ARTICLES BY TRISHA GLADD
How To Prepare A Facility For The Biopharmaceutical Revolution
Drug discovery is an inherently inefficient process. It takes thousands of failed compounds before one can get approved as safe and efficacious, and this effort does not come at a low cost. Because of this, the industry is constantly looking for ways to bring safe, compliant, and profitable drugs to market faster and cheaper. Patheon facility in Brisbane, Australia, exemplifies the facility needed to survive the future of pharma. But how did they do it?
Analytical QbD at Teva: Knowledge Is Power Only When You Share It
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.
FDA’s First Draft Guidance Under DSCSA – What It Tells Us And What It Doesn’t
On June 10th, the long-awaited first draft guidance under the DSCSA was released by the FDA.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 Whatever the intent, the draft guidance does provide some learning opportunities and also a very subtle call to action.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.
FDA Approval Pushes Novartis Into 21st Century Vaccine Development
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.
Where Do Ideas Come From? How To Transform An Idea Into A Product
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?”
AstraZeneca’s Focus On Supply Chain: With Change Comes The Obligation To Respond
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.
Merck Assesses Single Use: Does It Make Sense At A Large Scale?
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.
Using Spray Drying For Flu Vaccines: What Challenges Do We Need To Overcome?
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.”
BDP Week Highlights The Importance Of Communication In BioPharma
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.
Where Do Ideas Come From? Time Is Money, So Spend It Wisely
In a traditional office environment, hours upon hours are often spent collaborating with other people to come up with game-changing ideas. Even the time spent alone at your desk can be occupied with juggling multiple responsibilities and tasks. It’s usually only during downtime at the end of the day, whether it’s a quiet ride home in the car or lying in bed at night, that we allow ourselves time to relax and reflect. Tony and Oliver Stauffer, president and chief operating officer at Packaging Technology & Inspections, as well as father and son, believe it’s during these moments to ourselves that we have the ability to come up with some of our best ideas.