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.

"The Good News"

Standard Approach

Presenting great clinical data.

n = 10

25%

response

10 mg dose

n = 10

55%

response

50 mg dose

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

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

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

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?"

The Low-Resolution Data

Standard Approach

13 marker panel cannot differentiate between doses.

44 Immune Subsets Measured

n = 10

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.