How Substance Forecasting Works
Understand how Prognosis calculates drug substance requirements across your clinical trial portfolio.
Overview
Drug substance forecasting answers a critical question for pharmaceutical teams: "How much active ingredient do we need to support our clinical trials?"
Prognosis traces the relationship from raw materials all the way to patients, giving you a clear picture of upstream requirements. This guide explains how it works and how to get the most accurate projections.
The Relationship Chain
Understanding substance requirements starts with understanding how materials flow through your supply chain:
- Drug Substance (API) -- the raw active ingredient
- Drug Product (tablets, vials, etc.) -- manufactured from the substance
- Kits -- packaged for clinical use
- Treatment Arms -- dispensed per visit
- Patients -- enrolled in trials
Prognosis works backwards through this chain. Starting with how many patients need kits, it calculates how much drug product is required, and from that, how much drug substance is needed.
What Drives Substance Requirements
Several factors determine how much substance you'll need:
Patient Volume
The most direct driver--more patients means more kits, which means more substance.
| Factor | Example Impact |
|---|---|
| Total enrollment | 100 patients vs. 500 patients |
| Treatment arm allocation | 60% active vs. 40% placebo |
| Drop-out rates | Fewer patients completing = less substance |
Visit Frequency
How often patients receive kits affects total consumption:
| Factor | Example Impact |
|---|---|
| Number of visits | 6 visits vs. 12 visits per patient |
| Kits per visit | 1 kit vs. 2 kits dispensed |
| Visit intervals | Weekly vs. monthly dosing |
Product Formulation
How much substance goes into each dose:
| Factor | Example Impact |
|---|---|
| Dose strength | 50mg tablet vs. 200mg tablet |
| Units per kit | 30 tablets vs. 90 tablets per kit |
Manufacturing Realities
Real-world production isn't 100% efficient:
| Factor | Example Impact |
|---|---|
| Yield loss | 5% vs. 15% lost during manufacturing |
| Quality failures | Batches that don't meet specifications |
How Prognosis Calculates Requirements
Step 1: Start with Patient Demand
First, the system looks at your trial forecasts:
- How many patients in each trial?
- Which treatment arms are they in?
- How many visits will they have?
- What kits do they receive at each visit?
This gives the total kit demand across all your trials.
Step 2: Trace Back to Drug Product
For each kit type, Prognosis knows:
- Which drug product is inside the kit
- How much product is in each kit
This converts kit demand into drug product requirements.
Step 3: Trace Back to Drug Substance
For each drug product, Prognosis knows:
- Which drug substance it contains
- How much substance is in each unit of product
This converts product requirements into substance requirements.
Step 4: Account for Manufacturing Loss
Manufacturing processes aren't perfect. Some material is lost to:
- Processing inefficiencies
- Quality testing
- Equipment residue
- Failed batches
Prognosis adjusts the requirement upward to account for this, ensuring you have enough raw material to produce the needed finished product.
Reading Your Substance Forecast
Trial-Level Breakdown
See how much substance each trial requires:
| Trial | Product | Substance Required |
|---|---|---|
| Phase 2 Study A | 100mg Tablet | 2.5 kg |
| Phase 3 Study B | 100mg Tablet | 8.0 kg |
| Phase 3 Study B | 50mg Tablet | 2.0 kg |
This helps you understand which trials are driving demand.
Product-Level Summary
See totals aggregated by drug product:
| Product | Base Requirement | With Yield Adjustment |
|---|---|---|
| 100mg Tablet | 10.5 kg | 11.7 kg |
| 50mg Tablet | 2.0 kg | 2.2 kg |
The "with yield adjustment" column shows what you actually need to procure.
Overall Totals
See the bottom line--total substance needed across your portfolio:
| Total Base Requirement | Total Adjusted |
|---|---|
| 12.5 kg | 13.9 kg |
Using Substance Forecasts
Procurement Planning
Know how much API to order:
- Use the adjusted total as your procurement target
- Factor in your own safety stock preferences
- Consider supplier lead times when timing orders
Manufacturing Scheduling
Align substance production with trial timelines:
- Review trial start dates to understand when substance is needed
- Plan upstream manufacturing accordingly
- Coordinate with downstream drug product production
Budget Estimation
Estimate material costs:
- Multiply substance requirements by your cost per unit
- Factor in multiple products if applicable
- Include yield adjustment in cost calculations
Portfolio Optimization
See the big picture across all trials:
- Identify which trials drive the most demand
- Find opportunities to consolidate production
- Balance substance allocation across competing needs
Getting Accurate Forecasts
Input Quality Matters
Your substance forecast is only as good as your inputs:
| Input | Impact |
|---|---|
| Patient numbers | Directly scales substance needs |
| Kit formulations | Determines substance per kit |
| Yield loss % | Affects the adjustment factor |
| Trial linkages | Ensures all trials are counted |
Common Mistakes to Avoid
Missing trial linkages: If a trial isn't connected to a drug product, its demand won't be included in substance calculations.
Outdated formulations: If kit substance amounts change, update them to keep forecasts accurate.
Ignoring yield loss: Optimistic yield assumptions lead to substance shortfalls.
Forgetting placebo: Placebos with active substance (for blinding) need to be included.
Tips for Accuracy
- Link all relevant trials -- Ensure every trial using the substance is connected
- Verify formulation data -- Confirm substance amounts per product with your formulation team
- Use realistic yield -- Base yield loss on actual manufacturing history
- Update as trials evolve -- Refresh when enrollment targets or formulations change
Frequently Asked Questions
Why are there two numbers (base and adjusted)?
The "base" requirement is pure demand--what patients need. The "adjusted" requirement accounts for manufacturing losses. Procure based on the adjusted number.
What if one substance is used in multiple products?
Prognosis handles this automatically. Requirements from all products are summed to give you the total substance needed.
How do I handle different dose strengths?
Each dose strength is typically a separate drug product. Link each product to the substance with its specific formulation, and Prognosis calculates requirements for each.
What about clinical supplies vs. commercial?
Prognosis focuses on clinical trial demand. For commercial planning, you'd use different tools, but the clinical forecast helps you understand near-term needs.
How far into the future can I forecast?
As far as your trial plans extend. If you have enrollment dates and patient targets, Prognosis can calculate substance requirements for the full trial duration.
Summary
Substance forecasting helps you answer the critical upstream question: "How much API do we need?"
By understanding the chain from patients to substance, and the factors that affect requirements, you can:
- Plan procurement with confidence
- Avoid supply shortfalls
- Optimize manufacturing schedules
- Manage budgets effectively
Next Steps
- Managing Drug Substances -- Learn how to set up substances and products
- Demand Analytics -- Understand the kit-level forecasts that drive substance calculations