As part of the Phase 2 virtual accelerator, the LymeX Diagnostics Prize hosted a webinar with Noel Gerald, Branch Chief for Bacterial Respiratory and Medical Countermeasures at the U.S. Food and Drug Administration (FDA). The ultimate goal of the multiphase competition is to nurture the development of these diagnostics toward FDA review.
During the virtual session, the accelerator cohort had the opportunity to learn more about the FDA pre-submission process, or Q-submission. FDA’s voluntary Q-submission process allows innovators to request formal feedback on a diagnostic before it is submitted for review and approval. Following a presentation on Q-submissions and sample requirements for clinical studies and development, Gerald answered questions from the teams.
Through September 2023, the cohort will participate in webinars on clinical studies and device design, as well as roundtable discussions with patients and clinicians.
A look at the Phase 2 accelerator
In January 2023, the U.S. Department of Health and Human Services and the Steven & Alexandra Cohen Foundation invited the 10 Phase 1 winners to participate in the Phase 2 virtual accelerator. The nine month accelerator offers the cohort access to virtual learning, mentorship, biorepository subject matter expertise, and networking opportunities designed to help the teams progress toward FDA review.
By using a prize competition, rather than relying on traditional grantmaking, the LymeX Diagnostics Prize offers cash prizes alongside a range of non-monetary resources. Following the accelerator, the cohort will submit concept papers that detail solution refinement, clinical and patient input, and a roadmap from lab to market. The cohort will also participate in a presentation and Q&A session with the competition judges.
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