2nd clinical trials - exl eventsinfo.exlevents.com/rs/exlevents/images/c628-web.pdf · the 2nd...

Optimize Efficiency and Explore Innovative Strategies Behind Increasing Success in Early Phase Clinical Studies

MAY 7-8, 2015 • SHERATON BOSTON HOTEL • BOSTON, MA

NEW SUMMIT LEARNING OBJECTIVES FOR 2015:

• Hear case studies about effective approaches

to pharmacogenomics, pharmacokinetics and

pharmacovigilance from industry experts

• Learn strategies to proactively accelerate Phase I

clinical development partnerships that can drive trial

efficacy

• Discover best practices to seamlessly implement and

qualify biomarkers for a clinical study

• Increase the effectiveness of a Phase IB proof-of-

concept study

• Understand successful experiences in Phase I

and Phase IIA development and enhancement

procedures

Jamie Oliver, PharmD Chief Science Officer, ACCELOVANCE

Larry Blankstein Senior Director of Clinical Research, GENZYME

Matt Anderson, PhD, Director, Clinical Pharmacology and Experimental Therapeutics, MERCK RESEARCH LABORATORIES

Jesse Cedarbaum Head, Neurology Early Clinical Development, BIOGEN IDEC

Tami Crumley Global Trial Management, Early Development, MERCK

Stephen Furlong Safety Science Lead, ASTRAZENECA

Mark Day, Ph.D, Senior Director, Corporate Development, ALEXION PHARMACEUTICALS

Alessandra Tosolini Associate Director, Clinical Oncology, MERCK

SPOTLIGHT FACULTY MEMBERS

SPONSORED BY:

CLINICAL TRIALS PHASE I & PHASE IIA

SUMMIT

“VERY VALUABLE CONTENT! GREAT INFORMATION AND APPROACH!”

– Clinical Operations Lead, BIOGEN IDEC

CHAIRMAN

2ND

TO REGISTER CALL 866-207-6528 OR VISIT WWW.EXLEVENTS.COM/PHASE1

“VERY ENTERTAINING

AND INFORMATIVE AT

THE SAME TIME.”

– Associate Principle Scientist, Early Stage

Development, MERCK

DEAR COLLEAGUE,

We all know that the early phases are the most crucial steps behind planning for

clinical trial success. During Phase I, a drug is tested among a very small number of

patients, ranging anywhere from 20 to 100 individuals. The main objective here is

to assess the safety of the product being examined. Side effects are studied and

monitored, and dosage sizes are tested as well. Different drug formulations can be

explored in order to uncover the most effective version. As soon as the drug is deemed

safe, a clinical trial heads to Phase IIA. At this time, drug efficiency is optimized over a

much larger number of patients. Dosage quantity and frequency are considered with

pharmacogenomics and proof-of-concept evaluations.

On average, achieving approval behind a new drug can cost upwards of $2

billion. Increased cost during the early stages of a clinical study can stem from an

undetermined trial plan, among many other causes. In order to lessen these costs,

study timelines must be shortened and efficiency must be guaranteed.

The 2nd Clinical Trials Phase I and Phase IIA Summit, taking place May 7-8, 2015 in

Boston, MA, will provide the audience with a surefire plan to ensure that the early

stages of their clinical trials are conducted in the most seamless and cost-effective

manner.

This event will gather scientists and senior-level executives from pharmaceutical

and biotechnology companies to explore case studies and early phase efficiency

strategies. With a focus on early development, pharmacokinetics, pharmacovigilance

and biomarkers, our speaking faculty is comprised of thought leaders dedicated to

ensuring that the audience gains various methods to proactively improve their clinical

practices.

We look forward to welcoming you to Boston this May!

Sincerely,

Brendan Weiss Conference Production Director ExL Pharma [email protected]

• Clinical Operations/Research

• Pharmacovigilance/Pharmacokinetics

• Early Development

• Early Phase Research

• Formulation

• Compound Development

• Biologics

• Clinical Development Statistics

• Clinical Informatics

• Outsourcing

• Product Development

• Drug Safety

• Trial Design Management

• Clinical Regulatory Affairs/

Compliance/Outsourcing

• Medical Research/Affairs

• Translational Science/Medicine

WHO SHOULD ATTENDThis conference is designed for professionals

from pharmaceutical and biotechnology

industries as well as clinical research

organizations with responsibilities in the

following areas:

VENUE

Sheraton Boston Hotel 39 Dalton St.

Boston, MA 02199

Room Reservations: If you require overnight accommodations, please contact the hotel to book your room. ExL Pharma has reserved a block of rooms at a discounted rate for conference participants. We encourage conference participants to make reservations by April 16, 2015 in order to receive the discounted rate. Please make your reservation early as rooms available at this rate are limited.

To make reservations guests can call 1-888-627-7054 and request the negotiated rate for “ExL’s May Meeting.”


8:00 CONTINENTAL BREAKFAST AND REGISTRATION

9:00 CHAIRPERSON’S OPENING REMARKS

Jamie Oliver, PharmD, Chief Science Officer, ACCELOVANCE

9:15 UNCOVER THE MAJOR CHALLENGES IN EARLY CLINICAL DEVELOPMENT AND OPTIMIZE STRATEGIES BEHIND DRIVING EFFICIENCY

• Uncovering the fundamental measurements that need to be taken during the early phase of a clinical trial

• Basing acceleration on solid data and evaluating the difference between cutting corners and successful fast-tracking

• Understanding the pharmacodynamic effect of a particular drug

• Applying imaging, pathological and other various types of bio-markers to complete pharmacokinetic studies

Larry Blankstein, Senior Director of Clinical Research, GENZYME

10:00 CONDUCT CLINICAL TRIALS BASED ON LOCAL PATIENT PROFILING

• Utilizing analytical data to determine available patient groups at developed clinical trial sites

• Adjusting clinical trial regulatory protocols and requirements to target a specific, available population group

• Implementing patient profiling to decrease time and potential issues

Tami Crumley, Global Trial Management, Early Development, MERCK

10:45 NETWORKING AND REFRESHMENT BREAK

11:15 CLINICAL STUDY PROTOCOL EXPLORATION IN EARLY PHASE ONCOLOGY DEVELOPMENT

• Understanding expected outcomes from optimized assessment of trial data

• Structuring clinical endpoints to yield useful and optimized infor-mation

• Integrating early phase work with clinical development plans


12:00 LUNCHEON

1:15 BEST PRACTICES AND METHODS TO SELECT STARTING DOSAGE FOR FIRST-IN-HUMAN STUDIES

• Analyzing animal-to-human model conversion techniques to develop starting dosage in human trials

• Harnessing methodologies to identify the number of doses necessary to show a positive therapeutic effect

• Optimizing the right dosage and number of participants to prove proper dosage without accruing additional costs and extraneous data

Larry Blankstein, Senior Director of Clinical Research, GENZYME

Lawrence Lesko, Ph.D, F.C.P., Former Director of the Office of Clinical Pharmacology in the Center for Drug Evaluation and Research, FDA & Current Professor of Pharmaceutics and Director of Center for Pharmacometrics and Systems Pharmacology, UNIVERSITY OF FLORIDA COLLEGE OF PHARMACY

2:00 DRIVE EFFICIENCY IN EARLY CARDIAC SAFETY EVALUATION USING HIGHLY AUTOMATED SYSTEMS VS. A STANDARD SEMI-AUTOMATED METHOD

• Examining a new paradigm for early drug development including “near thorough” ECG studies and data review

• Improving efficiency in ECG data review and analysis to reduce the time and resources for evaluating QT prolongation and arrhythmia risk

• Reviewing analyses of thorough QT study using highly automated (HA) methods provided by five vendors vs. a standard semi-auto-mated (SA) method

• Discussing systematic differences in baseline adjusted QTcF for five HA methods vs. reference SA method

Joy Olbertz, PharmaD, PhD, Senior Director, Cardiovascular Safety Services, CELERION

Matt Anderson, PhD, Director, Clinical Pharmacology and Experimental Therapeutics, MERCK RESEARCH LABORATORIES


3:15 DISCOVER BIOMARKER DIFFERENTIATIONS AND APPLICATIONS IN EARLY STAGE CLINICAL DEVELOPMENT

• Understanding that biomarkers vary and one size does not fit all

• Enhancing early stage biomarker design for drug development programs

• Validating biomarkers in addressing target engagement, disease biology, safety and patient selection

Jesse Cedarbaum, Head, Neurology Early Clinical Development, BIOGEN IDEC

4:00 PREPARE FOR INTRODUCTION OF NOVEL SAFETY BIOMARKERS INTO AN EARLY STAGE CLINICAL TRIAL

• Generating biomarker background information and identifying possible biomarker candidates for qualification suitable to support clinical trials

• Understanding the practical concerns about safety biomarker intro-duction

• Evaluating the assay validation package of a biomarker to ensure it is suitable for implementation

Stephen Furlong, Safety Science Lead, AstraZeneca

4:45 DAY ONE CONCLUDES

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8:00 CONTINENTAL BREAKFAST

9:00 CHAIRPERSON’S OPENING REMARKS


9:15 EARLY STAGE CLINICAL FEASIBILITY AND ONCOLOGY BIOMARKER IMPLEMENTATION TECHNIQUES

• Developing biomarker enhancement strategies within regulatory and compliance boundaries

• Establishing strategic approaches to identifying biomarker targets for clinical trials

• Optimizing operational challenge solutions and increasing clinical feasibility

• Assessing biomarker methodologies for clinical relevance Alessandra Tosolini, Associate Director, Clinical Oncology,

MERCK

10:00 DEMONSTRATE CLINICAL TRIAL EFFICACY WITH OPTIMIZATION OF PHASE IIA PROOF-OF-CONCEPT STUDIES

• Cultivating the direct relationship between drug dosage and the desired treatment at hand

• Implanting proof-of-concept studies in order to lessen risk and optimize the go/no-go decision process

• Understanding the correlation between a proactive proof-of-concept study and increasing cost trends

Alessandra Tosolini, Associate Director, Clinical Oncology, MERCK

Jesse Cedarbaum, Head, Neurology Early Clinical Development, BIOGEN IDEC


11:15 PROACTIVE STRATEGIES BEHIND DRIVING EFFICACY INTO CLINCAL TRIALS IN THE EARLY STAGES

• Exploring go/no-go decision processes for patients with hepatitis C

• Assessing naïve rheumatoid arthritis patient biological protocols for First-in-Human studies

• Optimizing practices to fast-track patient recruitment processes in Phase IB/IIA clinical trials

Tatiana Beletskaya, Manager of Business Development, ARENSIA EXPLORATORY MEDICINE

12:00 LUNCHEON

1:15 EFFECTIVE STRATEGIES AND TOOLS FOR PHASE I AND PHASE IIA SUCCESS FROM AN FDA PERSPECTIVE

• Leveraging pharmacokinetics for single and multiple dosage quantities in order to save on thorough QT studies

• Cultivating a genetic study in order to substitute for a pharmacogenomic drug interaction study

• Maximizing pharmacovigilant knowledge of relevant molecules in order to predict potential adverse events

Lawrence Lesko, Ph.D, F.C.P., Former Director of the Office of Clinical Pharmacology in the Center for Drug Evaluation and Research, FDA & Current Professor of Pharmaceutics and Director of Center for Pharmacometrics and Systems Pharmacology, UNIVERSITY OF FLORIDA COLLEGE OF PHARMACY

2:00 IMPROVE THE PROBABILITY OF SUCCESS IN CLINICAL POC AND ENHANCE IMPLICATIONS FOR DECISION MAKING

• Treating Phase I and Phase II Scientifically With Preparations for Trial Conduction

• Combining Power of Target Engagement and Pharmacodynamic Biomarkers on the Probability of PoC Success

• Adapting Trial Design Limitations to Decrease Biomarker Usage Mark Day, Ph.D, Senior Director, Corporate

Development,ALEXION PHARMACEUTICALS

2:45 CHAIRPERSON’S CLOSING REMARKS


3:15 CONFERENCE CONCLUDES

AGENDA | Friday, May 8, 2015

“EXCELLENT CONTENT AND

ENTERTAINING SPEAKERS!”

– Director, Early Stage Development, MERCK

“EXCELLENT DISCUSSIONS AND

PRESENTATIONS OF BIOMARKER

UTILITIES.”

– Associate Director, Early Stage Development, MERCK

“INTERESTING, CLEAR AND

GOOD PRESENTATIONS.” – President, PRISMA CORPORATION

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Payment:Make checks payable to ExL Events, Inc. and write code C628 on your check. You may also use Visa, MasterCard, Discover or American Express. Payments must be received in full by the conference date. Any discount applied cannot be combined with any other offers and must be paid in full at the time of order. Parties must be employed by the same organization and register simultaneously to realize group discount pricing options. **Please note, there will be an administrative charge of $300 to substitute, exchange and/or replace attendance badges with a colleague occurring within five business days of any ExL conference.**

Cancellation and Refund Policy:If you need to cancel your registration for an upcoming ExL event, please note the following policies derived from the Start Date of the event:

• Four weeks or more: A full refund (minus a $295 processing fee) or a voucher to another ExL event valid for 12 months from the voucher issue date.

• Less than four weeks: A voucher to another ExL event valid for 12 months from the voucher issue date.

If you cancel within five business days or at any time after receiving the conference documentation, the voucher issued will be $395 less.To receive a refund or voucher, please fax your request to 888-221-6750.

Substitution Charges:There will be an administrative charge of $300 to substitute, exchange and/or replace attendee badges with a colleague occurring within five business days of the conference.ExL Events reserves the right to cancel any conference it deems necessary and will not be responsible for airfare, hotel or any other costs incurred by registrants.

ExL Events’ liability is limited to the conference registration fee in the event of a cancellation and does not include changes in program date, content, speakers or venue.

*The opinions of ExL speakers do not necessarily reflect those of the companies they represent or ExL Events, Inc.

Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, significant effort to find a suitable replacement will be made.

REGISTRATION INFORMATION

GROUP DISCOUNT PROGRAMS*Offers may not be combined. Early Bird rates do not apply.*

Save 25% For every three simultaneous registrations from your company, you will receive

a fourth complimentary registration to the program (must register four at one

time).

Save 15% Can only send three? You can still save 15% off of each registration.

REGISTRATION FEES

EARLY BIRD PRICING Register before March 27, 2015

Registration Fee: $1,895

STANDARD PRICING Register after March 27, 2015


ONSITE PRICING


MEDIA PARTNERS

QUESTIONS? COMMENTS? Do you have a question or comment that you would like to be addressed at this event? Would you like to get involved as a speaker or discussion leader? Please email Conference Production Director Brendan Weiss at [email protected].

SPONSORSHIP AND EXHIBITION OPPORTUNITIES

Do you want to spread the word about your organization’s solutions and services to potential clients who attend this event? Take advantage of the opportunity to exhibit, present an educational session, host a networking event or distribute promotional items to attendees. ExL works closely to customize a package that suits all of your needs. To learn more about these opportunities, contact Andrew Ferguson, Business Development Manager, at 917-258-5150 or [email protected].

WAYS TO REGISTER5

Online: www.exlevents.com/Phase1

Phone: 866-207-6528

.................................

.................................

Email: [email protected].................................

Fax: 888-221-6750.................................

.................................

Mail: ExL Events, Inc. 494 8th Ave, Fourth Floor New York, NY 10001

Optimize Efficiency and Explore Innovative Strategies Behind Increasing Success in Early Phase Clinical Studies

MAY 7-8, 2015 • SHERATON BOSTON HOTEL • BOSTON, MA

CLINICAL TRIALS PHASE I & PHASE IIA

SUMMIT

2ND

□ Yes! Register me for the conference!

Please contact me:

□ I'm interested in marketing opportunities at this event

□ I wish to receive email updates on ExL Pharma's upcoming events

Name: Title:

Company:

Dept.:

Address:

City: State: Zip:

Email:

Phone: Fax:

Method of Payment: □ Check □ Credit Card

Make checks payable to ExL Events, Inc.

Card Type: □ MasterCard □ Visa □ Discover □ AMEX

NEW SUMMIT LEARNING OBJECTIVES

• Hear case studies about effective

approaches to pharmacogenomics,

pharmacokinetics and

pharmacovigilance from industry

experts

• Learn strategies to proactively

accelerate Phase I clinical development

partnerships that can drive trial efficacy

• Discover best practices to seamlessly

implement and qualify biomarkers for a

clinical study

• Increase the effectiveness of a Phase IB

proof-of-concept study

• Understand successful experiences in

Phase I and Phase IIA development and

enhancement procedures

WAYS TO REGISTER5

Online: www.exlevents.com/Phase1

Phone: 866-207-6528

.................................

.................................

Email: [email protected].................................

Fax: 888-221-6750.................................

.................................

Mail: ExL Events, Inc. 494 8th Ave, Fourth Floor New York, NY 10001


2nd clinical trials - exl eventsinfo.exlevents.com/rs/exlevents/images/c628-web.pdf · the 2nd...

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