Toxicology &
Background Control
Data Sharing Initiative
A subsidiary of TransCelerate BioPharma Inc.
01
BioCelerate
Overview
Inception of BioCelerate
BioCelerate, a subsidiary of TransCelerate, was launched in 2015 by
6 founding Member Companies
Origin Story
BioCelerate was formed out of
growing support from
TransCelerate Member
Companies to launch a
preclinical industry consortium
that could effectively identify,
prioritize, and deploy industry
initiatives aimed at making
early stage R&D more efficient
and have the potential to
make a meaningful difference
in drug development.
Copyright ©2016 BioCelerate, All rights reserved. A subsidiary of TransCelerate BioPharma Inc.
* Confidential - NOT FOR DISTRIBUTION *
3
BioCelerate Organizational Structure
TransCelerate/
BioCelerate CEO
BioCelerate
Director of
Operations
BioCelerate Governing Council
1 Leader from Each Participating Organization
Initiative #1
Toxicology &
Background Control
Data Sharing
§ Workstream Lead
§ Project Manager
§ At least 1 Core Team
Member per each
Participating
Organization
BioCelerate has been established as
a separate legal subsidiary of
TransCelerate with separate funding
and support
§
Membership in TransCelerate is
a prerequisite for BioCelerate
membership
BioCelerate’s Governing Council is the
Governing body of the organization
Future
Initiatives
Currently
Being Scoped
Copyright ©2016 BioCelerate, All rights reserved. A subsidiary of TransCelerate BioPharma Inc.
§
The Governing Council
approves BioCelerate projects
and associated budgets
§
Each participating company
has been afforded a seat on
the Governing Council
* Confidential - NOT FOR DISTRIBUTION *
4
Disciplined Approach to Delivery
Centralized PM resources
Industry leaders & expertise
Enables adherence to
timeline & scope
Dedicated & decisive
Focused on solution
excellence
Member
Company
Resources
Project
Mgmt
Drives progress &
decision-making
Toxicology
Data
Sharing
Executive-level
oversight
Visionary ideas and
guidance
Dedicated legal team
Governing
Council
Commitment to innovation
Copyright ©2016 BioCelerate, All rights reserved. A subsidiary of TransCelerate BioPharma Inc.
Legal
Maximizes ability to
collaborate
Ensures compliance,
mitigates risk
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5
02
Toxicology Data Sharing
Initiative & Platform
R&D Data Sharing Platform
Data Lake Concept
Preclinical Toxicology
& Background Control
Data Sharing
Clinical Placebo &
Standard of Care
Data
Future Data Sharing
Initiatives
Stores unstructured and structured data giving users
advanced search and visualization capabilities
Vision
Ultimate Value: Draw valuable
translational insights across datasets
Copyright ©2016 BioCelerate, All rights reserved. A subsidiary of TransCelerate BioPharma Inc.
* Confidential - NOT FOR DISTRIBUTION *
7
Toxicology Data Sharing Initiative
Value Proposition
Vision
This workstream will enable participating companies to make more informed
decisions on compound progression based on increased understanding of ontarget and off-target toxicity.
Unmet Need
• Due to a deficit of published
toxicology study results, there is
limited institutional/industry
understanding of target-related
toxicity
• Inability to answer toxicity questions
due to lack of a centralized,
searchable repository housing data
in a standardized format
• Databases within each member
company are limited; as such,
regulators tend to have a better
view of the data landscape than
companies do
Copyright ©2016 BioCelerate, All rights reserved. A subsidiary of TransCelerate BioPharma Inc.
Value Proposition
• Reduce drug development costs by
enabling participants to identify
fatally flawed compounds early
• Increase ability to separate ontarget and off-target toxicity
• Via access to a robust data
repository, determine the
significance of rare and incidental
findings
• Improve ability to answer questions
from regulators regarding toxicity
through access to a broad set of
data
* Confidential - NOT FOR DISTRIBUTION *
8
Toxicology Data Sharing Initiative
Key Benefits
Reduce drug
development
costs
…by identifying fatally flawed compounds earlier
…through the replacement, refinement, and reduction of
animal use by optimizing toxicity study design
Increase
confidence in
early decision
making
…through greater understanding of on-target and offtarget toxicity
Improve ability
to respond to
regulators
…by leveraging a larger set of data to determine the
significance of rare and incidental findings
Increase IT
Systems
efficiency
…by leveraging an industry standard software model for
the data repository to capture economies of scale, cost
savings, and enhanced functionality
Copyright ©2016 BioCelerate, All rights reserved. A subsidiary of TransCelerate BioPharma Inc.
* Confidential - NOT FOR DISTRIBUTION *
9
System Use Cases
Capability
Use Case Focus
Identity Management
§ De-identification of structured and
unstructured data
Import & Export
§ Data Import for structured (e.g. CDISC) and
unstructured data (e.g. PDF)
§ Data Export for de-identified and
harmonized data
Data & Document
Management
§ Linkages between datasets
§ Derivation of background data
(pre-treatment & control animal)
Search
§ Data harmonization
§ Unit conversion
§ Search unstructured/structured data
Data Visualization
§ Visualization across structured datasets
Copyright ©2016 BioCelerate, All rights reserved. A subsidiary of TransCelerate BioPharma Inc.
* Confidential - NOT FOR DISTRIBUTION *
10
System Business Requirements
57 business requirements across 6 categories were determined to be key
platform competencies
Identity &
Access Management
1
Access & Security
Management
2 reqs
Data Sharing
Decision Support
Data Import & Export
2
3
4
11 reqs
Data & Document
Management
11 reqs
5
6
Search
24 reqs
Data Analysis &
Visualization
8 reqs
Data Quality
Management
Copyright ©2016 BioCelerate, All rights reserved. A subsidiary of TransCelerate BioPharma Inc.
1 req
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11
Vendor Selection Progression
Landscape
Evaluation
Preclinical & Clinical Data Sharing Vendor
Landscape Research
[23 vendors assessed]
RFI Development
& Distribution
7 vendors
RFI Responses & Demos
4 vendors
Responding Tools
RFP Responses & Oral Demos
2 vendors
Scoring & Roundtable
Discussions
Commercial
Proposal
Defense
Commercial Evaluation
& Negotiations
Vendor Selected
Copyright ©2016 BioCelerate, All rights reserved. A subsidiary of TransCelerate BioPharma Inc.
* Confidential - NOT FOR DISTRIBUTION *
12
Database Project Timeline & Deliverables
Month 1-3
Platform
Month 4-6
Month 7-9
Platform
Setup
Year 2
Year 3
Beyond
On-Going Platform Support
Capability
Release 1
Phase 1:
Base Functionality
System Implementation
Month 10-12
Capability
Release 2
Phase 2: Search &
Visualization
Program Management & Communications
Access, Security, Identity
Management
Data & Document Management
Import & Export (UI)
Search
System Implementation Deliverables:
1. SDLC deliverables (Planning & Analysis, Design,
Build, Test, Deploy)
2. Identity & Access Management
3. Data processing tools (de-identification,
harmonization, movement/ingestion)
4. Big data storage (structured, unstructured)
5. Search capability
6. Web User Interface (import/export)
7. Reports (single study, multi study, ad-hoc)
Data Visualization
Change Management /
Solution Adoption Planning
Copyright ©2016 BioCelerate, All rights reserved. A subsidiary of TransCelerate BioPharma Inc.
* Confidential - NOT FOR DISTRIBUTION *
13
Solution Architecture
Member Company
On-Premise Module
Data Input
Files
Activities occur
within Member
Company firewall
VPN
Member Company
Private Area
Unstructured
Import / Export
PDF
[Web Interface]
Structured
SAS XPT
De-Identification
De-identification
and sensitive
data redaction
[Web Interface]*
Data Validation
CDISC
Structure
Verification
Member
Company
Mapping
Database
(Study ID,
Compound ID)
Data Harmonization &
Standardization
BioCelerate Data
Standards Reference
Library
Data Standardization/
Harmonization to
BioCelerate version of
CDISC standards
Resolve data
issues/provide new
mapping rule for Library
Data Sharing Platform
Shared Area
Identity & Access Management
User registration, provisioning, login, role mgmt
Data & Document Store
Data Search,
Visualization & Reporting
Structured
Data
Unstructured
Data
Monitoring & Exception Handling
* Prior to upload, Member Company reviews
de-identified datasets for compliance with
Data Sharing Agreement
Copyright ©2016 BioCelerate, All rights reserved. A subsidiary of TransCelerate BioPharma Inc.
* Confidential - NOT FOR DISTRIBUTION *
14
Data Preparation & Upload Process:
Structured Data
Member Company
BioCelerate/TransCelerate Standards & Sharing Governance
Data Sharing Platform
Member
Company
Data/Study
Member Company
On-Premise Module
Convert
Study*
1
*For structured
data:
Member company
conforms to CDISC
standard
Redact
PII
2
Redact all
PII and
company
sensitive
data
Confirm
Rules & DeIdentify
3
Member confirms
de-identification
rules to apply
(Programmatic
de-identification)
Shared Area
Member Company Private Area
Toxicology/Background Control Studies
Import &
Harmonize
4
Member loads files to a
private cloud area
Harmonization:
- BioCelerate standard
conversions (units, terms)
- Operational
harmonization
Member Company Admin Support
Verify
Share
6
5
Member
company
reviews deidentified,
harmonized files;
approves for
sharing
Preclinical
Data (future)
Study published
to shared
repository
Clinical
Data (future)
Data available in
secure, hosted
Cloud
BioCelerate/TransCelerate Admin Support
Vendor Capability Support – hosting, admin, tech, maintenance support
Copyright ©2016 BioCelerate, All rights reserved. A subsidiary of TransCelerate BioPharma Inc.
* Confidential - NOT FOR DISTRIBUTION *
15
Search, Visualization, and Analytics:
Structured Data
1
Search/Visualization
Use Cloud Dashboards
& Tools
Member Company personnel
use search and visualization
tools and reports in the Cloud
Data Sharing Platform
Shared Area
De-identified, structured, and
harmonized data
BioCelerate
Synonyms, Mappings, Conversions
From
To
Synonyms
1L
1000 mL
Cancer
Oncology
Cancer
Medicine
2 Analysis
Use Member Tools
within the Cloud
Member Company personnel
use their own analytics tools
(deployed in Member-specific
area of the Cloud)
Copyright ©2016 BioCelerate, All rights reserved. A subsidiary of TransCelerate BioPharma Inc.
3 Analysis
Export Data
Member Company personnel
export data back to Member
Company local environment,
use in-house tools for analysis
* Confidential - NOT FOR DISTRIBUTION *
16
Thank you!
For additional information:
[email protected]
A subsidiary of TransCelerate BioPharma Inc.