INSIGHTS ON CELL & GENE REGULATORY ISSUES

• Operating And Maintaining Pharmaceutical Gas Distribution Systems

  Drug manufacturers face stringent requirements when using gas that comes into direct contact with the product. This guide discusses operation, maintenance, and monitoring of gas systems.

• Leveraging AI And Data Science For Biologics Characterization

  Modern analytical tools produce more data than we know what do with. Artificial intelligence helps condense, interpret, and utilize what's most meaningful.

• Manage, Analyze, And Visualize Sequencing Data

  Simplify NGS workflows with a platform that automates analysis, integrates diverse data types, and supports GMP validation to extract meaningful insights and streamline regulatory documentation.

• The New Era Of Project Optimus: Implications for Oncology Development Strategy

  In this presentation, expert speakers bring the impact of Project Optimus to life through real-world case studies and practical examples.

• Best Practices For Operationalizing Global, Early-Phase Oncology Trials

  In this presentation, industry experts will share real-world lessons learned from managing global early-phase oncology trials.

• How Single-Use Technologies Are Simplifying Contamination Control

  Learn how single-use technologies help reduce contamination risks and support compliance with updated EU GMP Annex 1 guidelines for aseptic processing and sterile drug manufacturing.

• Navigating What's Next For Global Drug Development: What Sponsors Need To Know

  Learn how new FDA initiatives and global regulatory changes can impact your strategy for 2025 and beyond.

• Exploring Ex-US Markets To Reduce Risk For Your Clinical Trials

  How biotech and emerging pharma companies are increasingly leveraging regions such as APAC and Eastern Europe to accelerate trial start-up, secure high-quality data, and optimize costs.

• Navigating GMP Certification In Cell And Gene Therapy Manufacturing

  CGT regulations are rapidly evolving. With hundreds of therapies in development, scalable automation and smarter systems are essential to meet compliance, reduce complexity, and protect patient lives.

• How To Build Flexibility Into Your CGT Manufacturing Process

  Scaling production demands both flexibility and strict compliance. Discover how innovators can rethink strategies to meet demand without compromising patient safety or regulatory standards.