Early Access Programs: What They Are And How To Plan For Them

Early access programs are crafted to grant patients grappling with life-threatening unmet medical needs or diseases access to promising treatments that haven't yet garnered marketing approval. These programs encompass named patient initiatives tailored to individual sufferers of rare, ultra-rare, or life-threatening conditions, as well as cohort programs, which target groups of patients afflicted with the same disease.

About The Speaker: Patrick Larcier is Senior Director at PharmaLex, where he draws on his 30 years of experience in drug development and regulatory affairs at biotechnology companies, CROs, and in consulting. Patrick works on Strategic Product Development Solutions for PharmaLex’s global projects. His expertise lies in the design and implementation of regulatory strategies for complex and innovative medicinal products at all stages of clinical development.