JPM 2025 recap: Panelists discuss life sciences growth strategies, policy uncertainties, and promising regulatory opportunities

Weighing the potential FDA impact of the imminent changes in U.S. government leadership, Kelliann Payne, partner in the Hogan Lovells medical devices practice, kicked off the panel discussion by highlighting how FDA line reviewers are likely to remain in their current positions throughout the changes in the executive branch. Kalah Auchincloss, a principal at Eliquent Life Sciences, agreed that most FDA daily review activities are unlikely to change within the next year. However, Auchincloss predicted, there may be long-term effects of the Trump administration’s stated plans to cut government expenditures.

Elizabeth Oestreich, Senior Vice President for Regulatory Compliance at Eliquent, correctly predicted that president Trump would implement regulatory freeze: a temporary moratorium on new regulations. Oestreich also anticipated hiring freezes that could slow agency activities and impact FDA review timelines. Regarding international inspections, however, Oestreich said she does not see any slow-down in the short-term.

Discussing prospective government leaders in the Trump administration, Auchincloss said that Dr. Marty Makary, Trump’s pick for FDA commissioner, has a well-regarded reputation in the life sciences industry, which could signal that the agency will continue to preserve high standards of scientific rigor. Citing Trump’s creation of the Department Of Government Efficiency (DOGE), Brian Carey, partner in the Hogan Lovells health care practice, forecast a potential tension in the second Trump administration between the goal of cutting administrative barriers to expedite adoption of new technologies, and a renewed focus on budgetary pressures at the state and federal level that could be impacted by government reimbursement for health care.

Firms involved in life sciences dealmaking may be aware of FDA regulatory concerns, but Auchincloss also spotlighted the “need to start thinking about coverage earlier and earlier” in the market preparation process. Carey provided examples underscoring the complexity involved in predicting coverage policies, noting the non-binary nature of reimbursement decisions, and outlining how budgetary trends may be affected by macro-economic policies and political priorities, among other factors. “Opportunities for regulatory reform will compete with other political priorities including reductions in government spending,” Carey warned.

Shifting the conversation toward questions over the impact of the evolving regulatory paradigm for artificial intelligence on dealmaking, Payne spotlighted the critical distinction of whether new technology is “Clinical Decision Support” software. Predicting little change from 2024 to 2025, Payne observed “nothing controversial” in FDA’s latest draft guidance on artificial intelligence, which Hogan Lovells recently summarized online here. “The status quo is increasing,” Payne concluded, observing movement towards the need for scientific evidence to defend AI algorithms.

From the drug development side, Lowell Zeta, partner in the Hogan Lovells pharmaceutical and biotechnology regulatory practice, pointed to new FDA draft guidance focused on credibility assessment documentation for “intended use,” and establishing good governance and documentation that is inspection-ready. However, Zeta added, FDA has clarified in its latest guidance that the principles discussed in that document do not apply to drug discovery. “Data quality is paramount,” he emphasized. Payne echoed that on the medical device side, FDA is prioritizing the need for a sponsor to clearly explain clinical utility.

Diving into novel policy concerns developing for compounding of obesity medications, Auchincloss said industry observers are closely watching the ways in which FDA may bring enforcement actions against GLP-1 compounding facilities, and how companies are engaging in private lawsuits to litigate the issue. Oestreich similarly noted that FDA’s Center for Drug Evaluation and Research (CDER) has indicated that GLP-1 and safety inspections issues are priorities for the FDA Center moving forward. Asked about how to weigh on in the obesity coverage proposed rule, which would require Medicare Advantage (MA) and Part D drug plans to cover drugs and biologics for the treatment of obesity, Carey advised submitting a comment before the deadline of January 27 to build support for the proposal which could have a large budgetary impact.

Considering potential changes in the laboratory developed test (LDT) regulatory landscape, Auchincloss speculated that it is likely past the point in time when a judge would stay implementation of FDA’s final rule that explicitly asserts the agency’s authority to regulate LDTs. That rule starts to take effect on May 6, and FDA has distributed information on what to expect during the next couple years of rule implementation, indicating the agency plans to follow through with timely enforcement of the rule. “Companies should be prepared to comply,” Auchincloss advised, noting registration requirements and the need to have a quality system in place.

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.