A third of drug-development costs comes from patient studies. Novartis wants to make them cheaper.
Discoveries of new cancer-fighting and antiviral medicines grab headlines and sometimes win Nobel Prizes. But after the breakthroughs and backslapping are over, Big Pharma’s grunt work is just beginning.
Companies carry out years of costly studies to prove treatments are safe and effective: finding hospitals and clinics to participate, hunting down patients who fit precise descriptions, tracking their health in minute detail for years while ensuring they take their medications, and then combing through heaps of data that will determine whether doctors can prescribe them. It’s the unsexy side of the industry, and it’s a big reason it can take more than $2 billion and 12 years to launch a new treatment.
Drugmakers “do an excellent job of drug discovery,” says Justin Hoss, a consultant at KPMG who specializes in technology and life sciences. “Then they get to a point of doing clinical trials, and it’s a big bottleneck. The faster they get people through clinical trials, the faster they’re going to know whether their investment was worth it or not.”
Pharmaceutical products have a limited time under exclusive patents, and the majority of drugs undergo delays during human testing. French drugmaker Sanofi estimates that as many as 7 out of 10 trials are hit by enrollment snags. Every extra week getting to market subtracts about $300,000 from sales before cheaper copies emerge, according to TriNetX Inc., a Cambridge, Mass.-based company that helps drugmakers speed up trials. Stung by such setbacks and feeling pricing heat from insurers and health systems, companies from Novartis AG to Sanofi to AstraZeneca Plc are turning a microscope on the efficiency of their drug trials. The area is “completely ripe for disruption,” Hoss says.
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