Accelerating Drug Development: Insights From 2020–2024 Rapid Approvals

By Bradley Smith, Vice President, Therapeutic Strategy; Christopher Hart, Senior Director, Drug Development Lead; Alexander Roland, R&D Research Director; Brian Healey, Global Head, Drug Development And Regulatory Strategy; Lisa Spigelmyer, Director, Regulatory Affairs

Getting a new therapy from first-in-human trials to approval usually takes close to a decade. An analysis of drugs first approved between 2020 and 2024 found that the typical (median) program took about eight years from the start of Phase I to first approval. Immunology took longest (about 9.2 years) and infectious disease was quickest (about 7.6 years). Yet a small group of programs reached approval in three to five years. This white paper looks at what those fast programs had in common: a focus on rare diseases or genetically defined patient groups, early use of fast-track regulatory routes such as Accelerated Approval, newer kinds of treatment like CAR-T and RNA therapies that produced clear, measurable responses, and lean operations that ran activities side by side.

Case studies, including a targeted lung cancer drug approved in under three years, show how these factors worked together as well as the trade-offs. Rather than chasing record-breaking timelines, learn how to spot and plan for the conditions that let your program cut avoidable delays and reach approval faster and more predictably.