About this episode

The episode discusses how emerging biotechs can strategically approach patient access before commercialization.

In this episode of The Emerging Biotech Leader , Kim Kushner sits down with Nicky Wisener , Vice President, Managed Access Practice at Clinigen Group, to explore how emerging biotechs can think more strategically about patient access well before commercialization. The discussion shifts the focus from market access to patient access, viewed globally, and across the product lifecycle. Nicky brings nearly two decades of experience working at the intersection of clinical development, medical affairs, and commercialization, helping companies navigate managed access pathways in complex regulatory environments. The conversation challenges a common assumption in early-stage biotech: that managed access is either too complicated, too costly, or only relevant for large pharma. Instead, this episode reframes managed access as a continuum that can support patients, inform strategy, and strengthen long-term launch readiness when designed with intent. Key Takeaways for Emerging Biotech Leaders Managed access should be considered a strategic option for emerging biotechs, not an exception reserved for large organizations. Access programs can be designed to complement clinical development without…

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