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CV and Non-CV Drug Development

CardiovascularSafety 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 Medical Team Leader, Food & Drug Administration

PLUS!

Distinguished Conference Chairs:

Gary Gintant, Ph.D., Research Fellow, Department Integrative Pharmacology, Integrated Science and Technology, AbbVie

Sherahe Fitzpatrick, M.D., Medical Director, Patient Safety, AstraZeneca

• Evaluate evolving methods that could replace TQT 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

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 [email protected].

“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, bridgecommunities 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.


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 orinvolvement 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-Edge Topics Including:

DAY ONE Tuesday, February 10, 20157:30 Conference Registration and

Continental Breakfast

8:30 Co-Chair’s Welcome and Opening Remarks



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 monitoringJames Keirns, Ph.D., Vice President, Chief Clinical Pharmacology Scientist, 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

Borje Darpo, M.D., Ph.D., Global Medical Director, 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

Marek Malik, Ph.D., M.D., DSc, Professor of Cardiac Electrophysiology, 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

Timothy Callahan, Ph.D., Chief Scientific Officer, Biomedical Systems

11:55 In Vitro Evaluation of Proarrhythmic Risk — The Evolving CiPA ParadigmThis 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


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


• 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

Naresh Chand, DVM, MS, MVSc, Ph.D., Medication Discovery and Toxicology Branch, Division of Pharmacotherapies and Medical Consequences of Drug Abuse, HHS/NIH/NIDAJoel Xue, Ph.D., Principal Scientist, 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

Colette Strnadova, Ph.D., Senior Scientific Advisor, Health Products and Food Branch, 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

Richard Clinton Becker, M.D., Mabel Stearns Stonehill Professor of Medicine, Chief and Director of the Heart, Lung and Vascular Institute, University of Cincinnati College of Medicine


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: Thomas Marciniak, Former Medical Team Leader, 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: Eric Michelson, M.D., FACC, Senior Medical Director, AstraZeneca Panelists: Chris Regan, Director, Investigative Safety Pharmacology, Merck

Rajesh Shukla, Senior Director, Pfizer Inc Scott Megaffin, Senior Vice President, Commercial Development 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

Peter Gardiner, MB ChB, MRCP, MFPM, Scientific Advisor, Medical Imaging, PAREXEL

6:05 Close of Day One

Networking, Wine and Cheese Receptionimmediately following the final session on day one


PANEL

DAY TWOWednesday, February 11, 2015

8:00 Continental Breakfast

8:30 Chairperson’s Welcome and Opening Remarks


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

Ignacio Rodriguez, M.D., Senior Science Safety Leader, 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

Eugene Storozynsky, M.D., Ph.D., F.A.C.C., Associate Professor in Medicine, Director, Cardio-Oncology Program, University of Rochester Medical Center


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

Neeraj Gupta, Ph.D., Director, Clinical Pharmacology, Takeda

11:30 ROUND TABLE 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?

Edward O’Mara, M.D., Executive Director, Clinical Pharmacology, 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

Mary Jane Geiger, M.D., Ph.D., FACP, Senior Director, Cardiovascular & Metabolism Therapeutics, 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

Joseph R. Carver, M.D., Chief of Staff, Abramson Cancer Center; Bernard Fishman Clinical Professor of Medicine, Abramson Cancer Center of the University of Pennsylvania

3:00 Close of Conference

CASE STUDY


CASE STUDY

SCAN HERE

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PHONE800-817-8601 339-298-2100 outside the U.S.

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WEBSITEwww.cbinet.com/ cardiacsafety

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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.

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 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

CardiovascularSafety 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 REGISTERCALL Bret Steiman 339-298-2141

or FAX TO MY ATTENTION 781-939-2696 email: [email protected]

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