The RWD & RWE Podcast

20 September 2023: Conversation with Matt Veatch MBA and Aaron Kamauu MD MS MPH, Real-World Wednesdays (RWW) co-hosts, senior advisors in RWD, RWE, Decentralized Research; and co-founders of Navidence – We discussed our respective journeys, interests & passions in this field.

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

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.

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.

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.

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.

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.

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.

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?

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.

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?

10 May 2023: We’re at ISPOR and we discussed interesting things we saw/heard/learned. ISPOR attendees joined the discussion and provided their thoughts/insights

03 May 2023: Conversation with David Lindsay, MD, PhD, CEO of Oncora Medical – We discussed the use of public health real-world data and associated RWE use cases.

26 April 2023: Conversation with Andrea Thoumi MPP MSc and Kamaria Kaalund of the Duke-Margolis Center for Health Policy – We discussed the use of real-world data to inform community-engagement, diversity and inclusiveness across race and ethnicity.

19 April 2023: Conversation with Eirini Schlosser, Founder & CEO at Dyania Health – We discussed large language models (LLMs) — what are they, how are they used, what context is needed, availability, deployment — and the ROI of NLP turn healthcare inefficiencies into redundancies

12 April 2023: Conversation with Alex Vance MS, SVP Clinical Data Strategy & Operations at Holmusk – We discussed RWD’s role in behavioral healthcare and Life Science research.

05 April 2023: Conversation with Mauro Bucalo, CTO at Biomeris, – We discussed the health data systems in Italy and implementation of standards (e.g., i2b2 & OMOP) to support data analysis and clinical research across health systems.

29 March 2023: Conversation with Jacob Milliron PharmD MHA, Senior National Director, RWD & Solutions at Inovalon – We discussed social determinants of health (SDOH) RWD, specifically use cases where SDOH allows (or enhances) insights to assess and then improve health equity and research in underrepresented patient populations.

22 March 2023: Conversation with Charlie Barr MD MPH, Managing Director and Founder of Pivotal Strategic Consulting, and Sudhir Venkatesan PhD MPH, Director, Medical & Payer Evidence Statistics at AstraZeneca – We discussed considerations to appropriately match cohorts for real-world comparative analyses, including robust propensity score matching, negative controls, etc.

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. Standards 2. Company View 3. Interoperability 4. Longitudinal Record 5. Platforms 6. 3rd Party Vendors 7. IG’s 8. Use Cases 9. Federated Analytics 10. Futures