January / February 2017

Pharmaceutical Engineering January / February 2017 Issue Cover

Cover: The New Face of Leadership
Robin Kumoluyi, Johnson & Johnson’s Vice President of Quality Systems and Services talks about her career path, willingness to take chances, and determination to be a leader.

Feature: The Catastrophe of Drug Shortages in Pediatric Oncology
Pediatric hematologist/oncologist Dr. Yoram Unguru calls drug shortages “a national disgrace” that delay lifesaving treatments, and lead to patient deaths. Drug companies must be part of the solution, he says.

Special Report: YP Voices
We asked ISPE Young Professionals to share their perspectives on the pharmaceutical industry. We also caught up with former student poster competitors to see how that experience helped shape their careers.

Subscribe to January / February 2017
Special Reports
ISPE knows that the future of the pharmaceutical industry lies with its youth—and to prove it, we’ve contacted five former contestants to see how the competition affected their careers.
Insights
William Fenical is frustrated that the pharmaceutical industry hasn’t developed new antibiotics for more than 20 years. Without them, it will be impossible to check the surge of superbugs—antibiotic-resistant infectious agents such as...
Technical
This paper was written by members of the BioPhorum Operations Group CPV and Informatics team and widely reviewed across the BPOG collaboration. As such, it represents the current consensus view of process verification subject matter experts in the biopharmaceutical industry, but does not represent...
Technical
As part of their quality risk management (QRM) programs, many biopharmaceutical manufacturers have made deliberate efforts to classify systems, equipment, and components by their potential to affect product quality. In assessing these risks, it is...
Technical
The Food and Drug Administration (FDA) report “Pharmaceutical Quality for the 21st Century: A Risk-Based Approach”14 was an introduction to quality by design (QbD), the concept that quality should be built into a product. According to the FDA report...
Special Reports
I’m a pharmaceutical professional, toxicologist, project manager, validation specialist, wife, mother, and daughter. I did not get where I am in my career without the support, wisdom, and mentoring of others. My mother, who majored in math and minored in...
Special Reports
For eight years I’ve attended ISPE educational sessions across the country, from Kansas City and Saint Louis to Chicago, from Atlanta and Baltimore to San Diego and San Francisco. I’ve learned...
Special Reports
As I walked up to the Atlanta Marriott Marquis, the magnitude and grandeur of the building set the stage for how much bigger this ISPE event was than any business event I’d previously attended. The atrium was packed to the brim. There were polished...
Features
What will be the most important industry drivers, its innovations, if any? What indeed! During the ISPE 2016 Annual Meeting Pharmaceutical Engineering caught up with a few industry leaders and asked for their perspectives. Here's what they had to say.
Features
After much focus at recent conferences and in publications on understanding the manufacturing- and quality-related causes of drug shortages, delegates at the 2016 ISPE Annual Meeting & Expo in Atlanta, Georgia, had the opportunity to hear from a panel of...
Features
In the 1960s, almost all children diagnosed with the most common pediatric cancer, acute lymphoblastic leukemia (ALL), were dead within 5 years. The steady and dramatic rise in survival rates since then means that today these kids have a near-90% chance...
InTouch
Four Latin abbreviations are staples of scientific writing: i.e., e.g., etc., et al. Despite their ubiquity, however, their meanings and usage are often confused or misunderstood. How can this be—especially when the terms are used so...
InTouch
Jamie Sigmon readily acknowledges that she has done a lot in her young, yet varied career. “I have really been fortunate,” she says. “I have worked as an intern in manufacturing sciences for a regenerative medicine company, I worked in technical...
InTouch
9–10 March 2017 Are your process control systems fit for use? Using a lifecycle approach for the development and management of process control systems, A Risk-Based Approach to GxP Process Control Systems: Applying the GAMP® Good Practice Guide: A...
InTouch
“The future is already here—it's just not very evenly distributed.” That quote by sci-fi novelist William Gibson captures an important component of ISPE’s successful 2016 Facilities of the Future Conference, which brought together diverse experts sharing...
InTouch
Henrik Goldschmidt was elected Chair of the ISPE Nordic Affiliate’s Board of Directors at the affiliate’s Annual Meeting, which was held in Copenhagen on 17 November 2016. Congratulations to Henrik, and many thanks to outgoing Chair Anders Widov for a...
InTouch
ISPE was present at the recent Brazil Affiliate Conference, held 24–26 October 2016 in São Paulo. The conference was attended by ISPE CEO and President John Bournas, who spoke on the worldwide status of the biopharmaceutical market and provided an...
InTouch
With deep cultural roots, gorgeous architecture, thriving industry, and inviting climate, Barcelona has it all. From 3–5 April 2017, the city will play host to the ISPE 2017 Europe Annual Conference. “Barcelona is a hot spot for the pharmaceutical...
InTouch
Quality issues continue to be a driving force behind sterile injectable drug shortages in the United States. This is one of the key conclusions of a Pew/ISPE joint study that interviewed 50 executives from 10 pharmaceutical companies in the United...
Features
Three generations ago, a university degree granted admission to a well-paying 40-year career at a single company whose end point, often as not, was an engraved watch. Today, things are different. According to the US Bureau of Labor Statistics, the...
Insights
A new year typically begets resolutions and the promise of change from most people. The promise of hope, really. Industry does the same, as well, albeit under different monikers—better drugs, better access for patients, better facilities, and stronger...