The dissertation defense is open and will be held both virtually and in-person.
Participants are requested to RSVP to receive the link to the presentation.
The PhD in Translational Health Sciences Program is proud to announce the Dissertation Defense of:
PhD Candidate: Thomas Matthew Porter, MBA, MPH
Integrated Evidence Strategy in the Development, Commercialization, and Clinical Adoption of New Medicines
Dissertation Committee Co-Chairs: Sabrina Figueiredo, PhD, MSc and Kathleen M. Andersen, PhD, MSc
Thursday, October 1, 2026, 9:00 AM ET
Regulatory approval is a critical milestone in drug development, but it does not, by itself, bring a new medicine into routine care. Payers, guideline committees, health systems, clinicians, and patients make additional decisions about coverage, recommendations, prescribing, and use. These decisions often rely on evidence beyond a product’s safety and efficacy data generated for regulatory approval. Integrated evidence generation and planning (IEGP) has emerged as a cross-functional, lifecycle-oriented approach to identifying, prioritizing, coordinating, and addressing these evidence needs from early development through commercialization and post-launch clinical use; however, the published literature has remained largely conceptual, describing how IEGP should work rather than how it operates in practice.
This descriptive qualitative study analyzed in-depth interviews with 19 senior medical affairs and related medicine function leaders employed across seven of the 15 largest pharmaceutical companies by revenue. Participants described how their organizations framed evidence gaps, weighed competing stakeholder needs, decided which gaps to act on, monitor, or defer, and how recommendations to act became approved and resourced evidence activities. The SELECT Model synthesizes these findings, mapping organizational conditions and decision points that shape a product’s evidence strategy. The study provides an empirical basis for evaluating how companies align evidence generation with the regulatory, access, and clinical decisions that influence a medicine’s use in real-world practice.
