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

Episodes

Sep 17, 2023

1 hr 1 min

13 September 2023: Conversation with H. Jack West MD MPhil, Medical Oncologist & Clinical Associate Professor at City of Hope and VP of Network Strategy at AccessHope – We had a thought-provoking discussion from clinical point-of-care around the real-world use of medical evidence. Though RWD may not be perfect "in the land of the blind, the one-eyed man is king!"Reference: Clinical Decision Making in the Real World—The Perfect as the Enemy of the Good: https://jamanetwork.com/journals/jamaoncology/fullarticle/2805799

Sep 17, 2023

1 hr 1 min

Jul 26, 2023

1 hr 1 min

26 July 2023: Conversation with Joris Van Dam, Digital Health Intrapreneur, VP Digital Strategy at Exact Sciences and former Executive Director, Head of Digital Therapeutics at Novartis/NIBR – We discussed the pressing opportunity & need for RWD in diagnostic device development from both a pharma and medical device perspective.

Jul 26, 2023

1 hr 1 min

Jul 23, 2023

1 hr 2 min

19 July 2023: Conversation with Andrew Ecob MBA, advisor and consultant in the RWD/RWE arena, former Head of Emerging Design Delivery, Innovation and Data Strategy - Real World Solutions at IQVIA and former VP of RWE Strategy at Parexel – We discussed how organisations manage innovation that is radical or sustaining, and how will this affect delivery models for generating RWE.

Jul 23, 2023

1 hr 2 min

Jul 13, 2023

1 hr 2 min

12 July 2023: Conversation with Mike LaChance, former CEO of OneMedNet and Co-Chair AI/ML Industry Liaison Sub-Committee, Society for Imaging Informatics in Medicine (SIIM) – We had an interactive conversation about imaging RWD and RWE.

Jul 13, 2023

1 hr 2 min

Jun 30, 2023

58 min

28 June 2023: Conversation with Dan O'Connor, Managing Partner at Contour Ridge – We had an interactive conversation on the RWD/RWE market, trends, and future.

Jun 30, 2023

58 min

Jun 24, 2023

1 hr 1 min

21 June 2023: Conversation with AI entrepreneur, Aaron Leibtag, CEO of Pentavere.ai – We discussed AI based approaches to clinical care and research patient selection, including a great foundation on what NLP is and how it is evolving.

Jun 24, 2023

1 hr 1 min

Jun 15, 2023

59 min

14 June 2023: Conversation with Tom Dougherty MBA, Director of RWE Partnerships & Innovation at Pfizer – We discussed challenges navigating the RWD market space and characteristics of the ideal RWD partner; as well as driving innovation within a large life sciences company.

Jun 15, 2023

59 min

Jun 7, 2023

1 hr 2 min

07 June 2023: Conversation with serial entrepreneurs Keith & Kevin Kallmes (Nested Knowledge, Marblehead Medical, Superior Medical Experts) – We discussed a non-technical, exploratory conversation about the use of AI to establish a unified protocol supporting evidence synthesis in global Health Technology Assessment (HTA) regulatory submissions.

References during the discussion:
- https://www.eunethta.eu/
- https://about.nested-knowledge.com/2023/01/18/can-chatgpt-do-your-next-systematic-review/
- https://www.linkedin.com/posts/nested-knowledge_how-is-nested-knowledge-deploying-ai-today-activity-7055245807561687040-TglG

From the live chat:
[00:21] Madhusudan Kabra: SLR - clinical, economic, utility values etc. in a embase etc.
[00:22] Stu McCully: The requirements of EUnetHTA will be replaced by the EU Health Technology Assessment Regulation in May 2025
[00:22] David Thompson: And it's pronounced yoo-NET-uh
[00:29] Stu McCully: ChatGPT - totally agreement with Kevin’s concerns about its limitations
[00:40] Charlie Barr: Would add “priorities” and “silos” to “urgency” as reasons why the ideal global dossier isn’t always created at the beginning of HTA preparation process
[00:42] Madhusudan Kabra: There are auto- SLR options available - DistllerSR etc. what you are saying Kevin is the next level in this evolution as to what does it make me understand from this data? Is this correct?

Jun 7, 2023

1 hr 2 min

May 26, 2023

1 hr 49 sec

24 May 2023: 100th RWW: Conversation with David Thompson PhD, RWE thought-leader – We discussed his reflections on the market for RWD and RWE services, how it is simultaneously crowded and highly fragmented; the influence of regulatory agencies on RWE generation, both pro & con; the confluence of AI and RWE, and how these might combine to radically alter medical decision making at the point of care.

May 26, 2023

1 hr 49 sec

May 18, 2023

59 min

17 May 2023: Conversation with Leanne Larson, MHA, Principal at ZS Associates – We discussed the future of RWE - what will the Inflation Reduction Act (IRA) and FDA guidances on drug development mean for RWE?

May 18, 2023

59 min

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