REGISTER AT WWW.CBINET.COM/IMAGINGCT 800-817-8601

A division ofUBM Americas

IMAGING INCLINICAL TRIALS Strategic Solutions to Optimize Clinical Trialswith Imaging Endpoints

MARCH 28-29, 2018 • COURTYARD PHILADELPHIA DOWNTOWN • PHILADELPHIA, PA

Media Partners:

REGISTER BY 2/2/18 AND SAVE UP TO

$300!

Incorporate Imaging Endpoints into Clinical Trial Protocol Planning

Learn to Standardize Imaging Data in Clinical Trials

Streamline Operational Challenges

Overcome the Digital Bottlenecks to Clinical Trial Data Capture and Image Transfer

Optimize Your Imaging Budget and Maximize Value

Explore the Future of Imaging in Clinical Trials

DISCUSS INDUSTRY HOT TOPICS:

Jacob Agris, Director, Medical and Clinical Affairs, MCA Lead Informatics and AI,

Bayer

Andrea Baioni R.T (ARRT)(CV), Principal Clinical

Medical Imaging Specialist, Medtronic Spine and

Biologics

Richard Baumgartner, Senior Principal

Scientist of Biostatistics, Merck

Colin Scott, Former Global Clinical Leader,

Bayer Healthcare

David Holmes, Ph.D., Biomedical Imaging

Resource Core Facility, Mayo Clinic College

of Medicine

Richard Patt, Co-Founder & Principal,

RadMD

Julia Publicover, Program Manager – QIPCM Imaging

Core Lab, Techna Institute at the University Health Network

Todd Joron, President & Chief Operating Officer, Intrinsic Imaging

DISTINGUISHED FACULTY:

Imaging can make or break a trial by representing the efficacy of a drug or a medical device. Join us for CBI’s Imaging in Clinical Trials — a two-day program that aims to explore current challenges, advancements and the opportunities that imaging data presents in clinical trials.

CBI is bringing together leaders from pharma, biotech, CROs and vendors to share insights on imaging best practices and methodologies utilizing new technologies. Attendees will walk away with strategies they can apply to more effectively aggregate, analyze and leverage imaging data to enhance pre-clinical research and clinical trials.

WHO SHOULD ATTEND:

Senior-level professionals and their teams from the bio/pharma industry with responsibilities or involvement in the following areas:

This conference will also benefit imaging consultants, technology vendors and companies providing services to the above audience.

Clinical Imaging

Clinical Operations

Clinical Research

Therapeutic Area Heads

Translational Medicine

Data Management Statistics Medical Affairs QA/QC

REGISTER AT WWW.CBINET.COM/IMAGINGCT 800-817-8601

Biomarker Development

DAY ONE WEDNESDAY, MARCH 28, 2018 8:00 Registration & Continental Breakfast

9:00 Chairman’s Welcome & Opening RemarksJacob Agris, Director, Medical and Clinical Affairs, MCA Lead Informatics and AI, Bayer

Incorporate Imaging Endpoints into Protocol Planning and Design

9:15 Devise Strategies to Increase Reliability and Reproducibility of Pre-Clinical and Early Development Clinical Trials• Review early development studies with imaging

components to inform clinical trial design

• Understand factors that can impact repeatability and reproducibility of collected data on an example of Positron Emission Tomography (PET) receptor occupancy studies

• Explore statistical methods and solutions to inform stakeholders on repeatability and reproducibility of trial data and provide insights for their improvement

Richard Baumgartner, Senior Principal Scientist of Biostatistics, Merck

10:00 Understand the Challenges Facing Niche Imaging Applications • Learn how imaging endpoints can be better

utilized for pulmonary clinical trials

• Examine atypical use of imaging to assess clinical trial progression

• Uncover how emerging technologies can be utilized to increase image fidelity and reduce clinical trial cost

• Learn how to craft protocols for new imaging applications

Colin Scott, Former Global Clinical Leader, Bayer Healthcare

10:45 Networking and Refreshment Break

11:15 Learn How to Standardize Imaging Data in Clinical Trials• Understand how data quality affects clinical trial

results and how image standardization can help

• Learn the obstacles that stand in the way of imaging standardization

• Develop standardized imaging protocols to allow for universal use of imaging data across multi-site trials

• Develop quality control measures to ensure image standardization and reduce sources of error, such as phantom measurements

• Explore standardization in image review and analysis techniques Julia Publicover, Program Manager, QIPCM Imaging Core Lab, Techna Institute at the University Health Network

12:00 Understand FDA Guidance and Expectations for Clinical Trial Imaging Endpoints • Learn how EU regulation of gadolinium will

impact ongoing clinical trials• Understand possible future FDA action and its

impact on widely used biomarkers• Benchmark industry best practices to

standardize FDA regulatory submissions

12:45 Networking Luncheon

2:00 Learn How Clinical Trial Protocols Impact Downstream Processes and Affect Data Capture and Integrity • Understand the unique workflow issues of a 3D

lab when performing on-site clinical trial reads

• Learn to properly integrate tumor response assessments in clinical trials using imaging endpoints

• Review the financial challenges of on-site clinical reads and learn strategies to mitigate risk

Hans-Christoph Becker, Professor of Radiology, The Stanford University Medical Center Shannon Walters, Executive Manager, The Stanford University Medical Center

Explore the Future of Imaging Clinical Trials

2:45 Explore the Promise of Artificial Intelligence and Understand its Effect on Clinical Trials• Understand how AI is being assessed in today’s

clinical trials

• Explore the challenges faced when designing effective AI clinical trials to achieve FDA clearance

• Learn how AI will augment intelligence and will enhance accuracy rather than replace readers

Todd Joron, President & Chief Operating Officer, Intrinsic Imaging

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SPOTLIGHT ON AI

3:30 Networking and Refreshment Break

4:00 Future Focus — Imaging in Clinical Trials in 2020 • Learn how clinical trials with imaging endpoints

will change in the future and how to begin preparing for instructional change

• Understand how emerging technologies will impact clinical trial design

• Learn to build a flexible infrastructure that will compliment change rather than impede progress

David Holmes, Ph.D., Biomedical Imaging Resource Core Facility, Mayo Clinic College of Medicine

4:45 Close of Day One

NETWORKING, WINE AND CHEESE RECEPTION

immediately following the final session on day one

DAY TWO THURSDAY, MARCH 29, 20188:00 Continental Breakfast

8:30 Chairman’s Review of Day OneJacob Agris, Director, Medical and Clinical Affairs, MCA Lead Informatics and AI, Bayer

Streamline Operational Challenges Using Technology Solutions

8:45 Overcome the Digital Bottlenecks to Clinical Trial Data Capture and Image Transfer• Learn to create effective SOPs for

imaging processes by developing standardized processes

• Understand how the imaging community can integrate digital data protocols to facilitate information exchange and increase data security

• Automate your medical image data review process from manual processes to efficient automated processes to reduce read data discrepancies and reduce review time

Andrea Baioni R.T (ARRT)(CV), Principal Clinical Medical Imaging Specialist, Medtronic Spine and Biologics

9:30 An Examination of Changes in Systems, Software and Services for Clinal Trials • Explore the impact on time, cost and

reimbursement in the age of value based medicine

• Understand the strengths and weaknesses of dominant imaging software solutions

• Learn the importance of integrating the imaging software with RIS/EMR

• Examine how Imaging Solutions During Trials can effect reimbursement

Jacob Agris, Director, Medical and Clinical Affairs, MCA Lead Informatics and AI, Bayer

10:15 Networking and Refreshmeant Break

10:45 Technology ShowcaseHear from vendor trailblazers who are applying technology to solve systemic challenges facing the imaging community. Benchmark with peers and participate in rapid-fire technology demonstrations with companies that are using novel solutions to streamline trials, manage data, and innovate in the field of imaging. FACILITATOR Colin Scott, Former Global Clinical Leader, Bayer Healthcare

11:45 Networking Luncheon

Streamline Clinical Trial Administration Through Strong CORE Lab Partnership

12:45 Use Imaging Subject Matter Experts to Develop Proactive Imaging and Operational Strategies to Identify and Control Risks• Learn to address some of the primary challenges

confronting imaging-based trials today — Significant variability among radiological assessments, difficulty in making an accurate choice of imaging criteria to assess response to treatment and cumbersome data workflows

• Use imaging subject experts to jumpstart early operational planning and help optimize trial design

• Understand how technology can reduce reading and reporting errors and help automate workflow

Catherine Klifa, Ph.D., MBA, Scientific Liaison Director, Median Technologies

1:30 Form Strategic Partnerships With CORE Labs to Inform Trial Design • Understand how to choose a CORE Lab

contractor that will serve your future needs• Explore the benefits of standardizing your

protocols by integrating CORE Lab procedures into the design of a new trial

• Ensure contracted CORE Labs are given input into clinical trial protocols during trial design phase

Allen Borowski, RDCS, Lead Imaging Specialist, C5 Research – Cleveland Clinic

2:15 Networking and Refreshment Break

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CASE STUDY

“This is a PHENOMENAL EXPERIENCE to interact

with and listen to best practices of

industry colleagues”

— Principal Scientist, Merck

“Greatly benefitted from this conference’s overall context from data management

to read – VERY INFORMATIVE”

— Radiology Assistant, Stanford University

“CBI assembled a TRUE GROUP OF EXPERTS

that present the material in a way that was easy to

understand and generated great discussion”

— Director, Medical and Clinical Affairs, MCA Lead

Informatics and AI, Bayer

REGISTER AT WWW.CBINET.COM/IMAGINGCT 800-817-8601

2:45 Maximize Your Imaging Budget — Where to Cut Costs and How to Maximize Value • Understand what CORE Lab services you need

based on study type, disease process and patient population

• Learn value-based review of common imaging services — Where is the best “bang for my buck?”

• Identify the risks of imaging in various trials and how to best apply your budget to mitigate these risks

Richard Patt, Co-Founder & Principal, RadMD

3:30 CLOSING CONVERSATION Faculty Think-Tank — The Permanence of ChangeDuring this session, attendees and speakers proactively prepare for the future. Participants present questions to our faculty and the audience to consider, with the goal of providing strategic guidance on pressing challenges and forces of change.MODERATOR: Jacob Agris, Director, Medical and Clinical Affairs, MCA Lead Informatics and AI, Bayer

4:00 Close of Conference

A GREAT PLACE TO MEET YOUR MARKET!Maximize your access to decision-makers and align your brand with the life sciences industry’s premier

thought-leaders and industry innovators. CBI’s custom sponsorship programs are designed to support your organization’s overall business development and marketing initiatives through meaningful prospect and

customer interactions, brand assertion campaigns and content-rich thought-leadership opportunities. Capitalize on the life sciences community’s premier platform for peer-to-peer exchange, solution-driven

content and first-in-class networking opportunities. For more information on how to position your company as a sponsor or exhibitor, contact Steve Sica at 339-298-2281 or email steven.sica@cbinet.com.

CONFERENCE SPONSORS

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EMAILcbireg@cbinet.com

PHONE800-817-8601339-298-2100 outside the U.S.

LIVE CHATwww.cbinet.com/imagingct

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A division ofUBM Americas

IMAGING IN CLINICAL TRIALS PC18328

VENUE: Courtyard Philadelphia Downtown21 North Juniper StreetPhiladelphia, PA 19107Hotel Direct Line: 1-215-496-3200Reservations: 1-800-321-2211 Hotel Direct Line: (215) 561-7500

ACCOMMODATIONS: To receive CBI’s special discounted hotel rate online or by phone, please go to:

• Online: www.cbinet.com/imagingct• Phone reservations: (800) 766-3782 and mention CBI’s Imaging in Clinical Trials

Book Now! The Courtyard Philadelphia Downtown 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 Pharma/Biotech $1999 $2299 $2399 Non-Profit/Academic Research Sites $799 $999 $1099

Register by February 2, 2018 and UP TO $300. Fee includes continental breakfast, lunch, wine and cheese reception, refreshments and conference documentation. Credit Card (Visa, MC, AMEX, Discover) 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.

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.

SUBSTITUTION AND 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.

REGISTER AT WWW.CBINET.COM/IMAGINGCT 800-817-8601

MARCH 28-29, 2018 • COURTYARD PHILADELPHIA DOWNTOWN • PHILADELPHIA, PA

REGISTER BY 2/2/18 AND SAVE UP TO

$300!

ANY QUESTIONS OR TO REGISTER CONTACT:

John Kuchinski phone 339-298-2112 email jkuchinski@cbinet.com

IMAGING INCLINICAL TRIALS Strategic Solutions to Optimize Clinical Trialswith Imaging Endpoints