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

Friday Oct 21, 2022

19 October 2022: Conversation with Nicole Bailey MPH Vice President Real-World Data at Aetion – We discussed the variety of career opportunities in the RWD/RWE industry

Wednesday Oct 19, 2022

12 October 2022: Conversation with Alexa Berk PhD (Medical Affairs Director, Digital Health and Data Platforms) and Elli Brimble MS (Research Director, Rare DiseaseResearch Director, Rare Disease) at Invitae (formerly Ciitizen) – We discussed a recent drug approval based on RWE from a RWD-driven digital natural history study in rare disease: https://www.prnewswire.com/news-releases/invitaes-real-world-ciitizen-data-utilized-in-praxis-precision-medicines-prax-222-ind-filing-301627677.html

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?

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