Explore the Agenda
Pre-Conference Day
Tuesday, June 9
Day One
Wednesday, June 10
Day Two
Thursday, June 11
8:00 am Check-In & Morning Coffee
Workshop A
8:30 am Increasing Supply Chain Adaptability & Resilience in a Geopolitically Uncertain World
2025 has reshaped the geopolitical landscape, introducing a period of heightened complexity for the cell and gene therapy sector. While the industry is navigating tariff increases, tighter investment conditions, and challenges in entering new markets, these industry shifts are sharpening focus on resilient, adaptable network design to support sustainable growth and long-term innovation. This hands-on, interactive workshop will demonstrate how to strengthen supply chain efficiency through real-world case studies and practical frameworks. Attendees will gain the tools necessary to navigate evolving regulatory requirements and reliably scale operations in an increasingly complex and uncertain global environment.
This workshop will explore:
- Navigating Costs: exploring strategies to manage tariff increases, raw material price volatility, and other unforeseen cost pressures whilst maintaining operational efficiency
- Scaling Amid Regulatory Uncertainty: approaches to navigating evolving regulatory landscapes while accelerating effective and compliant scale-up
- Expanding into Challenging Markets: discussing entry and expansion strategies for complex regions, including Latin America, Africa, and Australia, and addressing the associated regulatory, economic, and logistical hurdles
1:00 pm Networking Break
Workshop B
11:00 am Digital Readiness From Clinical to Commercial: Building Scalable Business Systems for CGT Supply Chains
As cell and gene therapy programs move from early trials into pivotal studies and launch, many teams discover that spreadsheet‑driven processes and isolated tools can no longer support patient‑level supply chains, growing partner networks, and rising regulatory expectations for data integrity and traceability. This interactive workshop will unpack what “digital readiness” really means for CGT supply chains, going beyond an ERP go‑live to include process design, data governance, integration, and validation from Phase 2/3 through commercial launch. Using an anonymized composite case and facilitated roundtable discussions, participants will explore key lifecycle inflection points, common timing mistakes, and practical patterns for sequencing business systems decisions. Attendees will leave with a short checklist of non‑negotiable capabilities, warning signs that they are falling behind digitally, and priority actions for the next 12–24 months.
This workshop will explore:
- Defining digital readiness for CGT: clarifying the combination of processes, systems, data, and ownership required to reliably support vein‑to‑vein supply from clinical through commercial
- Sequencing business systems across the lifecycle: identifying which capabilities must be in place before pivotal trials, PPQ, and BLA/MAA submission, and which can be deferred without creating future re‑work
- De‑risking inspections and traceability: understanding where digital gaps most often surface during regulatory review, and how to address data integrity, chain‑of‑identity/ custody, and validation issues early
- Orchestrating a fragmented ecosystem with the right data foundations: outlining minimum‑viable architectures and KPIs to connect sites, CMOs, couriers, and internal teams today while preparing for advanced analytics and AI tomorrow
Workshop C
2:00 pm Driving Industry Transformation Through Digitalization: From Fragmented Systems to Integrated, Data-Enabled Operations
It has long been recognised that cell and gene therapy must embrace digitalization, but the question remains: how do we get there? As AI adoption accelerates across the industry, establishing the right digital foundations is critical to enabling this transformation. Whilst there is broad agreement on the need for this transition, organizations face constraints around time, cost, and resources. Attendees will learn how to digitalize effectively, manage costs, and embed digitalization into a sustainable business plan.
This workshop will explore:
- Preparing for AI Adoption: laying the digital groundwork by assessing current digital maturity, implementing robust data governance, and identifying areas where AI can deliver immediate operational benefit
- Industrializing Personalized Manufacturing: using digital platforms to accelerate patient-to-product journeys through improved chain of identity, logistics integration, and real-time operational visibility
- Optimizing Cost and Time: reducing implementation timelines and controlling costs by prioritizing high-impact digital initiatives, leveraging scalable platforms, and avoid redundant digitalization efforts
- Digitalizing Emerging Biotechs: learn from industry leaders how to leverage industry-standard platforms, demonstrating the phased adoption of digital tools, and aligning digital investment with organizational maturity