ARTICLE | Regulation

Enabling efficiency in TB

How a real-time biomarker in TB could enable more efficient, novel trial designs

August 5, 2017 12:06 AM UTC

In combination with adaptive study designs, a real-time biomarker of treatment response that is making its way toward FDA could shave years off the development of tuberculosis regimens, according to multiple stakeholders who attended a July 19 meeting.

On June 9, Otsuka Pharmaceutical Co. Ltd. and Critical Path Institute submitted a letter of intent to FDA to submit a qualification package for sputum lipoarabinomannan (LAM) as a pharmacodynamic biomarker that can be used as a decision-making tool in adaptive trials...