The RWD & RWE Podcast

*** Join our weekly Real-World Wednesdays (RWW) Clubhouse room every Wed @ 11am Eastern US Time*** All things related to the collection, creation & use of Real-World Data (RWD) in generating Real-World Evidence (RWE) for clinical research, drug development, medical devices, value access and other activities for BioPharma and the Life Sciences! Real-World Data (RWD): data relating to a person’s health status or well-being, or the care received by a person, as collected from real-world settings (as opposed to the controlled clinical trial setting) [aka observational data, healthcare data, etc.] Real-World Evidence (RWE): the appropriate analysis of RWD Reliable RWD + Appropriate Analysis = Meaningful RWE

Episodes

Jul 31, 2026

1 hr 1 min

Ep 225 [29 July 2026]: Sarah Daugherty PhD MPH (Principal Scientist at @Carelon) and Daniel Beachler PhD MHS (VP of Safety & Epidemiology at @Carelon) – We discussed their unique background and personal experiences, which led to a great discussion on what makes real-world evidence more meaningful? Beyond the Myths: The Value of Patient-Centered Research. We will discuss how incorporating patient preferences, experiences, and needs can strengthen evidence generation and help ensure research focuses on what matters most to patients.Please read Daniel's LinkedIn post: https://www.linkedin.com/feed/update/urn:li:activity:7414688910959611904/Please check-out our website to join the club, get updates and see podcast recordings: https://rwd-rwe.clubDisclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Jul 31, 2026

1 hr 1 min

Jul 22, 2026

1 hr 55 sec

Ep 224 [22 July 2026]: Leon Rozenblit PhD, Founder, lecuturer and podcaster with a focus on healthcare AI, data strategy, and governance models – We discussed Leon's unique background and discussed that the hyphen between RWD and RWE is rarely considered but represents vast amounts of work and expertise: RWD does not automatically translate into RWE. In this episode, we will explore data refineries and their role in sourcing, aggregation, engineering, methodology, and the engineering to turn raw data into real-world evidence. Please check-out our website to join the club, get updates and see podcast recordings: https://rwd-rwe.clubDisclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Jul 22, 2026

1 hr 55 sec

Jul 10, 2026

1 hr 42 sec

Ep 223 [08 July 2026]: Schiffon Wong MPH, Founder and Principal of Schiffon Wong Strategic Advisory, where she advises biopharma executive leaders on evidence strategy for market access. She brings over 20 years of healthcare and life sciences experience, including nearly two decades inside pharma evidence functions — most notably as VP and Head of Neurology & Immunology, Global Value Demonstration at EMD Serono, with earlier roles at Bristol-Myers Squibb and Deloitte. She holds an MPH in Epidemiology from Columbia University and has authored approximately 100 publications and presentations.We discussed Schiffon's unique background and discussed that policy changes today are forcing a step-change in evidence rigor, Schiffon will focus on what that pressure exposes organizationally, and why research methodology is now table stakes, not the differentiator it was in the past. JCA — Joint Clinical Assessment, the EU-level HTA (Health Technology Assessment) process that took effect in 2025, requiring coordinated clinical evidence evaluation across member states before national reimbursement decisions.MFN — Most Favored Nation, a U.S. drug pricing policy concept requiring manufacturers to match the lowest price paid by comparable countries, with implications for how value must be demonstrated domestically.IRA — Inflation Reduction Act, the 2022 U.S. legislation that introduced Medicare drug price negotiation, among other provisions, fundamentally reshaping how manufacturers think about evidence requirements earlier in development.Please check-out our website to join the club, get updates and see podcast recordings: https://rwd-rwe.clubDisclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Jul 10, 2026

1 hr 42 sec

Jul 2, 2026

1 hr 46 sec

Ep 222 [01 July 2026]: Katherine Byrne MS, Director of RWE and Innovative Evidence at Novartis – We discussed Katherine's unique background and discussed a truism today: that real-world evidence is powerful, but only if it resonates across industry and patients alike. How can we align data, language, and insights with what patients truly value in their care and health outcomes?Please check-out our website to join the club, get updates and see podcast recordings: https://rwd-rwe.clubDisclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Jul 2, 2026

1 hr 46 sec

Jun 25, 2026

1 hr 1 min

Ep 221 [24 June 2026]: Yin Ho MD MBA, serial health IT entrepreneur and AI humanist – We discussed Yin's unique background and we explored the not-so-firm foundation of RWD for AI, exploring historical, present day and future implications of AI insights from healthcare data.Please check out Yin's book -- Rushing Headlong: https://www.amazon.com/Rushing-Headlong-Health-Legacy-Responsible/dp/B0G3H4G484Please check-out our website to join the club, get updates and see podcast recordings: https://rwd-rwe.clubDisclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Jun 25, 2026

1 hr 1 min

Jun 20, 2026

59 min

Ep 220 [17 June 2026]: Sandeep Pawar PhD, GM of Life Sciences at Manifold – We discussed Sandeep's unique background and drew on his experience building data and alliances functions at TempusAI and Verana Health to unpack how purpose-built agents are reshaping the biopharma value chain — from translational research through commercial and launch. We covered what makes data agents harder than software agents, what separates a pilot from a scalable solution, and the governance responsibilities that come with this shift. We also explored the ROI should you expect — and where the field is heading.Please refer to his recent blog post for additional background: https://www.linkedin.com/posts/activity-7442251820174929920-8808Please check-out our website to join the club, get updates and see podcast recordings: https://rwd-rwe.clubDisclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Jun 20, 2026

59 min

Jun 11, 2026

1 hr 1 min

Ep 219 [10 June 2026]: Wendy Charles PhD, a professor, scientist, and former IRB Director with extensive experience in applying ethical, regulatory, and practical frameworks to real-world healthcare data – We discussed Wendy's unique background and she unpacked the often ambiguous boundary between quality improvement, analytics, and human subjects research—clarifying when real-world data activities require IRB review and how to navigate those decisions with confidence.Please check-out our website to join the club, get updates and see podcast recordings: https://rwd-rwe.clubDisclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Jun 11, 2026

1 hr 1 min

Jun 4, 2026

1 hr 56 sec

Ep 218 [03 June 2026]: Mal Postings MBA, CEO of Vincigravitas and a RWD industry chief architect – We discussed Mal's unique background and catch-up since his past episodes 32 (12/1/2021) & 90 (3/15/2023). Then we discussed TechnoHealth's 12 Domains: AI-powered care, digital twins, agentic AI, quantum biology, and the move from reactive medicine to proactive health engineering.Shared Material: https://sites.google.com/vincigravitas.org/vincigravitas/technohealth/framework?authuser=0Please check-out our website to join the club, get updates and see podcast recordings: https://rwd-rwe.clubDisclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Jun 4, 2026

1 hr 56 sec

May 28, 2026

59 min

Ep 217 [27 May 2026]: Claire Manneh MPH, Senior Practice Lead for Research Institutions at Datavant – We discussed Claire's unique background and discussed how researchers use real-world data to improve research partnerships, privacy, and patient outcomes.Please check-out our website to join the club, get updates and see podcast recordings: https://rwd-rwe.clubDisclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

May 28, 2026

59 min

May 15, 2026

1 hr 1 min

Ep 216 [13 May 2026]: Kathleen Mandziuk RN MPH, Athena Innovations founder and research industry veteran – We discussed Kathleen's unique background and explored RWE's evolution—from claims & EHR data to tokenized, AI-driven evidence generation shaping the future of clinical research.References cited during the discussion:> Adjunctions Pro: https://adjunctions.com/pro> PACE Council: https://www.linkedin.com/company/pace-council/Please check-out our website to join the club, get updates and see podcast recordings: https://rwd-rwe.clubDisclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

May 15, 2026

1 hr 1 min

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