JPM2024: Investing in preemptive medicine programs

The annual J.P. Morgan Healthcare Conference (JPM) provides a unique opportunity to make connections among life sciences and health care emerging companies, pharma/biotech companies, investors, and advisors.

An already challenging financing market can seem especially daunting for innovative technologies that seek to go beyond merely treating a disease in order to promote healthy longevity. Innovators inspired by the promise of healthspan opportunities face a number of hurdles, including how to establish the safety and efficacy of their therapies while arguably lacking a clear regulatory pathway for preemptive interventions. Notwithstanding, stakeholders can take strategic steps now to better position their healthspan early development programs for success.

Healthspan funding opportunities

Pre-clinical and clinical development programs require a lot of cash, and opportunities in healthspan are no exception. Early stage funding can either be dilutive, which requires selling equity in the company in exchange for cash or other value and in which the founders’ and early shareholders’ ownership percentage is reduced, or non-dilutive, which does not result in a percentage reduction in founder ownership. Particularly in today’s challenging fundraising market, emerging companies should consider available non-dilutive funding opportunities to avoid impacting their cap table. In the U.S., these include government grants, such as from National Institutes of Health (NIH), National Cancer Institute (NCI), National Science Foundation (NSF), Biomedical Advanced Research and Development Authority (BARDA), U.S. Department of Defense (DOD) as well as regional options including the Cancer Prevention and Research Institute of Texas (CPRIT) and California Institute for Regenerative Medicine (CIRM).

The newly announced and constituted Advanced Research Projects Agency for Health (ARPA-H) research funding agency may provide a unique opportunity for healthspan innovators to seek this type of non-dilutive funding from the federal government and the timing couldn’t be better for life sciences entrepreneurs launching such efforts. ARPA-H aims to support fundamental research that cannot readily be accomplished through traditional research or commercial activity. In particular, ARPA-H’s Proactive Health initiative supports preventative programs that will promote treatments and behaviors that will reduce the likelihood that people will become patients. ARPA-H also provides opportunities to work directly with the Food and Drug Administration (FDA) to accelerate innovation and accelerate better health outcomes, i.e., companies seeking to introduce new healthspan technologies into the market. As with any government funding program, there are considerations regarding governmental rights and other restrictions on the use of funds that grantees will need to navigate and account for in their other fundraising efforts.

Finally, public-private partnerships will likely play an outsized role in the healthspan area not least because of the less clear regulatory pathways for approval of these therapies, as we discuss in more detail below. Many chronic disease have national nonprofit foundations that can provide funding opportunities for companies involved in research and commercialization within specific focus areas. Strategic development partnerships with similar foundations are another funding source to consider in the path to developing and commercializing products without impacting the cap table.

Preemptive care within a treatment framework

Existing regulatory frameworks are well-suited for the approval of new drugs and biologics intended to treat a disease or condition after onset, and to some extent, to preventive measures indicated for certain specific diseases. However, these established pathways often lack a clear mechanism for examining healthspan and other products intended to preempt multifactorial chronic conditions. Moreover, the clinical trial designs used to investigate products within these more traditional pathways do not necessarily lend themselves to the study of healthspan products, which are intended to demonstrate more generalized clinical improvement over decades rather than discreet, acute clinical outcomes. Notwithstanding, there are ways in which healthspan stakeholders can think strategically about how an appropriate regulatory approach can advance their technologies. 

Investigate qualified biomarkers, where possible. Biomarkers serve as an objective measure that can be evaluated as an indicator of normal versus pathological biological processes and can be used to evaluate responses to therapeutic interventions. Where a biomarker is a well-established indicator of a disease state, it can also, in appropriate circumstances, be used as a clinical endpoint in evaluating therapeutic efficacy. Establishing a biomarker as “qualified” often requires extensive data collection and years of research.

In the healthspan area there is often a wide gap between exploratory biomarkers that are appropriate for research purposes, and those which would be reliable to FDA or other regulatory bodies in demonstrating a clinical effect. For this reason, healthspan researchers should consider including more established biomarkers or other indicia that have been qualified by FDA, in addition to any exploratory measures, while they investigate the mechanistic pathways of chronic disease in higher-risk individuals with a goal of identifying potential root cause(s) of a pre-disease state. Clinical trials reflecting an appropriate level of uncertainty for a targeted patient population should also be designed with these principles in mind.

Take advantage of existing agency programs. Healthspan stakeholders should also consider engaging FDA as early as possible in their development and commercialization planning, especially where their investigations involve novel assessment parameters. FDA has a number of available programs that can help sponsors work more closely with the agency and provide important tools in the path towards approval success.  

For example, the accelerated approval pathway allows for interim approval based on a surrogate endpoint, followed by appropriate confirmatory data. While not a direct measure of clinical benefit, surrogate endpoints can nevertheless inform clinical trials where they are either known to, or reasonably likely to, predict clinical benefit. The accelerated approval pathway is understandably reserved for the most serious and life threatening conditions, but could provide insights to healthspan investigators on the standard of evidence that might be adaptable or suitable for approval of products with preemptive benefits. These standards could also be helpful in guiding conversations around FDA/ARPA-H funding opportunities. 

Advocate. Healthspan stakeholders should also consider opportunities to advocate for more transformative policy changes before FDA in the U.S., the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, and other global regulators. For example, FDA routinely conducts patient outreach in connection with stakeholder meetings on specific disease states. Healthspan stakeholders should consider advocating to include the perspective of currently healthy, but pre-disease state, individuals in FDA outreach as well. In addition, stakeholders should consider opportunities to advocate for changes to pricing and reimbursement systems to recognize the overall societal value of preemptive solutions. Here again, strategic partnership with nonprofit foundations and other patient organizations may support opportunities for outreach.

Real change may require a move away from the current sickness-centered approach while preserving the core principles of evidence-based claims, patient safety, and advancing public health for a broader population base. There are many potential upsides to keeping currently healthy individuals healthy for as long as possible. Finally, it is important to remember that preemptive care approaches should be viewed as complimentary to continued research and investment into new therapies to treat disease in the overall health ecosystem.

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Authored by Barry Burgdorf, David Fox, Beth Roberts, and Blake Wilson.



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