Driving productivity in biotech clinical trials: How to maximize valuation for minimal cost
In today’s evolving biotech landscape, productivity in clinical trials is increasingly essential. As protocols grow more complex and trials span more endpoints, sites and patient visits, the resulting surge in costs and timelines has become a significant challenge, especially in the face of recent market uncertainties.
How can biotechs maximize their valuation through strategic investments? To explore this, Dr. Ken Park, VP of R&D Strategy and Innovation Consulting at Fortrea, moderated a series of three podcasts with a panel of industry leaders:
- Tracy Newbold, Vice President of Clinical Operations, Lexicon Pharmaceuticals
- Terry Athreya, SVP and Global Head of Clinical Operations, Fortrea
- Alaric Jackson, Chief Technology and Data Officer, Fortrea
We invite you to listen to the podcasts and learn about the panelists’ perspectives on the evolving definition of productivity, the use of emerging technologies and how biotechs can maximize their commercial viability and deliver more effective trials.
Episode 1: Defining productivity in clinical trials for biotechs
Key Themes: Flexibility, Risk Assessment, AI/ML, Resource Allocation
The panelists each contributed their perspectives on defining productivity in a clinical trial. Tracy shared the importance of “starting with the end in mind” and creating thoughtful key performance indicators. Terry discussed how productivity is often captured by pursuing the notion of “right the first time,” which is facilitated by eliminating the friction, incorporating the ability to assess risk and flexibly standardizing processes.
From a technology perspective, Alaric emphasized the value of using advances in technology to carve out time for innovation and improve efficiency. Terry also mentioned how AI/ML technologies can reduce costly human errors. Natural language processing can support study monitoring and also optimize the site visit process for both the CRA and site investigator.
“Being able to use our data in different ways is really important,” said Terry. She mentioned how data can also support resource allocation and help teams be more predictive to have right person in the right place at the right time to create an efficient operating model for biotech clients.
To conclude the conversation, Tracy shared thoughts on balancing a near-term opportunity or objective with a long-term exit strategy as a biotech. She emphasized the importance of managing expectations to achieve near-term goals and the ability to quickly self-correct, while being mindful of reaching long-term objectives.
Episode 2: Biotechs’ use of technology and data-driven strategies to impact productivity
Key Themes: Biometrics, Predictive Analytics, Patient Enrollment, Change Management
As mentioned in Episode 1 of the podcast, technology is playing an increasingly important role in supporting productivity in clinical trials. During this conversation, the panelists discussed how technology has enhanced their operations.
Tracy revealed that biometrics have boosted productivity by helping verify data and identifying potential “duplicate participants” who may skew results and impact study outcomes.
Terry discussed enrollment KPIs and how predictive analytics and centralized data collection tools can help identify inefficient sites, monitor risk and redirect resources to enrolling sites to ultimately accelerate enrollment.
Alaric shared his excitement about the speed of “frictionless” data from sites to electronic data capture (EDC) to a CRO.
“We can provide collaborator’s with oversight and visibility to all those metrics to see signals earlier in the process and be proactive,” he said. And, as technologies evolve, Alaric also mentioned the importance of change management to gain leadership buy-in and drive adoption.
Terry concluded by mentioning that the use of technology “is not about trying to do more with less,” but rather doing a lot more with the same number of people, which leads to more cost-effective studies.
Episode 3: A productive clinical trial is a collaborative one
Key Themes: Communication, Transparency, Hybridized Roles
In the final discussion, the panelists exchanged views about the importance of communication and shared understanding between a biotech and its CRO.
To Tracy, it’s important that CRO reviews a biotech’s protocol to provide early feedback, talk through potential decisions and help the biotech avoid time-consuming amendments.
Terry agreed that her work with biotech clients involves being “willing to help and answer and test the protocol,” noting that biotechs rely on CROs to be more adaptable and quicker with certain processes, such as hybridizing roles.
Alaric mentioned that biotechs may utilize CRO systems more holistically than large pharmaceutical companies and may also implement changes more quickly.
“I fully believe the [CRO] relationship can make or break the success of a trial,” Tracy said. “And that's one of the reasons we've been collaborating with Fortrea for over 10 years … there's a relationship there.”