How Can Integrating Preclinical Insights into Trial Design Cut FIH Timelines? (Part 2)

*Full transcript available below

In the conclusion of his interview with BioPharm International®, Ben Edwards, chief operating officer at Avance Clinical, explains how purpose-built infrastructure is rapidly becoming a defining advantage in early-phase drug development, particularly for biotechs approaching first-in-human (FIH), or Phase I, trials. These early studies demand not only operational excellence but also deep scientific guidance that links preclinical decision-making directly to clinical strategy.

A key differentiator, Edwards highlights, is access to highly trained scientific teams that can help biotechs design an optimal preclinical package that truly de-risks the move into human studies. This includes advising on which preclinical studies are essential, how to position those data for regulators and ethics committees, and how to ensure the science supports a seamless transition into Phase I. By tightly aligning preclinical planning with clinical trial design and patient selection, sponsors can generate the right endpoints to inform their Phase II package and avoid costly redesigns or delays, he says.

Edwards also emphasizes that specialized contract research organization (CRO) partners with dedicated Phase I/FIH infrastructure can further compress timelines by anticipating ethics and regulatory questions early. In Australia, for example, a well-constructed protocol can move through ethics and regulatory approval in as little as four to five weeks, provided the design and data strategy are robust from the outset.

How does data-driven trial design accelerate FIH studies?

Beyond regulatory strategy, the cadence of first-in-human trials depends on expert project teams who understand sites, patient journeys, and vendor relationships, including labs and other data-generating partners. This operational insight reduces friction and accelerates time to data readout. Equally critical is a CRO’s ability to recognize and meet biotechs’ evolving data needs in real time.

“Data is key,” Edwards stresses, pointing out that specialist biometrics teams that can rapidly capture, clean, and deliver the precise data biotechs require are now central to competitive early-phase development. Such teams can enable faster decisions, smarter Phase II planning, and ultimately, a more efficient path to patients.

Click here to watch the first half of Edwards’ interview.

About the speaker

Ben Edwards, Chief Operating Officer, Avance Clinical

Working closely with the CEO, Edwards leads business growth and aligns operations with future goals. With more than 24 years of industry experience, including over 19 years in CROs, he has supported global and Asia-Pacific clients in achieving pharmaceutical market registrations, including approvals from FDA, the European Medicines Agency, Japan’s Pharmaceuticals and Medical Devices Agency, and China’s National Medical Products Administration. Edwards champions an action-oriented, ethical, and accountable, team-first culture focused on delivering client value and improving patient access to treatment.

Transcript

Editor's note: This transcript is a direct, unedited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

Speaker 1

The purpose built infrastructure is really important, especially for phase one trials. And I see sort of three areas where that purpose built team is very important. Firstly, a lot of biotechs as they're approaching phase one really do need strong advice from well informed clinical experts in understanding what does the pre clinical package need to look like, and what is the optimal pre clinical package to get to phase one clinical trials. And that's where expert scientific teams can provide really good advice to drug developers in crafting not only the clinical strategy, but the pre clinical strategy, and optimize that so that it really streamlines the time to get from pre clinic into the clinic, so that high science advice pre clinically is really critical that then can be really tied in closely to trial design and patient selection, and so that scientific team also working with biotechs to design a trial, to design the right patient population, to get the necessary endpoint data to inform your Phase Two package is critical. So not only do we just need medical writers, but we need highly trained scientists, which you get at advanced clinical to help design your pre clinical package and your clinical package, and ultimately that then streamlines ethics and regulatory approval. Once you have the right clinical design you anticipate ethics and regulatory questions, you're able to streamline ethics approval and advance can effectively, Once you finalize your protocol, achieve ethics and regulatory approval through Australia within four to five weeks after a final protocol using highly trained scientists to inform biotechs in their early phase drug development.

So it's important to choose specialized teams for phase one, healthy volunteer studies, or first in human studies, to really reduce the friction and reduce the timelines that are required to generate data. And there's three ways that really are important to do that. Firstly, it's important to have a project team and project leaders that understand the cadence and the speed of first in human trials, and that's really about understanding the sites, understanding of the patient journey, understanding lab vendors and other vendors that produce the data within that clinical trial, understanding those Relationships, the time it takes to generate data really reduces friction and also reduces the timelines to accessing that data. Secondly, it's really important for a CRO to understand biotechs and their need to access data, and that is really key. So data is key. So understanding what data biotechs need understanding the speed of which they need to obtain that the type of data and giving them access to that data quickly. So our specialist biometrics teams are able to do that for biotechs.