Addressing Preclinical Gaps to Prevent Biotech Trial Delays

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: Operational delays such as toxicology data gaps and manufacturing issues are often bigger contributors to biotech slowdowns than scientific failures. Which of these challenges do you think is most commonly overlooked during early planning?

Edwards: Yeah, it's a good question. Both of these issues can cause delays in the startup, definitely, but what we see with initiating trials and accelerating trials through Australia, it's most often those preclinical package gaps, that we see that can cause delays. It's really critical for our clients and biotechs to select the right CRO that has really deep scientific capability, not just the CRO that's going to regurgitate back the information that they provide them, but really critically assess have they got the right tox package? Have they got that in place, and are they ready to go for the clinic? Really, then our scientific team can create a really sound scientific argument, especially for new drugs and new modalities today that are quite different, and perhaps the regulations haven't kept up. It's really important to have a scientific team that can help create that narrative and then achieve approval through ethics and the regulatory system.