4th Clinical Trials Phase I & Phase IIA Summit -

4th Clinical Trials Phase I & Phase IIA Summit
October 19 - 20, 2017
Philadelphia, PA

Understand the operational challenges of early phase development and leverage innovative strategies to conduct efficient, cost-effective clinical trials

Agenda – 4th Clinical Trials Phase I & Phase IIA Summit



Day One

 Day One – Thursday, October 19

9:00AM – 9:15AM

Chairperson’s Opening Remarks


Laura Vessey, Director of Translational Pharmacology Clinical Operations and Outsourcing Merck Research Laboratories, MERCK

9:15AM – 10:00AM

(Mis)adventures in Drug Development: Lessons Learned


Lorie Fitzpatrick, Chief Medical Officer, RADIUS HEALTH, INC.

10:00AM – 10:45AM

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

10:45AM – 11:15AM

Networking Break


11:15AM – 12:00PM

Design a Bayesian Adaptive Phase II Proof-of-Concept Trial for the Treatment of Alzheimer's Disease


Chad Swanson, Director, Clinical Neuroscience, EISAI

12:00PM – 1:15PM

Luncheon


1:15PM – 2:00PM

Identify, Prepare for, and Recruit Special Populations


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

2:00PM – 2:45PM

Pivot in Early-Phase Clinical Development for Strategic Advancement


Jennifer Newman, Global Clinical Project Leader, CELLDEX THERAPEUTICS

2:45PM – 3:15PM

Networking Break


3:15PM – 4:00PM

Develop a New Chemical Entity Using Phase I cGMP Manufacturing


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

4:00PM – 4:45PM

Escalation and Expansion of a Multi-Party Study


Victor Lucariello, Business Analytics, Celgene Corporation


Day Two

 Day Two – Friday, October 20

8:00AM – 9:00AM

Continental Breakfast


9:00AM – 9:15AM

Chairperson’s Recap of Day One


Laura Vessey, Director of Translational Pharmacology Clinical Operations and Outsourcing Merck Research Laboratories, MERCK

9:15AM – 10:00AM

Manage Risk in Early Development Trials


Jill Kearney, Director of Global Clinical Development Operations, Janssen R&D

10:00AM – 10:45AM

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.

10:45AM – 11:15AM

Networking Break


11:15AM – 12:00PM

Challenges and Opportunities for Early Development in Asia


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

12:00PM – 1:00PM

Luncheon


1:45PM – 2:45PM

PANEL: Identify Early-Phase Signals of Safety to Reduce Risks Involved With Drug Development


MODERATOR:
Laura Vessey, Director of Translational Pharmacology Clinical Operations and Outsourcing Merck Research Laboratories, MERCK

PANELISTS:
Barry Ticho, M.D., Ph.D., Chief Medical Officer, STOKE THERAPEUTICS
Robert Pyke, Chief Medical Officer, S1 Biopharma, Inc.
Pranab Mitra, Associate Principal Scientist, MERCK

2:45PM – 3:00PM

Chairperson's Closing Remarks


Laura Vessey, Director of Translational Pharmacology Clinical Operations and Outsourcing Merck Research Laboratories, MERCK


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