Ian Berry's slides from the Pistoia Alliance RSC Evening Event 2015.

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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