JPM 2026: Fewer, Better Decisions Will Win in Biopharma
The question for leaders is no longer if opportunity exists, but whether their organization is built to capitalize under these conditions.
At the 2026 J.P. Morgan Healthcare Conference, sentiment across healthcare and life sciences reflected a shift from defensive positioning toward measured optimism. After two years defined by capital constraints and heightened uncertainty, much of it shaped by fears that ultimately did not fully materialize, investors, strategics, and operators pointed to stabilizing markets, renewed deal dialogue, and improving regulatory clarity as signals of a more constructive environment. At the same time, conversations consistently emphasized discipline, selectivity, and late-stage readiness over expansive growth narratives. Across regulation, technology, capital allocation, and global innovation sourcing, expectations are converging around demonstrable outcomes rather than potential alone. Capital is increasingly concentrated, commitments are being structured with greater optionality, and timelines are being assessed with greater scrutiny. WittKieffer is presenting this perspective to examine how these shifts are reshaping the operating environment for biopharma organizations — and what they imply for leadership, governance, and talent as the industry enters a more execution-focused phase. Nowhere was this shift more evident than in how regulatory expectations are evolving.
CUTTING RED TAPE WHILE MAINTAINING GOLD STANDARDS
At JPM 2026, FDA leadership signaled a recalibration to prioritize speed, flexibility, and scientific relevance while preserving evidentiary standards.
Evidentiary flexibility moves upstream. One of the clearest signals of policy evolution reinforced at JPM 2026 was the FDA’s continued openness to greater evidentiary flexibility. While the agency previewed a more flexible interpretation of the substantial evidence standard in December 2025, FDA officials used the conference to further contextualize how this framework is being applied. Discussions emphasized that approval decisions are no longer anchored to a rigid two-trial requirement, with the FDA increasingly allowing a single pivotal trial to demonstrate substantial evidence when statistical rigor and clinical relevance are met.
Updated approach to cell and gene therapies. Just ahead of the conference, FDA leadership also signaled a more pragmatic approach to regulating cell and gene therapies, reflecting the agency’s effort to align regulatory expectations with the realities of developing complex, novel modalities. FDA leaders emphasized a phase‑appropriate approach to chemistry, manufacturing, and controls (CMC), allowing manufacturing strategies, specifications, and validation to evolve as clinical understanding matures. For developers, this signals that the CMC strategy is no longer a downstream operational exercise, but a strategic consideration that must be integrated early into development planning and regulatory engagement.
If executed consistently, this shift has meaningful implications for how companies build and structure teams, how investors assess risk, and which geographies emerge as long-term innovation hubs.
AI AS INFRASTRUCTURE: FROM EXPERIMENTAL TOOL TO OPERATING CONDITION
AI has become a core infrastructure — an expected, embedded capability across discovery, development, and operations.
AI investment at scale. The scale and durability of AI investments announced at JPM 2026 underscored a shift from experimentation to infrastructure. Strategic partnerships reflected multi‑year commitments focused on embedding AI directly into core discovery and development workflows, most notably Eli Lilly and NVIDIA’s up‑to‑$1 billion, five‑year co‑innovation lab spanning talent, compute, and platform infrastructure. These investments were framed as foundational operating commitments, comparable to manufacturing capacity or enterprise data platforms, rather than near‑term innovation initiatives.
Outcome-driven AI implementation. Executives and investors consistently emphasized that AI must deliver measurable operational outcomes, not theoretical potential. Discussions focused on tangible improvements such as reduced discovery timelines, faster protocol design, improved patient recruitment, and lower manual burden in regulatory documentation. This outcome-driven mindset reflects growing investor discipline and regulatory scrutiny. AI narratives that rely on abstract claims or technical sophistication without demonstrable impact are increasingly viewed as insufficient.
M&A: SELECTIVITY, OPTIONALITY, AND ASSET QUALITY
Conversations at JPM 2026 around mergers and acquisitions – historically one of the central themes of the conference – reflected a clear evolution in how growth is being pursued across biopharma. Notably, the conference passed without a headline‑grabbing biopharma megadeal announced on stage, signaling a shift away from scale for its own sake and toward transactions grounded in strategic fit, clinical maturity, commercial value, and execution readiness.
Disciplined M&A strategies. That discipline was evident in both the assets attracting interest and the structures used to secure them. Buyers consistently emphasized late‑stage or registrational programs with defined development paths and line‑of‑sight to value creation, often favoring licensing, options, and staged investments over full takeouts. In this environment, deal structure has become an extension of strategy rather than a secondary consideration.
Dealmaking driven by quality, clarity, and credibility. Underlying this shift is a broader recalibration driven by capital discipline and portfolio pressure. With public markets remaining selective and patent expirations approaching across large biopharma portfolios, leadership teams are increasingly focused on transactions that strengthen durability rather than expand breadth. Where strategic adjacency and execution clarity were unmistakable, capital continues to move decisively, as reflected by Boston Scientific’s approximately $14.5 billion acquisition of Penumbra in MedTech.
As regulatory timelines compress and development risk concentrates earlier, transactions are being evaluated not only on strategic rationale, but on whether organizations have the operational capacity and leadership alignment to realize value post‑deal. In this sense, M&A has become a mirror of broader operating conditions, rewarding coherence and judgment over ambition alone.
CHINA: FROM OPTIONAL ENGAGEMENT TO STRUCTURAL REALITY
At JPM 2026, conversations about global innovation sourcing reflected a broader reassessment underway across large biopharma portfolios. As capital discipline tightens and pressure to replenish pipelines intensifies, leadership teams are increasingly revisiting long‑held assumptions about where differentiated innovation originates and how efficiently it can be developed. In this context, China was no longer discussed as a regional exception, but as a normalized and increasingly influential contributor to global biopharma innovation.
This shift was evident in how Chinese‑originated assets were positioned throughout the week. Programs emerging from China were featured across oncology and next‑generation biologics and evaluated alongside Western assets on scientific quality, development speed, and capital efficiency, rather than on geography alone. While diligence expectations remain high, evaluation is increasingly data‑driven and asset‑specific, rather than origin‑based. Conference‑week licensing activity reinforced this normalization, including high-profile agreements such as AbbVie-RemeGen, underscoring that global biopharma companies are actively competing for Chinese‑originated assets as part of mainstream business development strategy.
Taken together, these dynamics indicate that engagement with China is no longer a discretionary layer on global strategy. It is becoming a standing operating condition — one that increasingly differentiates organizations with the governance, judgment, and leadership capacity to integrate China‑sourced assets into global development and commercialization pathways at scale.
LEADERSHIP IMPLICATIONS: WHERE EXECUTION NOW SEPARATES
Evidence as enterprise risk
Evidence strategy is no longer a functional optimization problem. As single pivotal pathways become more common, the cost of being “mostly right” has increased materially. The differentiator is not analytical rigor alone, but whether leadership is willing to decide when evidence is sufficient to stand behind a regulatory strategy and commit the organization’s capital, credibility, and future optionality.
Evidence as enterprise risk
CMC has become a credibility test, not an operational afterthought. Regulatory flexibility has not reduced scrutiny; it has shifted it forward. Phase‑appropriate CMC decisions now simultaneously influence speed, partnering confidence, and inspection outcomes. Teams that bring manufacturing and quality leadership into pivotal‑stage decisions gain time and trust. Those that do not often discover their constraint when it is no longer movable.
Evidence as enterprise risk
Organizations differentiate on AI not by launching pilots, but by having the discipline to stop initiatives that do not deliver impact. AI capability itself is now largely treated as table stakes rather than a source of differentiation. What differentiated organizations was their willingness to narrow use cases, establish clear accountability for outcomes, and measure impact in operational terms. With this discipline in place, leaders enable AI infrastructure to function as a durable source of operating leverage rather than overhead.
Capital rewards coherence
Capital markets are rewarding coherence over ambition. Optionality is no longer granted for breadth; it is increasingly contingent on clarity around value inflection and regulatory and integration readiness. Business development teams are increasingly evaluated on their ability to credibly say “no,” not just on deal flow. This places new pressure on leadership to align portfolio narrative with execution reality.
Evidence as enterprise risk
Integration, rather than access, has become the primary leadership challenge. China‑sourced innovation has moved from an exception to an operating condition. The question is no longer whether to engage, but whether the organization can integrate assets across data standards, CMC approaches, and regulatory expectations without friction. Here, leadership capability — not scientific access — is the binding constraint. Governance, not structure, is becoming the limiting factor.
Evidence as enterprise risk
Across all four themes, the common failure mode is not lack of talent, but leaders’ reluctance to commit when decision-making is compressed, and ambiguity remains high. Boards and executive teams that distinguish early between reversible and irreversible decisions move faster with fewer regrets. Those that do not often preserve consensus at the expense of momentum, putting a premium on intentionally building both boards and executive leadership teams.
JPM 2026 marked a shift from recovery narratives to execution accountability. The operating environment has changed in ways that compress timelines, concentrate capital, and expose capability gaps earlier. In a year defined by proof, advantage increasingly rests with organizations that make fewer, higher‑stakes decisions with clarity — and that align leadership, governance, and talent to support those choices. The question for leaders is no longer if opportunity exists, but whether their organizations are built to convert it under these conditions.
