Healthcare and Life Sciences: Two Industries Separated by Common Data

Life Sciences and Healthcare –
Two Industries Separated by Common Data
James T. LaPointe - Managing Director Healthcare and Life Sciences
2020-Apr-08

©2020 Cambridge Semantics Inc. All rights reserved.
Agenda
● What health data and why share it?
● Health sciences data landscapes – now and future
● Addressing the remaining data challenges
● More information

What health data and why share it?

Two Industries with One Goal - Better Patient Outcomes
COMPLAINT
Health Insurance
Care Provider
PATIENT
Demographics
DIAGNOSIS
Medical History
Family History
Social Determinants
Lab Results
Genomics
TREATMENT
Standard of Care (SoC)
Therapy / Medication
Lab Results / Notes
Adverse Reactions
OUTCOMES
Health & Wellbeing
Quality of Life (QoL)
Cost
Adverse Reactions

What Data?
Healthcare
Electronic Medical
Records (EMR)
-PATIENT
-DIAGNOSIS
-TREATMENT
-OUTCOMES
Claims
MEMBER
Care Program
Procedure (ICD10)
Cost
Labs
-PATIENT
-Results
COMPLAINT
Health Insurance
Care Provider
PATIENT
Demographics
DIAGNOSIS
Medical History
Family History
Social Determinants
Lab Results
Genomics
TREATMENT
Lab Results / Notes
Adverse Reactions
OUTCOMES
Health & Wellbeing
Cost
Adverse Reactions
PayorsProviders

What Data?
Study Protocol
Indication / TA
Compound / Intervention
Phase / Endpoints / SoA
Inclusion/Exclusion
Subjects
Randomization / Visits (SoA)
Demographics
Medical History
Family History
Social Determinants
Genomics
Life Sciences
Intervention (Treatment)
Visit Schedule
Medication / Dosage
Lab Results / Notes
Adverse Reactions
Endpoints
Efficacy
Safety
COMPLAINT
Health Insurance
Care Provider
PATIENT
Demographics
DIAGNOSIS
Medical History
Family History
Social Determinants
Lab Results
Genomics
TREATMENT
Lab Results / Notes
Adverse Reactions
OUTCOMES
Health & Wellbeing
Cost
Adverse Reactions

What Data?
Study Protocol
Indication / TA
Inclusion/Exclusion
Subjects
Demographics
Medical History
Family History
Social Determinants
Genomics
Life Sciences
Visit Schedule
Medication / Dosage
Lab Results / Notes
Adverse Reactions
Endpoints
Efficacy
Safety
Healthcare
Electronic Medical
Records (EMR)
-PATIENT
-DIAGNOSIS
-TREATMENT
-OUTCOMES
Claims
MEMBER
Care Program
Procedure (ICD10)
Cost
Labs
-PATIENT
-Results
PayorsProviders

Why Share Data?
Study Protocol
Indication / TA
Inclusion/Exclusion
Subjects
Demographics
Medical History
Family History
Social Determinants
Genomics
Life Sciences
Visit Schedule
Medication / Dosage
Lab Results / Notes
Adverse Reactions
Endpoints
Efficacy
Safety
Healthcare
Electronic Medical
Records (EMR)
-PATIENT
-DIAGNOSIS
-TREATMENT
-OUTCOMES
Claims
MEMBER
Care Program
Procedure (ICD10)
Cost
Labs
-PATIENT
-Results
Real-World Data (RWD) / Real-World Evidence (RWE)
• Drugs underperform, efficacy & adverse reactions
• Sicker populations, e.g., comorbidities
• More complex treatments, e.g., concomitant medications
Translational Medicine
Observational / Retrospective studies
Support Health Economic & Outcomes Research (HEOR)
Outcomes-based Reimbursement
Better Patient outcomes
• Better / faster Standard of Care (SoC)
• Increased drug efficacy
• Reduced Adverse Reactions
Lower costs
Translational Medicine
Better Payor acceptance
Off-label Therapies
PayorsProviders

Industry data landscapes – now and future

Health Sciences Data Landscape
Study Protocol
Indication / TA
Inclusion/Exclusion
Subjects
Demographics
Medical History
Family History
Social Determinants
Genomics
Life SciencesHealthcare
Electronic Medical
Records (EMR)
-PATIENT
-DIAGNOSIS
-TREATMENT
-OUTCOMES
Claims
MEMBER
Care Program
Procedure (ICD10)
Cost
Labs
-PATIENT
-Results
PayorsProviders
Claims Processing Solutions
Claims Processing automates member management, benefits administration,
claims management, electronic submission, collections and more
Key Payors:
UnitedHealthcare Group
Anthem
Aetna
Signa Health
Humana …
Key Data Aggregators
Optum
Cerner
IQVIA (IMS Health)
Truven
Definitive Healthcare …

Study Protocol
Indication / TA
Inclusion/Exclusion
Subjects
Demographics
Medical History
Family History
Social Determinants
Genomics
Life Sciences
Visit Schedule
Medication / Dosage
Lab Results / Notes
Adverse Reactions
Healthcare
Electronic Medical
Records (EMR)
-PATIENT
-DIAGNOSIS
-TREATMENT
-OUTCOMES
Claims
MEMBER
Care Program
Procedure (ICD10)
Cost
Labs
-PATIENT
-Results
PayorsProviders
Key Payors:
Anthem
Aetna
Signa Health
Humana …
Optum
Cerner
Truven
Definitive …
Electronic Medical / Health Records (EMR / EHR)
Electronic medical records (EMR) software automates the documentation,
storage and retrieval of patient records including Patient Case Management,
Patient Management, Medical Billing, Medical Scheduling, Hospital Management
and Long-term Care.
Key Suppliers:
- Epic
- Cerner
- Meditech
- Siemens
- CPSI
- MEDHOST
- Athena Health
- Allscripts …

Study Protocol
Indication / TA
Inclusion/Exclusion
Subjects
Demographics
Medical History
Family History
Social Determinants
Genomics
Life Sciences
Visit Schedule
Medication / Dosage
Lab Results / Notes
Adverse Reactions
Healthcare
Electronic Medical
Records (EMR)
-PATIENT
-DIAGNOSIS
-TREATMENT
-OUTCOMES
Claims
MEMBER
Care Program
Procedure (ICD10)
Cost
Labs
-PATIENT
-Results
PayorsProviders
Key Payors:
Anthem
Aetna
Signa Health
Humana …
Optum
Cerner
Truven
Definitive …
Electronic Medical / Health Records (EMR / EHR)
Electronic medical records (EMR) software automates the documentation,
storage and retrieval of patient records including Patient Case Management,
Patient Management, Medical Billing, Medical Scheduling, Hospital Management
and Long-term Care.
Key Suppliers:
- Epic
- Cerner
- Meditech
- Siemens
- CPSI
- MEDHOST
- Athena Health
- Allscripts …
Laboratory Information Management System
Laboratory Information Management System (LIMS) helps laboratories manage
and track samples, orchestrate workflow and store and analyze laboratory data
including Medical Lab Administration and case management, Medical Inventory,
Statistical Analysis Software, Data Analysis and Quality.
Key Labs:
- Hospitals
- LabCorp
- Quest
- Independent Labs …

Study Protocol
Indication / TA
Inclusion/Exclusion
Subjects
Demographics
Medical History
Family History
Social Determinants
Genomics
Life Sciences
Visit Schedule
Medication / Dosage
Lab Results / Notes
Adverse Reactions
Endpoints
Efficacy
Safety
Healthcare
Protocol and Schedule of Activities (SoA)
The Protocol and SoA defines the controlled experiment to prove or
disprove the medical hypotheses leading to the approval of new
therapies, often taking 10+ years.
Key BioPharmaceutics:
Pfizer
Roche
Novartis
Merck
GlaxoSmithKline (GSK)
Johnson & Johnson (J&J)
Abbvie
Sanofi
Bristol Myers-Squibb (BMS)
AstraZeneca (AZ) …

Study Protocol
Indication / TA
Inclusion/Exclusion
Subjects
Demographics
Medical History
Family History
Social Determinants
Genomics
Life Sciences
Visit Schedule
Medication / Dosage
Lab Results / Notes
Adverse Reactions
Endpoints
Efficacy
Safety
Healthcare
Pfizer
Roche
Novartis
Merck
Abbvie
Sanofi
Electronic Data Capture (EDC)
Electronic Data Capture (EDC) automates the collection of data from
clinical sites via a series of sequential electronic Case Report Forms
(eCRFs) and mapped to a prescribed set of data management variables.
Key Suppliers:
- Oracle InForm
- Medidata Rave
- IBM Clinical Development
- IQVIA Clinical (Quintiles)
- Veeva Vault Clinical Suite
- Electronic Patient Reported Outcomes (ePro) …

Study Protocol
Indication / TA
Inclusion/Exclusion
Subjects
Demographics
Medical History
Family History
Social Determinants
Genomics
Life Sciences
Visit Schedule
Medication / Dosage
Lab Results / Notes
Adverse Reactions
Endpoints
Efficacy
Safety
Healthcare
Electronic Medical
Records (EMR)
-PATIENT
-DIAGNOSIS
-TREATMENT
-OUTCOMES
Providers
Pfizer
Roche
Novartis
Merck
Abbvie
Sanofi
Key Suppliers:
- Oracle InForm
- Medidata Rave
Data Management and Statistical Analyses
Data Management solutions are needed to setup, monitor, structure and
resolve quality issues for analysis by Bio-Statisticians using sophisticated
data modeling and statistical tools.
Key Suppliers:
- SAS
- Oracle Argus, Data Management Workbench (DMW), CTMS
- Cambridge Semantics …

Study Protocol
Indication / TA
Inclusion/Exclusion
Subjects
Demographics
Medical History
Family History
Social Determinants
Genomics
Life Sciences
Visit Schedule
Medication / Dosage
Lab Results / Notes
Adverse Reactions
Endpoints
Efficacy
Safety
Healthcare
Electronic Medical
Records (EMR)
-PATIENT
-DIAGNOSIS
-TREATMENT
-OUTCOMES
Labs
-PATIENT
-Results
Providers
Pfizer
Roche
Novartis
Merck
Abbvie
Sanofi
Key Suppliers:
- Oracle InForm
- Medidata Rave
Data Management and Statistical Analyses
Data Management solutions are needed to setup, monitor, structure and
resolve quality issues for analysis by Bio-Statisticians using sophisticated
data modeling and statistical tools.
Key Suppliers:
- SAS
- Oracle Argus, Data Management Workbench (DMW), CTMS
- Cambridge Semantics …
Electronic Submission (eSub)
Electronics Submission (eSub) solutions enable to aggregation and synthesis
of clinical data into a comprehensive and well-structured ‘report’ for
submission, review and approval by Health Agencies (HAs) around the world
including electronic Trial Master File (eTMF) and electronica Common
Technical Document (eCTD).
Key Suppliers:
- Similar to EDC suppliers
- Similar to Data Management
- Many additional Independent Software Vendors (ISVs) …

Study Protocol
Indication / TA
Inclusion/Exclusion
Subjects
Demographics
Medical History
Family History
Social Determinants
Genomics
Life Sciences
Visit Schedule
Medication / Dosage
Lab Results / Notes
Adverse Reactions
Endpoints
Efficacy
Safety
Healthcare
Electronic Medical
Records (EMR)
-PATIENT
-DIAGNOSIS
-TREATMENT
-OUTCOMES
Labs
-PATIENT
-Results
Providers
Protocol and SoA
Pfizer
Roche
Novartis
Merck
Abbvie
Sanofi
Oracle InForm
Medidata Rave
IBM Clinical Development
IQVIA Clinical (Quintiles)
Veeva Vault Clinical Suite …
Data Mgt and Statistical Analysis
SAS
R
Oracle Argus, DMW, CTMS
Cambridge Semantics …
Electronic Submission
Similar to EDC suppliers
Similar to Data Management
Many additional ISVs …
Claims
MEMBER
Care Program
Procedure (ICD10)
Cost
Payors
Anthem
Aetna
Signa Health
Humana …
Optum
Cerner
IQVIA (IMS Health)
Truven
Definitive …
EMR / EHR
Epic
Cerner
Meditech
Siemens
CPSI
MEDHOST
Athena Health
Allscripts …
LIMS
Hospitals
LabCorp
Quest
Independent Labs …

Study Protocol
Indication / TA
Inclusion/Exclusion
Subjects
Demographics
Medical History
Family History
Social Determinants
Genomics
Life Sciences
Visit Schedule
Medication / Dosage
Lab Results / Notes
Adverse Reactions
Endpoints
Efficacy
Safety
Healthcare
Electronic Medical
Records (EMR)
-PATIENT
-DIAGNOSIS
-TREATMENT
-OUTCOMES
Labs
-PATIENT
-Results
Providers
Protocol and SoA
Pfizer
Roche
Novartis
Merck
Abbvie
Sanofi
Oracle InForm
Medidata Rave
SAS
R
Claims
MEMBER
Care Program
Procedure (ICD10)
Cost
Payors
Anthem
Aetna
Signa Health
Humana …
Optum
Cerner
IQVIA (IMS Health)
Truven
Definitive …
EMR / EHR
Epic
Cerner
Meditech
Siemens
CPSI
MEDHOST
Athena Health
Allscripts …
LIMS
Hospitals
LabCorp
Quest
Medical Dictionaries and Taxonomies
SnoMED
MedDRA
LOINC
ICD-9 / ICD-10
NCI Controlled Terminology …
WHO Drug
NLM Mesh
ClinicalTrial.gov
UMLS - Unified Medical
Language System …

Study Protocol
Indication / TA
Inclusion/Exclusion
Subjects
Demographics
Medical History
Family History
Social Determinants
Genomics
Life Sciences
Visit Schedule
Medication / Dosage
Lab Results / Notes
Adverse Reactions
Endpoints
Efficacy
Safety
Healthcare
Electronic Medical
Records (EMR)
-PATIENT
-DIAGNOSIS
-TREATMENT
-OUTCOMES
Labs
-PATIENT
-Results
Providers
Protocol and SoA
Pfizer
Roche
Novartis
Merck
Abbvie
Sanofi
Oracle InForm
Medidata Rave
SAS
R
Claims
MEMBER
Care Program
Procedure (ICD10)
Cost
Payors
Anthem
Aetna
Signa Health
Humana …
Optum
Cerner
IQVIA (IMS Health)
Truven
Definitive …
EMR / EHR
Epic
Cerner
Meditech
Siemens
CPSI
MEDHOST
Athena Health
Allscripts …
LIMS
Hospitals
LabCorp
Quest
SnoMED
MedDRA
LOINC
ICD-9 / ICD-10
WHO Drug
NLM Mesh
ClinicalTrial.gov
Language System …
What about data standards?

Study Protocol
Indication / TA
Inclusion/Exclusion
Subjects
Demographics
Medical History
Family History
Social Determinants
Genomics
Life Sciences
Visit Schedule
Medication / Dosage
Lab Results / Notes
Adverse Reactions
Endpoints
Efficacy
Safety
Healthcare
Electronic Medical
Records (EMR)
-PATIENT
-DIAGNOSIS
-TREATMENT
-OUTCOMES
Labs
-PATIENT
-Results
Providers
Protocol and SoA
Pfizer
Roche
Novartis
Merck
Abbvie
Sanofi
Oracle InForm
Medidata Rave
SAS
R
Claims
MEMBER
Care Program
Procedure (ICD10)
Cost
Payors
Anthem
Aetna
Signa Health
Humana …
Optum
Cerner
IQVIA (IMS Health)
Truven
Definitive …
EMR / EHR
Epic
Cerner
Meditech
Siemens
CPSI
MEDHOST
Athena Health
Allscripts …
LIMS
Hospitals
LabCorp
Quest
SnoMED
MedDRA
LOINC
ICD-9 / ICD-10
WHO Drug
NLM Mesh
ClinicalTrial.gov
Language System …
HealthcareDataStandards
OHDSIOMOPCDM
HL7FHIR
MicrosoftCDM-Healthcare
ClinicalDataStandards
CDISC:CDASH,STDM,ADaM,Send
CDISC:BRIDG
Transcelerate:CDM

HL7 FHIR (Fast Healthcare Interoperability Resources) Data Standard

Evolving Healthcare Data Standards - Microsoft

Evolving Healthcare Data Standards - Microsoft
Support for HL7 FHIR v3.0

Addressing the remaining data challenges

Remaining Data Challenges
Study Protocol
Indication / TA
Inclusion/Exclusion
Subjects
Demographics
Medical History
Family History
Social Determinants
Genomics
Life Sciences
Visit Schedule
Medication / Dosage
Lab Results / Notes
Adverse Reactions
Endpoints
Efficacy
Safety
Healthcare
Electronic Medical
Records (EMR)
-PATIENT
-DIAGNOSIS
-TREATMENT
-OUTCOMES
Labs
-PATIENT
-Results
Providers
Protocol and SoA
Pfizer
Roche
Novartis
Merck
Abbvie
Sanofi
Oracle InForm
Medidata Rave
SAS
R
Claims
MEMBER
Care Program
Procedure (ICD10)
Cost
Payors
Anthem
Aetna
Signa Health
Humana …
Optum
Cerner
IQVIA (IMS Health)
Truven
Definitive …
EMR / EHR
Epic
Cerner
Meditech
Siemens
CPSI
MEDHOST
Athena Health
Allscripts …
LIMS
Hospitals
LabCorp
Quest
SnoMED
MedDRA
LOINC
ICD-9 / ICD-10
WHO Drug
NLM Mesh
ClinicalTrial.gov
Language System …
OHDSIOMOPCDM
HL7FHIR
CDISC:BRIDG
Transcelerate:CDM
Gap

Remaining Data Challenges
Study Protocol
Indication / TA
Inclusion/Exclusion
Subjects
Demographics
Medical History
Family History
Social Determinants
Genomics
Life Sciences
Visit Schedule
Medication / Dosage
Lab Results / Notes
Adverse Reactions
Endpoints
Efficacy
Safety
Healthcare
Electronic Medical
Records (EMR)
-PATIENT
-DIAGNOSIS
-TREATMENT
-OUTCOMES
Labs
-PATIENT
-Results
Providers
Protocol and SoA
Pfizer
Roche
 Novartis
 Merck
 GlaxoSmithKline (GSK)
 Johnson & Johnson (J&J)
 Abbvie
 Sanofi
 Bristol Myers-Squibb (BMS)
 AstraZeneca (AZ) …
 Oracle InForm
 Medidata Rave
 IBM Clinical Development
 IQVIA Clinical (Quintiles)
 Veeva Vault Clinical Suite …
 SAS
 R
 Oracle Argus, DMW, CTMS
 IQVIA Clinical (Quintiles)
 Similar to EDC suppliers
 Similar to Data Management
 Many additional ISVs …
Claims
MEMBER
Care Program
Procedure (ICD10)
Cost
Payors
 Claims Processing Solutions
 UnitedHealthcare Group
 Anthem
 Aetna
 Signa Health
 Humana …
 Optum
 Cerner
 IQVIA (IMS Health)
 Truven
 Definitive …
EMR / EHR
 Epic
 Cerner
 Meditech
 Siemens
 CPSI
 MEDHOST
 Athena Health
 Allscripts …
LIMS
 Hospitals
 LabCorp
 Quest
 Independent Labs …
SnoMED
MedDRA
LOINC
ICD-9 / ICD-10
NCI Controlled Terminology
…
WHO Drug
NLM Mesh
ClinicalTrial.gov
Language System …
…
OHDSIOMOP
HL7FHIR
Transcelerate:CDM
CDISC:BRIDG
Gap
Legacy Legacy

“Extreme levels of diversity, distribution, scale and complexity in organizations’ data
assets are adding tremendous complexity to the overall data integration
and data management design.
This has led to a rise in demand for data fabric architectures that utilize active metadata,
semantics, AI/ML algorithms and knowledge graphs to drive augmented
data integration and data management.”
Rising Demand
for Data Fabrics heading into
2020
Source: Data Fabrics Add Augmented Intelligence to Modernize Your Data Integration, Gartner Group, Dec. 2019
health sciences

RDBMS/OLTP Big Data / Hadoop Document Repositories
Traditional BI Cloud
CUSTOMERS
PRODUCTS
CLAIMS
COMPOUNDS
onboard
model
blend
access
ANZO IN THE DATA FABRIC
ARCHITECTURE
Analytics-ready
Data Products WWW Consortium (W3C) Open Standards
• RDF - Resource Description Framework
• OWL – Web Ontology Language
• SPARQL – RDF Query Language

RDF Defines Data Context in a Machine-readable Format
London
?
http://hl7.org/fhir/HumanName.family
http://hl7.org/fhir/Address.city

HL7 FHIR RDF Basics
Resource Definition
http://hl7.org/fhir/HumanName
• http:// standard internet communications protocol
• hl7.org/fhir/ authoritative source path name (URI or IRI)
• HumanName resource fragment identifier
Shorthand Notation
• @prefix fhir: http://hl7.org/fhir/
• @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#>
Resource Description Framework (RDF) Graph Structure
Subject  Predicate  Object(value)
fhir:HumanName.family fhir:string “London”
fhir:HumanName.family rdfs:subClassOf fhir:HumanName
fhir:Patient.name rdfs:range fhir:HumanName
HumanName.family
“London”
HumanName
fhir:string
rdfs:subClassOf
Patient.name
rdfs:range

Clinical Study Records in the Data Fabric

Adding EMR Records to the Data Fabric

Adding the MedDRA Taxonomy to the Data Fabric

Exploratory Analytics in the Data Fabric

Adding Data Standards (CDISC & OMOP) to the Data Fabric

Real-world graphs
Get Big Fast!
Vast
Hundreds of sources, representing thousands of entity types
Siloed
Different technologies, schemas, formats
Complex
Sprawling schemas, wide flat records, and cryptic names
Unstructured
Documents, emails, web content
Valuable
Hidden connections and common business definitions

Enterprise Data Fabrics in Health Sciences
Modernizing clinical data standards
management to accelerate drug development
Integrated data layer to take cross-trial analytics
questions from weeks to hours.
Operationalized text analytics for
consumer feedback
Deliver a Regulatory Data Fabric for IDMP
Accelerate drug development through an
enterprise data fabric
Building a Submission Review platform for CDER
to integrate agency data sources
Accelerate scale and growth of M2Gen’s
ORIEN Program and Pharma partnerships
Discovery and Integration across Clinical and
R&D in support of global data sharing initiative
Integration, Discovery and insights for Global
Safety and PV

Anzo Enterprise Data Fabric
The leading platform for building a graph-based Data Fabric
Open StandardsEnd-to-end Enterprise Scale
More information:
Jim LaPointe - jtlapointe@cambridgesemantics.com
Anzo – info@cambridgesemantics.com
www.cambridgesemantics.com
Gartner Whitepaper:
“Life Science CIOs: Embrace Next-Generation
Data and Analytics Platforms to Manage Clinical
Data Challenges”

Healthcare and Life Sciences: Two Industries Separated by Common Data

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