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3rd Annual CPTR Workshop

In October, the Critical Path to TB Drug Regimens (CPTR) initiative convened partners from the academic, foundation, government/regulatory, pharmaceutical and scientific communities in Washington, D.C. for its 3rd Annual Workshop. Participants reviewed individual and collective accomplishments in advancing new TB drug regimen development, as well as the current global and regulatory landscape and other cross-sector challenges and emerging issues that impact efforts to bring new TB drug regimens to those who need them.

Dr. Edward Cox, Director of the Office of Antimicrobial Products in the Office of New Drugs, CDER at the US FDA provided the keynote address. Representatives from each CPTR consortium – regulatory science, research resources, and drug development – delivered updates on key programs. Discussion of emerging technologies in TB drug development and individual breakout sessions – focusing on biomarkers & clinical endpoints, TB disease progression modeling, data standards & integration, preclinical & clinical sciences, global regulatory pathways, access & appropriate use, and clinical trial infrastructure – rounded out day one activities.

A roundtable on TB drug development research kicked off day two with presentations by AstraZeneca, Bayer, Janssen/J&J, Otsuka, Pfizer, Sanofi, Sequella and the TB Alliance. The workshop concluded with an update on the global regulatory landscape for TB drug development by Vincent Ahonkai from the Bill & Melinda Gates Foundation followed by a Q&A panel session with Ahonkai and Hans-Georg Eichler of the EMA and Edward Cox and Joseph Toerner of the FDA.

Below is a link to the workshop agenda and brief descriptions of each speaker with links to their presentations and videos:

3rd Annual CPTR Workshop Agenda

Day One

Day Two

 

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