Cell and Gene Regulatory

1. The Stepwise Path Lilly Mapped From Paper To Digital Logbooks 4/30/2026

   Eli Lilly and Company started at the front lines, on the shop floor gathering operator input, when switching from paper to digital logbooks.

2. How To Establish Strategic Readiness For First-In-Human Trials 4/29/2026

   Most teams realize too late that sequential planning creates delays. FIH readiness depends on aligning IND and clinical strategy early; otherwise, programs risk setbacks that stall execution and timelines.

3. Data-Driven Predictive Maintenance And Production Transparency 4/29/2026

   Discover how integrated, data-driven solutions can help you reduce downtime, improve visibility, and streamline compliance across your manufacturing operations.

4. Strengthening Drug Product CMC through Drug Product Science | AAPS 4/27/2026

   At AAPS, drug product experts discuss how formulation, stability, and analytical services enable robust CMC strategies, reduce development risk, and support confident regulatory decision‑making.

5. Lipids CDMO Services: Custom Excipients Tailored To Your Needs 4/27/2026

   Advance your lipid‑based programs with a CDMO partner equipped to deliver customized excipients, proven scale‑up expertise, and reliable support from early development through commercialization.

6. Start Smart With IRB-Approved, Data Rich Samples 4/27/2026

   Learn about end-to-end biospecimen solutions that combine vast inventories with custom collections and specialized lab services to ensure sample integrity and trial success.

7. Why RWD Strategy Can't Wait With Price, Value And Evidence Pressures Everywhere 4/27/2026

   Overcome pricing pressures and reimbursement delays by integrating real-world evidence early in development to align clinical outcomes with payer demands and accelerate patient access.

8. From Bench To Breakthrough: How Custom Kitting Fuels Precision Trials 4/27/2026

   Reduce trial variability and ensure protocol compliance with standardized custom kitting that transforms complex sample collection into a streamlined, strategic advantage for clinical success.

9. The Switch To Cell-Free DNA: Strategic And Regulatory Considerations 4/24/2026

   Learn how risk-based studies, quality attributes, and proactive regulatory engagement support confident manufacturing transitions.

10. Successfully Navigating Opportunities With On-Body Delivery Systems 4/23/2026

    Drawing on insights from the global regulatory landscape, industry trends, and direct feedback from customers, Dr. Di Wu addresses some of the most frequently asked questions about on-body delivery system requirements.