CPTR Workshop 2014 Overview
September 22-25, 2014
Omni Shoreham Hotel, Washington, DC
More than 100 participants attended CPTR’s 2014 cross-sector gathering of academic, foundation, government/regulatory, pharmaceutical and scientific communities in Washington, DC to focus on advancing the development of new TB drugs and regimens. The workshops — the first of which focused on rapid drug susceptibility testing (DST) and the second of which focused on development of new treatment regimens — provided an opportunity for participants to continue discussions about emerging issues and technologies, consider regulatory processes, and to network in order to increase collaboration with partners and colleagues. In addition to the main plenary sessions, individual breakout sessions among the Consortium’s workgroups made tangible progress on ongoing and planned initiatives through valuable face-to-face work sessions.
RAPID DST WORKSHOP
Day One of the Rapid DST workshop began with a brief welcome by Marco Schito and a presentation on recent progress in drug development and CPTR’s goals for the future by Debra Hanna. This was followed by the keynote presentation by Lynn Bry, who focused on the expanding role for genome analyses and ways to best translate its benefits into impact.
Afternoon breakout sessions provided an opportunity for participants to engage in group discussions around progress and strategy relating to assay development, economic assessment and impact modeling, enabling science, and surveillance. The day concluded with a plenary session that invited all participants to discuss outcomes, challenges and recommendations from the afternoon’s breakout sessions.
Day Two of the Rapid DST workshop opened with a session that reviewed the impact of modeling efforts on diagnostics development and RDST Consortium work streams. The second panel discussion of the morning showcased emerging technical platforms and their direct impact on, and implications for, the Consortium’s work and goals. That was followed by a discussion of the scientific gaps for developing rapid nucleic acid tests for newer anti-TB drugs.
The afternoon sessions focused on the challenges and opportunities for implementing genotypic data for DST surveillance and harmonization requirements. The DST workshop concluded with a presentation by Martina Casenghi from Doctors Without Borders on her research, which engaged clinicians in the field to better define what they would consider success in the area of rapid DST testing.
NEW DRUG DEVELOPMENT WORKSHOP
Day One of the drug development workshop began with a brief welcome by Jan Gheuens of the Bill & Melinda Gates Foundation and a presentation on recent progress in drug development and future CPTR goals by Debra Hanna. This was followed by the keynote presentation from Kenneth Castro, who shared first-hand experience on past challenges and advances in stopping tuberculosis and the need to refocus on TB in light of recent spikes in the U.S. Following Castro’s presentation, he was presented with an award for his past and continued service to the public health community on efforts to fight TB. The morning’s program continued with updates from several developers of new TB drugs and regimens.
Afternoon breakout sessions brought members of the established workgroups together. The Regulatory Science Workgroup discussed preclinical and clinical sciences, modeling and simulation, and data standards and integration. The Research Resources Workgroup discussed drug access, appropriate use, regulation and clinical trials infrastructure. The breakout sessions were followed by a modeling and simulation panel, which concluded the day’s activities.
Day Two of the drug development workshop opened with a session focused on stakeholder and community engagement, field case studies, best participatory practice and the piloting of monitoring and evaluation tools to quantify the impact of these activities.
The final panel discussion of the workshop focused on emerging issues in regulatory science relating to regimen development. The workshop closed with Uvistra Naidoo’s powerful and personal story of TB survival and a call for continued commitment to progress in pursuit of new TB treatments.