Archives: Agenda

🗣️ ROUNDTABLE SESSIONS offer a valuable opportunity to connect with peers, share best practices, and collaborate on solutions to key industry challenges. These interactive discussions also help you expand your network and learn from others’ experience and expertise.

1.How to Prepare for U.S. Biological Material Importation: Navigating Regulatory Requirements, Operational Challenges, and Best Practices 

Moderators: Carmin Cerullo, Agriculture Operations Manager, San Francisco and Portland Field Office, U.S. Customs and Border Protection; Jolien Wychules, Biological Threat Operations Specialist, San Francisco and Portland Field Office, U.S. Customs and Border Protection

2. Small vs. Large CDMOs/CMOs: How to choose the right partner for agility, scale, and clinical supply success

Moderator: Umar Hayat, VP, CMC and Supply Chain, Union Therapeutics; Rabindra Shivnaraine, Director, Clinical Supply Pharmacology, Aerys Biosciences

3.How to meet big pharma standards on a startup budget: Scaling compliance with limited staff and high regulatory burdens

Moderator: Charisse Eary, Head of Quality, Aligos Therapeutics

4.How to accelerate clinical decision-making through system integrity: Moving beyond manual data reconciliation to gain instant, cross-functional visibility

5. Integrated Program Planning: Syncing CMC, Manufacturing, and Clinical Supply for Accelerated Timelines

Moderator: Joerg Wania, Head of Clinical Trial Supply / Export, Stadpharm

6. How to manage costs efficiently by producing smaller, on-demand batches strategically timed to patient enrollment, avoiding overproduction and waste

7. How to leverage consultants to fill expertise gaps, optimize QP resources, and stay audit-ready without scaling internal teams

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• How to ensure product authenticity, quality, and traceability when sourcing from the open market
• How to build relationships with manufacturers and qualified suppliers to improve access & reliability
• How to secure supply continuity for high-value trials with limited comparator availability
• How to navigate regulatory and documentation requirements across regions for comparator sourcing

• How to design flexible packaging strategies that can adapt to protocol amendments and regional requirements
• How to align JIT labeling with IRT and forecasting systems to enable demand driven labeling based on real-time enrolment and dose data
• How to make JIT work with limited resources by partnering with the right CDMOs and packaging vendors

3–4 California biotech companies share their perspectives in short, dynamic talks (5–10 minutes each)

Each company addresses a set of thought-provoking prompts:

• Biggest mistake in clinical trials today
• One thing pharma should stop doing
• One prediction for 2030
• What’s overhyped vs. what’s worth the hype
• What vendors misunderstand
• Where trials fail most often
• Biggest recruitment mistake