Andreas Persidis, CEO
Adverse Events and Side Effects (AESEs) are the risk element of the benefit/risk profile of every drug. They are an inevitable corollary of the complexity of biological systems and of our state of biological knowledge. They reflect the fact that we do not know exactly how biological systems work and interact, we do not know exactly how each disease modifies the “healthy state” of organisms, nor are we 100% sure how our drugs work within our bodies.
AESEs are a necessary inconvenience in our efforts to cure patients or increase their quality of life. They are also however “bad for business” since in the extreme case they can cause death, impact the reputation of pharmaceutical companies and decrease the potential market of any given drug. As a result AESEs are being treated by pharmaceutical companies with significant concern.
It is not that the industry does not wish to find a solution or be able to predict AESEs and take action proactively. Once again it has to do with the state of our knowledge and the fact that one is attempting to predict a negative event; in other words an AESE is not “acknowledged” until it actually occurs and so if a predicted AESE does not happen within a certain timeframe, this does not mean that it may not happen in some subsequent time period. Moreover, acting on AESEs proactively can be a very expensive proposition since it may cause a pharmaceutical company to spend large amounts of additional development funds to allay regulatory fears of a predicted SE that may never materialize.
Undue burden (loosely defined as “anything creating significant difficulty and/or expense to meet all aspects of some obligation”) is a legal concept that captures this possibility and provides pharmaceutical companies with a basis to refuse additional tests (suggested or demanded for example by the regulatory authorities) after a certain number have been carried out or to carry them out in the first place, if the prediction itself is not “sufficiently justified”. So this brings us full circle back to the necessity for a technical ability that predicts AESEs with sufficient confidence to justify the undertaking of additional expensive development work pro-actively.
Recently, Biovista’s COSS platform was used to predict risk factors in diabetes which have subsequently been confirmed in patient claims records belonging to Clalit, the biggest health insurance provider in Israel. This work, together with a collaboration with the University of Saarland through the p-medicine EU project is a significant step in the direction of presenting a technological capability that is capable of predicting AESEs with sufficient confidence for the these predictions to be “actionable” by the regulatory authorities and the pharmaceutical companies.
It is by no means the end of this very hard road but it is a first step in the right direction, that puts AESEs in a different light and removes some of the suspicion with which they are treated by the industry. It is also important because AESEs can be exploited by pharmaceutical companies and other stakeholders in a positive way. Rather than shying away from them, sponsors can use insights on AESEs to help optimize clinical trials and identify factors that can be used to meaningfully differentiate one drug from its competitors. In the emerging healthcare environment where the need to bring down costs and provide true value for money become paramount, we expect to see the demand for action in this respect increases significantly.