Life Sciences

  In the good ol’ days, walking in the clinic door and asking for a few minutes of a physician’s time was the main method used by sales reps to position a drug in the doctor’s mind. Physician outreach was, and still is, one of the most effective ways to penetrate the market with a […]

  As a big fan of efficiency, it pains me that most of us in life sciences still execute validation testing with pen and paper, present company included. All of those poor trees. All of that hand-cramping. All of that scanning. All of those migraine-inducing QA reviews in which we’re squeezing scanned test cases into […]

  The life sciences industry could learn a little something from Southwest Airlines’ “Transfarency” campaign, in terms of reporting clinical trial results. A recent investigation by the publication STAT found significant violations in the reporting of clinical trial results to the ClinicalTrials.gov database. Most academic research institutions, drug companies, and even the National Institutes of […]

  So, one of my spunky co-workers, who happens to be the prolific blogger behind www.adviceformydaughter.com, shared this on Facebook: “My daughter wants to use her Christmas money to buy a diabetes kit, just like daddy’s, for her American Girl Doll. It makes me happy that she will understand this part of his life a […]

  An interesting thing happened in pharma and investing. It involved Regeneron and their July 24, 2015 FDA-approved cholesterol drug, Praluent. Forbes outlined the situation, which caused Regeneron stock to drop significantly, in a January 6, 2016 article. According to Matthew Herper, a Forbes columnist, investors got a hold of data from the FDA’s Adverse […]

  Last week, I wrote that Vice President Joe Biden was going to meet with cancer researchers to talk about regulatory questions revolving around precision medicine. Today, we know much more about the cancer “moonshot” President Obama charged Biden with in this week’s State of the Union address. In a post on the publishing platform […]

  We’ve been getting a lot of requests, lately, to help companies decommission their old GxP systems. The systems were once validated and still contain GxP data that might someday need to be reviewed or analyzed, but they’re no longer being actively used. They’re just sitting there, taking up server space, undergoing basic IT maintenance, […]

  In case you missed the headlines, Mark Zuckerberg and Priscilla Chan got the best Thanksgiving gift ever last year – their daughter. Her name is Max. The proud parents wrote a breathtaking letter to her, sharing images of the world she lives in today and what they hope Max grows up to see. Just […]

  Today, January 12, 2016, Microsoft is ceasing support for Internet Explorer 8. If you’re a Siebel Clinical user, that news probably made your stomach drop, since IE8 is the highest version of Internet Explorer that works with Siebel pre-8.1.1.9. What does that mean for those of you running old versions of Siebel? Well, you […]

  According to Dr. Stephen M. Ostroff, FDA Acting Commissioner, and Dr. John K. Jenkins, Director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research, over 40 novel drugs were approved in 2015. The FDA’s website indicates the exact number as 45, which is slightly higher than the previous year and […]

  According to STAT, Vice President Joe Biden is meeting with over a dozen of the nation’s top cancer researchers today to talk about regulatory questions revolving around precision medicine. As you might recall, Biden’s son, Beau, recently died of brain cancer at the age of 46. 

  On December 17, 2015, the FDA issued a warning letter to Sun Pharmaceuticals Industries Ltd. in Gujarat, India. Sun Pharma’s website boasts that it is the “World’s 5th Largest Specialty Generic Pharmaceutical Company” with over 2,000 products in more than 150 markets across the globe. When an organization that large winds up with a […]