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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. <a rel="noopener noreferrer" target="_blank" href="http://www.amgenpipeline.com/pipeline/">Click here</a> for more information on Amgen’s pipeline. </p> <h1 class="title-description">Investigator Sponsored Studies (ISS) and ISS Sponsor</h1> <div class="principal-txt"> <p class="intro-description"> 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: </p> <ul> <li>An ISS can involve a licensed or unlicensed Amgen product(s)</li> <li>It can be based on a disease area of interest (e.g., a specific tumor type)</li> <li>It can be interventional or observational, including but not limited to health economic studies, epidemiological research, or analyses of existing data</li> </ul> <p class="intro-description"> Amgen will consider external proposals from a variety of potential ISS sponsors, including but not limited to: </p> <ul> <li>Investigators/Researchers</li> <li>Healthcare providers</li> <li>Members of the scientific community</li> <li>Healthcare institutions</li> <li>Academic medical centers</li> <li>Colleges and universities</li> <li>Networks and cooperative groups</li> <li>Government research institutions</li> </ul> <p class="intro-description"> 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. </p> </div>  <div class="accodionWrap panel panel-white ui-accordion ui-widget ui-helper-reset issOverviewAcc"> <div class="acoordItem custom_accordionTogglItem"> <h3 class="toggle custom_accordionTogglTab pan-col ui-accordion-header ui-state-default ui-accordion-icons ui-corner-all"> <span class="ui-accordion-header-icon ui-icon ui-icon-triangle-1-e"></span>ISS Overview </h3> <div class="content pane-me ui-accordion-content ui-helper-reset ui-widget-content ui-corner-bottom ui-accordion-content-active"> <p class="intro-description">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.</p> <p class="intro-description"> Amgen's financial and product support are subject to execution of Amgen's standard research agreement. Prior to proceeding with a proposal, <strong>please download and review</strong> <a target="_blank" href="-/media/Themes/CorporateAffairs/amgeniss-com/amgeniss-com/PDF/Amgen-ISS-Summary-of-Key-Contract" style="all: unset;color: #0063c3;cursor: pointer;">Amgen's required legal terms</a> with your institution to ensure alignment. As required by law, we disclose financial support provided to researchers and their institutions. </p> </div> </div> <div class="acoordItem custom_accordionTogglItem _accTwo" id="_accTwo"> <h3 class="toggle custom_accordionTogglTab pan-col ui-accordion-header ui-state-default ui-accordion-icons ui-corner-all _accBtnTwo"> <span class="ui-accordion-header-icon ui-icon ui-icon-triangle-1-e"></span>Process Summary </h3> <div class="content pane-me ui-accordion-content ui-helper-reset ui-widget-content ui-corner-bottom ui-accordion-content-active"> <div class="process"> <h1> ISS PROCESS </h1> <div class="first"> <div class="more-info"> <span>Sponsor</span> <ul> <li>Initiate ISS proposal and submit to Amgen</li> <li>Submit CV and preliminary funding request</li> <li>Sign Confidential Disclosure Agreement (as applicable)</li> </ul> <span>Amgen</span> <ul> <li>Review proposal</li> <li>Communicate decision to decline proposal or invite submission of full protocol for review</li> <li>Initiate Confidential Disclosure Agreement (as applicable)</li> </ul> </div> <div class="number-process process-info"> <p>1. Proposal Review <em class="fa fa-angle-double-right" aria-hidden="true"></em></p> </div> </div> <div class="first"> <div class="more-info"> <span>Sponsor</span> <ul> <li>Develop full protocol and submit to Amgen</li> </ul> <span>Amgen</span> <ul> <li>Review protocol</li> <li>Communicate decision to decline or support protocol</li> </ul> </div> <div class="number-process process-info"> <p>2. Protocol Review <em class="fa fa-angle-double-right" aria-hidden="true"></em></p> </div> </div> <div class="first"> <div class="more-info"> <span>Sponsor</span> <ul> <li>Submit detailed budget to Amgen (as applicable)</li> <li>Provide required documents</li> <li>Confirm location of sites for drug shipment</li> <li>Execute research agreement</li> </ul> <span>Amgen</span> <ul> <li>Perform Fair Market Value assessment </li> <li>Review all required documents</li> <li>Initiate and execute research agreement</li> <li>Ship drug to site(s)</li> </ul> </div> <div class="number-process process-info"> <p>3. Start-Up <em class="fa fa-angle-double-right" aria-hidden="true"></em></p> </div> </div> <div class="first"> <div class="more-info"> <span>Sponsor</span> <ul> <li>Conduct study</li> <li>Provide safety reports and study updates per research agreement</li> <li>Manage drug supply inventory (as applicable)</li> <li>Submit invoices for contractual milestones</li> </ul> <span>Amgen</span> <ul> <li>Monitor progress and provide appropriate safety and regulatory updates</li> <li>Manage ongoing drug supply shipments</li> <li>Verify completion of contractual milestones and issue payments</li> </ul> </div> <div class="number-process process-info"> <p>4. Conduct <em class="fa fa-angle-double-right" aria-hidden="true"></em></p> </div> </div> <div class="first"> <div class="more-info"> <span>Sponsor</span> <ul> <li>Submit final study report and manuscript, as applicable, in accordance with research agreement</li> <li>Support closeout reconciliation (safety reports, drug supply, milestone invoices)</li> </ul> <span>Amgen</span> <ul> <li>Reconcile final deliverables against research agreement</li> <li>Issue final milestone payment</li> </ul> </div> <div class="number-process process-info"> <p>5. Close-Out <em class="fa fa-angle-double-right" aria-hidden="true"></em></p> </div> </div> </div> </div> </div> <div class="acoordItem custom_accordionTogglItem"> <h3 class="toggle custom_accordionTogglTab pan-col ui-accordion-header ui-state-default ui-accordion-icons ui-corner-all _accBtnThree" id="_accBtnThree"> <span class="ui-accordion-header-icon ui-icon ui-icon-triangle-1-e"></span>Requirements and Responsibilities of Sponsor </h3> <div class="content pane-me ui-accordion-content ui-helper-reset ui-widget-content ui-corner-bottom ui-accordion-content-active"> <p> 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: </p> <ul class="ac-text fat-list"> <li> You are qualified in terms of background, education, and experience to conduct and complete the proposed research <ul> <li>You are not debarred, disqualified, restricted or excluded from engaging in activities relating to development or approval of drugs by any regulatory authority</li> <li>If research involves treatment of patients, your license is current</li> </ul> </li> <li>You assume all responsibilities and obligations to comply with all relevant laws and regulatory requirements (e.g. Good Clinical Practice and safety reporting regulations)</li> <li>You or your appointed representative holds the IND or equivalent clinical trial authorization (as applicable)</li> <li>You provide safety reports to Amgen, in accordance with the research agreement</li> <li>You provide study status updates in accordance with the research agreement</li> <li>You submit the final study report and manuscript, as applicable and in accordance with the research agreement</li> </ul> </div> </div> </div> </div> <div> <h1 class="title-description">Areas of Research Interest</h1> <p class="intro-description"> Amgen will only provide support for an ISS with research merit that aligns with Amgen’s product specific strategy and Areas of Research Interest. Please see a summary of the Areas of Research Interest per product by expanding the appropriate Therapeutic Area section below and clicking '<strong>Start Here</strong>' to begin a proposal submission. </p> <div class="accodionWrap panel panel-white ui-accordion ui-widget ui-helper-reset"> <div class="accodionWrap"> <div class="acoordItem nested_accordionTogglItem"> <h3 class="toggle nested_accordionTogglTab AR-heading pan-col ui-accordion-header ui-state-default ui-accordion-icons ui-corner-all"> <span class="AR-title ui-accordion-header-icon ui-icon ui-icon-triangle-1-e"></span>Bone </h3> <div class="content pane-me ui-accordion-content ui-helper-reset ui-widget-content ui-corner-bottom ui-accordion-content-active"> <div class="accodionWrap"> <div class="acoordItem nested_accordionTogglItem"> <h4 class="toggle nested_accordionTogglTab collapse nested-heading">Product: Evenity® (romosozumab) <em class="fa fa-angle-right" aria-hidden="true"></em></h4> <div class="custom_content coll-content"> <table class="main-table"> <tbody> <tr class="table-head"> <th class="name-product" colspan="2">Areas of Research Interest</th> </tr> <tr class="table-content"> <td> <ul> <li> Advancing the understanding of the burden of fragility fractures </li> <li>Advancing the understanding of sclerostin biology</li> <li>Advancing the understanding of EVENITY in approved indications</li> <li>Studying EVENITY in situations of high unmet need</li> </ul> </td> </tr> </tbody> </table> </div> </div> <div class="acoordItem nested_accordionTogglItem"> <h4 class="toggle nested_accordionTogglTab collapse nested-heading">Product: Prolia<sup>®</sup> (denosumab) <em class="fa fa-angle-right" aria-hidden="true"></em></h4> <div class="custom_content coll-content" style="display: none;"> <table class="main-table"> <tbody> <tr class="table-head"> <th class="name-product" colspan="2">Areas of Research Interest</th> </tr> <tr class="table-content"> <td> <ul> <li>Please go to Product: EVENITY and choose area of research interest that closely reflects your interest</li> </ul> </td> </tr> </tbody> </table> </div> </div> </div> <a class="ac-text" href="/login/submission-form">START HERE</a> </div> </div> </div> <div class="accodionWrap"> <div class="acoordItem nested_accordionTogglItem"> <h3 class="toggle nested_accordionTogglTab AR-heading pan-col ui-accordion-header ui-state-default ui-accordion-icons ui-corner-all"> <span class="AR-title ui-accordion-header-icon ui-icon ui-icon-triangle-1-e"></span>Cardiovascular </h3> <div class="content pane-me ui-accordion-content ui-helper-reset ui-widget-content ui-corner-bottom ui-accordion-content-active"> <div class="accodionWrap">     <div class="acoordItem nested_accordionTogglItem"> <h4 class="toggle nested_accordionTogglTab collapse nested-heading">Product: Repatha<sup>®</sup> (evolocumab)<em class="fa fa-angle-right" aria-hidden="true"></em></h4> <div class="custom_content coll-content"> <table class="main-table"> <tbody> <tr class="table-head"> <th class="name-product" colspan="2">Areas of Research Interest</th> </tr> <tr class="table-content"> <td> <div style="padding-left: 18px; margin-bottom: 2%;">Only studies including adults ≥ 18 years</div> <ul> <li><span style="text-decoration: underline;">Mechanistic studies</span> - evaluating the relationship between PCSK9 inhibition and non-LDLR effects, immune function, thrombosis , vascular wall biology, effects  on other organ systems.</li> <li><span style="text-decoration: underline;">Imaging studies</span> - with a preference for functional/perfusion imaging studies (rather than purely anatomical studies)</li> <li><span style="text-decoration: underline;">Patient characterization studies</span> - 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.</li> </ul> </td> </tr> </tbody> </table> </div> </div> </div> <a class="ac-text" href="/login/submission-form">START HERE</a> </div> </div> </div> <div class="accodionWrap"> <div class="acoordItem nested_accordionTogglItem"> <h3 class="toggle nested_accordionTogglTab AR-heading pan-col ui-accordion-header ui-state-default ui-accordion-icons ui-corner-all"> <span class="AR-title ui-accordion-header-icon ui-icon ui-icon-triangle-1-e"></span>Inflammation </h3> <div class="content pane-me ui-accordion-content ui-helper-reset ui-widget-content ui-corner-bottom"> <div class="accodionWrap"> <div class="acoordItem nested_accordionTogglItem"> <h4 class="toggle nested_accordionTogglTab collapse nested-heading">Product: Enbrel<sup>®</sup> (etanercept) <em class="fa fa-angle-right" aria-hidden="true"></em></h4> <div class="custom_content coll-content"> <table class="main-table"> <tbody> <tr class="table-head"> <th class="name-product" colspan="2">Areas of Research Interest</th> </tr> <tr class="table-content"> <td> <ul> <li>New insights into Enbrel efficacy in rheumatoid arthritis, psoriasis, psoriatic arthritis</li> <li>New insights into Enbrel safety in rheumatoid arthritis, psoriasis, psoriatic arthritis</li> <li>Evaluate disease states which have inflammatory and/or autoimmune pathology</li> </ul> </td> </tr> </tbody> </table> </div> </div>   <div class="acoordItem nested_accordionTogglItem"> <h4 class="toggle nested_accordionTogglTab collapse nested-heading">Product: Otezla<sup>®</sup> (apremilast)<em class="fa fa-angle-right" aria-hidden="true"></em></h4> <div class="custom_content coll-content"> <table class="main-table"> <tbody> <tr class="table-head"> <th class="name-product" colspan="2">Areas of Research Interest</th> </tr> <tr class="table-content"> <td> <ul> <li>Specific disease manifestations (e.g. locations, itch) and comorbidities associated with PsO or PsA, and neutrophilic driven disease</li> <li>Maintenance of efficacy, including post biologics / persistence </li> <li>APR mechanism of action</li> </ul> </td> </tr> </tbody> </table> </div> </div> <div class="acoordItem nested_accordionTogglItem"> <h4 class="toggle nested_accordionTogglTab collapse nested-heading active">Product: Tavneos<sup>®</sup> (avacopan)<em class="fa fa-angle-right" aria-hidden="true"></em></h4> <div class="custom_content coll-content show"> <table class="main-table"> <tbody> <tr class="table-head"> <th class="name-product" colspan="2">Areas of Research Interest (US Submissions Only)</th> </tr> <tr class="table-content"> <td> <ul> <li>Real-world evidence related to treatment with avacopan in patients with ANCA-associated Vasculitis</li> <ul> <li>Treatment of patients with specific disease manifestations and comorbidities</li> <li>Biomarkers to assess response to treatment with avacopan</li> <li>Physician/patient perspectives on definition of remission</li> <li>Treatment of early-onset manifestations</li> <li>Maintenance therapy </li> <li>Prevention of end-organ damage</li> </ul> <li>Other Disease Areas of Research Interest</li> <ul> <li>Efficacy, safety, and/or tolerability of avacopan for conditions where C5aR may play a role</li> </ul> </ul> </td> </tr> </tbody> </table> </div> </div> </div> <a class="ac-text" href="/login/submission-form">START HERE</a> </div> </div> </div> <div class="accodionWrap"> <div class="acoordItem nested_accordionTogglItem"> <h3 class="toggle nested_accordionTogglTab AR-heading pan-col ui-accordion-header ui-state-default ui-accordion-icons ui-corner-all"> <span class="AR-title ui-accordion-header-icon ui-icon ui-icon-triangle-1-e"></span>Hematology/Oncology</h3> <div class="content pane-me ui-accordion-content ui-helper-reset ui-widget-content ui-corner-bottom"> <div class="accodionWrap">  <div class="acoordItem nested_accordionTogglItem"> <h4 class="toggle nested_accordionTogglTab collapse nested-heading">Product: AMG 193 <em class="fa fa-angle-right" aria-hidden="true"></em></h4> <div class="custom_content coll-content"> <table class="main-table"> <tbody> <tr class="table-head"> <th class="name-product" colspan="2">Areas of Research Interest</th> </tr> <tr class="table-content"> <td> <ul> <li>Clinical studies evaluating efficacy in mesothelioma</li> <li>Translational studies in solid tumors with surgical window of opportunities</li> <li>Novel concepts in select tumor types including pancreatic ductal adenocarcinoma, non-small cell lung cancer, gastrointestinal malignancies, glioblastoma multiforme, bladder and hematologic malignancies</li> <li>Clinical studies evaluating proof of concept in MTAP-deleted tumors not already being explored</li> </ul> </td> </tr> </tbody> </table> </div> </div>  <div class="acoordItem nested_accordionTogglItem"> <h4 class="toggle nested_accordionTogglTab collapse nested-heading">Product: AMG 509 (xaluritamig)<em class="fa fa-angle-right" aria-hidden="true"></em></h4> <div class="custom_content coll-content"> <table class="main-table"> <tbody> <tr class="table-head"> <th class="name-product" colspan="2">Areas of Research Interest</th> </tr> <tr class="table-content"> <td style="text-align: left;"> <ul> <li>Observational studies to characterize unmet need and patient populations in prostate cancer</li> <li>Mechanisms of sensitivity and resistance to TCEs in prostate cancer</li> <li>Optimization of clinical outcomes through combinations, sequencing, or biomarker identification</li> <li>Proof of concept studies in novel populations or with novel combinations</li> </ul> </td> </tr> </tbody> </table> </div> <h4 class="toggle nested_accordionTogglTab collapse nested-heading">Product: Bemarituzumab<em class="fa fa-angle-right" aria-hidden="true"></em></h4> <div class="custom_content coll-content"> <table class="main-table"> <tbody> <tr class="table-head"> <th class="name-product" colspan="2">Areas of Research Interest</th> </tr> <tr class="table-content"> <td> <ul> <li>Combination studies with new and emerging standard of care therapies</li> <li>Observational and interventional studies for esophageal adenocarcinoma</li> <li>Special patient populations</li> <li>Non-clinical research on FGFR2b biology, heterogeneity and impact on tumorigenesis</li> </ul> </td> </tr> </tbody> </table> </div> </div>   <div class="acoordItem nested_accordionTogglItem"> <h4 class="toggle nested_accordionTogglTab collapse nested-heading">Product: BLINCYTO<sup>®</sup> (blinatumomab) <em class="fa fa-angle-right" aria-hidden="true"></em></h4> <div class="custom_content coll-content"> <table class="main-table"> <tbody> <tr class="table-head"> <th class="name-product" colspan="2">Areas of Research Interest</th> </tr> <tr class="table-content"> <td> <ul> <li>Addressing questions in ALL:</li> <ul> <li>Curative strategies</li> <li>Chemo sparing/minimization approaches</li> <li>Novel combinations including with other immuno-oncology drugs</li> <li>Reduced hospitalization strategies</li> </ul> <li>Investigating other CD19 positive hematologic diseases in areas of unmet needs including curative strategies and MRD-driven studies</li> </ul> </td> </tr> </tbody> </table> </div> </div>   <div class="acoordItem nested_accordionTogglItem"> <h4 class="toggle nested_accordionTogglTab collapse nested-heading">Product: IMLYGIC<sup>™</sup> (talimogene laherparepvec) <em class="fa fa-angle-right" aria-hidden="true"></em></h4> <div class="custom_content coll-content"> <table class="main-table"> <tbody> <tr class="table-head"> <th class="name-product" colspan="2">Areas of Research Interest</th> </tr> <tr class="table-content"> <td> <ul> <li>Research concepts are not being considered at this time</li> </ul> </td> </tr> </tbody> </table> </div> </div>   <div class="acoordItem nested_accordionTogglItem"> <h4 class="toggle nested_accordionTogglTab collapse nested-heading">Product: Kyprolis<sup>®</sup> (carfilzomib) <em class="fa fa-angle-right" aria-hidden="true"></em></h4> <div class="custom_content coll-content"> <table class="main-table"> <tbody> <tr class="table-head"> <th class="name-product" colspan="2">Areas of Research Interest</th> </tr> <tr class="table-content"> <td> <ul> <li>Kyprolis in combination with select new MOAs in RRMM</li> <li>Sequencing/combination of Kyprolis with T-cell therapies</li> </ul> </td> </tr> </tbody> </table> </div> <h4 class="toggle nested_accordionTogglTab collapse nested-heading">Product: LUMAKRAS<sup>™</sup>(sotorasib)<em class="fa fa-angle-right" aria-hidden="true"></em></h4> <div class="custom_content coll-content"> <table class="main-table"> <tbody> <tr class="table-head"> <th class="name-product" colspan="2">Areas of Research Interest</th> </tr> <tr class="table-content"> <td style="text-align: left;"> <p style="margin-bottom: 0in; line-height: normal;"><strong></strong><strong><span style="text-decoration: underline;">CRC (non-thoracic)</span></strong></p> <ul> <li>Exploratory combinations</li> <li>Optimal treatment sequencing</li> <li>Patient population not being studied in Amgen trials</li> <li>Pre-clinical and translational research with novel modalities</li> </ul> <p style="margin-bottom: 0in; line-height: normal;"><strong><span style="text-decoration: underline;">NSCLC (thoracic)</span></strong></p> <ul> <li>“Reverse translation” studies from CodeBreaK patient samples</li> <li>Improving efficacy of sotorasib monotherapy with rational, therapeutic combinations in PD-L1 subgroups and in special populations</li> <li>Practical management of sotorasib-related AEs</li> <li>Improve biomarker testing rates and modalities</li> <li>Real-world evidence of sotorasib monotherapy or in combination with chemotherapy</li> </ul> </td> </tr> </tbody> </table> </div> </div>                        <div class="acoordItem nested_accordionTogglItem"> <h4 class="toggle nested_accordionTogglTab collapse nested-heading">Product: Nplate<sup>®</sup> (romiplostim) <em class="fa fa-angle-right" aria-hidden="true"></em></h4> <div class="custom_content coll-content"> <table class="main-table"> <tbody> <tr class="table-head"> <th class="name-product" colspan="2">Areas of Research Interest</th> </tr> <tr class="table-content"> <td> <ul> <li>Immune thrombocytopenia (Nplate use in First line and/or in combination with other ITP therapies/immunotherapies, Mechanism of Action in ITP)</li> <li>Chemotherapy-induced thrombocytopenia (Hematologic Malignancies, Pediatric)</li> <li>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)</li> </ul> </td> </tr> </tbody> </table> </div> </div> <div class="acoordItem nested_accordionTogglItem"> <h4 class="toggle nested_accordionTogglTab collapse nested-heading">Product: Tarlatamab <em class="fa fa-angle-right" aria-hidden="true"></em></h4> <div class="custom_content coll-content"> <table class="main-table"> <tbody> <tr class="table-head"> <th class="name-product" colspan="2">Areas of Research Interest</th> </tr> <tr class="table-content"> <td> <ul> <li>Limited disease in Small Cell Lung Cancer</li> <li>Extensive disease in Small Cell Lung Cancer</li> <li>High Grade neuroendocrine tumors (DLL3+), including NEPC</li> <li>Other relevant DLL3 tumors (primary CNS tumors and others)</li> <li>Epidemiology, natural history studies and treatment patterns</li> </ul> </td> </tr> </tbody> </table> </div> </div>   <div class="acoordItem nested_accordionTogglItem"> <h4 class="toggle nested_accordionTogglTab collapse nested-heading">Product: Vectibix<sup>®</sup> (panitumumab) <em class="fa fa-angle-right" aria-hidden="true"></em> </h4> <div class="custom_content coll-content"> <table class="main-table"> <tbody> <tr class="table-head"> <th class="name-product" colspan="2">Areas of Research Interest</th> </tr> <tr class="table-content"> <td> <ul> <li>Biomarkers in colorectal cancer</li> <li>Epidermal growth factor receptor resistance in colorectal cancer</li> <li>Combination studies and treatment sequencing in colorectal cancer</li> </ul> </td> </tr> </tbody> </table> </div> </div>   <div class="acoordItem nested_accordionTogglItem"> <h4 class="toggle nested_accordionTogglTab collapse nested-heading">Product: XGEVA<sup>®</sup> (denosumab) <em class="fa fa-angle-right" aria-hidden="true"></em></h4> <div class="custom_content coll-content"> <table class="main-table"> <tbody> <tr class="table-head"> <th class="name-product" colspan="2">Areas of Research Interest</th> </tr> <tr class="table-content"> <td> RWE Related to prevention of Skeletal-related Events (SRE) in Solid tumors and multiple Myeloma: <ul style="font-size: 14px;padding-top: 5px;"> <li>Pain</li> <li>Treatment Patterns / Use of BTA</li> <li>Preference</li> <li>Compliance and duration of treatment with BTAs</li> </ul> Other Disease Areas of Research Interest <ul style="padding-top: 5px;"> <li> Where there is a critical unmet need and XGEVA/denosumab may uniquely address this unmet need </li> <li style="list-style-type: disc;">Fibrous Dysplasia </li> </ul> </td> </tr> </tbody> </table> </div> </div> </div> <a class="ac-text" href="/login/submission-form">START HERE</a> </div> </div> </div> <div class="accodionWrap"> <div class="acoordItem nested_accordionTogglItem"> <h3 class="toggle nested_accordionTogglTab AR-heading pan-col ui-accordion-header ui-state-default ui-accordion-icons ui-corner-all"> <span class="AR-title ui-accordion-header-icon ui-icon ui-icon-triangle-1-e"></span>Neurology </h3> <div class="content pane-me ui-accordion-content ui-helper-reset ui-widget-content ui-corner-bottom ui-accordion-content-active"> <div class="accodionWrap"> <div class="acoordItem nested_accordionTogglItem"> <h4 class="toggle nested_accordionTogglTab collapse nested-heading">Product: Aimovig™ (erenumab) <em class="fa fa-angle-right" aria-hidden="true"></em></h4> <div class="custom_content coll-content"> <table class="main-table"> <tbody> <tr class="table-head"> <th class="name-product" colspan="2">Areas of Research Interest</th> </tr> <tr class="table-content"> <td> <div style="padding-left: 18px; margin-bottom: 2%;">Only studies including adults ≥ 18 years</div> <ul> <li>Efficacy, safety, and/or tolerability of erenumab for conditions where CGRP may play a role, including headache and non-headache disorders </li> <li>Biomarkers related to erenumab response in migraine</li> <li>Patient reported outcomes, including novel or existing parameters and instruments</li> <li>Real world evidence for erenumab including burden of illness, real world effectiveness, treatment patterns, healthcare resource utilization, and predictors of outcomes</li> </ul> </td> </tr> </tbody> </table> </div> </div> </div> <a class="ac-text" href="/login/submission-form">START HERE</a> </div> </div> </div> <div class="accodionWrap"> <div class="acoordItem nested_accordionTogglItem"> <h3 class="toggle nested_accordionTogglTab AR-heading pan-col ui-accordion-header ui-state-default ui-accordion-icons ui-corner-all"> <span class="AR-title ui-accordion-header-icon ui-icon ui-icon-triangle-1-e"></span>Nephrology </h3> <div class="content pane-me ui-accordion-content ui-helper-reset ui-widget-content ui-corner-bottom"> <div class="accodionWrap"> <div class="acoordItem nested_accordionTogglItem"> <h4 class="toggle nested_accordionTogglTab collapse nested-heading">Product: Aranesp<sup>®</sup> (darbepoetin alfa) <em class="fa fa-angle-right" aria-hidden="true"></em></h4> <div class="custom_content coll-content"> <table class="main-table"> <tbody> <tr class="table-head"> <th class="name-product" colspan="2">Areas of Research Interest</th> </tr> <tr class="table-content"> <td> <ul> <li>Not currently accepting ISS proposals</li> </ul> </td> </tr> </tbody> </table> </div> </div>   <div class="acoordItem nested_accordionTogglItem"> <h4 class="toggle nested_accordionTogglTab collapse nested-heading">Product: EPOGEN<sup>®</sup> (epoetin alfa) <em class="fa fa-angle-right" aria-hidden="true"></em></h4> <div class="custom_content coll-content"> <table class="main-table"> <tbody> <tr class="table-head"> <th class="name-product" colspan="2">Areas of Research Interest</th> </tr> <tr class="table-content"> <td> <ul> <li>Not currently accepting ISS proposals</li> </ul> </td> </tr> </tbody> </table> </div> </div>   <div class="acoordItem nested_accordionTogglItem"> <h4 class="toggle nested_accordionTogglTab collapse nested-heading">Product: Parsabiv™ (etelcalcetide) <em class="fa fa-angle-right" aria-hidden="true"></em></h4> <div class="custom_content coll-content"> <table class="main-table"> <tbody> <tr class="table-head"> <th class="name-product" colspan="2">Areas of Research Interest</th> </tr> <tr class="table-content"> <td> <ul> <li>New insights into Parsabiv efficacy in Secondary Hyperparathyroidism and associated labs (Ca, Phos, PTH)</li> <li>New insights into use of Parsabiv and its tolerability profile, such as in those who have failed prior use of cinacalcet</li> <li>Evaluate benefit of IV administration with Parsabiv</li> <li>Use in home hemodialysis</li> </ul> </td> </tr> </tbody> </table> </div> </div> </div> <a class="ac-text" href="/login/submission-form">START HERE</a> </div> </div> </div>  <div class="accodionWrap"> <div class="acoordItem nested_accordionTogglItem"> <h3 class="toggle nested_accordionTogglTab AR-heading pan-col ui-accordion-header ui-state-default ui-accordion-icons ui-corner-all"> <span class="AR-title ui-accordion-header-icon ui-icon ui-icon-triangle-1-e"></span>Rare Disease </h3> <div class="content pane-me ui-accordion-content ui-helper-reset ui-widget-content ui-corner-bottom"> <div class="accodionWrap">  <div class="acoordItem nested_accordionTogglItem"> <h4 class="toggle nested_accordionTogglTab collapse nested-heading">Product: Dazodalibep <em class="fa fa-angle-right" aria-hidden="true"></em></h4> <div class="custom_content coll-content"> <table class="main-table"> <tbody> <tr class="table-head"> <th class="name-product" colspan="2">Areas of Research Interest</th> </tr> <tr class="table-content"> <td style="text-align: left;"> <ul> <li>Understanding the effect of Dazodalibep on specific systems and organs affected by Sjogren's </li> <li>Biomarker research <br /> <ul> <li style="margin-bottom: 0px;">Biomarkers of disease activity</li> <li style="margin-bottom: 0px;">Role of different cell types in pathobiology of disease</li> <li style="margin-bottom: 0px;">Predictors of treatment response</li> </ul> </li> <li>Real-world evidence (RWE) <ul> <li style="margin-bottom: 0px;">Global burden of disease</li> <li style="margin-bottom: 0px;"> Natural history and progression of Sjogren's</li> </ul> </li> </ul> </td> </tr> </tbody> </table> </div> <h4 class="toggle nested_accordionTogglTab collapse nested-heading">Product: Krystexxa <sup>®</sup> (Pegloticase)– Chronic Refractory Gout <em class="fa fa-angle-right" aria-hidden="true"></em> </h4> <div class="custom_content coll-content"> <table class="main-table"> <tbody> <tr class="table-head"> <th class="name-product" colspan="2">Areas of Research Interest</th> </tr> <tr class="table-content"> <td> <ul> <li>Biomarker/Imaging research <ul> <li style="margin-bottom:0px;">Novel methods or biomarkers to assess the impact of gout and/or pegloticase on clinical outcomes including comorbidities </li> <li style="margin-bottom:0px;">Novel use of imaging techniques to better characterize the systemic burden and impact of monosodium urate deposition </li> </ul> </li> <li>Other Disease Areas of Research Interest <ul> <li style="margin-bottom:0px;">Efficacy, safety, and/or tolerability and long term clinical outcomes of pegloticase in uncontrolled gout</li> <li style="margin-bottom:0px;">Novel methods to reduce immunogenicity/increase efficacy with pegloticase treatment</li> </ul> </li> </ul> </td> </tr> </tbody> </table> </div> </div>   <div class="acoordItem nested_accordionTogglItem"> <h4 class="toggle nested_accordionTogglTab collapse nested-heading">Product: PROCYSBI® (cysteamine bitartrate) - Nephropathic Cystinosis <em class="fa fa-angle-right" aria-hidden="true"></em></h4> <div class="custom_content coll-content"> <table class="main-table"> <tbody> <tr class="table-head"> <th class="name-product" colspan="2">Areas of Research Interest</th> </tr> <tr class="table-content"> <td style="text-align: left;"> <ul> <li>Retrospective & prospective investigations that will improve the diagnosis, care, and monitoring of cystinosis patients on cysteamine </li> <li>Leveraging of databases to demonstrate clinical outcomes in cystinosis (including pregnancy registries) </li> <li>Examining benefits of early & aggressive cystine depleting therapy (CDT) </li> <li>Investigate the genetics of cystinosis—genotype/phenotype vs. severity of disease </li> <li>Assess incidence of comorbid clinical manifestations/symptoms associated with cystinosis</li> </ul> </td> </tr> </tbody> </table> </div> </div>   <div class="acoordItem nested_accordionTogglItem"> <h4 class="toggle nested_accordionTogglTab collapse nested-heading">Product: Tepezza <sup>®</sup> (Teprotumumab)– Ophthalmology <em class="fa fa-angle-right" aria-hidden="true"></em> </h4> <div class="custom_content coll-content"> <table class="main-table"> <tbody> <tr class="table-head"> <th class="name-product" colspan="2">Areas of Research Interest</th> </tr> <tr class="table-content"> <td> <ul> <li>Biomarkers and Mechanism of Action <ul> <li style="margin-bottom:0px;">Biomarkers to assess response to treatment with teprotumumab</li> <li style="margin-bottom:0px;">Biomarkers of disease activity </li> <li style="margin-bottom:0px;">Predictors of improvement for TED clinical outcomes with teprotumumab treatment </li> <li style="margin-bottom:0px;">Preclinical research of IGF-IR</li> <li style="margin-bottom:0px;">Mechanism of action of teprotumumab</li> </ul> </li> <li>Real-world evidence (RWE) <ul> <li style="margin-bottom:0px;">Prospective observational real world evidence generation and natural disease course and or progression in different populations</li> <li style="margin-bottom:0px;">Patient reported outcomes, patient experience, and quality of life</li> <li style="margin-bottom:0px;">Healthcare resource utilization including economic and clinical burden of illness</li> <li style="margin-bottom:0px;">Thyroid Eye Disease Burden on Activities of Daily Living (ADRs), Absenteeism, and Work Productivity</li> </ul> </li> <li>Other Disease Areas of Research Interest <ul> <li style="margin-bottom:0px;">Safety and effectiveness of teprotumumab in extended heterogenous TED patient population <ul> <li style="margin-bottom:0px;">e.g., Chronic (Longer duration)/Low CAS (Low activity), Strabismus/ Diplopia, Compressive Optic Neuropathy, Previous surgeries, Previous treatments (steroids, radiation) </li> </ul> </li> <li style="margin-bottom:0px;">Assessments of current grading scales and diagnostic tools for TED</li> <li style="margin-bottom:0px;">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</li> <li style="margin-bottom:0px;">Optimal Dosing for retreatment in Longer Term management of TED (Treat & Extend and/or Maintenance Dosing Regimens)</li> </ul> </li> </ul> </td> </tr> </tbody> </table> </div> </div>   <div class="acoordItem nested_accordionTogglItem"> <h4 class="toggle nested_accordionTogglTab collapse nested-heading">Product: Uplizna<sup>®</sup> (Inebilizumab)– Neuroimmunology <em class="fa fa-angle-right" aria-hidden="true"></em> </h4> <div class="custom_content coll-content"> <table class="main-table"> <tbody> <tr class="table-head"> <th class="name-product" colspan="2">Areas of Research Interest</th> </tr> <tr class="table-content"> <td> <ul> <li style="margin-bottom:0px;">Biomarkers to assess response to treatment with inebilizumab</li> <li style="margin-bottom:0px;">Clinical outcomes in special populations of neuromyelitis optica spectrum disorder (NMOSD) AQP4+ patient populations (i.e., minority populations, pregnant women, ages 65+)</li> <li style="margin-bottom:0px;">Real world evidence for inebilizumab including burden of illness, real world effectiveness, treatment patterns, healthcare resource utilization, and predictors of outcomes</li> <li style="margin-bottom:0px;">Patient reported outcomes in NMOSD, including novel or existing parameters and instruments</li> <li style="margin-bottom:0px;">Investigating other autoimmune and inflammatory disorders where CD19+ B cells may play a role</li> </ul> </td> </tr> </tbody> </table> </div> </div>  </div> <a class="ac-text" href="/login/submission-form">START HERE</a> </div> </div> </div>  </div> </div> <div class="contact-info"> <h1 class="title-description">Contact Information</h1> <p class="intro-description">For any questions pertaining 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