Ep 137 [15 May 2024]: The ISPOR 2024 Experience! With distinguished co-host, David Thompson, we attended ISPOR 2024 and on this RWW we discussed interesting things we saw/heard/learned. We also heard from other guests and RWW participants about their ISPOR 2024 experience! Disclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Ep 136 [01 May 2024]: Conversation with Micha Hanson, VP Product Partnerships at COTA Healthcare – We discussed the identification and sourcing of oncology RWD and the evolution of linking/connection of various types of RWD. Disclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Ep 135 [24 April 2024]: Conversation with Craig Lipset, advisor to technology and biopharmaceutical companies, leading universities, and the venture community. He shared a recap and his thoughts on the Enhancing Adoption of Innovative Clinical Trial Approaches by FDA/CDER, public workshop convened by Duke-Margolis on March 19-20, 2024. Disclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Ep 134 [10 April 2024]: Conversation with Alonzo Sexton MD, a private practice orthopedic surgeon and Founder/CEO of nCight, an RWD company focused on AI-enabled democratization of data to support clinical care and research — We discussed Orthopedic RWD: delivering insights and improving outcomes across independent orthopedic practices, while advancing RWE opportunities. Disclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Ep 132 [27 March 2024]: Conversation with Emily Zacherle DHSc MS, Associate Director, RWE Partnership Studies – We discussed key learnings & challenges from use of trial tokenization & data linkage within a pragmatic randomized clinical trial: driving efficiencies with early collaborative engagement & at a multi-site level. You can review Emily's ISPOR abstract: https://www.ispor.org/conferences-education/conferences/past-conferences/ispor-2023/program/program/session/intl2023-3666/126006 For further background on the topic of linkage of real-world data via tokenization (including the trial tokenization use case): - [EP 2] 4/7/21 with Jason Colquitt: Real-World Data: Integrate to Interrogate (pre-podcast) - [Ep 15] 7/7/2021 with Jason Martin: Linking RWD w/ trial data (pre-podcast) - [Ep 53] 5/11/2022 with Ryan Everist & Danielle Walsh: RWW: Next-generation RWD tokenization - [EP 64] 8/3/2022 with Ryan Moog: RWW: Building the Bridge between Trial data and RWD - [EP 84] 1/18/2023 with Lucinda Orsini: RWW: The Power of Clinical Trial Tokenization Disclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Ep 131 [20 March 2024]: Conversation with Sudhir Venkatesan PhD MPH, Director, Medical & Payer Evidence Statistics at AstraZeneca – We discussed correcting underpowered RWD studies due to information bias. Sample size and power calculations are often applied to real-world data (RWD) in the same manner as RCTs, but without the operational control as present in RCTs, the results are subject to greater information bias. Some sources of bias may have little impact on the effect estimate, but they will result in greater uncertainty and potentially in failure to reach desired power if not accounted for while planning. Quantitative Bias Analysis (QBA) provides a useful framework to incorporate estimated bias into sample size calculations for RWD studies. You can review Sudhir's ICPE abstract #153: https://onlinelibrary.wiley.com/doi/10.1002/pds.5687 Disclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Ep 130 [13 March 2024]: Conversation with Purav Gandhi MBBS MBA, CEO of Healthark Insights – Prior to starting his own firm, Purav worked with Deloitte for 5 years, where he was a member of the founding team for Deloitte’s RWE venture called ConvergeHealth by Deloitte. Additionally, Purav recently published a book titled ‘Lead from the Front’ covering leadership stories from armed forces that can inspire everyone to become better leaders. He has several international publications and patents, and also teaches about Health Informatics & AI in Healthcare. Major topics for RWW discussion include; RWE products and platforms, especially Purav’s experience observing limited adoption in the market, rapid-cycle analytics and alignment of RWE between healthcare providers and life sciences, and the talent shortage and skills development in the RWE/RWD sector. Book: Lead from the Front: Book Launch Announcement (https://drpuravgandhi.medium.com/lead-from-the-front-book-launch-announcement-c4996adf0c31) Disclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Ep 129 [06 March 2024]: Conversation with Bo Holland, serial technology entrepreneur; and Founder and CEO at AllClear ID – We discussed his personal journey and its impact shaping his entrepreneurial path and leading to the identity resolution, patient consent and RWD aggregation focus of AllClear ID to serve the data access needs of patients and the life science industry. Disclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated. References during the discussion: www.beckershospitalreview.com/cybersecurity/providers-losing-100m-daily-over-change-healthcare-hack-report.html From the live chat: [00:15] Charlie Barr: What was the reason for Citrix eventual success? A technical pivot? Or waiting for the market to emerge and mature? [00:16] Matt Veatch: Great question, will pose next. [00:20] Matt Veatch: FYI...www.beckershospitalreview.com/cybersecurity/providers-losing-100m-daily-over-change-healthcare-hack-report.html [00:21] Jane Myles: I love the sled dog analogy. It so pertinent [00:21] Aaron Kamauu: I'm definitely going to remember and use it as well :-) [00:24] Jane Myles: change mgt in tech / life sciences devt [00:28] Charlie Barr: Thank you, very interesting: Citrix pivoted from operating systems to remote computer access. Relevant to today's topic since several companies have tried to integrate patient data across sites (Picnic Health, Ciitizen, Xcures) but hasnt been widely adopted yet. [00:30] Aaron Kamauu: Great points and would love to have you join us soon to discuss futher [00:32] Jane Myles: Agree with Charlie 100% [00:34] Charlie Barr: So excited as I have been seeking this kind of solution for over 10 years! [00:34] Jane Myles: How might our healthcare systems/ policy makers be over-interpreting HIPAA and adding friction more than protecting privacy? [00:41] Charlie Barr: Now it's exciting to think of the use-cases this technology can facilitate like innovative clinical studies (trials, registries, decentralized and pragmatic trials), matching to trials, etc. [00:42] Jane Myles: I am convinced that a significant segment of the population who would share data if they thought they had agency over it. I believe that a big part of the resistance. - but its opinion not fact [00:43] Jane Myles: The safety of the data is table stakes. The ability to share it is the game changer IMO [00:44] Charlie Barr: More use-cases: Facilitating clinical consultations, telemedicine, molecular tumor boards, etc. [00:44] Jane Myles: It's a key access point for any DCT enabled trial too @charlie [00:45] Charlie Barr: Yes, Jane! [00:50] Charlie Barr: This seems like a pivotal technology which can transform healthcare by enabling many use-cases. It can build on the years of work on interoperability, data standards and harmonization. [00:55] Charlie Barr: It seems likely "the devil is in the details" for how to operationalize potential use cases.

Ep 128 [28 February 2024]: Conversation with Lana Denysyk MPH, Head of RWD Assets at Novo Nordisk – We discussed the definition and critical importance of fit-4-purpose use of RWD as well as the challenges and solutions to conducting effective qualification of RWD as fit-4-purpose. Disclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Ep 127 [21 February 2024]: The SCOPE 2024 Experience! We attended SCOPE 2024 and we discussed interesting things we saw/heard/learned. Thank you to those who joined RWW live on Clubhouse … we loved hearing your SCOPE 2024 experience! Disclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Ep 126 [07 February 2024]: Conversation with Winson Cheung MD MPH, Co-Founder at Inka Health – We discussed the assessment/grading of RWE in oncology for HTA & regulators, and what is acceptable in the absence of a randomized clinical trial. Disclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Ep 125 [31 January 2024]: Conversation with David Talby PhD, CTO at John Snow Labs – We discussed how Generative AI, NLP & LLMs enable new types of RWE projects – and how the technology is applied today at the FDA, academic medical centers and in the life sciences. Disclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Ep 124 [24 January 2024]: Conversation with Brigham Hyde PhD, CEO at Atropos Health – We discussed closing the evidence gap in medicine with real world patient data. It was an interesting conversation on the importance of democratizing access to data and how accelerating the generation of actionable evidence from a federated network of data will improve healthcare for everyone. Disclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Ep 123 [17 January 2024]: Conversation with Alicia Bertone DVM PhD, an equine orthopedic surgeon, CSO at Equine Performance Labs, industry advisor and endowed Chair of "One medicine" research, with past roles as a University Dean, Provost and Vice Chancellor – We discussed innovative medicines for humans that already exist for animals and focus on the overlap of animal & human health, centralization and personalization of health records, clinical trials that employ RWD, as well as environmental RWD & RWE for various diseases and behavioral risks. Disclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Ep 122 [10 January 2024]: Conversation with MaryAnne Rizk PhD (“Mar”), from Rizk Management Advisors, for a special “Live from JPM” episode. Building on Mar’s vast industry experience, she currently advises clients on the creation of strategic partnerships across the life science ecosystem. Mar will discuss the profound impact of RWD and the surge in Digital Health Technology adoptions. In this episode, we’ll unpack the significance of RWD within these clinical trials, exploring RWD’s pivotal role amidst the rise of digital health solutions. Additionally, we will unravel some of the latest insights from the FDA’s groundbreaking guidance on Digital Health Technology (December 2023), specifically its implications for remote care and impact on clinical investigation.

Ep 121 [03 January 2024]: Conversation with Janak Joshi, former CTO of LifeImage and currently the Chief Digital Officer for State of Massachusetts – We discussed Real World Evidence, specifically, what has worked and where are we heading into the future to address challenges with RWE programs in pharma research. We'll focus on future considerations for RWE and Fully Consented Real World Networks, the potential value of AI, exploring ways to mitigate the burden of RWD accessibility and acceleration of time cycles with improved diversity and retention.

Ep 120 [13 December 2023]: Conversation with Dan Poscover MBA, CEO and Co-Founder of Graticule, and Dr. Patrick Hanson, Chief Alliance Officer of Graticule – We discussed the EU lessons learned while establishing am RWE network in Italy, France, and Spain within the context of evidence readiness that aims to meet global needs for studies on immunocompromised patients.

Ep 119 [06 December 2023]: Conversation with Kathy Belk, Sr Dir Analytics & Chief Data Scientist for Spacelabs, Co-founder of Elev8Evidence and Founder of Health Clarity Solutions – A great conversation that explored the complexities of healthcare challenges in the rural population, including social drivers of health, access to care, and the often-overlooked nuances impacting rural communities. We discussed how real-world data and data-driven solutions can help provide actionable insight to tackle these challenges head-on.

Ep 118 [29 November 2023]: Conversation with Mark Shapiro PhD MS MBA, Chief Operating Officer (COO) at xCures – We discussed how RWD can be created from electronic health records; in particular, our experience with collection from disparate EHR sources to produce a more complete patient journey, with some of the challenges and risks using disparate EHR sources and to talk about data normalization, privacy concerns and how EHR-derived RWD can benefit patient care and medical research.

Ep 117 [15 November 2023]: Conversation with Georges De Feu, CEO and co-founder of LynxCare – a European RWD provider is joined by his RWE Services Director – Shahbaz Pervaiz – We discussed the need for NLP-AI to unlock European unstructured data and the enablers for federated networks of hospital.