Rationale
90% of drugs fail overall in clinical development and 30% of drug failures are due to unmanageable toxicity or side effects1,2. Industry practice designed to anticipate these observations are limited.
TransCelerate is uniquely positioned to advance a Translational Safety solution that drives value for key stakeholders by improving the use of historical data to increase patient safety, reduce cycle times, promote sustainability and advance science.
The desired outcome is to bring therapies to patients faster. Achieved through improved decision making around compound toxicity and focused use of resources.
1. Mullard, A. Parsing clinical success rates. Nat Rev Drug Discov 15, 447 (2016). https://doi.org/10.1038/nrd.2016.136
2. Harrison, R. Phase II and phase III failures: 2013–2015. Nat Rev Drug Discov 15, 817–818 (2016). https://doi.org/10.1038/nrd.2016.184
Benefits
Patient Safety
- Reduce the patient burden of participating in clinical trials
- Strengthen the overall patient experience
- Optimize public health outcomes
Attrition Rate Improvement
- Enhance the data-driven approach to identifying safety concerns earlier in the development process to preclude costly late-stage failure or delays
- Promote agile allocation of resources to accelerate the delivery of safe and effective therapies to patients
Sustainability
- Optimize R&D resources to promote reusability and reliability
- Reduce animal usage and stimulate non-animal methods
Advancing Science
- Introduce a new paradigm that leverages the aggregation of data within a proven data-sharing platform to support the development of novel translational safety models to improve drug safety profiles throughout the drug development process
- Leverage industry expertise to realize harmonized models that instill confidence and trust in all stakeholders