Life Science Connect Blog

1. What Will Be The End Result Of Bullying Biopharma? 3/1/2016

   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.”

2. What Is Going To Be The Next Big Thing For Biopharma In 2016? 1/4/2016

   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.

3. Write Thinking — Biopharma At the Turn of the Year 12/31/2015

   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. 

    

4. FDA/CMS Summit Demonstrates Need For Innovative Hiring Solutions 12/17/2015

   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 same time trying to fix or improve whatever isn’t working. And though she and her team have done admirably in piloting the organization for the past several years, I wonder how long they can continue to do so. For despite CDER’s significant accomplishments last year (e.g., first biosimilar approval), one priority that hasn’t moved — at all — is the organization’s glaring need for staffing. From a PowerPoint released at the conclusion of last year’s summit, at the bottom of slide four you see a 2015 front burner priority listing of “Improve staffing” that notes over 600 vacancies at CDER.. One year later, Woodcock stated that CDER still has 600 vacancies – (see slide 10 of this year’s presentation)! Now, one could argue that CDER, like most organizations, probably had its share of routine turnover. Perhaps the agency hired more than 600 people last year. But at an organization that employs approximately 3,200 civilians, 600 vacancies represents trying to fly and fix the CDER plane with about 20 percent less staff than you need. Constant pressure in other industries to do more with less has been shown to increase employee burnout. If the CDER employee hiring needle hasn’t moved at all in 12 months (probably longer), perhaps it is time to start asking about what needs to change, because the current approach isn’t working, and employee burnout could further exacerbate the problem.

5. 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.

6. FDA News Roundup: Otsuka, AstraZeneca, Ipsen, And More 7/17/2015

   What FDA decisions have you missed recently?

7. Human Error: What Pharma Should Know And Do About It — Part One 7/16/2015

   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 the industry currently stands in identifying the root cause of a problem, as well as the extent to which industry turns to human errors as an explanation.

8. Venture Philanthropy: Is It Really Promoting Patient Centric Drug Development? 7/14/2015

   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.

9. FDA News Roundup: Pfizer, Eli Lilly, Vertex, And More 7/10/2015

   What FDA decisions have you missed recently?

10. Is Pharma Truly Equipped For Transparency? 7/8/2015

    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?