Why is this important?
In vitro Pharmacology screening is performed extensively in the drug discovery process before IND (Investigational New Drug) applications for the best drug candidates are submitted to the FDA and regulatory bodies who assess their safety. These requirements are important for drug candidates to move into preclinical and clinical development. Due to the lack of standards, data input, reporting, and submission done through multiple applications, each with its own data formats, significant inconsistencies with regulatory submissions are observed. Moreover, the data submitted are non-findable, non-exportable, and with minimal reusability.
Using the Pistoia Alliance’s framework for collaboration, organizations including pharmaceutical companies, Clinical Research Organisations (CROs), technology platforms and eLN providers, and regulatory bodies can work together in a shared model to develop data standards for in vitro bioassays. Moreover, the data structure will use new or existing ontologies for the description of common assays, target genes or proteins, providing more consistency with regulatory submissions and enabling faster reviews, more effective analysis, and interpretations by regulatory agencies, leading to deeper insights that result in better decision making. Accelerated regulatory submissions will help ensure that new therapies reach patients as quickly as possible.
What will the project achieve?
Two themes will be discussed:
- A “What” theme: where the data content that needs to be collected and transmitted along the chain from CRO-to-Pharma-to-Regulators will be discussed
- A “How” theme: where data formats and transmission methods will be discussed
The resulting deliverables will include:
- Creation of a pilot template for safety pharmacology
- Devize or amend an ontology to incorporate standardized terminology into template
- Devizing a repository of in vitro bioassays
- Incorporate the full scope of bioassays into the ontology and submission template
- Widening the scope of the template for other safety pharmacology
Ready to Get Involved?
There has never been a more important time to collaborate to innovate as an industry! If you would like to find out more about the benefits of Pistoia Alliance membership and how you can get involved with all the different initiatives we run, please send an email to Membership@PistoiaAlliance.org.