Pistoia Alliance and FDA collaborate to accelerate regulatory submissions
Pistoia Alliance, a global not-for-profit that advocates for greater collaboration in life sciences R&D, has announced the creation of a new In Vitro Pharmacology Working Group. The mission of the group is to improve the data structures and standards for in vitro pharmacology (IVP) data in regulatory submissions, to enable faster reviews and interpretations of submissions and ensure new therapies reach patients as quickly as possible.
Key highlights:
- The Pistoia Alliance has formed a new In Vitro Pharmacology Working Group with a mission to improve regulatory submissions and enable a faster reviewing process.
- The group was formed in collaboration with the US FDA, biopharma companies, CROs and regulatory agencies to ensure a consistent data structure across all stakeholders.
- The data template from the IVP will include detailed and standardised descriptions of in vitro methodologies used for investigational drug safety characterisation.
The group will include liaisons from the US Food and Drug Administration’s Center for Drug Evaluation and Research, as well as representatives from biopharmaceutical companies, contract research organisations (CROs), technology suppliers and regulatory agencies.
The working group will create a shared data structure based on FAIR principles to ensure data consistency in IVP screening across all stakeholders. Companies carry out extensive IVP screening throughout the drug discovery process to support Investigational New Drug Applications (IND) that are submitted to the FDA, which then assesses the drug candidate’s safety before a candidate moves to the next stage of development and into clinical testing.
The current lack of consistent standards around data input, reporting and submission is a common challenge that causes significant inconsistencies in regulatory submissions and limits the accessibility and interoperability of the data.
“The aim of everyone involved in the drug development ecosystem is to get the most safe and efficacious therapies to patients in the shortest possible time. By working collaboratively, biopharmaceutical companies, CROs, technology suppliers and regulatory agencies can accelerate the timeline by standardising how IVP data is reported. Working together also reduces the cost and time burden of individually developing solutions to a shared problem,” commented Veronique Francois, project manager, Pistoia Alliance.
“The Alliance’s experience in bringing together experts to solve common challenges, alongside our formal framework for collaboration, empowers members to cooperate on initiatives that are driving change at the highest levels. We are keen to hear from both members and non-members interested in contributing to this collaborative community of interest and encourage them to get in touch.”
The data template that the IVP working group develops will include detailed and standardised descriptions of in vitro methodologies used for investigational drug safety characterisation, alongside a repository of annotated in vitro assay methods. The data structure will utilise new or existing ontologies for the description of common assays to provide greater consistency in regulatory submissions.
By employing a common standard, data outputs will also be computer readable. This safeguards the provenance of data and provides a secure audit trail, as well as enabling more effective data analysis to support better decision-making.
The Pistoia Alliance is calling on members and non-members– including biopharmaceutical companies, CROs, technology and solution providers, and electronic laboratory notebook (ELN) developers – who are interested in contributing to help establish new standards to get involved.