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Clinical Submissions

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 product support are subject to execution of Amgen's standard research agreement. Prior to proceeding with a proposal, please review Amgen's required legal terms with your institution to ensure alignment. 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 burden of fragility fractures
  • Advancing the understanding of sclerostin biology
  • Advancing the understanding of EVENITY in approved indications
  • Studying EVENITY in situations of high unmet need

Product: Prolia® (denosumab)

START HERE

Cardiovascular

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.
START HERE

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

Product: Otezla® (apremilast)

Areas of Research Interest
  • Specific disease manifestations (e.g. locations, itch) and comorbidities associated with PsO or PsA, and neutrophilic driven disease
  • Maintenance of efficacy, including post biologics / persistence
  • APR mechanism of action

Product: Tavneos® (avacopan)

Areas of Research Interest (US Submissions Only)
  • Real-world evidence related to treatment with avacopan in patients with ANCA-associated Vasculitis
    • Treatment of patients with specific disease manifestations and comorbidities
    • Biomarkers to assess response to treatment with avacopan
    • Physician/patient perspectives on definition of remission
    • Treatment of early-onset manifestations
    • Maintenance therapy
    • Prevention of end-organ damage
  • Other Disease Areas of Research Interest
    • Efficacy, safety, and/or tolerability of avacopan for conditions where C5aR may play a role
START HERE

Hematology/Oncology

Product: AMG 509 (xaluritamig)

Areas of Research Interest
  • Observational studies to characterize unmet need and patient populations in prostate cancer
  • Mechanisms of sensitivity and resistance to TCEs in prostate cancer
  • Optimization of clinical outcomes through combinations, sequencing, or biomarker identification
  • Proof of concept studies in novel populations or with novel combinations

Product: Bemarituzumab

Areas of Research Interest
  • Combination studies with new and emerging standard of care therapies
  • Observational and interventional studies for esophageal adenocarcinoma
  • Special patient populations
  • Non-clinical research on FGFR2b biology, heterogeneity and impact on tumorigenesis

Product: BLINCYTO® (blinatumomab)

Areas of Research Interest
  • Addressing questions in ALL:
    • Curative strategies
    • Chemo sparing/minimization approaches
    • Novel combinations including with other immuno-oncology drugs
    • Reduced hospitalization strategies
  • Investigating other CD19 positive hematologic diseases in areas of unmet needs including curative strategies and MRD-driven studies

Product: IMLYGIC™ (talimogene laherparepvec)

Areas of Research Interest
  • Research concepts are not being considered at this time

Product: Kyprolis® (carfilzomib)

Areas of Research Interest
  • Kyprolis in combination with select new MOAs in RRMM
  • Sequencing/combination of Kyprolis with T-cell therapies

Product: LUMAKRAS™(sotorasib)

Areas of Research Interest

CRC (non-thoracic)

  • Exploratory combinations
  • Optimal treatment sequencing
  • Patient population not being studied in Amgen trials
  • Pre-clinical and translational research with novel modalities

NSCLC (thoracic)

  • “Reverse translation” studies from CodeBreaK patient samples
  • Improving efficacy of sotorasib monotherapy with rational, therapeutic combinations in PD-L1 subgroups and in special populations
  • Practical management of sotorasib-related AEs
  • Improve biomarker testing rates and modalities
  • Real-world evidence of sotorasib monotherapy or in combination with chemotherapy

Product: Nplate® (romiplostim)

Areas of Research Interest
  • Immune thrombocytopenia (Nplate use in First line and/or in combination with other ITP therapies/immunotherapies, Mechanism of Action in ITP)
  • Chemotherapy-induced thrombocytopenia (Hematologic Malignancies, Pediatric)
  • Other areas that may be evaluated (e.g. Aplastic Anemia in 1st line setting, Mechanism of action in Aplastic Anemia; Hematopoietic Stem Cell Transplantation; Primary Immunodeficiency; autoimmune diseases, role and clinical value in relation to COVID-19 pandemic, Dengue fever and similar situations)

Product: Tarlatamab

Areas of Research Interest
  • Limited disease in Small Cell Lung Cancer
  • Extensive disease in Small Cell Lung Cancer
  • High Grade neuroendocrine tumors (DLL3+), including NEPC
  • Other relevant DLL3 tumors (primary CNS tumors and others)
  • Epidemiology, natural history studies and treatment patterns

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
RWE Related to prevention of Skeletal-related Events (SRE) in Solid tumors and multiple Myeloma:
  • Pain
  • Treatment Patterns / Use of BTA
  • Preference
  • Compliance and duration of treatment with BTAs
Other Disease Areas of Research Interest
  • Where there is a critical unmet need and XGEVA/denosumab may uniquely address this unmet need
  • Fibrous Dysplasia
START HERE

Neurology

Product: Aimovig™ (erenumab)

Areas of Research Interest
Only studies including adults ≥ 18 years
  • Efficacy, safety, and/or tolerability of erenumab for conditions where CGRP may play a role, including headache and non-headache disorders
  • Biomarkers related to erenumab response in migraine
  • Patient reported outcomes, including novel or existing parameters and instruments
  • Real world evidence for erenumab including burden of illness, real world effectiveness, treatment patterns, healthcare resource utilization, and predictors of outcomes
START HERE

Nephrology

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

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
START HERE

Rare Disease

Product: Krystexxa ® (Pegloticase)– Chronic Refractory Gout

Areas of Research Interest
  • Biomarker/Imaging research
    • Novel methods or biomarkers to assess the impact of gout and/or pegloticase on clinical outcomes including comorbidities
    • Novel use of imaging techniques to better characterize the systemic burden and impact of monosodium urate deposition
  • Other Disease Areas of Research Interest
    • Efficacy, safety, and/or tolerability and long term clinical outcomes of pegloticase in uncontrolled gout
    • Novel methods to reduce immunogenicity/increase efficacy with pegloticase treatment

Product: Tepezza ® (Teprotumumab)– Ophthalmology

Areas of Research Interest
  • Biomarkers and Mechanism of Action
    • Biomarkers to assess response to treatment with teprotumumab
    • Biomarkers of disease activity
    • Predictors of improvement for TED clinical outcomes with teprotumumab treatment
    • Preclinical research of IGF-IR
    • Mechanism of action of teprotumumab
  • Real-world evidence (RWE)
    • Prospective observational real world evidence generation and natural disease course and or progression in different populations
    • Patient reported outcomes, patient experience, and quality of life
    • Healthcare resource utilization including economic and clinical burden of illness
    • Thyroid Eye Disease Burden on Activities of Daily Living (ADRs), Absenteeism, and Work Productivity
  • Other Disease Areas of Research Interest
    • Safety and effectiveness of teprotumumab in extended heterogenous TED patient population
      • e.g., Chronic (Longer duration)/Low CAS (Low activity), Strabismus/ Diplopia, Compressive Optic Neuropathy, Previous surgeries, Previous treatments (steroids, radiation)
    • Assessments of current grading scales and diagnostic tools for TED
    • Imaging of TED to assess natural progression of autoimmune disease and/or outcomes of teprotumumab treatment to include: Ocular Anterior Segment Imaging, Facial Imaging, CT scans, MRI
    • Optimal Dosing for retreatment in Longer Term management of TED (Treat & Extend and/or Maintenance Dosing Regimens)

Product: Uplizna® (Inebilizumab)– Neuroimmunology

Areas of Research Interest
  • Biomarkers to assess response to treatment with inebilizumab
  • Clinical outcomes in special populations of neuromyelitis optica spectrum disorder (NMOSD) AQP4+ patient populations (i.e., minority populations, pregnant women, ages 65+)
  • Real world evidence for inebilizumab including burden of illness, real world effectiveness, treatment patterns, healthcare resource utilization, and predictors of outcomes
  • Patient reported outcomes in NMOSD, including novel or existing parameters and instruments
  • Investigating other autoimmune and inflammatory disorders where CD19+ B cells may play a role
START HERE

Contact Information

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 Submissions

Nonclinical proposal for which funding is being requested

Nonclinical proposal submission has a prerequisite of preliminary discussion having occurred with a representative of Amgen Global Medical Organization. START HERE

Request for an Amgen material

CLICK HERE