Archives: Agenda

• Simulating Disruptions: Testing the impact of sudden supplier failures, customs delays, or enrollment spikes virtually before they disrupt real-world trials
• Optimizing Budgets & Inventory: Running predictive scenarios to find the perfect balance between overproducing expensive investigational drugs and risking stockouts
• Driving Aggressive Lead-Time Reduction

Vendor Opportunity

• The Seduction vs. The Reality: Dissecting the gap between a CDMO’s glossy sales pitch and actual operational delivery
• The Sovereignty Trap: Identifying where cost-cutting turns into a dangerous loss of internal technical expertise, and how to maintain “intellectual sovereignty” over your own product
• Is it actually cheaper and easier to hire outside help when we get super busy, or will managing those outsiders create more work than it saves!

Reserved for vendor

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🗣️ 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. 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 clinical supply teams work with 3PLs and carriers to design bulletproof shipping lanes, build smart backup plans, and ensure that high-value biologics survive the realities of global transit; How to manage “just-in-time” logistics for cancer drugs with ultra-short shelf lives, where even a brief flight delay can ruin the therapy. How to meet big pharma standards on a startup budget: Scaling compliance with limited staff and high regulatory burdens
Small vs. Large CDMOs/CMOs: How to choose the right partner for agility, scale, and clinical supply success

4. How to start implementing AI in your day to day workflows to deliver real outcomes in your clinical supply

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

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

7. Moving away from audit nightmares to real-time accountability and audit readiness approach

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

• The Power of Connected Digital Systems: How to replace paper workflows to optimize supply chain traceability, streamline patient scheduling and accelerate manufacturing release times with zero-error
• Site-Sponsor Digital Integration: How to leverage collaborative platforms to align clinical programs with manufacturers, backed by clear frameworks to assess digital maturity and prioritize high-impact transformation
• How to leverage Digital Twins to simulate clinical trial material manufacturing and packaging to anticipate any bottlenecks and optimize clinical supply chain ahead of physical execution

• 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