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Pistoia Dragon’s Den




Restricted Compound List
       Management




                           1
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
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 drug




methylenedioxypyrovalerone (MDPV)                                                     3
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.


                                                                                            4
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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Compound Exchange Standards

  • 1. Pistoia Dragon’s Den Restricted Compound List Management 1
  • 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. 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 drug methylenedioxypyrovalerone (MDPV) 3
  • 4. 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. 4
  • 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