Building and strengthening a culture of quality and continuous improvement Ensuring accountability and ownership of quality practices at all levels Partnering with the business to deliver quality as a strategic value driver Enhancing agility by leveraging innovation and risk-based quality management approaches, while maintaining global regulatory compliance

Building agility into facility design and planning to meet evolving capacity needs Making informed decisions on internal vs. external manufacturing for complex modalities Best practices for de-risking capital investments in a fast-changing regulatory and commercial environment Leveraging modular and single-use technologies to accelerate timelines and reduce cost

Autologous Cell Therapy Manufacturing – Current and Future Using Cell biology to drive adaptive manufacturing Automation for both Process and QC Vector Manufacturing Operations and TAT

The Four Failure Patterns that compound to create systematic execution breakdown in 70-80% of organizations The Behavioral Architecture that explains why initiatives fail despite capable people and sound strategies A practical Diagnostic Framework leaders can use immediately to pinpoint barriers and design targeted, high-impact interventions

Biotech organizations are under increasing pressure to scale. Yet many remain stuck in siloed planning, making it difficult to scale across lab, manufacturing, and commercial operations. What works in early-stage development often breaks down as volumes increase, modalities diversify, and patient-centric models become the norm. This session explores why scaling planning in biotech is uniquely complex, starting in the lab…

Execution speed improves when continuity replaces handoffs, keeping the same team from startup through C&Q to reduce rework and delays MC readiness—not paperwork—must be the true gate to qualification, ensuring systems, utilities, and vendors are genuinely prepared Early integration of startup, QA, and suppliers enables parallel execution, minimizing late‑stage surprises and deviations A risk‑based, streamlined C&Q model delivers predictable outcomes,…

Demonstrating an integrated AI and synthetic biology platform that routinely achieves high clonal titers across antibody modalities, from mAbs to complex multispecifics Highlighting model-guided process development using a hybrid AI/mechanistic model to drive improved performance Case studies spanning vector design, cell line development, and bioprocess optimization showing how computational methods reduce empirical iteration and accelerate manufacturing readiness

Partnering for success: Selecting and managing CDMOs with ADC capabilities Mitigating risk in sourcing high-potency payloads and linker chemistries Coordinating upstream biologics and small molecule manufacturing timelines Ensuring compliance and safety in handling and transport of cytotoxic components Aligning supply strategy with clinical and commercial goals for ADC programs