1Day Sooner

Through structured volunteer input, the Participant Council aims to strengthen trust, transparency, and participant-centered research worldwide. Learn more by visiting the website or reading the meeting notes: t.co/tIhhCbDkZj

The discussion focused on how to communicate potential impact in ways that are clear, credible, and accessible, while remaining attentive to equity concerns such as rare diseases and global differences in disease burden.

Pre-meeting survey results showed that 75% of members consider a study’s potential impact a major factor in their decision to enrol, yet many noted how difficult it can be to assess real-world benefits at the point of consent.

Last month, 1Day Sooner convened the first meeting of its Participant Council, bringing together 19 healthy research volunteers from 8 countries to help shape the future of clinical trial participation.

The solution: shared leadership, sustained investment, and stronger regional trial and regulatory capacity. Expanding early-phase research in Africa isn’t charity—it’s smart, ethical, and economically sound.

This is both an equity and a science issue. Genetic diversity, environment, and lived context shape how medicines work—early-phase trials must reflect that reality to ensure treatments are truly safe and effective.

Sub-Saharan Africa bears the highest global disease burden—yet <3% of clinical trials take place there, and very few are early-phase. That means key safety and dosing decisions are often made without data from the populations most affected. www.nature.com/articles/s44...

FDA Transparency Happy Hour · Luma Join 1Day Sooner, the Institute for Progress (IFP), and The Foundation for American Innovation (FAI) for a casual happy hour with complimentary drinks and…

This issue and more will be up for discussion at the FDA Transparency happy hour we're hosting on Feb. 11th with @ifp.bsky.social and the Federation for American Innovation in Washington, DC. luma.com/l2i3s3wm

The result is a growing public record that’s clearer, more accessible, and more informative—showing how technology can strengthen transparency in drug regulation.

AI can also help people actually use CRLs—by making them easier to search, compare, and learn from across products and disease areas.

Used thoughtfully, AI tools could streamline redactions and make it easier to publish detailed FDA letters without slowing down the review process.

The key insight: AI can help the FDA share more information, faster—without adding strain to already busy staff.

The FDA’s decision to publish Complete Response Letters (CRLs) is a big step forward for transparency. Our new report explains how AI can help make this shift sustainable over time.
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FDA Transparency Happy Hour · Luma Join 1Day Sooner, the Institute for Progress (IFP), and The Foundation for American Innovation (FAI) for a casual happy hour with complimentary drinks and…

Note that this event has been rescheduled for February 11, 2026 due to inclement weather in Washington. You can still register here: luma.com/l2i3s3wm

FDA Transparency Happy Hour · Luma Join 1Day Sooner, the Institute for Progress (IFP), and The Foundation for American Innovation (FAI) for a casual happy hour with complimentary drinks and…

Or, if you're in the Washington, DC area, join us for happy hour on Tuesday from 6:30-8:30 pm at the Institute for Progress to discuss how this project fits into a broader set of initiatives designed to accelerate biomedical innovation! Register here: luma.com/l2i3s3wm

Get Involved your impact 1Day Sooner and Renaissance Philanthropy are working to build the most comprehensive open-access repository of Common Technical Documents. By making regulatory and scientific data freely a...

@1daysooner.bsky.social is proud to support this initiative. Find out how you can get involved: www.ctdcommons.org/get-involved

We should stop burning pharma trials’ lab notes, with Ruxandra Teslo What if the main bottleneck to faster drug development isn't the science?

To learn more, check out @ruxandrabio.bsky.social's (one of the leaders of this initiative) interview w/ Patrick McKenzie on www.complexsystemspodcast.com/episodes/rux... yesterday, where she lays out the stakes and possibilities!

The long-term vision goes further: AI systems trained on real regulatory submissions could help anticipate FDA questions, improve trial design, and surface patterns across thousands of past programs.

Home The Mission The FDA holds a trove regulatory data and valuable scientific knowledge from thousands of failed biotech companies which could accelerate drug development if made accessible. The CTD Commo...

CTD Commons could change that. Access to prior filings lets teams see how similar therapies were evaluated, how regulators responded to risks, and where programs failed. Mistakes avoided = time and cost saved. www.ctdcommons.org

Today, only large pharma companies benefit from decades of accumulated regulatory precedent. Smaller startups rely on consultants, fragmented guidance, and trial-and-error, which can add years of delay and massive costs.

Think of regulatory filings not as paperwork, but as one of the richest scientific archives ever created: detailed preclinical data, clinical trial outcomes, manufacturing processes, and real-world regulatory decision-making!

With the support of @1daysooner.bsky.social and @renphil21.bsky.social, CTD aims to recover, analyze, and share regulatory filings from failed biotech companies.

Home The Mission The FDA holds a trove regulatory data and valuable scientific knowledge from thousands of failed biotech companies which could accelerate drug development if made accessible. The CTD Commo...

CTD Commons is built on a simple idea: this loss isn’t inevitable. Much of this data can be legally recovered through U.S. bankruptcy proceedings without requiring disclosure by the FDA. www.ctdcommons.org

Home The Mission The FDA holds a trove regulatory data and valuable scientific knowledge from thousands of failed biotech companies which could accelerate drug development if made accessible. The CTD Commo...

Biotech loses an enormous amount of knowledge every year—and almost no one talks about it. When startups fail, their regulatory and clinical data usually disappears with them. A new initiative—called CTD Commons wants to change that. www.ctdcommons.org

www.1daysooner.org/council/

1Day Africa's grant program for African researchers is now accepting applications! Please share far and wide! The deadline for applications is February 28th.

Opinion | Why I Chose to Get E. Coli Human challenge trials can accelerate medical innovation

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ETEC causes millions of infections each year and remains a major cause of child mortality worldwide. Josh’s experience highlighted something we see every day: research only moves when volunteers step forward. His full reflection on participating is here: bit.ly/4rYx0K5