Is Your Data Strategy Ready for the “In Silico” Revolution? Navigating the FDA’s Current Stance on Synthetic Evidence

Move beyond traditional patient recruitment hurdles. Discover how 2026’s regulatory breakthroughs in synthetic data and “Digital Twins” are accelerating approvals for rare diseases, oncology, and complex therapies.

The New Reality: Clinical Trials Without Traditional Placebos?
The “gold standard” of randomized controlled trials (RCTs) is facing a challenge. In 2026, the industry has reached a tipping point where recruiting real-world control arms for rare diseases or life-threatening conditions is often ethically impossible or practically unfeasible.
Enter Synthetic Data. From Synthetic Control Arms (SCAs) to In Silico clinical trials, the FDA is no longer just “watching” this space—they are actively shaping it. Following the landmark January 2025 Draft Guidance on AI in drug development and the April 2025 decision to phase out mandatory animal testing for specific programs, the agency has signaled a massive shift toward human-relevant, model-informed evidence.

Why Mid-Level and Senior Leaders Must Pivot Now
Regulatory experts and clinical trial directors who master the nuances of In Silico evidence will lead the next generation of blockbuster approvals. Understanding the FDA’s “case-by-case” assessment logic is the difference between a groundbreaking approval and a costly Refusal to File (RTF).

What We Will Cover?
In this 60-minute executive briefing, we will analyze the technical and regulatory requirements for successful synthetic data integration:

• The 2026 FDA Framework: Deep dive into the latest CBER-CDER Data Standards and how the FDA distinguishes between “process-driven” (mechanistic) and “data-driven” (AI-generated) synthetic data.
• Digital Twins & Virtual Cohorts: How to build high-fidelity patient models that meet FDA “fit-for-purpose” standards for safety and efficacy substantiation.
• Synthetic Control Arms (SCA) in Practice: Real-world examples where SCAs were accepted as primary evidence in lieu of a concurrent placebo.
• Overcoming the “Black Box” Barrier: Strategies for achieving transparency and model explainability that FDA reviewers now demand under the 2025 AI Transparency guidelines.
• Risk Mitigation: Addressing data drift, bias amplification, and the “memorization” risks of Generative Adversarial Networks (GANs).

Who Should Attend?

• Clinical Trial Strategists & Designers
• Biostatisticians & Data Scientists
• Regulatory Affairs Professionals (Drug & Device)
• Chief Medical Officers & VPs of R&D
• Ethics Committee & IRB Members

The Future of Evidence starts here.
Don’t let your clinical program be held back by recruitment bottlenecks. Learn how to augment your dossiers with the power of virtual evidence.

About Your Expert Partner
With 20 years of front-line experience during the FDA’s most transformative eras, our lead expert Dr. Mukesh Kumar provides the “insider” view on how the agency evaluates New Approach Methodologies (NAMs). They sat in the room for INTERACT and Pre-IND meetings where these digital strategies were debated and won.