THE
PROBLEM
The drug development process is very expensive and requires very long times. It is estimated that, to put a new drug on the market, are required more than $2B and 10-12 years in R&D.
MOREOVER, THIS PROCESS IS
HIGHLY INEFFICIENT
Current preclinical drug safety and efficacy evaluations are performed using basic/standard cell culture technologies and animal models, and these procedures do not guarantee a direct results translation to human beings. Traditional in vitro cell models have a reduced predictivity because of their limited suitability to reproduce a tissue-like structure.
On the other hand, animal models fail to fully guarantee the results translation to humans and their use introduces ethical concerns. Despite the costs sustained in preclinical evaluation of a new drug, more than 80% of the investigated candidate drugs fail the clinical tests, with 60% of those failures due to a limited efficacy and another 30% due to cell/organ toxicity or to difficulty in the release to targets.
FDA Modernization Act 2021
“To amend the Federal Food, Drug, and Cosmetic Act to allow manufacturers and sponsors of a drug to use alternative testing methods to animal testing to investigate the safety and effectiveness of a drug, and for other purposes”.
Micro Physiological Systems (MPSs) have been introduced in the last decade, providing the basis for preclinical assays with greater predictive power with respect to traditional cell cultures. They are believed to have the potential to revolutionize the pharmaceutical industry, providing reliable in vitro models able to replicate key structures and functions of specific human tissues, using human-derived material.
A reduction of 10-26% in R&D costs per new drug has been estimated upon full adoption of these technologies in the drug development pipeline.
TToP aims at improving the effectiveness of preclinical prediction of human responses to drugs reducing costly failures in clinical trials and minimizing the controversial use of animal models.
LEARN ABOUT OUR IDEA FOR A POSSIBLE
SOLUTION
easy to use systems.
Our products are easy to use, for everyone, with our plug and play technology.