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

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Episodes

Saturday Feb 22, 2025

Ep 165 [19 February 2025]: Justin Spencer, CEO at Azimuth Research Group – We discussed how to unlock healthcare data through research partnerships that work: partnering with health systems provides access to rich, fit-for-purpose data that empowers retrospective and prospective research, driving better outcomes and innovation in precision medicine.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.

Sunday Feb 16, 2025

Ep 164 [12 February 2025]: Mayowa Oyesanya MD, Medical Director at Holmusk and practising NHS psychiatrist in the UK – We discussed how to maximise the potential of real-world data in neuropsychiatry by; leveraging different types of data, applying newer methods, and carefully considering use cases for RWD.Disclaimer: 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.

Friday Jan 31, 2025

Ep 163 [29 January 2025]: Jack DiGiovanna PhD, the CSO of Velsera, which resulted from the merger of Seven Bridges, Pierian and UgenTec back in January 2023. – We discussed that the merged firms continue building across digital diagnostics, bio­informatics, healthcare data and advanced analytics to enable better healthcare, diagnostics, and precision medicine research. Velsera is working across the spectrum, from unique data generation, to data assembly and data access, generating substantial impact in the market.Disclaimer: 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.

Saturday Jan 25, 2025

Ep 162 [22 January 2025]: Chuka Esiobu, Principal at Define Ventures – We discussed the investor's perspective of the RWD/RWE sectors and key considerations for both investors -- and those raising capital -- in this dynamic and rapidly evolving arena.Disclaimer: 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.

Thursday Jan 16, 2025

Ep 161 [15 January 2025]: Len Rosenberg, PhD, Head, Clinical Operations at Beat AML, LLC, a division of The Leukemia & Lymphoma Society and Managing Partner of eP2Consulting, Inc. – Len is the co-founder of several companies in the biotech & clinical services/CRO sector and a board memberat multiple companies including non-profits, sharing several decades of experience in the life science arena.Disclaimer: 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.

Wednesday Jan 08, 2025

Ep 160 [08 January 2025]: Christer Nilsson, CEO of Replior and serial entrepreneur – We discussed Christer's fascinating career journey and background ... then we discussed the evolving transition to sensor-based measurements, representing a fundamental transformation in data access and quality. Instead of relying on traditional Patient Reported Outcomes (PROs) that capture subjective experiences ("How often did you scratch today?" or "What was your sun exposure level?"), sensors provide objective, quantifiable measurements of actual behavior. This Device Reported Outcome (DRO) shift eliminates significant inherent bias and reliability issues associated with self-reported data, replacing subjective "feelings-based" information with precise, automated measurements to support diverse clinical research study designs.Disclaimer: 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.

Thursday Dec 19, 2024

Ep 159 [18 December 2024]: Joseph Beals PhD MBA FAMIA, CEO and Kathy Belk, COO at Health Clarity Solutions – We discussed overcoming many of the challenges associated with the use of RWD for RWE, specificially focusing on the Accuracy, Clarity & Value framework for anticipating and assessing risk to the RWE program.Disclaimer: 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.

Thursday Dec 12, 2024

Ep 158 [11 December 2024]: Gary Schneider, MSPH, ScD, founder of Delve-RW LLC – We discussed his learnings from his organizations’ niche offering of conducting independent review of Statistical Analysis Plans (SAPs) for Pharma sponsored, regulatory agency committed, observational, non-interventional studies. Disclaimer: 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.

Wednesday Dec 11, 2024

Ep 157 [04 December 2024]: Expriences at CNS Summit / DTRA / ISPOR EU 2024! With distinguished co-host, David Thompson and other live participants to Real-World Wednesdays, we attended CNS Summit / DTRA / ISPOR EU 2024 this year, and discussed things we saw/heard/learned.Disclaimer: 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.

Friday Nov 08, 2024

Ep 156 [06 November 2024]: Viraj Narayanan MBA, CEO at Cornerstone AI – We discussed what Decision Science is and why it provides an important foundation to how Viraj considers solutions to challenges in the RWD/RWE field. We also discussed why Viraj is focused on rapid and comprehensive data assessments as well as steps to improve the underlying quality of RWD; data optimized for use -- is critical for efficient RWE generation and machine learning models can generate unique, clinically relevant data cleaning rules for every dataset more more effectively than traditional methods leveraged by technical teams.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.

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