LAC seamlessly bridges for you clinical pharmacology, regulatory science, and pharmacometrics expertise, for generic or new products, drugs or biologics.
The name “Learn and Confirm” is a tribute to the great Lewis B. Sheiner, MD (1940-2004) who published the following manuscript in 1997:
Sheiner LB. Learning versus confirming in clinical drug development. Clin Pharmacol Ther 1997 Mar; 61(3): 275-91.
In his seminal paper, Professor Sheiner described concepts which were innovative at the time and are now widely accepted. At the heart of his proposal was the idea that the drug development process should not only allow researchers to demonstrate a product’s safety and efficacy, but that knowledge could be enriched at every step of the process. In other words, every piece of information gleaned throughout drug development provides an opportunity to improve our understanding.
At Learn and Confirm Inc., we wholeheartedly embrace this philosophy and believe in maximizing prior knowledge while incorporating new information as it becomes available in order to optimize the drug development process.
Our approach in the drug development process is based on maximizing our knowledge, modeling, simulations and predicting clinical trial results, rather than being reactive once results become available.