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PROCOVA - is it the right tool for your medicinal development?
PROCOVA - is it the right tool for your medicinal development?
EMA qualified PROCOVA™ (Prognostic Covariate Adjustment); with this you can increase confidence in clinical results and potentially use smaller sample size for Phase II and III randomised controlled trials for regulatory decision making.
Is this a game changer for medicinal development? What can it do and can not do? Let us answer some common questions for the medicinal developers.
FDA & AI: Risk-Based Credibility (Part 1 Assess Model Risk)
FDA & AI: Risk-Based Credibility (Part 1 Assess Model Risk)
The landscape of AI in drug development has shifted from "Can we do this?" to "How do we establish credibility?"
In this video, we break down the FDA’s framework for Risk-Based Credibility. It ultimately comes down to a simple mental equation:
Model Influence + Decision Consequence = Model Risk
We explore this through two contrasting scenarios:
1️⃣ High Risk: AI acting as the "Sole Determinant" for patient safety stratification.
2️⃣ Medium Risk: AI acting as a "Support Tool" for manufacturing fill-volume checks.
Can an Algorithm replace a Diagnostic?
Can an Algorithm replace a Diagnostic?
Yes - but, how do you prove the algorithm is safe and effective to use as a diagnostic?
Read the model credibility assessment, applying FDA 7-step risk-based approach outlined in the 2025 draft guidance.
FDA & EMA 10 Joint Guiding Principles for AI in drug development
It signals a powerful, unified global roadmap.
For Biotech and TechBio leaders, this is the blueprint for a defensible AI advantage.
✨ 4 Strategic Mandates for the C-Suite:
1️⃣ Human-Centric Design: AI is a force multiplier for human decision-making, not a replacement.
2️⃣ Unified AI Governance: build one framework and ensure global regulatory readiness.
3️⃣ "Fit-for-Use" Data: move beyond data collection—operationalise rigorous tracking and continuous life-cycle monitoring.
4️⃣ Interdisciplinary Integration: embed multi-disciplinary expertise (Clinical + Data + Regulatory) from day one, and throughout life cycle.
Regulatory clarity is the catalyst for innovation. Companies that can operationalise the principles will prevail.
Is your organisation built for the new standard? We are here to help you lead and succeed.
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