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

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Episodes

Friday May 06, 2022

04 May 2022: Conversation with Lucinda Orsini DPM MPH, Ashley Jaksa MPH & Aaron Kamauu MD MS MPH, co-chairs of the ISPOR RWE SIG – We introduced the ISPOR RWE SIG 2022 topics as well as had a discussion about their value and what would be of most interest to the community

Wednesday May 04, 2022

27 April 2022: Conversation with Canter Martin MBA, Executive Vice President, Managing Director of LUMEN Value & Access – we discussed Rare disease = rare RWD: Driving innovation & outcomes -- overcoming RWD limitations & challenges to drive innovation and improved outcomes in rare diseases

Thursday Apr 21, 2022

20 April 2022: Conversation with Jim Shalaby PharmD, CEO at Elimu Informatics – We discussed connection between health informatics and clinical research, purpose-driven data cleaning, data governance, access of the data for sharing, and the trends in identified data sharing

Friday Apr 15, 2022

13 April 2022: Conversation with Radek Wasiak PhD, Chief Data Officer, Head of Real World and Advanced Analytics BU, Head of Europe at Cytel – We discussed 'Regulatory Grade' RWD and its acceptance or use within the FDA decision-making process

Monday Apr 11, 2022

06 April 2022: Conversation with Steve Chick, Vice President, Business Development at Symphony Health – We discussed RWD from the supplier perspective, especially concepts that will help RWD consumers to optimize their planning and decision making.

Friday Apr 01, 2022

30 March 2022: Conversation with Eirini Schlosser, CEO of Dyania Health – We discussed utilizing unstructured RWD in a regulatory compliant manner for observational studies and external control arms.

Friday Mar 25, 2022

23 March 2022: Conversation with Tom Kaminski MBA, CEO of Clinetic – We discussed the surveillance of EHR-based data at the point-of-care to accelerate support for clinical research.

Thursday Mar 17, 2022

16 March 2022: Conversation with David Lindsay PhD, CEO of Oncora Medical – We discussed the use of comprehensive RWD to support the generation of meaningful RWE, particularly around the inclusion of medical images. David also shared his journey as a health tech entrepreneur concurrent with his MD/PhD education.

Friday Mar 11, 2022

09 March 2022: Conversation with Sadiqa Mahmood DDS MPH, General Manager & SVP Life Sciences Business at Health Catalyst – We discussed Sadiqa's career transition into real world healthcare data, her passion for improving RWD quality, and the need for industry metrics with a quality framework. [Sadiqa also shared some insights from her passion for car racing with Formula 1.]

Friday Mar 04, 2022

02 March 2022: Conversation with Steve Galen, PhD, Galen F P Solutions – Leveraging Steve's vast experience in mathmatical simulation for engineering, now applied to clinical research, we will have a non-technical conversation about the business implications of simulations that can optimize clinical trials and RWE studies.

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