Keynote Presentation: Engineering the Quantum Leap that Drug Development Needs

What does a quantum leap in drug development look like and what is necessary to make it happen? Our greatest opportunity to deliver significant increases in the speed and effectiveness of drug development won’t come from the lab; it will happen from new, more efficient and equitable clinical trials. What we spend today to get 1 successful NME to market could have covered 90 drugs just 70 years ago, even after we adjust for inflation. R&D is getting more expensive, but less efficient. And looking at representation, 75% of the 32,000 participants in the trials of 53 novel drugs approved in 2020 by the FDA were white. The status quo must be changed to make clinical trials human centric. Only then can medicines serve our broad and diverse humanity. 

We already have the technologies available to transform clinical trials from highly costly, time intensive and centralized undertakings to rapidly scalable, decentralized, collaborative exercises that dramatically increase access to a broader range of participants and improve retention throughout the life of a study and even beyond. We know that rapid change is possible. When COVID 19 vaccines were developed, they were developed in less than 10% of the time it takes for a typical vaccine to be developed, by working together as an industry, with regulatory support and the use of sophisticated digital solutions. 

Now is the time for the entire drug development ecosystem, together, to redefine the effectiveness equation. Solving for ways to improve the rigor, speed and inclusivity of clinical trials will deliver a significant shift in the overall drug development value chain. If we succeed, we will also solve for equity, cost, and unmet health needs. 

Learning Objectives:

1. Identify key barriers to delivering faster drug development.

2. Examine technologies and processes to deliver more responsive, streamlined clinical trials.

3. Define potential outcomes from having decentralized clinical trials.