Regulatory Pathway Opportunities for New TB (Tuberculosis) Drug/Regimens
Greetings on behalf of the Critical Path to TB Drug Regimens (CPTR) Global Regulatory Pathways Workgroup (GRP-WG). In collaboration with WHO Stop TB Department, we are planning an evening dinner satellite session at the 2014 International Conference of Drug Regulatory Authorities in Rio de Janeiro, Brazil. This session, titled “Regulatory Pathway Opportunities for New Tuberculosis Drugs and Regimens” will be held on Monday, August 25 from 18:00 – 21:30. I am writing to extend an invitation for you to join us and participate in our session.
This meeting will be an opportunity to highlight some of the recent progress in TB drug approvals (e.g. bedaquiline and delamanid). Our main objectives for this session are:
- Provide overviews of the regulatory reviews of bedaquiline and delamanid, including discussion on the rationale behind the approval decisions
- Review WHO plans for rational introduction of new TB drugs, including bedaquiline and delamanid. WHO interim guidance on use of bedaquiline can be found at: http://www.who.int/mediacentre/news/notes/2013/bedaquiline_mdr_tb_20130613/en/
- Promote the development of collaboration with and between national regulatory authorities for the rational introduction and optimal uptake of new TB drugs in programmatic conditions
For background, the CPTR Initiative is a cross-sector program that aims to greatly reduce the time needed to develop and make available novel drug regimens for tuberculosis, including multi-drug resistant and extensively drug resistant strains. The CPTR Global Regulatory Pathways Workgroup is charged with: identifying and addressing challenges in current regulatory processes. This includes working to identify and promote new and existing regulatory pathways to facilitate efficient review processes for TB drugs. Additional information can be found at: http://cptrinitiative.org/.
CPTR & WHO sponsored a similar session (“New Tuberculosis Drugs on the Horizon: Regulatory Strategies and Opportunities”) accompanying the 2012 ICDRA meeting in Tallinn, Estonia. We intend for this meeting to build on the concepts discussed in the previous session from 2012, especially in light of the recent progress in new TB drug approvals. Due to the nature of our intended focus for the session, it is highly recommended that regulators with responsibilities for the review of TB drugs attend this satellite meeting.
A more detailed outline of the session can be accessed here. A summary from the 2012 Tallinn meeting can be accessed here. I hope you will consider joining us and lending your perspective and experience to the discussion. We ask that you please RSVP by Friday, July 25, 2014.