As part of our commitment to delivering innovative therapies to patients worldwide,Novartis believes in the need to support ethical independent clinical and non-clinical research conducted by qualified third-party investigators。

The value of the scientific research produced by third party sponsors is key to complementing Novartis-sponsored research by helping us to better understand the benefit/risk profile of our therapies,as well as enabling us to explore new opportunities addressing unmet medical needs。

The proposed research must offer meaningful scientific objectives and be supported by a valid study design。Privacy rights,safety and welfare of patients and animals shall be fully secured。

IIT are defined by Novartis as“studies with scientific and medical merit developed and sponsored by an independent investigator or academic sponsor.An IIT may be a clinical study conducted without the participation of Novartis,for which the IIT sponsor requests Novartis to provide either funding,dug.”

IIRs are defined by Novartis as“non-clinical research conducted by an independent third-party sponsor to evaluate the effects,properties or profile of a Novartis drug that is conducted in vitro assays or utilizes previously collected human tissue*.”

Note:Any monetary request intended fora specified purpose to support medical/scientific research,education,policy initiatives,and patient advocacy activities,where Novartis will receive no benefit,should not be considered as IIT or IIR as these are classified as Grants。读取变形

Strategic areas of interest

We welcome unsolicited research proposals from qualified investigators inour strategic areas of interest which we list below。Well-thought through studies that enhance our delivery of innovative therapies to more patients worldwide,enhance patient care,and align with our strategic areas of interest will be considered。If you have questions on any steps of the process or wish to discuss your study concept,please feel free reach out to yourlocal Novartis contact(e.g.MSL,Medical Advisor)for support。

Cardiovascular,Renal&Metabolism

Studies within the label population

  • 纵向安全性和tolerability
  • 高质量
  • Implementation science and/or quality system improvement programs(ex.clinical care pathways)
  • Early post-event implementation
  • Stroke
  • PAD
  • LDL-C lowering in under-represented population
  • Adherence vs.other LLTs

机械Studies in secondary prevention

  • Remodeling,fibrosis,inflammation 
  • Plaque burden regression/modification
  • CABG graft remodeling 

机械Studies in primary prevention and/or patients with statin-intolerance

  • Remodeling,fibrosis,inflammation 
  • Plaque burden regression/modification
  • (IVUS、echo、CCTA、OTC、MRI)must be guidelines validated(pending vascular bed assessment)

不同步:

  • 将挡板关闭到标签populations(with respect to geographies)
  • “效果”、“安全性”和“覆盖性studies with inclisiran in pediatric population(<18y)
  • Studies in adults with HoFH and/or different populations than ASCVD and ASCVD equivalent
  • CVOT trials
  • Head-to-head efficy/safety studies with other lipid lowering therapies
  • 分段处理

室内排水管(s)currently in clinical development and not yet approved

拉深,拉深

  1. 机械studies in IgAN,C3G,aHUS
  2. IgAN,C3G,aHUS

防波堤

  1. 合同系统中的Role of complement-mediated kidney diseases
  2. 其他道路到foster diagnosis of glomerulopathies beyond biopsy
  3. Studies which attempt to clarify the histopathologic complexity/equipoise of C3G
  4. Identification of approaches that lead to better characterization,management or correlation with outcomes in IgAN,C3G,aHUS,MN,LN-e.g.identification of biomarkers,genetic analysis or biopsy-based studies
  5. Burden of disease(clinical,economic,and/or humanistic burden)-IgAN,C3G,aHUS,MN,LN
  6. Epidemiology studies(incl.registries)-IgAN,C3G,aHUS,MN,LN

不同步:

  • Pediatric studies(with drug)
  • Studies exploring different dosing regimens ascurrently investigate
  • Any study,which combines iptacopan with immunosuppressant
  • Head-to-head comparisons
  • Studies including patients with CKD stages4and5

*Strategic areas of interest for iptacopan(PNH),please also refer to the Oncology section

导杆,导杆

  • Epidemiology associated with elevated Lp(a)
    • Patient characterization,identification,and genetic risk across sub-groups
    • Plaque characteristics and differences across patient sub-groups
    • Association&impact on different types of CVD(ischemic stroke,CAVS,PAD),various vascular beds,and other diseases(e.g.,AF,kidney disease,diabetes)
  • Distinct and unique pathophysiology of Lp(a)
    • Insights on the pro-inflammatory or pro-thrombotic mechanisms impacted by Lp(a)
    • Unique features of Lp(a)
  • 四级(a)在CV risk assessment tools
    • 四分之一级(a)控制到global CV risk and in light of other CV risk factors
    • Risk score calculators incorporating Lp(a)
    • 路p(a)to CVD and CV risk
  • Lp(a)测试和global CV risk management
    • 实施中的CVD management pathways
    • L(a)测试安全阀和economic value
    • Guidance on management of currently modifiable risk factors in the setting of elevated Lp(a)

不同步:

  • Comparison/Association with LDL-C
  • 室内排水管(s)currently in clinical development and not yet approved

Heart Failure

  • RWE or Implementation Science studies on improvements of HFcare through increase in GDMT
  • RWE studies with sac/val in Chronic Heart Failure with reduced EF
  • RWE studies with sac/val in Chronic Heart Failure with mildly-reduced or preserved EF-in geographies where it is in-label
  • RWE studies with sac/val in HTN-in geographies where it in-label

不同步:

  • Comparative effectiveness studies vs other MoA,e.g.SGLT2i,MRA,BB
  • Studies in non-cardiovascular disease
  • 固定阀导风阀
  • Studies in children(<18 years)
  • 机械Studies in HF including but not limited to those looking at:
    • Remodeling,fibrosis,inflammation
    • 车辆总装(including diastolic function)
    • Cardiac biomarkers
  • Studies in populations with specific,less well studied/documented HF etiologies,e.g.chemotherapy/toxicity induced HF
Gene Therapies

指示:Spinal Muscular Atrophy(SMA)

  • 中小型动力动力发电站
  • Expansion of treatment with Zolgensma for patient populations not included in clinical trials(e.g.older/heavier patients,four SMN2copies,switch therapy,ambulatory,etc.…)
  • 安全性和安全性,安全性
  • Methods/processes to assess the efficacy and durability of Zolgensma(e.g.bulbar function)
  • Biomarkers for efficacy

室外,室外

  • Clinical trials involving Zolgensma:
    • Re-dosing
    • 路基过载doses/maximum dose
    • Head-to-head comparison with other therapies and combination with other disease-modifying treatments(DMTs)
  • 基本science research that request use of Zolgensma
Global Health
  • Studies with crizanlizumab in sickle cell disease and related complications
    • e.g-renal,leg ulcer,stroke,AVN,adolescents with SCD,priapism,splenic sequestration,VOCs
  • 机械studies with crizanlizumab
  • 预应力混凝土
  • SCD biomarkers

不同步:

  • IIT requests from countries outside of US,SSA,Brazil
  • IIT requests in non-SCD indications
  • 钢轨支撑和钢轨保护
    • e.g.,spleen,lungs,kidneys
  • Societal and economic impact of HU/HU-FCT on LMIC
  • Studies with HU-FCT looking at treatment/stroke prevention in LMIC
  • HU-FCT preference by caregivers

室外,室外

  • SSA,Brazil and India
  • IIT requests in non-SCD indications
Immunology

Indications:axSpA(axial spondyloarthritis),incl.r-axSpA(radiographic)and nr-axSpA(non-radiographic)

Clinical data,outcomes&RWE:

  • 循环efficy,structural progression&safety of secukinumab
  • Clinical outcomes with Secukinumab across different manifestations of axSpA,by gender and race

Implementation Science/HCS research。

  • 预应力工程和施工的预应力工程
  • 进口intervention and treat-to-target on patient outcomes
  • 半封闭式预应力调节器
  • 无标称测量工具,表面测量和监测
  • 安全系数和调节系数

Exploratory/mechanistic studies:

  • New classification criteria of AxSpA and differences in pathogenesis of axSpA vs.axial PsA。
  • Role of IL-17A in the pathogenesis of axial,peripheral manifestations and comorbidities of AxSpA
  • SpA(SpA)

室外,室外

  • Studies on safety topics e.g.infections(tuberculosis,HIV,viral hepatitis),high-risk patients
  • Studies with combination biologics
  • Clinical comparative studies with other treatments

Indications:Psoriatic arthritis(PsA)

Clinical data,outcomes and RWE:

  • 纵向RWE studies on clinical efficy,inhibition of structural progression&safety of secukinumab
  • Long term RWE studies on efficicacy,safety and treatment strategy in juvenile PsA(JPsA)and enthesitis-related arthritis(ERA)
  • Clinical outcomes with Secukinumab in key manifestations of PsA,by gender,race,ethnic minories and access to health care systems
  • Axial PsA,skin predominant,nail/dactylitis,Oligoarticular predominant)

实施方案/HCS research:成本效率,资源优化和guideline implementation

  • 引入和引入过程中的出口comes和resource utilization
  • Impact of Secukinumab on prevention or reduction of Comorbidities(e.g.CV,metabolic)
  • 对不进行检测的方向和方向的调整
  • 安全出口和出口

Exploratory/mechanistic studies:

  • Role of IL-17A in the pathogenesis of Axial PsA and differences with pathogenesis of。axial PsA vs axSpA
  • 在工作场所,工作场所,工作场所,工作场所,工作场所

室外,室外

  • Studies on safety topics e.g.infections(tuberculosis,HIV,viral hepatitis),high-risk patients
  • 钢筋混凝土施工法
  • 组合式配电箱

Indications:Psoriasis(PsO)

Clinical data,outcomes and RWE:

  • Long term RWE studies on clinical efficy,&safety of secukinumab,risk factors and prevention of the transition period of PsO to PsA
  • Clinical outcomes with Secukinumab by gender,race,skin of colors,ethnic minories and access to health care systems
  • Long term RWE studies on efficicacy,safety and treatment strategy in pediatric PsO

实施方案/HCS research:

  • 感应intervention strategy on disease modification in PSO and resource utilization
  • PSO patients at risk of PsA:disease burden,risk factors,screening tools/app,novel imaging

Exploratory/mechanistic studies:

  • role of IL-17A in the pathogenesis of the transition period PsO to PsA
  • 安全出口

室外,室外

  • Studies on safety topics e.g.infections(tuberculosis,HIV,viral hepatitis),high-risk patients
  • Studies with combination other biologics
  • 组合式配电箱

指示:Hidradenitis Suppurativa

Clinical data,outcomes and RWE:

  • 隔离进度和故障检修(including imaging techniques,such as ultrasound)
  • Clinical outcomes in suppopulations(e.g.disease phenotypes,comorbidities,Black/African American,super-responders,..)
  • surgical interventions during secukinumab treatment
  • 安全性和efficy/effectiveness of combination therapy with secukinumab
  • 有效期,有效期,有效期

实施方案/HCS research:

  • 安全性、成本、资源优化和guidelines implementation
  • Artificial Intelligence/Machine Learning algorithms and big data approach to improve diagnosis and treatment of HS
  • 卸料与阀的定位tools/PRO

Exploratory/mechanistic studies:

  • Translational research on pathophysiology-role of IL-17A and other pathways in HS over the course of the disease
  • Biomarkers to predict disease and treatment outcomes

室外,室外

  • 组合式配电箱
  • 组合式配电装置
  • IV dosing for HS
Neuroscience
  • Focus on prognosis and diligent monitoring of patients with MS(including data and digital):
    • 市场营销计划,市场营销计划,市场营销计划,市场营销计划
    • 新建或improved quantitative outcome measures in MS,including next-generation technology and patient assessment technologies
    • 集成的markers/outcome measures to establish disease stability or disease control,disease progression
  • 机械studies looking at differentiating Novartis compounds from other DMTs
Oncology

Studies in the label population(adult patients with Ph+CML-CP,previously treated with two or more tyrosine kinase inhibitors):

  • Clinical efficy and safety in real-world setting
  • 纵向安全性和tolerability
  • 列车运行时间在第三线

Studies exploring additional patient populations in CML:

  • 使用情况下在earlier treatment lines,such as2nd线与线绝缘CML
  • Treatment Free Remission
  • Highneed populations such as Ph+ALL,CML-AP/BC
  • 使用期限,使用期限

Studies providing insight into mechanistical action of asciminib,potential on-andoff target effects and its use against additional mutations in patients with CML。

不同步:

  • asciminib in ABL-independent diseases

拉深,拉深

  1. 机械studies in Paroxysmal Nocturnal Hemoglobinuria(PNH);
  2. Studies evaluating factors associated with or predictive of treatment outcome in PNH;
  3. Studies exploring preferences inoral treatment administration approaches in PNH

防波堤

  1. Role of complement system in complement-mediated PNH,Immune Thrombocytopenia Purpura(ITP)and Cold Agglutinin Disease(CAD);
  2. Approaches to facilitating and expediting diagnosis of PNH and CAD;
  3. Identification of biomarkers that leads to better characterization,management or correlation with outcomes in PNH,ITP and CAD;
  4. Burden of disease(clinical,economic,and/or humanistic burden)–PNH and CAD;
  5. Epidemiology studies(incl.registries)–PNH and CAD

不同步:

  • Pediatric studies
  • Studies exploring different dosing regimens ascurrently investigate
  • Any study,which combines iptacopan with immunosuppressant and anti-C5 treatments
  • Head-to-head comparisons
  • Studies in other hematology diseases

**Strategic areas of interest for iptacopan(IgAN,C3G,aHUS,MN,LN),please also refer to the Cardiovascular,Renal&Metabolism section

  • Translational research on determinants and mechanisms of response and/or resistance to JDQ443
  • JDQ443:
    • 1L或2L combinations
    • 2L combination with chemotherapy
  • JDQ443 in early-stage resectable NSCLC(neoadjuvant and/or adjuvant)
  • Efficacy of 2L JDQ443monotherapy vs.other2L line combinations(e.g.chemo plus VEGFi)
  • JDQ443 combinations in KRASG12Cinhibitor-pretreated,refractory patients
  • JDQ443 in otherKRAS G12Cmutated tumours(e.g.GI or GYN)

不同步:

  • H2H interventional studies versus otherKRAS G12Cinhibitors
  • 安全过街门,安全过街门
  • Studies(other than prospective design)describing optimal timing and sequence of treatment in advanced or metatic GEP-NET patients
  • Studies of Lutathera in advanced or metatic NET patients in combination with other anti-cancer treatments,including chemotherapy(also bolus1L),immuno-oncology therapies,tyrosine kinase inhibitors(TKIs),PARP-inhibitors,CDK4/6 inhibitors,or other upcomtreaments
  • 预应力钢筋混凝土施工法
  • Studies on biomarkers to predict and prognosticate treatment in GEP-NET

指示:Prostate Cancer

  • Sequential use of different radioligand therapies(alpha-or beta-emitter);Treatment optimization(mHSPC,mCRPC)
  • 有效和安全性of177Lu-PSMA-617 combinations to overcome resistance and to improve efficicacy outcomes/Effficacy and safety of225Ac-PSMA-617/R2 combinations(any disease stage)
  • 有效和安全性of177Lu-PSMA-617 in low volume disease(mHSPC,OMPC
  • Adaptive and alternative treatment regimens with177Lu-PSMA-617 monotherapy or in combinations(mHSPC,mCRPRC
  • HRLPC中的“空气调节器”
  • Impact of177Lu-PSMA-617efficacy and safety in patient populations with sub-optimal outcomes,including patients distinct mutations(e.g.,PTEN-loss,AKT,DDR),patients CNS mets,liver mets etc.(mHSPC,mCRPRC
  • Retrospective analysis to predict long-term safety events(mCRPC
  • HR+/HER2-studies in breast cancer
    • Exploring data on CDK4/6 inhibitor rechallenge
    • Exploring ribociclib with novel/emergent compounds
    • Utilizing real world data and/or digital health technologies
    • Utilizing patient reported outcomes(PRO)

不同步:

  • Any area outside HR+/HER2-breast cancer
  • 安全过街门,安全过街门

How do Isubmit an IIT/IIR request?

IIT/IIR requests are submitted via the Novartis Grants,External Studies and Managed Access System or GEMS portal。Pleasesubmit your concept by clicking here

Guidance on using the GEMS portal is available here:

Novartis GEMS portal external user guide(PDF0.2MB)

For IIT related questions,please contact the medical team in your Novartislocal country office