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
Sunday Apr 16, 2023
Sunday Apr 16, 2023
12 April 2023: Conversation with Alex Vance MS, SVP Clinical Data Strategy & Operations at Holmusk – We discussed RWD’s role in behavioral healthcare and Life Science research.
Friday Apr 07, 2023
Friday Apr 07, 2023
05 April 2023: Conversation with Mauro Bucalo, CTO at Biomeris, – We discussed the health data systems in Italy and implementation of standards (e.g., i2b2 & OMOP) to support data analysis and clinical research across health systems.
Thursday Mar 30, 2023
Thursday Mar 30, 2023
29 March 2023: Conversation with Jacob Milliron PharmD MHA, Senior National Director, RWD & Solutions at Inovalon – We discussed social determinants of health (SDOH) RWD, specifically use cases where SDOH allows (or enhances) insights to assess and then improve health equity and research in underrepresented patient populations.
Thursday Mar 23, 2023
Thursday Mar 23, 2023
22 March 2023: Conversation with Charlie Barr MD MPH, Managing Director and Founder of Pivotal Strategic Consulting, and Sudhir Venkatesan PhD MPH, Director, Medical & Payer Evidence Statistics at AstraZeneca – We discussed considerations to appropriately match cohorts for real-world comparative analyses, including robust propensity score matching, negative controls, etc.
Tuesday Mar 21, 2023
Tuesday Mar 21, 2023
15 March 2023: Conversation with Mal Postings, CEO of Vincigravitas and a RWD industry chief architect – We discussed on the potential value of FHIR & interoperability standards in support of RWE. Where are we now? Is it being used? What are the benefits? What are the challenges?Ten key aspects of FHIR:1. Standards2. Company View3. Interoperability4. Longitudinal Record5. Platforms6. 3rd Party Vendors7. IG’s8. Use Cases9. Federated Analytics10. Futures
Friday Mar 10, 2023
Friday Mar 10, 2023
08 March 2023: Conversation with Hugh Glover, Michael van Campen, Jean Duteau & Craig Parker MD MS FHL7, leadership of the @HL7 Vulcan initiative – First of several sessions as we discuss the much requested topic of FHIR & interoperability standards: Background & HL7 Vulcan. What are interoperability standards? Why are they important? What is HL7 Vulcan and how is it leading the advancement of FHIR in practical and meaningful ways?
Wednesday Mar 01, 2023
Wednesday Mar 01, 2023
01 March 2023: An open discussion on the recently published draft FDA guidance on Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-design-and-conduct-externally-controlled-trials-drug-and-biological-products).
Thursday Feb 23, 2023
Thursday Feb 23, 2023
22 February 2023: Conversation with Leah Burns MPH (Sr Director, RWE Strategy at BMS) & Jennifer Christian PharmD PhD (VP & GM, Medical & Scientific Services, US Real World Solutions at IQVIA) – We discussed ...
Thursday Feb 16, 2023
Thursday Feb 16, 2023
15 February 2023: Conversation with Jeremy Brody & Jade Cusick, Chief Strategy Officer & Chief Commercial Officer at Aetion – We discussed the current state and exciting advancements to expect in RWD & RWE market for Life Sciences.
Wednesday Feb 08, 2023
Wednesday Feb 08, 2023
01 February 2023: Conversation with Doug Fridsma, MD, PhD, Chief Medical Informatics Officer (CMIO) at Datavant – We discussed the role of RWD in emergency clinical trials, particularly within the context of the recent OSTP RFI: https://www.federalregister.gov/documents/2022/11/18/2022-25166/request-for-information-rfi-on-data-collection-for-emergency-clinical-trials-and-interoperability