No more “freeloaders” in clinical development?

While “America First” is a rallying cry for supporters of President Donald Trump, one thing they don’t want to be first in is prescription drug pricing. Following up on last week’s proposal to mandate the displaying drug pricing in TV ads, the US President took aim at the pharmaceutical industry for charging more in the States as compared to other industrialized nations. He criticized those countries for freeloading on the US’s inflated prices saying, the “American middle class is effectively funding virtually all drug research and development for the entire planet.” To address this, the Department of Health and Human Services released a proposal that would tie Medicare Part B payments for medicines to the levels that other nations pay. HHS Secretary Alex Azar did note this could cause companies to stop selling some drugs in other countries… probably not a big concern for the America First crowd.

Hearts two sizes too small

No, it’s not The Grinch, but organoids are a great Christmas in July gift for the preclinical researchers in your life. Drugmakers spend tons just to get their drugs to Phase I research but could lose big if too many side effects occur in these first rounds of human trials. For instance, only 6.6% of Phase I cardiovascular INDs make it to Phase II. Wouldn’t it be nice if we could test a drug’s effects on say, a model of the human heart? Some biotech companies have recently developed the means to create 3D assays known as organoids—artificially-grown cell structures that can actually mimic organ functions instead of just the compositions of those organs (i.e. older 3D assays.) Watch out for more companies contracting their services to cut down on investment and—more importantly—patient risk.

Invented (not Made) in China, there’s a big difference

Pop quiz: When was the last time China produced a new drug for the global pharmaceutical industry? The answer: The early 1970s. The product was artemisinin and it treated malaria. Times, they are a changin’. According to a New York Times article, “20 or 30 Chinese-made drugs could seek Phase 3 trials in the United States within the next five years.”  If you think about the R&D and early clinical development needed to get ~25 compounds into Phase III, you can see that Chinese drug developers have been working hard for a while. A little perspective: Jiangsu Hengrui has the largest research budget of all Chinese drug firms, but its $180M annual outlay pales in comparison with the $7.8B Pfizer spent in 2016. True, but a journey of a thousand miles begins with a single step (and other deep thoughts from Lao-Tzu).

2. What’s plural for Novartis?

Restructuring is fun, right? Employees at Novartis are about to find out. That’s because Novartis is splitting into two business units with one focusing on oncology (Novartis Oncology) and the other focusing on just about everything else (Novartis Pharmaceuticals). The move comes as the company now has, thanks to its bringing on board GSK’s oncology assets, enough oncology assets to warrant a separate business unit. What is unclear from published reports is where within the company the split occurs. For example, are drug discovery, preclinical, clinical development, and commercial operations all aligned within a business unit or are some of these still “shared” resources between the units? Nobody likes a restructuring, not the employees and especially not service providers. Here’s hoping your Novartis rolodex is in pencil.