💁🏻 Executive Summary
The compressed timelines for multiple vaccines in 2020 were the result of global effort. Domestically, Operation Warp Speed enabled public-private partnerships between vaccine sponsors, such as the biotech Moderna, and the inter-agency network of the FDA, HHS, NIH, and others.
In this exceptional crisis, P21 was able to play a part in supporting Moderna's submission to the FDA for its COVID-19 vaccine. Our client-vendor partnership served the expedited regulatory filing. Under the auspices of the FDA’s review, only a few weeks elapsed between the filing and the issuance of the EUA—a landmark in accelerated submission.
🧬 Early R&D and Client-Vendor Relationship
Moderna was planning to commercialize their mRNA technology for multiple therapies, including personalized cancer treatments.
Anticipating FDA submissions in the coming years, Moderna had begun their relationship with P21 in 2019 well before the COVID-19 outbreak. They completed their onboarding to our P21 Enterprise platform in January and February 2020.
Moderna pivoted to work on a COVID-19 vaccine in January 2020. As a biotech with a younger pipeline, they were facing their first FDA submission. Failure was not an option, so P21 committed to remove any submission blockers from their path.
🚀 Market Accelerant and Confident Collaboration
True to our open-source roots, P21 offered Moderna pro bono (free and unlimited) support to fill in gaps in their eSubmission infrastructure. We provided 24/7 uncapped resources to remove resource allocation barriers. Moderna’s team of 800 gave nights and weekends to achieve results like a firm 100x that size, and P21’s small team of 50 kept pace—all to speed this life-saving vaccine to market.
P21’s role transformed from IT vendor to regulatory submission consultant. Moderna saw that in subscribing to our tech platform, they had also gained access to our expertise during this critical and unexpected challenge.
Despite the high pressure, Moderna expended great effort in following guidance and best practices fastidiously. They needed to enable an efficient and responsive path through the regulatory review. P21 rose to the challenge with:
Ad hoc advising in data standards and access to key stakeholders, as the FDA had specific expectations about how the SDTM and ADaM datasets were to be implemented in the expedited process.
Training and technical support for our tools to validate data from 30,000 participants, build define.xml, and write a Reviewer's Guide.
Consulting for resolution of data issues to achieve optimum “fitness for use,” reducing the usual year-long preparation time for the data package to less than 4 months.
Finalizing deliverables in just a few days during off-hours, alleviating their documentation burden and resulting in a high-quality submission package that met FDA expectations.
⏳ Approval Timeline
This timeline was achieved through exceptional public-private collaboration during a time of crisis. Moderna and P21 played a part in removing blockers to serve health authorities and the public good.
January 2020 | Moderna “goes live” on their P21 Enterprise environment. |
March, May, July 2020 | Clinical trials begin for Phase I, II, and III, respectively. |
May 2020 | P21 ramps up consultative support as data are delivered. |
November 2020 | Moderna's vaccine undergoes interim analysis, and EUA application starts being prepared. |
December 2020 | EUA submitted to FDA. FDA validates data with P21’s DataFit software, and grants EUA to Moderna. |
Special thanks to the team at Moderna for their collaboration and approval to share this case study!
For all our clients, if your team has a case study or success story to share, please email us your idea so we can discuss it and your publishing options: support@pinnacle21.atlassian.net.