Thinking Inside – and Outside – the Box

How did you decide the focus of your career?

You’re probably wondering how you can get excited over packaging! But medicines save lives and packaging is an important element in the protection and safety of medicines – it’s very rewarding. Packaging materials and configurations must be proven suitable for each pharmaceutical product and process throughout the whole lifecycle of the product. It is stimulating to look at all the different dependencies and measurements that influence the performance, safety and compatibility of each packaging component, as well as what happens under various processing conditions and with different types of pharmaceutical products. That’s what really excites me – and, even after 25 years, the learning never ends.

How did you get started in industry?

I started out as an associate analytical chemist. I worked in a small contract lab that specialized in applied research and I worked with some brilliant scientists who really took the time to teach. We worked across many industries and the role gave me a great opportunity to understand material chemistry and applications. I was there for about 20 years. West purchased our laboratory and we combined forces – West’s expertise in drug delivery and packaging, and our lab’s knowledge of analytical chemistry. It’s a great combination in light of the emphasis on quality by design to meet the needs of patients. You begin by identifying the patient’s target needs, and then build a final product to meet the defined requirements. Having appropriate packaging – and evidence to support its compatibility and safety – is a key part in that process.

Outside of your day job, you’re very much involved with industry groups and associations…

Yes – it’s like my second job, although I don’t get paid for it! It’s a great avenue to help connect with like-minded colleagues and to share knowledge – and in the end we all grow. I’ve been involved with the Parenteral Drug Association (PDA) for around 20 years. Most of the activity there has focused on leachables and extractables, and my background in materials analysis is really good for this type of discussion. I also chair conferences and co-develop training courses for the PDA on leachables and extractables, and I'm involved in ongoing efforts to modernize and update chapters in the United States Pharmacopeia (USP). I am now in my sixth year of serving on committees and expert panels. In 1999, I was nominated to be a member of the Product Quality Research Institute (PQRI), which is a forum that promotes critical thinking to advance drug product development and I have been participating in Working Groups ever since. It’s a huge benefit and a great experience because you can see the full circle of how analytical chemistry and the results are being used to solve real-life industry problems.

What is your current focus with these industry groups?

Right now, I’m chairing PQRI’s working group for parenteral and ophthalmic leachables and extractables. We’re working very closely with the US FDA to understand the agency’s perspective and what it thinks should be included in best practice guides in this area. One of the great things about PQRI is that the forum allows exchange of relevant (non-competitive) information without judgment or consequence, so ideas can be discussed very freely. It’s very much about working together to overcome problems. One revelation for me from talking and meeting with people from the FDA was that they looked to us for help on understanding appropriate information on leachables that will ultimately help patients. Helping people to understand good science is the mission of our PQRI working group; we provide recommendations for best practices on leachables and extractables – and then travel nationally and internationally to explain and train others on the concepts.

What are the hot topics in packaging?

Some of the most-talked about issues are container-closure integrity, particles and compatibility, among other safety issues. The ever-growing field of biologics is another area of focus since the many types of materials used to manufacture, store and deliver biologics can impact the products’ quality and safety. The risks to patients really depend on the combination of each unique packaging system with the biologic – and identifying and mitigating these risks from the outset, which is much easier than trying to fix them once they’ve occurred. It’s a huge area that we’re still learning about. A lot of work is being done on correlating biologics to different types of container closure system interactions. The key lies in acquiring appropriate data and interpreting that data.

How do you think the industry should tackle the challenges?

I believe that we must build trusted partnerships that can advance the science and innovation of product development. Unfortunately, intellectual property remains a challenge; it’s not always possible to share certain information while protecting business intelligence or when looking for a competitive advantage. I enjoy working with outside organizations because it’s a non-competitive environment where I can work to understand and advance science based on common interests. There can be tension between suppliers and pharmaceutical companies but alignment of expectations and cooperative scientific exchange will enable quality medicines to be delivered to patients. I’d like us all to work closer and I’m sure that we will be able to find ways of doing this in the future – we certainly need to.