tHEORetically Speaking

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/

Introducing Trial Insights—the essential tool for pharma researchers and biotech investors. 

Seamlessly track clinical trials in r...

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/

Introducing Trial Insights—the essential tool for pharma researchers and biotech investors. 

Seamlessly track clinical trials in real-time, refine searches by key criteria, and receive timely notifications on important updates. With Trial Insights, ensure your research and business initiatives are always informed and str...

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/

Introducing Trial Insights—the essential tool for pharma researchers and biotech investors. 

Seamlessly track clini...

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 F...

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...

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...

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/

Introducing...

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!

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 Ne...

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, cli

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...

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.

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.

In this episode of tHEORetically Speaking, join Dr. Pamela Landsman-Blumberg, Amanda O’Hora, and Ajay Keshava from Magnolia Market Access, who answer questions from a recent webinar on how early stage planning taking into account commercial production, logistics, reimbursement, and health inequities can lead to successful approvals and market adoption.

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

In this episode of tHEORetically Speaking, join Drs. Megan Gower and Edward Chou from Takeda, and Richard Tsai, MS from Inspire, who answer questions from a recent webinar on the challenges and solutions for generating patient-centered real-world evidence (RWE) in the context of rare diseases, to support clinical development through commercial post-approval.

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

In this episode of tHEORetically Speaking, join Drs. Javier Cid, Nahila Justo, and Delphine Saragoussi from Evidera and PPD, who answer questions from a recent webinar on why strong connections with registry groups and stakeholder populations are important for generating relevant real-world evidence to advance treatments.

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

In this episode of tHEORetically speaking, join Christelle Giroudet, MA and Ana Alvarez, MA, COA Linguistic Validation Leaders with ICON, as they highlight the importance of Linguistic Validation and how equivalence should be a key focus during the development of Clinical Outcome Assessment translations.

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

This episode of tHEORetically Speaking is the third installment of Panalgo’s ‘Between Two Scientists’, featuring host Meg Richards, Executive Director of Solutions at Panalgo, who chats with Norstella’s General Manager of RWD, Ted Search, General Manager of RWD at Norstella about new types of unstructured real-world data and the challenges of incorporating them with structured data.

Have a listen to the second ‘Between Two Scientists’ podcast which covered the privacy certification of linked data with Bobby Samuels of Datavant.

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

HEOR Ltd. have been working on an exciting new framework called Total System Value™. This episode of tHEORetically speaking features their CEO Phil McEwan and CGO Jeff Anderson to talk to us about this dynamic approach to value demonstration.

Total System Value™ (TSV)™ is a new, dynamic framework designed to assess the value of adopting a new technology or policy initiative at a population level.

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

This episode of tHEORetically Speaking is the second installment of Panalgo's 'Between Two Scientists', featuring host Meg Richards, Executive Director of Solutions at Panalgo, and Bobby Samuels, General Manager of Privacy Hub at Datavant.

In the first episode of ‘Between Two Scientists', we talked about data linkages and the need to certify the linked data before they can be used for research. In this episode, we’re picking up the data certification thread. Like the first episode, this one is also to wine-making.

For more information or to access other resources, clic...

The hype around AI is finally translating into real-world value, and we are seeing broader adoption of real-world data in Dermatology. This episode of tHEORetically Speaking features Dr. Stefan Weiss, Managing Director of Dermatology and Dr. Joseph Zabinski, Managing Director of AI and Personalized Medicine at OM1, who discuss the path to personalized medicine and AI-powered clinical decision support in dermatology.

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

This episode of tHEORetically Speaking features real-world evidence experts Alexandrina Balanean, Parisa Asgarisabet, and Danielle Gentile from Cardinal Health discussing the problems caused by lack of diverse representation in clinical trials.

The underrepresentation of disproportionately burdened groups limits information on therapeutic response, safety, and efficacy to a small subset of the population—which tends to be healthier, more well-educated, and financially advantaged. However, recent findings show that real-world evidence (RWE) may be able to help with this underrepresentation. Listen in to learn more about these findings and what it may mean for the fu...

This episode of tHEORetically Speaking features our host Meg Richards, Executive Director of Solutions at Panalgo, who will be speaking with Erik Maul, Senior Director of Data Partnerships at Panalgo about data linkage.

The healthcare and life sciences industries are currently experiencing transformative times of growth. The explosion of real-world data, new regulatory programs and frameworks, and a focus on AI and machine learning are only a few of the factors contributing to this rapidly evolving landscape. In this podcast – we’re aiming to illuminate these catalysts of change by talking to the experts themselves. From...

The landscape for Alzheimer's disease is rapidly changing. This episode of tHEORetically speaking features Dr. Carl Marci from OM1 and Dr. Luke Stoeckel from NIA, as they discuss the critical need for earlier detection leading to potentially life changing earlier interventions.

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

In this episode of tHEORetically speaking, Gary Curhan, Chief Medical Officer and Jessica Paulus, Vice President of Research at OM1, as they answer questions on Leveraging Real-World Data for Precision Obesity Treatment.

For more information or access other resources, click here.

In this episode of tHEORetically Speaking, join ICON experts Mark McCoy, Dr. Earlene Biggs, Bruce Capobianco, Dr. Tanja Obradovic, Ki Park, and Nancy Risebroughas they answer questions on the Centers for Medicare and Medicaid Services’ negotiations on the fair market prices for Medicare Part D products.

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

In this episode of tHEORetically Speaking, join Dr. Eunice Chang and Dr. Michael Broder from PHAR, and Mitra Corral from Genentechas they answer questions on the how and why use of Medicare data for conducting various types of RWD analysis is important.

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

In this episode of tHEORetically speaking, join Dr. Pamela Landsman-Blumberg from Magnolia Market Access and Dr. Rick Chapman from Innovation and Value Initiativeas they answer questions on the importance of social determinants of health (SDOH) and describe the benefits of linking SDOH data with other real-world data when conducting health economics and outcomes research (HEOR).

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

In this episode of tHEORetically speaking, join Dr. Bruce Feinberg, Dr. Danielle Gentile, Dr. Parisa Asgarisabet, and Alexandrina Balanean from Cardinal Health as they answer questions on the economic impact and role of real world evidence (RWE) in improving representativeness of research.

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

In this episode of tHEORetically speaking, join Gillian Sibbring, Sue O’Leary, Ben Rousseau, Patti Peeples, and Rachel Forrest as they answer questions on systematic literature review issues that can negatively affect your Global Value Dossiers (GVDs) and how automation can improve your product's market access.

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

In this episode of tHEORetically Speaking, join Michael Grabner, Alexander Turchin, and Shivani Pandya as they answer questions on causal inference and designing these studies using real-world healthcare data.

In this episode of tHEORetically Speaking, join Deepak Sahu as he answers questions on developing Health Economics and Outcomes Research (HEOR) studies for generating short- and long-term effectiveness data for medical technology.

In this episode of tHEORetically speaking, join Elodie de Bock, Valentin Barbier, Adel Mebarki, and Joelle Malaab as they answer questions on how to collect, use, analyze, and interpret social media data in different contexts.

In this episode of tHEORetically speaking, join Chris Waters-Banker, Maria Arregui, Rajshree Pandey, Lee-Anne Bourke, and Patti Peeples as they answer questions on what Health Technology Assessment (HTA) agencies do and the types of literature reviews they do.

In this episode of tHEORetically speaking, join Priti Jhingran and Tijana Ignjatovic as they answer questions on opportunities for using agile platforms and fit-for-purpose engagement models that can drive an iterative approach to obtaining payer insights and developing impactful evidence generation strategies.

In this episode of tHEORetically Speaking, join Jincy Paulose, George Joseph, and Michael Broder as they answer questions around leading Delphi panels, their experience participating in the discussions, and how they have used the results.

In this episode of tHEORetically Speaking, join Danielle Drachmann, Josie Godfrey, Kristine Sorensen, Beth Lesher, Kelly McCarrier, and Gavin Jones as they answer questions on how to improve health literacy and the understandability of the HEOR process to enable effective partnerships, as well as to assist patients to participate in shared decision making with their physicians.

In this episode of tHEORetically Speaking, join Marija Zivkovic-Gojovic, Richard Pitman, and Pragya Khurana as they answer questions on infectious disease modeling, the assessment of interventions, and the challenges around these analyses. 

In this episode of tHEORetically speaking, Bill Saunders from IntegraConnect discusses  Real-World Data and Real-World Evidence in the context of value-based care and precision medicine for specialty care.

To read the full blog and watch the interview click here.

In this episode of tHEORetically Speaking, join Nitin Baliga, Insitute for Systems Biology, and Thomas Brown, Syapse as they answer questions on utilizing real-world data, machine learning, and systems biology for benefiting therapeutic development.

 We recently sat down with Preeti Patel, MPharm, CEO and Founder of GPI, to learn what is driving the growing importance for early stage asset value and price prediction, how GPI is supporting clients through these challenges, and how this solution was developed.

Global Pricing Innovations (GPI) is a price and access insights company that uses analytics to provide data-driven, evidence-based support, and helps clients make better investment decisions for drug development and commercialization.

Read the full blog post here.

In this episode of tHEORetically speaking, join Colin Oliver, Anila Dede, Erwin De Cock, and Arshi Gupta from Syneos Health as they answer questions on evidence generation planning for clinical and commercial success and improvement of patient outcomes.

In this episode of tHEORetically speaking, join Renee Willmon as she answers questions on Health Storylines, a disease-agnostic and customizable platform that connects healthcare stakeholders to engaged patients.

In this episode of tHEORetically speaking, join Earlene Biggs, Gary Owens, and Renee Fleming, as they answer questions regarding information sharing with healthcare decision-makers for optimized engagement.

In this episode of tHEORetically speaking, join Raina Olexa and Mui Van Zandt as they answer questions on embracing FDA’s guidance on the use of real world data (RWD) to understand how your organization can navigate data quality, curation, and management challenges for better research.

In this episode of tHEORetically Speaking, join Eric Benchimol, Karina Raimundo, Anil Vachani, and Michael Broder as they answer questions on validation of code algorithms for Real World Evidence (RWE).

In this episode of tHEORetically Speaking, join Eric Stanek, Michael Grabner, Deb Discenza, Jennifer Degl, and Thomas Miller as they answer questions on improving neonatal outcomes using Real World Evidence (RWE).

To learn more, click here.

In this episode of tHEORetically speaking, join Shirley Sylvester, Vardhini Ganesh, Richa Goyal Rai, and Lee-Anne Bourke as they answer questions where they discuss how literature review automation helps solve the daily challenges facing research professionals.

To learn more click here.