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Welcome to the Investigator Sponsored Studies (ISS) Portal

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.

Investigator Sponsored Studies (ISS) and ISS Sponsor

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:

  • An ISS can involve a licensed or unlicensed Amgen product(s)
  • It can be based on a disease area of interest (e.g., a specific tumor type)
  • It can be interventional or observational, including but not limited to health economic studies, epidemiological research, or analyses of existing data

Amgen will consider external proposals from a variety of potential ISS sponsors, including but not limited to:

  • Investigators/Researchers
  • Healthcare providers
  • Members of the scientific community
  • Healthcare institutions
  • Academic medical centers
  • Colleges and universities
  • Networks and cooperative groups
  • Government research institutions

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.

ISS Overview

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.

Process Summary

ISS PROCESS

Sponsor
  • Initiate ISS proposal and submit to Amgen
  • Submit CV and preliminary funding request
  • Sign Confidential Disclosure Agreement (as applicable)
Amgen
  • Review proposal
  • Communicate decision to decline proposal or invite submission of full protocol for review
  • Initiate Confidential Disclosure Agreement (as applicable)

1. Proposal Review

Sponsor
  • Develop full protocol and submit to Amgen
Amgen
  • Review protocol
  • Communicate decision to decline or support protocol

2. Protocol Review

Sponsor
  • Submit detailed budget to Amgen (as applicable)
  • Provide required documents
  • Confirm location of sites for drug shipment
  • Execute research agreement
Amgen
  • Perform Fair Market Value assessment
  • Review all required documents
  • Initiate and execute research agreement
  • Ship drug to site(s)

3. Start-Up

Sponsor
  • Conduct study
  • Provide safety reports and study updates per research agreement
  • Manage drug supply inventory (as applicable)
  • Submit invoices for contractual milestones
Amgen
  • Monitor progress and provide appropriate safety and regulatory updates
  • Manage ongoing drug supply shipments
  • Verify completion of contractual milestones and issue payments

4. Conduct

Sponsor
  • Submit final study report and manuscript, as applicable, in accordance with research agreement
  • Support closeout reconciliation (safety reports, drug supply, milestone invoices)
Amgen
  • Reconcile final deliverables against research agreement
  • Issue final milestone payment

5. Close-Out

Requirements and Responsibilities of Sponsor

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:

  • 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

Areas of Research Interest

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.

Bone

Product: Evenity® (romosozumab)

Areas of Research Interest
  • Advancing the understanding of the osteoporosis treatment landscape and the burden of osteoporosis
  • Preclinical studies to advance the understanding of sclerostin biology
  • Romosozumab use in sequential/combination therapy studies, bone imaging studies, bone-related conditions

Product: Prolia® (denosumab)

Areas of Research Interest
  • Advancing the understanding of the osteoporosis treatment landscape and the burden of osteoporosis
  • Advancing the understanding of Prolia in approved indications
  • Studying Prolia in situations of high unmet medical need
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Cardiovascular

Product: AMG 423

Areas of Research Interest
  • Not currently accepting ISS proposals

Product: Corlanor® (ivabradine)

Areas of Research Interest
  • Not currently accepting ISS proposals

Product: Repatha® (evolocumab)

Areas of Research Interest
Only studies including adults ≥ 18 years
  • Mechanistic studies - evaluating the relationship between PCSK9 inhibition and non-LDLR effects, immune function, thrombosis , vascular wall biology, effects  on other organ systems.
  • Imaging studies - with a preference for functional/perfusion imaging studies (rather than purely anatomical studies)
  • Patient characterization studies - Subpopulation identification of high unmet need for LDL reduction with high risk of CVD ; epidemiology studies; strategies to improve  compliance and persistence ; solid organ transplantation.
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Inflammation

Product: Enbrel® (etanercept)

Areas of Research Interest
  • New insights into Enbrel efficacy in rheumatoid arthritis, psoriasis, psoriatic arthritis
  • New insights into Enbrel safety in rheumatoid arthritis, psoriasis, psoriatic arthritis
  • Evaluate disease states which have inflammatory and/or autoimmune pathology
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Hematology/Oncology

Product: BLINCYTO® (blinatumomab)

Areas of Research Interest
Addressing questions in ALL:

  • Sequencing with CAR-Ts
  • Sequencing with transplant
  • Curative strategies and expansion of cure fraction studies
  • Addressing high disease burden
  • Chemo sparing/minimization approaches
  • Combinations including with other immuno-oncology drugs
  • Home administration and reduced hospitalization
Investigating other CD19 positive diseases in areas of unmet needs including curative strategies and MRD-driven studies

Product: IMLYGIC™ (talimogene laherparepvec)

Areas of Research Interest
  • Injectable solid tumors
  • Combination with approved chemotherapy, approved targeted therapy, approved immunotherapy
  • Combination with radiotherapy
  • New settings eg neoadjuvant therapy, post-PD-1/PD-L1 refractory disease
  • Research that addresses mechanism of action of talimogene laherparepvec
  • Biomarker and tumor microenvironment immune profiling (pre- and post- treatment)
  • Investigation (mono- or combo) in cutaneous/subcutaneous or nodal metastases of various tumors eg non-melanoma skin cancers, anal and cervical squamous cell carcinoma

Product: Kyprolis® (carfilzomib)

Areas of Research Interest
  • Combinations/sequencing with immuno-oncology agents in Multiple Myeloma
  • Curative intent Minimal Residual Disease driven studies in Multiple Myeloma
  • Modalities to overcome resistance to carfilzomib in Multiple Myeloma
  • Treatment sequencing concepts to optimize clinical outcomes, with particular focus on 1st relapse
  • Safety or outcome observational studies that address a defined data gap in Multiple Myeloma
  • Regimens that can safely address unmet need in Multiple Myeloma patients (i.e. elderly frail, high-risk) or other indications with strong scientific rationale (i.e. WM, T-cell lymphoma)

Product: NEUPOGEN® (filgrastim) / Neulasta® (pegfilgrastim)

Areas of Research Interest
  • Myelosuppressive potential role of Neupogen/Neulasta and myelosuppressive chemotherapy
  • Research that address febrile neutropenia burden
  • Research that address relative dose intensity, febrile neutropenia risk assessments, barriers to appropriate use

Product: Nplate® (romiplostim)

Areas of Research Interest
  • Immune thrombocytopenia
  • Myelodysplastic syndromes
  • Chemotherapy-induced thrombocytopenia
  • Stem Cell Transplant
  • Chronic Liver Disease

Product: Vectibix® (panitumumab)

Areas of Research Interest
  • Biomarkers in colorectal cancer
  • Epidermal growth factor receptor resistance in colorectal cancer
  • Combination studies and treatment sequencing in colorectal cancer

Product: XGEVA® (denosumab)

Areas of Research Interest
  • Potential anti-tumor effects
  • Skeletal related events (Preference / Compliance / Tolerability / Quality of Life / Pain)
  • Health economic evaluations
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Neurology

Product: Erenumab

Areas of Research Interest
  • CGRP-related preclinical and clinical pharmacology studies
  • Studies on migraine pathophysiology, burden of disease, and real-world impact of migraine
  • Potential role of Erenumab in conditions in which CGRP dysregulation may occur
  • Therapeutic role of Erenumab in migraine
START HERE

Nephrology

Product: Parsabiv™ (etelcalcetide)

Areas of Research Interest
  • New insights into Parsabiv efficacy in Secondary Hyperparathyroidism and associated labs (Ca, Phos, PTH)
  • New insights into use of Parsabiv and its tolerability profile, such as in those who have failed prior use of cinacalcet
  • Evaluate benefit of IV administration with Parsabiv
  • Use in home hemodialysis

Product: Aranesp® (darbepoetin alfa)

Areas of Research Interest
  • Not currently accepting ISS proposals

Product: EPOGEN® (epoetin alfa)

Areas of Research Interest
  • Not currently accepting ISS proposals
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Contact Information

For any questions pertaining specifically to the requirements of your ISS proposal submission, contact your Amgen Regional Medical Liaison (RML) or email us at Web-ISS-Query@amgen.com