THE
PROBLEM
The drug development process is extremely costly and time-consuming. Estimates suggest that launching a new drug requires over $2 billion and 10 to 12 years in R&D.
THIS PROCESS IS
HIGHLY INEFFICIENT
Current preclinical evaluations of drug safety and efficacy rely on conventional cell culture technologies and animal models, which often fail to accurately predict human responses. Furthermore, the effectiveness of traditional in vitro cell models is too limited due to their inability to mimic tissue-like structures accurately.
On the other hand, animal models do not fully ensure that results will be applicable to humans, and their use raises ethical issues. Despite the significant expenses incurred during the preclinical evaluation of a new drug, more than 80% of the investigated candidate drugs fail the clinical tests.
Among these failures, 60% are attributed to limited efficacy, while 30% result from cell/organ toxicity or challenges in
delivering the drug to its intended 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.