A new In Vitro Pharmacology Working Group to accelerate regulatory submissions has been created by the Pistoia Alliance, a global advocate for greater collaboration in life sciences R&D.
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 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 ensure new therapies reach patients as quickly as possible.
It is hoped that a new shared data structure will address the current lack of consistent standards around data input, reporting and submission.
“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,” commented Veronique Francois, Project Manager, Pistoia Alliance.
“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.”
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.
The Pistoia Alliance is calling on those who are interested in contributing to help establish new standards to get involved. Any interested party should contact the Pistoia Alliance via: projectInquiry@pistoiaalliance.org.
