The RWD & RWE Podcast

Ep 130 [13 March 2024]: Purav Gandhi MBBS MBA – Insights from the current RWD/RWE landscape

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]: Bo Holland – Patient-consented RWD access: The future of RWE?

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.htmlFrom 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]: Lana Denysyk MPH – RWD: Does it always fit? Why Fit-4-Purpose is Critical

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]: Real-World Wednesdays: The SCOPE 2024 Experience

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]: Winson Cheung MD MPH – HTA and regulatory acceptability of RWE in oncology

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]: David Talby PhD – Accelerating RWE with NLP and Large Language Models

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]: Brigham Hyde PhD – Closing the RWE gap in medicine with real-world patient data

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]: Alicia Bertone DVM PhD – One Medicine: Unlock RWD/E from our animal companions

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]: MaryAnne Rizk PhD – The impact of RWD with Digital Health Technology adoption

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]: Janak Joshi – Its time to get real about real world evidence

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.