On Monday afternoon, a manufacturing and operations discussion group focused on the topic of global competition. Session chair Julian Wilkins, Vice President of PharmaConsult US, Inc. and a part-time professor of Pharmaceutical Manufacturing at Stevens Institute set the stage with an introduction spelling out the issues and challenges.
One of the points he made was about education in the U.S. Among OECD countries, he noted, the US has slipped to #16 in high school graduates, and 9th in post secondary enrollments. He also noted that 7 out of 10 U.S. students nationally graduate without completing courses needed to succed in college or the workplace….India and China are rapidly moving ahead of the US and Europe in terms of education, he noted, pointing to his own students at Stevens, most of whom are Indian. Currently, he said, he does not have one U.S.-born student in his pharma manufacturing classes.
He discussed the need for innovation, which is percolating in Indian life sciences, despite lack of capital and an often chaotic infrastructure.
Innovation Inversely Proportional to R&D Facility Cost
At this point, he introduced the "law of pipeline development": The discovery of NDA candidates is in inverse proportion to the cost and luxuriousness of the R&D facility. "I’ve seen many [unproductive] palaces, where the innovation is coming from universities and small operations…..remember HP's garage?"
He also challenged the West-centric belief that compliance is necessarily more lax abroad. Compliance, and noncompliance, know no boundaries, he said, posting FDA 483's from Sandoz in the U.S. and Ranbaxy in India, side by side. and noting the many similarities between them.
Dangers of Short-Term Thinking
Wilkins criticized the industry's reliance on acquisition, joint ventures and consortia to develop innovative new compounds, emphasized the need for safety and ergonomics, citing studies by Dave Eherts PhD, Medical and Aviation Safety, Sikorsky Aircraft Corp. (For more information on a recent review, click here) He also mentioned the need for green product development.
Failure to think long term, he noted, often shows in a failure to respect the workforce and a management that "flies blind to details that matter."
He then cited a number of statistics and trends from a groundbreaking Regent Atlantic report on changing forces at work within the industry that you can access here.
As a company moves from short-termism and a view of the workforce as the enemy, one sees a shift in employee attitudes, from “rebel or quit” to “malicious obedience” to "willing compliance" to "cheerful cooperation" to "hearfelt commitment" to creative excitement…There is a need for cultural change within the industry, he noted.
John Fielding, Senior Director at Genentech, later expanded some of these points in an extended report on issues facing the industry. He hinted at the company's Factory of the Future program (which we'll hope to cover in greater detail) as well as its efforts in sustainable design, energy efficiency and environmental safety, as part of the LEED program.
There was no applause from the audience for any of the speakers...until Dr. Afnan's presentation at the end of the session. Surely, anyone who prepares powerpoints and a talk before a discerning group of engineers and technical people deserves some applause!