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Making Better Go/No-Go Decisions: Improving Success Rates and Reducing Costs

Track:
Project/Portfolio Management and Strategic Planning

Day & Time:
June 16, 8:30AM - 10:00AM (Pacific Standard Time)

Session Number:
105

Room Number:
5A

Level:
Advanced

Type:
Session

Title:
Making Better Go/No-Go Decisions: Improving Success Rates and Reducing Costs

Chair(s):
Joseph A DiMasi, PhD
Director, Economic Analysis
Tufts Center for the Study of Drug Development, United States

Description:
This session will examine trends in success rates and recently developed methods which establish a set of factors that can be scored and combined to improve the predictability of approval for compounds that have undergone mid-stage clinical testing.

Learning Objective(s):
Analyze the historical record concerning technical risks in clinical development of new drugs and biologics; Assess how clinical, compound, operational, and economic characteristics can be used to make better go/no-go development decisions.

Presentation(s) & Speaker(s):
APGAR Begets ANDI: What Drug Developers Can Learn from Orchestra Auditions and Crying Newborns
Wayne Rackoff, MD, MA
Vice President, Clinical Oncology
Janssen Research & Development, LLC, United States

Improving Phase 2 Go/No-Go Decision-Making with a Simple Scoring Algorithm
Joseph A DiMasi, PhD
Director, Economic Analysis
Tufts Center for the Study of Drug Development, United States

Looking at Cost/Time/Risk/Value Scenarios to Improve Clinical Program Decision-Making
Rick Sax, DrMed, FACP
Senior Vice President, Clinical Design and Reporting Services
Quintiles Transnational Corporation, United States