For over 100 years the National Institute of Health (NIH) has been the primary agency of the United States government responsible for biomedical and public health research. Each year, they are providing about $32 billion dollars to various grant programs1. Its work to accelerate the development of various drugs and devices has been a net positive on society. As it is usually the first to fund scientific discoveries, the NIH has a track record for funding innovations that overshadows the biggest and most successful investment firms. The rigorous scientific and council reviews provide a wealth of important feedback that undoubtedly improves the grant and in most cases positively impacts the results of the proposed study. When awarded, an NIH grant, can be a stamp of approval for the proposed science, the investigator, and in the case of a potential intellectual property, a reason for investment. In many cases the NIH grant award provided the lifeline and springboard to many successful drugs, biotech innovations, diagnostic tools, vaccines, and many more.
As a personal example, our startup, EncepHeal Therapeutics, could not have existed without the early research and data from the National Institute on Drug Abuse’s (NIDA) Intramural Research Program and funding of our various SBIR grants. We have the utmost respect for the researchers and program officers that were our first believers and our best sources of feedback when we started EncepHeal.
This is at the core of what the NIH does extremely well. Their grant review process begins with a rigorous and independent scientific review, where scientists related to a specific field will review a grant application, give it an objective score, and provide detailed feedback on the data collected and the scientific approach. This style of review directly led to changes in EncepHeal’s scientific plan where we completely changed the design of our functional assay after a reviewer for our grant correctly identified potential metabolism issues.
The NIH were also our first funders and are typically the first money into a technology, whether funding its basic research with R01 or R21 grants, or providing the first seed capital into the startup with an SBIR/STTR grant. Lastly the program officers were extremely supportive and clear. Letting us know upfront if we had a fundable project and providing core feedback along the way.
Despite all the positives the NIH brings to biomedical research and development, the process desperately needs some revisions. It is common for submission to spendable funds to take close to a year. That’s assuming the first submission is funded, which is rarely the case. It’s understandable that before adoption of computers and the internet, the paper submissions process contributed greatly to the long delays. It must have been grueling printing and mailing 5+ copies of every full grant submission. Now with years of technological advancement, the system is antiquated. In this current system, potential technologies can be stuck in academia indefinitely. The scientific review process also leads to another problem: younger investigators are at a big disadvantage.
Let’s breakdown the NIH grant process:
Researcher submits a grant application before one of three due dates
Researcher waits 2-4 months
Scientific Review Committee meets to discuss the grant applications. Those triaged to the full meeting will receive a score.
Researcher waits 0.5-1 month
Researcher receives a detailed summary statement outlining the reviewers thoughts on the application.
If the researcher did not receive a score, they must resubmit and go back to step 1. If they did, they are waiting 2-3 months.
Advisory Council of the specific agency meets and reviews scored grants. Approvals here get a notice of intent designation.
Grants management agent reaches out to researcher for additional materials. Researcher submits. Process can take 1-2 months.
Researcher receives a Notice of Award.
If you add up all the bolded items, a researcher is looking at a 6-10 month process as the best case scenario. If they have to resubmit, now he or she is looking at over a year. In addition, requiring specific due dates leads to its own set of problems. At EncepHeal, we submitted a grant for the January due date that was ultimately not scored. With the next due date being in April, we were eager to potentially resubmit based on the feedback. However, since the scientific review committee did not meet until the end of March, we did not get our feedback until after the due date, pushing the process back a half a year!
At the core, this is the antithesis of what it means to run a successful translational science program or biotech startup. Specifically as biotech founders, our goal is to move quickly: gather data and get to our milestones. Bio founders know that each day delayed can cost the company $1 million dollars in potential revenue. This makes it almost impossible to be successful when relying on grants. Sure there are other funding mechanisms like angel and VC funding, but there are certain disease areas that do not get the right attention from those sources.
This leads to a lack of momentum for great ideas and inventions making the leap to translational science and eventually industry. We believe there could be plenty of new technologies with great applied potential that are currently lost/stuck in basic science! Additionally, the slow funding has a negative effect on academic scientists looking to make the leap to a startup or industry.
In a recent blog post from our friends at Molecule: It is estimated that the NIH allocates just 2% of its funding to scientists under 36, and 98% to those 36 and older.2In order to join a scientific review committee, a scientist must be a principal investigator on a research project. Therefore if only 2% of scientists under 36 receive funding as PIs3, then only 2% of younger scientists are eligible to serve on the committee responsible for initial funding decisions! Clearly the current NIH system is not set up to solve this problem.
As younger investigators ourselves, this problem plagued us during the early days of EncepHeal. Both Omeed and I were sure that we would not pass scientific review if one of us was the principal investigator. We ended up getting lucky when our more experienced cofounder stepped down from his position at Wake Forest and joined us full time.
This idea of favoring more experienced scientists, who tend to be older in age, is not a new phenomenon in the scientific world. Unlike the tech industry, which has founders who come directly out of high school and college, the Biotech industry is a much older demographic. The SF Business Times found that of 47 biotech companies that IPO’d, the average age of the executive team was 51!4 The idea being that you need “grey hairs” on your head to understand how to take a technology to the next level. We believe that this is false. As long as the individual is driven towards R&D and commercialization, asking and answering the right questions, and surrounded by the right individuals then Biotech founders from any age group can be successful.
Our goal now is to solve these problems. We are here to introduce the Next Institute of Health. Our plan is to utilize a large community of academic scientists to review NIH style grant applications in 2-4 weeks as well as a community of scientific consultants to form a team around the academic scientist to take their basic science onto the developmental path. The project is still in its early stages, but in the coming weeks, we will publish more blogs highlighting the details of how we plan to become the Next Institute of Health. If you cannot wait until then, please come join us on discord to help us further build this out and contribute to our working groups. If you are interested in applying for one of our grants, please fill out this form.