If as adults we could invisibly walk on school playgrounds during recess, we might hear the stock response recited when encountering a bully — ‘Sticks and stones may break my bones, but words will never hurt me.”  Continue Reading..

There are plenty of industry insights available, such as Life Science Leader’s comprehensive December 2015 Outlook issue for 2016 or our four-part trendsetter series. And while these provide a wealth of insight, I felt compelled to put together one last blog to prevent you from being blindsided by the “Next Big Thing” in biopharma in 2016.  Continue Reading..

Writing is reinforced thinking. It is a stronger, more constructive way of moving through the thought world. Because I am a trade journalist covering the life science industry, all of those things tend to appear to me in industry terms. Take the drug-pricing debate, for example.     Continue Reading..

When Janet Woodcock, M.D., kicked of this year’s FDA/CMS Summit for biopharmaceutical executives, the FDA’s director for the Center for Drug Evaluation & Research (CDER) did so by recapping what was achieved in 2015, as well as sharing her lengthy list of priorities for the coming year. According to Woodcock, the challenge to successful implementation of various priorities is analogous to keeping an airplane flying while at the...  Continue Reading..

Stepping out of my hotel room on the last day of the 2015 International Society of Pharmaceutical Engineering (ISPE) annual meeting in Philadelphia (November 8 – 11), I reach down and pick up the USA Today that is blocking my egress. Flipping through the newspaper the headline “Allen Always Aimed High” catches my eye. As writer Nicole Auerbach relates how Duke University basketball standout Grayson Allen strived to achieve his...  Continue Reading..

What FDA decisions have you missed recently?  Continue Reading..

When it comes to determining the underlying cause of a breach in good manufacturing practices, industry often falls back on human error and looks no farther into the matter. However, as Life Science Training Institute’s expert Joanna Gallant describes, retraining employees is only going to go so far and, more often than not, will not even be the appropriate CAPA for the issue. In part one of this four-part series, Gallant discusses where...  Continue Reading..

Within the last 10 years, a number of nonprofit groups, including the Michael J. Fox Foundation and the Multiple Myeloma Research Foundation, have taken a similar approach to ensuring that their targeted patient populations are being well represented in pharma R&D.  Continue Reading..

What FDA decisions have you missed recently?  Continue Reading..

As the call for transparency grows louder in the pharma industry, the question arises: are drugmakers equipped with all they need to be transparent — especially when it comes to demonstrating their drugs’ economic value?  Continue Reading..