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How
clients have benefited
In Drug Development:
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Chemistry, Manufacturing and Controls
(CMC) documents were provided in support of >10 Investigational New Drug
Application (IND), New Drug Application (NDA), and postapproval filings
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Chemistry concerns raised by
regulatory agencies were successfully addressed
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Two drugs received
U.S. marketing approval
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Active pharmaceutical
ingredients (APIs) and drug products were manufactured under cGMP,
enabling clinical trials
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Technical challenges were solved in
API synthesis
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API manufacturing costs were reduced
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Toxic and environmentally hazardous
chemistry was eliminated from an API synthetic process
In Drug Discovery:
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Several chemical series were
prioritized according to their potential to yield drug-like leads
for an anti-cancer target
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The binding mode, structure-activity
relationships and likely sites of off-target binding were elucidated
for two leading chemical series
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Predicted off-target binding was
experimentally verified for several key cross-reactivity sites
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Testing strategies were designed and
implemented for efficient prioritization of new compounds and
minimization of off-target interactions
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New analogs with improved selectivity
for the desired target were identified
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Patent applications were carefully written,
Examiner concerns were addressed and patents were issued
In Litigation:
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