Amgen is committed to serving the needs of patients facing serious illness. We work to advance this mission by developing novel therapies, and also by supporting externally sponsored clinical research. We are happy to receive, review, and respond to unsolicited proposals from qualified health care professionals, scientists, and researchers with promising ideas in areas of mutual scientific interest. The investigator sponsored studies to which we extend support are those that are based on scientifically sound proposals to advance science, clinical medicine, and patient care. We also expect results from any externally sponsored research that Amgen supports to be communicated in appropriate scientific forums, including peer-reviewed publications. This website provides information to researchers interested in submitting a proposal to Amgen for an Investigator Sponsored Study. Click here for more information on Amgen’s pipeline.
An ISS is a clinical study that is initiated, developed, designed, and conducted by a qualified sponsor external to Amgen who assumes sole responsibility for the conduct of the study. An ISS can take a variety of forms. For example:
Amgen will consider external proposals from a variety of potential ISS sponsors, including but not limited to:
For interventional studies, where appropriate, the ISS sponsor or appointed representative will hold the Investigational New Drug (IND) application or equivalent clinical trial authorization and be responsible for overseeing the study and/or administering study drug to human subjects.
Amgen will only provide support for an ISS with research merit that aligns with Amgen’s product specific strategy and areas of research interest. A summary of the areas of research interest can be found by clicking on the appropriate therapeutic area link below.
For any questions pertaining specifically to the requirements of your ISS proposal submission, contact your Amgen Medical Science Liaison (MSL) or email us at Web-ISS-Query@amgen.com
Nonclinical proposal submission has a prerequisite of preliminary discussion having occurred with a representative of Amgen Global Medical Organization. START HERE