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.
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.
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.
Denice Torres is the president of McNeil Consumer Healthcare, a Johnson & Johnson company, and winner of HBA’s 2015 WOTY award. Listening to her acceptance speech reminded me of legendary pro football coach Vince Lombardi’s philosophy — “Adversity doesn’t build character, it reveals it.”
Peter Young, a 35-year biopharmaceutical industry veteran, presented at the 2015 BIO International, and his valuable session includes some key industry trends biopharmaceutical executives should be paying a close attention to.
In my role as the 2015 co-chair of the BIO International’s educational planning committee, I am privy to what goes into creating one of our industry’s largest annual events. As many of you are involved in organizing your own customer educational programs (e.g., The Emerson Exchange) or have been asked to serve on an event planning committee, I thought a behind the scenes look into how BIO goes about the process would be helpful to your efforts. Here are some of the best business practices I have witnessed thus far.
While all The Seven Habits of Highly Effective People listed by Stephen Covey remain relevant and timeless, the one which resonates with me most is the seventh — sharpen the saw. In the life sciences industry, Covey’s concept of continuous improvement is more than just a habit, but a way of life. This is especially true for those who work in pharma and biopharma manufacturing — striving to maintain high quality, be on time with delivery, increase productivity (often with fewer resources) and so on. If you work in manufacturing, you are probably tempted to stop reading and get back to work. Though pharma and biopharma manufacturing executives most certainly work long and hard hours, I am sure the manufacturing executives I know would rank working smarter above working harder as a best business practice. Working smarter requires making the time to sharpen your saw. As we are just seven weeks away from a very unique saw sharpening continuous improvement conference for the pharma and biopharma manufacturing executive (Outsourced Pharma West), I thought it a good time to put together a list of the seven habits of the highly effective pharma and biomanufacturing executive — so you can sharpen your saw.
Most of those in our industry are only viewing the tip of the iceberg when it comes to looking at how to use Big Data — ignoring the massive amounts residing below the water’s surface. When I think of the potential Big Data presents for the field of life sciences, it reminds me of The Rime of the Ancient Mariner — “Water, water, everywhere, nor any drop to drink.”
In the pharmaceutical industry, gaps often exist between companies and internal working groups. Consider one of the industry’s largest players, Johnson & Johnson (NYSE: JNJ), which has more than 127,000 employees and operates more than 250 companies organized into several business segments in 60 countries.
Allowing the application of a “one-size- fits-all” intellectual property policy that affords the same protection for Frisbees as lifesaving and sustaining medicines would be, quite frankly, moronic and short-sighted. It would also be a disincentive for companies to develop R&D-intensive drugs because the longer it takes to develop, the shorter patent life you have. The converse is also true — less costly drugs brought to market more quickly get longer patents.