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CPTR Workshop 2016: Full Content Day 4

Opening Remarks

Speaker: Marco Schito, Critical Path Institute

March Schito opened the last day of the CPTR 2016 Workshop recapping the progresses and challenges relating to DST development and summarizing the diagnostic development pathway. Schito shared insight on the future of DST, including the need for new policies to support the work and implementation of new technologies.

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The Use of Surveillance Date to Inform, Record, and Influence Clinical Practice and Trial Planning

Introduction

Speaker: Angela Starks, CDC

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EpiSeq: A Next-Generation Sequencing Service for Infectious Disease Outbreak Management

Speaker: Marc Rodrigue, bioMerieux

Marc Rodrigue presented on Episeq, a next generation sequencing service/platform available to hospitals and public health services. Physicians or workers at the point of care can send specimens to the service lab, where reports are generated and returned to clinicians within a week’s time.

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Acquired Resistance to New TB Drugs: Insights for Diagnostics and Treatment

Speaker: Sebastien Gagneux, Swiss Tropical & Public Health Institute

Sebastien Gagneaux reminded participants that knowledge of how bacteria evolve and acquire resistance to new drugs will be critical to protecting newly developed TB therapies. Gagneaux relayed the case study of a Tibetan refugee in Switzerland who had primary resistance to seven TB drugs and who then developed resistance to bedaquiline and delamanid when exposed. Though best practices were not followed in this case, the anecdote served as a reminder of how fragile new tools can be, and that realties on the ground are not always perfectly in line with best practices. Gagneaux also presented interesting research on the effect of mutations on the fitness of TB strains. While dogma suggests that the more mutations, the less fit the strain becomes, the data suggested that this relationship is not constant, and highlighted that more research is needed on the disease, and its relationship with the host and between hosts (transmission).

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Standardized Reporting Language Workshop: Outcomes

Speaker: Angela Starks, CDC

Angela Starks noted an increase in ongoing, valuable DNA sequencing work, but observed that the outputs of such work can vary widely in format. Currently, there is not a template or standard determining how these reports are presented. Starks summarized a workshop held earlier this year that included many experts and began the discussion of standardizing the language, content, and formats of these reports. She covered themes that arose from that discussion, including priorities and ideal values, as well as challenges – especially as they related to interpretive comments, and the need to be clear and consistent on a global basis, across languages, etc. Starks concluded by summarizing next steps for advancing this need.

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ReSeq TB Platform: Transforming Sequencing Information to Actionable Treatment Decisions

Introduction

Speaker: Claudio Koser (University of Cambridge)

Claudio Koser highlighted that current phenotypic DST practices present problems and inconsistencies. Koser urged that ongoing on planned trials do not simply calibrate DST methods against old methods, but really give thought to how we determine the definitions of resistance.

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Process for Classifying and Validating Mycobacterium Tuberculosis Mutations According to their Predicted Association with Phenotypic Drug Resistance

Speaker: Paolo Miotto, San Raffaele Scientific Institute

Paolo Miotto presented on how the community validates mutations, covering concepts like Likelihood Ratio and Odds Ratio. Based on thresholds commonly used in evidence-based medicine, his group applied algorithms to grade TB mutations to determine the confidence with which they can be said to indicate resistance. Miotto noted 33 specific high confidence mutations that indicate resistance to various TB drugs

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Meeting the Needs of Assay Development

Speaker: David Dolinger, Foundation for Innovative New Diagnostics (FIND)

David Dolinger began his presentation by noting that in addition to resources, one of the major needs of assay developers in knowledge. The TB and CPTR communities have that; but have we done the best job possible communicating and translating that knowledge to industry partners? Dolinger stressed that knowledge of the market and user base is as important as scientific knowledge – the “best” assay is only the best if it is appropriate for the needs of those using it. He stressed that developer must continue to further integrate access plans in the product development process itself, and discussed specific key elements for inclusion in development plans. More accurate data and more appropriate products lead to a better business case for the products and, in turn, improve the community’s ability to attract partners and resources.

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Intersection between Drug Development and Diagnostics

Speaker: Konè Kaniga, Janssen

The integration of drug and diagnostic development begins with the acknowledgment that development of companion diagnostics are integral to drug development efforts. Konè Kaniga discussed learnings on resistance issues relating to bedaquiline from a technical perspective. Koniga reflected on the need for strongly powered and globally representative data for making decisions about and definitions of resistance.

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Challenges Beyond Technology: Implementation Challenges within the Health Care Ecosystem

Speaker: Jim Gallarda, Bill & Melinda Gates Foundation

Jim Gallarda put much of the day’s content into perspective by urging the TB community to approach the challenges of TB control from a systems perspective by acknowledging the reality of situations on the ground. Gallarda remarked that solutions and innovation must be comprehensive; scientific innovation is necessary but not sufficient to reach our goals.

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Closing Keynote Address

Speaker: Tiong Xun Ting: Physician and Patient Advocate

Tiong Xun Ting offered a moving account of her personal battle with MDR-TB. As a physician in training, she took several proactive steps to help identify and treat her own disease, but had to endure toxic and debilitating treatment, which nearly derailed her professional path. Her story reminds us all of the cruel and indiscriminate nature of TB and drug-resistant TB. CPTR – and the entire TB control and research community ­– acts with urgency because of people like her, and to ensure that as few as possible will face the challenging and depressing hardships she did. Though her story has a happy ending, many of those stricken with the disease do not. Stories such as hers move the heart and underscore the importance of all the work covered in this Workshop.

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Closing Remarks

Speaker: Jim Gallarda, Bill & Melinda Gates Foundation

Jim Gallarda concluded the Workshop by thanking the participants and reflecting that the work and engagement of the previous four days reaffirm the community’s conviction and confidence that we can bring people together with the same overall goal and push toward success more rapidly and effectively than ever.

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