Data Science and Bioinformatics in CGT Process Development and Manufacturing

As cell and gene therapies advance toward industrial-scale manufacturing, the role of data science and bioinformatics is becoming critical. Yet many CGT developers are still building the foundational digital infrastructure needed to unlock these capabilities. The gap between the promise of AI-driven optimization and the reality of implementation remains significant.

This exclusive roundtable brings together CGT executives to explore how data science and bioinformatics can transform process development and manufacturing—beyond the hype. We'll discuss practical approaches to building digital-first strategies, from establishing digital shadows to creating predictive models that inform real-time decisions during CAR-T expansion and other critical processes.

Join your peers to share insights on overcoming the skills gap, generating meaningful data, standardizing approaches, and determining the right balance of critical quality attributes—all while navigating the realities of regulatory requirements and limited resources.

Discussion Points

📌Building the Foundation: Digital Infrastructure and Automation Moving toward Industry 4.0 requires more than aspirations—it demands robust digital infrastructure and automation. How are leading organizations building this foundation? What are the essential first steps, and where should companies focus their initial investments to enable future data science capabilities?

📌From Digital Shadows to Digital Twins: Practical Implementation Digital shadows (one-way data representation) offer a stepping stone to true digital twins (closed-loop control). Where should CGT developers start? What are realistic applications for digital shadows in process development and manufacturing—such as real-time insight during CAR-T expansion—and what impact have early adopters seen on efficiency and output?

📌Data Quality and Quantity: Generating Meaningful Insights Are current analytical methods and characterization tools sufficient to generate the robust data needed for predictive models? How much data is ‘enough’ to train reliable models, and who defines these benchmarks? What role should consortia like AIDPATH play in establishing standards and pooling non-competitive data

📌Critical Quality Attributes: Finding the Right Balance More CQAs mean more out-of-specification events and potentially more failed batches—yet too few may miss critical process insights. What's the optimal balance between comprehensive characterization and practical manufacturability? How are organizations approaching this challenge while maintaining regulatory compliance?

📌The Skills Gap: Building In-House Expertise vs. External Partnerships Data science and bioinformatics expertise remains scarce in the CGT sector. Are companies better served building internal capabilities, partnering with specialized firms, or collaborating through industry consortia? What talent strategies have proven most effective, and how can organizations avoid the trap of pursuing ‘AI for AI's sake’ without deep domain understanding?

What You'll Gain

✅ Practical strategies for building digital infrastructure and data capabilities specific to CGT manufacturing

✅ Insights into implementing digital shadows and models that enable smarter, data-driven decisions during process development

✅ Real-world approaches to data standardization, CQA selection, and generating sufficient, meaningful data

✅ Candid discussion of the skills gap and whether consortia or non-commercial entities offer viable solutions

Schedule

As everyone arrives, we take time to settle in, get comfortable, and begin connecting with those around us. The journey starts here.

Welcome and introductions

10:00 – 10:10am

Roundtable discussion

10:10 - 11:10am

Conclusion and next steps

11.10 - 11.30am

Peer-to-Peer Virtual Roundtables

Cell and Gene Council virtual roundtables are an exclusive forum that bring together life science executives to engage in candid discussion, share insight and collaborate on common challenges facing cell therapy developers today.

Facilitated by Michael Adeniya, an events strategist with 15+ years in advanced therapies, you'll be an active participant in the discussion.

You'll leave with practical strategies to implement in your organization.

Enhance your approach and drive growth with insights gained from the roundtable. All gained from the comfort of your own office!

Michael Adeniya

Founder - Cell and Gene Council

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We explore the possibilities beyond this moment, making space for growth, action, and forward momentum. As we end our time together, we honor the experience, the growth, and the connections made along the way.

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We explore the possibilities beyond this moment, making space for growth, action, and forward momentum. As we end our time together, we honor the experience, the growth, and the connections made along the way.