Send us Fan Mail

The episode features Patrick R. Coyle speaking with Mark Lovern about how model-informed drug development can help teams make smarter, earlier decisions about clinical development, commercial viability, and patient benefit. They explore why approval alone does not guarantee success, how quantitative models can inform investment choices, and why patient access, health economics, and profitability need to be part of the same conversation from the start.

In this episode

• Why drug development teams should consider commercial viability and patient benefit earlier in the development process
• How net present value and probability of technical and regulatory success can shape better portfolio decisions
• Why an independent, objective review can help organizations avoid chasing weak development programs
• How health economics and outcomes research can support payer and access planning before approval
• What rare diseases reveal about balancing societal benefit with sustainable investment
• How model-informed drug development, synthetic control arms, and virtual twins can improve decision-making
• Why real-world data, patient monitoring, consent, and data governance matter after a therapy reaches patients

Mark's views are his own and are not presented on behalf of his employer or any other organization.

Explore the frameworks behind Patients + Profitability™: The 10 Exits of Therapy™ at patrickrcoyle.com and The 5 Layers of GTN™ at nextgengtn.com.