Through innovative collaboration, identify areas for harmonisation of oligonucleotide CMC development and regulatory strategies, and propose good practices and solutions to influence the external regulatory environment; ultimately expediting patient access to life-changing medicines.
The European Pharma Oligonucleotide Consortium (EPOC) was founded by seven pharmaceutical companies that came together to assemble and make freely available knowledge that will promote harmonisation of strategies for oligonucleotide development.
The founding companies proactively engaged with each other to form the consortium and since the beginning of 2018 have worked to develop an operating framework and have progressed the first topics of interest, evaluating and interpreting our individual experience in preparation for publication.
The consortium operates pre-competitively, not aiming to develop intellectual property, harnessing the information each company can share with the aim of publishing common findings and strategies to enable all of the oligonucleotide community, regardless of their direct involvement in EPOC, to benefit from enhanced understanding and harmonised approaches.
Teams have been set up to address the following topics, and the aim for each is to provide an output by the end of May 2019. It should be noted that these first topics focus on drug substance, reflecting the priorities identified by the consortium members.
- Starting materials – justification of the rationale for selection of staring materials (for example amidites) and guiding principles for justification of starting material specifications
- Identity testing – justify strategies for identity testing (including questioning the need for sequence testing at release).
- Solution drug substance – a balanced assessment to enable the oligonucleotide community to consider the opportunities for use of solution drug substance.
- Impurity Purging – explore the opportunities to justify the exclusion of small molecule impurities and solvents from release testing through the use of purge arguments and demonstration with data that these arguments will hold in different processes.
Current topic teams contain up to two members from each participating company; however, we are open to additional collaborators from organisations who are not part of EPOC contributing to individual papers.
EPOC will look to integrate any new companies to the consortium at the annual steering team face to face meeting (in April/May 2019). These partner companies will be expected to uphold the mission statement and ethos of the consortium (embodied in our charter), confidentiality disclosure agreement and general ways of working of the consortium.
Additional contributors to EPOC are welcomed at any time through review and contribution to ongoing papers and suggestions of future topics.
You can contact EPOC at the following email address: contact.us@EPOConsortium.com