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The growing need to optimize the cost-effectiveness of drug safety testing was a major discussion topic at last week’s Drug Discovery and Development conference in Boston, sponsored by IBC Life Sciences.
As drug development costs hover around $1 billion per medicine, and the feds toughen guidelines for drug approval, maximizing the value of toxicity testing becomes ever more important, attendees said.
Several local firms were on hand to discuss strategies for deciding when to test, how much to test and how testing should guide the selection of which drug targets to bring forward.
Rory Curtis, Elixir Pharmaceuticals Inc. director of research, said the company uses a variety of cardiac testing models to determine the potential cardiac risks to patients. The simplest tests for cardiac toxicity can cost $1,000 per sample, while the most expensive ones can cost upwards of $10,000 for each sample, Curtis said.
“There’s no formula for how much toxicity testing should be done early. Some companies don’t do any testing early because they are focused first on determining the efficacy of the drug,” Curtis said.
Guidance from the U.S. Food and Drug Administration is often murky. The regulatory agency mandates just one cardiac toxicity study, for instance. Aside from that test, it’s up to the company to decide how many additional tests are necessary.
It often depends on what disease the potential drug seeks to treat. Drug targets geared toward the most deadly diseases, such as pancreatic cancer, can generally be approved with more serious side effects because the alternative for the patient is likely death. But Vivek Kadambi, senior director of drug safety at Millennium Pharmaceuticals Inc., says that as medicines get better at treating cancer, patients live longer, and cumulative side effects become much more serious. The safety bar for oncology drugs, Kadambi says, is going up.
The bar is highest for so-called incremental drugs — such as the next drug to treat high cholesterol. The FDA is looking for a new drug in an established class to have an improved risk profile.
It is of huge value to companies such as Millennium and Elixir to have access to better, more precise tests for toxicity, and local researchers are working on this. Bridget Wagner, group leader in the chemical biology program at the Cambridge-based Broad Institute, presented data at the conference that measures the effects of many different marketed drugs on mitochondria in mouse muscle models.
The researchers found a pattern. Several cholesterol drugs, called statins, created mitochondrial toxicity. Wagner believes that this toxicity may be responsible for the myopathy, or muscle weakness, that is a side effect of some statins.
Wagner says the model might be used to predict which new drug candidates could cause myopathy. She and the other researchers are filing a patent on the testing model and it could potentially be bought by a biotech company somewhere down the road.
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