PRE-CONFERENCE WORKSHOP DAY | Tuesday, October 7
9:00 am Pre-Conference Day Welcome Breakfast
WORKSHOP A | 10.00-12.30
Building Supply Chain Resistance through Dual Sourcing Strategies
Synopsis
In an increasingly volatile global environment, companies are being challenged to protect their supply chains against disruptions caused by tariffs, political shifts, outbreaks and logistical breakdowns. This workshop will explore practical approaches to dual sourcing as a key strategy for building resilience into your operations. By leveraging multiple qualified suppliers for critical materials, biopharma can reduce their dependency on a single source and ensure continuity in production.
- Learn how to incorporate multiple suppliers into your process without disrupting supply, quality or overall product
- Explore how to include multiple suppliers into regulatory framework and work to approval with multiple suppliers of one product
- Discuss case-based scenarios for building resilience through supplier diversification, and how this will create a robust supply chain and product security
12:30 pm Lunch Break & Networking
WORKSHOP B | 1.30-4.00
Seamlessly Integrating New Raw Materials into CGT Manufacturing, an End-to-End Qualification Strategy
Synopsis
As cell and gene therapies evolve, so too does the complexity of their raw material requirements. Introducing a raw material into an existing CGT process demands a coordinated approach across technical, quality, regulatory, and supply chain functions. This session will cover an end-to-end frame work of adding a new supplier into your manufacturing process, working through hypothetical scenarios to identify the biggest challenges as we head into the main conference days.
- Gain a practical framework for assessing the need for a new raw material and initiating vendor scouting and evaluation
- Understand key strategies for technical onboarding, including comparability studies, risk assessments, and process validation
- Explore how to integrate new materials into existing regulatory filings and manage global health authority engagement
- Review case studies where early vendor partnerships and cross-functional collaboration enabled successful material transitions in cell and gene therapy pipelines