July / August 2017

New Technology, Ambition, & Patient Safety

Anna Maria Di Giorgio

Technology is not new. Biotechnology is not new; it’s new-ish. Yet when the two come together to look at how they can transform medicine, its creation, delivery, and access, well, that is new and can be extraordinary. Extraordinary enough that the FDA established the Emerging Technology Team (ETT) in the Office of Pharmaceutical Quality (OPQ) of the Center for Drug Evaluation and Research (CDER) in 2015.

Sau Lee, PhD, who chairs the team, explains the ETT’s intentions and outlook in our cover story, “Just Getting Started: 3D Printing and Bioprinting in Pharmaceutical Manufacturing.” In that story, author Scott Fotheringham, PhD, looks at 3D printing and bioprinting. He pursues still other technological advances in his feature “A Good Fit: The Marriage of Pharma and Tech Yields Benefits for Patients,” discussing several pharma/tech alliances and their ambitions.

Our chapter profile highlights ambition, too. Mike McGrath spoke with the Great Lakes Chapter President Deborah Geyman about its recent financial struggles and how she sees brighter days ahead—did you know Great Lakes serves more than 800 members scattered across the six states surrounding Lake Erie and Lake Michigan? On this same topic of ambition, tenacity, and diligence, Mary Foss offers thoughtful advice to students entering the industry for the first time, and our regular columnist David Smith reveals the best way to “ace” a telephone interview.

Our technical authors look at patient safety from novel angles: applying QRM to reduce HVAC costs (Appleby, et al.), the benefits of ozone technology in water pharmaceutical systems (Cohen and Johnson), how to minimize and control microbiological contamination in water systems (Sandle), the reliability of sterility assurance tests (Stering), and a method for demonstrating content uniformity (Stepanic and Saeed).

All in all, we have a little bit of something for everyone in this issue, and I hope you enjoy it.

Happy summer and I look forward to seeing you at the 2017 ISPE Annual Meeting & Expo in San Diego, California.

PS: Remember to vote for your new Board of Directors—look for your electronic ballot via email by late July.