Longer description of your proposed project

This is a grant application on behalf of 1Day Sooner in support of a project that I’m currently leading as part of our wider FDA campaign.

What’s the problem?

The FDA, specifically the Center for Biologics Evaluation and Research (CBER), authorized the COVID-19 vaccines in record time. To give you a sense of their acceleration: priority review within FDA takes 6 months, as opposed to regular review which takes 10, whereas the COVID-19 vaccines were authorized in less than a month. They did this by streamlining clinical trials, increasing FDA-sponsor communication, providing proactive guidance, and rapidly reviewing applications (with the help of rolling review).

CBER’s covid response is a good example of how a product’s availability can be accelerated safely and how increased FDA communication and clarity can make a massive difference to the vaccine development pipeline. This has big implications for future medical countermeasure development and vaccine and drug development more broadly. However, CBER’s success relied heavily on the dedication of its reviewers and staff. They worked around the clock to prioritize rapid processing and review of submissions. This resulted in burnout, and seriously impacted other important products waiting for review, since staff had to be redeployed to increase the number of FTEs working on covid.

While impressive, CBER’s response to covid is an unsustainable model, especially with the threat of novel epidemics continuing to increase.

What’s the solution?

In 2022, 1Day Sooner began socializing a proposal for a new office focused on the expedited review of medical countermeasures. Early in 2023, the FDA included an “Emerging Pathogens Preparedness Program” under its FY24 Legislative Proposals (final paragraph here). The program would provide FDA with an additional ~25 FTEs housed within CBER, who would rapidly respond to identified threats and, during interpandemic periods, support agencies and sponsors working on medical countermeasures through the challenging development pipeline. This program was later introduced as a bipartisan bill by Senators Hickenlooper and Budd, which was included in the Senate’s draft of the Pandemic And All Hazards Act (PAHPA) bill, which is due for reauthorization.

This project’s goal will be to secure enough federal funding (minimum $7million) to stand up an Emerging Pathogens Preparedness Program.

What’s an “Emerging Pathogens Preparedness Program”?

In the FDA’s own words, the Emerging Pathogens Preparedness Program would be a “specialized program within the Center for Biologics Evaluation and Research (CBER) to defend against emerging pathogens so the agency is better positioned to respond to identified threats of concern and focus experienced resources to work quickly on medical countermeasure development to address these concerns.” As well as increasing CBER’s capacity, an Emerging Pathogens Preparedness Program would increase institutional expertise and experience related to essential emergency mechanisms and processes, such as Emergency Use Authorization review, which currently relies on a very small number of staff (at the beginning of the pandemic there were only ~2 staff within CBER who were familiar with the EUA process. CBER has ~1,300 staff).

Why focus on FDA reform?

Major advances in enabling biotechnologies like gene sequencing, mRNA platforms, rational drug design, and synthetic biology open up big possibilities for vaccine development. But any innovation must pass through the regulatory gateway. The success of Operation Warp Speed relied on FDA’s response, and replicating that success requires regulatory policy commitments. 1Day’s FDA agenda aims to build innovative regulatory capacity within FDA, starting with the Emerging Pathogens Preparedness Program and using medical countermeasures (specifically, next-generation COVID vaccines under Project NextGen) as a prototype for replicating the Warp Speed approach more broadly.

Describe why you think you're qualified to work on this

1Day Sooner has been developing its FDA campaign over the past year and a half. Therefore, the core team working on the campaign are familiar with the subject matter, have existing relationships with key players, and have already made progress on this project.

1Day’s Track Record:

1Day has built a strong support base for its FDA program, resulting in our top policy priority for 2023/24—the creation of an “Emerging Pathogens Preparedness Program” within FDA—being introduced to the Senate as a bipartisan bill, which was later voted by the Senate HELP committee to be included in its draft Pandemic and All Hazards Preparedness Act (PAHPA) bill.

In September, we sent a letter to Secretary Becerra in support of the program. This letter garnered the support of 13 co-signers: American Society for Microbiology, BIO, Coalition to Stop Flu, Federation of American Scientists, Global Health Technologies Coalition, Infectious Diseases Society of America, Institute for Progress, International Vaccine Institute, Medical Countermeasures Coalition, National Foundation for Infectious Diseases, Technologies for Pandemic Defense.

We’ve held well-attended conferences and workshops on the topic, the most recent being a workshop on the regulatory science of pandemic preparedness attended by officials from FDA, BARDA, NIH, DoD, ARPA-H, CEPI, pfizer, Janssen & Janssen and others.

Josh Morrison (1Day Sooner President - josh@1daysooner.org) and Julia Murdza (1Day Sooner COO - julia@1daysooner.org) would be more than happy to be contacted for references.

Other ways I can learn about you

Here is 1Day Sooner's website: www.1daysooner.org

Here is an article we co-authored for STAT News on the need for a pandemic preparedness office within FDA: https://www.statnews.com/2023/03/30/fda-pandemic-response-h5n1-office-of-preparedness/

Here is an article we authored published in Cato on the same issue: https://www.cato.org/regulation/fall-2023/we-need-fda-office-preparedness-response

Here’s a preprint we co-authored entitled: Vaccines at Velocity: Evaluating Potential Lives Saved by Earlier Vaccination in the COVID-19 Pandemic: https://www.medrxiv.org/content/10.1101/2023.06.16.23291442v1

How much money do you need?

$100,000 would cover the majority of the advocacy costs for the project. Advocacy costs for 2024 include: US advocacy lead (0.5 FTE) Advocacy consultant/lobbyist Legal council (FDA experts)

Links to any supporting documents or information

Here is a 1-pager that summarizes 1Day’s FDA Policy Agenda over the next few years (creating an Emerging Pathogens Preparedness Program is the immediate agenda priority): https://docs.google.com/document/d/1mFwFSb6vgMlyy3IQPveYLzByfmWu19jgdoh5B_YUkmY/edit

Here is a 1-pager explaining the need for an Emerging Pathogens Preparedness Program): https://docs.google.com/document/d/1WNyjakGe4yzBuj5sgQzwBf7cBgreNdC1UkrVx_iIM6c/edit

Here is our letter of support for an Emerging Pathogens Preparedness Program which we sent to Sec. Becerra: https://www.1daysooner.org/1day-sooner-blog/1day-letter-establish-fda-emerging-pathogens-preparedness-program

Here is the Hickenlooper/Bud bill language for an Emerging Pathogens Preparedness Program: https://www.congress.gov/bill/118th-congress/senate-bill/2329/text

Estimate your probability of succeeding if you get the amount of money you asked for

I estimate a 60% probability of success (definition of success=our proposed FDA program is funded by the end of 2024).