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B3 - OLX Process

After Molecule Identified

B3 - Project Gantt
B3 - B3 - Brief Labs - Single owner from B3.
Must Have and Optional Criteria
Product References
Fill Size & Cadence
BOM range, ex. F&A
OLX - Ingredient Briefs to B3
Ingredient Data Sheet - mg. scale: Toxicity, In-Vitro Efficacy, Safety, Pricing (?)
Solubility Constraints (if known), pH range, Solvents (and associated concentration range), Compatibility, rec. concentration based on in vitro studies
Logistics -Pricing & Ramp up constraints of the ingredient; Molecule lead times
OLX - Formulation Research & Analysis and Mapping of constraints
Scenario 1 - Exact brief formulation + Molecule
Scenario 2 - New formulation, expected similar efficacy, trade-offs on other parameters
Formulations - Scenario 1-
B3 - R0 Samples Evaluation Of Several Different Formulas
OLX to provide sample QQs
Share BOM Range
B3 Evaluate and submits feedback based on the metrics defined in Formula Brief (
Template
⁠
,
Example
⁠
)
B3 Evaluate claims and alignment with Brief
OLX - R0 Reformulations based on feedback
OLX - R1+2 Samples Evaluation & Reformulation
B3 & OLX - Final Formulation or decision to outsurce formulation to an OEM
Formulation - Scenario 2-
B3 - Brief update, agree on refined brief
B3 - R0 Sample Evaluation
OLX to provide sample INCI
Share BOM Range
B3 Evaluate and submits feedback based on the metrics defined in Formula Brief
B3 Evaluate claims and alignment with Brief.
B3 - R0 Reformulation
OLX - R1+2 Samples Evaluation & Reformulation
B3 & OLX - Final Formulation or decision to outsource formulation to an OEM
B3 Focus Group Design - (Other party is approver)
Study Design - Eligibility, Controls, Comps
Comp Selection
Surveys Writeup
Participant Recruitment, eligibility criteria definition
Improvement Claims (PDP Oriented)
OLX - Manufacturing scale up
Ingredient Order
Formulation Tests
Formulation Scale up to FG scale
B3 - FG Implementation
Recruitment
Participant Selection
Package Shipment
Dashboard Building
Data Analysis
OLX - Molecule Commercialization
OLX/B3 - Trademarks
TBD - Naming
Martha - Filing
OLX - Patents
OLX - INCI Name
OLX - Clinical Claims
OLX - Regulatory Constraints
Post FG Reformulation
B3 - Formulations Feedback and Changes
OLX - Reformulation
B3 - Packaging
Primary Packaging Design
Labels Design
Secondary Design
B3 - Product Marketing
Claims , Names
Safety data
PDPs
OLX - Formula Tech Transfer
Tech Transfer
Q/A
Pilot Run
B3 - Operationalization & Supply Chain
F&A & Q/A
End To End Pilot Batch

Action Items & Gaps
Define a template for a standard ingredient data sheet.
Why don’t we work with OEMs directly with the molecule
Labs samples to focus group scale up concern -
Texture & formulation changes


Martha’s Insights

Define Discovery Process Framework -
Molecule Efficacy & Value Proposition - Minimal & Optimal Efficacy, TAM Assessment
Definition and numbers of future SKUs.

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