How Substance Forecasting Works

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)
       ↓
Drug Product (tablets, vials, etc.)
       ↓
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.

Visit Frequency

How often patients receive kits affects total consumption:

Product Formulation

How much substance goes into each dose:

Manufacturing Realities

Real-world production isn't 100% efficient:

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:

This helps you understand which trials are driving demand.

Product-Level Summary

See totals aggregated by drug product:

The "with yield adjustment" column shows what you actually need to procure.

Overall Totals

See the bottom line—total substance needed across your portfolio:

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:

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

1. Link all relevant trials — Ensure every trial using the substance is connected
2. Verify formulation data — Confirm substance amounts per product with your formulation team
3. Use realistic yield — Base yield loss on actual manufacturing history
4. 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