What delivers.
What sustains.

09:00

Chair's opening · confirmed

What the vector must survive.

CGTI opens on the manufacturing question, not the science question. The biology is extraordinary. The process is fragile. The distance between a successful vector and a patient who needs it is measured in manufacturing decisions — yield, purity, scalability, consistency at doses the clinical trial never required. The room is here because those decisions are being made now, under pressure, often before the consequence is fully visible.

09:30

Opening Keynote · confirmed · 45 min

Scaling cell therapy from clinical exception to standard of care.

Cell therapy has achieved what was once considered impossible — durable remission in diseases that had no answer. The manufacturing question is now the access question. At Bristol Myers Squibb, Thomas Potgieter has led the operations that turned clinical-scale cell therapy into commercial reality — not as a pilot, but at the volumes where patient access is determined by whether the manufacturing system holds. This session examines what that transition actually required: the process decisions, the infrastructure investments and the manufacturing discipline that separates a therapy that reaches patients from one that remains a promise.

• What commercial-scale cell therapy manufacturing actually required — the process architecture, quality systems and operational decisions that held under the transition from clinical to commercial volumes
• Where the field is structurally exposed — the capacity and process decisions being made now that will determine patient access in 2028 and beyond
• The decisions that compound from early manufacturing choices — the platform, vector and process commitments that cannot be easily unwound at commercial scale

11:00

Keynote · Joint · BILS + CGTI · confirmed · 40 min

The decision you rarely revisit — but always pay for.

Platform selection is the decision that compounds. In biologics manufacturing it determines process fit, scale-up trajectory, regulatory strategy and CDMO relationship architecture for the life of the programme. In cell and gene therapy it is made earlier, under clinical pressure, before commercial consequences are visible — and the error cost is higher. The BILS room has made this decision and operates its consequences. The CGTI room is making it now. Dénes Zalai has seen it made across both modalities from the CDMO side — what the organisations that got it right did, and what the ones that did not had in common. This is the one session where the corridors converge.

• The platform decision most organisations make once — what the ones that got it right did differently, and what the pattern looks like across modalities from the CDMO vantage point
• What the cell and gene therapy room is deciding now that the biologics room already knows — where the lessons transfer and where the biology makes them irrelevant
• The operational, regulatory and commercial consequences that compound from this decision — the ones that are invisible at the time and expensive to unwind later

12:00

Keynote · confirmed · 45 min

From the gene edit. Through the programme. To the patient.

The CGT portfolio management decision is not a scientific decision alone. It is a manufacturing decision, a regulatory decision and a patient access decision made simultaneously — often before the full consequence of each is visible. At Novartis, Angela Vollstedt has managed the global portfolio of cell and gene therapy programmes at the intersection of all three. The question this session examines is not which therapy is most promising, but which manufacturing decisions determine whether the promising ones reach the patients who need them.

• Portfolio decisions as manufacturing decisions — how the choice between programmes is constrained by what the manufacturing infrastructure can hold, not only by what the science can deliver
• Where CGT portfolio management diverges from biologics — the process fragility, regulatory novelty and patient urgency that make the decision architecture fundamentally different
• What the field has learned about programme-to-commercial transition — the decisions that hold, the ones that compound and the gap between clinical success and manufacturing readiness

14:00

Partner session · Asahi Kasei · confirmed · 30 min

Viral safety as process design.

Viral safety clearance is not a compliance event appended to the manufacturing process. It is an engineering decision made at the beginning of it — or it becomes a risk at the end. This session addresses the process design choices that make viral clearance reliable at commercial scale. Asahi Kasei brings operational authority in membrane-based viral filtration and clearance validation — from the plant floor, not from a regulatory text.

• Where current practice leaves clearance gaps — and how integrated process design eliminates them before the regulator asks
• What a viral safety architecture looks like when it is built in, not appended — the engineering decisions that determine reliability at scale
• The organisations that treat clearance as a terminal documentation step versus the ones that design for it upstream: what the difference looks like in practice

15:00

Panel · 50 min

Vector purity at scale: what downstream actually requires.

Viral vector purification is where the upstream yield meets the downstream reality. Chromatography steps, ultracentrifugation, tangential flow filtration — the sequence that converts crude harvest into a releasable vector product determines potency, purity and process economics at clinical and commercial scale. The challenge in CGT is that the biological material is more fragile, the process windows are narrower and the regulatory requirements for what constitutes a pure product are still being defined. This panel examines what downstream purification actually requires in practice — not in theory.

• The real constraints in viral vector downstream processing — where the process steps that work at 50-litre scale begin to fail at 500-litre scale and what that means for commercial access
• Platform versus bespoke: where a standardised purification approach is viable and where the vector biology forces a process-specific solution
• What purity actually means for a viral vector — the analytical methods, release specifications and manufacturing decisions that determine whether the product that leaves the facility is what the patient needs

09:00

Chair's opening · confirmed

What the patient is waiting for.

Day Two opens on the patient. Not as an abstraction — as the person at the end of the manufacturing process this room spent yesterday building. The gap between the vector that leaves the facility and the patient who receives it is where every manufacturing decision in this room becomes a consequence. This session names that gap — and holds the room to it for the day that follows.

09:20

Keynote · Day Two Opening · confirmed · 35 min

The R&D decision that determines the manufacturing outcome.

The manufacturing problem in cell and gene therapy is often a research decision made too early or too late. The choice of vector platform, the gene editing approach, the cell source and the ex vivo process design all carry manufacturing consequences that are not fully visible at the R&D stage — and are very expensive to unwind at the clinical stage. Harsukh Parmar has led global research and early development at the scale where those decisions are made and where their consequences are first encountered. This session examines the R&D to manufacturing handoff — the moment where the science becomes the process.

• The research decisions that constrain manufacturing — vector platform, gene editing modality, cell source and process design choices made in R&D that the manufacturing organisation then has to hold
• Where the R&D to manufacturing handoff breaks down — the assumptions that carry across and the ones that do not survive contact with the process at scale
• What the field needs to do differently in early development to make commercial manufacturing viable — the design-for-manufacture discipline that CGT has not yet fully established

14:00

Plenary · confirmed · 40 min

The CDMO relationship in advanced therapies.

In cell and gene therapy, the CDMO relationship is more structurally consequential than in any other modality. The biological material is often patient-specific. The process knowledge is frequently held by the CDMO, not the sponsor. The regulatory obligations sit with the sponsor regardless. When the manufacturing relationship is under pressure — a failed batch, a capacity constraint, a quality event — the accountability question in CGT is not just commercial. It is clinical. Christina Salado-Manzano has managed advanced therapy programmes at the point where the sponsor-CDMO relationship meets the patient who is waiting.

• What the CDMO relationship in CGT actually requires — the process knowledge transfer, the quality oversight and the accountability architecture that makes it viable when the stakes are highest
• Where the CGT sponsor-CDMO relationship breaks down — the failure modes that are unique to advanced therapies and that cannot be managed with the accountability frameworks the industry built for biologics
• What the next generation of CGT CDMO partnership must contain — the operational, technical, regulatory and human dimensions of shared accountability for a therapy where the patient is the process

14:45

Keynote · confirmed · 30 min

What operations learns that R&D never sees.

The operational reality of cell therapy manufacturing at commercial scale is still being written. Most organisations have not yet run enough commercial batches to know where their process truly holds and where it does not. At Bristol Myers Squibb, Nicole Costa has led the operations that are writing that reality now — at the interface between development decisions and the manufacturing consequences that follow. This session brings the operational view that only exists inside an organisation that has actually run commercial cell therapy at scale.

• What commercial cell therapy manufacturing reveals about the process — the failure modes, the surprises and the operational decisions that only become visible when you are running at scale
• The gap between clinical-scale process development and commercial manufacturing reality — what transfers, what does not and what the field needs to design for earlier
• What the organisations that are running commercial cell therapy now know that the rest of the field does not yet — and what that knowledge means for the decisions this room is making today

16:00

Joint close · Chair · 20 min · no slide deck

What both rooms share.

The joint close does not merge the two forums. It names what they share. The biologics manufacturer and the gene therapy operator work in different processes with different biology. They are accountable to the same outcome.

From bioreactor to release. From vector to vein.

16:45

Forum close · confirmed · 15 min

The platform decision the CGT field keeps making twice.

Two days. Every session in this room — vector manufacturing, process platform, R&D to manufacturing handoff, downstream purification, CDMO accountability, operational scale, patient-specific process intelligence — traced back to one decision made earlier than most organisations realised was a decision. Platform. In CGT the cost of making it twice is not measured in capital alone — it is measured in patients who wait longer. Dénes Zalai has sat on the CDMO side of that decision across both biologics and advanced therapy programmes. His fifteen minutes will not summarise the forum. They will name the pattern behind it.

Format: 10 min · one opening frame · no deck · Chatham House · witness authority from across client programmes · not a product pitch · closes CGTI 2027