharmaceutical companies.
u  Budget 300 M€
u  22 projects / research consortia
u  TraIT is the Translational Research IT project
supporting these projects with a joint IT infrastructure
10
TraIT Consortium
Growing TraIT project team
TraIT data workflow
Hospital (IT) Translational Research (IT)
data domains
clinical data
imaging data
experimental data
biobanking
integrated data translational
analytics
workbench
HIS
PACS
LIS
Galaxy
tranSMART/
cohort explorer
R
tranSMART/i2b2
datawarehouseCBM-NL
OpenClinica
NBIA + AIM
e.g. PhenotypeDB,
Annai Systems
e.g.
Galaxy, Chipster
Samples (IT)
P
s
e
u
d
o
n
y
m
i
z
a
t
i
o
n
Public Data
BIMS
12
TranSMART Platform: Scientific Function
CLINICAL GENETICS SENSORS IMAGING
DATA
UNDER
STANDING
BIOLOGY MEDICINE
13
TranSMART Open Source History
u  February 2012: J&J releases tranSMART as open
source on GitHub under GPL v3
u  December 2012: CTMM TraIT project decides to use
tranSMART as core infrastructure component
u  January 2013: IMI eTRIKS starts, uses tranSMART as
core infrastructure component
u  February 2013: kickoff of tranSMART Foundation, U.
Michigan publishes PostgreSQL port
u  March 2014: IMI EMIF kickoff, tranSMART is used as
data integration component
Contributors
Amsterdam, June 2013: tranSMART Workshop
Attendees from 10 Pharma companies, 11 University Medical Centers and 12 IT companies
http://lanyrd.com/2013/transmart
15
VUmc
Sanofi
Recombina
nt / Deloitte
University
of
Michigan
Thomson
Reuters Pfizer
Astra
Zeneca
CDISC
University of
Luxembourg
Philips
Johnson
&
Johnson
The Hyve
70
Ann Arbor, Michigan, October 2014: Annual Meeting
http://lanyrd.com/2014/transmart
16
130
Bio IT World, Boston, April 2015
http://bit.ly/1R2N6uz
17
TranSMART wins all the prizes: Best Show Award, Best Practices Award, Best Poster Award
Amsterdam, October 2015: Annual Meeting
http://lanyrd.com/2015/transmart-foundation-annual-meeting/
18
160
TranSMART: working with clinical data
cBioPortal for Cancer Genomics
20
current community a.o.
Focus: intuitive exploratory analysis of the data
2.
POPULATION HEALTH DATA
22
What Ewan Birney has to say
about it …
(GA4GH Leiden 2015)
23
Time To Market: 11 – 18 years
6
NegotiationforReimbursement
27memberStates
EMAFiling
Pre-ClinicalResearch
Closed&OpenInnovation
Clinical Trials
EMAApprovalforSale
HTAApproval
Phase 1 Phase 2 Phase 3
5,000
10,000
Compounds
250
Compounds
3 – 6 Years 6 – 7 Years
5
Therapies
1
Therapy
2 – 5 Years
Number of Patients/Subjects
20-100 100-500 1000-5000
Regulatory
Review
Drug
Discovery
Pre Clinical
Testing
PhV
Monitoring
Total Cost: $2 - $4 Billion USD
Sources: Drug Discovery and Development: Understanding the R&D Process, www.innovation.org;
CBO, Research and Development in the Pharmaceutical Industry, 2006;
Forbes, Matthew Herper, “The Truly Staggering Cost Of Inventing New Drugs”, February 10, 2012
Current EU “Patient Journey” is expensive and slow
New therapies
don’t reach
patients until here
Phase 4 : $0.6BDrug Development : $2.6B
Secondary use of health data to enrich research
25
The value of healthcare data for secondary uses in clinical research and development — Gary K. Mallow, Merck, HIMSS 2012
1 2 3 4 5 6 7 8 9
1,000
10,000
100,000
1 million
Years
#PatientExperiences/Records
The “burning platform” for life sciences
Pharma-owned highly controlled clinical trials
data
Clinical practice, patients, payers and providers
own the data
Product
Launch
R&D
Phase IV
Challenge
Today, Pharma doesn’t have ready access to this
data, yet insights for safety, CER and other areas are
within this clinical domain, which includes medical
records, pharmacy, labs, claims, radiology etc.
26
Clinical Trials vs Observational Studies
Clinical Trials Observational Studies
Study Design Controlled (hypothesis driven) “Real world” data
Sample Size Small (10.000 is large) Large (millions of people)
Endpoints Efficacy, safety Effectiveness, economic value
Statistics Descriptive statistics (e.g. ANOVA) Epidemiological modeling
Cost Expensive Not so expensive
Perspective Study population Society in general
To become the trusted
European hub for health
care data intelligence,
enabling new insights into
diseases and treatments
EMIF vision
27
Discover
Assess
Reuse
Data available through EMIF consortium
§  Large variety in “types” of data
§  Data is available from more than 53 million subjects from seven
EU countries, including
Primary care data
sets
Hospital data Administrative data Regional record-
linkage systems
Registries and
cohorts (broad and
disease specific)
Biobanks
>25,000
subjects in
AD cohorts
>90,000
subjects in
metabolic cohorts
>40million
MAAS
SDR
EGCUT
PEDIANET
SCTS
IMASIS
HSD
AUH
IPCI
ARS
SIDIAP
PHARMO
THIN
100 1,000 10,000 100,000 1,000,000 10,000,000 100,000,000
Approximatetotal(cumulative)numberofsubjects
Available data sources in EMIF
29
EMIF-Platform
EMIF-Available Data Sources; EXAMPLES
1K
2K
52K
400K
475K
2.8M
2.3M
10M
Status Jan 2016
3.6M
1.6M
1M
12M
6M
30
OMOP & OHDSI - Overview
u  OMOP: Common Data Model for observational healthcare data:
persons, drugs, procedures, devices, conditions etc.
u  OHDSI: Large-scale analytics tools for observational data
An open source community, a.o. developing:
u  Tools to support the ETL / mapping process into OMOP (White Rabbit etc.)
u  Tools to perform analytics: e.g. Achilles for data profiling, Calypso for
feasibility assessment
www.omop.org
www.ohdsi.org
31
OMOP Common Data Model v5.0
v  OMOP =
Observational
Medical
Outcomes
Partnership
v  CDM = Common
Data Model
v  SQL Tables
32
OHDSI: Example Query Result
Slide from P. Ryan, Janssen
Re-use of healthcare data
33
Prof. Johan van der Lei
Erasmus MC University Medical Center
“We need to learn from experience and find ways
to unite the large volumes of data in Europe. At
the end of the day, we are in this for better health
care.”
Co-coordinator EMIF-Platform
EMIF-Platform
3.
PERSONAL HEALTH DATA
34
35
Challenges in managing chronic diseases
u  Health assessments via physician visits are time
limited and subjective, often not representative
for everyday life of the patient
u  The disease state can change a lot in between
visits, and important events are not visible to the
physician
But… it’s 2016: it’s now possible to objectively, remotely, and continuously
measure aspects of patient physiology, behavior and symptoms
36
RADAR-CNS: Focus areas
from diagnose & treat à predict & pre-empt
u  Epilepsy
u  Monitoring and predicting epileptic seizures
u  Multiple Sclerosis
u  Monitoring exacerbations and disease state
u  Depression
u  Monitoring for possible relapses, plan timely interventions
u  Predict bipolar state transitions
37
Continuous Patient Assessment
38
Potential digital biomarkers
39
Preliminary Technology Stack
Analytics
Using Healthcare Data for Research @ The Hyve - Campus Party 2016

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Using Healthcare Data for Research @ The Hyve - Campus Party 2016

  • 1. Using healthcare data for biomedical research MAY 27, 2016 Kees van Bochove, CEO & Founder, The Hyve
  • 2. Open Source u  Source code openly accessible and reusable for everyone u  Enables pre-competitive collaboration: both academics and industry can use and enhance it u  Transparency: verification (scientific as well as IT security) can be done by anyone, no ‘black box’
  • 4. Interdisciplinary team so5ware engineers, data scien1sts, project managers & staff; exper1se in bioinforma1cs, medical informa1cs, so5ware engineering, biosta1s1cs etc. 4
  • 5. YoungCB meeting @ The Hyve 5
  • 6. New The Hyve offices being built at the Arthur van Schendellaan in Utrecht, The Netherlands 6
  • 7. 7 3 Health Data Areas The Hyve is active in u  Translational Research Data (‘Clinical & bioinformatics data’) u  Population Health Data (‘Real world data’) u  Personal Health Data (‘Wearable sensors data’) Example project:
  • 9. 9 Center for Translational Molecular Medicine (CTMM) u  Public-private consortium u  Dedicated to the development of Molecular Diagnostics and Molecular Imaging technologies u  Focusing on the translational aspects of molecular medicine. u  120 partners u  universities, academic medical centers, medical technology enterprises and chemical and pharmaceutical companies. u  Budget 300 M€ u  22 projects / research consortia u  TraIT is the Translational Research IT project supporting these projects with a joint IT infrastructure
  • 11. TraIT data workflow Hospital (IT) Translational Research (IT) data domains clinical data imaging data experimental data biobanking integrated data translational analytics workbench HIS PACS LIS Galaxy tranSMART/ cohort explorer R tranSMART/i2b2 datawarehouseCBM-NL OpenClinica NBIA + AIM e.g. PhenotypeDB, Annai Systems e.g. Galaxy, Chipster Samples (IT) P s e u d o n y m i z a t i o n Public Data BIMS
  • 12. 12 TranSMART Platform: Scientific Function CLINICAL GENETICS SENSORS IMAGING DATA UNDER STANDING BIOLOGY MEDICINE
  • 13. 13 TranSMART Open Source History u  February 2012: J&J releases tranSMART as open source on GitHub under GPL v3 u  December 2012: CTMM TraIT project decides to use tranSMART as core infrastructure component u  January 2013: IMI eTRIKS starts, uses tranSMART as core infrastructure component u  February 2013: kickoff of tranSMART Foundation, U. Michigan publishes PostgreSQL port u  March 2014: IMI EMIF kickoff, tranSMART is used as data integration component
  • 15. Amsterdam, June 2013: tranSMART Workshop Attendees from 10 Pharma companies, 11 University Medical Centers and 12 IT companies http://lanyrd.com/2013/transmart 15 VUmc Sanofi Recombina nt / Deloitte University of Michigan Thomson Reuters Pfizer Astra Zeneca CDISC University of Luxembourg Philips Johnson & Johnson The Hyve 70
  • 16. Ann Arbor, Michigan, October 2014: Annual Meeting http://lanyrd.com/2014/transmart 16 130
  • 17. Bio IT World, Boston, April 2015 http://bit.ly/1R2N6uz 17 TranSMART wins all the prizes: Best Show Award, Best Practices Award, Best Poster Award
  • 18. Amsterdam, October 2015: Annual Meeting http://lanyrd.com/2015/transmart-foundation-annual-meeting/ 18 160
  • 19. TranSMART: working with clinical data
  • 20. cBioPortal for Cancer Genomics 20 current community a.o.
  • 21. Focus: intuitive exploratory analysis of the data
  • 23. What Ewan Birney has to say about it … (GA4GH Leiden 2015) 23
  • 24. Time To Market: 11 – 18 years 6 NegotiationforReimbursement 27memberStates EMAFiling Pre-ClinicalResearch Closed&OpenInnovation Clinical Trials EMAApprovalforSale HTAApproval Phase 1 Phase 2 Phase 3 5,000 10,000 Compounds 250 Compounds 3 – 6 Years 6 – 7 Years 5 Therapies 1 Therapy 2 – 5 Years Number of Patients/Subjects 20-100 100-500 1000-5000 Regulatory Review Drug Discovery Pre Clinical Testing PhV Monitoring Total Cost: $2 - $4 Billion USD Sources: Drug Discovery and Development: Understanding the R&D Process, www.innovation.org; CBO, Research and Development in the Pharmaceutical Industry, 2006; Forbes, Matthew Herper, “The Truly Staggering Cost Of Inventing New Drugs”, February 10, 2012 Current EU “Patient Journey” is expensive and slow New therapies don’t reach patients until here Phase 4 : $0.6BDrug Development : $2.6B
  • 25. Secondary use of health data to enrich research 25 The value of healthcare data for secondary uses in clinical research and development — Gary K. Mallow, Merck, HIMSS 2012 1 2 3 4 5 6 7 8 9 1,000 10,000 100,000 1 million Years #PatientExperiences/Records The “burning platform” for life sciences Pharma-owned highly controlled clinical trials data Clinical practice, patients, payers and providers own the data Product Launch R&D Phase IV Challenge Today, Pharma doesn’t have ready access to this data, yet insights for safety, CER and other areas are within this clinical domain, which includes medical records, pharmacy, labs, claims, radiology etc.
  • 26. 26 Clinical Trials vs Observational Studies Clinical Trials Observational Studies Study Design Controlled (hypothesis driven) “Real world” data Sample Size Small (10.000 is large) Large (millions of people) Endpoints Efficacy, safety Effectiveness, economic value Statistics Descriptive statistics (e.g. ANOVA) Epidemiological modeling Cost Expensive Not so expensive Perspective Study population Society in general
  • 27. To become the trusted European hub for health care data intelligence, enabling new insights into diseases and treatments EMIF vision 27 Discover Assess Reuse
  • 28. Data available through EMIF consortium §  Large variety in “types” of data §  Data is available from more than 53 million subjects from seven EU countries, including Primary care data sets Hospital data Administrative data Regional record- linkage systems Registries and cohorts (broad and disease specific) Biobanks >25,000 subjects in AD cohorts >90,000 subjects in metabolic cohorts
  • 29. >40million MAAS SDR EGCUT PEDIANET SCTS IMASIS HSD AUH IPCI ARS SIDIAP PHARMO THIN 100 1,000 10,000 100,000 1,000,000 10,000,000 100,000,000 Approximatetotal(cumulative)numberofsubjects Available data sources in EMIF 29 EMIF-Platform EMIF-Available Data Sources; EXAMPLES 1K 2K 52K 400K 475K 2.8M 2.3M 10M Status Jan 2016 3.6M 1.6M 1M 12M 6M
  • 30. 30 OMOP & OHDSI - Overview u  OMOP: Common Data Model for observational healthcare data: persons, drugs, procedures, devices, conditions etc. u  OHDSI: Large-scale analytics tools for observational data An open source community, a.o. developing: u  Tools to support the ETL / mapping process into OMOP (White Rabbit etc.) u  Tools to perform analytics: e.g. Achilles for data profiling, Calypso for feasibility assessment www.omop.org www.ohdsi.org
  • 31. 31 OMOP Common Data Model v5.0 v  OMOP = Observational Medical Outcomes Partnership v  CDM = Common Data Model v  SQL Tables
  • 32. 32 OHDSI: Example Query Result Slide from P. Ryan, Janssen
  • 33. Re-use of healthcare data 33 Prof. Johan van der Lei Erasmus MC University Medical Center “We need to learn from experience and find ways to unite the large volumes of data in Europe. At the end of the day, we are in this for better health care.” Co-coordinator EMIF-Platform EMIF-Platform
  • 35. 35 Challenges in managing chronic diseases u  Health assessments via physician visits are time limited and subjective, often not representative for everyday life of the patient u  The disease state can change a lot in between visits, and important events are not visible to the physician But… it’s 2016: it’s now possible to objectively, remotely, and continuously measure aspects of patient physiology, behavior and symptoms
  • 36. 36 RADAR-CNS: Focus areas from diagnose & treat à predict & pre-empt u  Epilepsy u  Monitoring and predicting epileptic seizures u  Multiple Sclerosis u  Monitoring exacerbations and disease state u  Depression u  Monitoring for possible relapses, plan timely interventions u  Predict bipolar state transitions