Why have you decided to present at the Smithers E&L USA 2020?

We presented our first study on migration kinetics at E&L USA 2019.  With the new data from our continued studies on this topic, we wanted to share this information with the E&L community and highlight the exciting progress we’ve made so far.

This year we instead of an in person meeting the conference will be 100% virtual. What value do you think this format will add to delegate experience?

I think an 100% virtual conference in 2020 ensures that everyone can still participate and that important information can still be disseminated.  Additionally, I think the virtual aspect provides delegates with more schedule flexibility and could increase attendance for some of the final presentations of the conference that might normally be impacted by travel plans.      

Your presentation is titled "Migration Kinetics 2: Continued Study on Extractables Migration from Container/Closure Systems" can you tell us why you felt this topic should be shared with the Smithers E&L USA audience?

This topic is of interest to us at PPD because we view it as a way to potentially design better experiments that in turn could enhance deliverables to our customers and ultimately benefit the patients.  Also, some of our conclusions support current E&L practices and this should also be highlighted to the wider E&L audience.

What industry barriers/challenges exist, technical or otherwise, that prevent progress? How does this event help to address those challenges?

One of the biggest barriers, in my opinion, are the differences in the various guidance documents and expectations of the different regulatory agencies.  This event highlights these guidance documents and provides meaningful updates so that we as a community can ensure that we are keeping up with current industry standards and best practices.        

What are some of the most interesting and/or innovative solutions that are impacting your work at this time?

Another challenging problem for E/L studies is being able to identify unknown extractables and leachables.  The high sensitivity and accurate mass capabilities Q-TOF high resolution LC/MS make it possible to identify unknown extractables and leachables at trace levels.

What are you most looking forward to at the conference?

PPD is highly experienced and a recognized leader in the E&L space, but I personally am a somewhat newcomer to the E&L field, relatively speaking, so I’m interested in learning more about the updates to the industry regulations and gaining a better understanding of these guidance documents.  Also, I’m looking forward to seeing and learning more about some of the innovative advances in E&L analysis.