1. IRTINTERACTIVE RESPONSE TECHNOLOGIES IN CLINICAL TRIALS
OCTOBER 25-26, 2016 | HILTON PHILADELPHIA AT PENN’S LANDING | PHILADELPHIA, PA
6TH ANNUAL
Leverage Next Generation Systems and Operational Best Practices to
Enable Supply Chain Agility and End-to-End Drug Accountability
2016
PROGRESSIVE INSIGHTS FROM INDUSTRY’S LEADING IRT EXPERTS:
ZSOLT GASPAR,
IRT SME,
AbbVie
CATHERINE HALL,
Associate Director, Clinical
Trial Material Management,
Sunovion
RITA HERMAN,
Associate Director, Clinical
Data Management, IVRS,
Merck
GREG HOTTELL,
Acting Senior Director, Global
Supply Chain Management,
GlaxoSmithKline
JACKIE KENT,
Senior Director, Product
Delivery Supply Planning
and Systems, Eli Lilly
JASON McCOY, M.S.,
Global Randomization and
Blinding Head, Biostatistics
Senior Manager, Amgen (Invited)
DOUG MEYER,
Associate Director,
Clinical Drug Supply,
Biogen
CRAIG MOONEY,
Director, IRT,
Bristol-Myers Squibb
REGISTER BY AUGUST 19, 2016 AND SAVE $300!
MICHAEL MOORMAN,
Executive Director, Global
Clinical Supply Systems and
Support, Pfizer Inc
KIRAN PAVULURI,
Associate Director,
PD IT Operations,
Bristol-Myers Squibb
HEIDI PFEFFERKORN,
Development Quality – TRD
QA, Integrated Release
Platform (iRelease), Novartis
Pharmaceuticals Corporation
KERRI YUSZKUS,
Senior Clinical
Business Analyst,
Vertex Pharmaceuticals
IRT strategy alignment with supply chain
analytics initiatives
IRT standards organization based on
functionality, reports, alerts and processes
Impact of the rejection of Safe Harbor
Principle on the IRT
Best practices for vendor evaluation,
selection and onboarding
Improved monitoring of IRT vendor
implemented randomization and dosing
systems to reduce medication errors
Change order mitigation for
end-of-life studies
Opportunities for leveraging IRT to
automate cold chain monitoring
IRT integration with eCOA to
manage patient dose compliance
Current challenges for sites with
arrivals, dispensing and returns tasks
to improve user-experience
Common findings by EMA/MHRA/FDA
inspectors
Necessity of a full audit trail within
IRT vs. other clinical systems and
resulting challenges
And so much more!
R E G I S T E R A T W W W . C B I N E T . C O M / I R T • 8 0 0 - 8 1 7 - 8 6 0 1
EDUCATIONAL SPONSORS:
A division of
UBM Americas
Practical Industry Case Studies and Interactive Discussions Addressing:
NEW FOR 2016!
Bio/Pharma-Only
Working Group
October 24th
—
Benchmarking to
Create Industry Best
Practices Whitepaper
2016 ACCESS SPONSOR:GOLD SPONSOR:

2. W W W. C B I N E T. C O M / I R T2
W HY AT T E N D?
The industry is rapidly moving towards end-to-end drug accountability in
clinical trials as there is a need to track the receipt of a drug from shipment
to dispensing, return and destruction. The IRT continues to gain momentum
as a critical component to clinical trial and supply chain strategy, and as the
complexity of trials continues to rise, optimizing the IRT is paramount.
Join industry colleagues at IRT 2016 — CBI’s Interactive Response
Technologies in Clinical Trials for benchmarking and practical case
studies. As the first and longest standing meeting dedicated to uniting
clinical operations, supply chain and clinical systems professionals charged
with utilizing the IRT to optimize clinical supply management, this industry
acclaimed meeting continues to be the must attend event of year.
Who Should Attend:
You will benefit from attending
this event if you have
responsibilities or involvement
in the following areas:
• IVR/IWR/IRT/RTSM Systems
• Clinical Supplies/
Supply Chain Management
• Supply Logistics
• Randomization and
Trial Supply Management
• Clinical Operations
• Clinical Trials Materials
• Clinical Business
Systems/Architecture
• Clinical Trial Management
• Clinical Data Management
• Clinical IT
• External Partnerships
• Biostatistics
Previous Attendee Acclaim:
“This is the best forum in the pharmaceutical
industry for exchanging solutions sponsor
to sponsor.”
— Manager, Clinical Data Management, Allergan
“Extremely informative and very educational.”
— Manager, Manufacturing Operations and Supply Chain, InterMune
“Good conference focusing on IRT in a broad
way with good spread/balance of involved
parties and lively discussions.”
— Associate Director, CTS, Grünenthal
“Provided a great perspective of IRT from a
sponsor and supplier perspective. Great examples
of innovation and procedures in IRT.”
— Manager, Returns, Reconciliation and Destruction, Fisher Clinical Services
“As a non-IRT professional, helped me
understand the complexities of this space and
how much I did not know.”
— Head, Data Management and Clinical Studies, Shire

3. Amy Black,
Head, Electronic
Trial Operations,
Amgen (Invited)
Michele Brown,
Associate Director, Clinical
Data Management, IVRS,
Merck
Bryan Clayton,
Director,
Client Solutions,
YPrime
Stéphan Cōté,
Compliance, Senior Manager,
Global R&D Compliance
and Audit, Amgen (Invited)
Pirmin Froehlicher,
Client Services Lead,
4G Clinical
Zsolt Gaspar,
IRT SME,
AbbVie
Alyssa Gilliam,
Director,
ICON Clinical Research
Catherine Hall,
Associate Director,
Clinical Trial Material
Management, Sunovion
Rita Herman,
Associate Director, Clinical
Data Management, IVRS,
Merck
Greg Hottell,
Acting Senior Director, Global
Supply Chain Management,
GlaxoSmithKline
Jon Hunter,
Associate Director,
IRT Operations,
YPrime
Jackie Kent,
Senior Director, Product
Delivery Supply Planning
and Systems, Eli Lilly
Lisa Li, Director,
Services Delivery,
Suvoda
Jason McCoy, M.S.,
Global Randomization
and Blinding Head,
Biostatistics Senior Manager,
Amgen (Invited)
Doug Meyer,
Associate Director,
Clinical Drug Supply,
Biogen
Craig Mooney,
Director, IRT,
Bristol-Myers Squibb
Michael Moorman,
Executive Director,
Global Clinical Supply
Systems and Support,
Pfizer Inc
Kiran Pavuluri,
Associate Director,
PD IT Operations,
Bristol-Myers Squibb
Heidi Pfefferkorn,
Development Quality –
TRD QA, Integrated
Release Platform (iRelease),
Novartis Pharmaceuticals
Corporation
Neeli Sharrett,
Associate Director,
ICON Clinical Research
James Streeter,
Global Vice President, Life
Sciences Product Strategy,
Oracle Health Sciences
Courtney Thomas,
Project Manager,
YPrime
Kerri Yuszkus,
Senior Clinical
Business Analyst,
Vertex Pharmaceuticals
D I S T I N G U I S H E D FACU LT Y
“Great
forum to
hear current
industry
challenges
with clinical
systems
related to
IRT and
understand
possible
solutions.
[It is] also
a great
conference
to see
the future
possibilities
of IRT.”
— Senior Manager,
Systems Operations
Genentech
W W W. C B I N E T. C O M / I R T 3

4. AGENDA AT A GLANCE
W W W. C B I N E T. C O M / I R T4
PRE-CONFERENCE WORKING GROUP — MONDAY, OCTOBER 24, 2016
1:00 Bio/Pharma-Only Summit Registration
1:30 Summit Host Welcome and Opening Remarks
1:45 NEW THIS YEAR! Bio/Pharma-Only Working Group
5:00 Close of Summit — Wine and Cheese Reception Commences
DAY ONE — TUESDAY, OCTOBER 25, 2016
7:30 Main Conference Registration and Continental Breakfast
8:15 Conference Co-Chairs’ Welcome and Opening Remarks
8:30 KEYNOTE ADDRESS Transform Organizational Operations, Processes and Systems to Deliver Fully Integrated End-to-End Supply Chain
9:00 KEYNOTE ADDRESS The Future of IRT — Where Are We Today and Where Are We Headed?
9:30 Optimize the IRT to Ensure Supply Chain Agility
10:00 Networking and Refreshment Break
10:30 TRANSCELERATE ADDRESS TransCelerate Initiative Update on e-Labeling
11:00 5 Critical Ways IRT Must Change to Meet Our Industry’s Rapidly Evolving Business Needs
11:25 Need for Next-Generation, Flexible Systems
11:50 The Future of IRT Is in Your Hands — Leveraging Mobile Technology to Bring IRT into the 21st Century
12:15 QA Panel with IRT Thought Leaders
12:45 Networking Luncheon
1:45 C H O O S E F R O M T H R E E I N - C O N F E R E N C E B R E A KO U T S
ONE
Examine Processes for
Implementing, Documenting
and Executing IRT Standards
TWO
Expiry Date
Management and the
Safe Harbor Principle
THREE
Illuminating Clinical Trials with
Actionable Data Analytics
3:05 Networking and Refreshment Break
3:35 Lessons Learned in IRT Vendor Evaluation, Selection and On-Boarding
4:00 Reduce Risks of Medication Errors in Clinical Trials through Vendor Oversight and Monitoring
4:25 Leverage IRT to Manage Complex Protocols in Oncology
4:50 Implement Barcode Scanning to Eliminate Dispensation/Transcription Errors During Clinical Trials
5:15 QA Panel with IRT Thought Leaders
5:30 Close of Day One and Wine and Cheese Reception Commences
DAY TWO — WEDNESDAY, OCTOBER 26, 2016
7:30 Continental Breakfast
8:00 Conference Co-Chairs’ Review of Day One
8:15 Biogen’s Cold Chain Approach and Vision for Automation through the IRT
8:40 Does IRT Drive Your Supply Strategy?
9:05 Comparison of Clinical Supply Forecasting Methodologies and a Peek into Best Practices for Implementation
9:30 Integrate IRT with eCOA to Manage Patient Dose Compliance — The Good, the Bad and the Ugly
9:55 QA Panel with IRT Thought Leaders
10:10 Networking and Refreshment Break
10:40
FIRESIDE CHAT
Open Exchange and Dialogue — Balancing Regulatory Requirements and Needs of the End User
11:40 Best Practices to Improve the IRT Site User Experience
12:05 QA Panel with IRT Thought Leaders
12:30 Networking Luncheon
1:45 Leverage Internal Audits to Promote Continual Business Process Improvement
2:30 Best Practices for an Inspection-Ready IRT — True Audit Trail vs. Data History
2:45 QA Panel with IRT Thought Leaders
3:30 Close of Conference

5. PRE-CONFERENCEWORKINGGROUP
1:00 Bio/Pharma-Only Summit Registration*
*Attendees who register for the working group must be employed
by a biotech or pharmaceutical company at the time of the
conference. Final approval is at the discretion of CBI.
1:30 Summit Host Welcome and Opening Remarks
1:45 NEW THIS YEAR!
Bio/Pharma-Only
Working Group
Summit Objective:
This exclusive, bio/pharma-only working group
serves as an unparalleled opportunity to benchmark
and talk openly about internal best practices/
processes and external partnership collaborations.
The goal of this working group is to uncover
areas where industry best practices and standard
processes can be developed with a focus on
SOPs and workflow, organizational structure and
governance, as well as technology capabilities.
To ensure a productive conversation, attendees
are given advanced questions to consider prior to
the event and the structure of the discussions are
kept vendor agnostic. Post-event, the leader of
the working group is developing a whitepaper to
publish these best practices which is to be sent to
all attendees prior to publication in Applied Clinical
Trials for a comment period. Additional contributors
are welcome.
Summit Outline:
I. Setting the Stage —
Goals, Discussion Format and
Ground Rules
II. Evaluate Responses to Pre-Event
Survey — Industry Feedback on
High Potential Areas for Industry
Best Practices Development
III. Brainstorming Session
• Spec Development
• UAT and Vendor Oversight
• Scope of System
• Sponsor IRT Group Responsibilities
IV. Whitepaper Development —
Timelines, Expectations
and Next Steps
to be published in
Applied Clinical Trials
5:00 Close of Summit
There will be a 30-minute networking and
refreshment break at 3:00 p.m.
MONDAY, OCTOBER 24, 2016
Heidi Pfefferkorn,
Development Quality – TRD QA, Integrated Release Platform (iRelease),
Novartis Pharmaceuticals Corporation
Jeremy Bolton,
Associate Director, Clinical Trial Supply Management,
Jazz Pharmaceuticals
WORKING
GROUP
LEADERS:
NETWORKING, WINE AND CHEESE RECEPTION
immediately following the conclusion of the pre-conference working group
W W W. C B I N E T. C O M / I R T 5
“The presentations and enthusiasm of the presenters
was infectious.”— Director, Project Management, ICON

6. 7:30 Main Conference Registration and Continental Breakfast
8:15 Conference Co-Chairs’ Welcome and Opening Remarks
Craig Mooney,
Director, IRT,
Bristol-Myers Squibb
Enable Supply Chain Innovations
through IRT Optimization
8:30 KEYNOTE ADDRESS
Transform Organizational Operations,
Processes and Systems to Deliver Fully
Integrated End-to-End Supply Chain
• Gain insight into massive transformation
connecting the supply chain from raw materials
all the way to the site
• Analyze the consolidation of large number
of systems and devices in trials to a
streamlined system
* highly customized, yet flexible, home-grown IRT
* balance internal investments with gain in
long-term efficiencies
* challenges and solutions of operationalizing
this transformation
• Realize benefits of supply chain efficiencies
* reduction in operating expenses, decreased
cycle times
* strategic sourcing of materials
* improved on-time delivery and out-of-drug
metrics by 2x
• Assess the future of clinical trials, CT material and
the implications for IRT
* eMeds and eLabeling
* scenario planning on need assessment/IRT
capability projections for 2018, 2020, 2025
and beyond
Jackie Kent, Senior Director,
Product Delivery Supply Planning and Systems,
Eli Lilly
9:00 KEYNOTE ADDRESS
The Future of IRT — Where Are We Today
and Where Are We Headed?
Rapidly advancing science and new technologies
such as mHealth and the Internet of Things are
transforming clinical trials. We will look at how
these and other industry changes will impact trial
design and conduct — especially screening and
randomization, supply and depot management and
clinical data management — to improve trial speed,
quality and accuracy with less effort and cost.
James Streeter,
Global Vice President, Life Sciences Product Strategy,
Oracle Health Sciences
9:30 Optimize the IRT to Ensure Supply Chain Agility
• Understand the positioning of the IRT as a
critical component of an integrated end-to-end
supply chain
* avoid focusing on the IRT, in isolation, which
results in sub-optimizing the supply chain
• Support supply chain agility and responsiveness
through integration across planning platforms
* enhance timely and effective decision making
* integrate upstream with the MRP engine
• Optimize the IRT strategy through alignment with
supply chain analytics initiatives
Greg Hottell,
Acting Senior Director, Global Supply Chain Management,
GlaxoSmithKline
10:00 Networking and Refreshment Break
10:30 TRANSCELERATE ADDRESS
TransCelerate Initiative Update on e-Labeling
This Address provides an update to the TransCelerate
e-Labeling Initiative.
• Overview of the initiative and its purpose
• Understand progress to date
• Insight into the critical tie-in to IRT systems and
what lies ahead
Michael Moorman,
Executive Director, Global Clinical Supply Systems and
Support, Pfizer Inc
Next-Generation Agile, Interoperable
IRT Systems
This section of the program features succinct presentations offering insight
into next generation agile, interoperable IRT systems. A QA panel between
the presenters and the audience concludes the discussion.
11:00 5 Critical Ways IRT Must Change to Meet Our
Industry’s Rapidly Evolving Business Needs
This session presents industry case studies and
research showing the “road ahead” for IRT from a
technology standpoint. We will explore the changes
required to ensure that IRT — a critical component
that can make or break a trial — meets the needs of
the business and the people charged with managing
the systems, including:
• Becoming a “proactive” vs. a “reactive” system,
with predictive analytics, will dramatically increase
study design efficiency and reduce cost and risk
• Supporting more of the regulatory and supply
chain e.g. inspections and drug pedigree
• Eliminating point-to-point integrations with other
key eClinical systems from planning and initiation
to post-marketing — Increasing quality, accuracy
and efficiency with data updating automatically
across all clinical systems
James Streeter,
Global Vice President, Life Sciences Product Strategy,
Oracle Health Sciences
11:25 Need for Next-Generation, Flexible Systems
Finding the right balance between off-the-shelf
functionality and protocol-specific needs is a
challenge within the IRT industry. Systems should
allow for customizations to ensure proper compliance
for patient dosing and clinical supply forecasts while
also offering efficient execution and consistent
system quality. This type of system architecture
allows vendors to ensure a higher level of quality and
more consistent system-build timelines. While some
of these components can be implemented without
any additional programming, the modules also have
DAY ONE — TUESDAY
6
Bryan Clayton,
Director, Client Solutions,
YPrime
CASE
STUDIES

7. Y, OCTOBER 25, 2016
B R E A K O U T O N E
Examine Processes for
Implementing, Documenting
and Executing IRT Standards
• Understand key considerations in
the development of IRT standards
• Organize standards based on
functionality, reports, alerts
and processes
• Optimize stakeholder engagement
• Harmonize with IVRS vendors
• Governance and oversight —
Striking a balance between rigor
and flexibility
• Develop a standards change
request process
Michele Brown,
Associate Director, Clinical Data
Management, IVRS, Merck
Rita Herman, Associate Director,
Clinical Data Management, IVRS,
Merck
B R E A K O U T T W O
Expiry Date Management and
the Safe Harbor Principle
• Understand how to use IRT
effectively to manage the mandatory
expiry dates on labels in packaging
• Evaluate the implications on ways
sponsors manage expiry dates and
how to cope with it
* what could be done to help in
terms of technology to ease the
process should it become law
• Assess the impact of the rejection of
the Safe Harbor Principle on the IRT
* evaluate the consequences of
rejecting the Safe Harbor Principle
* which data are concerning?
* assess the implications on ways to
manage the rejection of the Safe
Harbor Principle
* potential options that could be
considered when transferring
patient-sensitive data
B R E A K O U T T H R E E
Illuminating Clinical Trials with
Actionable Data Analytics
The right analytics and data visualizations
have the power to transform clinical
development. RTSM systems play a key
role in providing the type of real-time
data that enables faster, more informed
decision making and lead to increased
efficiencies and productivity.
• Develop insights into trial demand
that transform push-driven supply
chains into demand-driven networks
• Translate clinical supply chain
priorities from the point of product
consumption and usage back
into operations and synchronized
“inside-out” execution
• Define interdependent metrics that
align functional stakeholders, and allow
proactive, collaborative decisions
• Utilize performance metrics with
a common goal of focusing on
the patient, providing insights into
the root cause of problems, cycle
times and overall effectiveness of
trial conduct
Wade Wirta,
Managing Director,
Medidata
CASE
STUDY
7
flexibility to allow for to be modified as per a given
study’s requirements. With this flexible approach,
the following is achieved:
• Build and retain a central library of IRT standards
• Better support for changes mid-study and ability
for sponsors to make changes themselves
• Monitor common functionality across vendors to
implement better, more efficient solutions
Alyssa Gilliam,
Director,
ICON Clinical Research
Neeli Sharrett,
Associate Director,
ICON Clinical Research
11:50 The Future of IRT Is in Your Hands —
Leveraging Mobile Technology to Bring IRT
into the 21st Century
In the past year, clinical IRT has undergone some
disruptive transformations. Workers involved with
clinical trials are carrying connected smartphones in
their pockets and using it with their daily routines.
Many IRT vendors have made Web pages mobile
friendly which is a really good start. In this session, a
discussion of some extraordinary study management
benefits for moving into an app-based clinical IRT
approach. This session provides insight into managing
and operationalizing various aspects of clinical trials
as well as identifying challenges and the technology-
based solutions needed to overcome them.
• Provide a better site-patient experience with
the aid of mobile technology
• Minimize study medication dispensation errors
and ensure accurate, correct subject identifiers
* correct subject, correct investigational
product, at the correct dose
• Streamline the IMP inventory and
accountability process
• Capture subject input and the effects of
study medication
• Test the BYOD waters with an online-only
patient diary platform leveraging a specific
patient-oriented branded app
Kelly Knowles, PMP,
Director, Client Services,
Bracket
12:15 QA Panel with IRT Thought Leaders
12:45 Networking Luncheon
1:45 C H O O S E F R O M T H R E E I N - C O N F E R E N C E B R E A K O U T S
3:05 Networking and Refreshment Break

8. Operational Best Practices —
Study Start-Up, Conduct and Close
This section of the program features succinct presentations offering
insight into operational best practices for utilizing the IRT in clinical trial
management. A QA panel between the presenters and the audience
concludes the discussion.
3:35 Lessons Learned in IRT Vendor Evaluation,
Selection and On-Boarding
This case study discusses Vertex’s process of vendor
evaluation, selection and on-boarding as they are adding
additional IXRS vendors to support their trials. Insight
into the process and lessons learned are discussed.
• Evaluate Vertex’s process for vendor evaluation
and selection
• Assess what worked well and gain perspective on
what did not work
• Understand what was not accounted for within the
original planning for this process
• Analyze the audit process used to determine the
best vendors for the trial needs
• Learn the nuances of the vendor on-boarding plan
and discuss results to date
Kerri Yuszkus,
Senior Clinical Business Analyst,
Vertex Pharmaceuticals
4:00 Reduce Risks of Medication Errors in Clinical
Trials through Vendor Oversight and Monitoring
Errors in programming of randomization and dosing
algorithms remain a risk factor leading to medication
errors for subjects in a clinical trial. Regulatory agencies
have maintained that it is ultimately the sponsor’s
responsibility to maintain oversight of the IRT vendor’s
systems used in their clinical trials. This case study
details Amgen’s method for improved monitoring of
IRT vendor-implemented randomization and dosing
systems, which shortened detection time and reduced
the impact of system errors. Details of the process to
be discussed include:
• Development of the vendor oversight program
• Continuous monitoring of randomization and
dosing algorithms to uncover dosing discrepancies
within 24 hours
• Reduction of systematic errors that could impact a
large number of subjects
Jason McCoy, M.S.,
Global Randomization and Blinding Head,
Biostatistics Senior Manager, Amgen
4:25 Leverage IRT to Manage Complex Protocols
in Oncology
Oncology trials have unique requirements that
can make software systems built for those trials
a challenge to manage. A flexible IRT system can
mitigate the complexities of these studies by building
in ways to manage functionalities that drive business
needs. This session covers IRT considerations for
oncology trials including the following functionalities:
• Unscheduled visits to deal with dose changes
• Subject specific dynamic visit schedules to manage
repeating cycles
• Unknown cohort doses
• Multiple phases with different disease/tumor
type management
Lisa Li, Director, Services Delivery, Suvoda
4:50 Implement Barcode Scanning to Eliminate
Dispensation/Transcription Errors During
Clinical Trials
Most new drugs are delayed by the FDA because they
lack adequate information or incorrect information
from clinical trials, according to study published in
JAMA (JAMA. 2014;311(4):). The study concluded
that several potentially preventable deficiencies
accounted for significant delays in the approval of
new drugs. FDA delays are costly for companies and
bad for patients who are waiting for new treatments.
This case study discusses how Bristol-Myers Squibb
made changes to container dispensation process to
eliminate dispensation errors and enable automation
of the data entry process using barcode scanning to
eliminate transcription errors. This new functionality
eliminated dispensation and transcription errors. As
a result of this initiative, data reconciliation and data
validation efforts are significantly reduced, which in
turn, boosted the clinical trial success and expedited
submission process. Changes to be discussed include:
• Container verification using barcode scanning
• Increase automated checks
• Fully leveraging the advancements in IRT
• Automation of container number data entry
• Increased connectivity between IRT EDC systems
Kiran Pavuluri, Associate Director, PD IT Operations,
Bristol-Myers Squibb
5:15 QA Panel with IRT Thought Leaders
5:30 Close of Day One
NETWORKING, COCKTAIL RECEPTION
immediately following the final session on day one
HOSTED BY:
DAY TWO — WEDNESDAY, OCTOBER 26, 2016
7:30 Continental Breakfast
8:00 Conference Co-Chairs’ Review of Day One
Craig Mooney,
Director, IRT,
Bristol-Myers Squibb
Supply Chain Systems Integration and
Forecasting Methodologies
This section of the program features succinct presentations offering
insight into supply chain systems integration and implementation
with the IRT. A QA panel between the presenters and the audience
concludes the discussion.
8:15 Biogen’s Cold Chain Approach and Vision for
Automation through the IRT
• Evaluate Biogen’s legacy practices
• Assess the impact of implementing a
Temperature Monitoring System
* gain efficiencies by automating
temperature monitoring
* evaluate the advantages of capturing data
for all shipments
* address challenges at the clinical sites
• Determine opportunities for leveraging IRT to
automate cold chain monitoring
* review current best practices
* explore potential integration and
automation options
* gain insight into Biogen’s future vision
Doug Meyer,
Associate Director, Clinical Drug Supply,
Biogen
CASE
STUDY
CASE
STUDY
CASE
STUDY
8
CASE
STUDY
CASE
STUDY
Bryan Clayton,
Director, Client Solutions,
YPrime

9. 8:40 Does IRT Drive Your Supply Strategy?
Brett Castano,
Lead Project Manager,
endpoint
Dan Hilby,
Lead Technical Services Manager, IxRT,
Takeda
9:05 Comparison of Clinical Supply Forecasting
Methodologies and a Peak into Best Practices
for Implementation
This session provides an overview of different clinical
supplies forecasting methodologies and the business
value of each, such as deterministic planning, simulation
or statistical calculations. The session also includes best
practices and methods for implementing and managing
forecasting in your supplies organization.
Pirmin Froehlicher,
Client Services Lead,
4G Clinical
9:30 Integrate IRT with eCOA to Manage Patient Dose
Compliance — The Good, the Bad and the Ugly
While electronic dose data has great potential to
provide you with real-time insight to support your
risk-based monitoring effort, there are pitfalls that
need to be considered when tying this data together
with your IRT system. This session focuses on recent
real-world experience in fully integrating the IRT
system with patient reported dose compliance data
as gathered by patient handheld devices.
Jon Hunter,
Associate Director, IRT Operations,
YPrime
Courtney Thomas,
Project Manager,
YPrime
9:55 QA Panel with IRT Thought Leaders
10:10 Networking and Refreshment Break
IRT Optimization and Inspection
Readiness at the Site Level
This section of the program features succinct presentations offering
insight into IRT adoption, operations and inspection readiness at
the site level. A QA panel between the presenters and the audience
concludes the discussion
10:40 FIRESIDE CHAT
Open Exchange and Dialogue —
Balancing Regulatory Requirements and
Needs of the End User
This session is an interactive dialogue between
a sponsor and site putting context around the
regulations and requirements with regards to the
experiences at the research site.
• Requirements for system testing and roll-out
• Training
• Investigator credentials
• Receiving shipments
• Impacts of delayed shipments on site operations
• Processes for destruction and returns of supplies
Catherine Hall,
Associate Director, Clinical Trial Material Management,
Sunovion
Roger DeRaad,
MN, CNP, Director,
Black Hills Cardiovascular Research
11:40 Best Practices to Improve the IRT Site
User Experience
• Assess current challenges for sites with arrivals,
dispensing and returns tasks
• Automate temperature excursion and inventory
management tasks
• Evaluate future advances to enhance product
quality data before dispensing
Speaker TBA,
PAREXEL
12:05 QA Panel with IRT Thought Leaders
12:30 Networking Luncheon
Luncheon Sponsored by:
1:45 Drug Returns/On-Site Destruction and Best
Practices to Send Drug Back to the Depot
With varying regulations on shipping drug between
countries, there needs to be a defined process for
drug destruction. Decisions need to be made on
destroying drug at the clinical site directly vs. sending
drug returns to the depot. This session discusses the
challenges of each approach to drug destruction and
offers insight into incorporating this functionality
within the IRT.
• Evaluate regulations for shipping drug between
various countries within the EU and the globe
• Assess whether it makes sense to utilize regional
distribution centers vs. depots
• · Determine whether to destroy drug product
directly at the clinical site vs. ship back to depots/
distribution centers
• Leverage IRT to streamline the drug returns
process
Speaker TBA
2:30 Best Practices for an Inspection-Ready IRT —
True Audit Trail vs. Data History
A true audit trail of IRT data would lead to unblinding
of the trial, so what are best practices for the industry
in regards to an inspection-ready IRT? This session
navigates the complexities of ensuring an inspection-
ready IRT and addresses the key question of providing
a full audit trail vs. a data history.
• Analyze common IRT findings by EMA/MHRA/FDA
inspectors
• Evaluate the necessity of full audit trail within IRT
vs. other clinical systems and resulting challenges
• Discuss the importance of maintaining a full data
history and how to leverage IRT and reporting
capabilities to do so
• Create audit reports that are in readable format
and can be pulled/read in real-time
• Develop best practices for effectively preparing
for inspections
Zsolt Gaspar,
IRT SME,
AbbVie
2:45 QA Panel with IRT Thought Leaders
3:30 Close of Conference 9
CASE
STUDY

10. SPONSORS EXHIBITORS
MEDIA PARTNERS
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MyTrials® eClinical platform, is a service for managing real-time enrollment, randomization,
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flexible and scalable to meet the varied demands of study timelines and complexity of different
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primary IWR interface and IVR back-up are delivered and supported by an expert team.
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transparency to meet the challenges of today’s increasingly complex, sensitive and competitive
clinical and regulatory environment. Working for industry leaders worldwide, we harness
information to help clients effectively plan and manage clinical trials on time and within budget.
EDUCATIONAL SPONSORS
ACCESS SPONSOR
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate
the development of drugs and devices that save lives and improve quality of life. We do this by
delivering best in class information, solutions and performance, with an unyielding focus on quality
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global network of offices in 37 countries. We focus our innovation on the factors that are critical to
our clients — reducing time to market, reducing cost and increasing quality — and our global team
of experts has unparalleled experience in a broad range of therapeutic areas.
SUPPORTING SPONSORS
A Great Place to Meet Your Market!
Take advantage of the best opportunity to meet potential clients face-to-face. Build relationships while
demonstrating thought leadership and sharing expertise. For more information on how to position your company
as a sponsor or exhibitor, contact Robert Boucini at 339-298-2150 or email robert.boucini@cbinet.com.
W W W. C B I N E T. C O M / I R T10
GOLD SPONSOR
Backed by the resources of a Global 500 company, Oracle Health Sciences provides you with the
industry’s most comprehensive set of software solutions addressing every aspect of the health
sciences value chain from discovery and clinical development through submission and clinical care.
With thousands of professionals in offices throughout North America, EMEA and Asia, Oracle Health
Sciences offers unmatched resources to enable your organization’s goals today and in the future.

11. VENUE
Hilton Philadelphia at Penn’s Landing
201 S. Columbus Boulevard
Philadelphia, PA 19106
Phone Reservations: (800) 445-8667
Hotel Direct Line: (215) 521-6500
SUBSTITUTION CANCELLATION
Your registration may be transferred to
a member of your organization up to
24 hours in advance of the conference.
All cancellations received in writing
on or before 14 days prior to the start
date of the event will be refunded,
less a $399 administrative charge. No
refunds will be made after this date;
however, the registration fee less the
$399 administrative charge can be
credited to another CBI conference if
you register within 30 days from the
date of this conference to an alternative
CBI conference scheduled within the
next six months. In case of conference
cancellation, CBI’s liability is limited to
refund of the conference registration
fee only. Cancellation of a conference
due to events beyond our control*
are subject to a $399 administrative
charge should you or a colleague be
unable to attend the rescheduled date.
CBI reserves the right to alter this
program without prior notice. Please
Note: Speakers and agenda are subject
to change. In the event of a speaker
cancellation, every effort to find a
suitable replacement will be made.
The opinions of the conference faculty
do not necessarily reflect those of the
companies they represent or CBI.
*Events beyond our control include: severe
weather conditions, natural and man-made
disasters and any other similar events.
ACCOMMODATIONS:
To receive CBI’s special
discounted
hotel rate:
Online: cbinet.com/irt
Phone reservations:
800-445-8667
(Mention CBI’s IRT for
Clinical Trials)
BOOK NOW!
The Hilton Philadelphia at Penn’s
Landing is accepting reservations on
a space and rate availability basis.
Rooms are limited so please book
early. All travel arrangements are
subject to availability.
GROUP RATE:
Looking to bring your team?
Contact Information Services to learn
about potential group savings.
Call 800-817-8601 or email
cbireg@cbinet.com.
* Advantage pricing rates do apply when
applicable. Offer may not be combined with any
other special pricing promotions. Offer may be
used at CBI co-located events.
SATISFACTION GUARANTEED:
CBI stands behind the quality
of its conferences. If you are
not satisfied with the quality of
the conference, a credit will be
awarded towards a comparable
CBI conference of your choice.
Please contact 800-817-8601 for
further information. Advanced
preparation for CBI conferences is
not required.
WEBSITE
cbinet.com/irt
EMAIL
juliet.nelson@cbinet.com
PHONE
800.817.8601
3 EASY WAYS TO REGISTER
1
PC16167
REGISTRATION
W W W. C B I N E T. C O M / I R T
2 3
11
REGISTRATION FEE:
ADVANTAGE PRICING BY 8/19/16
Conference + Bio/Pharma-Only
Working Group $2,099
Conference Only $1,799
*Please note the bio/pharma only working group takes place
a day prior to the main conference – October 24. Attendees
who register for the working group must be employed by
a biotech or pharmaceutical company at the time of the
conference. Final approval is at the discretion of CBI.
STANDARD PRICING AFTER 8/19/16
Conference + Bio/Pharma-Only
Working Group $2,399
Conference Only $2,099
ONSITE PRICING
Conference + Bio/Pharma-Only
Working Group $2,499
Conference Only $2,199
CHOOSE BETWEEN
Breakouts 1 2 3
Fee includes continental breakfast, lunch,
wine and cheese reception, refreshments
and conference documentation. Credit Card
(Visa, MC, AMEX) or checks accepted.
Please make checks (in U.S. funds drawn on
a U.S. bank) payable to: CBI. (No personal
checks accepted.) PLEASE NOTE: All
advertised discounts are taken from the full,
Standard Rate.
PLEASE NOTE: All advertised discounts are
taken from the final, Standard Rate.
Best
Value!

12. R E G I S T E R A T W W W . C B I N E T . C O M / I R T • 8 0 0 - 8 1 7 - 8 6 0 1
CBI
70 Blanchard Road
Burlington, MA 01803A division of
UBM Americas
IRTINTERACTIVE RESPONSE TECHNOLOGIES IN CLINICAL TRIALS
OCTOBER 25-26, 2016 | HILTON PHILADELPHIA AT PENN’S LANDING | PHILADELPHIA, PA
6TH ANNUAL
Leverage Next Generation Systems and Operational Best Practices to
Enable Supply Chain Agility and End-to-End Drug Accountability
2016
REGISTERATWWW.CBINET.COM/IRT•800-817-8601
Adivisionof
UBMAmericas
IRTINTERACTIVERESPONSETECHNOLOGIESINCLINICALTRIALS
OCTOBER25-26,2016|HILTONPHILADELPHIAATPENN’SLANDING|PHILADELPHIA,PA
6THANNUAL
LeverageNextGenerationSystemsandOperationalBestPracticesto
EnableSupplyChainAgilityandEnd-to-EndDrugAccountability
2016
PROGRESSIVEINSIGHTSFROMINDUSTRY’SLEADINGIRTEXPERTS:
REGISTERBYAUGUST19,2016ANDSAVE$300!
ZSOLTGASPAR,
IRTSME,
AbbVie
CATHERINEHALL,
AssociateDirector,
ClinicalTrialMaterial
Management,Sunovion
RITAHERMAN,
AssociateDirector,Clinical
DataManagement,IVRS,
Merck
GREGHOTTELL,
ActingSeniorDirector,Global
SupplyChainManagement,
GlaxoSmithKline
JACKIEKENT,
SeniorDirector,Product
DeliverySupplyPlanning
andSystems,EliLilly
JASONMcCOY,M.S.,
GlobalRandomizationand
BlindingHead,Biostatistics
SeniorManager,Amgen(Invited)
DOUGMEYER,
AssociateDirector,
ClinicalDrugSupply,
Biogen
CRAIGMOONEY,
Director,IRT,
Bristol-MyersSquibb
MICHAELMOORMAN,
ExecutiveDirector,Global
ClinicalSupplySystems
andSupport,PfizerInc
KIRANPAVULURI,
AssociateDirector,
PDITOperations,
Bristol-MyersSquibb
HEIDIPFEFFERKORN,
DevelopmentQuality–TRD
QA,IntegratedRelease
Platform(iRelease),Novartis
PharmaceuticalsCorporation
KERRIYUSZKUS,
SeniorClinical
BusinessAnalyst,
VertexPharmaceuticals
IRTstrategyalignmentwithsupply
chainanalyticsinitiatives
IRTstandardsorganizationbased
onfunctionality,reports,alerts
andprocesses
ImpactoftherejectionofSafeHarbor
PrincipleontheIRT
Bestpracticesforvendorevaluation,
selectionandonboarding
ImprovedmonitoringofIRTvendor
implementedrandomizationanddosing
systemstoreducemedicationerrors
Changeordermitigationfor
end-of-lifestudies
OpportunitiesforleveragingIRTto
automatecoldchainmonitoring
IRTintegrationwitheCOAto
managepatientdosecompliance
Currentchallengesforsiteswith
arrivals,dispensingandreturnstasks
toimproveuser-experience
CommonfindingsbyEMA/MHRA/FDA
inspectors
Necessityofafullaudittrailwithin
IRTvs.otherclinicalsystemsand
resultingchallenges
Andsomuchmore!
PracticalIndustryCaseStudiesandInteractiveDiscussionsAddressing:
NEWFOR2016!
Bio/Pharma-Only
WorkingGroup
October24th
—
Benchmarkingto
CreateIndustryBest
PracticesWhitepaper
ANY QUESTIONS OR TO REGISTER
CONTACT: Juliet Nelson
phone 339-298-2140
email juliet.nelson@cbinet.com
EDUCATIONALSPONSORS:2016ACCESSSPONSOR:GOLDSPONSOR: