How it works

Stop showing up to EOP1/2* regulatory interactions with an incomplete story.

Why low-resolution data creates risks that high-resolution data can prevent.

1
"The Good News"
Standard Approach
Presenting great clinical data.
n = 10

25%

response
10 mg dose
n = 10

55%

response
50 mg dose
2
The FDA Challenge
Standard Approach
An unexpected pushback under Project Optimus.
"Your clinical data is encouraging, but how do you justify the higher dose without a mechanistic rationale?"
The Standard Approach
The High Resolution Advantage
3
Low-dimensional cytometry
Standard Approach
13 marker panel cannot differentiate between doses.
44 Immune Subsets Measured
n = 10
High-dimensional cytometry
High Resolution Approach
The 41-marker panel reveals the full picture.
858 Immune Subsets Measured
n = 10
Outcome
The Risky Path
The team is left without a convincing biological story. They can't justify the optimal dose, leading to potential delays, requests for more data, and increased program risk.
The Confident Path
The team confidently answers the FDA's question with deep mechanistic data. They justify their dose, de-risk the program, and proceed to the next phase without delay.
Timeline A: The Standard Approach
0
Timeline B: The High Resolution Advantage
"The Good News"
Presenting seemingly great clinical data.
n = 10

25%

response
10 mg dose
n = 10

55%

response
50 mg dose
1
The FDA Challenge
An unexpected pushback under Project Optimus.
"Your clinical data is encouraging, but how do you justify the higher dose without a mechanistic rationale?"
2
The Low-Resolution Data
Standard Approach
13 marker panel cannot differentiate between doses.
44 Immune Subsets Measured
n = 10
3
The High-Resolution Data
High Resolution Approach
The 41-marker panel reveals the full picture.
858 Immune Subsets Measured
n = 10
The Risky Path
The team is left without a convincing biological story. They can't justify the optimal dose, leading to potential delays, requests for more data, and increased program risk.
Outcome
The Confident Path
The team confidently answers the FDA's question with deep mechanistic data. They justify their dose, de-risk the program, and proceed to the next phase without delay.

Reference Material*

EOP1 (End-of-Phase 1) and EOP2 (End-of-Phase 2) meetings are critical regulatory milestones where sponsors discuss development plans and evaluate study adequacy with the FDA.

Key evaluation areas include Phase 3 protocols, current study adequacy, pediatric safety plans, marketing application requirements, and CMC readiness.

Source: FDA - OTP IND End-of-Phase Meetings

Stop showing up to EOP1/2 regulatory interactions with an incomplete story.

Why low-resolution data creates risks that high-resolution data can prevent.

Timeline A: The Standard Approach
Step 1: "The Good News"
Presenting seemingly great clinical data.
n = 10

25%

response
10 mg dose
n = 10

55%

response
50 mg dose
Step 2: The FDA Challenge
An unexpected pushback under Project Optimus.
"Your clinical data is encouraging, but how do you justify the higher dose without a mechanistic rationale?"
Step 3: The Low-Resolution Data
13 marker panel cannot differentiate between doses.
44 Immune Subsets Measured
n = 10
Outcome: The Risky Path
The team is left without a convincing biological story. They can't justify the optimal dose, leading to potential delays, requests for more data, and increased program risk.
Timeline B: The High Resolution Advantage
Step 1: "The Good News"
Presenting the same great clinical data.
n = 10

25%

response
10 mg dose
n = 10

55%

response
50 mg dose
Step 2: The FDA Challenge
The same pushback under Project Optimus.
"Your clinical data is encouraging, but how do you justify the higher dose without a mechanistic rationale?"
Step 3: The High-Resolution Data
The 41-marker panel reveals the full picture.
858 Immune Subsets Measured
n = 10
Outcome: The Confident Path
The team confidently answers the FDA's question with deep mechanistic data. They justify their dose, de-risk the program, and proceed to the next phase without delay.

Show up to EOP1/2 with the data they can’t push back on.

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