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tHEORetically Speaking

HealthEconomics.com
FDA
Novo Nordisk
Real World Evidence
Market Access
Eli Lilly
Medicaid
Health Economics
Real World Data
Clinical Trials
Medicare Advantage
Covid-19
Artificial Intelligence
Pfizer
Abbott
Moderna
Astrazeneca
RSV
Executive Orders
Real-World Data
Roche

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

PublishesWeeklyEpisodes86Founded4 years ago
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ScienceLife Sciences

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Latest Episodes

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 I... more

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 ca... more

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 ... more

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 contri... more

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Recent Guests

Mark Larkin
Founder and CEO of Vitaccess, digital healthcare researcher
Vitaccess
Episode: INsights & OUTcomes with Mark Larkin
Radek Wasiak
Expert in real world data generation and real world evidence
Adigens Health (Director)
Episode: INsights & OUTcomes with Radek Wasiak
Mir Sohail Fazeli
Physician Scientist and Founder of Evidino Outcomes Research
Evidino Outcomes Research (now part of UBC)
Episode: Integrated Evidence Delivery: Why HEOR belongs at the heart of the Modern CRO
Taylor Hirschberg
Award-winning writer, activist, and academic; leads Metli Consulting
Metli Consulting
Episode: INsights & OUTcomes with Taylor Hirschberg
Dalfoni Banerjee
An award-winning entrepreneur and consultant with over 30 years of experience in drug development.
360 Pharma Solutions
Episode: INsights & OUTcomes with Dalfoni Banerjee
Aaron Berger
Senior Vice President, Evidence Development Solutions at United Biosource
United Biosource
Episode: tHEORetically Speaking: Rethinking Decentralization in Direct-to-Patient Studies
Dr. Renée Arnold
Passionate about evidence-based medicine and health economics
Episode: INsights & OUTcomes with Renée Arnold
Matt McLoughlin
Senior Vice President for Compliance and Categories at scientists.com, with over 25 years in the pharmaceutical industry, including experience as a geneticist for AstraZeneca.
scientists.com
Episode: INsights & OUTcomes with Matt McLoughlin
Catherine Bacon
Founder of FingerPost Consulting, with over 15 years of experience in market access.
FingerPost Consulting
Episode: INsights & OUTcomes with Catherine Bacon

Host

Sarah McFarland
Primary host of the show series, consistently guiding interviews and HEOR discussions.

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Talking Points

Recent interactions between the hosts and their guests.

INsights & OUTcomes with Radek Wasiak
Q: Is AI-ready, unstructured EHR data within reach for regulatory-grade evidence, and what must happen next?
AI-derived evidence can reach regulatory-grade status with large-scale validation, rigorous pre-specification, and adherence to guidance; the key is to validate methods across studies, maintain patient privacy, and have regulators endorse the approach through clear guidelines.
INsights & OUTcomes with Radek Wasiak
Q: From a regulatory and payer perspective, what is the most important change companies should make to bridge the gap between approval and reimbursement?
Submitters should treat regulators and HTAs as equally important audiences, providing high-quality, pre-specified real-world evidence that aligns with the agency's and payer's decision criteria, and ensure transparency about data provenance and methodological choices.
Integrated Evidence Delivery: Why HEOR belongs at the heart of the Modern CRO
Q: What problems are pharma companies really facing today when it comes to evidence generation?
The answers highlighted that evidence generation is often siloed and sequential, leading to misalignment between regulatory, payer, and clinical narratives. Early HEOR involvement creates a single, cohesive value story and more flexible design, improving efficiency and reducing the risk that separate tracks fail to support all objectives.
INsights & OUTcomes with Taylor Hirschberg
Q: How do you see PROs shaping the future of patient-centered care and health equity?
PROs will serve as the connective tissue between clinical care, quality measurement, and research, with growing regulatory emphasis from bodies like the FDA and CMS pushing for their integration into decision-making, while digital tools offer real-time data capture that can close gaps for historically excluded populations.
INsights & OUTcomes with Dalfoni Banerjee
Q: How do you see these mandates influencing the future of public and private partnerships or PPPs?
Dalfoni suggests that there is still uncertainty surrounding the impact on PPPs, particularly regarding legal exposures and political challenges.

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Frequently Asked Questions About tHEORetically Speaking

What is tHEORetically Speaking about and what kind of topics does it cover?

The show's episodes consistently center on health economics, outcomes research, and value-based decision making in healthcare, with heavy emphasis on policy shifts, drug pricing, regulatory changes, and industry partnerships. A recurring pattern highlights how policy, reimbursement, and real-world data intersect with clinical development and market access, often featuring executive-level guests discussing grant funding, RWE, and strategic pivots in biopharma and health tech. A notable strength is the ability to translate complex policy and economic topics into actionable insights for professionals navigating healthcare markets, payer strategies, and biomedical innovation. The format blends timely news roundups with in-depth interviews that ... more

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These podcasts share a similar audience with tHEORetically Speaking:

1. The Immunology Podcast

How many episodes of tHEORetically Speaking are there?

tHEORetically Speaking launched 4 years ago and published 86 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

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What guests have appeared on tHEORetically Speaking?

Recent guests on tHEORetically Speaking include:

1. Mark Larkin
2. Radek Wasiak
3. Mir Sohail Fazeli
4. Taylor Hirschberg
5. Dalfoni Banerjee
6. Aaron Berger
7. Dr. Renée Arnold
8. Matt McLoughlin

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