The Clinical Trial Bottleneck Is Not Discovery

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“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