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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: https://healtheconomics.com/theoretically-speaking/
77 Episodes
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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-str...
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...
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 Congres...
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 ...
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 ...
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...
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 ...
This week’s tHEORetically Speaking News Roundup covers Medicare’s 10% Part B premium hike for 2026 and its potential to push more seniors toward Medicare Advantage, Clairity’s $43M raise to expand its FDA-cleared predictive AI platform beyond mammography, and the RISE Committee’s controversial move to exclude public health degrees from its professional program definition. Tune in for this concise recap of these pivotal policy, innovation, and workforce updates!
This week on tHEORetically Speaking, we’re covering four major stories shaping the landscape across medtech, neurotech, drug development, and global pharma: Laborie buys Organon’s Jada system, NextSense raises a new round to launch EEG Smartbuds, Evotec and BMS hit an IND milestone, and Merck goes big with a $9.2B antiviral acquisition. A fast, focused roundup of the headlines you need to know. Subscribe for weekly drops!
This week’s tHEORetically Speaking News Roundup covers the sudden resignation of the FDA’s top drug chief amid controversy, Novo Nordisk’s sweeping restructuring and strategic reset in the obesity and diabetes markets, and a groundbreaking data partnership between ŌURA and Tidepool driving innovation in diabetes research. We also explore how rising healthcare costs threaten the future of clinical trial diversity. Tune in for this concise recap of these pivotal industry updates!
This week’s tHEORetically Speaking News Roundup covers Evotec and Bristol Myers Squibb’s progress in developing next-generation therapies for neurodegenerative diseases, the FDA’s game-changing move to streamline biosimilar approvals and lower drug costs, and Novo Nordisk’s bold $6.5B counteroffer to outbid Pfizer for Metsera in the obesity treatment race. Tune in for this concise recap of the top stories shaping HEOR, RWE, and Market Access this week.
This week’s tHEORetically Speaking News Roundup covers Astellas Pharma’s Phase 4 findings showing fezolinetant’s real-world benefits for menopausal symptom relief, improved sleep, and daily functioning. We also dive into Takeda’s $11 billion collaboration with Innovent Biologics to advance next-generation cancer therapies and expand its global oncology pipeline. Tune in for this concise recap of these pivotal industry updates!
This episode features Dalfoni Banerjee, an award-winning entrepreneur and consultant with over 30 years of hands-on experience and her expertise spans the full drug development cycle. In 2011, Dalfoni founded and continues to operate 3Sixty Pharma Solutions, which has a mission to support startup and established pharmaceutical, biotechnology, and medical device companies with subject matter experts who help teams accelerate development, overcome challenges, and avoid preventable delays....
This week’s tHEORetically Speaking News Roundup covers the FDA’s new boxed warning for J&J’s CAR-T therapy Carvykti, a major study linking post-Dobbs abortion restrictions to rising intimate partner violence, and Pelage Pharmaceuticals’ $120M funding to advance a next-generation hair loss treatment. We also spotlight Ōura’s $900M investment to expand its AI-driven health tech platform. Tune in for this concise recap of these pivotal industry updates!
This week’s tHEORetically Speaking News Roundup covers nirsevimab’s real-world success in reducing RSV hospitalizations among infants, Boehringer Ingelheim’s FDA approval of Jascayd for idiopathic pulmonary fibrosis, and Arthrosi Therapeutics’ $153 million raise to advance a next-generation gout drug. We also highlight this year’s Nobel Prize in Medicine, honoring discoveries in immune tolerance that continue to shape today’s biggest breakthroughs. Tune in for this concise recap of these pivo...
In this episode of tHEORetically Speaking, Paige McGarry interviews Aaron Berger, SVP & Head of Evidence Development Solutions at UBC discussing the evolution of direct-to-patient (DTP) study designs and how they are reshaping the landscape of clinical research. Learn more here: https://healtheconomics.com/theoretically-speaking-rethinking-decentralization-in-direct-to-patient-studies/
This week’s tHEORetically Speaking News Roundup covers Pfizer’s new Medicaid pricing deal with the current administration, Cartography Biosciences’ $67M raise to advance its next-generation colorectal cancer therapy, and calls for a U.K. anticompetition probe into pharma investment freezes. Tune in for this concise recap of the key HEOR, RWE, and Market Access headlines shaping our industry.
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