Virtual Lunch & Learn: AI-Powered Clinical Trials: De-Risking Enrollment, Timelines, and Investor Confidence for Biotech

Clinical trials are the single biggest operational and financial risk for small to mid-size biotech companies. Fifty to eighty percent of trials miss enrollment targets, unplanned amendments cost $150-300K each, and database lock delays push readouts back months. For companies with just 18-24 months of runway, every setback erodes investor confidence, delays financing, and gives faster rivals the edge. This session tackles the five pain points keeping CEOs awake: on-time First Patient In, fewer costly amendments, better enrollment and retention, faster database lock, and predictable execution that protects investor confidence.

Learn how AI, already delivering measurable results for IQVIA, ICON, and Syneos Health, can cut timelines 20%, boost recruitment 26%, and preserve $15-22M of runway per Phase 2b/3 trial. Walk away with a practical roadmap from targeted pilots to portfolio-wide adoption that turns clinical trial risk into a competitive advantage. Join us and give your next trial the advantage it deserves.

Speaker: Ndeye Makalou

Ndeye Makalou, PharmD, is a global biopharma strategist and Founder & CEO of Global Impact Bio Consulting, a mission‑driven advisory firm that helps life sciences leaders turn complex science into viable products, clinical programs, and markets. She has led cross‑functional initiatives spanning biologics manufacturing, drug development, access strategies, Health Equity, and global supply chains across the U.S., Europe, and emerging markets, giving her a rare end‑to‑end view of how therapies move from discovery through clinical trials to patients.

Drawing on over two decades in pharma and biotech, Ndeye now advises small and mid‑sized biotechs, health systems, and global health organizations on R&D strategy, clinical development, and AI‑enabled transformation, including how to use agentic AI platforms like RapidCanvas to redesign critical workflows in trial design, feasibility, and operations. Her work is grounded in health equity and practical execution: helping lean teams improve trial success, reduce operational risk, and build investor‑ready stories without adding unnecessary complexity.

Ndeye is based in Portland, Oregon and actively supports the regional bioscience ecosystem through mentoring and strategic advisory work with innovators in the Oregon Bioscience Incubator and beyond.

This program was organized by Oregon Bioscience Incubator. http://www.otradi.org