Archives: Agenda

• How to move beyond qualitative promises by building a hard-data business case that measures time-to-market acceleration, waste reduction, and compliance risk avoidance
• Key strategies for aligning clinical operations, IT, and fi nance around shared digital goals, addressing operational resistance, and justifying initial capital expenditure
• Actionable frameworks for transitioning successful digital supply chain proofs-of-concept into fully integrated, enterprise-wide production workflows without disrupting ongoing trials

• Understanding local, regional, and centralized sourcing approaches
• Assessing the benefi ts, risks, and trade-offs of local sourcing
• Ensuring global standardization while accommodating country-specifi c operational needs
• Proven strategies for scaling local sourcing across multinational clinical studies
• Impact of sourcing strategy on timelines, quality, cost, and stakeholder experience

🏆 PRIZE DRAW: Visit our exhibitors’ booths throughout the day and collect stamps to enter our Prize Draw and be in for a chance of winning Apple prizes or Amazon gift cards. The Prize Draw will take place in the Exhibition Hall. Make sure you don’t miss out!

🗣️ 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. Vendors Opportunities

1. Shifting from reactive vendor management to strategic, transparent, patient-focused partnerships
Martina Endzhova, Global Category Lead, RWD/RWE, Bayer

2. Architecting the ATMP Supply Chain: A Practical Guide to Planning & Orchestration Excellence
Tom Walls, Former Head of Supply Chain Planning, Spark Therapeutics

3. How IRT integration eliminates blind spots between CMO production and 3PL distribution
Shawn Gehen, Senior Manager, Clinical Supply, Lexeo Therapeutics

4. Streamlining Biological Imports: Overcoming CBP & Partner Agency Regulatory Bottlenecks in Evolving Clinical Trials ; Elliot Ortiz, Port Director; Jeffrey Yocum, Supervisory Import Specialist, David Ng, Senior Agriculture Operations Manager, U.S. Customs and Border Protection , Area Port of Philadelphia

5. Beyond the Molecule: Managing ancillary sourcing to keep trials on track
Marsha G. Meron, Sr Manager Clinical Drug Supply Logistics – Ancillary Supply Management, Regeneron

6. Overcoming the Legacy Trap: How to start modernizing your clinical supply systems
Camille Pataki, Senior Computational Product Discovery Engineer, AI Projects, Eikon Therapeutics

7. Unblinding the Forecast Process: How Modern Tools Are Resolving Early-Stage Clinical Trial Forecasting Lucas Outcault, Manager, Clinical Drug Supply & Logistics, Regeneron

• CBP’s Bio-Defense Role: Overview of CBPAS and BTOS missions in protecting U.S. agriculture and resources from foreign biological threats
• Multi-Agency Compliance: Guidance on navigating partner agency requirements (USDA, CDC, FDA, FWS, EPA) via the ACE portal
• Import Best Practices: Key steps for properly classifying, packaging, and documenting biological imports to avoid delays, seizures, or research disruptions

• Creating a smart evaluation framework to assess external drugs program to accurately determine their strategic fit, commercial viability and long-term value before making the acquisition
• Uncover hidden risks and verify facts: Learn exactly what to look for and what to ask during confidential data reviews to avoid surprises
• How to build collaborative, cross-functional relationships with your counterparty teams to ensure smooth operations and prevent activities from slipping through

• Baseline & Scope: Defi ne Scope 1–3 environmental impacts across all supply chain stages
• Operationalize & Measure: Establish actionable KPIs, updated SOPs, and governance models
• Execute & Scale: Prioritize initiatives that balance carbon reduction, cost, and supply continuity

• Learn how a customized generative AI approach streamlined a complex RFI process, slashing time and effort while enhancing, rather than replacing, human expertise
• Discover real-world results and data showing exactly how Clinical Procurement can accelerate market reviews and signifi cantly lower operational burdens
• Smarter, Faster Clinical Decisions: See how these combined strategies empower Clinical Development teams to make high-impact, rapid, and well-informed decisions