In Vitro Pharmacology

Project Charter

The goal of the In Vitro Pharmacology cross-industry project is to develop an open-shared data template that couples the detailed and standardized description of the in vitro methodologies used for investigational drug safety characterization with a repository of annotated in vitro assay methods.

Aishwarya Balajee, Head Scientific Data & Digital Transformation, Zifo

New: IVP Assay Repository Now Live

The IVP Assay Repository — an important deliverable and milestone of the In Vitro Pharmacology project — is now live and we ask for community feedback!

Developed through cross-industry collaboration and informed by insights from pharma companies, contract research organizations, enterprise informatics partners, and regulators, the repository standardizes how in vitro pharmacology assays are captured, shared and reused. By enabling more consistent, FAIR-aligned data, it helps reduce duplication and supports more efficient research and regulatory processes.

Watch the demo video to see how it works and contact Veronique Francois to try it for yourself.

Challenge

In vitro assays are essential for evaluating the safety and efficacy of active substances, metabolites, and impurities in IND and NDA submissions. Screening metabolic enzymes, transporters, receptors, and enzymes helps predict drug interactions, variability in response, and potential safety risks (secondary pharmacology). These studies support target specificity, safety profiling, and clinical trial readiness, and are recommended under ICH S7A guidance.

However, there is currently no consistent data standard for in vitro pharmacology (IVP). As IVP data must be shared with regulators throughout drug development, inconsistent formats, structures, and nomenclature can delay regulatory review and approval.

Solution

The IVP Working Group aims to develop standardized data formats and tools for in vitro bioassays in collaboration with regulators (including the FDA), industry, and vendors. The group brings together scientists, pharmacologists, and reviewers to establish a unified data framework based on existing ontologies for regulatory submissions.

This includes creating a repository of standardized assay descriptions linked to submission data. The outcome will be computer-readable data that improves traceability, connectivity, and analytical insight. The first release of this repository has been launched (see above).

Importance of the IVP working group

For Biopharmaceutical companies

Faster regulatory review
Reduced pre- and post-marketing requirements
Improved data reuse and interpretation

For Regulatory bodies:

Easier cross-application review
More efficient organization of IVP data

For CROs:

Standardized data exchange with industry and regulators
Improved data structuring in eLNs for search and analysis
Better data reuse and understanding

Deliverables

Standardized platform for IVP data submission during IND registration
Platform for registering in vitro assays in safety and secondary pharmacology
Expansion of ontologies and templates to cover a broader range of bioassays and safety pharmacology