Today we took a closer look at a new theme we are exploring now that the Food & Drug Administration has finally rolled out guidance for one of the critical components of its Real World Evidence Program: Real World Evidence: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-making for Drugs and Biologics.
Medical Claims Data and Electronic Health Records will, of course, form the core of the Real World Data that can be deployed to participate in a Real World Evidence Program.
Interest in the area has accelerated in the last several months with CERN's acquisition of Kanter; development of Distributed Clinical Trial programs at Optum, LH and others; and, of course, the founding of a new trade group called the Decentralized Trials and Research Alliance. Silicon Valley and the venture community at large have taken note. Lessons learned from COVID are going to be deployed and concerns raised, especially with respect to the role co-morbidities played in the death toll.
There is no one better to explore a developing theme than Marcus Whitney of Jumpstart Health Investors. Access replay with links to materials and audio here. Timestamps below.
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0:00 - 2:27 Intro, overview of recent FDA actions 2:27 - 5:22 What are Distributed Clinical Trials, Real World Data and Real World Evidence 5:22 - 7:32 Moving Clinical Trials Forward, Overcoming Social Forces and Bad Data 7:32 - 15:42 Meeting Need to Trial Diverse Populations Post-COVID; Growth Opportunity for VC; Resistance to Clinical Trial Participation 15:42 - 16:23 Knock-on Problems from Clinical Trial Participation. 16:23 - 33:40 Three Trends in Collecting and Using Real World Data on Path to Real World Evidence; Health Systems' Efforts; CROs Approach & New Intermediary Companies and the Role of Facebook 33:40 - 47:45 Privacy Concerns ME v Health Systems and Empowering the Patient as a Way to Build Trust; Future of CROs 47:45 - 52: 20 Role of Big Tech in Health Care; Lowering the Threat Assessment 52:20 - 59:52 Diversification of Research Sites and How CROs Can Help 59:52 - 1:02 Takeaway: Real World Evidence Trails Can Make the System Move Faster and Cheaper |
About Marcus Whitney:
Marcus is a self-taught software developer, entrepreneur, and venture capitalist with a track record of success in all areas.
Prior to co-founding Jumpstart Health Investors, he was the Director of Technology and Partner at Emma Email Marketing, acquired by Campaign Monitor, and Co-Founder at Clariture Health, a HIPAA compliant digital ad management platform, acquired by Trilliant Health.
Marcus is the founder and General Partner of Jumpstart Nova, the first Black healthcare venture fund in America, launched in 2020 to make seed and Series A investments in promising Black-led healthcare companies. Marcus was the founder and CEO of the Health:Further conference, which operated from 2015-2018, adding thousands of leaders in health innovation from around the country to Jumpstart Health Investors' network. As Founding Partner of Jumpstart Health Investors, Marcus was the initial architect of the algorithm used to score over one thousand early-stage healthcare companies for consideration by Jumpstart Foundry, the firm's pre-seed index fund.
Marcus has made his mark on the city of Nashville through a variety of avenues. Marcus brought professional soccer to the city as co-founder and minority owner of Major League Soccer team, Nashville Soccer Club. Marcus is also a member of the board of the Country Music Hall of Fame® and Museum, the Nashville Convention and Visitors Corporation, and Launch Tennessee.
Marcus is the author of the Amazon #1 best-selling book "Create and Orchestrate", about claiming your Creative Power through entrepreneurship. Marcus has been featured by Entrepreneur, CNBC, Inc., NPR, Fast Company, and The Atlantic.
Emily Evans
Managing Director – Health Policy
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