Internal Project Tracker: US J&J AD Biopsy Images Add On

• Deal Id: 57784063799
• Deal name: US Pharma Johnson & Johnson Clinical Trial - AD Biopsy Images Add On
• Study ID: ASTAR

This document tracks internal meetings and decisions for the J&J ASTAR AD Biopsy Images Add On project.

Meeting History

Date	Type	Topics	Key Highlights
2026-04-09	Internal	Go/No-go decision, RFP doubts clarification	Project GO confirmed by COO, CTO, CIAO, BDD, PMT; desired delivery 2026-06-01 subject to ≥30 days from contract signature; ASCORAD out of scope (separate future quote); UI flow TBC; next step: offer and SOW
2026-03-18	Internal	Project overview, pending to receive RFP	Image capture protocol options (random lesions vs. fixed perspectives); data transfer format options; scope defined (image capture, DIQA, visual signs — ASCORAD/Pose out of scope); feasibility for a 1-month timeline: No

2026-03-18 Internal Meeting

Objective: Cross-department coordination to review the deal scope, image capture protocol options, and data transfer specifications.

Context

• Deal stage at time of meeting: Discovered
• No development to start until the SOW is defined and the contract is signed.

Topics Discussed

Image Capture Protocol Options

6 images per visit. Two options were evaluated:

• Option A (Random lesions): 6 steps, 1 image per step. Photos taken of three biopsy locations (non-lesional pre/post biopsy, lesional pre/post biopsy, lesional resolved pre/post biopsy) from a cosmetically accepted area of the body (lower back, buttocks, thighs, arms).
• Option B (Fixed perspectives): 6 images using fixed body perspectives (upper front, upper back, lower front, lower back).

Scope: Image capture, image quality control, visual signs. Out of scope: Pose, ASCORAD Global.

Data Transfer Specifications

Two data transfer formats were discussed:

• Option A (1 row per image): Each of the 6 images has its own row. Total images per row in the data transfer = 1 + 1 (anonymized) = 2.
• Option B (1 row per visit): All 6 images in a single row. Total images per row = 6 + 6 (anonymized) = 12.

Both options are TBD pending contract signature and further clarification from the MDS and OSD teams.

Data Transfer structure (visit information per row):

• study_code, site_id, site_code, subject_id, subject_code
• diagnostic_report_id (UNIQUE ID)
• visit_code, timestamp, condition_code
• Image paths: image_N_anonymized_image_path, image_N_anonymized_segmentation_image_path

Target S3 bucket: s3://jnj-{{study-ID}}-prod-data-transfer

Next Steps (2026-03-18)

• Pending formal Request for Proposal (RFP) with full details.
• No development until the contract is signed.
• Feasibility for a 1-month timeline: No.
• Internal meeting to confirm efforts and viability (scope and dates) — also No for a 1-month timeline.

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2026-04-09 Internal Meeting

Objective: Go/No-go decision, doubts clarification based on the RFP received on 2026-03-27, and next steps for the offer.

Go / No-Go Decision

All stakeholders confirmed Go:

Role	Decision	Notes
COO	Go
CTO	Go	~1 week of UI development required
CIAO	Go
BDD	Go
PMT	Go

Doubts Clarified

The following doubts were clarified during or after the meeting based on the RFP and client communications:

• Masking: Confirmed to refer to standard anonymization (not lesion segmentation). No photos of head or neck are captured.
• Image capture UI: Site staff capture one photo per step; no pose estimation needed. Labels identify the 6 biopsy locations.
• Notifications / TAT: Deviation notifications are not required (single timepoint per patient, no predictable entry). TAT = Turn Around Time. Image receipt visibility: site staff see subject activities in the webapp; Sponsor has real-time visibility through the dashboard.
• Independent Review Charters (IRC): The IRC field in the RFP is likely erroneous.
• Protocol: No imaging protocol exists. The current ASTAR protocol covers molecular data and samples only.
• Imported timepoints: Not required. Date/timestamp of image uploads is captured automatically.
• Deviation notifications: Not needed (single timepoint, no way to predict patient entry).
• Retrospective photos: No management by us required.
• ASCORAD / Severity Assessment: Out of scope for this RFP. The underlying objective is AD phenotyping (building a training dataset). Scoring may be quoted as a separate future RFP.

Next Steps (2026-04-09)

• Offer & pricing: Decide between pricing by features or a general lump-sum approach (responsible: Alba & Giuseppe).
• SOW documentation: Prepare SOW, technical requirements, and Investigator Manual draft including dashboard and data mockups (responsible: Alba).
• UI flow: TBC — 2-step flow (3 images per step) vs. 6-step flow (1 image per step).
• OSD meeting: On hold until RFP approval and specifications are clear. Topics: separated logic for image capture and image processing (e.g., anonymization), configurable vs. hardcoded UI steps.
• CT alignment meeting: Scheduled for 2026-04-14 at 11:00 — future Clinical Trials technical alignment on RFP and SOW templates.