The RWD & RWE Podcast

Ep 148 [11 September 2024]: Derk Arts MD PhD, Founder & CEO at Castor (https://www.castoredc.com/) – We discussed technology considerations and the support necessary to launch and sustain a successful RWE study.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 147 [04 September 2024]: This was a special episode of Real-World Wednesdays (RWW) as part of the RWEsearch Annual Summit 2024: https://healtharkinsights.com/event/rwesearch-virtual-annual-summit-2024/C. K. Wang MD, Chief Medical Officer at COTA – We discussed the RWD Trifecta: Data Quality, Fit-for-Use, and AI -- Leveraging "quality" RWD to develop and validate AI for current RWE use cases - examples & experiences.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 146 [31 July 2024]: Craig Parzynski, Executive Director and Head of Biostatistics & Analytics at Genesis Research Group – We discussed major considerations in the use of RWD in RWE and for clinical trials. This was a conceptual conversation at the business leader level, with no expectation of biostatistical experience or expertise.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.

Ep 145 [24 July 2024]: Aaron Mann, CEO of the Clinical Research Data Sharing Alliance (CRDSA, https://crdsalliance.org/) – We discussed the Clinical Research Data Sharing Alliance (CRDSA) and strategies to reuse prior clinical trial data when paired with RWD to optimize the creation of external or supplemental controls as well as the underlying regulatory considerations and challenges with access to the appropriate RWD needed by the research team.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.

Ep 144 [17 July 2024]: Myla Maloney MBA, Chief Growth Officer at PINC AI Applied Sciences – We discussed the importance of having an embedded relationships within healthcare systems in order to optimize clinical care alignment across care settings & specialties that support technological transformation and advancement faciliting access to RWD that help bridge gaps between life sciences, clinical research and health care.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.

Ep 143 [10 July 2024]: Martin Willemink MD PHD, co-founder and CEO of Segmed.ai – We discussed his professional journey in the RWD/RWE arena and explore many reasons to consider the use of actual image files rather than over-reliance on radiology reports for RWE studies.Optional read: "Inter-observer variability of expert-derived morphologic risk predictors in aortic dissection" (https://pubmed.ncbi.nlm.nih.gov/36029344/)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.

Ep 142 [26 June 2024]: Conversation with MAJ Tiara Walz PhD MHA MBA MSEd FACHE -- Assistant Professor at Army-Baylor University MHA/MBA Program | Healthcare Admin Officer | Program XO | Deputy Consultant (70A) – We discussed the Army-Baylor Program as they strive to optimize healthcare in the Military (across the services) through education, innovation and research.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.

Ep 141 [12 June 2024]: Conversation with Jason Martin, Managing Director and Founder at Global Outcomes (former COO Signant Health; former SVP Parexel - Global Data Operations; former VP Medidata) – we explored the landscape of clinical site and investigator data that is on the boundaries and borders of traditional RWD, that is, the important but supplemental data that plays a critical role in determining the context for use of site-level RWD to support clinical research. We discussed general principles and approaches of this "site metadata" alone and in conjunction with RWD, use for planning and operational execution of studies and the role of AI in defining and accelerating the adoption of supplemental datasets.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.

Ep 140 [05 June 2024]: Conversation with Brent Clough, CEO at Trio Health and a significant background in financial support and development of meaningful software solutions (e.g., for oncology clinical workflows and RWD) – We discussed the Trio Health model that moves beyond continuous RWD collection, leveraging custom disease networks in order to "understand real-world patients, we must measure how each stakeholder impacts real-world patient performance."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.

Ep 139 [29 May 2024]: Conversation with MaryAnne Rizk PhD, Managing Partner of Rizk Management Advisors — Board Member, Advisor, Coach, Investor, and Digital Health Innovator — We had a fun and engaging discussion on how RWE & digital twins revolutionize clinical trials. Discover their role in enhancing trial design, improving outcomes, and promoting sustainability in medical research.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.