ARPA-H "Sprint" Awards: All Women Are Winners

ARPA-H AWARDS: ALL WOMEN ARE WINNERS?

On October 24th, Arpa-H announced the 23 winners of its “Sprint for Women’s Health” initiative. I’ve had a chance now to read the announcement carefully and assess the impact. Having done so, I can share that I’m impressed, grateful, and certain that decades from now we’ll look back on the Biden Administration’s accomplishments and count progress on #womenshealth as chief among them.

But the question of whether the $110 M in grants awarded last month will make an impact won’t take that long to determine. The unique thing about the ARPA-H mission and methodology is that it allows for some big bets with short time-lines. Awards were divided into two tracks: “Sparkplug” projects representing high potential research with grants of about $3 M; and “Launchpad” projects where initiatives already at or near prototype get? $10 M in funding to take a product to market. And the expectation is that Launchpad efforts, if successful, will be launched in two years.

Just two years. Some of these represent huge, breakthrough therapies and approaches attacking some of the most persistent problems in Women’s health. If even one-third of these land, the impact will be great. Let’s take a deeper look at 6 projects that could be making a difference in our lives by the end of 2026.

A quick caveat: I’m not professionally connected to ARPA-H, which is its own institution. All of my opinions are my own, representing just my unique very inquisitive perspective.

Addressing the Criticisms

Before unleashing my excitement, let’s acknowledge some of the criticisms that have been lodged.

$110 Million for research into women’s health is too little. It is true that the Arpa-H initiative, or any single initiative, can’t bridge the gap in all that remains to be understood about the bodies of more than half the population. And it doesn’t have to. For the moment, at least, other institutions - from the Department of Defense, to the 27 institutes of the NIH, to the National Science Foundation - all have initiatives. This was incremental funding, directed specifically towards big ideas capable of moving the needle.?

The items funded represent “trendy” ideas. Yes, with 6 different topic areas, the awards represent a huge swath of topics with the $3M “sparkplugs” addressing 18 different projects. But there was already deep research on the 5 topic areas of focus. That research informed hypotheses about what projects would move the needle. I am inspired rather than frustrated by the choices.?

?There’s a lack of logic to the type of organization awarded - ranging from university, to start up, to public company. Regarding the range of organizations: remember, these are not SBIR grants. Arpa-H had the freedom to review international proposals, the work of universities, start-ups approaching their first dilutive funding rounds, as well as public companies. The emphasis seems to have been on choosing the project based on its merit as long as the maturity of the organization matched the requirements for success.?

Six Big Questions; Six Meaningful Bets

“Sprint for Women” asked for applications that addressed six big questions. I’ll share how many awards and how many dollars were allocated per topic and highlight the largest in each category. In all cases but one these are “launchpad initiatives” that have a two-year timeframe.?

• ARTEMIS: Understanding Sex Differences (One award given; Sparkplug, $3 M)

The topic question was “What if we could revolutionize female-specific research models to ensure equitable and effective treatments.” In other words, could improvements made to a research MODEL take a big whack at the gap in women’s health research??

The awardee is a doozy: Over 90% of FDA drugs aren’t recommended during pregnancy because there’s been insufficient research into possible impacts on the fetus. This means pregnant women can’t avail themselves to most therapies for most conditions. This one project aims to create a platform that will allow dozens of drugs to be tested at a time, creating a path towards evaluating all FDA-approved drugs to identify those that are safe for mom and fetus and identify appropriate dosing. This would be a leap forward at ANY time. But given that in a Post-Dobbs world OBGYNs in some states are subject to legal action if they do anything to mom that could harm a fetus, it is sorely needed right now.

Principal Investigator: @Dr. Corin Williams; @The Charles Stark Draper Laboratory.?

• Prioritizing Ovarian Health. ($13.5 M ; 2 projects - 1 Launchpad $10M)

Topic Question: What if prioritizing ovarian health could actively prevent or delay the chronic conditions and diseases associated with perimenopause and menopause??

The “big bet” in this category is a show stopper. To keep the ovary functioning and keep at bay the comorbidities of menopause including dementia, cancer and cardo disease, this project envisions an implant that could replace deficient ovarian function and restore hormonal processes. The age-related diseases we now know are connected to menopause are the major reason why women’s “health spans” are so much shorter than their life spans. We are going to know in 2 years whether there’s something in the works that could change that. Wow.?

Principal Investigator: @christian Kramme at @Gameto Inc.?

• Women’s Health at Home. ($22.5 M awarded; 5 projects - 1 launchpad, $10 M)

Topic question: What if women were empowered to address their healthcare needs through diagnostics and treatments at home across all ages and stages of life?

The launchpad in this category is pre-emptive cure for persistent high-risk papillomavirus (HPV) - the cause of cervical cancer. The treatment will be an easy to use at-home gel containing two well-known antiretroviral drugs with a known safety profile. It intervenes earlier than current products and will eliminate “watchful waiting” doctor visits.?

Principal Investigator: @dr. Isabella Johnson at @Dare Bioscience.

• Women’s Brain Health. ($24.7 M awarded; 6 projects - 1 launchpad, $9 M)

It’s now known that the lymphatic and glymphatic system helps filter fluid and clear waste from brains. Understanding these functions may help demystify neurodegenerative diseases and unlock therapies.

The launchpad in this category asks a billion dollar question: What if we could use non-invasive imaging to understand how gender affects the health of women’s brains? The project will validate and commercialize an MRI metric of glymphatic function and lead to measurement of the myriad neurological disorders that are more prevalent in women, leading to breakthroughs in assessment and therapy.?

Principal Investigator: @david Alsop, PHD @Beth Israel Deaconess Medical Center

• Measurements of Chronic Pain. ($17.5 M; 5 projects, 1 launchpad, $8.1M.)

Topic Question: What if women’s pain were taken seriously? (editorial comment: ‘Nough said.)?

Women’s pain is vulnerable to subjective assessment on both sides: Women often wonder if it’s really that bad and so do their providers. But if we had objective measurement? The launchpad project here posits that women’s eyes provide the window for that measurement. The project will develop a physiologic biomarker to objectively characterize pain type and intensity. When developed, it could go beyond asking the question “how bad is this pain really” to the critical question of “is this therapy working to make her feel better?”?

Principal Investigator: @julia finkel, M.D @Children’s Research Institute

• Revolutionary Breakthroughs. ($32 M; 6 projects, 2 launchpads, each at $10M.)

Topic Question: What if we could shatter the glass ceiling of women’s health research with innovations so bold they rewrite the rules of the game?

This is the 6th and last category, and the question is so big and promising that it serves as a grand finale, illustrating what the “Sprint” stands for. And two launchpad projects were chosen that measure up to the ambition of the question.?

Number One: One out of 10 women suffer from endometriosis, but there is still no definitive diagnostic (though several solid efforts are making their way through the research cycle.) This launchpad seeks to address why the effort has proven so difficult by using a multi-mode approach to track disease progression to unlock both new diagnostics and new treatments.?

Principal Investigator: @Sandra Milligan @Aspira Women’s Health

Number Two: What if our own immune systems could be engineered to eradicate ovarian cancer?? This launchpad project believes that personalized nanoparticles can be derived from a patient’s own body and create effective, non-toxic treatments for late stage cancers.

Principal Investigator: @Jill Kolesar? @The University of Iowa

By the way, the above uses a platform technology - meaning if it works on ovarian cancer it can be applied to others. In fact, many of the breakthroughs sought above (i.e. creating a biomarker for measuring pain through an image of the eyes) will create innovations that treatment people with penises as well as those with boobs. So maybe the Biden administration will get to claim accomplishments that solve big health problems for ALL people?

Oh, I forgot. With earth-moving accomplishments including lowering the price of insulin, they already have…. test test