1. REGISTER AT WWW.CBINET.COM/IRT • 800-817-8601
R E G I S T E R BY A U G U S T 2 1 , 2 0 1 5 A N D S AV E U P TO $ 4 0 0 !
The Industry Leading IRT Community Event Driving Clinical Operations and Supply Chain Excellence
IRTINTERACTIVE RESPONSE TECHNOLOGIES IN CLINICAL TRIALS
5TH ANNUAL
2015
OCTOBER 26-27, 2015 | HILTON PHILADELPHIA AT PENN’S LANDING | PHILADELPHIA, PA
Practical Industry Case Studies and Interactive Discussions Addressing:
Innovative ways to streamline management
of controlled substances
Industry’s movement of IRT to web and
smartphone-based interfaces
Integration and migration of GSK’S IRT
to NOVARTIS
GENENTECH’S creation of a dashboard to
manage patient enrollment and site activity
using IRT data
CSL BEHRING’S utilization of Pre-UAT
instead of the traditional UAT process
GRÜENTHAL’S integration of temperature
system with IRT to mitigate temperature
excursion challenges
ASTELLAS’ roadmap to IRT forecasting
and supply demand planning
Panels on electronic drug accountability,
potential bias and unblinding
Media Partners:Educational Sponsors:
CBI, a division of
UBM Life Sciences
NEW THIS YEAR!
IRT End-Customer Weighs in on Usability
and Impact on Study Conduct
Fabian Sandoval, M.D.,
CEO & Medical Director,
Emerson Clinical Research Institute, LLC
TRANSCELERATE ADDRESS:
Impact of TransCelerate e-Label
Initiative on IRT
Terry Walsh,
Head Comparator Strategy and Planning,
TransCelerate Supply Chain Director,
GlaxoSmithKline
Imran Shakur,
IRT Expert, Deputy Head,
Boehringer Ingelheim
Bryan Clayton,
Director, Product Strategy and Innovation,
YPrime
DISTINGUISHED CONFERENCE CO-CHAIRS:
IRT Strategy Development —
Best Practices for Governance,
Oversight and Outsourcing Models
IRT System Integration,
Migration and
Data Stewardship
Choose from Two
Pre-Conference
Workshops
A B

2. Conference Sponsors:
PREVIOUS ATTENDEE ACCLAIM:
“This is the best forum in the pharmaceutical industry
for exchanging solutions — sponsor to sponsor.”
– Manager, Clinical Data Management, Allergan
“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
“It’s great to have an IRT-specific conference where
vendors and sponsors can discuss and look for solutions
that can further enhance the IRT experience.”
– Senior Trial Account Manager, Novartis
“Extremely informative and very educational.”
– Manager, Manufacturing Operations and Supply Chain,
InterMune
“This is one of the few IRT focused conferences where
you can get discussions of rapidly growing IRT technology,
use and competitive market landscape.”
– Director, CTM Management, Sunovion Pharmaceuticals
“With constantly changing regulations and advances
in technology, the IRT conference is vital to me and my
business unit to stay current.”
– Supply Chain Systems Manager, GlaxoSmithKline
REGISTER AT WWW.CBINET.COM/IRT • 800-817-8601
Who Should Attend:
You will benefit from attending this
event if you are from a bio/pharmaceutical
company and have responsibilities or
involvement in the following areas:
• IRT/IVR/IWR Systems
• Clinical Business Systems/Architecture
• Clinical Supplies
• Supply Chain Management
• Clinical Operations
• Clinical Data Management
• Clinical IT
• External Partnerships
• Vendor Management
• Biostatistics
• Clinical Trials Materials
• Shipping & Distribution
• Randomization
• Drug Safety
• Clinical Trial Management
This conference will also benefit consultants,
technology vendors and companies providing
services to the above audience.
IRT 2015, CBI’s Interactive Response Technologies in Clinical Trials Forum,
is the industry’s first and only meeting dedicated to uniting clinical operations, supply
chain and clinical systems professionals charged with utilizing the IRT to optimize clinical
supply chain management. See why this industry acclaimed meeting is the must attend
event of the year for the IRT community.
ClinPhone® RTSM (Randomization and Trial Supply
Management, part of the Perceptive MyTrials®
eClinical platform, is a service for managing
real-time enrollment, randomization, treatment
allocations, dosing and managing clinical supplies. ClinPhone RTSM services are agile, flexible
and scalable to meet the varied demands of study timelines and complexity of different
development phases, study types and geographical regions. Our systems, which provide a
primary IWR interface and IVR back-up are delivered and supported by an expert team.
EDUCATIONAL SPONSORS:
Innovative and collaborative software solutions
from YPrime are bringing a new level of
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.
ADDITIONAL 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.

3. Workshop Objective:
IRT systems play an integral role in clinical
trials and there is no ‘one-size-fits-all’ model.
It is critical to build the IRT right upfront since
costly amendments can add up during the
trial. In doing so, there are so many moving
parts involved from protocol development/
review from data management to clinical
operations to statistics and clinical supply
making it hard to determine the roadmap to
success.This workshop provides best practices
for IRT strategy development from internal
governance structure and resource allocation
to outsourcing models and vendor oversight.
Key Questions to Be Addressed:
• Where do you begin developing an IRT
strategy? What are best practices for
organizational structure?
• What role should clinical operations, supply,
data management and statistics play?
• Configurability vs. customization —
What are the pros/cons of each approach?
• How important is vendor oversight in IRT?
• How do you determine the most appropriate
modality of IRT for your
study — IVR/IWR/IMR?
Workshop Outline:
I. Key Considerations for IRT
Strategy Development
• Configurability vs. customization —
Insights into various approaches
• IVR, IWR and IMR — What modality is
appropriate for your trial?
* security/infrastructure
II. Internal Governance Structure
and Resource Allocation
• Determine the role of clinical operations,
supply, data management and statistics
• Assess the need/feasibility of a dedicated IRT
systems group
• Examine level of standardization
required in the IRT across studies
• Resource allocation and system support
III. Outsourcing Trends and
Challenges in IRT — IF and HOW
Various Models Matter
• Should you competitively bid all work
or establish strategic relationships?
• Pros and cons of sourcing models
• Does governance and oversight
matter in IRT?
• Key factors involved in relationships
with IRT vendors
Workshop Leader:
Laurin Vincent,
GlobalCategoryManager—IxRS&ePRO,
ExternalAlliance&CategoryManagement|GPPS,
Genentech, A Member
of the Roche Group
Dawn Sorenson,
SeniorManager,GSODataManagement|ETO,
Amgen
DAY ONE MONDAY, OCTOBER 26, 2015
7:30 Workshop Registration and Continental Breakfast
REGISTER AT WWW.CBINET.COM/IRT • 800-817-8601
There will be a 30-minute networking and refreshment break at 10:00a.m.
IRT Strategy Development — Best Practices for
Governance, Oversight and Outsourcing Models
12:00 Close of Workshop A
W
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H
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8:30 Choose from Two Pre-Conference Workshops

4. There will be a 30-minute networking and refreshment break at 10:00a.m.
Workshop Objective:
IRTs are very powerful systems. In addition to
enabling clinical trial designs that would not
be possible otherwise, these systems hold
immense amounts of data vital to the success
of these trials. Integrating IRT with other clinical
and supply systems is important to allow
real-time access to information for making
critical decisions. Challenges also arise when
IRT systems are migrated from legacy systems
or due to an M&A. Care needs to be taken to
avoid duplicate data entry, ensure timely data
transfers and quality data to maintain the
integrity of the trial. This workshop provides
best practices for IRT data stewardship from
system integration and migration.
Key Questions to Be Addressed:
• What system integrations are critical?
What are the benefits and pitfalls of
various integrations?
• What are best practices when migrating from
one IRT system to another?
• What are solutions to common data quality
challenges from integrations?
• When is manual data entry and data transfer
a better solution? If at all?
Workshop Outline:
I. Data Stewardship — Ensuring IRT
Data Quality and Visibility
• Data quality challenges and
potential solutions
• In-depth look at inputs and outputs
of the IRT
• Examine internal and external data feeds
II. IRT System Integration —
Avoiding Data Reconciliation
and Improving Data Visibility
• CTMS and IRT system integration
and benefits
• EDC and IRT integration and benefits
• Integrating inventory management systems
with IRT
• Imaging/lab data to IRT
• Integrating other eClinical system
(ePRO, QA/compliance, etc.)
• Integrated reporting and decision making
III. CASE STUDY
Integration and Migration
of GSK’s IRT to Novartis
Workshop Leaders:
Cindie Kazmer,
ProgramDirector,
eClinicalDataServices,
PAREXEL
Deanna Sanders,
GlobalHead,ClinAdminCoE,
GlobalOperationsServices,
Novartis
Adrian Hsing,
SeniorDirector,HeadDataManagement,
Transition Therapeutics Inc.
REGISTER AT WWW.CBINET.COM/IRT • 800-817-8601
12:00 Close of Workshop B
IRT System Integration, Migration and
Data Stewardship
W
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K
S
H
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B
8:30 Choose from Two Pre-Conference Workshops
DAY ONE MONDAY, OCTOBER 26, 2015
7:30 Workshop Registration and Continental Breakfast

5. 12:00 Main Conference Registration
1:00 Conference Co-Chairs’
Welcome and Opening Remarks
Imran Shakur,IRTExpert,DeputyHead,
Boehringer Ingelheim
Bryan Clayton, Director,ProductStrategyandInnovation,
YPrime
Optimize IRT for Clinical and
Supply Chain Excellence
1:00 OPENING INTERACTIVE Q&A
IRT End-Customer Weighs in
on Usability and Impact on
Study Conduct
Since the IRT plays such a major role in helping sites
manage global clinical supplies, attention should
be paid on the usage and impact of IRT at the site
level. What are the perceptions of sites regarding the
IRT? What areas can be improved and be viewed as
opportunities to progress study conduct? This Q&A
session provides attendees the opportunity to ask
a site questions regarding the usability of different
IRT systems/platforms, pinpointing challenges and
offering insight into opportunities and solutions.
Questions addressed include:
• IVR, IWR and IMR — What is preferred?
• How can communication be improved to help sites
accommodate supply shipments and returns more
effectively and efficiently?
• What are barriers to usability and adoption
of IRT systems?
• What level and type of training do sites need?
Fabian Sandoval, M.D.,
CEO&MedicalDirector,
Emerson Clinical Research Institute, LLC
1:40 IMR — The Movement of IRT to Web
and Smartphone-Based Interfaces
Many sponsor companies no longer utilize the
interactive voice response (IVR) interface for their
site investigators to manage subject treatment
assignments, randomization and investigational
medical product (IMP) dispensation for their clinical
studies in various therapeutic areas. Instead, many
biotech and pharma companies have streamlined
their efforts across different technology vendors
who host clinical trial systems that require sites and
patients to interact daily with their systems. With
increasing frequency, web- and smartphone-based
interfaces are also being rolled out for studies to
address a multitude of challenges.
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 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 the study medication
Cecilia Tran-Muchowski,
SeniorClinicalProgramManager,ClinicalOperations-HIV,
Gilead Sciences, Inc.
Yet Mui, Director,ProductManagement,ProductInnovation,
Bracket
2:20 TRANSCELERATE ADDRESS
Impact of TransCelerate
e-Label Initiative on IRT
The time is right for pharma companies to embrace
e-labeling as a critical component to their clinical
supply chain strategy. This initiative works to enhance
label utility for patients, provide more consistent
labeling approaches for sites and offers the potential
to reduce clinical labeling timelines and increase
efficiency. Also, this is one of the first steps to enable
the future of digital patient centric supply chain. The
initiative, in collaboration with regulatory agencies,
will develop guidance to facilitate implementation of
e-Labeling. This address discusses:
• An overview of the initiative
• The potential to leverage mobile devices to
display the label
• Progress to date
• Insight into the critical tie-in to IRT systems
and what lies ahead
Terry Walsh, HeadComparatorStrategyandPlanning,
TransCelerateSupplyChainDirector,GlaxoSmithKline
3:00 Networking and Refreshment Break
3:30 Big Data Analytics —
Leveraging IRT as a Powerful Tool
to Inform Trial Decisions
This case study discusses Genentech’s story on
how they went about creating a business changing
application to better manage patient enrollment and
site activity using IRT data.
• Aggregate data from multiple clinical databases
• Quest to find the true source of data
in a timely fashion
REGISTER AT WWW.CBINET.COM/IRT • 800-817-8601
CASE
STUDY

6. • Building a direct feed of IxRS data into a
centralized warehouse
• Transforming data into a dashboard
view of site enrollment and activity
Linda Chan, SeniorManager,SystemsOperations,
Genentech
4:10 Proper Implementation of an
IRT Template
Aspects of IRT design are customized to match
sponsor-specific requirements (operational workflow,
integrations, nomenclature, report format, etc.).
Ideally, the IRT template contains as much sponsor-
specific functionality as possible for re-use from
one study to another. This metrics-based case study
provides best practices and compelling outcomes to
consider for the IRT industry to achieve:
• Pristine quality
• Accelerated study start-up
• Continuous template improvement
• Repeatable delivery process
• Time spent on deep customizations to support
complex trial designs, not ‘the easy stuff’
Christine Oliver,VicePresident,Operations, Endpoint
4:50 How to Apply IRT to Adaptive Trial
Designs — An Interactive Case Study
Adaptive trial designs are becoming more common
in the pursuit of more agility and lower cost in
clinical trials. But how are these best accommodated
within IRT systems? During this interactive session,
the presenters explain how to best accommodate
adaptive trial designs within IRT systems and examine
the specific challenges created by these types of trial
designs to maximize the benefits of an IRT system. The
session includes:
• A brief overview of adaptive design trials —
What do we mean, how and when is this type of
design being used?
• Design considerations — Important factors to
consider for supplies and IRT when designing
adaptive trials
• Practical application for IRT and supplies
management — An interactive approach to
discussing the specific challenges which these
type of trials represent and how to overcome
those challenges
Sy Pretorius,M.D.,M.S.,M.B.A.,ChiefScientificOfficer,
PAREXEL
Richard Roberts,SeniorStatisticalDesignandTrialSupplies
Consultant,PAREXEL
5:30 Close of Day One
Networking, Wine and Cheese Reception
immediately following the final session on day one
DAY TWO
TUESDAY, OCTOBER 27, 2015
7:30 Continental Breakfast
8:00 Conference Co-Chairs’ Review of Day One
Imran Shakur, IRTExpert,DeputyHead,
Boehringer Ingelheim
Bryan Clayton, Director,ProductStrategyandInnovation,
YPrime
8:15 To Be or Not to Be — Pre-UAT?
When going through the traditional UAT process,
there is always a chance you will find something
that needs to be reworked, even after spending so
much time with a vendor making sure the system
specifications are accurate, the vendor understands
the protocol and you are on the same page on how
the system performs. What if you could avoid that
process by going through Pre-UAT? This case study
highlights CSL Behring’s use of Pre-UAT and addresses
the following questions:
• UAT vs. Pre-UAT — What is the difference?
• When would you do a Pre-UAT?
• Why do a Pre-UAT — What does it accomplish?
• What about my timelines?!
• Who performs the Pre-UAT —
Do I have to write more scripts?
• How do I get buy in from key stakeholders
to do a Pre-UAT?
• What happens if I don’t do a Pre-UAT?
Erinn Rohan Kober, eClinicalManager,CSL Behring
9:00 Best Practices for an FDA
Inspection-Ready IRT for Biologics
What does the Biologics License Application process
have to do with your IRT provider? As the bio/pharma
landscape continues to shift emphasis towards large
molecule compounds, a unique set of regulatory
challenges are emerging – including increased focus
on IRT processes and providers. This session discusses
the challenges and must-knows for trial sponsors to
consider when planning for biologic programs.
• Key focus area for FDA
* contract between sponsor and vendor
* requirements
* control of data — rand and medication
assignment (including titration or dosing)
* identification and alerting of anomalies
* CAPA and incident reporting
REGISTER AT WWW.CBINET.COM/IRT • 800-817-8601
CASE
STUDY
CASE
STUDY
CASE
STUDY

7. • Temperature excursion monitoring —
The FDA’s interest in the overall supply
management effectiveness
• Integrations with other systems, error handling and
timely imports
• CAPA and incident reporting processes are of
particular interest
• 21CFR Part 11, change control over data —
Demonstrating to the FDA that solid controls
are in place to protect key data points
Val Higgins, EVPofOperations,
Almac Clinical Technologies
9:45 Networking and Refreshment Break
Mitigate Supply Chain Challenges
through Effective IRT Management
10:15 Optimizing Scheduled Drug
Management via IRT
Scheduled drug management is just one of the latest
features to be introduced into the IRT marketplace.
This session highlights some of the innovative ways
clinical supply teams, distribution vendors and IRT
providers are partnering to streamline management
of controlled substances.
• Manage DEA form 222
• Manage end-to-end chain of custody
• Integrate with distribution vendors
Vincent Puglia,DirectorPMO,YPrime
11:00 Build Electronic Drug
Accountability into the IRT
• Discuss industry uptake of electronic
drug accountability
* who are the pioneers?
* what is the hesitation?
• Ensure traceability of every kit through
the complete lifecycle
• Successfully transfer from paper to
electronic processes
• Assess impact on patient compliance
• Gain insight into successes and lessons learned
Craig Mooney, Director,IRT, Bristol-Myers Squibb
SpeakerTBA,Quintiles
SpeakerTBA,Cenduit
11:45 Oops… Preventing Accidental
Unblinding or Bias in Clinical
Supply and the IRT
Maintaining the study blind is one of the critical
components of the clinical supply strategy, the setup
and operation of the IRT and the packaging and
labeling of an investigational agent in a clinical trial.
The study blind is at the heart of the scientific process
and validity of a study and something FDA and other
regulators watch carefully. When study coordinators
and other actors in the study manage the blinded
drug, there may arise instances where the blinding
may be compromised without explicit intent. This
could happen in the shipping, assignment and return
of study material. This session identifies some of
these instances, discusses methods of prevention of
unblinding and introduction of possible bias, followed
by opportunity for questions, comments
and discussion.
Steve Zimmerman, FounderandDirectorofSystems
Development,Veracity Logic
12:30 Networking Luncheon
1:45 Utilize the IRT for Advanced
Clinical Supply Forecasting
This session features a succinct, innovative
presentation offering insight into Astellas’
development of a forecasting tool integrated
with their IRT solution.
• Overview of current CTM forecasting
challenges and need for a new tool
• End-goal, the ability to pull back live study data into
a forecasting tool to reforecast supplies
• Roadmap to implementation in first study
• Lessons learned to date
Matthew Sargent, Manager,CTMOperations,
SystemsandProcessExcellence,Astellas
2:30 Temperature Excursion — Integration
of Temperature System with IRT
Although most supplies are delivered and stored
properly upon receipt, temperature excursions can
still occur. By the time CRAs become aware of these
issues, there may be false out-of-spec uploads. Ideally,
due to the unavailability of temperature data, supplies
should be considered out-of-spec and not given to
subjects. However, since the receipt of supplies has
been recorded in the IRT, sites begin to enroll subjects
and assign supplies. This case study highlights the
integration of a ‘temperature system’ with IRT to
prevent assigning supplies to subjects in cases where
there is no temperature data.
• Overview of the receipt process of temperature
monitored clinical supplies at sites
• Examine common challenges to handling
temperature excursions
• Analyze IRT and temperature system integration
• Assess potential solutions
Henk Dieteren, ClinicalSupplyLogisticsExpert,Development,
Grünenthal Innovation
3:15 Close of Conference
REGISTER AT WWW.CBINET.COM/IRT • 800-817-8601
PANEL
CASE
STUDY

8. WEB
www.cbinet.com/irt
EMAIL
cbireg@cbinet.com
PHONE
800-817-8601
339-298-2100 outside the U.S.
LIVE CHAT
www.cbinet.com/irt
WAYS TO REGISTER NOW!
SCAN HERE
CBI
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Burlington, MA 01803
CBI, a division of
UBM Life Sciences
IRT2015 PC15167
R E G I S T E R BY A U G U S T 2 1 , 2 0 1 5 A N D S AV E U P TO $ 4 0 0 !
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
ACCOMMODATIONS:
To receive CBI’s special discounted hotel rate online or by phone, please go to:
• Online: www.cbinet.com/irt
• Phone reservations: 800-445-8667 and mention CBI’s IRT 2015
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 subject to availability.
PLEASE NOTE: All hotel reservations for this conference should be booked directly
with the hotel. CBI does not use Housing Bureaus and none are authorized to call
on our behalf.
REGISTRATION FEE:
ADVANTAGE PRICING STANDARD ONSITE
Conference + Workshop $1799 $2199 $2299
Conference Only $1699 $1999 $2099
Register by August 21, 2015 and SAVE up to $400. Fee includes continental
breakfast, lunch, wine and cheese reception, refreshments and conference documentation. 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.
TEAM DISCOUNT:
For every three paying registrations from your company, you will receive a fourth complimentary*
registration to the conference (must register four at same time to qualify). To receive the team discount
you must register with our customer service department by calling 339-298-2100.
* 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.
SUBSTITUTION AND CANCELLATION:
Your registration may be transferred to a member of your organization up to 24 hours in advance of the
conference. 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. 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 without notice. The opinions of the conference faculty do
not necessarily reflect those of the companies they represent or CBI.
R E G I S T E R AT W W W.C B I N E T.CO M / I R T • 8 0 0 - 8 1 7- 8 6 0 1
The Industry Leading IRT Community Event Driving Clinical Operations and Supply Chain Excellence
IRTINTERACTIVE RESPONSE TECHNOLOGIES IN CLINICAL TRIALS
5TH ANNUAL
2015
OCTOBER 26-27, 2015 | HILTON PHILADELPHIA AT PENN’S LANDING | PHILADELPHIA, PA
ANY QUESTIONS OR TO REGISTER
CALL Juliet Nelson 339-298-2140
or FAX TO MY ATTENTION 781-939-2696
email: juliet.nelson@cbinet.com