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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.

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The episode features Patrick Coyle speaking with Roger Ouimet, VP of PMO at Project Farma and 30-year Navy veteran. They discuss how service, operational discipline, and accountability carry over into pharmaceutical manufacturing, where quality and reliable supply can directly affect patients.

In this episode

• How Roger Ouimet’s 30 years in the Navy shaped his approach to pharmaceutical manufacturing
• Why serving patients who may never be seen in person is a shared mission across the military and pharma
• How the “Blue Mile” at Novo Nordisk helped keep patient impact and quality visible to employees
• Why project managers must balance speed, risk mitigation, and product quality
• How role clarity and accountable leadership help teams raise concerns and prevent quality failures
• Why AI should support project managers while humans remain responsible for decisions and review
• The difference between projects and programs, and how PMOs can align work with organizational strategy

Roger'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.

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In "Safety as a Culture with Joe Gilliland," Patrick R. Coyle and Joe Gilliland discuss safety, patient care and the choices organizations make every day. Joe shares how a fatal workplace incident early in his career reinforced his commitment to preventing harm. He explains why safety depends on more than written procedures or low incident rates.

In this episode

• How a workplace tragedy shaped Joe's approach to safety and investigation
• Why safety should be foundational, not a priority that competes with other goals
• How listening to employees can reveal risks that might otherwise be missed
• What incident-rate metrics can and cannot tell us about risk
• Why patient-first thinking and worker safety belong in the same conversation
• Joe's perspective on volunteerism and giving back to the community

Joe'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.