Soon, C-Path’s commitment to Europe and European organizations will be solidified, as the plan for a C-Path subsidiary in Ireland evolves. As its parent organization does in the U.S., Critical Path Institute (Ireland) will form consortia of scientists and clinicians from the biopharmaceutical industry, governmental regulatory agencies, academic institutions, and patient groups. These consortia will work on novel methodologies, submit them to European regulatory agencies for approval, and make them available to the broader community.
Novel methodologies include:
- Biomarkers to identify which patients are most likely to benefit from a specific treatment or to better determine which new therapies might be harmful to patients
- Clinical outcome assessment instruments to better assess the efficacy of new therapies
- Computer models to determine how diseases progress and ascertain why some patients progress faster than others
- Clinical trial simulation tools to aid in designing clinical trials, to ensure that they have the right number of patients enrolled and that the trial is the right duration
- Data standards to help expedite the review of new drug applications and facilitate the aggregation of data from multiple clinical trials.
- Databases of standardized and aggregated clinical trials, to serve as a resource for researchers to better understand variability on patients
- Master clinical trial protocols to standardize and optimize the design and conduct of clinical trials
- Novel approaches to the challenges of conducting trials in the neonatal population, especially premature babies
Critical Path Institute (Ireland)’s objectives are to:
- Accelerate the development of new therapies to patients who suffer from a wide range of diseases and other medical conditions.
- Enable faster regulatory review of new therapies by government agencies like the European Medicines Agency.
- Reduce the risk and cost of medical product development to enable new drugs to be less expensive.
- Collaborate with other organizations to resolve difficult issues in the field of drug development that no one organization can do alone.