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1. Could 96 Percent FDA Drug Approval Rate Harm Biosimilar Market? 9/1/2015

   Last week, Matthew Herper of Forbes published an eye-opening article providing a closer look at FDA approvals in recent years, coming to the conclusion that the industry is facing what could be a dangerously high approval rate for new drugs. But how could high approval rates be a bad thing?

2. The Generic And Biosimilar Markets: Are They Really That Different? 10/19/2015

   As the FDA continues to compose guidances on the labeling and interchangeability of biosimilar medicines, there remains one big, overarching concern in the industry, and that is making sure biosimilar medicines are not treated as small molecule generics. But should we really be considering the two types of drugs as drastically different as we have been over the past few months?

3. ISPE Meeting Provides Emotional Rollercoaster 11/13/2015

   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 childhood dream, I am struck by the similarity between the story and this year’s ISPE annual meeting. “I had so much joy,” recalls Allen of the sensation experienced the first time he successfully slam dunked a basketball on a 10 foot hoop — a goal that took years of persistent practice to finally achieve. It is important to remember that biopharma executives and engineers are not immune to deeply experiencing human emotions (e.g., joy, sorrow). And while attendees of ISPE were certainly treated to high-caliber networking and educational opportunities at this year’s show, they were also provided a strong dose of emotional reality to fuel their passionate pursuit of excellence. Like Duke’s Allen, to achieve beyond your expectations, sometimes it is important to be reminded of why it is you do what you do.