Explore every episode of the podcast 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. 

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.

Learn more about 3Sixty Pharma Solutions here: https://3sixtypharma.com/

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 pivotal industry updates!

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, with numerous publications in her field.

Learn more about some of Renée's work here: https://healtheconomics.com/modex-revolutionizing-cancer-drug-pricing-and-access-through-open-source-health-economic-models/

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 industry updates! 

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 reshape the pharmaceutical landscape.

Tune in for this concise recap of these pivotal industry updates! 

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.

Tune in for this concise recap of these pivotal industry updates! 

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 of these pivotal industry updates! 

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 concise recap of the week’s most important HEOR, RWE, and Market Access updates! 

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 in for this concise recap of the week’s most impactful industry updates! 

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 a rare respiratory disease. 

Tune in for this concise recap of these pivotal industry updates!

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 AstraZeneca's precision strategy in lung cancer treatment. 

Tune in for a concise recap of these pivotal industry updates!

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 resistance. 

Tune in for this concise recap of these pivotal industry updates!

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 role of real-world evidence in supporting biotechs, and how to navigate uncertainty in the biotech landscape. Additionally, strategies for effective data collection are introduced, while emphasizing the need for flexibility and adaptability in the ever-evolving life sciences sector.  Genesis Research Group's Flexible Integrated Team (FIT) model is also discussed as an adaptable and fit-for-purpose program to support biotechs, ensuring development and launch are optimized, regardless of size, resources, and specific needs. Representing a true paradigm shift in strategic partnerships, David explains how the Genesis team is able to adapt their extensive global expertise in areas such as pricing, real-world evidence, HEOR, and market access as they support emerging biotechs to ensure commercial success.

For more information or to access other resources, click here.

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 while cutting costs and project timelines.

To stay connected with us, visit our LinkedIn page and subscribe to our newsletter!

Learn more about Scientist.com and how they can help with planning your book of work here: https://www.healtheconomics.com/5-key-questions-to-ask-before-you-launch-a-value-evidence-plan

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, predominantly as a consultant. Driven by a passion for addressing the challenges of high-cost, innovative treatments, she is committed to ensuring these therapies reach the right patients at the right time and price.

To stay connected with us, visit our LinkedIn page and subscribe to our newsletter!

Learn more about FingerPost Consulting:
https://healtheconomics.com/partner/fingerpost-consulting-ltd/

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 nearly 30 years of HEOR, RWD, and RWE industry experience.

To stay connected with us, visit our LinkedIn page and subscribe to our newsletter!

Learn more about Epilogix: https://healtheconomics.com/suppliers/epilogix-llc/

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 clients to identify and address gaps in their evidence packages, and more recently, helping them to plan for the new EUHTAR.

To stay connected with us, visit our LinkedIn page and subscribe to our newsletter!

Learn more about Decisive Consulting: https://healtheconomics.com/suppliers/decisive-consulting/

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 Access solutions for Pharma clients at a global and regional level.

BOSUN MA has over 20 years of expertise in payer understanding, and they use the latest AI technologies to help align clinical outcomes and Payer Need. Bosun MA is a leading architect of AI SaaS tools which enable clients to develop value messages that are underpinned by clinical evidence and which can be tested systematically against the value drivers in multiple geographies and Payer environments. They work globally in all major therapeutic areas and have a rich experience in developing value strategies across all development stages: helping to drive investment decisions and launch programs.

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.

Subscribe now!

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 approval and post-market monitoring — comes increasing scrutiny about the quality of the data.

To watch the full interview, click here.

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 General Manager of RWD, Ted Search, highlighted the challenges of incorporating new types of unstructured real-world data with structured data.

For more information or to access other resources, click here. 

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 can generate using traditional analysis techniques alone. At OM1, our PhenOM technology uses AI to isolate subtle signals in real-world data associated with outcomes we care about - diagnoses, treatment response, and future risks. The insights we derive integrate into our existing patient journeys to answer questions we couldn't without this technology, including who remains undiagnosed or misdiagnosed, and how patient subcohorts take different trajectories within the same broader condition.

To learn more, click here.