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 Oct 09, 2022

5 October 2022: Conversation with Jeffrey Yu MD, radiologist and founder of OneMedNet – We discussed Dr. Yu’s journey in the RWD arena and tremendous value of imaging data in the research ecosystem today

Tuesday Oct 04, 2022

28 September 2022: Conversation with Jen Cubino MA, Chief Operating Officer at BC Platforms – We discussed maturing the global market for sharing large scale, RWD, ethically! This discussion will build on Jen's article: Meeting the challenges of real-world data access: https://www.mednous.com/system/files/2022-04/Real-world%20data%20Jennifer%20Cubino%20Apr%202022.pdf

Tuesday Sep 27, 2022

21 September 2022: Conversation with Michael Howley PA-C PhD and Peter Malamis MBA – We discussed the articles they have published on AppliedClinicalTrialsOnline.com: "The Limited Future of Real-World Data", "The Real-World Data That Matters", and "Current and Future Use of Real-World Data".

Saturday Sep 17, 2022

14 September 2022: Conversation with Elise Berliner PhD, Global Senior Principal of RWE Strategy at Cerner Enviza – We discussed on patient registries as sources of RWD. What are they, how are they set-up, what are their major benefits, differentiators, limitations, etc.

Monday Sep 12, 2022

7 September 2022: Conversation with Jason Martin MS MBA, Managing Director & Founder of Global Outcomes LLC – We discussed characterizing & addressing the complexities of running rwd studies and why adoption has been slow.

Wednesday Sep 07, 2022

31 August 2022: Conversation with Sheila Mahoney MBA, creator of LifeSciHub – We discussed LifeSciHub, an actionable Community of small independent workforce businesses in Life Sciences R&D; and we then discussed her poster presented at DIA 2022, found at: https://www.eposters.net/poster/rwe-thought-experiment-could-rwe-have-prevented-todays-opioid-epidemic-lessons-from-19th-century: "RWE Thought Experiment: Could RWE Have Prevented Today's Opioid Epidemic? Lessons from 19th Century China."

Friday Aug 26, 2022

24 August 2022: Conversation with John Cai, MD, PhD, FAMIA, Executive Director, Real-world Data Analytics and Innovation at Merck – We discussed the article published on ClinicalLeader.com: "RWD/RWE: To Replicate Or Continue To Learn In The Real World?" (https://www.clinicalleader.com/doc/rwd-rwe-to-replicate-or-continue-to-learn-in-the-real-world-0001).

Thursday Aug 11, 2022

10 August 2022: Conversation with Viraj Narayanan, MBA, Chief Commercial Officer at Ontada – We discussed: How do we close the gap between patients who could benefit from a therapy and what happens in the real world? How can we ensure that patients that could benefit from a therapy are enrolled in respective clinical trials or receive the appropriate therapy post-approval? How can we build representative RWE for these populations, while understanding social determinants of health that may influence patient’s accessibility and availability for clinical research and long-term follow up?

Thursday Aug 11, 2022

3 August 2022: Conversation with Ryan Moog, MBA, Clinical Trials Solutions at Datavant – We discussed about Building the Bridge between Trial data and Real-World Data: what is 'trial tokenization', how is it conducted, and why should we care? (i.e., how do we use these tokens in the future to enrich our studies?)

Thursday Aug 11, 2022

27 July 2022: Conversation with Jess Rabourn, CFA, CEO of WideTrial and Executive Producer of the Expanded Access Summit – We discussed the primary objective of any EAP to provide pre-approval treatment options in situations of unmet medical need ... and a critical secondary objective to generate ongoing RWD from a larger and more representative set of patients within the targeted indication.

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