Articles By Trisha Gladd

  1. GSK Discusses The Transformation Of Biopharmaceutical Manufacturing: Single Use Is Only Part Of The Strategy 8/26/2014

    Historically, biopharmaceutical manufacturing has always been slow, expensive, and inflexible. However, the pressures in today’s biopharma space are driving trends in the opposite direction, which is causing experts to look for ways to drive costs down while improving flexibility and efficiency. GSK’s Randy Maddux, VP and Site Director of the company’s Global Manufacturing and Supply (GMS) site in Rockville, believes there are many factors involved in transforming biopharmaceutical manufacturing. And while single-use technology plays a key role, there are plenty of other aspects to consider.

  2. FDA's First Draft Guidance Under DSCSA – What It Tells Us And What It Doesn't 6/23/2014

    On June 10th, the long-awaited first draft guidance under the DSCSA was released by the FDA. For those holding high expectations that the guidance would offer specific direction on how to handle suspect/illegitimate products internally, you may come away feeling a little shortchanged. However, in the past, the FDA has come under scrutiny for using guidance to replace rule making, since this requires legislative involvement, so the lack of detail in the draft may be an effort to make room for flexibility that industry felt they weren’t getting before. Whatever the intent, the draft guidance does provide some learning opportunities and also a very subtle call to action. I recently spoke with David Colombo and Dawn Wang with KPMG Life Sciences Advisory to find out what can be learned from this draft and where we go from here.

  3. QbD: Lessons Learned From An FDA Filing 2/24/2014

    Implementing quality by design offers not only a proactive approach to product development, but also the opportunity to streamline your filing process.

  4. Three Ways A Logistics Partnership Can Reduce The Cost Of Global Expansion 8/30/2013

    By Trisha Gladd, editor, Pharmaceutical Online and Bioprocess Online

    In order to meet the needs of an expanding global market, healthcare executives find themselves facing the daunting challenge of not only making their product accessible to foreign markets but also maintaining quality during shipment. I recently spoke with Robin Hooker, director of Global Healthcare Logistics Strategy at UPS, about how a logistics partnership can help reduce the costs associated with these challenges and provide advantages beyond the bottom line.