November / December 2017

Transitions Our Members & Pharma Industry are Making

Anna Maria Di Giorgio

The end of a year, the start of a new job, a groundbreaking scientific development: These are events that give us pause, moments that help us transition to a new mind-set, focus, or even a new career. Managing these moments is as important as being a part of them. In this issue, we look at transitions that our members—and the industry in which they operate—are experiencing.

We welcome Tim Howard, ISPE Board of Directors Chair for 2017–2018. His editorial provides insight into his plans for the next year and articulates his top priority: strengthening ties at the grassroots level with chapters and affiliates.

Our cover story by Rick Lawless, Director of Industry Programs at the Biomanufacturing Training and Education Center (BTEC) at North Carolina State University, addresses how engineers in traditional pharma can move to biopharma, discussing the skills that are transferable and those that require additional training. Kelly Scalva and Kerren Bergman, both of Hyde Engineering + Consulting, Inc., look at the subject of mentoring from the perspectives of a Gen Xer and a Millennial.

Nissan Cohen, industry consultant and member of the Pharmaceutical Engineering Committee, is guest editor of our Special Report on Data Integrity. We look at what we can learn from the Sarbanes-Oxley Act when implementing a data integrity strategy, how we must control privileged access to protect the integrity of database content, and how we can prepare suppliers for data integrity audits.

On the membership front, ISPE adviser John Berridge reports on an EMA workshop about shared facilities, GPMLF members Ferdinando Aspesi and Tony Moreira discuss a new workforce of the future initiative, we welcome a new affiliate to the fold, zoom in on two Guidance Documents, and highlight training and milestones in Thailand and Japan. We also provide a sneak peak of the environs in which the Europe Annual Conference will unfold next April in Rome.

In our technical articles, John Noble looks at capacity challenges in biopharmaceutical facility development; John Klostermyer, Bruno Aze, Alberto Garcia, and Don Eddington make the case for integrated VPHP systems; and Jeremy Lewis, Cuong Nguyen, Anh Lam, and Keith M. Forward discuss free-surface electrospinning of microemulsions to increase API solubility. Roger Zanon, Limin Shi, Kyle Johnson, and Jeff Hanson present a new statistical methodology for CU testing of CPV batches.

And to wrap it all up, Dr. Yoram Unguru, a physician at Children’s Hospital at Sinai, Baltimore, Maryland, addresses the issue of ethics in pediatric oncology, where young patients face drug shortages, their parents endure an anguish we can't imagine, and hospitals must make decisions no health care facility should have to make.

Thanks for reading and I Iook forward to serving your needs in 2018!