
Charlie Paterson, partner at PA Consulting, explains how mixed signals on FDA risk tolerance are accelerating the globalization of clinical trial programs and reshaping how sponsors align development activities worldwide.
Health and Life Sciences Expert, PA Consulting

Charlie Paterson, partner at PA Consulting, explains how mixed signals on FDA risk tolerance are accelerating the globalization of clinical trial programs and reshaping how sponsors align development activities worldwide.

Charlie Paterson, partner at PA Consulting, describes how FDA capacity constraints are creating uncertainty from initial submissions through late-stage approval, elongating timelines and influencing global development strategies.

Charlie Paterson, partner at PA Consulting, outlines how limited FDA guidance on innovative designs, decentralized models, and digital endpoints is forcing clinical operations teams to recalibrate expectations and minimize regulatory risk.

Charlie Paterson, partner at PA Consulting, discusses how fewer new guidance updates are pushing sponsors to rely on historical precedents and non-US standards when making trial design and operational decisions.

Charlie Paterson, partner at PA Consulting, explains how reduced FDA capacity and staff turnover have led to longer regulatory timelines, increased preparation for agency interactions, and delayed feedback during early trial planning.

Why future-ready pharma companies must embrace AI-driven, real-time decision-making.