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
Moderators: 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 start implementing AI in your day to day workflows to deliver real outcomes in your clinical supply
Moderator: Jamie Goldman, Logistic Program Manager, Orca Bio
5. Integrated Program Planning: Syncing CMC, Manufacturing, and Clinical Supply for Accelerated Timelines
Moderator: Joerg Wania, Head of Clinical Trial Supply / Export, Stadpharm
6. Real Change Demands Synergy: Unifying the People, Process, and Tech Triad
Moderator: M. David (Dave) Malenfant, Executive Supply Chain Leader, Trainer, Mentor, TCU

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📊 LIVE POLL

• How to reposition CTS from a pure logistics function to a strategic partner and enable teams to advocate their value internally to improve ClinOps outcomes
• Protocol vs. Reality: How to close the gap between protocol design and operational reality through early collaboration to ensure the supply chain matches the realities of patient care
• How to establish shared goals, KPIs, and communication frameworks between CTS and ClinOps to sustain alignment and ongoing collaboration throughout the study

Panelists will share their perspectives in short, dynamic talks
Each company addresses a set of thought-provoking prompts:

• Biggest mistake in clinical trials today

• One thing pharma should stop doing

• Navigating Funding Challenges

• One prediction for 2030

• What’s overhyped vs. what’s worth the hype

• What vendors misunderstand

• Where trials fail most often

• Biggest recruitment mistake

• Early engagement between clinical operations and the manufacturing network for the biggest impact on waste

• Forecasting and supply strategies to reduce waste without increasing stock-out risks

• Organizational foundations to enable effective inventory and waste management