cscs expert community business case for cscs iii - 2016
TRANSCRIPT
CSCS Expert Community
Business case for CSCS III - 2016
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CSCS Future
Situation• There are topics and issues that are worth investigating• We would also like to keep meeting to share best practice and
continue to build links to regulators
Proposal• CSCS continues to run in order to complete feasibility studies
for areas that could become new projects in their own right• China import/export declarations• Energy-rich compounds• INCB de-minimus standards
• And the group would have the potential to take on more if they arose
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Enhancing best practice
Feasibility Studies
CSCS Expert Community
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2016
Regulator communication
China import/export declarations
Discussion
INCB de-minimus exemption
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China Import/Export declarationsProblem Statement• China requires explicit declaration of any compounds being imported or
exported. This is unique in the world and make it difficult to conserve research confidentiality.
Current practice• Companies provide generic descriptions, but these vary from company to
company and aligning them with HTS codes is difficult.• There is limited software that can support the process. Either unreliable or
does not cover China
ProposalInvestigate the feasibility of encouraging the creation of a commercial system that would automatically generate HTS codes and compound descriptors for China
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China Import/Export declarations
Feasibility Study output
A business case including:• What level of investment would be required to create such a system?• Is there ‘in principle’ vendor interest?• What level of benefit is there for life science companies?• What resources are required to execute a Pistoia Alliance project to support
the creation of such a system?
A test set of compounds that could be used to test such as system
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INCB de-minimus limits
Problem Statement• Currently many countries do not discriminate between the import of
screening compounds in nM quantities and kgs of material.
Current practice• Even the smallest quantities are declared or taken out of screening sets.
Proposal• The group explore ways of contacting the INCB and encouraging them to put
de-minimus limits on import/exports. • We believe that countries would then implement in agreement with their
treaty obligations.
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INCB de-minimus limits
Feasibility Study output
An assessment of the processes in the INCB.A summary of the individuals and roles involved and any contacts our members have.An assessment of the likelihood of being able to influence the thinking.
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Leadership and Funding
Leadership• Derek is stepping down at the end of December. • Zofia Jordan (GSK) has stated she would be willing to lead
from January.
FundingFunding requirement for the group for one year - $45KThis includes• Paid management support for 1 day per week• 10% Pistoia Alliance project taxWe will look to expand the contributors from the present set of 5 to ~10 and ask for ~$5K each.
