Wilmington, NC - In today’s high-stakes biotech environment, the timeline to IND (Investigational New Drug application) and first-in-human (FIH) studies is no longer just a benchmark of operational efficiency, it’s a critical determinant of funding, valuation, and survival.
Over the past few years, the pressure on early-stage biotechs to demonstrate tangible progress has intensified. While reaching IND-readiness has always been a key milestone, investors and boards are now pushing companies to hit this mark faster than ever before. The downstream result? Clinical Operations is on the front lines of a new race, one where every month counts and every delay carries significant strategic risk.
The Clock Is Ticking Louder Than Ever
Traditionally, biotech timelines to IND could stretch over 18–24 months, often longer for complex modalities. But in the current capital-constrained environment, that luxury is fading. With investors demanding clearer de-risking before committing capital, many companies are under pressure to achieve IND and initiate FIH studies in 12–15 months post-funding or less.
“Investors want to see momentum and proof that a company can execute,” said a Clinical Development executive at a Series A biotech. “Speed to IND is becoming one of the most visible signals of that.”
This acceleration isn't driven solely by investor impatience. In a landscape where hundreds of early-stage biotechs are competing for attention, getting to FIH first can shape partnering opportunities, secure lead position in a therapeutic space, and generate critical human data that justifies continued investment.
Clinical Operations in the Hot Seat
The implications for Clinical Operations are profound. No longer a downstream, execution-only function, Clin Ops is now a strategic partner in early development planning tasked with building the roadmap to IND and FIH from day one.
“Operational timelines used to be reactive to the science. Now, they’re embedded in the company’s value inflection strategy,” noted a clinical project management consultant. “The pressure to compress startup activities, vendor selection, site engagement, and protocol finalization, means Clin Ops must be brought in much earlier, with a much stronger voice.”
This often includes parallel-path planning for regulatory submissions, manufacturing readiness, and even site activation strategies before protocols are finalized. There's also greater reliance on pre-vetted vendor ecosystems, risk-based quality management, and leveraging geographies that offer faster trial startup (like Australia, as discussed in our previous article).
Risk and Reward
Of course, speed introduces new risks. Rushing IND-enabling studies or cutting corners in trial design can jeopardize data quality and regulatory outcomes. The challenge is striking the right balance between acceleration and rigor.
The best clinical operations leaders are responding by building agile teams, leaning heavily on digital tools, and implementing development strategies that anticipate bottlenecks before they appear. Scenario planning, protocol simulation, and proactive regulatory engagement are no longer “nice to haves”, they’re essential.
What This Means for the Ecosystem
This shift is reshaping how early-stage companies are staffed, how investors assess operational readiness, and how CROs and consultants pitch their services. Experience in IND acceleration, especially for novel modalities, is becoming a prized asset.
It also changes the role of the Chief Development Officer or Head of R&D. These leaders must now work hand-in-glove with Clinical Ops to ensure alignment between scientific strategy and operational feasibility from the earliest stages of company formation.
In conclusion, speed to IND and FIH is now a core value driver in biotech, not just a regulatory checkpoint, but a strategic milestone that can make or break a company’s trajectory. For clinical operations teams, this means rising to a new level of influence, integration, and intensity.
In today’s biotech climate, fast isn’t just better. It’s expected.
-Katie Leath, Director, Prestige Scientific
About Prestige Scientific:
Prestige Scientific is an executive search firm that advises our clients on recruiting impactful leaders. We provide our clients with a performance-based hiring system that identifies leaders with past success meeting similar corporate objectives as their own, while overcoming challenges and adhering to critical timelines. We have dedicated experts in eleven practice areas that mirror a typical biopharma company, allowing us to support our client's growth from Discovery through Commercial.
