That’s a Wrap

Dec. 15, 2017
Penetrating the layers of 2017 regulatory actions helps pharma construct a productive narrative

Unfortunately for mummies, their cinematic fame somewhat fell by the wayside when zombies took over as pop culture’s new favorite not-quite-dead terror.

Researchers, however, have not yet lost interest in mummies (apparently due to a widespread shortage of zombies in the scientific research community) and have now enlisted the help of X-ray technology to further their work.

Just recently - and for the first time ever - scientists, researchers and art curators utilized Argonne National Laboratory’s Advanced Photon Source synchrotron technology to look inside the linen-wrapped remains of an 1,800-year-old Egyptian mummy. The technology - the brightest X-ray source in the Western Hemisphere - speeds up electrons along a 3,600-foot circular track to produce high energy X-rays. The APS technology is used for research across a multitude of scientific areas on a regular basis. In the pharma industry, the X-ray technology can offer researchers a picture of a protein’s structure, which has aided in the development of inhibitor drugs such as Abbott Labs’ HIV drug, Kaletra, and Roche’s melanoma drug, Zelboraf.

As I wrote this month’s regulatory review cover story, researchers in Illinois were using this advanced X-ray technology to non-invasively investigate the mummified remains of a five-year-old girl unearthed in Egypt in 1911 (I’ll let you decide whose job is more fun). While most would argue that pharma regulations come wrapped in red tape rather than resin-soaked linens, both tasks involve penetrating layers upon layers of details.

In the mummy’s case, using X-rays to study the wrappings, skeleton and internal matter enables researchers to gather clues that will shine light on the life, culture and trade networks of the Roman Empire. When speaking about pharma and regulatory intelligence, gathering and analyzing regulatory data against the backdrop of the industry enables manufacturers to derive meaningful outputs that can be used to guide regulatory strategy.

Essentially, it’s all about constructing a story, piece by piece. Personalized medicines, global harmonization and quality were the stars of 2017’s regulatory tale, while political change in the United States and Europe left mysteries that have yet to unfold.

X-ray technology is valuable to the study of these ancient artifacts because the mummies will be completely unharmed during the process. It is our hope that this month’s cover story, as well as the Regulatory Intelligence Brief (complete with charts and links) from Meredith Brown-Tuttle, principal consultant for Regulatorium, will provide our readers with a painless review of 2017 regulatory actions.

We can’t promise you immortality, but maybe we can settle on helping to preserve your regulatory sanity...

About the Author

Karen P. Langhauser | Chief Content Director, Pharma Manufacturing

Karen currently serves as Pharma Manufacturing's chief content director.

Formerly the editor-in-chief of Food Manufacturing magazine, Karen was particularly successful at eating all of the snacks that were mailed to her from food companies, as well as reaching readers by establishing her own unique voice and tone on the brand. She made the decision to trade food for drugs in 2013, when she joined Putman Media as the digital content manager for Pharma Manufacturing.

As an award-winning journalist with 20+ years experience in the manufacturing space, Karen passionately believes that B2B content does not have to suck. As the content director, her ongoing mission has been to keep Pharma Manufacturing's editorial look, tone and content fresh and accessible.

Karen graduated with honors from Bucknell University, where she majored in English and played Division 1 softball for the Bison. Happily living in NJ's famed Asbury Park, Karen is a retired Garden State Rollergirl, known to the roller derby community as the 'Predator-in-Chief.'