Road Ahead Still Difficult for Biosimilar Producers in US

In today's ACT Brief, we examine how data drives honest enrollment assumptions, why RWE infrastructure lags ambition, and the disconnect between FDA rulemaking and enforcement on compounded therapies.

RWE is finding a role earlier in drug development than ever before, but the data quality, integration, and organizational alignment required to make it regulatory-grade are still catching up to the ambition.

In this video interview, Claire Riches, VP of clinical solutions at Citeline, explains why combining analog trial performance data with real-world patient data and site-level recruitment history gives sponsors a far more honest picture of whether their enrollment assumptions are actually achievable.

In today's ACT Brief, we examine what AI simulations surface in trial design, how RBQM delivers measurable financial returns, and three new FDA-approved treatments across hair loss, movement disorder, and bone disease.

In this Q&A, Sylviane de Viron of CluePoints and Abigail Dirks, MS, of Tufts CSDD discuss the findings of a collaborative study quantifying the financial value of RBQM, why time savings emerged as the largest driver, and what sponsors struggling to justify adoption now have that they didn't before.

In this video interview, Claire Riches, VP of clinical solutions at Citeline, walks through the categories of hidden protocol risk that AI-driven simulations can identify—from overly restrictive eligibility criteria to patient dropout patterns and structural trial assumptions.

In today's ACT Brief, we examine how AI is surfacing endpoint options beyond traditional design thinking, why sponsor oversight of outsourced work often fails on inspection despite being robust in practice, and a new combination drug for advanced kidney cancer.

Sponsor oversight of outsourced CRO work is often robust in practice but fails inspection because oversight decisions are fragmented across systems and lack an audit trail, requiring sponsors to document oversight as a connected operating system with clear decision records, escalation pathways, and issue resolution from start to finish.