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Navigator for Drug Labels: Faster product label creation means faster time to market for rare-disease drug manufacturer

Jul 21, 2020 | Drug & Biologic Product Submissions, Pharmaceutical and Cosmetics

Solutions at Work

A front-line perspective on the value of Reed Tech Navigator™ for Drug Labels for a rare-disease biopharmaceutical manufacturer.

In working with life sciences customers, we often hear recurring themes on product labeling. Some companies lack the time or resources to handle the process smoothly and efficiently; others simply want to focus more on the core mission of their business. For companies specializing in treatments for very rare diseases, product labeling can be even more complex and challenging.

That was the situation for one of our customers, which is dedicated to developing and commercializing new products for serious – and extremely rare – genetic diseases. The company aims to deliver treatments that are safe and effective and to do so as quickly as possible. Unfortunately, they found themselves spending months on research – yet still unable to find the information they needed.

As it prepared to launch a new drug in 2019, the company’s global labeling team was aggressively tackling product labeling requirements. The professionals were using Google and the FDA database to try to identify similar, already approved drugs. By following the labeling precedents established by those products, the global labeling team could save hours of content development and back-and-forth efforts with the FDA.

That approach wasn’t working due to a lack of advanced search capabilities in the online resources they were using and the fact they were supporting a new rare-disease drug. There simply wasn’t one “direct” competitor, and that meant they had to research multiple drug labels for each section of their product labeling.

Using free resources like Google and the FDA databases is OK if you know exactly what you’re looking for. But any time you’re looking for something outside the basic information, it gets harder and harder to narrow down to the results you need. It can get overwhelming.

– Associate Director, RA Global Labeling
Rare-Disease Biopharmaceutical Manufacturer

The Navigator for Drug Labels tool proved to be a valuable solution to the challenges they were facing. Navigator goes well beyond “the basic information” to incorporate advanced search, comparison, analysis and alerts into a U.S. human drug label database.

Using this tool, the global labeling team was able to:

  • Quickly identify drugs on the market that were the same drug type, specifically indicated to the same disease or in the same dosage form – providing a “fast lane” to approved language they could incorporate into the new labeling
  • Conveniently save various searches in an organized manner – making it much faster and easier to pull information for each section as needed in the future
  • Prepare the new product labeling and obtain FDA approval – supporting the timely launch of the new product
“I used Navigator’s section selection feature. I can easily and quickly compare other label sections, and not the entire label, to see perhaps how another company states an adverse reaction, or other parameter of interest.”

– Associate Director, RA Global Labeling
Rare-Disease Biopharmaceutical Manufacturer

No one wants to spend hours on product labeling research that leads to a dead end – or that delays the launch of a novel treatment. No one should have to. Consider how you can use Reed Tech Navigator for Drug Labels to gain competitive insights, expedite drug label creation and approvals and simplify drug label monitoring.

To learn more, contact [email protected] or call us at (215) 557-3010.