Bala Krishnamurthy

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