Archives: Agenda

END OF CONFERENCE

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CASE STUDY: Moving away from audit nightmares to real-time accountability and audit readiness approach

  • How to make sure you are building accountability and reconciliation practices into the study planning up front, before the first shipment is dispatched
  • How to clearly define the accountability process and primary system of record to ensure sites and CROs understand expectations for documentation, reconciliation and destruction
  • How to standardize site-level data capture while accommodating local practices to prevent mismatches and delays at study closeout
  • How to leverage electronic systems to embed audit-ready accountability into daily workflows, shifting from reactive clean-up to real-time documentation
  • How to ensure a controlled IRT closure that eliminates discrepancies and supports complete, audit-ready records that helps you to save money in the long run

KEYNOTE: China’s Biotechnology Sector and What It Means for America

  • China’s Rise as a Clinical Trial Hub: How rapid patient accrual, cost advantages, and government support are diverting early-phase development offshore
  • The Global Regulatory Reality: Navigating FDA expectations for multi-regional data while leveraging overseas trial efficiency
  • Western CRO Competitiveness: Adapting to aggressive competition from Chinese trial scale through niche domain expertise, specialized therapeutic focus, and process automation

Interactive Breakfast Speaker – Hosted Roundtable Discussions

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