The document discusses Evotec's implementation of ChemAxon's Compliance Checker system to ensure compliance with controlled substance regulations. Compliance Checker allows Evotec to automatically check compounds against controlled substance lists during key processes like compound design, purchasing, storage, shipping and more. By integrating Compliance Checker throughout its operations, Evotec can effectively and efficiently comply with substance laws in a cost-saving manner compared to its previous manual system. The Pistoia Alliance helps fund tools like Compliance Checker that solve industry-wide compliance challenges.

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Building innovative
drug discovery alliances
Implementing CSCS with Compliance
Checker at Evotec
Compliance Checker, Pistoia Alliance RSC Evening Event 2015, 11th February 2015

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The Controlled Substance Challenge
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Controlled Substances Compliance Service
• Legislation exists at local, national and international levels to restrict the production,
import/export, supply, use and possession of certain substances
• But it doesn’t stop at research…restricted substances can be found in all areas of pharma
operations, including final products.
• Legislation has to be interpreted and
transformed from legal wording into
scientific nomenclature to be useful, i.e.
words into chemical structures e.g.
‘Acetorphine’ into
• Pharmaceutical companies must hold
multiple licenses to conduct research
across the field of restricted substances

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Commercially available systems
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 Two commercial products are now available
ChemAxon/Patcore – Compliance Checker an existing system based on
ChemAxon technology - CSCS requirements included as enhancements
Scitegrity – CS2 a system based on Accelrys technology

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About ChemAxon’s Compliance Checker
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 Developed by ChemAxon partner Patcore for the Japanese market where it is well established

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Compliance Checker
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SOAP I/FWeb Client Windows Client Command Line
Compliance Checker Server

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Why does Evotec need a (new) Compliance Checker
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 Absolute need to stay compliant (legal and commercial)
 Our existing system was updated manually (cumbersome, inefficient)
 Frequency of updates a challenge
 Regulations change frequently, keeping up-to-date and ensuring accuracy is difficult, resource
intensive and costly.
 It was only built in to some of our key processes - with a new system we would
look to integrate further
 Compliance is not optional
 Prosecution (fines, imprisonment)
 Loss of commercial reputation

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How will we use it?
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Compound Synthesis
 Within Compound Design
 Identifying matches with known drugs
 Avoiding compounds that might be covered by compliance (e.g. client requirement, or to prevent
shipping issues)
 Managing storage of intermediates and final compounds
 Checks made during the registration process
 Checks made when received for storage + regular checks made when new rules uploaded

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How will we use it?
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Compound Purchasing / Storage / Management
 When compounds are ordered a check is made for compliance requirements
 So Stores is aware of incoming compounds with compliance issues
 When compounds are received into store from vendor
 Secondary check made against vendor provided data and Compliance Checker to ensure correct
storage.
 When compounds are stored in the Lab
 Regular checks for compliance
 When compounds are returned to the Chemical Store from labs
 Check made against Compliance Checker
 Regular check of whole store (after updates)
 To ensure continued compliance

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How will we use it?
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Compound Shipping
 As a CRO, we ship compounds to our clients all over the world (as well as to our other
sites in Europe and USA
 When we ship a compound we need to ensure that the correct procedures and
documentation are followed for the country we are shipping the compound to
 Compliance Checker will be fully integrated into our dispatch workflow (rather than being a
manual process)

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Conclusions
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 By integrating Compliance Checker into all processes where compounds are handled we are
using commercial best efforts to stay abreast of current legislation (and to comply with existing
laws).
 ChemAxon’s Compliance Checker helps us to do this effectively and efficiently
 We see a real life cost saving compared with our previous methodology
 It is only through the support of the Pistoia Alliance that tools like this get funded, get the
community involved and solve problems that every company has…

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Your contact:
Building innovative
drug discovery alliances
Ian Berry
Global Informatics Delivery Leader, Evotec
Ian.Berry@Evotec.com
@PistoiaAlliance #UpAtNight