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HTT update 20210930

Upcoming activities

8/6/2021: Discussion about patient sampling for HTT pivotal study

  • Lead: Victor Garcia is a new FDA fellow with an MD (board ready) and a Clinical Informatics Fellowship.

8/8/2021: Presentation at the American Statistical Society Joint Statistical Meetings

  • “Pathologist Agreement from Quantitative Measurements: a Pilot Study”
  • In coordination with this presentation and the corresponding proceedings paper, we intend to make public a GitHub repository (name “HTT”) with an R data package containing the pathologist annotations.
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8/12/2021: FDA Annual Summer Student Scientific Poster Day

  • 9:30 – 11:30am EDT
  • POSTER TITLE #1
  • POSTER TITLE #2
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Recent accomplishments

7/2021: Statistical Methods Presentation

  • Si Wen, Statistician FDA/CDRH/OSEL/Division of Imaging, Diagnostics, and Software Reliability
  • Title: Quantitative Agreement Analysis for HTT Pilot Study Data
  • Presentation video and GitHub repo with methods coming and will be linked here LINK LINK LINK LINK LINK LINK LINK LINK LINK LINK LINK LINK
  • Related manuscript: Preprint on arXiv – 2107.08891. It has been submitted to Statistics in Biopharmaceutical Research.

7/2021: Shipped eeDAP system to Yale for microscope-mode data collection

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  • Looking for pathologists to provide annotations
  • Upgraded eeDAP hardware for speed
  • Resolved third-party software version conflicts (Bioformats, Java, and Matlab – LINK LINK LINK LINK LINK LINK LINK LINK LINK LINK LINK LINK )

7/2021: We have executed two research collaboration agreements (RCA) for slide sourcing.

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6/2021: Hired six summer research assistants to support related research

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