Every year thousands of new drugs are developed and must undergo preclinical safety studies before clinical trials in man. Significantly, 1 in 4 compounds fail during this important evaluation stage, preventing significant side effects and adverse events in patients. These studies are primarily performed in animals (mostly rodents) due to the complexity of drug/ compound metabolism in humans and are evaluated by highly experienced toxicologist pathologists, who undergo a minimum of 10 years of training. However, there is a skills gap crisis looming due to reducing numbers of experienced pathologists, which is projected to get worse over the next decade, which could delay new drug development.
This project is focused on addressing this major challenge in toxicology pathology, to drive digitisation and efficiencies into the toxicology pathology arena. This PATH-TOX project is led by Janssen R&D and Deciphex Ltd, an Irish SME who developed the technology, in collaboration with PDS, a Swiss-based SME. This PATHTOX project has brought together a multidisciplinary team, essentially to digitise the microscopic analysis of tissues derived from drug safety studies, to drive efficiencies in the system.
In this PATHTOX project, we intended create an innovative pathology Computer-Aided Diagnosis (CADX) system called ‘PATHOLYTIX-PRECLINICAL’ to analyse organs for the presence of toxicity. The system uses Artificial Intelligence (AI) to identify normal/abnormal organs, prioritising abnormal organs for review. Benefits include streamlining workflow to enhance productivity and efficiency for users, saving time for pathologists in whole slide imaging review, slide sharing and expediting drug safety analysis for clinical trials.
At the start of this project, Deciphex had prototype AI technology and required the support of key partners to fast-track the development of the PATHOLYTIX system. Specifically, this project enabled:
- Access to proprietary drug studies samples from Janssen Pharmaceutical, which is vital for the development and validation of AI algorithms.
- Integration with laboratory information management systems (LIMS) which holds treatment/organ/slide information, specifically PDS LIMS platform software called Ascentos and its pathology module Pathdata.
- Accommodate the multi-layered IT security systems in Pharma/CROs, in order to validate the system on-site.
The aim was to design the system based on feedback from pathology users, continuous technology development and validation, in collaboration with partners. This was also be supported by a comprehensive commercialisation, dissemination, and IP plan, to ensure the successful commercialisation of the product.
