SSU, SIV, FPI and KPIs – oh my

It isn’t often you find real data in conference presentations, but we did. Clinical trials get delayed, no news there. A 2017 report from CenterWatch showed each additional month in a phase III trial added a median expense of $671,000. There are lots of “fixes” out there, but if you’re involved in oncology trials, you’ll find an insightful site start-up presentation from Alicia Williams, Senior Project Manager at MedSource here. InsightCity reached out and asked her “What’s the one thing people should know?” Her response, “The key to improving site start-up time and efficiency lies in proper planning, information sharing, and transparency. Working collaboratively with our sponsors and sites and putting in the preparation to drive timelines leads to success.  It’s not easy, but it has a proven track record.”  Well said and thanks for not creating another conference presentation that looks like this.

Effects of menu calorie counts—also, IHOP is terrible

A study at Cornell University has demonstrated a modest effect on ordering habits resulting from posted calorie counts on menus. Comparing the orders of customers who were given menus with calorie counts against those without calorie counts showed a 3% per meal reduction in calories ordered. According to the study’s author, 3% would lead to about a 1-pound reduction in a person’s weight in 3 years. It’s not a lot but in the age of the absurd 2,000 calorie IHOP breakfast, we’ll take it. Here’s Jim Gaffigan’s take on IHOP (and a few other cake-related jokes). In summary, IHOP suuuuuucks. Don’t go there.

Not playing by your own rules

The well-known oncology researcher José Baselga has resigned his position as Chief Medical Officer at Memorial Sloan Kettering after an NYT/ProPublica investigation showed he failed to disclose millions in payments from pharma and healthcare companies in dozens of his research articles. The payments themselves aren’t at issue, it’s the fact that he didn’t make his ties explicitly known. Which is kinda funny since those financial reporting rules were set by the American Association for Cancer Research while he was president of the group. Critics say Baselga’s fall illustrates the bigger problem of the revolving door between academic research and industry, as well as a general laziness towards enforcing ethical standards from the academic community. Expect a rush of researchers who ‘forgot’ to include their financial ties in previous papers to quietly go add those in.

This stuff is really cool

A team of scientists at the University of Edinburgh have collaborated for the past year with Interactive Scientific to develop virtual reality prototype software to revolutionize drug-design visualization, using Interactive Scientific’s Nano Simbox technology. The proof of concept developed offers insight into a VRUI that allows efficient visualization of sets of molecular dynamics trajectories. The software has been used to explore molecular motions of different complexity on a set of therapeutically relevant proteins. As everyone knows, ensemble-based drug design (EBDD) is an emerging alternative to structure-based drug design (SBDD). They have some pretty interesting apps for schools where students can see how atoms go together to make molecules, build the molecule, learn how the periodic table works and see the patterns different atoms form. Like we said, cool.

E-cig epidemic enforcement incoming

The FDA is getting serious about e-cigarette enforcement. In a statement released last week, the agency announced a crackdown on 1,300+ retailers and five manufacturers who make up 97% of the US market. That includes JUUL, which has been widely criticized for making vaping cool (Editor note: LOL is this really that cool?) and itself accounts for over half the US market. The FDA says vape use has increased to epidemic levels in teens, and it is intent to not “allow a whole new generation to become addicted to nicotine.” The agency expects the manufacturers to submit plans within 60 days to explain how they’ll stop teens from getting addicted to their products. If not, the agency could pull e-cigs from the market, a move which Big Tobacco is a fan of.

Generally mad with generics

Seven organizations representing about 500 U.S. hospitals are joining up to make their own generics. Sick of high prices and drug shortages, the group is forming a non-profit, FDA-approved manufacturer by the name of Civica Rx. It’ll be headed up by former Amgen chief quality officer Martin Van Trieste, and its initial goal is to manufacture 14 generics for hospital patients. The exact generics Civica will focus on haven’t been named yet, but they’ll either produce them themselves, or outsource the work. You know what they say, if you want something done right, delegate it yourself.

Take that, opioids

The good people at Wake Forest University are working to find a safe, non-addictive pain killer to help fight the current opioid crisis. As published in Science Translational Medicine, researchers “have developed a bifunctional MOP/NOP agonist, called AT-121, that showed potent analgesic effects in nonhuman primates without inducing hyperalgesia, respiratory depression, or dependence. The results suggest that bifunctional MOP/NOP agonists might represent a safe and effective pharmacological tool for treating severe pain.” Well done. Can anyone say Fast Track designation? Researchers observed that AT-121 showed the same level of pain relief as an opioid, but at a 100-times lower dose than morphine and it blunted the addictive effects of oxycodone. Yes, it’s early and the tests were not in humans, but it looks like these researchers are off to a promising start. Best of luck!

Secrets that don’t stay secret

Sometimes you want to get a head start when starting a new company. And sometimes you get caught by the feds for stealing trade secrets. Former GSK scientist Yu Xue pleaded guilty to conspiring to do just that when starting her own biopharmaceutical company in China while still employed by the pharma giant. Prosecutors say Xue transferred documents related to products under development, research data, as well as GSK’s R&D and manufacturing processes to her colleagues in China. Xue, on top of serving up to 10 years in prison, could also be forced to pay restitution to GSK. The court graciously capped that at a reasonable number for a single person to pay, just $2B. Fun fact: that’s larger than the GDP of 26 nations according to the World Bank.