June 29, 2010 at 3:08 PM by cdisc
The Critical Path to TB Drug
Regimens (CPTR) is a recently formed collaboration of global pharmaceutical companies; government and regulatory agencies; foundations and donors; academia; and patient advocacy groups. The CPTR initiative was created and is managed by a partnership of the Bill & Melinda Gates Foundation, the Global Alliance for TB Drug Development (Global TB Alliance) and the Critical Path Institute (C-Path). CPTR seeks to test promising TB drug candidates in combination and identify new regulatory pathways to speed approval of novel TB therapies. This will be achieved through a new development paradigm that seeks to significantly accelerate the registration of new TB combinations around the world. Global standards for Tuberculosis are seen as a critical component of this work. CDISC was recently invited to participate in the CPTR launch working meeting held in Washington DC. This meeting included 2 breakout sessions - Regulatory Science and Research Resources. In the Regulatory Science sessions, Data Standards were a primary topic of discussion in addition to Biomarkers and Clinical Disease Progression Modeling.
Additionally, CDISC has been invited to participate and possibly present at an upcoming TB meeting in Ethiopia entitled Open Forum 4 - Key Issues in TB Drug Development. This meeting is being sponsored by Bill & Melinda Gates Foundation, The Global TB Alliance, Treatment Action Group and the Stop TB Working Group on New Drugs. This will be the fourth meeting of its kind dedicated to regulatory issues surrounding the development of new TB drugs. The meeting in Ethiopia will focus on regulatory challenges specifically relevant to the African region and be one of the first platforms available to discuss the regulatory implications of the CPTR new TB drug development paradigm.