JPM panelists see opportunities under new U.S. regulators for venture capital and investing in emerging life sciences fields

Teeing up the conversation over “healthspan” products, Dave Fox, partner in the Hogan Lovells pharmaceutical & biotechnology regulatory practice, explained how existing U.S. regulatory frameworks are well-suited for the approval of new drugs and biologics that are intended to treat a disease or condition after onset, and to some extent, for preventive measures indicated for certain specific diseases. However, these established regulatory 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, Fox advised.

Pointing out that a large portion of drug and biological product innovation stems from university research, which is funded via identification of a specific target, Barry Burgdorf, partner in the Hogan Lovells Corporate & Finance practice, explained how the potential “Make America Healthy Again” (MAHA) movement could create a “sea change” in life sciences research, enabling a broader focus on health and opening up new types of treatments to investment. Burgdorf observed how venture capital funds are being set up in response to the potential appointment of RFK Jr. to lead HHS, and the MAHA campaign, with a heightened focus on products like nutraceuticals, pre-disease assessment tools, and preventive treatments aiming to extend the average lifespan.

Indeed, Andrew Brack, Ph.D., program manager at the Advanced Research Projects Agency for Health (ARPA-H) forecast the investment climate toward treating diseases like dementia and cellular decay could become friendlier in the coming months. Dr. Brack, previously the co-founder of Arrive Bio, a longevity company that uses machine learning to identify drugs to treat age-related diseases, explained that by preventing health declines, scientists may be able to delay diseases as well. “We need pre-disease treatments,” he urged, advocating for greater awareness of the importance of funding “healthspan” treatments. Making America healthier could occur by finding drugs that move the needle toward general health and physiology improvements, he said, describing how ARPA-H funds research in that direction.

Beth Roberts, partner in the Hogan Lovells health regulatory practice, discussed challenges associated with the divided payer system the U.S. and how many private payers follow Medicare’s lead. Medicare coverage is governed by the Social Security Act, which generally limits coverage to items and services that are “reasonable and necessary for the diagnosis or treatment of an illness or injury.”  “Aging” is not viewed as a “illness,” and preventive drugs and services only are covered if specifically listed in the statute, or recommended by the US Preventive Services Task Force. Dr. Brack further explained how researchers may define “ageing” from a “systems biology” approach, following the World Health Organization model that assesses “intrinsic capacity,” which considers factors like cognitive function, sleep patterns, and muscle function, in order to define “health.” 

Asked what it may take to get private insurers to divorce themselves from looking to Medicare to set reimbursement policies, Roberts suggested that private insurers may start covering healthspan products to attract more healthy patients to their plans, or to help make the patients who they’re already covering healthier. Indeed, she observed, more private insurers are covering obesity therapies for this reason. Roberts expressed optimism that additional coverage will be extended as obesity treatments – and potentially healthspan therapies – generate more clinical evidence that they indeed prevent diseases such as diabetes and heart disease, and reduce future health care costs as a result.

Roberts predicted that when encouraging clinical data is received from organizations like ARPA-H, there are novel paths that payers may use to reimburse health-focused treatments that might be able to “turn back the clock” on ageing. Adding on to this optimism, Burgdorf cited the benefits of Real-World Evidence (RWE) in encouraging in investment in medicinal products in the healthspan space.

As an investor committing funds toward healthspan treatments, Ross Barrett, managing partner at the Cancer Focus Fund, predicted increased investor confidence with regards to regulatory paradigms in the new U.S. government administration, which could lead to greater innovation. Barrett promoted Congressional action to permit reimbursement for emerging medicines, looking forward to increased deployment of capital into university research. 

Burgdorf spotlighted the importance of transparency in investing, which he said underscores the critical nature of quality due diligence. Describing MAHA’s stated goals, Burgdorf explained the new administration has said it favors enhancing the flexibility of choice in health care, in part by permitting states and privates insurers to experiment with reimbursement incentives programs. 

Responding to a question over risks associated with cross-border transactions involving the new U.S. government administration, Fox cited how although the proposed BIOSECURE Act did not become law, the investment climate toward China-entangled transactions “remains to be seen,” as his colleagues previously summarized online here.

Asked about changes in U.S. Food and Drug Administration (FDA) leadership, Fox strong, evidence-backed leadership from incoming Commissioner nominee Marty Makary may allow the agency to generally “operate within its normal range of activities” with the usual changes we see in emphasis from new administrations, but not categorical changes.  However, he pointed out that FDA may be affected the most, in the near-term by a change in resources, staff, or funding, such as ”an order requiring full-time return to office, which could be l be devastating to the agency given its historical reliance, dating back more than 20 years, on flexible and remote workschedules and hiring,” he predicted.

The annual J.P. Morgan Healthcare Conference (JPM) provides a unique opportunity to make connections among life sciences and health care emerging companies, pharmaceutical & biotechnology firms, digital health companies, med tech sponsors, investors, and advisors. The article above is part of our JPM 2025 “Fireside Chat” series of presentations, through which our team of attorneys spoke with stakeholders at the conference about the most critical global health care issues emerging today.