ELSIE - A Brief History
The Extractables and Leachables Safety Information Exchange (ELSIE) was established in 2007, when Doug Ball (then at Pfizer) and Jon Cammack (then at Baxter) brought together leading scientists to advance the concept of sharing pre-competitive safety information on extractables and leachables, among industry. The vision was that such a collaborative effort would reduce duplicative safety studies across companies, streamline development projects, and allow industry and other stakeholders to share experiences and information to help advance the practice and science of extractables, leachables and materials evaluation. A driving ethos for ELSIE’s formation, as articulated by founding Board member Lewis Kinter (then at AstraZeneca), was that “companies should not compete on safety”. ELSIE’s mission is to facilitate its member companies’ ability to efficiently and effectively develop safe, efficacious products that sustain and save lives.
“With the guiding principle ‘we do not compete on safety,’ the ELSIE Consortium has fostered exemplary collaboration across the pharmaceutical industry.”
Founding ELSIE Chair
“The ELSIE Consortium has the ability to properly and effectively shape the future of E&L thanks to its Safety Information Database, numerous contributions to the scientific literature, and active participation in scientific debates.”
Former ELSIE Chair
In its formative years, ELSIE’s founding member companies initiated creation and population of the Safety Information Database, starting with 30 high priority compounds identified by the members. In parallel, ELSIE members developed a comprehensive extractables protocol and tested it with the objective of creating a streamlined protocol focusing on key solvents and techniques that could serve as a generally applicable protocol for a wide range of plastic materials and components, and as a platform for generating extraction data that could be shared among the members. These early efforts led to a significantly expanded Safety Database, now containing reports on nearly 500 compounds; and a series of publications on the protocol testing pilot. The consortium is developing the next phase ELSIE Knowledge Base, which will combine compound safety information with material and chemical data. ELSIE has expanded its activities to include active outreach to global regulators and standard-setting bodies, including commenting on guidelines and standards, and working with FDA, to develop and present a regulatory training course on E&L assessment. ELSIE has also held impactful
workshops, and webinars addressing safety risk assessment and development of PDEs, materials quality and supply chain engagement, and single-use systems. ELSIE members regularly present on ELSIE work at leading conferences worldwide.
Twelve years later, ELSIE is a thriving consortium of 22 diverse companies, spanning biotech, pharma, and medical devices. ELSIE continues to be the preeminent organization recognized for its expert knowledge of E&Ls in the biopharmaceutical and medical device industry.
Core Objectives of ELSIE
Advances principles of Quality by Design by enhancing the prospects for identifying potential safety issues at the initial stages of the development processes.
Supports member companies’ regulatory filings.
Reduces duplication of effort and minimize testing.
Decreases the risk of substantial, unanticipated delays and associated costs.