Info & Opinion
April 25, 2019
With news about big data, Aetna, Covance, GNS, Scrip, Quintiles, PPD, Icon, BioClinica, Merge, Medidata and GSK.
With news about FDA, CTMS, PMG Research, Inclinix, EMA, Hemofarm, Parexel and the Korea Drug Development Fund
David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
With news about Roche, Quintiles, Allscripts, Janssen, SGS, Oracle, TriReme, OpenClinica and FDA
In a new exercise in government by symbolic gesture, the Obama administration announced a plan to delay or eliminate a small number of federal regulations while simultaneously implementing thousands of new ones. Such announcements typically arrive during the doldrums of the late summer news cycle, when U.S. reporters are even more drowsy than usual. Among the newly scuttled FDA rules: a proposed regulation to have unique identifying numbers on medical devices. Here's a page of rules under review.
In the "one hand giveth, another taketh away" department, FDA is also seeking comments on a guidance document for "high quality" clinical research on medical devices. The unstated implication is that there are "low quality" trials in the devices niche. "The proposed guidance outlines agency expectations for clinical trial design issues such as minimizing data bias and variability, setting appropriate study objectives, selecting the appropriate type of study, and choosing study sites and study participants," the release states.
Finally, NPR has a story on the recent JNJ reconsideration of artificial hips with a metal-on-metal design. The word "recall" doesn't seem correct to apply to a product that is deep inside the human body. The public's understanding of the relaxed body of regulations for medical devices is spreading beyond a small number of medical cynics.
Late in July, Pfizer was the focus of a long article in Fortune. The incoherent 8,750-word story about the ouster of former CEO Jeffrey Kindler is a case history in the irrelevance of print media. It's not clear whether Kindler deserved to be axed, or whether he was simply entangled in the political machinations that afflict any large organization. The article also failed to get to the bottom of whether Pfizer's cultural and strategic problems are uniquely insoluble in the aftermath of so many mergers and reorganizations. The firm's issues could just be super-sized versions of the same quandaries facing all drug firms. The article is memorable for one detail: Pfizer's helicopters, which were first reported by Pharmalot.
Quintiles named a new chief medical officer: cardiologist Jeffrey Spaeder taught at Johns Hopkins prior to working at Abbott and Takeda, according to the news release. The big contract research organization (CRO) also hired a consultant with deal-making experience at McKinsey and Biogen: Troy Norris, a Harvard MBA, was named the VP and managing director, this news article states.
A group of private investors is hoping to buy PPD at a large premium to its current stock price. Such a deal would further shrink the ranks of big, publicly traded CROs. The Bloomberg news service, citing anonymous sources, reports that PPD has narrowed a list of potential acquirers to one firm: the Carlyle Group. Based in Washington, D.C., Carlyle is the world's third-largest such group, with $150 billion in assets and historical links to the Bush and Bin Laden family fortunes.