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Media Partners:
CV and Non-CV Drug Development
Cardiovascular
Safety and Efficacy
The Latest Approaches in the Evaluation of Drugs that Affect Heart Rate,
Blood Pressure, QT Prolongation, and Other CV Safety Related IssuesEvolving Pre-Clinical, Clinical and Imaging Strategies for Optimal CV Monitoring
FEBRUARY 10-11, 2015 • HILTON ALEXANDRIA OLD TOWN • ALEXANDRIA, VA
Are You Prepared for the New Paradigm in Cardiac Safety?
Elite Speaking Faculty From:
AbbVie • Astellas Pharma • AstraZeneca • Celgene • Merck • NIH • Penn Cardiology
Regeneron Pharmaceuticals, Inc • Roche • Takeda • University of Cincinnati College of Medicine
University of Rochester Medical Center
Participate in an exclusive conversation on how to optimize cardiac drug interaction identification with
Thomas Marciniak, Former MedicalTeam Leader, Food & Drug Administration
PLUS!
Distinguished Conference Chairs:
Gary Gintant, Ph.D.,
Research Fellow, Department
Integrative Pharmacology,
Integrated Science andTechnology,
AbbVie
Sherahe Fitzpatrick, M.D.,
Medical Director,
Patient Safety,
AstraZeneca
• Evaluate evolving methods that could
replaceTQT studies
• Discuss the Comprehensive in vitro
Proarrhythmia Assay (CiPA) as it proceeds
towards industry and regulatory acceptance
• Incorporate strategies and approaches for
facilitated rapid-drug development,
approval and competitive post-approval
commercial success
• Take advantage of circulating biomarker
detection to examine compound toxicity
• Examine essential components in conc-QTc
analysis to increase its chances of acceptance
by regulators in lieu of a dedicated study
• Inspect the benefits of utilizing other types of
tests during clinical development

2. 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
Karen Hanover at 339-298-2184 or email karen.hanover@cbinet.com.
“This conference covers a good breadth of topics and has a great mix of pre-clinical
and clinical content. I think this is a good opportunity to challenge the field, bridge
communities and broaden the cardiovascular toxicity conversation.”
– Previous Attendee, GlaxoSmithKline
CBI’s CV and Non-CV Drug Developing Cardiovascular Safety and Efficacy provides a venue to further
the discussion on the varying paradigms for monitoring cardiac safety, including novel technologies,
as well as oncology trials and other therapeutic areas with heightened CV risk.
Join us in February to benchmark with industry counterparts and discuss the future of cardiac safety
and risk assessment, including pre-clinical, clinical and imaging strategies for optimal CV monitoring.
REGISTER AT WWW.CBINET.COM/CARDIACSAFETY • 800-817-8601
WHO SHOULD ATTEND
You will benefit from attending this event if you are a CMO, CSO, Vice President, Medical Director, Executive,
Scientist or Investigator at a biotech, pharmaceutical or medical device company with responsibilities or
involvement in the following areas:
Clinical Development/Operations • Medical Operations • Clinical Pharmacology • Toxicology
Clinical Development • Cardiac Safety (Pre-Clinical and Clinical) • Pharmacovigilance
Translational Research/Medicine • Drug Discovery/FIH Studies Phase I • Biostatistics • Cardiology
Experimental Medicine • Regulatory Affairs • Medical Affairs • Oncology
This conference will also benefit consultants, contract research organizations, technology providers, ECG labs,
service providers, data management companies and industry analysists providing services to the above audience.
CONFERENCE SPONSORS:
• Assessing concentration response
relationships and how they can support
cardiovascular risk assessment
• Hearing early examples where a CiPA
approach would be useful for the “rescue”
of worthy hERG positive candidates
• Discussing challenges in translation of
pre-clinical cardiovascular risk assessment
to clinics
• Understanding how the FDA factors a
qualitative drug interaction into an approval
• Communicating risks identified in pre-clinical
studies to improve drug development and
prevent late stage failures
• Reviewing best approaches to avoid cardiac
and cardiovascular liabilities
• Establishing early endpoints that are
potentially predictive on their own
• Discovering clinical development approaches
and statistical considerations for Type 2
Diabetes outcome trials
Cutting-EdgeTopics Including:

3. DAY ONE Tuesday, February 10, 2015
7:30 Conference Registration and
Continental Breakfast
8:30 Co-Chair’s Welcome and Opening Remarks
SheraheFitzpatrick,M.D.,MedicalDirector,PatientSafety,
AstraZeneca
GaryGintant,Ph.D.,ResearchFellow,DepartmentIntegrative
Pharmacology,IntegratedScienceandTechnology, AbbVie
Examine the Changing
Cardiovascular Regulatory Landscape
8:30 KEYNOTE
The Evolution of TQT Studies —
Should TQT Studies Be Replaced?
• Discuss the benefits and limitations of TQT studies
• Examine various possibilities for cardiovascular
monitoring that could take the place of TQT
studies, including:
* pre-clinical data
* CiPA (non-clinical testing, including:
stem cells, ion channels and in silico)
* concentration QTc analysis of ECGs
from early phase 1 studies
• Discuss types of outside analysis aiding regulators with
cardiovascular safety decisions
• Evaluate evolving methods that could replace TQT
studies, making them obsolete
• Catalog personal experiences with regulatory feedback
on TQT protocols
• Assess concentration response relationships and how
they can support cardiovascular risk assessment
• Consider what standards the FDA is looking
for when submitting dossiers
• Examine what can be utilized with the lack of new
guidance for cardiovascular safety monitoring
JamesKeirns,Ph.D.,VicePresident,
ChiefClinicalPharmacologyScientist,Astellas Pharma
9:25 Further Insight into the IQ-CSRC Prospective
Study to Replace the TQT Study —
How can Early Phase QT Assessment
Become Acceptable for Regulators?
• Examine differences between the IQ-CSRC study
and a standard first-in-human study —
Does this impact the results?
• Discuss whether or not we can do without the positive
control in early clinical phase ECG assessment studies
• Identify how the clinical conduct and the ECG
methodology impact our ability to replace the TQT study
with ECG assessment in early phase clinical studies
BorjeDarpo,M.D.,Ph.D., GlobalMedicalDirector,
iCardiac Technologies, Inc.
10:05 Data Quality in Small QTc Studies
• Discuss the electrocardiographic challenges
linked to the conduct of small clinical studies
such as the first-in-man investigations
• Review possible metrics for the assessment
of QTc data quality
• Discuss implications of QTc quality for power calculations
of QTc studies and for their regulatory acceptance
• Examine the methods leading to replacement and/
or avoidance of standard positive control in small QTc
studies and in conc-QTc analyses
• Review possible approaches to conc-QTc modeling
with the distinction between linear and
non-linear assumptions
• Provide suggestions of methods reducing QTc
variability in small clinical studies
MarekMalik,Ph.D.,M.D.,DSc,ProfessorofCardiacElectrophysiology,
Imperial College, London
10:45 Networking and Refreshment Break
11:15 Cardiac Safety in the Post E-14 Era
• Review the advances and pitfalls of TQT trials for
developing new chemical entities (NCEs) and
identifying Torsade de Pointes (TdP)
* Vioxx removal due to sudden death
• Understand the evolving regulatory guidelines for
cardiac safety of NCEs
* pre-clinical and clinical data
* use of Ambulatory Blood Pressure Monitoring
and Echo
• Examine additional analyses that can assess
cardiovascular safety in both CV and non-CV drugs
* multiple ion-channel interactions
* computer modeling
* early clinical phase exposure response modeling
TimothyCallahan,Ph.D.,ChiefScientificOfficer,
Biomedical Systems
11:55 In Vitro Evaluation of Proarrhythmic
Risk — The Evolving CiPA Paradigm
This presentation discusses the evolving Comprehensive
in vitro Proarrhythmia Assay (CiPA) as it proceeds towards
industry and regulatory acceptance.
• Discuss the strengths and limitations of ICH S7B studies
to evaluate Torsades-de-Pointes proarrhythmia
• Highlight the goals and expectations of this
mechanism-based paradigm designed to improve
specificity and efficiency of present preclinical S7B
and clinical E14 guidances
• Discuss the CiPA framework and three main assay
components (ionic currents, in silico reconstructions,
cardiac myocyte studies) that comprise CiPA and how
they are integrated into an early safety assessment
• Provide early examples where a CiPA approach would
be useful for “rescue” of worthy hERG positive
drug candidates
GaryGintant,Ph.D.,ResearchFellow,DepartmentIntegrative
Pharmacology,IntegratedScienceandTechnology, AbbVie
12:35 Networking Luncheon Sponsored by:
1:35 Challenges in Translational and Pre-Clinical
Cardiovascular Risk Assessment —
Regulation versus Innovation (Early R&D)
• Review the past 17 years and the advances that
have been made in developing models of cardiac
safety assessment
REGISTER AT WWW.CBINET.COM/CARDIACSAFETY • 800-817-8601

4. • Discuss the challenges in translation of pre-clinical
cardiovascular risk assessment to clinics
• Consider how humanized pigs can be better utilized in
early R&D as a predictive and reliable model for CV and
liver safety evaluation prior to Phase I studies
NareshChand,DVM,MS,MVSc,Ph.D.,MedicationDiscoveryand
ToxicologyBranch,DivisionofPharmacotherapiesandMedical
ConsequencesofDrugAbuse,HHS/NIH/NIDA
JoelXue,Ph.D.,PrincipalScientist,GE Healthcare
2:15 Exploring Alternative Cardiac Safety
Paradigms — A Regulatory Perspective
• Examine the opportunities and challenges
presented by the Comprehensive in vitro
Proarrhythmia Assay (CiPA) strategy
• Consider the opportunities and challenges of
concentration-effect modelling of ECG data
from first in human trials
• Reconsider the design and endpoints of the
thorough ECG study
ColetteStrnadova,Ph.D.,SeniorScientificAdvisor,HealthProductsand
FoodBranch,Health Canada, Government of Canada
Build an Efficient and Effective Bridge
From Pre-Clinical to Clinical
2:55 Identify Circulating Biomarkers to Investigate
Early Signs of Myocardial Injury
• Take advantage of circulating biomarker detection
to examine compound toxicity
* partner with imaging counterparts to
create a more complete picture of patient health
• Establish early endpoints that are potentially
predictive on their own
• Discuss how cell-free nucleic acids and histones
could potentially serve as markers for drug toxicity
• Apply findings to drug development, including
specific applications to cardio-oncology
and a maturing benefit-risk assessment
RichardClintonBecker,M.D.,MabelStearnsStonehillProfessorof
Medicine,ChiefandDirectoroftheHeart,LungandVascularInstitute,
University of Cincinnati College of Medicine
3:35 Networking and Refreshment Break
4:05 Open Dialogue — Are We Missing Cardiac
Drug Interactions?
Polypharmacy is the rule for treating heart failure,
hypertensive and coronary artery disease patients.
Large cardiovascular outcome trials offer the opportunity
to explore drug interactions based on adverse events
and endpoints rather than pharmacokinetics alone.
This session highlights issues with case studies from FDA
deliberations. Engage in open dialogue regarding the
specific issues, as well as the general implications for
cardiovascular drug development.
• Discuss issues with identifying drug
interactions, including:
* can an organic cation transporter inhibitor
interact with ACE inhibitors?
* how much do statin interactions affect
mortality endpoints?
* how does the FDA factor a qualitative
drug interaction into an approval?
Facilitator: ThomasMarciniak,FormerMedicalTeamLeader,
Food & Drug Administration, Center for Drugs
4:45 Incorporating Strategies and Approaches
for Facilitated Rapid Drug Development,
Approval and Competitive Post-Approval
Commercial Success
During this extended session, examine the different
pieces of strategic drug development translation, from
pre-clinical to clinical, early phase clinical to late phase
clinical and late phase clinical to real-world approval
and post-marketing.
• Optimize translation risk assessments in
pre-clinical and early development
• Explore pre-clinical assessment of cardiac
safety along with cardiovascular
assessment during clinical development
• Employ pre-clinical cardiovascular monitoring to realize
a compound’s full potential, including:
* modality and echo strain analysis
* surrogates, lab tests and genomics
• Utilize flexible, fit for purpose in vivo
pre-clinical approaches for cardiovascular risk
assessment to drive decision enabling data across
stages of drug development
• Understand and communicate risks identified in
pre-clinical studies to improve drug development and
prevent late stage failures
• Identify translation facets, as well as the ultimate
goal of successful approval, clinical uptake and
competitive use of the product
• Characterize your development program fully to
ensure more data in post-approval real-world instances
• Review best approaches to avoid cardiac
and cardiovascular liabilities
Moderator: EricMichelson,M.D.,FACC,SeniorMedicalDirector,
AstraZeneca
Panelists: ChrisRegan,Director,InvestigativeSafetyPharmacology,Merck
RajeshShukla,SeniorDirector,Pfizer Inc
ScottMegaffin,SeniorVicePresident,CommercialDevelopment
Onconova Therapeutics
5:25 Optimize Quality and Consistency through
Centralized Cardiac Safety Imaging
• Support determination of inclusion and/or
exclusion criteria prior to patient randomization
to establish eligibility
• Ensure quality data by performing ongoing, robust data
review to monitor trends, identify and correct errors
and provide clarification to the independent reviewers
• Perform investigator site vs. central reviewer
discordance analysis outside of the independent review
to monitor variance between independent reviewers
• Understand inter and intra reader variability
testing to ensure harmonization between the
entire independent reviewer panel
• Establish consistent reading methods by training
independent reviewers through a multitude of
methods and evaluations throughout the life
of the trial
PeterGardiner,MBChB,MRCP,MFPM,ScientificAdvisor,
MedicalImaging,PAREXEL
6:05 Close of Day One
Networking, Wine and Cheese Reception
immediately following the final session on day one
REGISTER AT WWW.CBINET.COM/CARDIACSAFETY • 800-817-8601
PANEL

5. DAY TWO
Wednesday, February 11, 2015
8:00 Continental Breakfast
8:30 Chairperson’s Welcome and Opening Remarks
SheraheFitzpatrick,M.D.,MedicalDirector,PatientSafety,
AstraZeneca
8:45 Optimization of Cardiovascular Safety
Detection and Prediction in Early
Clinical Development
• Examine integrated risk management using
pre-clinical and early clinical data
• Discuss how we can avoid dedicated studies
• Review recent HESI, CSRC, IQ and FDA initiatives to
predict/detect potential proarrhythmic risk
IgnacioRodriguez,M.D.,SeniorScienceSafetyLeader,Roche (remote)
Utilize Next-Generation Technology
to Advance Cardiovascular Safety,
Risk Evaluation and Monitoring
9:30 Utilize Advanced Imaging
Techniques to Identify Drug
Induced Cardiovascular Toxicity
• Explore echocardiography techniques in identifying
microscopic abnormalities in cardiac function
secondary to medication toxicities
• Consider novel nuclear imaging techniques in
evaluating cardiac medication side-effects
• Examine the utility of cardiac MRI to
evaluate cardiotoxicity
EugeneStorozynsky,M.D.,Ph.D.,F.A.C.C.,AssociateProfessor
inMedicine,Director,Cardio-OncologyProgram,
University of Rochester Medical Center
10:15 Networking and Refreshment Break
10:45 Ongoing Risk Assessment Innovations —
Concentration-QTc Analysis to Obviate the
Need for a Dedicated QTc Study in
Cancer Patients
• Discuss ixazomib, an investigational proteasome
inhibitor in cancer patients, as a case study
• Examine essential components in conc-QTc analysis to
increase its chances of acceptance
by regulators in lieu of a dedicated study
• Discuss framework to guide strategies for QTc
assessment in oncology drug development
NeerajGupta,Ph.D.,Director,ClinicalPharmacology,Takeda
11:30 ROUNDTABLE
Are ECG Tests the Future of Cardiovascular
Safety Monitoring in Clinical Trials?
During this round table, participants break into small
groups to share experiences surrounding utilizing ECG
tests to monitor cardiovascular safety. Participants then
reconvene for shared learning to highlight key insights
and discussion points of each individual group. Examples
of questions to be addressed include:
• Are there situations in which the FDA will consider
approval of dossiers without TQT studies?
• How can we increase the efficiency of TQT studies?
• Are there benefits to using a Holter monitor versus
traditional 12-lead ECGs in collecting
and analyzing QT data?
• What are potential alternatives to the
traditional TQT study?
• Is there potential value to predicting TQT results using
multiple ion channel screens?
Is there a role for genetic screening?
EdwardO’Mara,M.D.,ExecutiveDirector,ClinicalPharmacology,
Celgene
12:15 Networking Luncheon
Toxicity Monitoring and Management of
Cardiovascular by Therapeutic Area
1:30 Clinical Development Approaches and
Statistical Considerations for Type 2 Diabetes
Drug Development
• Review the 2008 FDA Guidance and what has been
learned from diabetes outcome trial regulations
• Discuss clinical development approaches
and statistical methodological issues
MaryJaneGeiger,M.D.,Ph.D.,FACP,SeniorDirector,
Cardiovascular&MetabolismTherapeutics,
Regeneron Pharmaceuticals, Inc.
2:15 Develop a Successful Cardio-Oncology
Program with a Low Risk Profile
• Identify specific precautions that must be taken during
oncology drug development to prevent adverse
cardiovascular events in patients who are often at
higher risk for such occurrences
• Review the benefit-risk tolerance for oncology
drug development
• Explore best practices for cardio-oncology
program development
JosephR.Carver,M.D.,ChiefofStaff,Abramson Cancer Center;
BernardFishmanClinicalProfessorofMedicine,Abramson Cancer
Center of the University of Pennsylvania
3:00 Close of Conference
CASE
STUDY
REGISTER AT WWW.CBINET.COM/CARDIACSAFETY • 800-817-8601
CASE
STUDY

6. SCAN HERE
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PHONE
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339-298-2100 outside the U.S.
E-MAIL
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WEBSITE
www.cbinet.com/
cardiacsafety
LIVE CHAT
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cardiacsafety
Cardiovascular Safety and Efficacy for Drug Development PC15007
VENUE:
Hilton Alexandria Old Town
1767 King Street
Alexandria, VA 22314
Phone Reservations: 1-800-445-8667
Hotel Direct Line: 1-703-837-0440
ACCOMMODATIONS:
To receive CBI’s special discounted hotel rate online or by phone, please go to:
• Online: www.cbinet.com/cardiacsafety
• Phone reservations: 1-800-445-8667 and mention CBI’s Cardiovascular
Safety and Efficacy Conference.
Book Now! The Hilton Alexandria Old Town is accepting reservations on a space
and rate availability basis. Rooms are limited, so please book early. All travel
arrangements subject to availability.
REGISTRATION FEE:
ADVANTAGE PRICING Standard
Conference $1799 $2099
Register by December 5, 2014 and SAVE $300. 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.
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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.
REGISTER AT WWW.CBINET.COM/CARDIACSAFETY • 800-817-8601
R E G I S T E R BY D E C E M B E R 5 , 2 0 1 4 A N D S AV E $ 3 0 0 !
CV and Non-CV Drug Development
Cardiovascular
Safety and Efficacy
The Latest Approaches in the Evaluation of Drugs that Affect Heart Rate,
Blood Pressure, QT Prolongation, and Other CV Safety Related Issues
Evolving Pre-Clinical, Clinical and Imaging Strategies for Optimal CV Monitoring
FEBRUARY 10-11, 2015 • HILTON ALEXANDRIA OLD TOWN • ALEXANDRIA, VA
ANY QUESTIONS OR TO REGISTER
CALL Bret Steiman 339-298-2141
or FAX TO MY ATTENTION 781-939-2696
email: bret.steiman@cbinet.com