The RWD & RWE Podcast

Ep 155 [30 October 2024]: John Shon MD MS – RWD in a decentralized observational COVID biomarker study

Ep 155 [30 October 2024]: John Shon MD MS, Chief Technology Officer at SerImmune Inc. – We discussed leveraging highly multiplex serology assays to study SARS-CoV-2 antibody dynamics in individuals in response to vaccines and infections informing the study insights with RWD.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 154 [23 October 2024]: Tom Kaminski MBA – Converting real-world data into ENROLLED patients

Ep 154 [23 October 2024]: Tom Kaminski MBA, CEO of Clinetic (former SVP Strategy for Labcorp) – We discussed the last mile of patient engagement, leading to enrollment and leveraging health-system based RWD to accelerate research trials and RWE.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 153 [16 October 2024]: Liisa Palmer PhD – Ep 153: Finding balance with RWD

Ep 153 [16 October 2024]: Liisa Palmer PhD, Portfolio Leader, Real-Word Data Research & Analytics at @Merative (Truven MarketScan) – We discussed important considerations around “fit-for-purpose” data in a rapidly expanding ecosystem, especially as researchers have more choice in RWD than ever before!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.

[10 October 2024] Special Crossover Episode from TGIF-DTRA + Real World Wednesday: The Venn Diagram of Point of Care Trials, DCTs, and RWD

[10 October 2024] Special Crossover Episode from TGIF-DTRA + Real World Wednesday: The Venn Diagram of Point of Care Trials, DCTs, and RWD.With the release of the FDA Draft Guidance on Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice, it was the perfect topic to bring together the DCT and RWE community for a conversation around this guidance.We discussed why this guidance was aligned to RWE, the distinctions between decentralized, pragmatic, point-of-care trials, and real-world evidence, and how RCTs and DCTs can drive access for all patients.Read the guidance here --> https://www.fda.gov/regulatory-information/search-fda-guidance-documents/integrating-randomized-controlled-trials-drug-and-biological-products-routine-clinical-practicePlease 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 152 [09 October 2024]: Tom Haskell – Specialty EMR = Specialized RWD/RWE

Ep 152 [09 October 2024]: Tom Haskell, General Manager, Real-World Data at Modernizing Medicine (ModMed) – We discussed the optimization of RWE through the use of medical specialty-aligned EHRs. Indication-specific outcomes are enhanced by EHRs developed to support the unique attributes or measures of the medical specialty itself, ensuring relevant data are included in the RWD, accelerating RWE research.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 151 [02 October 2024]: Doug Fridsma MD PhD – AI in EHR RWD - important regulatory changes coming soon!

Ep 151 [02 October 2024]: Doug Fridsma MD PhD, Chief Medical Informatics Officer (CMIO) at Health Universe – Former CMIO at Datavant, Former President and CEO at the American Medical Informatics Association (AMIA), and Former Chief Science Officer at the Office of the National Coordinator for Health IT (ONC/HHS) – We discussed regulatory changes in the EHR decision support arena.He provided an overview policy changes and delve into the relevance of these changes for the RWD/RWE market, specifically focusing on the new ONC, 45 CFR § 170.315(b)(11) Decision Support Interventions (DSI) Criterion, a set of updated rules for health IT systems that go into effect by January 1, 2025. These changes aim to make health IT systems more interactive and data-driven, ultimately helping healthcare providers and researchers alike.https://www.healthit.gov/test-method/decision-support-interventionsONC/HHS (b)(11) primer: https://www.healthit.gov/sites/default/files/2024-07/DSI_Explainer_9_Key_Functionalities_DSI_Criterion_508.pdfPlease 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 150 [25 September 2024]: Christopher Blanchette PhD MBA – Ready, Set, Launch: Importance of Evidence at Product Launch

Ep 150 [25 September 2024]: Christopher Blanchette PhD MBA, Vice President, Clinical Data Science & Evidence, NNI, Novo Nordisk – Our 150th Real-World Wednesdays (RWW): we discussed the importance of meaningful RWE at product launch ("Evidence at Launch") and how trial tokenization as well as other methods support these efforts. In addition, a great perspective on the real-world evidence and epidemiology career path.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 149 [18 September 2024]: Aaron Leibtag (AI entrepreneur) – The Reality of Real-World Data

Ep 149 [18 September 2024]: AI entrepreneur, Aaron Leibtag, CEO of Pentavere.ai – We discussed the current state of RWD and acceptance to support research use cases.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 148 [11 September 2024]: Derk Arts MD PhD – Tech & Teams in RWE: Pulling It All Together

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]: C. K. Wang MD – The RWD Trifecta: Data Quality, Fit-for-Use, and AI

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.