Podcast Notes Playlist: Startup

• Check out Beginner’s Mind Episode Page & Show Notes

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:

• Strategic considerations for setting up a clinical trial
• Inhouse vs Outsourced Clinical Study Management
• Why do some clinical trials fail?
• Steps to getting your clinical trial back on track
• Future trends of clinical trials
• and much more

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

• Check out the 20VC Episode Page & Podcast Notes

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.

1.) Origins:

• How David made his way into the world of startups and technology from academia and physics?
• What were David's biggest takeaways from scaling The Climate Corp to $930M exit to Monsanto?
• How did the exit put pressure on David for all future companies he builds? How does he manage that?

2.) The Macro: Venture + The Economy

• How does David foresee the impending rate hikes? What impact will this have on venture and the economy?
• What segment of the market will be first to be hit? Why is growth investing last to be hit? How does early stage play out in this very new environment?
• How will we see the velocity of capital deployment change in this new period? What does David believe are some of the crucial flaws of the venture model?
• How does David reflect on his own price sensitivity? What lessons has he learned from deals he has done or missed that have changed his perspective?

3.) David Frankel: The Business Builder

• What is David's rubrik for business value creation? How has this changed with time?
• How mentally plastic does one have to be around the time it takes to see margins, unit economics etc change from negative to positive?
• How does David and the team approach building new companies at TPB? Where do they find the founding teams? How do they incentivise them?
• How does TPB approach continuous funding for the companies they create? What milestones need to be hit? How do they assess them?
• How does David approach liquidity with regards to exits for the companies they create? Why does their holding company structure mean they have different incentives to VCs?

4.) David Friedberg: Father and Husband

• How does David reflect on his own relationship to money today? How has it changed over time?
• What have been David's biggest realisations on what provides him true happiness?
• How did having children change his operating mentality? What does being a great father mean to David?

David’s Favourite Book: Zen Mind, Beginner's Mind

• “Place your biggest bet on a focused strategy and iterate until it works” – Aaron Levietweet
  • Never hedge your bets as a company – if you have two paths, you have no paths
  • You have limited resources, don’t lower your ceiling with two bets
• Design and innovation are directly influenced by the architecture of your organization, it’s important to know your identity
  • Amazon: decentralized with an innovation focus
  • Apple: centralized with a design focus
• Serial entrepreneurship is overrated
  • Choosing the right market at the right moment is more valuable than any years of experience
• Network design comparison: Airbnb vs Crypto
  • Crypto networks experience a value plateau as new participants have less and less upside
  • Airbnb users and hosts gain more value when the network grows, regardless of when you joined

Aaron Levie is the Founder and CEO @ Box, the company incorporating the best of secure content collaboration with an intuitive user experience suited to the way people work today. Prior to their IPO in 2015, Aaron raised from some of the best in the business including the main man Mark Cuban, a16z, Emergence, DST, Coatue, DFJ and many more. Aaron founded the company from his dorm room at the University of Southern California and has led the company to 1,900 employees and over $770M in revenue, as of 2021 data.

1.) How Aaron founded Box from his dorm room at the University of Southern California? What was that founding a-ha moment? What did the first year look like? Does Aaron agree, "serial entrepreneurship is overrated"?

2.) Phases of Leadership and Company Growth:

• How does Aaron define the different phases of leadership required as a company grows?
• Which phase did Aaron find the most challenging? How did he overcome it?
• What are the first things to break when companies grow? What can founders do to prevent this?
• Does Aaron agree, "the best CEOs are the best resource allocators"?

3.) The Market:

• How does Aaron thinkj about the dislocation between private company valuations and public company market caps?
• What does Aaron believe are the biggest challenges founders face when they are over-capitalised?
• What does Aaron mean when he says, "raise when cash is cheap, spend as if it was expensive"? How does Aaron advise founders on fundraising today?

4.) The Team and Culture:

• How does Aaron create a safe space where all team members can come to him with anything?
• How does Aaron approach effective goal setting? How does one balance between achieveable and also aggressive goals?
• How does Aaron approach the art of delegation? What is his decision-making framework for what to delegate vs what to control?

Aaron’s Favourite Book: Innovator's Dilemma: When New Technologies Cause Great Firms to Fail (Management of Innovation and Change)

In this episode of Infinite Loops we have Sahil Lavingia with us. Sahil is the founder and CEO of Gumroad, and author of the book “The Minimalist Entrepreneur”.

• The rise, and fall, and rise of Gumroad
  
• Physical vs. Digital Communities
  
• Befriending ‘volatility’
  
• Applications of Web 3
  
• And MUCH more!
  

Follow Sahil on Twitter at https://twitter.com/shl and buy his book from Amazon at amzn.to/2ZnIGOl

Today's episode is with one of the greatest business authors ever, Jim Collins. Jim is one of the most inspirational figures in James' career. Not only did he inspire James, but he also is one of James' fathers, favorite authors. This has formed a bond at a young age between the two and has helped form many ideas in James' head. James and Jim cover many topics today, in one of our longest podcasts ever recorded, they talk about a wide range of VERY useful topics for founders and creators. From, breaking down Jim's personal rubric on writing a book to how an idea turns into a book. Jim explains why it is important to keep turning the flywheel even when you feel like abandoning it. James and Jim, also speak about how great leadership, can take a company, far beyond what is projected on paper. Jim also explains the difference between Good and Great. To conclude the episode, Jim speaks about luck and how not only good luck is inevitable but so is bad luck, he explains how not all time in life is equal and how you should zoom in on the good luck and reevaluate the bad luck.  

Find out more about Jim Collins here:

Buy Jim's new book, Beyond Entrepreneurship 2.0.  

https://bit.ly/Go_BelowtheLine

Hit the show hotline and leave a question or comment for the show at 424-272-6640, email James questions directly at [email protected] or follow us on Twitter @ twitter.com/gobelowtheline

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About your host, James:

“Below the Line with James Beshara" is brought to you by Another Podcast Network.

• “This not a new normal, this is a new abnormal. The planet will never will cooler tomorrow than it is today”– John Doerr
  • Speed & Scale: An Action Plan for Solving Our Climate Crisis Now by John Doerr – The wholesale transition plan for every human activity from a fossil fuel-based system to a renewable-based system: how we produce, consume, transport, and organize
    • Electrify transportation
    • Decarbonize the grid – shift to wind, solar, and safe nuclear
    • Fix food systems – reduce the amount of meat and dairy, how we grow plants, and reduce waste
    • Protect nature – reduce deforestation and protect the oceans
    • Clean up the industry – change how we produce things like steel and cement
    • Remove the stubborn carbon that remains – plant more trees, make the sequestering of carbon economic
  • Global governments are the largest obstacle – we must go for the gigatons, the messages sent to individuals to ‘go green’ are often just distractions from the bigger problem

John Doerr is an engineer, venture capitalist, the chairman of Kleiner Perkins, and the author of the #1 New York Times best-seller Measure What Matters. For over 40 years, John has helped build some of the most generational defining companies of our generation. He was an original investor and board member at Google and Amazon, helping to create more than a million jobs. A pioneer of Silicon Valley’s cleantech movement, John has invested in zero emissions technologies since 2006. Check out his latest book, Speed & Scale: An Action Plan for Solving Our Climate Crisis Now.

1.) What was John's entry into climate change investing? Having backed the likes of Amazon and Google, why did John decide then was the right time to do a climate fund, a pandemic fund, an iPhone fund? How does John think about market timing risk today? How does John determine between risks he is vs is not willing to take?

2.) What was one of John's biggest lessons on risk and upside from working alongside Tom Perkins? How did the Google deal come together? Where did John first meet Larry and Serge? What convinced John to write them a $12M check for 12% of the company? Why was it a contested deal within the partnership? How did the discussion go internally?

3.) Why and how is climate innovating and investing different today than it was in 2008? What are the core OKR's laid out in the book, that we need to achieve as a society? Why does John believe that governments are the biggest problem to us achieving these objectives? What does John mean when he says, "I am hopeful but not optimistic"?

4.) What does truly great listening mean to John? How would John describe his style of board membership? What do the truly special board members do? What does John do that makes him often cited as one of the best at recruiting? What is John's biggest investing miss? How did it change his mindset and approach? What investment is John most proud of, that no one knows? 

John’s Favourite Book: How to Avoid a Climate Disaster: The Solutions We Have and the Breakthroughs We Need