I'm going into my sixth year working on PharmTech and it's been quite an exciting few years given the changing industry dynamics
and major shifts in regulation—both of which are becoming more global and more transparent. It's also an exciting time because
Pharmaceutical Technology is celebrating its 35th anniversary. In fact, you'll find unique retrospectives and forward-looking pieces from industry experts throughout the
pages of this issue and on our website, at http://PharmTech.com/.
One area of change that I've been following closely is the globalization of the industry. Companies are now expected to perform
site visits and audits of all of their suppliers and contact service providers in addition to the multiple audits that they
must host from regulators each year. It's been fascinating to watch industry form its own consortiums and third-party auditing
schemes to address these needs. The industry is becoming more open to sharing information as well, which is quite a feat in
a patent-driven environment.
At the same time, FDA has taken a much stronger stance during the past few years—and really the agency has had to do this—to
manage the complexities of the pharmaceutical supply chain and related challenges, such as counterfeiting and economically
motivated adulteration. Our Washington Editor Jill Wechsler had the opportunity to speak with FDA's Deputy Commissioner Deborah
Author about these issues and where the agency is headed to meet the ever-expanding needs that come with globalization. See
"FDA Adopts New Strategies to Oversee Global Economy", or listen to the full interview as a podcast on http://PharmTech.com/.
Industry is also making great strides in the way it approaches manufacturing and testing as it works to implement risk- and
quality-based approaches. People are questioning current practice and seeking ways to find and share best practices. We're
especially seeing this in the area of impurities and visible particles (see "Atypical Visible Particles"), as well as in continuous
processing and platform approaches. In this anniversary issue, we take a look back at how manufacturing, drug delivery and
formulation, analytical methods, and outsourcing have changed in terms of key achievements and trends. In addition, experts,
including the presidents of PhRMA, BIO, and AAPS (see "Future Innovation"), provide their views on what the future holds for
I am happy to say that PharmTech is, and has been, right in the middle of these issues. We are working with the industry and
standard-setting organizations to get the best information available to you, whether it's the latest monograph change or FDA-issued
guidance, troubleshooting tips for equipment and processing, emerging pipeline and business strategies, or novel approaches
to manufacturing. We believe that this magazine offers the most relevant material for the global industry as it carries out
day-to-day work, and we intend to continue carrying out that mission.
Looking ahead to the next 35 years, PharmTech is taking advantage of the industry's transformation and regulatory dynamics
to make some changes of its own. Readers and online users are already taking part in our growing online communities through
LinkedIn and Twitter (check out the PharmTechGroup feeds). We're also planning to make some visual changes to the magazine
in the coming months. Overall, I'm quite excited about what the future has in store and hope to bring you along with us.
Angie Drakulich is editorial director of Pharmaceutical Technology. Send your thoughts and story ideas to email@example.com