Formula One solved twenty years ago what clinical trials are still working on: designing the pressure out before the lights go on. This talk explores what we can learn from the fastest teams on earth, how our industry can adjust and how those lessons apply to cell and gene therapy in neuroscience and rare disease.
- Live data, live decisions: moving from retrospective reporting to real-time operational intelligence so enrollment, safety and site performance data can guide decisions while they still make a difference.
- Designed handovers, not heroic firefighting: rehearsing the sequence across regulatory, contracts, drug supply and training before the study starts so site activation becomes fast, predictable and scalable across regions.
- Adaptive by default, efficient by design: treating adaptability and cost discipline as one engineering problem rather than a trade-off in cell and gene therapy for neuroscience and rare disease where every patient counts.
China has become a major source of biopharma innovation, clinical assets, and evidence. For global sponsors, the practical question is where China can add value to a program, what limitations need to be considered, and what it takes for China-generated evidence to support development decisions in other regions.
Drawing on recent discussions with biotech and pharma leaders in China and the United States, this session will offer a sponsor-side framework for:
- Understanding the sources of China’s development speed and how much the potential advantage depends on the asset, indication and development stage
- Determining where China can add value in a global program: as a location for clinical development, a source of assets and evidence, or a strategic partner
- Examining the factors that shape EMA and FDA assessments of China-generated evidence, including patient population, dose and exposure, standard of care, comparators, treatment sequencing and data integrity
- Choosing the next development step: using the existing package, adding a focused bridging component, or designing a multiregional clinical trial
- Defining the clinical, CMC, quality, and data governance requirements for a cross-regional program
Taking control of development to accelerate proof of concept and maximize value.
- Is your strategy accelerating development—or delaying it? Align regulatory and operational planning from day one
- Your sites can make or break your timeline
- Case study: Spend less. Move faster. Prove more
Backgrounds, challenges and how Toyota FS responded
- State of Norway’s long term “transportation plan”
- Disruption by definition
- Changing consumer behaviours
- Impacts to an established captive business model
- How Toyota FS transposed their Leasing DNA into the new BEV age
