INsights & OUTcomes with Mark Larkin

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 about Norstella: www.norstella.com

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 recap of these pivotal industry updates! 

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: https://www.terrapinn.com/WODC/US/2026/HealthEconomicsUse code HE25 for an extra 25% off your registration fee!

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 merely "patient-advised." Mark explains how longitudinal data is filling the gaps left by RCTs, from capturing the granular daily impacts of rare diseases to understanding the ripple effect of treatments on caregivers.Watch the full conversation here: https://youtu.be/ApKzubFy4Ao

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 "America-First" fee structure for medtech. Tune in for this concise recap of these pivotal industry updates!

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 industry updates! 

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, RWE, and market access landscape. 

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 monitoring platform designed to modernize safety surveillance and improve transparency. Tune in for this concise recap of the key developments shaping the life sciences, HEOR, and market access landscape. 

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 its Huntington’s gene therapy. Tune in for this concise recap of the key developments shaping the life sciences and market access landscape. 

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-stakes world of Real-World Evidence (RWE).To watch the full interview, click here!Learn more about Adigens Health: https://www.adigenshealth.com/Adigens Health partners with life sciences companies to harness insights and real-world evidence to expedite clinical development and effectively prepare for asset launch.