Transcript S9_Updates on TransCelerate Initiatives(All presentation).ppsx

TransCelerate BioPharma, Inc
A Global Update
Carlo Maccarrone M.Pharm., Ph.D., ACF
Asia Pacific Regional Director – Clinical Operations
GSK, Australia
Session Agenda
• A
•
•
•
Global Update
History & Mission
How TransCelerate Operates
TransCelerate Portfolio
• Initiative Presentations
• Introduction to the Shared Investigator Platform
• The Clinical Quality Management System Initiative
• The eLabels Initiative
TransCelerate - a not for profit entity
created to drive collaboration
TransCelerate’s Organisational
Structure
High engagement from member talent is a key attribute in our success.
External Counsel
Board of Directors
Accounting Firm
CEO
Audit Firm
Oversight Committee
SVP, Global Operations
Portfolio
Management
Communication &
Engagement
Operations
Quality
Administrative Asst.
Active Portfolio Subcommittees
Leadership
Project Management
Team Members
Key:
Member Company Talent
Permanent Position
Enabling Functions
(Regulatory, Technology, Communications, etc.)
Leadership
Project Management
Team Members
Contracted Resources / Member
Resources
Finance
Collaboration with Key
Stakeholders
We embody deep and broad collaboration across many stakeholders,
all with a common goal of improving clinical trials.
TransCelerate Strategic Priorities
TransCelerate assesses industry challenges and selects initiatives
aligned with five strategic priorities:
TransCelerate’s
Portfolio of Initiatives
TransCelerate’s Portfolio of Initiatives focus on Quality, Patient Safety,
and Accelerated Development Timelines.
Active
Design,
Develop,
&
Deploy
Phase
Realization
Realization
Phase
Phase
Clinical Data
Standards
Clinical Data
Transparency
Clinical
Research
Awareness &
Access
eConsent
eLabels
eSource
Placebo /
Standard of
Care Data
Sharing
Quality
Management
System
Risk Based
Monitoring
Clinical
Trial
Clinical
Trial
Di
Diversification
versification
Pediatric
Trial
Efficiencies
Common
Protocol
Template
Comparator
Network
Investigator
Registry
Patient
Experience &
Technology
Site
Qualification
and Training
Shared
Investigator
Platform
Focus to discuss today
The Common Protocol
Template Initiative
The eConsent Initiative
TransCelerate
Accomplishments to Date

Designed a Risk Based Monitoring Methodology and issued subsequent publications across the industry showing an
improvement in quality metrics, and > 15,000+ Unique downloads of TransCelerate Papers.

Operationalized an effective Good Clinical Practice (GCP) certification program to eliminate investigator sites taking duplicative
GCP training with >130,000 GCP training certificates issued by 9 Member Companies and 150 external training providers have
attested that the training courses offered meet mutual recognition of minimum criteria.

Launched the Investigator Registry and Shared Investigator Platform that will greatly enhance communication between
sponsors and sites.

Operationalized a network of TransCelerate Member Companies to secure Comparator Drugs for studies, >60% of the top

Launched a Common Protocol Template containing common structure and model language to improve accuracy in data
recording and speed study start up.

Created a platform to share Placebo data from Clinical Studies across participating companies.

Published a Clinical QMS Conceptual Framework taking a proactive quality approach to all stages of clinical research.

Published a model approach for Data De-identification and Anonymization of Individual Patient Data in Clinical Studies.

Launched BioCelerate - A subsidiary of TransCelerate focused on
preclinical collaboration.
100 products sold globally are now covered in the CN product portfolio; Network has achieved > $150M in sales.
Stay Informed and Engaged!
Email: [email protected]
• Send questions, comments at any time
Newsletter & Monthly Emails
• Sign up on our website to hear from us!
Twitter: @transcelerate
• Industry articles and updates
LinkedIn: TransCelerate BioPharma Inc.
• Industry articles and updates on our initiatives
Co-Country Leads – South Korea
• Soo-Yeon Park, GSK
• Taehui Ahn, BMS
Watch our “About Us” Video:
http://www.transceleratebiopharmainc.com/videos/about
transcelerate/
Visit us, for more
information:
www.TransCelerateBioPharmaInc.com
The Shared Investigator
Platform
Kelly Kirsch
Consultant-Shared Investigator Platform
Clinical Development Information and Optimization
Eli Lilly & Co., USA
Agenda
•
•
•
•
•
•
SIP Overview
Value Proposition
Stakeholder Benefit / Impact
Accomplishments to Date
Who’s Involved
Roadmap – Now and the Future
The Shared Investigator Platform
Unmet Need:
Clinical trial sites must use many different websites, each requiring unique login credentials,
to perform clinical trial responsibilities and communicate with their Sponsors. Site staff
repeatedly prepare and provide the same information to each of their Sponsors. This is
time consuming, cumbersome and often difficult.
Objective:
Reduce the burden on investigative sites by providing
them with a single point of access, harmonized
content and services, and streamlined interaction
with participating clinical trial Sponsors.
Benefits:
Ease of use, reduced burden on sites, and harmonized
clinical trial content and services for investigative sites
and sponsors.
Value Proposition / Benefits
When Delivered
Through development of the Shared Investigator Platform…
Unmet Need
•
Different platforms, processes,
and data sources within sponsors.
•
High costs and redundant effort
in developing and maintaining in
dividual sponsor portals, and
mastering user and facility data.
•
Burdensome process – Multiple,
unique portals, processes, and to
ols increase cost and support
needed for sites/investigators,
and risk of errors.
Value Proposition
•
Investigator Sites: Increased efficiency and
reduced burden due to single sign-on,
more unified experience, harmonized
content and processes, streamlined use by
sites across participating sponsors, and
increased visibility to study opportunities
across participating Sponsors.
•
Participating Member Companies: Savings
through shared system investment &
maintenance costs; and harmonized
content and processes, which enhances
compliance.
•
Regulatory Bodies: Harmonized information
model allows expanded insights to clinical
trials.
Stakeholder Impact & Benefit
Member Company
•
Clinical Study costs reduced by
improvements in study start up,
conduct & site management
activities.
•
Increase efficiencies and decrease error
through reduction in duplicative work
and increased automation.
•
IT cost savings through shared
investment in platform development,
maintenance & support.
Regulatory Authorities
• Potential for streamlined expanded
insights into clinical trials.
Sites
•
Increase efficiency, reduce burden on
investigators & site personnel in
planning & conduct of clinical studies.
•
Streamline interactions, data exchange
with participating Study Sponsors
through a single application with
single sign on.
•
Align and harmonize data and
processes for interacting with
participating Study Sponsors.
Patients
• Less administrative time for site staff
leads to more time with patients.
Accomplishments To Date
Since endorsement as a workstream by the TransCelerate Board of
Directors:
• Identified partners for platform development; Cognizant & DrugDev
• Engaged with ACRO representatives on the Platform
• Established and expanded the Site Advocacy Group engagement efforts
with the Society for Clinical Research Sites (SCRS)
• Release 1.0 Go Live in January 2016; available for Member Company
adoption
Who’s Involved
SIP Roadmap
(www.sharedinvestigator.com)
SIP Release 1 and 1.1
Functionality
1
Single Sign On
Single Sign On
2
Secure Access across
Sponsors
andacross
Studies;Spo
Secure
Access
Sponsors
registration
nsors send
and Studies
invitation codes
4
Feasibility Survey
Survey creation, distribution,
completion & response
management
7
User Profile
Centralized Training History;
GCP training (mutually
recognized)
Profile
Centralized Site staff
information; re-used across
studies; PI and Clinical
Research User CVs
Centralized information;
re-used across studies. User
associates to facility or
Department
6
5
Study Workspace
Document Exchange
Sponsor specific workspace
for each study
Share, Post and Retrieve
documents
8
Training
3 Facility / Department
9
Home Pages
Dashboards ,News, Links,
Reports & Metrics
Task, Alerts, and
Notifications
Consolidated reminders &
information across studies
SIP Release 2
Proposed Functionality
1
Safety Notifications
Upload letters, central
distribution & notification
with tracking
acknowledgement
4
2
Study Workspace
Add/manage studies; allow
bulk load from MC CTMS.
Include tasks, workflows &
wizard
5
Reporting/Metrics
Expanded reporting for:
DocX, Safety Letters, and
other SIP functions
7
3
Add survey analysis & new
survey types wizard;
Expand functionality; add
Site User dashboard
Integrate to MC eTMF;
workflow, versioning,
e-signature, forms,
document submission &
distribution
Wizard-based data entry;
enhanced IR integration of
master data & profiles
6
Survey
DocX/eTMF
Profiles/IR
Integration
Training
Complete GCP and sponsor
-specific training; expand
tasks and notifications
8
General
Platform-level & core
functionality: UI, Workflow,
analytics, wizards
Thank you!
Questions?
The Quality Management
System Initiative
Hannah Chen
Director, Asia Pacific/China R&D
Janssen Pharma, China
Why Is QMS Important and a
TransCelerate Initiative?
TransCelerate Member Company Structured
Interview Results Indicate Opportunities for
Improvement
Overview of Clinical QMS Conceptual
Framework Concept Paper
What it outlines:
A proactive approach and flexible concept
ual framework for holistically managing
quality across the spectrum of clinical
activities (enterprise-focused)
A conceptual framework to enable consist
ent and timely delivery of reliable data
that may be used by an organization, its
partners, regulators, clinicians, and
patients to make informed decisions
Why it is needed:
No harmonized regulatory guidance
defining elements of a conceptual Clinical
QMS framework, leading to disparate
implementation and inefficiencies
28
A Structural, Philosophical,
Behavioral Approach
Proactive, Risk-based, Flexible
Assessing the CQMS
Processes
Resources, Roles & Responsibilities
Partnering
Risk Management
Issue Management
Knowledge Management
Documentation Supporting Achievement of Quality
Management Review
Elements of a Clinical QMS Conceptual Framework
Foundational Aspects
Understand the Context
Leadership Commitmen
t to Quality
Organizational Commit
ment to Quality
Continual Improvement
of the Framework
What’s the Relationship of QMS,
QBD and RBM?
Copyright ©2016 TransCelerate BioPharma Inc., All rights reserved.
Messages from the Stakeholders
Strong alignment and agreement with the framework, the approach,
the elements and the philosophy
The Conceptual Framework ….
 Is a valuable development
 Is comprehensive and includes all needed elements
 Will enable better partnership between sponsors, sites and other
stakeholders
 Will provide meaningful guidance for managing quality across
clinical development activities
 Will benefit from a graphic showing relationship between QMS,
QbD, and RBM
 Acknowledges the importance of establishing the context in
which the organization operates
What TransCelerate QMS Heard from
Health Authorities
EMA
FDA
Suggested ICHQ10 (GMP) was not
appropriate for a CQMS
Acknowledged benefit to patients and
clinical sites
Acknowledged common goals of a CQMS
for industry stakeholders
Suggested examples of practical
application would benefit organizations
seeking to apply a potential guidance
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Provided strong support for a CQMS
ICH guidance
Acknowledged importance of global
harmonization separate from ICH E6
R2
Strong interest in the benefit to
patients


Strong interest in the benefit to
patients
Very interested in standardizing model
s of quality to help inspectors
Would find specific examples
(case studies) helpful

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

Concept paper describes a meaningful
framework for clinical quality
Q10 (and Q9)only for manufacturing
Examples useful as practical guidance
for new companies
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
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Supportive to QMS concept for
clinical trials
Appreciated difference between ICH
Q10 and a variable clinical
environment
Good interest; some reticence until
they see how this works in practice
Suggested CQMS should be a standard
for clinical trial stakeholders
Noted CQMS guidance will improve
quality of all industry organizations
Indicated harmonized processes will
reduce (agency) review resources and
regulatory timelines
ANVISA
MFDS

Expressed strong interest in
TransCelerate CQMS. Acknowledged
importance of global harmonization
separate from ICH E6 R2
CQMS may benefit patients
Supportive provided flexible company
implementation
COFEPRIS
BfArM
CFDA
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
Health Canada

Provided strong support for a CQMS
ICH guidance
Encouraged strong focus on patient
safety and speed of medicinal products
to patients
PMDA


Indicated QMS should be a focus to
the country to develop not only the
industries but sites in Brazil.
Suggested initiative may improve the
quality and increase number of
qualified sites in Brazil.
Issue Management: Issues that
Matter “Triage” Framework
ISSUES
Examples of Sources of Issues
 Study management and monitoring
 Data trending and analytics (including internal surveillance /
metrics)
 Self-identified issues within the clinical development functions
 Issues reported by external parties
 Noncompliance to regulatory requirements throughout the
clinical development enterprise
 Audit and inspection results
 Conceptual funnel is a mechanism for filtering issues based
on the level of risk.
 Setting thresholds to allow focus on the “Issues that Matter”
 The number of and the definitions of the thresholds will
generally be established during risk assessments.
 Issues not meeting definition of “Issues that Matter” are
retained for trending and analytics
 In aggregate, filtered issues may uncover a potential risk
requiring “Issues that Matter” triage.
 Trending and analytics will feed back into a risk assessment
process.
 An issue(s) that matters will move quickly through the funnel
for appropriate escalation and CAPA process
 The preventive action will link back to risk assessment and
evaluation of risk mitigation strategies.
Knowledge Management For
Clinical Development
Clinical QMS Conceptual
Framework Concept Paper
“Strategies and processes designed to
identify, capture, structure, value, levera
ge, and share an orga intellectual to enha
nce the clinical development
organization’s performance and the
performance of QMS elements, including
issue management and risk management,
based on two critical activities:
1. Capture, storage and accessibility of
institutional explicit and tacit
knowledge, and
2. Its assimilation, interpretation,
dissemination, application and
maintenance within the organization”
“Getting the right information to
the right people at the right time”
Value
Connects people with information
more rapidly
Reduces unnecessary or redundant
re-work across teams/functions
Retains and facilitates sharing of
critical knowledge
Enables searching, finding and
applying information faster
Enhances decision making
Adapted from The Business Dictionary: http://www.businessdictionary.com/definition/kno
wledge-management.html)
QMS Strategy
QMS Asia Pacific Sub team:
Mission and Team
Define next steps for engaging our
QMS Asia Pacific team
Team Mission:
QMS Asia Pacific Team
•
Review and provide comment on TFA output
Lead Hannah Chen (JNJ China)
•
Test our messaging for the region and provide
feedback (is it understood, are there areas that
require more attention, etc)
•
Take our messaging and evolve it for use in
the region
•
Represent QMS at assigned conferences and
meeting
•
Identify areas that are opportunities for
additional messaging to support change
management implementations.
•
Pilot: Help to evolve regional workstream
sub-team concept
Confirmed members:
• Tatsuya Murakami (Pfizer-Japan)
• Bokjin Hyun(BMS - Korea)
• Ellyne Setiawan (BI - China)
• Helen Li (Pfizer - China)
• Helen Wong(Merck – China HK)
• Keiichi Ueda(Shionogi – Japan)
• Janet Chen(AZ - China)
• Tomoko Ban(AZ - Japan)
• Yumi Sugiura (BMS - Japan)
• Shuichiro Tatematsu (UCB -Japan)
• Saeki Satoshi (Astellas - Japan)
• Charmaine Soon(JNJ-Singapore)
• Kiyomi Hirayama (Merck-Japan)
Thank you!
Questions?
The eLabels Initiative
Jennie Deem
Regulatory Scientist
Eli Lilly & Co., USA
Objectives
• Introduce TransCelerate eLabels initiative
• Current clinical trial labeling challenges
• What is an eLabel?
• Insights from Patients and Sites
• Demonstration
• Key considerations for implementation
• TransCelerate eLabels plans
eLabels Initiative Overview
What does this TransCelerate initiative do?
This initiative will help industry progress on the journey to digitally-supported,
patient-centric clinical supply chains. The main output is not an eLabeling system,
but an implementation toolkit to facilitate external engagement and uptake in the
industry.
What is the approach?
What is the vision?
Act as a catalyst for clinical supply
chain transformation, enhanced
patient utility, reduced clinical
labeling timelines and costs,
promotion of consistent, up-to-date
information and coordinated,
effective Health Authority
engagement.
Prepare implementation toolkit to facilitate
voluntary, modular adoption of eLabeling and
to assist in coordinating Health Authority
engagement.
Develop and implement an external
engagement strategy including sites, patients
and Health Authorities.
Develop technology assessment and proof of
concept for regulatory and other stakeholder
engagement.
How is technology already mainstream
and a critically important aspect of our lives?
Digital technology is leveraged to secure safe
passage on air travel and to pay securely
from your mobile device
eDiaries are leveraged extensively in
Clinical trials to capture the patient
experience
Wearables are already
used in Clinical trials
Common stakeholder pain points across
the industry (Pain points may vary by sponsor)
Pain Points of Current Labeling
Patients
 Low usefulness of booklet labels: Few are opened, limited space and small fonts
 Booklet labels may impede functional use of a syringe or auto-injector
 Information on label is there to meet regulatory requirements, but may not include
helpful information for the patient (eg, administration information)
Sites
 Limited to no utility for sites except for the trial alias and kit number to aid in dispensing
 Limited or no space to write on the label
Health
Authorities
 New labeling technology has surpassed regulations
 Need to advance public health by accelerating innovation
Companies
 Paper labels are static, making updates lengthy and costly
 Multiple label groupings are needed to support global trials
 Long creation and approval times (multiple months) delay getting medicine to patients
eLabels will be an alternative to
booklet labels
Current State
Potential Future State
Universal Label
TX-4457
Booklet Label
123456789123
# 7-654321
Language neutral
content on
physical label to
identify material
www.company.com
Study-specific eLabel
Full regulatorycompliant label on
electronic device
* Detailed data may be added:
e.g. SubjectID, investigator name
Universal Label Example
The universal label attached to the physical packaging will
provide language neutral content that allow for traceability,
proper storage, warnings and contact information
TX-4457
Map ID
Description
TX-4457
Trial or molecule Indicator
123456789123
Kit Number
www.
# 7-654321
www.company.com
Pictograms from the ISPE Good Practice Guide Booklet Labels, USP Pictograms:
http://www.usp.org/usp-healthcare-professionals/related-topics-resources/usp-pictograms/d
ownload-pictograms
Company Address, Website, Logo
Batch or Packaging Reference
Number
Storage Conditions
Keep out of the Reach of Children
Device-readable code, e.g.,
barcode
Caution Statement reference
Insights on eLabels from Patients
Patients
5,000+ previous clinical trial patients surveyed indicated1
(3,000+ US, 109 EU and 1,935 China)
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Written and verbal instructions were valued most to ensure compliance
The most helpful instructions via demonstration or verbally from site personnel
where patients can ask questions
Most preferred means to obtain information:
 Email (EU and US)
 Text message and postal mail (China)
Patient Focus Group (n=12)2
…..and asked for the following information
Patients expressed dissatisfaction with current
labels (booklet and single panels)……
“Doesn’t contain
the information I
need”
“Font is too
small”
• Medication name
• Dosing instructions (especially important when taking multiple
medications and/or IMP/placebo from multiple containers)
• Contact Information for
- Sponsor name
- Study nurse
- Patient Advocate (specific role for all NIH studies)
• Adverse event information
• Ability to access only once on their device
When shown eLabel prototypes, patients positively responded to:
Caregiver “labelled bottle
s with a magic marker to
know when to take pills
from different bottles”
1Patient
•
•
•
•
•
•
•
Appearance: “Clean and simple”
Layout: Easy to find information
User Interface: Colors, layout, bolded headers, etc
Search function
Availability of native language
Update functionality and notifications
Contact info and ability to ease of making a call
Perceptions of Investigational Medicinal Products 2015 surveys in EU (and China), Esther Sadler-Williams 8th March 2016, Frankfurt
eLabels Patient Advisory Board Sept 2016
2TransCelerate
Insights on eLabels from
Investigational Sites
45 sites surveyed in EU, US, Latin America and Japan expressed support
for eLabels and acknowledged the potential to:
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
Sites
reduce human error and workload
enhance readability of the label
eliminate relabeling
provide detailed dosing instructions
track compliance
provide notification to patient
allow integration with patient diaries
provide access to supportive videos
Site Focus Group (n=12)2
…..and asked for the following information
Sites also expressed dissatisfaction with
current labels (booklet and single panels)……
“Difficult to locate an
d select correct
container based on
Kit ID”
“Patients rip it off
or don’t even open
it”
1TransCelerate
2TransCelerate
“We’d never
dispense something
like this in a retail
setting”
“A link for patients to
access information
on-line would be
premium”
Site Advisory Group and Lilly site interviews (SCRS)
eLabels Site Advisory Group Sept 2016
• Patient dosing reminders
• Electronic ways to improve efficiency and accuracy of drug
accountability
• Dosing videos and pictures which serve as reminders/information
when the patient is at home
• Machine readable ways to verify the site picked the right container
Sites indicated patients are motivated and most will use an electronic
device to obtain information
When shown eLabel prototypes, sites positively responded with:
•
•
•
•
•
Unanimously liked the concept
“Simple and clean”
Liked “push” real time updates and notifications
Making it language friendly allows patients to focus on what is useful to them
Extremely helpful to have detailed dosing instructions
eMeds/eLabel Technical Pilot1
Objectives
Patients Reported
• Technical evaluation of the different eLabel and
eMeds components
• Evaluation of user-friendliness and satisfaction of
subjects and sites
24 VOLUNTEERS
12 DAYS
• 18-40 yr
• Dutch
Morning
• 40-65 yr
• French
Noon
• > 65 yr
• English
Evening
3 LABEL UPDATES
• “1 morning & 1 evening capsule ”
2 SUBJECT SATISFACTION SURVEYS
+ INDIVIDUAL SUBJECT INTERVIEWS
• “2 morning, 1 noon & 2 evening
capsule”
Day 5
• “0 morning, 2 noon & 1 evening
capsules”
Day 12
• 1Janssen
“0 morning,
0 noon &
0 evening
eMeds/eLabel
Technical
Pilot
capsules”
1Janssen
eMed/ eLabel Technical Pilot
Final visit
• eLabel updates to be very clear
and acceptable (92%)
• 84% of subjects scored
smartphone use as easy to very
easy, despite only 25% having
smartphone experience
• Overall positive feedback on ease
of using eLabel and clarity of
eLabel update notifications
• 71% of subjects considered
eLabel as a very accessible and
user-friendly format when viewing
it independent of an update
• Being notified of dosing changes
(eLabel updates) was considered
the most important advantage of
the eMeds technology
eLabels provide benefits across the
industry (Benefits may vary by sponsor)
eLabel Benefits
 Increases efficiency in clinical development allowing for patients to receive medicines faster
Patients
 Increases patient safety
 Enhanced utility of clinical labels and potential for better compliance, e.g.:



Sites
Dosing videos
Supplements to communication
Improved usability (e.g. larger font size)
 Rapid access to up-to-date information
 Greater efficiencies in Labeling approaches
 Lays a future foundation for engaging with the patient about their medication
Health
Authorities
 Decreases potential for deviations during extension re-stickering: e.g.: sterility, tamper evident seal,
product mix-up, time out of environment
 Ensures latest information available for patients
 Ties into broader digital and innovation strategies
Companies
 Increases operational efficiencies in creation of label
 Allows for additional pooling strategies which decreases waste
 Decreases reaction time to study changes
 Increases options for significant value-adds such as adherence programs, patient analytics, patient
education
eLabel Technologies – Push versus Pull
Devices may either be provided by sponsor or patients utilize
their own device
Pull Technology
Action required by patient to retrieve the eLabel
Demonstration was developed by Sanofi in the ordinary course of business and contributed
to TransCelerate to facilitate engagement with Health Authorities.
Push Technology
Databases
eLabel and eLabel updates are
automatically sent to the patient
Key Consideration – Redundant
Systems and Back-up Plans
Potential eLabel Failure Points
Hardware
Software
• Device
inaccessibility
• eLabel application
bug
• Loss of power
• eLabel application
is not properly
installed on user’s
device
• Broken device
• Lost device
• Server
Potential Solutions
Human to Human Examples
• Call number on patient card for trouble
shooting and support on device /
application usage
• Retrain user
Digital Examples
• Business continuity plan developed
Signal Connectivity
• Loss of internet
• Loss of wireless
signal
Universal Label
• Unreadable Label
• URL printed on universal label to allow user
to enter a unique identifier (e.g. Kit Number)
to retrieve label
• Once label is scanned, it is available in the
device history off-line
• Can be downloaded to local electronic and/
or hard copy storage
Full compliance with 21 CFR Part 11 and Annex 11 Computerized Systems
Critical Considerations for
Sponsor Implementation
Items that must be addressed based upon technology chosen
 Patient Privacy
 Data Security
 Systems Validation
 Integration with Other Systems:
•
•
•
•
•
•
•
Interactive Response Technology (IRT)
Label Content Creation and Approval System(s)
Clinical Supply Demand/Planning and Distribution System(s)
Drug Accountability and Tracking System(s)
Sensor Systems (the Internet of Things)
Study/Site Portals
Enterprise Resource Planning (ERP) System(s)
Illustrative Cycle Time Improvement:
Conventional Model vs. eLabels Model
Conventional Model
Sequential
12 – 16 weeks
Up to 30 weeks
Country specific multi-language booklet
label design and manufacture
Clinical Supplies
packaging
QP release
final KIT
eLabels Model
Parallel
~1 week
Design
Universal
Label
~ 15-19 weeks
Clinical Supplies
packaging
QP release
final KIT
Ship to site
Design and
approve country
specific eLabels
QA release
Country
Specific KIT
label
Upload country/
language
specific label to
patient/
caregiver’s
device
Clinic
Dispenses
KIT
Ship to site
Clinic
Dispenses K
IT
TransCelerate eLabels Engagement Plans
Gathering stakeholder feedback and evolving the
eLabels concepts is a key deliverable of this initiative
FDA
EMA (& other
EU agencies)
Industry organiz
ations
(ie, EFPIA, ISPE)
Health Canada
eLabels
Concepts
Sites
Patients
(CISCRP)
AsiaPac Health
Authorities
Latin America
Health
Authorities
Where we’ve been and where we are
going…..
2015
2016
2018
2017
eLabels Design and Delivery Toolkit
Update
Update
• TransCelerate approved initiative
• Implementation toolkit for voluntary implementation
and to assist in HA engagement
eLabels
Assets
External
Engagements
Technology Assessment and Prototype
• Technology Landscape Assessment completed
• Use cases identified
• Proof of concept developed for Health Authority
and other stakeholder engagement
Legend:
• Proof of concept update with stakeholder
feedback
• Tech architecture to be developed
Health Authority Engagements
• Ongoing Health Authority engagements
Patient/Site/ Industry Organizations
• Ongoing Patient and Site Engagements
• Industry organization feedback via meetings and
conferences
eLabeling Lays the Foundation for
Future Innovation
Clinical Supply Labeling – Illustrative Maturity Model
TransCelerate is focusing
on building the foundation
of eLabels to enable future
innovation
Digitally Enabled,
Patient Centric
Value
Connected
•Foundation e-Label
functionality
Link to
Repository
•Phrase library
•Traceability through
adherence and
destruction
Disconnected •Regulations
database
•Integrated e-Label with
expiry updating
•Smart packaging with
automated temperature
tracking
•Proactive messaging
reminders administration
•Links to patient
•Focus only on
education
paper-based clinical
labeling
Digital Maturity, Patient Focus
Thank you!
Questions?
Appendix
Shared Investigator Platform Benefits
Shared
Investigator
Platform
Investigators
Quality, streamline processes,
regulatory compliance,
capacity.
Costs related to:
• Training
• Document exchange
• Support & maintain
• Help desk
Startup time
Productivity (via reduced
redundant tasks & streamlined
processes), access to
information.
Streamlined electronic
audit process, insight into
trial, harmonized
information model.
Study startup time, redundant
training.
Copyright ©2015 TransCelerate BioPharma Inc., All rights reserved.
58
SIP Enables a Site User to:
1
Join the Platform
One login; access to multiple participating sponsors.
2
Build a User Profile
Enter data once; maintain your credential centrally for use
across SIP sponsors & studies.
3
Complete GCP Training
Centralized history. Take GCP training once – credit may
be recognized by multiple participating sponsors.
4
Prioritize & Manage Your
Work
Consolidated view of a site tasks across SIP studies and
sponsors.
5
Manage a Facility Profile
Maintain information centrally for use across SIP sponsors
& studies. Facility is associated to users & studies.
6
Complete Feasibility Surveys
Central visibility to all SIP Feasibility surveys; shorter surveys
due to re-use of SIP user & facility profile data.
7
Access Your Study Workspace
Interact & collaborate with SIP study teams; SIP study
materials in one place.
8
Exchange Documents
Post, share and retrieve study documents with SIP sponsors.
Copyright ©2015 TransCelerate BioPharma Inc., All rights reserved.
59
SIP Enables a Sponsor User to:
1
2
3
4
5
6
7
8
9
Login to the Platform
Sponsor User has platform access from MC system.
Access PI information
Search central information to evaluate PI profiles for new
studies. User ownership of profile data improves quality.
Assign & Approve Training
Assign training across sites; site manager access to
centralized training documentation for site staff.
Access Facility Profile Data
Search central information for new studies; user ownership
of profile data improves quality.
Build/Send Feasibility
Surveys
Re-use previous surveys & templates to reduce duplication;
centralized surveys & automated follow-up reduce effort.
Build a Study Workspace
Unique study workspaces provide centralized access,
information & collaboration space.
Prioritize Work Across Studies
Consolidated view of tasks and deadlines across SIP
studies.
Exchange Documents
Post and retrieve SIP study documents quickly and easily.
Metrics & Reporting
Quickly and easily access key metrics and standard reports.
Copyright ©2015 TransCelerate BioPharma Inc., All rights reserved.
60
After Release2* SIP Will Enable a Site User to:
1
Join the Platform
One login; access to multiple participating sponsors
2
Build a User Profile
Centrally maintain your credentials; generate a detailed WORD
formatted CV.
3
Complete Training
Centralized history. Take GCP & Study training Request credit for
completed training.
4
Prioritize & Manage Your Work
5
Manage a Facility Profile
Maintain information centrally for re-use across SIP Sponsors & studies.
Broader facility relationships and affiliations
6
Complete Sponsor Surveys
Manage and track all SIP surveys (feasibility, study closeout,
satisfaction); Site User dashboards; survey analysis
7
Access Your Study Workspace
Interact & collaborate centrally with study team; study materials in
one place. Manage study site startup activities
8
Exchange Documents
Post, share and retrieve study documents with SIP sponsors; auto
complete standard forms using SIP data
9
New Opportunities/Historical data
Investigators can view new study opportunities with participating SIP
Sponsors; view historical enrollment data
10
Access Safety Notification
Central place to view and acknowledge safety letters from
participating sponsors
Consolidated view of a site tasks across SIP studies and sponsors.
* Orange text denotes proposed R2 new features/functions
Copyright ©2015 TransCelerate BioPharma Inc., All rights reserved.
61
SIP Public
Landing Page
Copyright ©2015 TransCelerate BioPharma Inc., All rights reserved.
62
Site
Site User Landing Page; Consolidated
Task List, quick access to Studies
Notifications,
Configurations,
Searchable
Help
Task
Dashboard
Consolidated
Task List
Quick Access
to Studies
Copyright ©2015 TransCelerate BioPharma Inc., All rights reserved.
63
Centralized location for User Profile;
Accessible by all SIP Sponsors
Site
Abbreviated CV generated
off User Profile Data
Copyright ©2015 TransCelerate BioPharma Inc., All rights reserved.
64
Study Workspace for Collaboration
with Sponsors
Site
Sponsor
Access to Study Milestones, Study Site Addresses and Staff,
Study Training, and Sponsor Contacts
Study Task
List
Quick access
to Study Links
The Latest
Study News
Copyright ©2015 TransCelerate BioPharma Inc., All rights reserved.
65
Securely Exchange Study Documents
with Sites; Enter metadata for easier
searching
Site
Sponsor
Copyright ©2015 TransCelerate BioPharma Inc., All rights reserved.
66
Manage Feasibility Surveys in a
Central Location; Build Survey Templates
Sponsor
Copyright ©2015 TransCelerate BioPharma Inc., All rights reserved.
67