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
![Ep 215 [06 May 2026]: Timothy Nobles – Safe Harbor Isn't a Strategy: RWD Compliance Mistakes](https://pbcdn1.podbean.com/imglogo/image-logo/13478154/5461863D-DD50-4985-A9DB-1CF441B320EE_nbtefi_300x300.jpeg)
May 8, 2026
May 8, 2026
1hr 37 sec
Ep 215 [06 May 2026]: Timothy Nobles, Chief Product Officer at Integral – We discussed Timothy's unique background (from musician in a band --> to marketing --> to data science) and discussed how claims and EMR don't speak the same language and explore semantic classification, de-id & compliant linkage to turn messy RWD into life sciences 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.
![Ep 214 [29 April 2026]: Mika Newton – From EHR Chaos to Clinical Clarity with AI](https://pbcdn1.podbean.com/imglogo/image-logo/13478154/5461863D-DD50-4985-A9DB-1CF441B320EE_nbtefi_300x300.jpeg)
May 1, 2026
May 1, 2026
57 min
Ep 214 [29 April 2026]: Mika Newton, CEO at xCures Inc. – We referenced Mika's unique background (and he was on RWW for Ep166 on 2025-02-26) and he shared how configurable AI checklists turn messy, unstructured medical records into workflow-ready, validated real-world data.Publication: A Scalable Method for Validated Data Extraction from Electronic Health Records with Large Language Models (https://www.medrxiv.org/content/10.1101/2025.02.25.25322898v2.full)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.
![Ep 213 [22 April 2026]: Wes Michael MBA – The Rare Patient Equation: RWD Access & Authenticity](https://pbcdn1.podbean.com/imglogo/image-logo/13478154/5461863D-DD50-4985-A9DB-1CF441B320EE_nbtefi_300x300.jpeg)
Apr 24, 2026
Apr 24, 2026
56 min
Ep 213 [22 April 2026]: Wes Michael MBA, President, Rare Patient Voice LLC, now part of Konovo – We discussed Wes' unique background and discussed how rare disease patients want to help science—but they have lives too. Wesley Michael shared how to find, engage, and protect rare patients along with their real-world data.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.
![Ep 212 [15 April 2026]: Steve Labkoff MD FACP FACMI FAMIA – AI Literacy: What does good look like?](https://pbcdn1.podbean.com/imglogo/image-logo/13478154/5461863D-DD50-4985-A9DB-1CF441B320EE_nbtefi_300x300.jpeg)
Apr 19, 2026
Apr 19, 2026
1hr 1 min
Ep 212 [15 April 2026]: Steve Labkoff MD FACP FACMI FAMIA, Principal at Luminant Consulting and Co-Host of the of the Practical AI in Healthcare podcast (https://practicalaiinhealthcare.com/) – We discussed Steve's unique background and he reflected on the evolution of AI in Healthcare. AI isn’t just a buzzword, but a tool transforming healthcare & clinical research. We discussed the benefits of greater AI literacy.SPECIAL GUEST: Steve Labkoff MD- Principal at Luminant Consulting- Collaborating Scientist at Beth Israel Deaconess Medical Center- Co-Host of the Practical AI in Healthcare podcast (https://practicalaiinhealthcare.com/): "Practical AI in Healthcare shines a spotlight on the stories that matter—how AI is truly transforming healthcare in ways that are measurable, meaningful, and lasting."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.
![Ep 211 [08 April 2026]: Josh Murphy MBA – The Evolution of RWD: Then vs. Now](https://pbcdn1.podbean.com/imglogo/image-logo/13478154/5461863D-DD50-4985-A9DB-1CF441B320EE_nbtefi_300x300.jpeg)
Apr 11, 2026
Apr 11, 2026
1hr 57 sec
Ep 211 [08 April 2026]: Josh Murphy MBA, SVP, RWD and Strategic Partnerships at Norstella – We discussed Josh's unique background and discussed how RWD has changed over the years, and RWD’s role in today’s drug landscape; including an overview of how linked RWD were used to conduct this interesting GLP-1 study: https://www.norstella.com/insight/early-oral-glp-1-uptake-half-story/.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.
![Ep 210 [01 April 2026]: Reyna Klesh MS – Unlocking Behavioral Health with EHR Data](https://pbcdn1.podbean.com/imglogo/image-logo/13478154/5461863D-DD50-4985-A9DB-1CF441B320EE_nbtefi_300x300.jpeg)
Apr 3, 2026
Apr 3, 2026
59 min
Ep 210 [01 April 2026]: Reyna Klesh MS, Senior Director of RWD Operations at Behavioral Health Insights – We discussed Reyna's unique background and discussed generating real-world evidence (RWE) from behavioral health assessments.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.
![Ep 209 [25 March 2026]: Michael Fronstin MBA – AI and RWD - Where are the opportunities in life sciences?](https://pbcdn1.podbean.com/imglogo/image-logo/13478154/5461863D-DD50-4985-A9DB-1CF441B320EE_nbtefi_300x300.jpeg)
Mar 26, 2026
Mar 26, 2026
1hr 5 min
Ep 209 [25 March 2026]: Michael Fronstin, GTM strategist, advisor and RWE industry veteran; senior advisor to many companies and founder of Vireo Strategies – We discussed Michael's unique background and discussed the practical considerations for AI in the life science arena, exploring the guardrails on use and validation.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.
![Ep 208 [18 March 2026]: Mark Larkin PhD – The power of science-driven patient-centric approach to RWE](https://pbcdn1.podbean.com/imglogo/image-logo/13478154/5461863D-DD50-4985-A9DB-1CF441B320EE_nbtefi_300x300.jpeg)
Mar 19, 2026
Mar 19, 2026
1hr 35 sec
Ep 208 [18 March 2026]: Mark Larkin PhD, CEO of Vitaccess – We discussed Mark's unique background and discussed the power of science-driven patient-centric approaches to Real World Evidence (RWE) and how AI-enabled dashboards are delivering real-time, real-world data (RWD) insights.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.
![Ep 207 [11 March 2026]: Nicolle Gatto PhD – Never too early! (To think about RWD)](https://pbcdn1.podbean.com/imglogo/image-logo/13478154/5461863D-DD50-4985-A9DB-1CF441B320EE_nbtefi_300x300.jpeg)
Mar 12, 2026
Mar 12, 2026
1hr 20 sec
Ep 207 [11 March 2026]: Nicolle Gatto PhD, Chief Science Officer, Life Sciences at Datavant – We discussed Nicolle's unique background and discussed the impact of RWD on early drug development decisions and strategy. Building on her published paper (reference below), Nicolle explored how systematic use of RWD informs critical decisions in early clinical development, shaping smarter clinical & regulatory strategy from the start (& why it has been hard to adopt).Reference: Gatto NM, Campbell UB. Hope is Not a Strategy: Using Robust Real-World Evidence to Make Better Clinical Development Decisions. Ther Innov Regul Sci. 2025 Nov;59(6):1288-1293. doi: 10.1007/s43441-025-00822-x. Epub 2025 Jul 18. PMID: 40679790; PMCID: PMC12579674.> https://link.springer.com/article/10.1007/s43441-025-00822-x (https://pubmed.ncbi.nlm.nih.gov/40679790/)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.
![Ep 206 [04 March 2026]: Scott Ponder – Demand meet supply: Fulfilling the need for RWD insights](https://pbcdn1.podbean.com/imglogo/image-logo/13478154/5461863D-DD50-4985-A9DB-1CF441B320EE_nbtefi_300x300.jpeg)
Mar 4, 2026
Mar 4, 2026
1hr 34 sec
Ep 206 [04 March 2026]: Industry luminary, Scott Ponder, CEO of Channel Mark Advisors – We discussed Scott's unique background and discussed RWD supply from the health system and data aggregator perspective, and the evolution occurring in the RWD sector. Link referenced in the discussion: https://www.linkedin.com/posts/scott-ponder-fachdm-6231515_the-real-world-data-market-a-confounding-activity-7325240643058819072-FCaGPlease 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.



