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CPTR 2014 Rapid DST Workshop Report Day 1

Day One: September 22, 2014

Welcome – Objective of Meeting

Speaker: Marco Schito, Henry Jackson Foundation (HJF), TB Clinical Research Branch, DAIDS, NIAID, NIH
Marco Schito welcomed participants to the CPTR Rapid Drug Susceptibility Testing (DST) 2014 Workshop and shared the goals for the meeting:

He also presented an overview of the current landscape for rapid drug susceptibility testing (DST), including target product profiles (TTPs). After reviewing the NIH’s Genomic Data Sharing (GDS) policy, he highlighted future opportunities for the community, including exploring new drug entities, publications for World TB Day, and an upcoming conference on Next-generation Sequencing (NGS) Technology.
See Marco Shito’s presentation and video.

CPTR Rapid Drug Susceptibility Testing Roadmap

Speaker: Debra Hanna, Critical Path Institute
Debra Hanna provided an overview of the CPTR Rapid DST Consortium, including the objectives for the group and its Working Group structure:

She reviewed the consortium’s overall progress since 2013 and then honed in on the focus, purpose, and accomplishments of each working group. She also shared future milestones for the group for 2015-2017:

See Debra Hanna’s Roadmap presentation and video.

Clinical Pathogen Genome Sequencing

Speaker: Lynn Bry, Center for Clinical and Translational Metagenomics
Lynn Bry focused on the expanding role for genome analyses and where its use is appropriate. Bry discussed the role of Clinical Laboratory Improvement Amendments (CLIA) labs and how they are evolving. She shared results and findings from a clinical case study from culture to sequencing. The presentation also covered recommendations for what governments and other agencies can do to better use and integrate these techniques into their work, including leveraging existing programs and structures, increasing standards for vendors, ramping up educational efforts, and providing clinical training programs for specialists.

Rapid DST Data Sharing Platform Session

Objective: Provide a comprehensive overview of the RDST data sharing platform, discuss challenges & opportunities, and discuss the regulatory perspective.

TB Drug Resistance Database
Moderator: Angela Starks

Current TB Sequencing Projects

Workgroup Breakout Sessions

Assay Development Workgroup Session
This breakout session discussed the varying costs, drivers of costs, and the general consensus on how the pricing of new technologies needs to be addressed. With varying characteristics, there is no simple formula in order to determine cost. The drivers of cost that need to be taken into consideration include making suitable tests, ease of use, drugs, reproducibility and infrastructure. The group concluded that making information more available to industry on TPPs, markets and market projects, and increasing transparency are key components to this work.

Economic and Impact Modeling Workgroup Session
This workgroup reviewed updates and progress since the group’s previous meeting, which included developing frameworks of models, publication of the “first principles model,” shifting focus to PaMZ in light of REMox TB results, and recognizing that modeling certainty is a major issue. Current issues for the group include efforts to understand the drivers of resistance and upcoming publications soon to be submitted. The group spent time discussing the first principles model in more detail and outlined upcoming plans for various models. They discussed key priorities emerging from the discussions and recent research, and potential next steps for the working group.

Enabling Sciences Workgroup Session
This workgroup discussion was focused on the discovery and validation of the molecular basis for resistance and correlation of resistance to clinical outcomes. The group discussed needs, including access to drugs/isolates and outcome data with strains, limiting the number of DST methods, standardizing strains from other regions of the world, and further evolved and updated bio banks. The group also discussed the RDST database. Key take-aways included a focus on genotypic and phenotypic data and the timing of data collection as it relates to the monitoring of clinical outcome.

Surveillance Workgroup Session
This workgroup discussion focused on the need for, and challenges to, obtaining high quality surveillance data. The group examined the WHO database project, the largest thus far based on phenotypic data. A discussion focused on how data is currently obtained and stored, and the challenges to obtaining accurate and current data as the TB community grows in scope and depth. Currently, few standards exist for language, numbering system, etc. However, the WHO plans to discuss data-gathering from published works and sequencing technologies next year.

Workgroup Plenary Session
All workgroups reconvened in a plenary session to discuss the outcomes, challenges, and recommendations from the preceding breakout session with the full workshop audience.

Moderators: Marco Schito, Claudia Denkinger. See moderators Marco Schito and Claudia Denkinger’s presentation and video.

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