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Designing Smarter and More Cost-Effective Phase 1 Protocols

Track:
Nonclinical and Translational Development/Early Phase Clinical Development

Day & Time:
June 18, 8:00AM - 9:30AM (Pacific Standard Time)

Session Number:
307

Room Number:
7B

Level:
Intermediate

Type:
Session

Title:
Designing Smarter and More Cost-Effective Phase 1 Protocols

Chair(s):
Gary L. Steinman, MS
President
Medexetech, United States

Description:
In this session, experienced phase 1 clinical and preclinical investigators will present realistic protocols, identify and evaluate the impact of unnecessary, costly and time-consuming requirements that can drive up conduct costs and/or impede timely study completion, offer protocol design recommendations that can improve study conduct efficiency and, by incorporating translational methodologies, more effectively discern the viability of drug candidates in early clinical development.

Learning Objective(s):
Identify and evaluate protocol features that drive up study conduct costs and/or impede timely study completion while adding little value to test article development; Design protocols that avoid such unnecessarily costly and challenging features and specifications; Consider the potential value of incorporating translational medicine methodologies in early phase 1 protocols.

Presentation(s) & Speaker(s):
Jazz, Tetris and CPUs: An Introduction
Gary L. Steinman, MS
President
Medexetech, United States

Designing and Executing Efficient Phase 1 Protocols: Clinical Aspects
William B. Smith, MD
President
New Orleans Center For Clinical Research and Volunteer Research Group, United States

Designing and Executing Efficient Phase 1 Protocols: Operations Aspects
Mary L. Westrick, PhD
Vice President, US Phase I
Quintiles Inc., United States