Your presentation is titled "Top 10 Mistakes you might be making in E&L." Why did you feel this topic should be shared with this audience?
This presentation focuses on and builds on several aspects of E&L testing which may be being used in the industry and challenges them as standard practice. While there is no universal approach to E&L there are best practices we all need to understand and use to help guide our approaches to this complex challenge. There are a lot of gray areas and this presentation explores several of those areas and highlights our company’s experience with them.
Why have you decided to present at Smithers E&L USA 2021?
The Smithers E&L conferences are always atop my list for presenting and attending. The E&L industry always has been a small niche. Even though it has increased over the years significantly, all the key stakeholders and subject matter experts can be found at this conference. It is also a key place to interact with regulators and discern industry trends across different products and dosage forms.
What do you hope delegates will take from your talk?
I’d like delegates to understand that every situation is unique and to be open to different approaches based on sound science. I’d also like regulators to understand the reasoning behind decisions we and others make in the industry when we are developing extractables testing protocols.
What industry barriers exist that prevent progress in commercialization? How does your presentation help to address those challenges?
Barriers have often been knowledge based in the past, and they continue to be so today. But I feel like the industry is mature enough that the barriers have evolved to be caused not by a lack of knowledge, but a misapplication of knowledge.