The first recap from CMO 360 2026 covered what panelists said about the ecosystem around drug development, including pharma partnerships, China, and academic collaborations. This second recap focuses on the discussions that turned inward to how CMOs are running their organizations day to day. Three themes stood out in particular: the practical application of AI in clinical development, leadership in a constrained operating environment, and the expanding scope of the modern CMO role itself.
The AI conversation has moved past conceptual discussions
The panel on practical approaches to leveraging AI in clinical development, moderated by Nushmia Khokhar of Biohaven, with Jose Trevejo of Enveda, Gavin Corcoran of Formation Bio, Billy Amzal of Phastar, and Scott Chetham of Faro Health, was the session where the discussion around AI finally felt operational rather than theoretical.
Rather than framing AI as a future capability, panelists described how it is already embedded across multiple layers of clinical development work. A useful framing that emerged across the discussion was a three-tier model of adoption.
The first tier is automation. This includes document drafting, safety narratives, and medical writing. Trevejo described an IND submission where large portions of the modules were AI-generated, compressing work that would typically take months into a matter of weeks. “It’s not sexy, but AI is incredibly good at not missing details,” he noted, underscoring that the near-term value of AI is often precision and speed rather than transformation.
The second tier is agentic analysis. In this model, AI systems synthesize prior protocols, benchmark trial design elements across indications, and generate structured decision-support packages for development teams. Panelists described workflows where an AI agent can take a protocol and generate downstream outputs such as recruitment strategies, translated materials, and IRB-ready content. The key shift here is not just efficiency, but the ability to compress cross-functional iteration cycles that previously required multiple handoffs.
The third tier is emerging autonomous decision support. Panelists pointed to early applications in predictive modeling and digital twins, where AI systems are beginning to inform clinical development decisions by projecting longer-term outcomes from shorter-term datasets. In some cases, these tools are being used as part of regulatory discussions, particularly in statistical modeling contexts where additional controlled studies may otherwise have been required. These applications remain iterative and collaborative, typically operating alongside statisticians, clinicians, and regulators rather than replacing them.
Across the discussion, one of the more practical insights focused on regulatory documentation itself. As several panelists noted, writing with AI systems in mind is becoming increasingly relevant. Regulatory agencies are also moving toward AI-enabled workflows, meaning documents structured for both human and machine interpretation may move more efficiently through review.
Two governance principles were consistently reinforced throughout the session. First, fit-for-purpose adoption. AI tools should be deployed to solve clearly defined problems with measurable outcomes rather than as broad experimentation. Second, enterprise-grade data control, ensuring proprietary inputs are not inadvertently incorporated into external model training environments.
What stood out most was how quickly the tone around AI has shifted. The conversation has already moved beyond whether teams should adopt AI and toward how organizations build governance, workflows, and operating models around it. While panelists varied in how aggressively they viewed adoption timelines, there was broad alignment that AI is rapidly becoming an embedded layer within clinical development rather than a peripheral capability.
Leadership in a constrained operating environment
The panel on managing and motivating a team in a challenging time, featuring Sarah Gheuens of Agios Pharmaceuticals, Joseph Elassal of Ankyra Therapeutics, Tanya Fischer of Tenvie Therapeutics, and Raul Lima of inSeption Group, focused on what it takes to lead organizations through sustained pressure and limited resources.
A consistent theme across the discussion was that teams reflect the behavior of their leaders more than any stated set of organizational values.
Raul Lima framed this directly. Teams adopt the personality of whoever is actually leading them in practice, regardless of formal hierarchy or written culture. Leadership, in this context, becomes behavioral rather than positional. He also emphasized the limits of fear-based management, arguing that while it may drive short-term compliance, it ultimately erodes trust and alignment within teams.
Tanya Fischer focused on decision ownership and accountability. She described an operating principle centered around assigning clear responsibility for key decisions while still encouraging open discussion and collaboration. The emphasis was less on hierarchy and more on ensuring organizational clarity during periods of pressure.
Joseph Elassal emphasized respecting the professionalism of team members at every level of the organization. Even more junior operators, he noted, should be treated as capable contributors rather than simply executors of direction. That level of trust becomes increasingly important as teams are asked to operate with leaner structures and broader individual responsibilities.
Sarah Gheuens focused on prioritization discipline within resource-constrained environments. As organizations navigate tighter budgets, compressed timelines, and growing operational demands, she emphasized the importance of aligning teams around what matters most rather than diffusing attention across too many competing initiatives.
Fischer also shared practical observations from operating a distributed organization with teams spread across multiple geographies. Her approach emphasized visible leadership through regular in-person engagement, accessibility, and consistent communication. The underlying principle was that leadership presence becomes even more important when organizations are operating under pressure.
Across the panel, the constraints facing biotech organizations were clear. Headcount remains tight, timelines continue to compress, and burnout risk is increasingly difficult to ignore. What stood out, however, was that the solutions discussed were rarely procedural. Instead, panelists repeatedly returned to transparency, mentorship, accountability, and deliberately modeling the behaviors they wanted teams to reflect back.
The modern CMO role is expanding beyond traditional development leadership
The keynote fireside discussion featuring Daniel Quirk, CMO and Head of Medical Affairs at Biogen, interviewed by Josh Bryson of argenx, provided a broader view into how larger organizations are adapting to increasing complexity across development, commercialization, and organizational scaling.
Much of the conversation centered on how the CMO role itself is evolving. Quirk described joining Biogen during a period of transformation, drawn by what he viewed as four defining factors: growth opportunity, the strength of the pipeline, alignment with the company’s long-term vision, and organizational culture. He pointed specifically to Biogen’s efforts to balance its neuroscience foundation with expansion into rare disease and immunology, describing it as a strategy designed to create more sustainable long-term growth.
A recurring theme throughout the discussion was the importance of maintaining a patient- and physician-centered perspective as organizations scale. Quirk, who spent two decades in clinical practice before transitioning into industry, framed many of his decisions through the lens of practical clinical relevance rather than purely regulatory endpoints. He emphasized that while Phase 3 studies are designed to secure approval, physicians ultimately need data that informs real-world treatment decisions. In his words, the obligation extends beyond generating approvable data to producing “practice-informing, clinically relevant” evidence that resonates with both physicians and patients.
That philosophy also shaped how he described the relationship between development and medical affairs. Rather than operating sequentially, Quirk emphasized earlier integration between the two functions, particularly around evidence generation and commercialization planning. He noted that organizations increasingly need to identify evidence gaps before approval and begin building supporting programs earlier in development, rather than relying exclusively on post-marketing studies.
The discussion also returned repeatedly to organizational scaling. As Biogen expands from a relatively limited number of expected registrational readouts to a substantially larger late-stage pipeline, Quirk emphasized that growth is less about structure than about people. Building teams willing to challenge leadership, rather than simply reinforce consensus, was described as essential to long-term success. He contrasted this with organizations where leaders “build a moat around them” and surround themselves with teams reluctant to challenge assumptions.
AI surfaced here as well, though in a more operational context than during the dedicated AI panel. Quirk described Biogen’s approach as deliberately disciplined: AI initiatives are pursued only when attached to a clearly defined problem, measurable success metrics, and a scalable implementation pathway. He cautioned against both extremes of the current AI narrative, neither viewing it as a universal solution nor dismissing its potential impact outright.
The keynote also underscored the increasing pressure organizations face to move quickly without compromising rigor. Quirk framed patient safety and scientific integrity as non-negotiable constraints, even as development timelines compress and commercialization expectations accelerate. His broader point was that speed alone is not a strategy. Prioritization, thoughtful evidence generation, and engaging the right stakeholders early are what ultimately allow organizations to move efficiently without sacrificing quality.
What emerged from the discussion was a picture of the modern CMO role as significantly broader than traditional clinical oversight. The role increasingly sits at the intersection of development strategy, medical affairs, organizational leadership, evidence generation, and operational scaling. Just as importantly, it requires balancing execution speed with scientific credibility while keeping patient impact as the organizing principle behind both.
Closing Thoughts
Across the AI, leadership, and keynote discussions, a consistent theme emerged: the CMO role is becoming broader, more operationally complex, and increasingly central to how biotech organizations scale and execute.
What stood out at CMO 360 was not just the technology or strategy being discussed, but the openness with which leaders shared how they are navigating real challenges inside their organizations. Whether the topic was AI adoption, evidence generation, organizational scaling, or team leadership, the conversations consistently returned to the same principles: clarity, accountability, collaboration, and keeping patient impact at the center of decision-making.
Personally, one of the most valuable parts of the conference was the opportunity to hear experienced leaders speak candidly about what is working, and just as importantly, what remains difficult. There is clearly no single playbook for how modern biotech organizations should operate, but there does seem to be growing alignment around the qualities that allow teams to execute effectively in increasingly complex environments.
Taken together with the first recap on partnerships, China, and academic collaboration, CMO 360 painted a compelling picture of where the industry is heading and how leadership roles continue to evolve alongside it.
I’m grateful to have had the opportunity to learn from and connect with so many thoughtful clinical and operational leaders throughout the conference. If any of these themes resonate with you, I’d genuinely welcome the opportunity to continue the conversation.