ARTICLES BY TRISHA GLADD
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FDA’s First Draft Guidance Under DSCSA – What It Tells Us And What It Doesn’t
On June 10th, the long-awaited first draft guidance under the DSCSA was released by the FDA.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 Whatever the intent, the draft guidance does provide some learning opportunities and also a very subtle call to action.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.
Building A Logistics Facility For The Future
When AmerisourceBergen, a global pharmaceutical sourcing and distribution services company, decided to build a new distribution center, their focus was twofold. First, they wanted to ensure they built a facility that offered the efficiency the manufacturing community needs. Second, in order to meet patient and customer needs, they had to be able to maintain product availability. To do this, they came up with a design they refer to as a “single-drop” facility.
3 Steps To Successful Cold Chain Shipping
Over the course of time, temperature-sensitive shipping models have become very complex. This is a result of several factors that include an increase in stakeholders, more products in demand of temperature control, and new regulations. As the complexity of the cold chain increases, it becomes more important for everyone involved to make the solutions as consistent and simple as possible.
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.”
Lo Jack SCI Partnership Integrates Cold Chain Solutions
Maintaining a product’s quality throughout shipment is a challenge in any industry, but delivering pharmaceuticals in the cold chain can be especially challenging because of the consequences related to temperature excursion. For this reason, Ted Wlazlowski, CEO and president of LoJack SCI, a company specializing in cargo and freight security, believes it’s necessary to offer clients both strategic planning and security for their cold chain shipments. And through their recent partnership with Modality, a supply chain environmental assessment and engineering solutions company, this is now possible.