Project summary

Metagenomic sequencing and Far-UVC are two promising technologies for dramatically decreasing the risks from future GCBRs. Convergent Research (CR) has laid the groundwork for accelerating both by incubating $30-50M focused research organizations (FROs). For both FROs, CR is looking for help from a medical doctor with safety and efficacy trial experience to increase the chances of funding for these FROs and their expected impact. 

Concretely, in this 3-month project, I will

(a) conduct on-the-ground interviews with clinicians to help CR find the best scope and design for a UK-based FRO to accelerate the development of clinical metagenomic sequencing for pandemic early warning.

(b) explore what it would take for the same hospitals to become early adopters of Far-UVC air disinfection and whether hospital adoption should be incorporated in a  Far-UVC FRO design.

(c) consult on the design of safety and efficacy trials for a CR Far-UVC FRO planned for 2025.

What are this project's goals and how will you achieve them?

1/ Metagenomic Sequencing (MGS)

The key goal of this project is to inform the design of a £30-50M focused research organization (FRO) in the UK focused on accelerating the development and adoption of point-of-care MGS. This FRO proposal will be submitted to two separate open calls in the UK: one co-funded by the government and Schmidt Futures, one announced by the Advanced Research and Invention Agency. CR has put together many of the building blocks for success (technology roadmap, contact with companies that can develop fit-for-purpose devices, leading UK clinicians) and estimates the chances of unlocking these resources at 20-40%.

A key goal for CR is to prioritize the workstreams to achieve maximum catalytic impact. To aid these decisions, I (Miti Saksena) will work closely with the Convergent Research team by visiting identified relevant hospitals and interviewing clinicians. In the case of MGS, a key question is whether to push primarily on technology development or clinical approval and adoption of existing MGS protocols. The outputs of this project will be

• Target product profiles for metagenomic sequencing tests in the context of British ICUs and emergency departments. Key variables to determine include the necessary cost and time to answer and modalities of integration into the healthcare and pathogen surveillance systems.

• Prioritized goals for data gathering for multi-site trials of MGS as a diagnostic.

• A clear plan for integrating point-of-care MGS into an early warning system.

• A “playbook” for clinicians interested in adopting clinical MGS as a diagnostic.

• A CRM of clinicians that could join multi-site trials of MGS cost-effectiveness and clinical utility.

2/ Far-UVC

Jasper Gotting and Vivian Belenky at CR have spent the last 9 months researching Far-UVC and finding the best design for a Far-UVC FRO. They gradually shifted their focus from the development of efficient emitters and came to believe that high-quality safety and efficacy trials would have a greater catalytic impact on the field. They are currently engaging with top experts in the field (David Brenner, Kenneth Wood, Ewan Eadie) on designing a FRO to coordinate this safety and efficacy work. They are looking for consulting on their ideal scope and design and help in finding the right performers for this FRO. In collaboration with Jasper and Vivian, I will iteratively identify priority work streams in Far-UVC with the aim of maximizing the chances that $50M for this project is unlocked and that it maximally accelerates Far-UVC adoption.

How will this funding be used?

• 3 mo FT salary for myself + benefits

• Travel costs
  

Who is on your team and what's your track record on similar projects?

To date, Convergent Research has officially launched 5 FROs [1] with total funding of $250M and reached approval for another 3. 

CR has shown commitment to long-termism by hiring a Biosecurity Program Associate as employee number 5 and providing an institutional home for technical roadmaps on Far-UVC and metagenomics. Outputs include state-of-the-art analyses of Far-UVC hardware, as well as general bottlenecks and a roadmap towards ubiquitous metagenomic sequencing.

[1] https://www.convergentresearch.org/fro-portfolio

Self (Miti Saksena)

• I currently work as an independent contractor for Securebio. I work on biosecurity policy papers and have assisted them in submitting a proposal to conduct a far-UVC efficacy clinical trial to the CDC.

• I was previously employed at Alvea, an EA-aligned for-profit biotech startup dedicated to the accelerated development of shelf-stable COVID vaccines. I was a physician on their clinical trials team and was responsible for their products' safety (Pharmacovigilance). This involved technical and operational setup and strategizing for the company.

• I was a Postdoctoral fellow in Microbiology at Mt Sinai Hospital, NYC. I worked with a virology lab, closely collaborating with renowned immunologists on crucial, early COVID vaccine research. This work resulted in influential recommendations for vaccine distribution efforts and informed clinical vaccination standards for different immunological profiles of patients. My lab operated its own clinical pathogen surveillance system across its hospital system in NYC, tracking the changes in the SARS CoV2 virus since the beginning of the NY outbreak. Although I did not contribute directly to this, I participated in operational and technical discussions.

• I led a team of healthcare personnel while managing a level-2 ICU in rural India while providing and coordinating comprehensive critical care to admitted patients with ad hoc interactions with other acute care areas at a resource-strapped tertiary hospital for a year. This is part of ~3 yrs of clinical experience as a Medical Officer in India.

What are the most likely causes and outcomes if this project fails? (premortem)

Failure mode 1: No funding is received in time for me to commit FT to the project. This would result in :

• CR continuing with the FRO proposal without incorporating the data I would collect or with an extreme MVP version aggregated by the existing staff. Ales Flidr estimates that this project could increase the chances of unlocking funding by 10-20 percentage points; we risk missing out on that.
  OR,

• I look for alternate funding sources from other sources; this would come at a substantial cost to the projected timeline for the timely incubation of the FRO.
  OR,

• I volunteer my time to work on this which comes with added personal financial stress, while being able only to contribute less than the ideal (ie. very little) amount of time.

Failure mode 2: The research is completed timely after funding, but the FRO incubation is unsuccessful (for any reason). The project output is generally valuable in this field, even outside the immediate utility for CR FROs. Making the results publicly accessible will still positively impact future projects.

What other funding are you or your project getting?

None atm. This was submitted for a 14-day decision with Lightspeed grants but was rejected after three weeks from submission.