A risk-benefit assessment framework for new drugs is a must for Pharmas, a leading industry expert told attendees at BIO 2012 in Boston.
Centre for Innovation in Regulatory Science (CIRS) executive director Lawrence Liberti said efforts like COBRA, the EMA's PROACT-URL and PhRMA's BRAT would establish a transparent risk-benefit analysis process, improve communication between stakeholders and help R&D teams make better candidate development decisions.
"When you have a process that allows you to clearly identify what the benefits and risks associated with a particular product are it forces you [the regulator] to think about analysis in a consistent way and allows you to communicate that information in a consistent manner.
"This is becoming critically improtant for decision makers - not only regulators and sponsors, regulators and patients and society in general - but those involved in R&D" he explained, adding "if you use a consistent approach... you can develop a profile that then becomes your tool to explain why development of the product should continue or not continue."
Cross border collaboration
Liberti also suggested clearer benefit-risk analysis would allow resource constrained agencies to share the review burden, citing CIRS' COBRA collaboration with Swissmedic, Health Canada, HSA Singapore, and TGA Australia as an example of the approach.
"These four regulatory agencies - with CIRS- have worked for the last four years to develop a model that would allow them to use a consistent approach to benefit risk assessment...that could help them with work sharing...maybe they can take the best expertise from across those agencies and have a shared review."
The project has completed proof-of-concept Liberti continued, adding that the CIRS and a number of Asia regulators have also developed a similar programme - Southeast Asia Benefit Risk Evaluation (SABRE) - which is due to be proposed at regional conference next month.