tHEORetically Speaking

<p>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/</p>

Weekly News Roundup – Vaccine Policy Shifts, AI-Powered R&D, and Billion-Dollar Investments

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 upda...

09-19
04:18

Weekly News Roundup – Pharma Acquisitions, Trial Triumphs, and Coding Controversies

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 We also explore the FDA’s draft guidance on non-opioid pain treatments and the AMA’s release of 2026 CPT codes amid growing scrutiny.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!

09-12
04:35

Weekly News Roundup – Obesity Drug Rivalry, Rare Disease Pathways, Vaccine Mandate Battles, and ACA Shake-Ups

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!

09-05
04:51

Weekly News Roundup – Ransomware Shocks, Vaccine Policy Shifts, and Billion-Dollar Pharma Investments

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!

08-29
03:48

Weekly News Roundup – Alzheimer’s Breakthroughs, Cancer Trial Advances, and High-Stakes Policy Battles

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!

08-22
03:24

Weekly News Roundup - Pharmacist Empowerment, Financial Shifts, and Innovative Health Solutions

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!

08-15
04:33

Weekly News Roundup - Pharma Pilots, Legal Battles, and Precision Medicine Breakthroughs

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 updat...

08-08
04:06

Weekly News Roundup - Vaccine Triumphs, Revolutionary Trials, and Data-Driven Health Futures

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!

08-01
04:33

tHEORetically Speaking: Meeting the Resource Challenge - Why Biotechs Need a Different Kind of Partner

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 ...

07-28
28:32

INsights & OUTcomes with Matt McLoughlin

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...

06-10
22:16

INsights & OUTcomes with Catherine Bacon

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 ...

05-20
24:42

INsights & OUTcomes with Vernon Schabert

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...

04-28
32:55

INsights & OUTcomes with Rosa Willock

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 t...

03-31
19:46

INsights & OUTcomes with Chris O'Neill

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 expertis...

03-10
31:33

INsights & OUTcomes - COMING SOON to tHEORetically Speaking

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!

02-24
01:18

tHEORetically speaking: Making Real-World Data Research-Ready

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. ...

11-07
23:03

tHEORetically speaking: Between Two Scientists: Care During Pregnancy - How RWD Can Help Balance the Needs of Mom and Baby

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 unstructu...

09-24
12:54

tHEORetically speaking: How AI-Powered Phenotyping Enhances the Patient Journey for Life Science Applications

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 iso...

04-25
14:41

tHEORetically speaking: Clinical Outcomes Assessments and Training

In this episode of tHEORetically Speaking, join Kelly Lipman, Heather Dickerson, and Ryan Murphy from ICON, who answer questions from a recent webinar on the dynamic landscape of clinical outcomes assessments, examining their historical significance, current uses and best practices, and making a case for greater standardization in their implementation. For more information, to watch the webinar, or access other resources, click here.

03-14
08:11

tHEORetically speaking: EU HTA Joint Clinical Assessments

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 webinar, or access other resources, click here.

03-14
13:07

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