Implement Market Launch Strategy, Pre-Approval

Episode four of De-risking Drug Development emphasizes the crucial pre-approval phase, where early commercial launch planning can significantly impact a product’s success. Biotechs, particularly those preparing for a first-time launch, are advised to initiate planning 2–3 years before marketing authorization to mitigate risks and enhance readiness.

The episode highlights key strategies for embedding launch excellence early, from aligning regulatory milestones with market entry goals to developing robust market access and commercialization frameworks. Experts share practical examples of how early preparation ensures smoother transitions from approval to market, helping companies avoid common pitfalls that can hinder a successful launch. By focusing on proactive planning and risk mitigation, this episode offers biotech leaders actionable insights to optimize their pre-launch strategies, setting the stage for a strong market debut and sustained commercial success.