Amgen’s decision to support a proposal will be based on its research merit and alignment with our therapeutic development strategies (see Therapeutic Areas and Areas of Research Interest). We have committees of medical and scientific staff from different therapeutic areas, and these committees review external research proposals on a regular basis. Amgen will communicate feedback for a proposal generally within 40 days of receiving a complete submission. If a sponsor is invited to submit a full protocol, it also will be reviewed by a committee of medical and scientific staff. Please note that Amgen's interest in a proposal does not guarantee we will ultimately support the submitted protocol.
Amgen’s financial and/or product support is contingent upon full execution by both parties of Amgen’s standard research agreement. As required by law, we disclose financial support provided to researchers and their institutions.
Requirements that need to be met for Amgen to consider support of your ISS proposal (and potential ensuing protocol) include, but are not limited to the following:
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You are qualified in terms of background, education, and experience to conduct and complete the proposed research
- You are not debarred, disqualified, restricted or excluded from engaging in activities relating to development or approval of drugs by any regulatory authority
- If research involves treatment of patients, your license is current
- You assume all responsibilities and obligations to comply with all relevant laws and regulatory requirements (e.g. Good Clinical Practice and safety reporting regulations)
- You or your appointed representative holds the IND or equivalent clinical trial authorization (as applicable)
- You provide safety reports to Amgen, in accordance with the research agreement
- You provide study status updates in accordance with the research agreement
- You submit the final study report and manuscript, as applicable and in accordance with the research agreement