Drugmakers are finding themselves getting into mining these days. And venture capital is taking notice.
Pharmaceutical companies have started to replace parts of clinical trials with mining medical records to speed drug approval, with the support of the U.S. Food and Drug Administration. Companies aren’t only using data mining for new drugs — they’re seeking approval for new uses for older medications.
Johnson & Johnson, Pfizer, Amgen, Roche are among the global pharma giants securing FDA approval for new drugs after submitting data-mining analysis as part of their applications. Breast cancer, bladder cancer and leukemia treatments are among the illnesses the approved drugs are designed to treat, the Wall Street Journal reports.
Pharma companies can parse hospital and doctor files where patients already took a drug to get readings including blood pressure and tumor size. Such record analysis typically take a few months, while a clinical trial might take years. It also alleviates the problem of enrolling enough patients in clinical trials for drugs targeting rare diseases.
Using medical records to replace parts of clinical trials has its critics, who argue that the idea is flawed since medical records often have errors.
“Real-world evidence should not be a means toward dropping standards, but rather a mechanism to have more efficiency in evidence generation while maintaining standards,” FDA Principal Deputy Commissioner Amy Abernethy told the WSJ in an interview.
Medical data mining’s cost and money-saving promise creates a sizable market demand. Investors have shown their appetite for startups focusing on AI-powered medical record systems since 2014, including Softbank Vision Fund’s $1.15 billion investment in Shanghai-based Ping An Medical and Healthcare Management’s series A last February.
- Venture capitalists spent $134 million in 33 deals this year, a 38% jump from last year excluding Ping An’s mega-deal. About two thirds of the companies that raised capital this year are located in the U.S., while China and Canada have five and two companies respectively, according to PitchBook data.
- Swiss drugmaker Roche Holding acquired New York-based medical database Flatiron for $1.9 billion last April. Roche got the FDA approval for its tumor drug Rozyltrek in August based on a combination of clinical trials involving 53 patients and data of 69 patients provided by Flatiron Health Analytics Database.
- The FDA also approved Johnson & Johnson’s application, which included Flatiron and Foundation data, for bladder cancer treatment Balversa in April.