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Episode Description:
Iñigo San-Millán is an internationally renowned applied physiologist and a previous guest on The Drive. His research and clinical work focuses on exercise-related metabolism, metabolic health, diabetes, cancer metabolism, nutrition, sports performance, and critical care. In this episode, Iñigo describes how his work with Tour de France winner Tadej Pogačar has provided insights into the amazing potential of elite athletes from a performance and metabolic perspective. He speaks specifically about lactate levels, fat oxidation, how carbohydrates in food can affect our lactate and how equal lactate outputs between an athlete and a metabolically unhealthy individual can mean different things. Next, he discusses how Zone 2 training boosts mitochondrial function and impacts longevity. He explains the different metrics for assessing one’s Zone 2 threshold and describes the optimal dose, frequency, duration, and type of exercise for Zone 2. Additionally, he offers his thoughts on how to incorporate high intensity training (Zone 5) to optimize health, as well as the potential of metformin and NAD to boost mitochondrial health. Finally, he discusses insights he’s gathered from studying the mitochondria of long COVID patients in the ICU.
We discuss:
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Did you know that almost 90% of all product ideas fail in clinical trials? The most obvious reason that a clinical trial fails is lack of efficacy.
Surprising to me was that lack of efficacy doesn't seem to be the main reason why clinical trials fail in the first place. Other factors are at play, and most of them are manageable risks when the right team is at work.
In this episode, we talk about:
Who is the expert in the show?
Heike Schön is the Managing Director and Co-Founder of Lumis International GmbH and Lumis Life Science Consulting GmbH.
She has more than 25 years of experience in leadership positions in international clinical research and drug development.
📞 Book a meeting here: Link
Youtube: https://youtu.be/r0qphO8Qs3o
Shownotes @ Podcastnotes: tbd
Timestamps:
(00:00) Intro
(02:25) Who Is Heike Schön, Lumis International and Lumis Consulting?
(04:20) Topics in the Episode
(04:30) Kick-Off
(05:00) Background to Lumis International and Heike Schön
(10:20) When is the Right Time to Start with the Planning of a Clinical Trial?
(12:10) The Role of a Sponsor of a Clinical Trial
(14:30) Who is Responsible for the Clinical Trial as a Sponsor?
(16:55) When Should a Company Start to Implement Clinical Trial Management in the Organisation?
(18:30) Funding Requirements for Clinical Trials
(20:00) The Reality of Inhouse and Outhouse Clinical Trial Management
(22:15) What to Think About When Planning Oversight Management
(25:00) Relationship and Culture Management in Clinical Trials
(27:25) Budget and Ressource Requirement for Clinical Trials
(28: 45) 3 Steps to a Successful Clinical Trial
(30:40) The 3 Main Reasons Why Clinical Trials Fail
(33:30) Considerations for Patient Enrollment as a Key Success Factor for Clinical Trials
(37:30) … and when enrolment fails, what are the steps to rescue the trial?
(42:45) Do Inhouse Studies Require Rescue?
(44:30) How to Rescue a Clinical Trial
(48:30) Root Cause Analysis as a Starting Point to Rescue a Trial
(52:25) Preventive Measures to Avoid Failure Early on
(53:30) How Important is Leadership in a Clinical Trial?
(56:30) The 3 Main Reasons to Stop a Clinical Trial – The Point of no Return
(59:00) How are the Cost Calculated for Rescue Study Management?
(01:00:15) Planning of a Clinical Trial – A Key Aspect of a Successful Trial
(01:02:15) How to Plan Realistic Timelines and Numbers
(01:07:15) The Role of Feasibility Studies in Clinical Trials
(01:09:30) How Clinical Trial Management Evolved in the last 30 years
(01:11:15) Upcoming Trends in Clinical Trial Management
(01:13:15) Decentralized Clinical Trials
(01:15:00) Artificial Intelligence And Big Data in Clinical Trial Management
(01:17:55) The Digital Twin
(01:19:15) The Human Factor and Leadership in Clinical Trial Management
(01:21:10) The Patient in Clinical Trials
(01:22:55) Planning and its contribution to clinical trial success
(01:26:55) Summary of What to Do When Clinical Trials Fail
(01:28:35) When is the Right Time to Add a Rescue Team to the Clinical Trial?
(01:31:00) A Risk Management Plan for Clinical Trials
(01:32:00) How to Cont
David Friedberg is Founder and CEO of The Production Board (TPB), a holding company established to solve the most fundamental problems that affect our planet, by reimagining global systems of production. Prior to founding The Production Board, David founded The Climate Corporation, a 10-year journey that culminated in their $930M acquisition by Monsanto. If that was not enough, David is the Founder and Chairman at Metromile and also sits on the board of Soylent, Clara Foods, Tillable, Cana Technologies and more.
In Today’s Episode with David Friedberg You Will Learn:
1.) Origins:
2.) The Macro: Venture + The Economy
3.) David Frankel: The Business Builder
4.) David Friedberg: Father and Husband
Item’s Mentioned In Today’s Episode with David Friedberg
David’s Favourite Book: Zen Mind, Beginner's Mind
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