Phases of the competition

NickOttensNickOttens Community ManagerAmsterdam, NetherlandsPosts: 896 admin
edited September 2020 in Prize Design
We are considering a competition consisting of three rounds, preceded by a brief awareness and recruitment phase.

The main elements of each round are listed below. We would appreciate your feedback on this high-level design.

Awareness and Recruitment Phase (3 months)
  • Promotion of the prize
  • Public feedback on competition guidelines
  • Teams register
  • Virtual team summit
  • Teams submit short proposals:
    • Explaining their proposed intervention, its novelty and scalability
    • Proof that they have a lab to work with
    • Résumés of team members

Only the teams with the most promising proposals, as determined by a panel of independent judges, advance to Round A.

Round A: Casting Out Nets Wide (1 year)
  • XPRIZE provides community, training in bio-entrepreneurship, webinars, connections
  • Competitors draft and submit their proposal for a clinical trial:
    • Preference for combination therapies that can be patented (to ensure financial incentive)
    • Only supplements / nutraceuticals, OTC drugs, repurposed drugs
    • Only interventions that are unlikely to require pre-clinical trials or Phase 1 clinical trials

Proposals would again be assess by a panel of independent judges (judging criteria here. Teams that qualify for Round B will receive a milestone award covering their expenses to submit a proposal to the FDA or equivalent regulatory body.

Round B: Registering Trials and Early Preparations (1 year)
  • Partner teams with contract research organization (CRO):
    • Sharing best practices and advice
    • Some teams may choose to merge
    • Help teams plan for clinical trials
  • Connect teams with investors
  • Competitors submit trial documentation to FDA or other regulatory

Teams whose trials are approved receive a second milestone award to cover their expenses during Phase 2 clinical trials.

Round C: Final Preparations and Phase 2 Clinical Trials (1.5 years)
  • Scheduling interventions and events
  • Obtaining compounds for interventions
  • CRO recruits cohorts and manages clinical trials
  • Data analysis by CRO or third party delivered to judges

Independent judges decide the winner, who are announced at an award ceremony.

Comments

  • NickOttensNickOttens Community Manager Amsterdam, NetherlandsPosts: 896 admin
    @mario_perez, @Terenceericson, @AlexandraW, what do you think of this competition structure?

    We're considering splitting the Age Reversal prize into three phases across almost 4 years.
  • mario_perezmario_perez Posts: 12
    Looks good, the first phase is key for attracting the most talented teams and interventions.

    The only thing I would make specific is that teams should cure an age-related disease. The FDA won't accept a trial that its only intent is biological age reversal. Am I right?
  • NickOttensNickOttens Community Manager Amsterdam, NetherlandsPosts: 896 admin
    Exactly. We're still deciding whether to give teams a narrower assignment (like the immune system focus) or keep it more open-ended. There are pros and cons for both.
  • NickOttensNickOttens Community Manager Amsterdam, NetherlandsPosts: 896 admin
    @dw2, @NikolaiKirienko, @Elena_Milova, @Oakshade, @pspiegel, @Living100, @Founder, I remember you shared your feedback at the of the Longevity Impact Roadmap. It would be great to read what you think of this structure now that we're designing the first longevity XPRIZE, which is a direct result of the Impact Roadmap we made last year.

    I hope you'll join the discussion! We're especially interested in the perspective of individuals, teams, and companies who might be interested in competing in this prize competition, once it is designed, funded, and launched.

    You can find discussions about our draft submission criteria and potential milestone awards here.
  • alouferaloufer Posts: 1

    If competitors are limited to only supplements / nutraceuticals, OTC drugs, repurposed drugs, and in general, interventions that are unlikely to require pre-clinical trials or Phase 1 clinical trials, then what is their chance of finding such an intervention with a big impact?

    Also, are 3 months enough for both raising awareness for this competition and recruiting teams (having them already come up with, and submit, a short proposal)?
  • NickOttensNickOttens Community Manager Amsterdam, NetherlandsPosts: 896 admin
    Thanks for your comment, @aloufer!

    In the first 3 months, teams would only have to submit essentially a one-pager explaining their proposed intervention. We would also have the possibility of extending that phase if the number of applications is underwhelming.

    Your first question - how likely are teams to find an intervention with big impact using only previously-approved drugs and treatment - is a good one, and one where we'd like more input on from the community.

    It's also why we're considering having two tracks in the competition: an "open innovation" track for repurposed and over-the-counter drugs, and a "cutting-edge innovation" track for interventions that aren't appreciated yet. That would probably require different timelines and milestones awards, and definitively require different judging criteria, though, so it would make the competition more complex.
  • NickOttensNickOttens Community Manager Amsterdam, NetherlandsPosts: 896 admin
    edited October 2020
    Following feedback from community members, outside experts, and our sponsors, we've decided to simplify the timeline and phases of the competition.
    • There would still be a 6-month Active Team Recruitment phase in the beginning, but the competition would be open-ended and teams could join at any time.
    • Every 6 months, an Ethics Committee would evaluate submissions and approve treatment plans. Once approved, teams can say they're officially competing in the XPRIZE and draft their Investigational New Drug (IND) - or non-US equivalent - application.
    • INDs are reviewed by XPRIZE prior to submission to the FDA or equivalent regulatory body in order to maximize the chances that they will be approved.
    • Teams that get IND approval will be recognized as Finalists. We may cap this at 20.
    • The first teams that get their INDs approved in a certain category will win milestone awards.
    • Teams then conduct their clinical trials with periodic oversight from our CRO partner to ensure fairness.
    • Clinical trial results are audited by the CRO before they are sent to the Judging Panel for review.
    • The first team to reach the goals of the prize wins!
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