See how early patient inclusion, integrated regulatory planning, and seamless CRO partnerships can help biotechs accelerate progression from Phase I to Phase II.
In a recent video interview with Applied Clinical Trials, Ben Edwards, chief operating officer, Avance Clinical, discussed common challenges in biotech, emphasizing the importance of addressing preclinical package gaps to avoid delays. He highlighted the need for CROs with deep scientific capabilities to create a sound scientific argument for new drugs. In the current funding climate, he stressed the importance of obtaining patient data early to inform decision-making. Edwards also noted the shift towards adaptive trial designs and the benefits of staying with the same CRO for continuity. Effective coordination across functions requires integrated teams and data visualization. Parallel execution strategies, combined with rigorous protocol design and early regulatory engagement, can accelerate development while maintaining compliance.
ACT: Some emerging biotechs are moving away from traditional linear development and instead mapping the full pathway from the start. How does this change the way trials are designed and executed?
Edwards: It's about adaptive design and really obtaining that patient data as part of the Phase I program. Historically, again, we used to see just that single Phase I SAD, MAD, healthy volunteer study, but most study designs today are looking for that patient cohort. So it's really about adaptive design, moving quickly from Phase I to Phase II as well. So rolling in a regulatory package and overlaying that so that you have your Phase I healthy volunteer study ongoing. You might look to accelerate that through Australia, engage with the regulators internationally, so that you can quickly move from whether it's a traditional Phase I or Phase Ia, to Phase Ib to Phase II, so that there's not a junction that's between those that's slowing that progress down. It's really working with the CRO or a program that can actually expand quickly, so really develop, high quality Phase I data, but also then quickly pivot into a broader patient study in the geographies that that they can find the patients. In my view, it doesn't really make sense for a biotech company, if they're looking to conduct a study and outsource that to a CRO to change CROs between Phase I and Phase II. I think there's time lost in that instance, so I would stay with the same provider, get to know the team, plan your regulatory strategy, and expand into Phase II to really obtain that data quickly. I think that's key for emerging biotech today.
