tHEORetically Speaking

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/HealthEconomics Use 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.

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 this, check out the deep-dive blog here: https://healtheconomics.com/integrated-evidence-delivery-the-strategic-role-of-heor-in-modern-cros

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 FDA scrutiny of SSRI and RSV antibody safety . Tune in for this concise recap of these pivotal industry updates!

This week’s tHEORetically Speaking News Roundup covers Takeda’s $1.7B AI-powered drug discovery partnership with Iambic , Moderna’s FDA setback for its mRNA flu vaccine , and AstraZeneca’s decision to keep UK investments on hold despite new pricing reforms . We also explore the launch of a European Life Sciences Coalition aimed at strengthening biotech funding and competitiveness across the EU. Tune in for this concise recap of these pivotal industry updates! Register for World EPA Congress 2026 here: https://www.terrapinn.com/EPA/2026/HealthEconomics

This week's tHEORetically Speaking News Roundup covers Humana’s rollout of a Google Cloud–powered AI tool to streamline 80 million annual member calls , Amgen’s pushback against the FDA to keep Tavneos on the market using real-world evidence , and AstraZeneca’s NYSE debut to fuel its global growth strategy . We also explore the new TrumpRx portal aimed at expanding discounted cash-pay prescriptions . Tune in for this concise recap of these pivotal industry updates! Register for World EPA Congress 2026 here: https://www.terrapinn.com/EPA/2026/HealthEconomics

This episode features Taylor Hirschberg, an award winning writer, activist, and academic. He is the CEO of Metli Consulting , an inclusive consultancy firm focused on helping to prepare for launch and providing a faster, more flexible approach to market access. Learn more about Metli Consulting: https://www.metliconsulting.com/ “Science without story fails to reach policymakers. Policy without equity fails communities. Story without evidence fails everyone. Metli is a life sciences and public health consulting firm founded at the intersection of science, policy, communications, and human impact.”

This week’s tHEORetically Speaking News Roundup covers the looming funding crisis for rare disease biotechs as FDA priority review vouchers expire , CMS’s proposed crackdown on Medicare Advantage upcoding , and Cellares’ $257 million raise to scale automated cell therapy manufacturing . We also explore Sanofi’s defense of vaccines amid shifting U.S. policy and a landmark EU–India free trade agreement set to reshape global pharma access . Tune in for a concise recap of these pivotal industry updates!

This week’s tHEORetically Speaking News Roundup covers Novo Nordisk’s early momentum with oral Wegovy amid intensifying GLP-1 competition , rising geopolitical trade tensions threatening pharma market access , and Europe’s push to secure medicine supply chains through the Critical Medicines Act . We also examine new warnings on the misuse of medical AI heading into 2026 . Tune in for this concise recap of the week’s most impactful HEOR, RWE, and market access developments.

This week’s tHEORetically Speaking News Roundup covers Novartis’ $1.5B Alzheimer’s licensing deal , the FDA’s push to accelerate drug development through Bayesian trial methods , and Bayer’s move to scale generative AI in antibody discovery . We also break down Oxford Biomedica’s takeover talks and a newly unveiled US healthcare cost plan . Tune in for a concise recap of these pivotal industry updates!

This week’s tHEORetically Speaking News Roundup covers GSK’s abrupt exit from its five-year synthetic lethality partnership with Ideaya , Whoop’s escalating regulatory clash with the FDA over its unapproved blood-pressure feature , and new evidence showing how minimum wage and EITC policies improve maternal mental health . We also break down Medra’s $52M raise and its new AI-driven drug-discovery partnership with Genentech . Tune in for this concise recap of these pivotal industry updates!

This week’s tHEORetically Speaking News Roundup breaks down four major developments shaping policy and biopharma. We cover the new US–UK trade deal exempting pharma from tariffs and resetting NHS pricing , the FDA’s push to curb non-human primate testing for monoclonal antibodies , and Capricor’s breakthrough Phase 3 results in Duchenne muscular dystrophy . We also highlight new HEOR research using copula modeling to better understand drivers of low birth weight and preterm birth . Tune in for a fast, 4-minute briefing on the most important shifts across science, regulation, and market access.