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
Wednesday Jan 04, 2023
Wednesday Jan 04, 2023
04 January 2023: Conversation with MD MPH DrPH PhD, Managing Director and Founder of Pivotal Strategic Consulting as well as Senior Advisor, Chief Medical Officer and Partner of multiple companies – We discussed Dr Barr's years of experiences regarding Data, Evidence and Knowledge by different stakeholder decisions, consequences, and requirements; and the current state of affairs towards future prospects.
Thursday Dec 22, 2022
Thursday Dec 22, 2022
22 December 2021: Conversation with the audience: RWD/RWE: A Year in Review (2022) – An open discussion with the audience on top RWD/RWE stories or topics of 2022 and thoughts leading into a new year.Live Room Chat:[00:01] Aaron Kamauu: - your top 2-3 RWD/RWE advancements you’ve seen in 2022 - your top 2-3 RWD/RWE-related news - the 1-2 things you are most excited about for RWD/RWE in the new year[00:17] Aaron Kamauu: given the time and great participation by you all, given the timing, let's have each of you go through your full lists for all three topics ... and provide some thoughts of things you heard from a previous guest, then we will move to the next person[00:18] Stuart McCully: ChatGPT is very impressive[00:18] Matt Veatch: Indeed! I enjoyed "testing" it.[00:22] Aaron Kamauu: I'm excited to see how some of these collaboration networks/ecosystems advance in the new you as well![00:25] Aaron Kamauu: RWD to support design of decentralized research; decentralized reserach methods to create/access more RWD; RWD & decentralized research methods used in concert to support meaningful evidence generation[00:27] Ryan Moog: ++ to Jane. Wanted to make sure everyone sees the DCT and pragmatic trial language in the US Omnibus bill. It starts around page 3,625 :)[00:28] Aaron Kamauu: 🙌[00:28] Stuart McCully: European Health Data Space and DARWIN EU are very exciting now/ future drivers to normalise the use of RWE in regulatory decisions[00:29] Jane Myles: Perfect explanation Leanne[00:30] Dan Pucci: I second Leanne’s comment - “such a great forum”. There’s nothing like this as a forum. Kudos to Matt and Aaron. As a new member of the club I look forward to sit back and listen and learn, maybe adding some thoughts in ‘23![00:30] Aaron Kamauu: Thanks Dan! It's the audience and participation that makes this work so well![00:31] Dan Pucci: CRAACO I find very exciting![00:34] Jane Myles: All in on CRAACO here. 💯[00:34] Aaron Kamauu: I distinctly remember a conversation with you (Kyle) and Tim McGarty at an early SCOPE Summit meeting many years ago about how to bring RWD more systematically to support RCTs[00:36] Jane Myles: In rare circumstances the folks were all in the room. But probably when the sponsor was about to enter a new TA or take in a very new sort of challenge[00:47] Jane Myles: I admit that having so many (600?) sources of rwd is daunting. We need SMES like you to help project teams navigate that complexity so they don’t get stuck[00:49] Leanne Larson: About the FDA program - given that it’s so few studies each year - do we feel the Agency will continue to have study-specific discussions as before? If not, it could really limit the use of RWE in submitted studies[00:49] Aaron Kamauu: Agreed, as both use cases and RWD sources increase, there is an increasing need to navigate the landscape in an effective & efficient way. This is one of my passions right now! ;-)[00:50] Aaron Kamauu: https://www.fda.gov/drugs/development-resources/advancing-real-world-evidence-program[00:50] Ryan Moog: I see Tom Haskell is in the group-he’d also be one of my first calls to help navigate the admittedly large, complex, and confusing RWD ecosystem. :) It’s a challenge to be sure.[00:51] Matt Veatch: Couldn't agree more Re: Tom...thanks Ryan![00:52] Aaron Kamauu: agree![0054] Leanne Larson: Great discussion today - looking forward to more in '23!![00:55] Charlie Barr: I would like to hear Tim McGarty if any updates from his perspective. He was a pioneer in getting RWD required for use in Trial feasibility and recruitment. What's the learnings? What's next frontier?[00:56] Kyle Martin Flickinger: Tim![00:57] Matt Veatch: Tim -- Pick your 2023 Wednesday...love to have you as a guest![00:59] Aaron Kamauu: Tim texted me saying he's listening in the background while on a client call. Let's find a time to have him on soon :-)
Tuesday Dec 20, 2022
Tuesday Dec 20, 2022
14 December 2022: Conversation with Stu McCully PhD, Connecting the Dots in RWE Regs as Founder/CEO of Phoenix-RWR & Co-Founder RWR-Regs – We discussed the latest updates from Europe and vision for 2023-2025. Background: https://www.ema.europa.eu/en/news/high-quality-data-empower-data-driven-medicines-regulation-european-union
Monday Dec 12, 2022
Monday Dec 12, 2022
7 December 2022: Conversation with Kathy Belk, SVP Client Services and Strategic Analytics at PeraHealth – We discussed the use of RWD to optimize and improve clinical care of patients
Wednesday Nov 16, 2022
Wednesday Nov 16, 2022
16 November 2022: Conversation with Matt Zierhut PhD MS MBA, VP Integrated Drug Development at Certara – We discussed the value of clinical trial data outside its initial purpose, that is, the secondary use of trial data to support RWE.
Sunday Nov 13, 2022
Sunday Nov 13, 2022
9 November 2022: Live from ISPOR Europe and AMIA 2022! On Nov 9th, we’ll discuss interesting things we’re seeing/hearing/learning. How is each organization contributing to advance RWD/RWE in the life sciences?
Saturday Nov 05, 2022
Saturday Nov 05, 2022
2 November 2022: Conversation with Jennifer Webster, Senior Director, Precision Medicine RWE Lead at Pfizer – We discussed the importance of metadata quality and completeness for real world evidence (RWE) and insight generation
Thursday Oct 27, 2022
Thursday Oct 27, 2022
26 October 2022: Conversation with David Lindsay MD PhD, CEO of Oncora Medical – We discussed the opportunities and risks associated with combining RWD & RWE with clinical care
Friday Oct 21, 2022
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
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