Nick Kenny, PhD, Chief Scientific Officer at Syntheos Health discusses his company’s efforts to streamline data management for clinical trials, including the need to determine the value that a new drug will have on the health care system.
Dr. Kenny said, “Syntheos Health is about a 24,000-person organization, globally. And we’re uniquely suited to not just to deliver clinical trials and regulatory quality data for drug approval, but also to bring in the commercial aspects of drugs so things like real world evidence access to patient and payer information and really try to create that full value package for a molecule so that it’s not just a drug – it’s actually going to have the opportunity to get to the patient.”
“We have to recognize that different groups – payers, healthcare authorities, etc – all have different data needs and for us to be able to wrap those different data needs around the core of the clinical data set is becoming increasingly important,” said Dr. Kenny, adding, “it’s a tremendously exciting time that to be able to bring all of those services together under one umbrella. It’s no longer good enough for most drugs simply to have a great clinical package. We really need to understand what the true value of that drug is to a patient.”
Regarding the ‘Value’ the drug, Dr. Kenny noted that it is important to know, using data that can be collected, that a new drug will change how other aspects of a patient’s care will (or will not) change. For example, the recently approved gene therapy for spinal muscular atrophy has a price tag of approximately $2 million.
“When we think about gene therapies which have very different curative intents compared to perhaps oral agents that you might be giving repeatedly and you’re sort of either delaying or adding into standards of care – so how do we think of the value of something that may remove multiple healthcare costs”” asked Dr. Kenny.
“We really should be more focused on the actual value to the patient and removal of healthcare costs and not so much on just what is the cost of the drug,” stated Dr. Kenny.