Articles By Trisha Gladd

51. An Exciting Change On The Horizon 8/12/2014

    In September, Bioresearch Online will become BioProcess Online. The transformation of our brand is intended to address our evolution as a media outlet and illustrate our editorial mission more clearly.

52. Analytical QbD at Teva: Knowledge Is Power Only When You Share It 7/3/2014

    Rosario LoBrutto, is currently Senior Director, Head of Development Parenterals at Teva. Throughout his career he has designed, coordinated, and implemented QbD programs and provided risk management trainings to product development units (quality, analytical, formulation, process chemists), and quality control, regulatory, and operations units. He understands the value of risk assessment and strategy for proactive failure reduction as opposed to reactive trouble shooting. In his interpretation of the ICH Harmonised Tripartite Guideline for Pharmaceutical Development Q9, a guidance document for QbD, LoBrutto breaks the QbD process down into three phases of risk facilitation as it relates to analytics.

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 FDA's First Draft Guidance Under DSCSA – What It Tells Us And What It Doesn't 6/23/2014

    On June 10^th, the long-awaited first draft guidance under the DSCSA was released by the FDA.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 Whatever the intent, the draft guidance does provide some learning opportunities and also a very subtle call to action.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.

54. FDA Approval Pushes Novartis Into 21st Century Vaccine Development 6/18/2014

    In 2009, the world experienced a global threat in the form of H1N1. Despite a prompt response to the need for a vaccine in the United States, it was still not available until six months later and not enough doses were even produced to cover all Americans. During the year-long battle with the deadly virus, the CDC estimates between 8,870 and 18,300 people died due to H1N1-related complications. In the world of influenza vaccine production using chicken eggs, the response experienced during the H1N1 outbreak is not uncommon. Is this the best our industry can do? Novartis says NO.

55. Riding An Acoustic Wave Into The Future Of Single Use 6/13/2014

    If you’ve ever walked out into an ocean, you’ve felt the impact of waves propagating on the surface of the water. Hit from the back and you fall forward; hit from the front and you’ll find yourself face first in the water. However, in very choppy waters, you could potentially get hit from the front by waves coming from the sea, while simultaneously being hit from the back by waves bouncing off of the shore line. If these waves are timed correctly, the equal and opposite forces could trap you in a stable position; this is referred to as a standing wave. FloDesign Sonic uses a specially-designed, 3D version of a standing wave to act as an invisible barrier (or filter) to catch cells while the remaining liquid and materials pass through. The cells group inside the standing wave and precipitate out of the fluid flow, where FloDesign Sonic uses specially-designed fluidics to continuously draw off the concentrated cells.

56. Where Do Ideas Come From? How To Transform An Idea Into A Product 5/30/2014

    Shabbir Dahod, president and CEO of TraceLink, has been working in the pharmaceutical industry for over 11 years, and in the last 30 years, has founded three companies prior to launching Tracelink. When asked how he comes up with the ideas that have brought him so much success, Dahod credits a very specific approach he learned about during the commencement speech at his wife’s college graduation. The speaker was the president of John Hancock at that time, and Dahod says he made a comment that sticks with him to this day. “He said what you need to do is look for connections and patterns from one segment to another,” says Dahod. “What it forces you to do is think a little bit more about what’s happening at the meta level. How could that pattern be applied somewhere else?”

57. AstraZeneca's Focus On Supply Chain: With Change Comes The Obligation To Respond 5/20/2014

    In the pharmaceutical industry, we have seen a number of changes over the last few years that have altered how companies operate and interact. To understand the impact of this trend and learn how some of the industry’s biggest names are adjusting to the transformation, I recently spoke to supply chain experts from AstraZeneca, GSK, Novartis, and Valeant Pharmaceuticals to find out what they’re doing to successfully ride this wave of change into the future. The first of these conversations was with Mark Holder, executive director, North American regional supply chain at AstraZeneca, who talked about how this strategic reconfiguration has required AstraZeneca to leverage their infrastructure and integrate it in a key way that saves money.

58. Merck Assesses Single Use: Does It Make Sense At A Large Scale? 5/14/2014

    In an industry as conservative as the pharmaceutical industry, it is common practice to be adverse to new technologies because they are often viewed as too much of a risk. However, in this effort to play it safe, companies force themselves into a repetitive state of employing technologies that may not be the most efficient or effective. Rather than getting stuck in old habits — or conversely, jumping too quickly into new ones — Merck has put together a group of teams it calls the Technology Encouragement Collaborators, or TEC, to look at new technologies and determine whether or not to implement them.

59. Using Spray Drying For Flu Vaccines: What Challenges Do We Need To Overcome? 4/14/2014

    When discussing the challenges of manufacturing flu vaccines, the conversation often shifts toward how manufacturers can meet the global demand each year. Currently there are some very innovative technologies aimed at addressing the challenge of manufacturing a larger supply of flu vaccines in a shorter amount of time, such as Novartis’ use of cell culture and Medicago and Fraunhofer’s use of tobacco plants. However, being able to deliver enough of a vaccine is only half the battle. It also needs to be delivered to its final destination within the appropriate temperature range. “It’s a huge misnomer for people who believe these technologies will unconstraint flu,” says Jim Robinson, VP of global technical operations, biological, and sterile products at Merck, who was involved in the manufacturing of billions of doses of flu vaccine prior to joining Merck. “The product still needs to get into a usable form and be delivered safely to the patient.”

60. BDP Week Highlights The Importance Of Communication In BioPharma 4/4/2014

    At this year’s Biopharmaceutical Development and Production (BDP) Week, March 24-27 at the Hilton Bayfront Hotel, I attended several sessions that focused on how to strengthen the relationship between partners in the pharmaceutical industry. One overwhelming theme in each presentation was the importance of communicating effectively and clearly with everyone involved in a project.