4th Clinical Trials Phase I & Phase IIA Summit (EXL)

19–20 October 2017
Philadelphia, PA 19104, United States
 

4th Clinical Trials Phase I & Phase IIA Summit (EXL)


Thu, Oct 19, 2017, 8:00 AM –
Fri, Oct 20, 2017, 5:30 PM EDT

Sheraton Philadelphia University City Hotel
3549 Chestnut Street
Philadelphia, PA 19104

4th Clinical Trials Phase I & Phase IIA Summit

Sponsors often take for granted the fact that early phase trial design and operations can make or break future studies. When hard data is severely limited and is used to predict well beyond its boundaries, the quality of that data is absolutely paramount. The data obtained from phase 1 first-in-human studies through phase 2 proof-of-concept and dose range finding studies are vital to effectively designing future registration studies. Early phase clinical trials should be safe experiments on humans, not small-scale phase 3 trials. Therefore, it is beneficial to intelligently optimize early phase clinical activity to ensure successful trial execution and regulatory approval.

The mission of the 4th Clinical Trials Phase I & Phase IIA Summit is to provide attendees with the strategies and insight necessary to ensure their early stage clinical trials are executed on time and within budget, while exploring how to leverage innovative approaches to managing clinical trials for all therapeutic areas.
Top Five Reasons to Attend

•    Implement adaptive study designs and predictive models to successfully accelerate early phase trials
•    Improve vendor identification and communication from negotiation to study execution
•    Overcome the evolving challenges of patient recruitment and retention for different diseases
•    Leverage techniques to help identify genetic predisposition and risk factors for adverse events and drug reactions
•    Discuss innovative strategies to optimize early phase clinical trial operations

Who Should Attend

This conference is designed for representatives from pharmaceutical, medical device and biotechnology companies with responsibilities in the following areas:

•    Clinical Research/Operations/Outsourcing/Affairs
•    Early Phase Research/Development
•    Pharmacology/Pharmacokinetics/Pharmacodynamics
•    Pharmacovigilance
•    Translational/Experimental Medicine
•    Biostatistics/Biometrics
•    Pharmacometrics

•    Clinical Data Management/Statistics
•    Clinical Innovation
•    Regulatory Affairs/Compliance
•    Medical Research/Affairs
•    Patient Recruitment/Engagement
•    Drug Safety


This conference is also of interest to:

•    Clinical Research Organizations
•    Clinical/Quality Risk Consultants
•    Medical Informatics Companies
•    Functional Service Providers

•    Patient Engagement and Retention Services
•    Clinical Technology and Data Management Solution Providers


AGENDA


Day One
Day One – Thursday, October 19

-8:30AM – 9:15AM
Continental Breakfast and Registration

-9:15AM – 9:30AM
Chairperson’s Opening Remarks

PROCESS IMPROVEMENT

-9:30AM – 10:15AM
Design Operating Models for Early Clinical Trials

Mary Westrick, Adjunct Professor, University of Wisconsin-Madison

-10:15AM – 11:00AM
Challenges and Successes With Outsourcing Early-Phase Clinical Studies to the Right Strategic Partner

Kristian Hubbard, Outsourcing Manager, Clinical Science and Operations Department, Bristol-Myers Squibb
Susan Lubin, Outsourcing Manager, Bristol-Myers Squibb

-11:00AM – 11:30AM
Networking Break

-11:30AM – 12:15PM
Look to the Future of Clinical Trials: Virtual Clinical Trials' Place in Early-Phase Development

-12:15PM – 1:00PM
PANEL: Identify Early-Phase Signals of Safety to Reduce Risks Involved With Drug Development

Panelists:
Barry Ticho, Head of Development CVMD, Moderna Therapeutics

-1:00PM – 2:15PM
Luncheon

-2:15PM – 3:00PM
Perfect Data Management Collection to Enhance Speed, Quality, and Safety in Early-Phase Therapeutic Interventional Oncology Studies

-3:00PM – 3:45PM
Develop a New Chemical Entity Using Phase I cGMP Manufacturing

Marcus Stavchansky, Pharm.D., Director, Pharmacy Services, Covance

-3:45PM – 4:15PM
Networking Break

-4:15PM – 5:00PM
PANEL: Practical Aspects of Integrating Wearable Technology to Advance Studies and Improve Patient Interaction and Retention

Moderator:
Samuel Volchenboum, Director, Center for Research Informatics, University of Chicago Graham School

Panelists:
TBD

-5:00PM –
Conference Day One Ends


Day Two
Day Two – Friday, October 20

-8:30AM – 9:15AM
Continental Breakfast

-9:15AM – 9:30AM
Chairperson’s Recap of Day One

Strategic Partnerships

-9:30AM – 10:15AM
CASE STUDY: Integration of Adaptive Trial Design and Dual-Purpose Biomarkers of Efficacy to Enhance Safety in Early-Phase Clinical Trials

Clayton Dehn, M.S., Senior Vice President Early SVC and Strategic Development, Clinical Trials of Texas, Inc.

-10:15AM – 11:00AM
Identify, Prepare for, and Recruit Special Populations

Dr. Margarita Nunez, Medical Director and Principal Investigator, High Point Clinical Trials Center

-11:00AM – 11:30AM
Networking Break

-11:30AM – 12:15PM
Challenges and Opportunities for Early Development in Asia

Rachael Easton, Senior Director, Translational Medicine & Clinical Pharmacology , SANOFI

-12:15PM – 1:00PM
Create Operational Standards That Allow Flexibility in Order to Effectively Adapt to Protocol Uncertainties

-1:00PM – 2:15PM
Luncheon

SAFETY & REGULATIONS

-2:15PM – 3:00PM
PANEL: Explore New Approaches to Reduce Risk and Ensure Safety in First-in-Human Early Clinical Development

Howard Greenberg, Global Medical Safety Physician, Janssen

-3:00PM – 3:45PM
Uncover the Next Wave of Breakthroughs in Clinical Cancer Research

Lucy Xu, Associate Director, Clinical Biomarker Research, Eisai

-3:45PM – 4:30PM
PANEL: Ensure New Best Practice Standards When Monitoring Patient Safety

-4:30PM – 4:45PM
Chairperson's Closing Remarks

-4:45PM –
Conference Concludes


Sponsors
Clinical Trials of Texas, Inc.
Clinical Trials of Texas, Inc. - sponsors 4th Clinical Trials Phase I & Phase IIA Summit

Clinical Trials of Texas, Inc. (CTT) is a San Antonio-based multitherapeutic research site, founded in 2001 by President/CEO Kay Scroggins, RN, CCRC. CTT conducts approximately 120 trials a year in phases I-IV, working with more than 15 doctors in metabolic disorders, mental health, women’s health, dermatology and Alzheimer’s disease. CTT also features an inclusive 6,000 foot, 20 bed facility for early phase services.


Covance
Covance - sponsors 4th Clinical Trials Phase I & Phase IIA Summit

Covance Inc., the drug development business of Laboratory Corporation of America Holdings (LabCorp) headquartered in Princeton, New Jersey, USA, is the world’s most comprehensive drug development company, dedicated to advancing healthcare and delivering Solutions Made Real�.
High Point Clinical Trials Center

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