Compound Exchange Standards

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Ramesh Durvasula (BMS) provides an overview of this potential Pistoia Alliance working group during the Dragons' Den session at the Pistoia Alliance Conference in Boston, MA, on April 24, 2012.

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Compound Exchange Standards

  1. 1. Pistoia Dragon’s DenRestricted Compound List Management 1
  2. 2. 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 2
  3. 3. Business Challenge • Legislation is constantly evolving and becoming more complicated as it attempts to mirror developments in substance abuse mephedrone U.S. bans chemicals in "bath salts" street drugmethylenedioxypyrovalerone (MDPV) 3
  4. 4. Vision for this Project‘The list’ – a single source of restrictedcompound knowledge for the pharmaceuticalindustry – 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. 4
  5. 5. 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 5

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