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Welcome to ELSIE

The Extractables and Leachables Safety Information Exchange (ELSIE) Consortium formed in 2007 seeking to be the leading industry voice and scientific resource on extractables and leachables (E&L). The consortium is comprised of pharmaceutical, biotechnology, and medical device companies.

The ELSIE Consortium

  • Collects, reviews, and compiles toxicological data on leachables and extractables in an information-rich database, enabling rigorous assessments.

  • Advances understanding of the impact of extractables and leachables on product quality and process performance.

  • Provides opportunities to share and leverage experiences, insights, and practices with respect to the potential safety impact of drug product packaging, delivery and manufacturing systems.

  • Advances the state of the art in chemical/toxicological assessment of leachables and extractables by supporting and publishing research and participating in the global scientific and regulatory communities.

2022 Year in Review

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Public Call for Expert in Sensitization Assessment of Extractables and Leachables (E&L) in Parenteral Drug Products - Deadline May 17

ELSIE is seeking an expert to join in discussions on: the development of a framework for sensitization assessment of E&Ls in parenteral pharmaceutical products through in silico sensitization analysis of an E&L dataset (~800 compounds from ELSIE and PQRI databases); expert review of sensitization data and potency classifications; for substances classified as a sensitizer, experimental or predicted potency values converted to a dose (µg/day) and distribution plotted to compare to existing safety thresholds. The ELSIE Sensitization workstream will evaluate the candidates and make the final recommendation for membership. Click here for more background and details on this volunteer role.

The ELSIE Consortium is proud to acknowledge the dedication and commitment of its members. Each year ELSIE presents awards to participants who made significant contributions to ELSIE initiatives. 

In 2022 the ELSIE Chair Awards went to Melisa Masuda-Herrera (Gilead Sciences) and Petra Booij (GSK) for their outstanding leadership and many contributions.

2022 ​ELSIE Excellence Recognition Awards Recipients:

  • Atish Sen (AstraZeneca)

  • Geraldine Whelan (GSK)

  • Stephen Warren (AstraZeneca)

  • Martyn Chilton (Lhasa Limited)

  • Carsten Worsøe (Novo Nordisk)

  • The Sensitization Subteam: Shawn Bairstow (Baxter), Joel Bercu (Gilead Sciences), Uma Bruen (Organon), Anders Burild (Novo Nordisk), Courtney Callis (Eli Lilly), Jessica Graham (Genentech), Troy Griffin (Teva), Jedd Hillegass (BMS), Esther Johann, Claire Kent (AstraZeneca), Agnes Koenig (BBraun), Kim Li (Amgen), Elizabeth Martin (AstraZeneca), Alina Martiosyan (BBraun), Melisa Masuda- Herrera (Gilead Sciences), Trish Parris (Pfizer), Constanca Porredon-Guarch (BBraun), Matt Schmitz (Takeda), Brad Stanard (Ultragenyx), Eric Tien (Biogen), Geraldine Whelan (GSK), Jessica Whritenour (Pfizer)

  • The TTC Subteam: Ragheb Abu Rmaileh (Hikma), Shawn Bairstow (Baxter), Tyler Bell (Takeda), Joel Bercu (Gilead Sciences), Thomas Broschard (EMD Serono), Uma Bruen (Organon), Anders Burild (Novo Nordisk), Courtney Callis (Eli Lilly), David Dolan (Amgen), Qiang Fu (Hikma), Jessica Graham (Genentech), Troy Griffin (Teva), Catrin Hasselgren (Genentech), Michael Helfrich (EVER Pharma), Michael Hessenberger (EVER Pharma), Jedd Hillegass (BMS), Esther Johann (EMD Serono), Naga Koduri (Hikma), Agnes Koenig (BBraun), Penny Leavitt (BMS), Andreja Lesnik (Xellia), Daniel Lettiere (Pfizer), Elizabeth Martin (AstraZeneca), Melisa Masuda-Herrera (Gilead Sciences), Eric Morinello (Genentech), Wolfgang Muster (Roche), Trish Parris (Pfizer), Matt Schmitz (Takeda), Brad Stanard (Ultragenyx), Bola Taiwo (Baxter), Yi Yu Rice (Amgen)

ELSIE Members:

Click here for an overview of ELSIE Membership options.

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