Innovation Pharmaceuticals Inc (IPIX)

[HolesInMyPockitz]

I sent an email to Inka Sastalla, “Scientific Review Officer | Microbiology Review Branch (B) | Scientific Review Program | DEA, NIAID, NIH”.

I asked her about the grant process. Here is her response:

I am not very familiar with all the ways that NIAID gets drugs into the pipelines for testing, and what you read in the news is often not NIH alone, but BARDA and other HHS entities, or DoD that make awards which might be handled differently. So what I am writing is how I believe it works, taking public information and my knowledge of NIH funding mechanisms and existing networks into account.

All new NIH grants have to, as mandated, go through peer review (https://grants.nih.gov/grants/peer-review.htm#:~:text=The%20NIH%20dual%20peer%20review,Research%20and%20Development%20Contract%20Projects%22.). This process takes several weeks, so there is no newly submitted grant from one company that is reviewed differently from, or faster, than all the others. I suspect that some drugs/companies you might be thinking about and referred to in your email may have already been supported by NIH grants and are now being moved quickly through established pipelines. Remdesivir, e.g., was funded by NIAID through a grant awarded to UNC in 2017 (which underwent peer review). https://sph.unc.edu/sph-news/gillings-researc...s-disease/. NIH-funded investigators can also apply for emergency supplements. These are competitive revisions to already existing, active grants. https://grants.nih.gov/grants/guide/notice-fi...0-059.html and awards can be made faster as they don’t undergo peer review as newly submitted grant applications do.

NIAID also has contracts/cooperative agreements that are designed as vehicles/centers to quickly respond to emerging infectious diseases and to move promising drugs through these the established centers. For example, the Vaccine Trial and Evaluation Units are 7-year cooperative agreements that were solicited in 2018 and underwent peer review in 2019 (https://grants.nih.gov/grants/guide/rfa-files/rfa-ai-18-046.html; https://www.niaid.nih.gov/research/vaccine-tr...nits-intro and https://med.emory.edu/departments/medicine/di...index.html. Since these are cooperative agreements and sometimes contracts, NIAID can provide input about what gets tested. I think the way it works is that NIAID looks at what is in their current research portfolio and then focuses on already funded promising drugs and approaches to see what can be expanded.

NIAID is also soliciting new ideas via new grants, such as the ones reviewed in the July 17 meeting, or via the SBIR links I sent in my previous email. The dates of the peer review meetings are not immediately set, but depend on the Scientific Review Officer (SRO) and the recruitment and availability of peer reviewers. Establishing a peer review panel, organizing the meeting and writing the reports (summary statements) takes several weeks, and applications NIH intends to fund are approved by the NIAID council, which consists of established scientists in the field and which meets 3 times a year. https://www.niaid.nih.gov/about/advisory-council. If you plan to submit, you would do so in response to active Funding Opportunity Announcements, which can be found here for NIAID: https://www.niaid.nih.gov/grants-contracts/opportunities . For example, https://grants.nih.gov/grants/guide/pa-files/PA-20-260.html solicits SBIR applications which can be submitted starting August 5 – September 5 (standard due date), with peer review some time in October-December, Council approval of to-be-funded applications in January, and earliest start date in April.

The R01/R21s FOAs I linked to in my previous email are a bit different because no standard due dates apply (applications can be submitted at any time), the peer review meetings are put together more quickly, and funding decisions are made quicker, too. However, these FOAs expire on August 14, and anything submitted after that would have standard due dates and the regular peer review/council approval timelines.

Best,
Inka