It seems that every part of the drug development and manufacturing process is moving toward automation, often improving processing speeds and information accuracy. Continuing this trend of increased automation is French company, Biocellvia, which provides intelligent, automated image analysis that identifies and evaluates candidate drug molecules for preclinical disease models.
Pharmaceutical Processing spoke with Olivier Julé, CEO and co-founder of Biocellvia about how this technology drastically speeds up drug discovery and development while ensuring accuracy.
Preclinical trials is where a drug’s efficacy is first determined, making this early stage of the process vital. Traditionally, a candidate molecule is evaluated using the scoring method, which relies on visual assessments made by pathologists. However, scores have been known to vary among pathologists, calling into question the accuracy and reliability of the scoring method. Additionally, according to Julé, the traditional scoring method can take about six weeks to complete.
Julé told Pharmaceutical Processing about the risks associated with visual assessments, explaining that “visual assessment takes time away from pathologists who can be concentrating on higher value tasks. Human intervention also brings subjectivity and variability. This is a well-known challenge in the field. For example, pathologists realize manual annotations on sections, or manual sweeping and each of these can result in errors. We want to reduce human intervention in order to reduce variability.”
Preclinical trials are time and labor consuming and can provide only limited accuracy, a fact even more problematic when the odds of discovering a drug compound that will make it all the way through to approval are on average one in 5,000.
“Biocellvia’s digital image analysis brings accuracy, reliability, and reproducibility thanks to quantitative and morphometric robust and objective data,” Julé claims. “Our technology is a smart decision-making tool that tells us if we should move forward with the study of the lead molecules from preclinical stage to clinical stage.”
Furthermore, the fully-automated technology can provide this information in 48 hours, compared to the nearly month and half it takes when using the traditional scoring method. The imaging technology can analyze approximately 100 images per hour.
Drug discovery and development are expensive and contribute significantly to the high drugs prices that plague U.S. patients across the country. Technologies like the one developed by Biocellvia have the potential to lower back end drug development costs, and possibly pass those cost reductions along to patients.
In collaboration with Boehringer Ingelheim, Biocellvia created a program dedicated to pulmonary fibrosis, publishing a scientific paper on the findings. Following this development, the company created programs for respiratory diseases and NASH (liver fibrosis). Julé says the company is currently developing image analysis programs dedicated to oncology.