US biotechnology group Entelos and Swiss drug major Novartis have linked up to help make the latter’s drug discovery safer and more efficient.
In return for research and development funding, Entelos will carry out biosimulation research for across various therapy areas using its PhysioLab platforms, which predict the effects of drugs using ‘virtual’ patients, thereby helping Novartis to design better Phase III clinical trials.
Although no one is willing to go as far as saying that such a move will completely eradicate the need for the traditional method of animal testing, the PhysioLab platforms can support target evaluation and compound optimisation, as well predict adverse events and define best patient groups to assess the candidate in, thereby reducing the likelihood of dangerous adverse events.
“The pharmaceutical industry is realizing the benefits of testing targets and drugs in silico before conducting expensive clinical trials,” remarked James Karis, Entelos' Chief Executive.
Drugmakers are increasingly looking at alternatives to animal testing to try and predict the effect of drugs in man and therefore make the discovery process safer, especially in light of the recent scares such as that earlier this year at Northwick Park Hospital in London, where six clinical trial volunteers ended up in a critical condition with multiple organ failure after being administered an experimental leukaemia treatment called TGN1412.
Thankfully nobody lost their lives, but TeGenero, the firm behind the drug, has since gone bankrupt and the tragic event has thrown early-stage research into the spotlight, with many calling for an overhaul of the process to avoid this happening again.
A UK expert group set up in the wake of the TGN1412 trial says that sponsors should think carefully about the justification for using healthy volunteers in Phase I studies of new compounds.
The group's report includes 21 other recommendations regarding issues around dosing, routes and rates of administration, and intervals between dosing, and procedures to enhance safety.