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.

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