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Editor's Message

Hot Topics Covered in 2019

As the year frantically marches to a close, I want to offer some highlights as we close out 2019 and enter 2020.

With the European Union's Annex 1 revision stretched out into 2019, frequent PDA Letter contributor, past-PDA Chair, and long-time PDA volunteer and instructor Hal Baseman (who is practically a fixture at PDA headquarters!) authored the February cover story on the controversial recommendation for pre-use, post-sterilization integrity testing (PUPSIT) of sterilized filters. Hal explained that PUPSIT could introduce unnecessary risks. Currently, Hal and other long-time PDA volunteers and filtration experts—including Past-Chair Maik Jornitz—are conducting research into, among other things, the "masking effect" of PUPSIT. Hal, Maik and PDA's Vice President of Scientific and Regulatory Affairs Tina Morris offered an in-depth assessment of this research in an article posted the Friday before the Labor Day holiday in the United States ("PUPSIT and the Annex 1 Revision"). We realized the importance of this research when hundreds of readers had viewed the article by the end of the holiday. Apparently, nothing stops PDA members from getting the information they need!

The February issue also included an infographic based off a survey we conducted of readers’ concerns about the proposed Annex 1 revision. In 2020, we will continue to produce infographics highlighting similar topics.

In the October PDA Letter, we published our first major profile of an industry thought leader, Jeffrey Galvin. Jeffrey went into great detail about his experiences in Silicon Valley and how that translated to his work in cell and gene therapies. Moving forward, we want to profile other industry thought leaders and readers are encouraged to send in recommendations.

We continued our successful “On the Issue” video series. Topics covered in these videos throughout the year have included gloveless isolators, cross-contamination control, container closure integrity and visual inspection. We also filmed some of the Young Professionals who volunteered for PDA at the 2019 Annual Meeting. Additional videos were filmed at the 2019 PDA Joint/Regulatory Conference and the 14th Annual PDA Global Conference on Pharmaceutical Microbiology. These will be available next year.

2020 promises to be a noteworthy year for the PDA Letter. As I mentioned in my previous Editor’s Message, we will continue to focus on the PDA Letter website as the primary content hub. We will also work on quarterly regional editions with content tailored for our readers in Europe and the Asia-Pacific region.

The year has moved fast (as everyone always says) and we are picking up the pace into 2020 and beyond. Get your seatbelts on!

Message from the Senior Director of Publishing

Online Pubs Expand Access and Areas of Focus

Over the last decade, PDA's publishing shifted from the traditional print format to online, or electronic publishing. This transition started with our technical reports in 2008, when PDA ceased mailing new technical reports with the PDA Journal of Pharmaceutical Science and Technology (PDA JPST) in favor of posting them to the online PDA Bookstore as PDF files. A year later, we partnered with High Wire Press, Inc. to provide the online edition of PDA JPST, saving even more trees and postage. In 2010, we expanded the online PDA JPST to include all issues dating back to 1980. A year later, we launched the online submission and review tool, and soon thereafter, we initiated our version of "publish ahead of press"—i.e.," Accepted Articles"—to reduce the time it took manuscripts to become referenceable resources. We also launched the Technical Report Portal, which gives all standard members access to every active technical report online.

The reaction to moving these critical member-benefit publications to the Web was predictably very positive. In the case of PDA JPST, the online version, complete with advanced search capabilities and other features, made the publication a vastly more useful vehicle for research. Virtual technical reports were a bit of a harder "sell" to PDA's community, but overall, members enjoy the ability to download their free PDF version of each new report so that they can "take" them anywhere on their laptops. And when an older report is needed, using the portal is infinitely more convenient than rifling through old booklets or bothering colleagues in the office for a copy!

In 2019, we completed a much-needed upgrade to the PDA JPST website and made improvements to the online submission and review website. I wrote extensively about the design and features of the new PDA JPST website in the Sept/Oct edition.

The PDA Letter— PDA's flagship member publication—lagged behind its sister membership publications when it came to electronic publishing. As of 2015, only PDF versions of the PDA Letter were posted along with a limited selection of articles online in HTML. In essence, the PDA Letter was crafted as a"print-first" publication, and online content was secondary.

That started changing in 2016 with the launch of the new PDA Letter W eb portal. With it, we launched our "On the Issue" videocast and published-ahead-of-print and online-only articles

As Managing Editor Rebecca Stauffer in her many, wonderful Editor's Messages this year, the evolution of the PDA Letter continues in 2020. A new effort is underway to expand the Letter's online content and to create regional editions to better serve the needs of our members in Europe and Asia. To help expand the online content, we will reduce the print editions from ten to six so that we can shift our focus and resources to online. The print editions will be a collection of content posted online in the previous two months. We are finally flipping the script for the Letter in that it will be a truly "online-first" publication.

It is of the upmost importance that PDA's member benefit publications meet the needs of our members. If you feel these changes do not serve you well, or if you have any other comments or suggestions, we need to hear from you. Please contact me or Rebecca to let us know how we can better serve you. Also, if you are on Twitter and LinkedIn, follow us!