Driving Global Patient Access: Managed Access as a Strategic Lever

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 compromising trial enrollment.
• Decisions around funding, reimbursement, and charging for product depend heavily on where an asset sits in the development and launch lifecycle.
• Early cross-functional alignment (clinical, medical, and commercial teams) improves both patient access and future commercialization outcomes.
• Proactive engagement with regulators, physicians, and patient communities can support smoother transitions toward launch.

The discussion offers practical perspectives for biotech leaders evaluating how patient access considerations can be integrated earlier into development and launch planning.