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The Biotech Startups Podcast
The Biotech Startups Podcast

The Clinical Trial Bottleneck Is Not Discovery | Scott Chetham (3/4)

31 min•19 oktober 2026

Om avsnittet

Excedr provides research labs with equipment leases on founder-friendly terms to support paths to exceptional outcomes. Learn more at https://www.excedr.com/partners.

“Our problem is the clinical funnel to shove things through this 12 year development cycle and the amount of capital it takes.”

Clinical development is not a simple scale game. Scott explains why large pharmaceutical companies can behave like highly optimized development machines, while smaller biotechs absorb the full cost of delays, amendments, interim analyses, and underused teams.

The conversation then moves to the decisions that determine whether a trial succeeds: what to measure, whom to enroll, and when to measure it. Scott uses Amgen's osteoporosis strategy to show how a focused endpoint and staged market entry can outperform an attempt to capture everything at once.

Scott also breaks down adaptive trials, global trial planning, patient consent, and the role of AI in compressing months of research into rapid scenario analysis. Automation can map the landscape, but judgment remains essential when the biology is new and the stakes are high.

Key Topics Covered:
  • Nonlinear clinical development economics
  • Why large pharmaceutical companies gain efficiency from fixed development infrastructure
  • The cost burden of amendments, interim analyses, and idle clinical teams
  • The division of labor between biotech discovery and pharmaceutical development
  • mRNA manufacturing and Moderna's personalized vaccine production model
  • Clinical endpoints as a strategic and competitive differentiator
  • Amgen's staged osteoporosis strategy
  • Adaptive trials and preplanned endpoint changes
  • Clinical trial failure rates and increasing biological complexity
  • Why clinical development, rather than molecule discovery, constrains the drug pipeline
  • The human realities of patient consent and family trust
  • Using AI and machine learning for protocol research and scenario modeling
  • Global trial sequencing, country selection, cost, and enrollment optimization

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Find our guest, Scott Chetham, at these links:
LinkedIn: https://www.linkedin.com/in/scott-chetham-2949001
Website: https://farohealth.com/

Find our host, Jon Chee, at these links:
LinkedIn: https://www.linkedin.com/in/jonchee/

Learn more about Excedr:
LinkedIn: https://www.linkedin.com/company/excedr/
Website: https://www.excedr.com

Intro & Outro Songs Created by OkKyojin:
https://flow.page/kyojin

Resources & Articles:
ClinicalTrials.gov: https://clinicaltrials.gov/
Amgen: https://www.amgen.com/
Merck: https://www.merck.com/

Companies, Universities, & People Mentioned:
Merck: https://www.merck.com/
Amgen: https://www.amgen.com/
Google: https://www.google.com/
Verily: https://verily.com/

Timestamps:
00:00 Intro
01:47 Why Clinical Economics Are Nonlinear
01:51 The Pharmaceutical Development Machine
04:29 What Makes Moderna Scalable
07:13 The Endpoint Is the Differentiator
08:07 How Amgen Beat the Broader Strategy
09:10 Where Human Judgment Still Wins
10:41 Why Clinical Trials Fail
11:53 The Bottleneck Is the Clinical Funnel
12:35 The Parts of Trials AI Cannot Automate
14:43 Adaptive Trials and Planned Pivots
16:19 Automating the Research Behind Trial Design
21:56 Why Domain Expertise Still Matters
26:03 Optimizing Global Trial Scenarios
29:09 Outro


The Biotech Startups Podcast gives you a front-row seat to the business and science of building a biotech. Hosted by Jon Chee, CEO of Excedr, the show features honest conversations with founders, execs, and investors about their work, their companies, and how they got there. From scientific breakthroughs to startup lessons, each episode explores what it really takes to grow a life science company—from pre-seed to IPO.

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