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tHEORetically Speaking

tHEORetically Speaking

HealthEconomics.com 87 episodes Jul 13, 2026

This podcast explores how data and evidence can guide value-based decisions in health care. It features insights, observations, and executive interviews on health economics topics. The show is produced by HealthEconomics.com and accompanies its related blog.

Episodes

From Data Access to Evidence Usability: Connecting Payer Policy, Real-World Data, and Clinical Context to Close the Evidence Gap
From Data Access to Evidence Usability: Connecting Payer Policy, Real-World Data, and Clinical Context to Close the Evidence Gap Jul 13, 2026 11:42 In this episode of tHEORetically Speaking, we sit down with Becky Hollenberg, MPH, Senior RWD Strategy Lead at Norstella, to explore why data access is no longer the ultimate differentiator. Instead, the true competitive edge lies in evidence usability—the ability to connect clinical context, lab values, unstructured clinical notes, and payer policy into a single, cohesive narrative. Learn more ab
Weekly News Roundup — Wegovy Pill’s Historic Debut, Lilly’s Manufacturing Expansion, and Robotic GI Breakthroughs
Weekly News Roundup — Wegovy Pill’s Historic Debut, Lilly’s Manufacturing Expansion, and Robotic GI Breakthroughs May 8, 2026 3:32 This week’s tHEORetically Speaking News Roundup covers Novo Nordisk’s oral Wegovy pill shattering market expectations with $355 million in first-quarter sales, and Eli Lilly’s massive $4.5 billion investment to expand its manufacturing footprint in Indiana. We also explore Neptune Medical’s Triton GI robot reaching major clinical milestones in its first-in-human trials. Tune in for this concise re
Weekly News Roundup — Real-Time Clinical Trials, Canadian Breast Cancer Standards, and FDA Data Integrity Concerns
Weekly News Roundup — Real-Time Clinical Trials, Canadian Breast Cancer Standards, and FDA Data Integrity Concerns May 1, 2026 4:37 This week’s tHEORetically Speaking News Roundup covers the FDA’s new real-time clinical trial initiative utilizing AI for faster drug development, and Breast Cancer Canada’s new unified national recommendations to eliminate regional disparities in care. We also break down the FDA’s proposal to withdraw Amgen’s Tavneos over data integrity issues and safety concerns.Register for the WODC USA here: h
INsights & OUTcomes with Mark Larkin
INsights & OUTcomes with Mark Larkin Apr 20, 2026 29:00 On this episode of INsights & OUTcomes, we sit down with Mark Larkin, real-world evidence expert at Vitaccess, to explore why the "gold standard" of clinical trials often falls short the moment a treatment hits the real world.We dive deep into the shift toward patient-centered science, discussing the critical difference between a study that is truly patient-centric versus one that is
Weekly News Roundup — PhRMA Leadership Transition, The ICHRA Shift, and MDUFA VI Preliminary Deal
Weekly News Roundup — PhRMA Leadership Transition, The ICHRA Shift, and MDUFA VI Preliminary Deal Apr 10, 2026 3:49 This week’s tHEORetically Speaking News Roundup covers Steve Ubl’s planned departure from PhRMA after a decade of navigating the industry through landmark legislative shifts, and the growing momentum of ICHRAs as employers move toward "defined contribution" healthcare models. We also break down the preliminary MDUFA VI agreement, which signals a major hiring push at the FDA and a new &qu
Weekly News Roundup — Medtech Mega Deals, EU Regulatory Delays, and Global Supply Chain Shock
Weekly News Roundup — Medtech Mega Deals, EU Regulatory Delays, and Global Supply Chain Shock Mar 27, 2026 2:40 This week’s tHEORetically Speaking News Roundup covers Abbott’s $21 billion acquisition of Exact Sciences, signaling a major expansion in cancer diagnostics, and Boehringer Ingelheim’s concerns over Europe’s slowing regulatory timelines compared to the U.S. We also break down a global supply chain shock triggered by the Strait of Hormuz closure. Tune in for this concise recap of these pivotal indu
Weekly News Roundup — Medicaid Maternal Care Expansion, Breakthrough Diabetes Data, and SMA Market Shakeups
Weekly News Roundup — Medicaid Maternal Care Expansion, Breakthrough Diabetes Data, and SMA Market Shakeups Mar 20, 2026 2:31 This week’s tHEORetically Speaking News Roundup covers Nadia Care’s $12M raise to expand Medicaid-focused maternal care, Eli Lilly’s breakthrough Phase 3 results for its triple agonist retatrutide in type 2 diabetes, and Roche’s decision to halt development of its SMA therapy—reshaping competition in the rare disease space.Tune in for this concise recap of the key developments shaping the HEOR, RW
Weekly News Roundup — Biosimilar Policy Changes, mRNA Leadership Shifts, and Rare Disease Market Growth
Weekly News Roundup — Biosimilar Policy Changes, mRNA Leadership Shifts, and Rare Disease Market Growth Mar 13, 2026 4:07 This week’s tHEORetically Speaking News Roundup covers the FDA’s new guidance aimed at streamlining biosimilar development and reducing drug costs, leadership changes at BioNTech as its founders step down to launch a new mRNA venture, and projections that the global rare disease drug market could surpass $400 billion by 2032. We also explore the FDA’s launch of a new unified adverse event monitori
Weekly News Roundup — mRNA Vaccine Milestones, Obesity Drug Manufacturing, and Gene Therapy Regulatory Tensions
Weekly News Roundup — mRNA Vaccine Milestones, Obesity Drug Manufacturing, and Gene Therapy Regulatory Tensions Mar 6, 2026 3:58 This week’s tHEORetically Speaking News Roundup covers Moderna’s progress toward European approval of its combination COVID-19 and flu mRNA vaccine, Novo Nordisk’s $501 million investment to expand Wegovy pill production in Ireland, and Moderna’s $2.25 billion settlement resolving a major mRNA patent dispute. We also explore the FDA’s disagreement with uniQure over clinical trial requirements for
INsights & OUTcomes with Radek Wasiak
INsights & OUTcomes with Radek Wasiak Feb 27, 2026 25:43 This episode features Radek Wasiak, an expert in real world data generation, and real-world evidence. He has provided research services to the life sciences for more than two decades and is currently the director of Adigens Health.This chat wasn't just a technical deep dive; it was a journey through the past, present, and future of how we prove medicine actually works, and highlights the high
Integrated Evidence Delivery: Why HEOR belongs at the heart of the Modern CRO
Integrated Evidence Delivery: Why HEOR belongs at the heart of the Modern CRO Feb 23, 2026 31:49 In this episode, we explore why the traditional 'clinical-first, value-later' model is becoming a strategic liability and why integrating HEOR into CRO operations is the new industry standard. Join us as Aaron Berger and Dr. Mir Sohail Fazeli break down how to eliminate vendor silos to build a seamless, lifecycle-wide evidence narrative that ensures regulatory success.To learn more about
Weekly News Roundup — RSV Breakthrough Data, Psychedelic Approvals on the Horizon, and Major FDA Policy Shifts
Weekly News Roundup — RSV Breakthrough Data, Psychedelic Approvals on the Horizon, and Major FDA Policy Shifts Feb 20, 2026 4:39 This week’s tHEORetically Speaking News Roundup covers new real-world data showing Sanofi’s Beyfortus delivering multi-season protection against RSV hospitalizations, Compass Pathways’ positive Phase 3 results for its psilocybin therapy in treatment-resistant depression, and the FDA’s move toward a single-trial approval standard. We also explore stabilizing telehealth utilization trends and new FD

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