At BioBuzz’s Insights to Impact event, industry leaders explored how moving discoveries from the bench to the clinic now demands earlier, more integrated planning across science, manufacturing, regulation, and partnerships to ultimately deliver therapies to patients.
At United Therapeutics earlier this month, Jay Cormier, Vice President of Strategy and Operations, opened BioBuzz’s Insights to Impact program with a simple reminder of why so many people end up in biotech in the first place.
“You could have done anything in your life,” Cormier said. “You could have gone into aerospace, you could have gone into agriculture, but you went into healthcare and biotech.”
When he pushed the audience on the underlying motivation, the answer was consistent and immediate: to help people. To help patients.
That question, and that conclusion, framed the evening and set the stage for the panel discussion that followed with Timothy Fouts, ABL; Greg Merril, Chariot Biosciences; Heidi Kenty, AstraZeneca; Cliff Carroll, AstraZeneca & Moderator, Jim Watson, Project Farma.
The focus quickly shifted from the why to the how: how do we move scientific discoveries from the bench to IND submission–effectively, responsibly, and at speed?
While the end goal of getting therapies to patients may be clear, the discussion made one thing equally clear: the path to get there is rarely linear.
IND Readiness Is More Than a Milestone
At its core, IND readiness is the preparation required to submit a credible IND and secure FDA clearance for first-in-human trials. Ultimately, it is about building confidence with regulators in the science, the process, and the strategy behind the program.
In today’s environment, that confidence is harder to earn. Regulatory expectations are higher, funding is tighter, and political and economic pressures increasingly shape development timelines. What may once have felt like a checklist has evolved into a necessary long-range operational strategy, one that forces teams to think well beyond the first clinical milestone.
The Manufacturing Reality Many Startups Underestimate
One of the most consistent themes throughout the discussion was how often early-stage companies underestimate the leap from lab-scale work to GMP manufacturing.
Process development, cost modeling, quality systems, and long-term scalability are frequently deprioritized in favor of short-term goals like hitting an IND or unlocking the next valuation inflection point. The problem is that those early shortcuts often resurface later, when timelines and budgets are far less forgiving.
As Timothy Fouts, Chief Scientific Officer, ABL, Inc. noted, innovators must think about getting into the clinic– and staying there.
“What we try to do is build processes that will last,” Fouts said, “from Phase 1 into a Phase 3 commercial state.”
CDMOs see this dynamic play out repeatedly. Teams arrive with promising science and a workable lab process, but without a clear understanding of whether that process will translate to later phases or commercial scale. Retrofitting manufacturability after Phase 1 can mean redoing work entirely, burning both time and capital along the way.
Thinking Beyond the First IND
Several panelists emphasized that IND readiness cannot be treated as a one-time hurdle. Decisions made for Phase 1 inevitably echo into Phase 2, Phase 3, and beyond.
One of the clearest takeaways from the discussion was how dramatically IND readiness shifts depending on modality. For monoclonal antibodies, well-established manufacturing platforms and analytical approaches allow teams to spend years refining and characterizing a process before filing. IND timelines of 12 to 24 months are common, and much of the risk is already understood.
Cell therapies, particularly autologous CAR-T, operate under very different constraints.
“When vein-to-vein becomes really important for the patient,” Heidi Kenty, Senior Director, Global Cell Therapy Business Strategy & Portfolio, AstraZeneca, explained, “first and foremost, you’ve got to go in with a smart and an early CMC strategy.”
Patient-specific manufacturing, tight vein-to-vein timelines, and inherent variability mean companies are often moving toward IND with less mature processes and fewer characterization data than would ever be acceptable for a mAb. IND-enabling work in cell therapy becomes an exercise in parallel execution—advancing clinical design, refining CMC strategy, and engaging regulators simultaneously.
Rather than locking a process early, cell therapy development often requires a continuous learning approach, in contrast to the more standardized pathways common in monoclonal antibodies.
In emerging modalities where uncertainty is high, robust quality systems, traceability, and well-designed SOPs provide essential stability as the science evolves. Without that foundation, even compelling programs can struggle to advance or attract partners. Scientific innovation alone is not enough if the program cannot be operationalized.
Partnerships as a Strategic Necessity
Another clear takeaway from the evening was the growing importance of partnerships. Startups, CDMOs, academic groups, and established biopharma companies increasingly rely on one another to bridge gaps in expertise, infrastructure, and funding.
Organizations working at the forefront of new modalities often play a dual role: supporting technical execution while helping founders think translationally, connecting discovery science to real-world therapeutic pathways. In some cases, that support extends to non-dilutive funding strategies or early regulatory engagement.
In today’s funding climate, panelists agreed, longer runways, earlier planning, and stronger external collaboration are no longer optional.
A Changing Landscape, A Shared Responsibility
The overarching message from the evening was clear: the landscape for advancing therapeutics is changing. IND readiness now requires earlier integration across science, manufacturing, quality, regulatory strategy, and commercial thinking.
More than ever, progress depends on partnership–between researchers and operators, startups and pharma, innovators and ecosystem builders. When those connections are made early and deliberately, the path from bench to patient becomes possible.
And as Cormier’s opening reminder underscored, the reason for navigating that complexity remains the same: getting meaningful therapies to the patients who need them most.
