ELSIE’S CURRENT PROGRAM AND ORGANIZATION
ELSIE is managed by a Board of Directors. The Board is comprised of two representatives from each member company and operates under bylaws approved by the Board. The ELSIE Board has formed a Working Group on Safety Information and a Working Group on Materials Information. After developing a successful prototype, the Safety Working Group has overseen the population of the Safety Information Database with data on compounds that are often seen as leachables and extractables. The safety database generally follows the format suggested by the Common Technical Document (CDT). A critical element of the safety database is the toxicological safety summary.
The operational Safety Information Database was launched in August 2011. As of February 2016, there are safety reports on more than 390 compounds in the database.
The Materials Working Group piloted a unique protocol designed to generate controlled extractables data on plastic materials that can be used in most drug product packaging and device applications. Unique features of the protocol includes creation of an extractables knowledge space over expected molding conditions and the generation of extractables data from an array of solvents chosen to cover most types of drug product applications. The pilot phase to test the controlled extraction studies protocol has recently been completed, and ELSIE expects to publish the results of the pilot soon.
All studies for the Materials Pilot Program were conducted by the following CRO’s on a voluntary basis. ELSIE is grateful to these organizations for their generous contributions and time.
The Pharmaceutical Group at Drinker Biddle and Reath, LLP provides ELSIE with scientific, legal and administrative support. The expense of this effort is shared equally, on a pro rata basis, by each member company of the consortium, pursuant to a budget agreed by the Board.