In-Vitro Pharmacology Working Group
Draft Title: Preclinical Pharmacology Data Standards Project Date: June 29th 2021
Who to Contact: project manager veronique.francois@pistoiaalliance.org; projectenquiries@pistoiaalliance.org
Problem Statement
Nearly every active substance, predominant metabolites and some impurities submitted in either INDs (investigational new drug applications) and NDAs (new drug applications) undergo a battery of in-vitro assays that are essential for predicting the potential efficacy and safety of a given substance. Many substances are also screened against a large number of receptors and enzymes that may or may not be related to the intended therapeutic effect or serious safety concerns. Advances in automation (high throughput screening), genetics, molecular biology and biochemistry have resulted in dramatic increases in the amount of in-vitro assay data submitted in regulatory applications. The amount of this type of data will continue to increase and is often essential in the design of clinical trials, using medicines in a more personalized manner and for avoiding serious adverse events. Although some pharmaceutical companies generate their own in-vitro preclinical pharmacology data, a very significant amount of data is generated by CROs (contract research organisations) with extensive experience in developing and using these bioassays. Unfortunately, the current electronic Common Technical Document (eCTD) does not structure or standardize this information in a manner that facilitates further analysis and reuse. The development of data standards that provide a common ontology and guidance for structuring this information will provide a significant benefit to both industry and regulators.
Value Statement.
Establish a Pistoia Alliance cross-company project team to develop data standards for in-vitro bioassays. The data standards will enable collaboration and sharing of data both during the experimental workflow and beyond. Instead of data being misinterpreted, the data standards will provide a mechanism to ensure consistency and clarity of meaning, allowing far greater value and reuse of data. Development of standards will have key benefits:
For biopharma
Submissions can be reviewed faster by regulators
Limited pre and post marketing requirements
Defined ontologies will enable better data reuse, interpretation and understanding
For CROs:
Standardised format to share data with biopharma and regulators will improve efficiency
Data can be structured in Electronic Lab Notebooks (eLNs) enabling more efficient search & analysis
Defined ontologies will enable better data reuse, interpretation and understanding
For Regulators:
Streamlined data ingestion into G-SRS to enable faster review and interpretation of pre-clinical pharmacology data submissions
The ability to review across different application
Organization of in-vitro data from INDs allows better evaluation of clinical studies
For technology platforms supporting the global emerging dossier:
Clear data standards for information within the eCTD structure
For eLN providers
Beneficial as standard allows for an eLN to be organized in a standards-based manner which will add value to the end user community