Biopharma is entering a new period of intense competition from new sources, requiring a change in approach to portfolio strategy and lifecycle management.

An increasing number of sophisticated tools are on offer to address new therapeutic challenges and remaining unmet needs.

Charting the development history and evolution of monoclonal antibodies as a therapeutic class reveals industry was slow to recognize their potential. The first 50 approvals took place over three decades, although the subsequent 50 were condensed into just five years as MAbs firmly revolutionized the treatment of a huge number of diseases. In Vivo asks whether RNA therapies, similarly underappreciated in the early days of development but now firmly in our collective conscience owing to their role in the pandemic response, are on the cusp of entering mainstream R&D?

The butterfly effect is an elegant analogy to describe the seemingly unpredictable and far-reaching implications of a relatively small and inconsequential event. The FDA’s approval of Aduhelm is not so much a butterfly gently flapping its wings, but rather a sonic boom emanating from a jet engine. Most immediately, it provides a new therapeutic option for millions of patients in dire need of hope, vindicating Biogen’s faith with a revenue stream running into many billions of dollars. Longer-term the reverberations may be felt across the entire industry, throwing into question the evidentiary requirement for drug development.

Two thirds of clinical trial sites are unable to meet original enrollment goals, with half of sites recruiting either a single patient or failing completely. Study sponsors must scrutinize their approaches to feasibility, as recruitment is such a critical part of overall trial success.