What is it about?
EPOC has been set up to enable pre-competitive sharing of prior knowledge on oligonucleotide development, with the aim of achieving consensus within the industry and initiating discussions with regulators on a harmonised approach. As a first step, the consortium is preparing papers on four topics; starting material justification and specifications, identity testing, purge arguments for small molecule impurities and solvents, and solution API.
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Why is it important?
There is currently a lack of regulatory guidance for oligonucleotide development and a lack of consensus within the industry on the most effective approach. This is partly due to the small number of oligonucleotide therapeutics approved and consequent lack of published data. EPOC is committed to bring prior knowledge together to provide a baseline for oligonucleotide development and use this as the basis for discussions with regulators, and ultimately provide input to ICH considerations on oligonucleotides.
Perspectives
Having worked within the pharma industry for over 30 years I have found it frustrating that effective decision making within drug development programmes can be hampered by ‘missing’ knowledge/information that may actually be available. The increase in interest in pre-competitive collaboration between companies is encouraging, and I am excited by the potential for collaboration that EPOC provides. Pooling information and know-how should help establish a wider knowledge base that will benefit all participants and ultimately bring medicines to patients more quickly.
Malcolm Hill
GlaxoSmithKline Plc
Read the Original
This page is a summary of: European Pharma Oligonucleotide Consortium, Therapeutic Innovation & Regulatory Science, August 2018, SAGE Publications,
DOI: 10.1177/2168479018793626.
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