Scientific White Papers

A Blueprint for Drug/Diagnostic Co-Development: Next-Generation Sequencing (NGS) in Oncology (September 2014)

A Risk-based Approach for In Vitro Companion Diagnostics Device FDA Approval Process Associated with Therapies that have Breakthrough Designation (September 2013)

Eliminating Breast Cancer Health Disparities: Communicating to At-Risk Populations (2012)

Developing Standards for Breakthrough Therapy Designation: Info Brief (2012)

Design of a Disease-Specific Master Protocol: Info Brief (2012)

Re-evaluating Criteria for Accelerated Approval: Info Brief (2012)

The New Role of Academia in Drug Discovery & Development (December 2010)