The Way Forward: 2022 Biotech R&D Innovation Survey Insights

By: Jim Anthony, EVP, Global Head Parexel Biotech & Mike Davitian, Vice President, Health Advances 

Where are we going? When will we get there?

Innovation is the lifeblood of the biotech industry. It has to be—new ideas and new ways of solving problems create the pathways to conquering diseases. It is exciting, here at the start of 2023, to find our industry advancing a host of innovative therapies and applications that are transforming clinical development for the future benefit of patients worldwide.

And yet, the drug development environment is traditionally cautious with innovation. The adoption of new approaches can be a very long road. There is often a disconnect between the advancing therapies, and the underlying technologies and processes that drive their advance.

The urgent needs posed by COVID-19 and the rising demand for new medicines have accelerated the use of three innovations that point to the future of clinical research: adaptive trial design, decentralized clinical trials (DCTs), and external control arms (ECAs). Due to advances in statistics, real-world data, artificial intelligence, and biosensors, these approaches have demonstrated their capabilities for high-speed, high-quality clinical evaluation in recent years. Social awareness of health disparities, regulatory imperatives and longstanding recruitment challenges are driving urgency for new methods to increase diversity in clinical trials.

So here in the post-pandemic landscape, we wanted to ask the question—where are we in terms of embracing these innovations? To what extent are biopharmas using adaptive designs, DCTs and ECAs? Are the new approaches being applied to best effect with early planning? What benefits and barriers are researchers encountering in actual practice?

In this eBook, we share insights from 33 biopharma executives who reported their experience using these bellwether approaches for the 2022 R&D Innovation Survey conducted by Health Advances and Parexel Biotech. This innovation snapshot shows biotechs adopting new approaches and encountering a variety of roadblocks but pushing forward to expand their use and deliver faster, more efficient development.

Innovation Snapshot

Looking ahead, biopharma executives expect improved clinical development using novel trials designs, earlier integrated regulatory and commercial strategies, and greater diversity among research participants. Considered as a whole, findings from the December 2022 R&D Innovation Survey lead us to three top-line insights: 

Regulatory and commercial strategies must be considered earlier.

• Clinical development often proceeds without sufficient consideration of regulatory and commercial strategy.
• Lack of early regulatory-commercial planning results in missed opportunities to reduce regulatory risks and optimize commercial success.

Adaptive designs, ECAs and DCTs are growing in importance.

• Despite their promise, applications are not always successful; biopharmas must thoroughly understand and plan early to use these approaches for optimal benefit.
• Biotech executives see increasing use of adaptive designs, ECAs and DCTs to accelerate timelines, reduce costs and mitigate risks.

Biopharmas must pursue new ways to increase diversity in clinical trials.

• Established approaches to enhancing diversity (concierge services, community organization partnering) achieve only modest results.
• Long term, the clinical research community should begin developing research sites in wider locations that provide access to more diverse study populations.