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Pistoia Dragon’s Den

Restricted Compound List Management

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Business Challenge

• Legislation exists at local, national and international levels to restrict the production, import/export, supply, use and possession of certain substances

• Pharmaceutical companies must hold multiple licences to conduct research across the field of restricted compounds

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Business Challenge

• Legislation is constantly evolving and becoming more complicated as it attempts to mirror developments in substance abuse

U.S. bans chemicals in "bath salts" street drug

methylenedioxypyrovalerone (MDPV)

mephedrone

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Vision for this Project

‘The list’ – a single source of restricted compound knowledge for the pharmaceutical industry

– Totally comprehensive in regards to current legislation– Have knowledge of all pending/proposed legislation – keep the pharma

industry ‘ahead of the game’– Have global coverage – it must be possible to check against the restricted

compound law in any country/region or check against global legislation– Have complete and correct interpretation of legislation, this interpretation

being confirmed by the legislative body concerned– Ideally be ‘certified’ by governments, i.e. use this list and you will be

compliant– The list to be provided as required by the industry – Individual Structures

(Molfiles, SMILES, INCHI, etc) , Markushes, Compound Names (INN, Trademark, etc), CAS No’s, other identifiers as required, legal status, legal documentation, etc.

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Business Case: Restricted Compounds List• Project cost

– $300,000 one-time, plus $100,000 annually

• Value Created– Reduce annual cost of $100,000 per

company