Introduction to the Author - Carolyn Kreuzkamp
Carolyn Kreuzkamp is a seasoned market strategist and scientific reviewer for the NIH SBIR/STTR program, empowering research-backed start-ups and small businesses across the US to secure millions in funding from both the private and public sectors. Leveraging both her technical and market expertise, Carolyn founded C. Kreuz Consulting to fuel growth and profitability for each of her clients.
How to design a competitive proposal for the Sprint for Women’s Health ARPA-H Program
Like many others, I have been very excited about the current investments for research in Women’s Health from both the public and private sectors, particularly the recent White House Initiative on Women’s Health Research and the subsequent $100 Million commitment to research and development (R&D) in Women’s health via the ARPA-H award mechanism. The announcement has attracted interest across private investors, small businesses, research teams, non-profits, and corporations, but the process for receiving Federal funding can be nuanced and confusing! If you and your team feel overwhelmed by the prospect of applying for non-dilutive Federal funding, such as that awarded by ARPA-H, you are not alone! What makes understanding each Federal funding opportunity difficult is that each Federal agency, such as the Department of Human Health and Services (HHS) or the Department of Defense (DoD), has different award requirements and expectations and that those requirements and expectations change frequently. In addition to that, each agency has many different funding paths, each with their own intent and specification.
For the simplicity of this article, I provide a Q&A-style guide on how to design a competitive proposal for the current ARPA-H $100 Million Sprint for Women’s Health program under HHS.
What exactly is the HHS ARPA-H program?
As stated on the ARPA-H website, The Advanced Research Projects Agency for Health (ARPA-H) supports research breakthroughs that can deliver transformative, financially sustainable, and broadly applicable health solutions for everyone. The Sprint for Women’s Health is a specific program under ARPA-H that invests in research topics and health innovations targeting women. However, ARPA-H funds various research topics throughout each fiscal year that could be aligned to your company’s women's health initiative, such as those in neurodegenerative diseases, immune therapies, and rural access to medical care.
Please note, Requests for Solutions for the Sprint for Women’s Health are due at midnight EST on Monday, April 15th.
What qualities make a competitive ARPA-H proposal?
Programs like ARPA-H rely on the technical merit of the solutions being proposed and the track record of the teams proposing them. These are advanced research projects and the review team will be assessing each solution for its technical feasibility, followed by its market feasibility.
What exactly does “Technical Feasibility” entail?
Technical feasibility shows that a research team has thought out their research plan in detail. A research plan should include specific milestones (often referred to as “Specific Aims”), which may include human subjects considerations and IRB approvals, ex vivo/bench testing, animal testing, in-human testing, academic/clinical/teaming partners, ISO certification and biocompatibility testing, patent filings and plans for IP, and more.
What about “Market Feasibility”?
Market Feasibility shows that a research team has considered their path to market once their research hypothesis has been tested, validated, and proven significant to proceed with commercialization. Depending on the end use-case of the product and service being researched, this may include regulatory pathways and FDA Approval, CPT code applicability for billing, licensing partnerships, competitive analysis, financial projections and return on investment (ROI) timelines, marketing and advertising strategies, high-level acquisition plans, and more.
My company is very interested in moving forward with submitting a competitive ARPA-H Sprint for Women’s Health RFS. Where should we begin in writing a competitive proposal?
The ARPA-H initial Request for Solutions (RFS) are high-level, yet must be backed by a thorough research plan that shows a comprehensive understanding of the research topic and its intended market application, competitive landscape, regulatory process, clinical adoption path, and business model. ARPA-H does provide Program Managers (PM) to assist with guiding research teams (“Performers”) on seeing the success of each proposed project through, but performers should not solely rely on PM’s to be aware of all the intricate details regarding their research.
Given this information, I strongly recommend that teams first write out an entire project proposal including all of the elements listed above in as much detail as possible, and then use that information to inform the content within the RFS. To help inform your team’s proposal, I am sharing a 6-step overview for writing a competitive ARPA-H RFS with related suggestions for each step.
1. Choose an evidence-based research hypothesis that is of interest to one of the ARPA-H Sprint for Women’s Health topics
Women’s Health Topic 01: Women’s Health at Home
Women’s Health Topic 02: Prioritizing Ovarian Health Through Mid-Life to Prevent Disease
Women’s Health Topic 03: ARTEMIS – Advancing Research Through Enhanced Models for Investigating the Influence of Sex Differences on Health Outcomes
Women’s Health Topic 04: Advancing Women’s Brain Health Via Lymphatic Targeting
Women’s Health Topic 05: Objective and Quantitative Measurement of Chronic Pain in Women
Women’s Health Topic 06: WILD CARD: Revolutionary Breakthroughs in Women’s Health
Note: If your hypothesis relies on existing data sets (i.e. innovations using existing data sets for AI/ML algorithm training), those sets must be tested and validated for bias. For example, If your proposal involves conducting research on women at-risk for preeclampsia using an open source data set, does that data set include information on BIPOC women? If not, part of your research plan should address this.
2. Tell reviewers why your particular research solution would be game changing to the current health landscape
Is your team changing the standard of care or building a new database for women’s health research?
Are you researching a new therapeutic or developing a new surgical procedure for female-specific pathologies?
If your team has performed preliminary research, now is the time to brag! This may include market research, in addition to lab or clinical research findings
3. Build out 2-3 detailed, data-driven research milestones (Specific Aims) around your hypothesis
Your proposal will be reviewed by clinical and scientific experts in this exact space, so use this as an opportunity to show that you are well-equipped to add significant value to the research landscape!
Does your research solution plan to involve animal testing? If so, your proposal must follow laws and regulations surrounding human animal testing and care.
Does your research solution plan to involve human subjects? If so, your proposal should include a plan for an IRB approval
Does your research solution plan to involve a clinical trial? If so, your proposal should be realistic and informed about the clinical trial process.
Does your research solution involve a medical device? If so, your proposal may need to discuss biocompatibility and ISO requirements.
4. Secure support from both public and private partners
The government loves to see formal involvement (i.e. teaming agreements, sub-awards, funding commitments) from multiple parties as it de-risks a project
For both formal and informal partnerships, get letters of support.
5. Write a high–level, yet thorough, budget including direct and indirect costs.
If you are unsure of your team’s calculated indirect rate, use a standard 40% of direct cost value.
6. Review the submission requirements multiple times prior to submitting your final RFS to ensure your application meets each requirement and specification; if there is a required part of a submission missing or the proposal is written not in accordance with what is asked, you risk your proposal not being reviewed.
Wow, that's a lot of information. I’m not sure if my team can prepare a truly competitive proposal before the April 15th deadline. Will there be other options for my research proposal to be funded by the US Government?
YES! If you are reading this but feel like this is a LOT of information to synthesize before the April 15th deadline, know that there are multiple ongoing funding programs that annually award $100M+ to innovative research projects, such as the SBIR programs held by over 10 Federal agencies! If your team does not apply for the Sprint for Women’s Health ARPA-H award or you apply and do not receive an award, there are many other non-dilutive funding options available to receive competitive funding to help get your product to market.
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If your team is looking to tap into the Federal funding space to fuel your research objectives, or if your fund is looking to diversify its portfolio with Federally-funded innovative research companies, let’s chat! Feel free to personally email me at Carolyn@ckreuz.com to set up a call.
