The RWD & RWE Podcast

15 March 2023: Mal Postings – RWW: The potential value of FHIR in support of RWE

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

08 March 2023: Hugh Glover, Michael van Campen, Jean Duteau & Craig Parker MD MS FHL7 – FHIR & interoperability standards: Overview & HL7 Vulcan

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?

01 March 2023: RWW: FDA Guidance on Externally Controlled Trials

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).

22 February 2023: Leah Burns MPH & Jennifer Christian PharmD PhD – RWW: RWE for Regulatory Decision-Making: Global Perspective

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 ...

15 February 2023: Jeremy Brody & Jade Cusick – RWD & RWE: What can we expect for Life Sciences in 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.

01 February 2023: Doug Fridsma – RWW: Role of RWD in Emergency Clinical Trials

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

18 January 2023: Lucinda Orsini, DPM, MPH – RWW: The Power of Clinical Trial Tokenization

18 January 2023: Conversation with Lucinda Orsini, DPM, MPH, Vice President - Value and Outcomes Research at COMPASS Pathways – We discussed the advantages of "planning for tomorrow's research...today" through the tokenization of clinical trials. Given that scientific questions and accessible RWD will change over time, tokenization helps plan for, and proactively address, research unknowns of the future.

11 January 2023: Mark Czubachowski & George Mathew MD MBA FACP – RWW: RWD’s role in reducing structural health inequities

11 January 2023: Conversation with Mark Czubachowski, Digital Health Executive Search & George Mathew MD MBA FACP, Chief Medical Officer at Dedalus North America – We discussed the socioecological implications of structural health inequities and how we can better understand and then address these inequities using RWD.

04 January 2023: Charlie Barr MD MPH DrPH PhD – Crossing the chasm from data to evidence to knowledge

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.

21 December 2022: Aaron Kamauu MD MS MPH, Matt Veatch MBA – RWD/RWE: A Year in Review (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 :-)