Membership Critical Path to TB Drug Regimens

Activity: Examination typesExternal reviewing


The Critical Path to TB Drug Regimens (CPTR) Initiative is a broad collaboration of pharmaceutical companies; government, regulatory, and multilateral agencies; academia; civil society; advocates; and non-government organizations, that aims to accelerate the development of new, safe, and highly effective tuberculosis (TB) treatment regimens with shorter therapy durations. Although TB is often thought of as a disease of the past, 1.7 million people die from it each year. The drugs are over 40 years old, have significant adverse effects and drug interactions, the treatment regimens are unacceptably long, resistance to current drugs is increasing, and the standard sequential regimen development process would be unacceptably long. The mission of CPTR is therefore to address an urgent global public health need, with the goal of saving millions of lives.

My role is in the biomarkers workstream: Biomarkers and Clinical Endpoints

Review and assess the current and emerging science regarding all biomarkers and clinical endpoints used in drug development and regulatory review, regardless of technology platforms: and

Prioritize the needs, develop consensus, and build the evidence base for biomarker discovery efforts; make recommendations for biomarker qualification for specific context of use.

The CPTR Initiative is managed by a partnership of the Critical Path Institute (C-Path), the Bill and Melinda Gates Foundation (BMGF), and the Global Alliance for TB Drug Development (TB Alliance). The CPTR operates under three arms, ie, Regulatory Science Consortium led by C-Path, Research Resources Group led by BMGF, and Drugs Coalition led by TB Alliance.
Period1 May 2011 → …