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Data Discussions

The Pistoia Alliance – a global not-for-profit working to increase collaboration in life sciences R&D – has created a new In Vitro Pharmacology Working Group, which will include liaisons from the FDA’s CDER, as well as representatives from biopharma companies, CROS, and more. The aim? To help standardize in vitro pharmacology data (IVP) in regulatory submissions.

“Before now, there has not been a consistent data standard for IVP data,” says Veronique Francois-Newton, Project Manager at The Pistoia Alliance. “Data not being properly structured or not meeting the standards required by the regulatory bodies are some of the main challenges that biopharmaceutical companies face when submitting IVP data. If data are not easy to access and assess by the regulatory body, they are more likely to request additional information, slowing down the process.”

The working group will develop a data template that will include standardized descriptions of methodologies, including a repository of annotated in vitro assays. Using existing ontologies and, if necessary, developing new ones, the group hopes to provide consistency in the descriptions of in vitro assays that are both human and computer-readable. “Ultimately, this will safeguard data provenance and provide a secure audit trail,” says Francois-Newton.

The inspiration for the project came from conversations between the Pistoia Alliance and its members. “By fostering a dialogue with our membership, we are able to identify the root causes of inefficiencies in the R&D industry and work on developing solutions,” says Francois-Newton. “The industry has a shared goal of getting safe and effective therapies to patients as quickly as possible. The results obtained from IVP screening need to be submitted to the regulatory agencies for safety assessment before first-in-human studies, and also for marketing authorization applications. Thus, working together to find a system that works is the best way to overcome inefficiencies in this process.”

Companies who may be interested in contributing to this project are welcome to get involved – whether biopharmaceutical companies, CROs, technology and solution providers, and electronic laboratory notebook (ELN) developers. You don’t have to be a member of the Pistoia Alliance to participate in discussions at this stage. Those interested in getting involved should get in touch at [email protected].

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