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The Extractables and Leachables Safety Information Exchange (ELSIE)
Consortium is comprised of pharmaceutical, biotechnology, and medical
device companies. The ELSIE Consortium:
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Collects, reviews, and compiles toxicological data on leachables and
extractables in an information-rich, database, enabling rigorous
assessments.
Current Members:
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Advances understanding of the impact of extractables and leachables on
product quality and process performance.
AbbVie
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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.
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Advances the state of the art in chemical/tox assessment of leachables
and extractables by supporting and publishing research and participating
in the global scientific and regulatory communities.
Amgen
AstraZeneca
Baxter
Biogen
Boehringer Ingelheim
Eli Lilly
ACCOMPLISHMENTS
Fresenius Kabi
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GlaxoSmithKline
LFB
Merck
Merck Serono
Novartis
Pfizer
Sanofi
AND
KEY DELIVERABLES
Created and populated a Safety Information Database with reports on over
350 compounds.
♦ Conducted a Materials Information Pilot Program to test a broad protocol
that could help companies select materials relevant for a number of
product types. The results were published in AAPS PharmSciTech.
BENEFITS OF
DATABASE
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Teva
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THE
ELSIE CONSORTIUM
AND THE
ELSIE SAFETY INFORMATION
Facilitate development of high quality and safe products for patients
Promote toxicological assessments that are more reproducible, consistent
and scientifically rigorous as they are based on the same comprehensive
and current data
Share collective knowledge and experience of consortium members on
leachables and extractables
Facilitate early understanding of risk in the pharmaceutical development
process
Reduce time and costs in literature searches and toxicology reviews
Reduce duplicative efforts and help minimize testing
Enable screening of materials and early development of drug delivery
systems and devices
Decrease the risk of substantial, unanticipated delays in bringing products
to patients
ELSIE SAFETY INFORMATION DATABASE: A VALUABLE RESOURCE
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Currently 359 compounds
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Categories of Information within the Safety Report
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Chemical information
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Acute to chronic toxicity
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Mutagenicity/carcinogenicity
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Reproductive/developmental toxicity
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Absorption, Distribution, Metabolism, and Excretion (ADME)
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Special studies (including irritation and sensitization)
Dedicated toxicologists develop and periodically update safety reports, which
are quality reviewed by ELSIE members
Full Membership:
• Research-based pharmaceutical, biotechnology, and medical device
companies are eligible to join ELSIE.
• Membership entitles each company to two seats on the Board of
Directors, representation on all Working Groups, and full access to
the safety information database.
• The ELSIE Board of Directors meets regularly to discuss ongoing
activities and identify issues and opportunities of mutual importance
to member companies.
• The Working Groups and Committees meet by teleconference on a
regular basis.
• Current fees: $39,000 per company per year.
Please Contact the ELSIE
Secretariat for a
Demonstration of the
Safety Database
Phone: + 1 202.230.5619
E-mail: ELSIEreply@dbr.com
Associate Membership:
• Research-based pharmaceutical, biotechnology, and medical device companies with a worldwide gross
revenue less than $2 billion annually are eligible for associate membership.
• Associate members can send two representatives (non-voting) to Board of Directors meetings and can
participate in all ELSIE Working Groups and Committees.
• Associate members can access ten safety reports of their choice and request one emergency report.
• Current fees: $10,000 per company per year.
Trial Membership:
• Research-based pharmaceutical, biotechnology, and medical device companies are eligible for trial
membership.
• Six month limited membership
• Cost: $3,000 per company (one time only)