tHEORetically Speaking

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.  Tun...

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 toleranc...

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. 

This episode features Dr. Renée Arnold, the President & CEO of Arnold Consultancy & Technology, LLC (ACT), focusing on outcomes research and software for healthcare sectors. She specializes in evidence-based health and real-world data modeling for healthcare decisions. Dr. Arnold is a founding member of ISPOR and chairs a special interest group at the Society for Medical Decision Making, w...

This week’s tHEORetically Speaking News Roundup covers the ACIP’s heated vaccine policy debates , growing state-level divides in COVID-19 vaccine access , and pharma’s race to develop multi-specific antibodies . We also explore the looming $32 billion revenue loss tied to expiring ACA subsidies and the latest legal battles over IRA drug pricing . Tune in for this concise recap of these pivotal ind...

This week’s tHEORetically Speaking News Roundup covers the CDC’s ACIP meeting and its implications for U.S. vaccine policy , GHO Capital’s acquisition of AI-powered R&D platform Scientist.com , and GSK’s $30 billion investment in U.S. drug manufacturing . We also explore Eli Lilly’s promising pediatric trial results for Mounjaro in type 2 diabetes and several upcoming FDA decisions poised to r...

This week’s tHEORetically Speaking News Roundup covers new research on social-genetic influences in adolescent depression , Novartis’s $1.4B acquisition of Tourmaline Bio for a promising heart drug , and encouraging Phase 2 results for rezatapopt in solid tumors . We also explore the FDA’s draft guidance on non-opioid pain treatments and the AMA’s release of 2026 CPT codes amid growing scrutiny ....

This week’s tHEORetically Speaking News Roundup covers Novo’s Wegovy showing superior cardiovascular benefits over Lilly’s Zepbound , the FDA’s new Rare Disease Evidence Principles to accelerate ultra-rare drug development , and Florida’s move to abolish vaccine mandates . We also explore HHS’s expansion of catastrophic health plans amid looming ACA premium hikes .  Tune in for this concise recap...

This week’s tHEORetically Speaking News Roundup covers DaVita’s massive ransomware attack impacting 2.7 million patients , the FDA’s updated COVID-19 booster approvals for high-risk groups , and Roche’s $700M investment in a new obesity drug facility in North Carolina . We also highlight Virginia’s success in attracting major pharma investments from AstraZeneca and Eli Lilly .  Tune in for this co...

This week’s tHEORetically Speaking News Roundup covers semaglutide’s potential in Alzheimer’s treatment , Delcath’s new Phase II trial for colorectal cancer , and a court ruling overturning limits on Medicare Advantage broker payments . We also break down CVS’s $290 million penalty for Medicare drug overcharges and the Supreme Court’s decision upholding NIH grant cuts tied to DEI policies .  Tune...

This week's tHEORetically Speaking News Roundup covers the impact of pharmacists prescribing minor ailments in Ontario , significant Medicaid payment cuts affecting US hospitals , and Kaiser Permanente's robust Q2 earnings amidst cost pressures . We also delve into the FDA's PreCheck program for boosting US pharma manufacturing and the approval of a groundbreaking immunotherapy for...

This week's tHEORetically Speaking News Roundup covers the U.S. Department of Health and Human Services' new 340B rebate model pilot , a lawsuit against Novo Nordisk over misleading sales projections for Ozempic and Wegovy , and the GAO's findings on illegal NIH grant cuts by the Trump administration . We also delve into Merck's $10 billion acquisition of Verona Pharma and Astr...

This week's tHEORetically Speaking News Roundup covers Moderna's strides toward COVID-19 vaccine approval in Europe , Eli Lilly's promising trial results for Jaypirca in leukemia treatment , and J&J's innovative CAR-T therapy ad campaign . We also explore the Trump administration's new health data sharing initiative and a groundbreaking platform predicting antibiotic r...

In this episode of Theoretically Speaking, Paige McGarry interviews David W. Miller, CEO of Genesis Research Group, discussing the unique challenges faced by biotech companies in evidence generation, market access, and stakeholder engagement. David W. Miller discusses how Genesis Research Group addresses these challenges, including the importance of demonstrating value early in development, the ro...

This episode features Matt McLoughlin, Senior Vice President of Compliance and Categories at Scientist.com. With 25 years in pharma R&D and Procurement, Matt has enhanced outsourcing for biopharma companies, focusing on speed, efficiency, and compliance. His expertise in regulated industries extends to RWE, HEOR, and Market Access, transforming access to external services to boost innovation w...

Welcome to INsights & OUTcomes, the newest podcast on tHEORetically Speaking from HealthEconomics.com, where we sit down with the leading professionals in HEOR, RWE, and market access, the experts shaping the future of healthcare decisions. This episode features Catherine Bacon, founder of FingerPost Consulting in Manchester. She has more than 15 years of experience in market access, predomina...

Welcome to INsights & OUTcomes, the newest podcast on tHEORetically Speaking from HealthEconomics.com, where we sit down with the leading professionals in HEOR, RWE, and market access, the experts shaping the future of healthcare decisions. This episode features Dr. Vernon Schabert, Founder of Epilogix. Vernon is an internationally-recognized health economist and pharmacoepidemiologist and has...

Welcome to INsights & OUTcomes, the newest podcast on tHEORetically Speaking from HealthEconomics.com, where we sit down with the leading professionals in HEOR, RWE, and market access, the experts shaping the future of healthcare decisions. This episode features Rosa Willock, a Senior Consultant at Decisive Consulting. She leads the RWE function at Decisive Consulting, which includes helping c...

Welcome to INsights & OUTcomes, the newest podcast on tHEORetically speaking from HealthEconomics.com, where we sit down with the leading professionals in HEOR, RWE, and market access, the experts shaping the future of healthcare decisions. This episode features Chris O'Neill, founder and CEO of Bosun MA. He has has over 20 years’ experience developing and delivering value and Market Acce...

Join us for INsights & OUTcomes where we sit down with the leading professionals in HEOR, RWE & RWD, and Market Access, the experts shaping the future of healthcare decisions. We'll dive into their careers, their passions, and the biggest trends in health economics today. We break down the numbers, challenge assumptions, and uncover what really drives healthcare decision making. Subsc...

This episode of tHEORetically Speaking features Jeffrey Brown, PhD and Matvey Palchuk, MD, MS, FAMIA of TriNetX, who discuss the rise of RWD and its role in revolutionizing healthcare research, and how the TriNetX team approaches data quality to ensure research-ready RWD. With increasing use of real-world data (RWD) throughout the drug development cycle — from initial discovery through to market a...

This episode of tHEORetically Speaking is the fourth podcast in Panalgo’s ‘Between Two Scientists’, featuring host Meg Richards, PhD, MPH, who sits down with Panalgo’s VP of Medical Affairs, Dr. Mark Friedman, to discuss balancing the health needs of a pregnant woman and her developing baby, and how RWD can help. Have a listen to the third ‘Between Two Scientists’ podcast , where Norstella’s Gener...

In this episode of tHEORetically speaking, Dr. Joseph Zabinksi, VP and Head of Commercial Strategy and AI at OM1, explains how AI-powered digital phenotyping can enhance our understanding of patients' experiences and inform access, treatment, and condition management. Real-world data provides an opportunity to understand what happens to patients, but there are limitations to the insights we c...

In this episode of tHEORetically Speaking, join Dr. Rosemary Jose, Dr. Sonja Kroep, and Nick Halfpenny from OPEN Health, Dr. Ansgar Hebborn from Roche, and James Ryan from AstraZeneca, who answer questions from a recent webinar on several policy aspects regarding the current challenges and implications of the EU Health Technology Assessment (HTA) regulation. For more information, to watch the webi...