tHEORetically Speaking

tHEORetically Speaking

By HealthEconomics.comScienceLife Sciences
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tHEORetically Speaking episodes

  • Integrated Evidence Delivery: Why HEOR belongs at the heart of the Modern CRO

    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



    32 min
  • Weekly News Roundup — RSV Breakthrough Data, Psychedelic Approvals on the Horizon, and Major FDA Policy Shifts

    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! 

    5 min
  • Weekly News Roundup — AI Drug Discovery Deals, mRNA Regulatory Setbacks, and Global Investment Shifts

    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

    5 min
  • Weekly News Roundup — Regulatory RWE Battles, Capital Market Moves, and Cash-Pay Drug Pricing Disruption

    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 

    5 min
  • INsights & OUTcomes with Taylor Hirschberg

    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.”

    28 min
  • Weekly News Roundup — Rare Disease Funding Risks, Medicare Advantage Reform, and Global Trade Shifts

    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!

    5 min
  • Weekly News Roundup — Oral GLP-1 Momentum, Trade Tensions, EU Drug Security, and AI Risk Warnings

    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. 

    4 min
  • Weekly News Roundup — Neurodegeneration Deals, Generative AI, and Drug Pricing Politics

    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! 

    4 min
  • Weekly News Roundup — Oncology Shakeups, FDA Wellness Crackdown, and AI-Powered Drug Discovery

    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! 

    4 min
  • Weekly News Roundup — Tariff-Free Pharma, Biologics Modernization, Duchenne Trial Success, and Maternal Health Advances

    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. 

    4 min

About tHEORetically Speaking

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Insights, observations, and executive interviews that discuss data and evidence to guide value-based decisions in health care. For more, visit our blog:…