In early-stage oncology development, time is no longer a nice-to-have. It’s the differentiator.
For many emerging biotechs, speed to first-in-human (FIH) data is a critical proof point that can determine whether a program secures its next round of funding or loses momentum altogether. I see this pressure every day. Investors are sharper, timelines are tighter, and expectations around capital efficiency have never been higher.
From what I’m seeing across the industry, a few clear shifts are emerging:
The pressure is especially acute in oncology, where demonstrating early biological activity before a Series B or crossover round can determine whether a program advances confidently or falls behind. Against this backdrop, many sponsors are looking for new execution models that combine regulatory integrity with operational speed.
I saw this shift firsthand in a U.S.-based biotech that partnered with Complete Phase and delivered its FIH dataset months ahead of schedule.
The sponsor, a U.S.-based biotech was advancing a novel immuno-oncology therapeutic for lung cancer and preparing for its FIH study. Under a traditional U.S. pathway, projected regulatory timelines pointed to a 7–9 month delay before dosing the first patient.
For my client, this wasn’t just an operational inconvenience. That delay posed a real risk to financing milestones, investor confidence, and overall program momentum.
To stay competitive, they needed early human data – fast – without compromising on regulatory integrity or data quality.
By partnering with Complete Phase, the sponsor was able to leverage Australia’s Clinical Trial Notification (CTN) to overcome these constraints. The CTN is a globally recognized regulatory pathway that enables faster study start-up while maintaining FDA and ICH alignment.
Our approach focused on four execution pillars:
In the current capital-constrained environment, this accelerated timeline gave the sponsor a clear edge, enabling them to maintain momentum, satisfy investors, and advance toward key clinical milestones ahead of schedule.
What I’m seeing across the industry is a re-calibration.
Capital access is stabilizing, but expectations for fiscal discipline and timeline efficiency have never been higher. This isn’t just my opinion; according to Reuters, contract research firms are seeing earnings stabilize, suggesting that the sector is re-calibrating after a period of over-expansion and layoffs. Amid this growth, sponsors are increasingly turning to expert-led, agile partners that can deliver quality data without delay, especially in high-stakes areas like oncology and immunology.
From my perspective, the Australian CTN model is the best alternative for companies seeking global regulatory credibility with shorter activation timelines. For sponsors evaluating alternatives to conventional CRO models, the case I shared above demonstrates how regulatory strategy and operational agility can unlock months of time, and potentially millions in value.
At Complete Phase, this is exactly how we work responsive, regulatory-aligned, and built for speed — without cutting corners.
Book a free discovery call with us today to learn how your team could move from preclinical to clinical, faster and with confidence.