Ahead of Extractables and Leachables Europe 2022, we spoke to James Vergis, Director Science, Research, & Innovation at ELSIE Secretariat.
Our interview covered an exclusive preview of his presentation on 'The ELSIE Knowledge Base: A novel research tool to advance collaboration on safety and extractables evaluation', as well as James' thoughts on the major challenges currently facing E&L professionals and ELSIE's current priorities and activities.
Your presentation will look at the ELSIE Knowledge Base. Can you give us a snapshot of what delegates will hear?
My presentation on the ELSIE Knowledge Base will review the effort to evolve our current Safety Database – a repository of safety reports generated from public-domain toxicology information on over 500 compounds commonly identified as extractables or leachables.
My presentation will describe the rationale and business case for creating a knowledge system that will contain both toxicology study information and extractable study information obtained from test articles all gathered not only from the public domain, but also from our members, suppliers and manufacturers, and joint studies conducted by ELSIE.
I will highlight key features of the data model and database software. These highlights will include video demonstrations walking through various use cases along with examples of toxicology and extractables report generation.
Tell us more about ELSIE’s priorities and current activities, and how this meeting supports that work, especially as you are supporting this year’s conference?
ELSIE’s core priority is promoting safety and quality in the field of E&L. ELSIE achieves this through sharing information and best practices, including providing comments and thought leadership on regulatory guidances, advancing the science by publishing in peer-reviewed journals, sponsoring workshops and webinars, and participating in various conferences and events relevant to the E&L and toxicology.
For the E&L Europe Conference in particular, ELSIE and its member representatives regularly attend as we view this conference (along with the USA-based version) as an important event to learn about the latest in the E&L space and engage with experts and stakeholders in the field. This conference is the perfect venue to debut the ELSIE Knowledge Base ahead of its official launch early next year.
What do you see as the major challenges that E&L professionals in general are facing? How might that change in the near-mid future – anything evolutionary/revolutionary on the horizon?
Like most industries, E&L professionals are being asked to “do more with less” which presents unique challenges when your overall goal is as critical as ensuring patient safety. This coupled to trends like new modalities, cell and gene therapies, the need for global harmonization, and an increase in new, and sometimes more complex combination of materials, drug products, delivery platforms and medical device types all contribute to some major challenges for E&L Professionals to acquire sufficient data or gather enough information to conduct a proper risk assessment. To address this, multiple stakeholders including regulators and suppliers are looking for better ways to obtain and/or share extractables related data that will help them to reduce leachables related risks.
Some other companies are applying existing and developing new predictive models to simulate and estimate the extractables and leachables based upon the physical properties and composition of the materials used in a process, packaging or device itself. These predictions can be used to, for example, inform the experimental design parameters in a E&L studies. In the future as these predictive models become further validated and accepted, they will become more than just a tool to guide experimental design but perhaps support submissions to regulatory authorities.
For this to happen, data will be needed to mature and test the models along with collaborations among stakeholders in the E&L community and regulators. ELSIE is exploring a possible initiative in this area, particularly where collaborative approaches are needed and investigating how to potentially incorporate the required modelling parameters into our Knowledge Base data model.
What are you most looking forward to hearing about and discussing with your peers at E&L Europe 2022?
Since I am immersed in ELSIE activities related to the Knowledge Base, I am most looking forward to learning about the case studies, the unique experiences and perspectives, and workflows in the E&L space in order to reflect on how these could be accommodated by the ELSIE Knowledge Base and if they can’t how we extend the Knowledge Base to accommodate them. I am also interested in discussing the importance of data sharing and joint studies to the community.
ELSIE’s guiding principle is “we should not compete on safety; sharing data and open dialogue are essential.” The sharing or co-generation of data benefits everyone by increasing the available information and having it readily available. This allows for informed and quicker decisions which potentially have the downstream effect of bringing products to market sooner and benefiting patients.