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CPTR 2014 New Drug Development Workshop Report Day 1

Day One: September 24, 2014

Welcome – Objective of Meeting

Speaker: Jan Gheuens, Bill & Melinda Gates Foundation
Jan Gheuens summarized the progress of CPTR since its inception and stressed the importance of a coordinated approach toward regimen development. He discussed the crucial steps in the drug testing process, and emphasized the importance of well-integrated drug development and DST efforts. He also urged participants to consider how they might further contribute to current such efforts.
See Jan Gheuens’ video.

CPTR Accomplishments and Future Direction

Speaker: Debra Hanna, Critical Path Institute
Debra Hanna presented CPTR’s recent accomplishments and hopes for the future. CPTR’s current aim is to accelerate the development of new, combination of clinically useful drug treatments. Hanna went on to mention that much more work is needed in order to reach this goal, noting the need for development of a new data platform. She also recognized and commended the continued expansion of the initiative, citing the CPTR’s growing engagement with, and progress on, DST issues over the past year.
See Debra Hanna’s presentation and video.

Keynote

Speaker: Kenneth Castro, formerly of the Centers for Disease Control and Prevention (CDC)
Kenneth Castro 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 U.S. TB cases after three decades of decline. Castro warned about complacency and urged support of a faster process of development, realized through partnership. After his address, Castro was presented with an award for his contributions to the fight against TB throughout his career.
See Kenneth Castro’s presentation and video.

TB Drug Co-Development Roundtable
Objective: Provide overviews of the status of each drug developer’s product development programs.

Moderator: Carl Mendel, TB Alliance. See moderator Carl Mendel’s video.

Workgroup Breakout Sessions

Preclinical and Clinical Sciences
This workgroup discussion focused largely on how to best evaluate data needs and decision making within the context of current and emerging models. The group also discussed resource allocation and how to ensure that resource gaps are strategically identified and met.

Modeling and Stimulation
This workgroup session included overview presentations from each of the M&S project teams and focused on the unanswered questions in the modeling of TB infection and whether these models can be used to more reliably predict cure and the results of trials. Scientific and administrative challenges were discussed, as well as the value of a sound model’s ability to ensure limited resources for drug development are used most effectively and with the highest likelihood of success.

Data Standards and Integration
The group focused their discussion around the development of a second version of the CDISC TB data standard. The new CDISC therapeutic area development process was covered, which included a presentation from an NCI Enterprise Vocabulary Services representative on developing TB specific controlled terminology. The work group commenced the initial scoping for the updated standard, which will include data examples on pediatric TB and rapid drug susceptibility testing.

Access and Appropriate Use / Global Regulatory Pathways
This workgroup reviewed regulatory and rollout challenges relating to future new drugs or regimens. The group discussed the WHO’s upcoming launch of a policy implementation plan of 6 principles (plus a checklist) for introduction of all new drugs/regimens. This is aimed at standardizing the process going forward, and will include a generic implementation plan that countries can tailor to their own needs.

Clinical Trials Infrastructure
This workgroup discussed the updates and tools to better communicate ongoing CPTR progress, both internally and externally.

MODELING AND SIMULATION PANEL
Objective: The main goal of this session if to discuss the key aspects to overcome uncertainty in anti-infective drug development.

Moderator: David Hermann, Certara. See David Hermann’s presentation and video.

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