Externally sponsored scientific research

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澳门葡京网赌游戏认识到外部资助的科学研究在扩展与药物和/或其相关疾病领域相关的知识方面可以发挥的重要作用。. This research can advance science and contribute to the development of better medicines for patients.

Externally Sponsored Scientific Research

外部资助的科学研究是指由外部研究人员发起和管理的研究,该研究人员根据相关国家的适用法规和法律对研究的进行和管理承担法律和监管责任.

We support:

  • Interventional Clinical Research (Phase I - IV),  involving authorised, unauthorised or discontinued AstraZeneca compounds no longer being developed.
  • Observational Research (i.e. Real World Evidence) - the product of interventional or non-interventional research, utilising data collected through observation of current clinical practice and/or patient-reported experience.
  • Non-clinical research involving compounds across all Disease Areas and phases of development. This includes in vitro, in vivo or ex vivo biomedical research across  pharmacodynamics, pharmacokinetics, animal studies, microbiologic and human biological samples (biomarkers, diagnostic assays). Requests for non-clinical research can be made via the AstraZeneca Open Innovation portal.

Transparency and Integrity

We are committed to maintaining Transparency and Integrity in all of our interactions with healthcare professionals. We follow a strict code of ethics which ensures we are compliant with regulations and ethical standards.

  • 研究提案将根据其科学价值和与公司整体研究和全球发展战略的一致性进行严格评估
  • As required by law, we disclose financial support provided to researchers and their institutions
  • Funding of research must not exceed local fair market value, nor be used for expenses not associated with the conduct of the research

How to participate

What does the Company require from Investigators who request support for ESR?

  • Submit a well-written proposal supported by pre-clinical or clinical data with strong scientific rationale
  • Have the scientific, technical and operational capabilities to conduct the study
  • Be able to submit an Investigational New Drug Application (IND)/Clinical Trial Application (CTA), if necessary
  • Deliver to agreed timelines
  • Write final report or manuscript
  • Provide contractual agreed-upon study status updates
  • Have expert statistical support available for data analysis

What is the submission review process? How and when are decisions made?

The Company accepts ESR submissions via our submission tool. Access to this tool, information on the available products/compounds, and the associated areas of interest for ESR can be found on this page. Please follow the instructions to register a user name and password to access the tool. 

The non-Company researcher should submit either a clinical ESR proposal or a non-clinical ESR protocol. Research proposals and protocols are reviewed on a regular basis by Company Review & Evaluation Groups, which include members from Medical, Biostatistics, and Regulatory functions. Decisions are typically communicated within 45 days of receipt of a complete submission.

Once a clinical ESR proposal is reviewed and approved, the non-Company researcher will be invited to submit a full protocol for review. Please note, approval of a proposal does not imply or guarantee approval of a protocol.


Compounds with areas of interest for Externally Sponsored Research are listed below. We aren’t accepting proposals at this time for the non-listed compounds.

Cardiovascular, Metabolic and Renal diseases

Brand / Substance

Mechanism of action

ESR - Areas of interest

Andexxa / Ondexxya
(Andexanet Alfa) 

Make a submission

Modified recombinant inactive factor Xa (FXa) designed to reverse FXa inhibitors

Epidemiology:

  • Epidemiology by type of Factor Xa (FXa) inhibitor-related bleeds (Trauma, Gastrointestinal (GI), Intracranial Hemorrhage (ICH))
  • Severity definitions and outcomes
  • Unmet needs with usual care approaches 

Impact of locally implemented treatment algorithms across all types of life-threatening or uncontrolled FXa inhibitor-related bleeds:

  • Characterization of barriers to optimal management
  • Early identification of appropriate patients for reversal therapy
  • Impact of early administration 

Quality measurements and/or process improvement initiatives: 

  • 旨在监测和改善所有类型危及生命或不受控制的FXa抑制剂相关出血患者的预后

FXa inhibitor-related  Trauma bleeds: 

Characterization of life-threatening or uncontrolled FXa inhibitor-related bleeds following traumatic injury.  

  • Unmet needs in management
  • Real World characteristics of current management and outcomes

FXa inhibitor-related Gastrointestinal bleeds:  

Characterization of life-threatening or uncontrolled FXa inhibitor-related GI bleeds.  

  • Unmet needs in management
  • Real World characteristics of current management and outcomes

Urgent Surgery:

  • Real World Evidence of unmet needs in the management of patients treated with FXa inhibitors who are in need of  Urgent Surgery.

Forxiga / Farxiga
(dapagliflozin))

Make a submission

 

 

SGLT2 inhibitor

 

  • Exploring the Renal and Heart Failure benefits of Dapagliflozin
  • Observational / RWE research about disease burden, patient reported outcome, treatment patterns, disease risk prediction and clinical management of kidney disease or heart failure, if study could be completed within a two-year timeframe.

 

Lokelma
(Sodium Zirconium Cyclosilicate)

Make a submission

An oral non-absorbed potassium binder that selectively captures potassium ions locally in the gastrointestinal tract, thereby reducing serum potassium (S-K) concentration and removing potassium from the body through increased faecal excretion.

Unbranded Data generation:

  • HK prevalence and HK treatment patterns based on local need
  • 实践改变倡议,以弥合指南(GDMT使用/RAASi优化也在高钾血症后)和临床实践之间的差距

SZC-specific Data Generation:

  • RAASi use, with SZC to manage HK as needed
  • Long-term treatment with SZC
  • SZC as part of in-hospital treatment pathway (acute – inpatient – discharge)
  • Real world descriptive analysis
  • Real world comparative analysis will be considered

Wainua
(Eplontersen)

Make a submission

Antisense oligonucleotide

  • Improve diagnosis and optimize treatment in transthyretin amyloidosis (ATTR) (mixed phenotypes, under recognized populations, etc.)
  • Biomarkers for early detection of ATTR amyloidosis
  • Patients with ATTR Amyloidosis can be identified via artificial intelligence (AI)/machine learning (ML) predictive models
  • Understand link between serum ATTR amyloidosis to patient reported outcomes (PROs) and/or clinical outcomes
  • New tools for ATTR amyloidosis patient monitoring (define and monitor disease progression (with/without treatments)

Vaccines & Immune Therapies

Substance

Mechanism

of action

ESR - Areas of interest

AZD1222

Make a submission

COVID-19 Vaccine

  • We are currently not accepting any ESRs related to COVID-19 vaccines research

AZD7442

Make a submission

COVID-19 Antibody

  • Please contact medical team before submitting a study proposal

AZD3152

Make a submission

COVID-19 Antibody

  • Please contact medical team before submitting a study proposal

Fluenz Tetra /

 

FluMist

 

Quadrivalent

 

(LAIV/QLAIV)

Make a submission

Live Attenuated Influenza Vaccine

  • Please contact medical team before submitting a study proposal

Oncology

Oncology Externally Sponsored Research Handbook – guidance on how to work successfully with AstraZeneca and advice on key challenges encountered during ESR. Please click here to download the Handbook.

Brand / Substance

Mechanism of action

ESR - Areas of interest

AZD0171

humanized monoclonal antibody (mAb), immunoglobulin G subclass 1 (IgG1)

Accepting limited Externally Sponsored Clinical Research Proposals

AZD4635

 

Oral inhibitor of adenosine 2a receptor (A2aR)

Not accepting Externally Sponsored Clinical Research Proposals.

Acalabrutinib

Make a submission

Highly selective, potent BTK inhibitor

Proposals evaluating the use of acalabrutinib in B-cell hematological malignancies

  • Novel combination approaches with acalabrutinib will be considered.  In particular, concepts that address an important scientific question and could be relevant across a range of B-cell diseases
  • Evaluation of surrogate marker endpoints predictive of long-term outcomes with acalabrutinib treatment
  • Data generation specific to regional needs where the standard of care may differ
  • Evaluation of treatment duration, including the addition of other therapeutic agents to assess the clinical benefit of continuing acalabrutinib beyond initial progression
  • Assessments of real world data, including comparison with other novel agents
  • Studies evaluating the role of maintenance therapy with acalabrutinib
  • Proposals will be prioritized accordingly based on scientific merit and fit with the clinical program.

AZD1390

Make a submission

Potent and Selective Brain Penetrant ATM inhibitor

  • Areas of interest include exploration of monotherapy or combination treatment in indications where there is a strong scientific, translational, or clinical rationale to target ATM inhibition
  • Proposals in combination with radiotherapy, other double strand break inducing agents or other novel combinations for solid tumour indications
  • Proposals will be prioritzed accordingly based on scientific merit and fit with the core development program.
AZD2811 Potent and Selective AURKB nanoparticle inhibitor

Not accepting externally sponsored studies at this time.

AZD5153

 

BRD4/BET bromodomain inhibitor

Not accepting externally sponsored studies at this time.

Capivasertib / AZD5363

Make a submission

AKT Inhibitor

Accepting Externally Sponsored Research Proposals on a drug only basis at this time

AZD6738 Ceralasertib

Make a submission

ATR Inhibitor

  • Available combinations: durvalumab, paclitaxel, monotherapy ceralasertib (note that new proposals for ceralasertib+olaparib or +platinums will not be approved)

  • Not supporting proposals for dose-finding new combinations

  • All concepts must have a compelling rationale, ideally with pre-clinical data, and have a clear path to registration

  • Drug-only requests entertained; however, they are subject to the same level of rigorous scientific review as all proposals. Combination projects will require  full support from the combination partner team.

AZD8186

Lipid kinase PI3Kß /d

Not accepting Externally Sponsored Clinical Research Proposals.

Dato-DXd

Make a submission

TROP2-directed Antibody Drug Conjugate (ADC)

 Dato-DXd in NSCLC

  • Understanding mechanism and clinical activity in patients with CNS involvement.
  • Defining acquired/primary resistance mechanisms and appropriate treatment approaches.
  • Identifying mechanisms, predictive factors  and optimal management of Dato-DXd Adverse Events.
  • Understanding TROP2 biology (beyond TROP2 diagnostic biomarker) and association with clinical outcomes.
  • Novel combinations where good rationale/supporting data exists, and where at least one agent is an approved SoC in the setting.
  • Optimal positioning of Dato-DXd in evolving clinical practice treatment.

Dato-DXd in Breast Cancer

  • Identifying risk factors and optimal management of Dato-DXd adverse events.
  • Defining mechanisms of primary or acquired Dato-DXd resistance.
  • *Optimal sequencing strategy of Dato-DXd in evolving clinical treatment algorithm.
  • *Understanding mechanism and clinical activity in patients with CNS involvement.
  • Understanding TROP2 biology and association with clinical outcomes .
  • Effectiveness in patient populations not represented in registrational studies.  
  • Novel combinations supported by strong rationale/data, and where one or more agent is an approved SoC in the proposed settings.

    (*) Indicates AOIs where company has already received multiple proposals

Pre-clinical studies will be considered through the AstraZeneca Open Innovation portal.

 

Imfinzi (Durvalumab)

Make a submission

Immuno-modulator; a human mAb of the immunoglobulin G1 kappa (IgG1κ) subclass that inhibits binding of Programmed Death Ligand 1 (PD-L1) to PD-1 and CD80


NSCLC
  •  Durvalumab +/- novel combinations in NSCLC patients excluded from the registration program (resectable, unresectable Stage IIIA / IIIB and Stage IV)
  •  Durvalumab-based combinations in immunotherapy pre-treated patients
  •  Durvalumab +/- novel combinations with chemotherapy, radiotherapy or other agents (immunotherapy / targeted therapies)
  •  Enhance knowledge of biomarker and mutational status to support and inform clinical decision making for durvalumab-based combinations
  •  Early predictors of clinical activity and immune-related adverse events
  •  Patient reported outcomes and patient experience of patients receiving durvalumab +/- novel combinations in NSCLC
  •  RWE Treatment patterns and clinical outcomes by stage of disease

SCLC

  •  Durvalumab-based combinations for limited-stage or extensive-stage disease
  •  Potential role of emerging biomarkers on outcomes to treatment
  •  RWE related to treatment patterns and clinical outcomes in SCLC

Urothelial Cancer

  •  Durvalumab + BCG in patients with non-muscle-invasive bladder cancer not represented in the POTOMAC trial
  •  在NIAGARA或VOLGA试验中未出现的肌肉侵袭性膀胱癌患者的围手术期durvalumab +/-新辅助化疗
  •  Durvalumab +/- tremelimumab combined with novel agents in front-line bladder cancer or after progression on immunotherapy
  •  Real-world evidence (RWE) on treatment patterns and outcomes with BCG treatment in non-muscle-invasive bladder cancer
  •  Durvalumab in combination with novel agents for patients with non-muscle-invasive or muscle-invasive bladder cancer
  •  Biomarkers to predict clinical outcome following durvalumab treatment for bladder cancer
  •  Patient reported outcomes and patient experience receiving durvalumab +/- tremelimumab as treatment for bladder cancer

GI Cancers

 Biliary Tract Cancer (BTC)

  •  Expand data for Durvalumab in 1L BTC special populations not included in registration program
  •  Durvalumab + alternative gem/platinum chemotherapy & regimens in 1L BTC
  •  Data on the impact of common BTC palliative therapies, (antibiotics or biliary stents) on Durvalumab efficacy in 1L BTC
  •  Patient-centric studies; QoL, patient preference
  •  Real World Effectiveness for Durvalumab
  •  Real World Evidence (RWE) to understand diagnosis, treatment practices and outcomes across BTC
  •  Addition of T300 to Durvalumab + Gemcitabine/Cisplatin
  •  Durvalumab in combination with Locoregional (TACE/TARE/Ablation/Radiotherapy) Therapies

Hepatocellular Carcinoma

  •  Data for STRIDE (T300+ Durvalumab) or Durvalumab mono in unresectable HCC special populations not included in registration program
  •  Data on the optimal sequencing of other unresectable HCC systemic therapies after STRIDE (T300+ Durvalumab)
  •  Response data for STRIDE (T300+ Durvalumab) in pts with fully characterized non-viral aetiology
  •  Real World Evidence (RWE) to understand treatment practices, regional differences, and therapeutic decision-making in unresectable HCC
  •  Optimal management of imAEs in unresectable HCC special populations (e.g., cirrhosis)
  •  Well-defined correlative science studies to identify biomarkers for response, non-response, and resistance

 Intermediate stage HCC

  •  Replace TACE / TARE with Durvalumab-based therapy
  •  Durvalumab-based treatment in combination with alternative embolization regimens (TARE, TAE)
  •  Effect of Durvalumab-based regimens on % of patients moving to curative therapies (downstaging)
  •  Durvalumab-based therapy + SBRT
  •  Predictors of efficacy & early progression (e.g., role of MRD, ctDNA as potential markers of progression
  •  Real World Evidence (RWE) to understand treatment practices and outcomes across Intra-hepatic cholangiocarcinoma
  •  TACE + Durvalumab (+ bev / other combo / STRIDE) + in special populations (pre-transplant setting)

 Early-stage HCC

  •  Durvalumab -based therapy in low-risk adjuvant setting
  •  Identification of low, intermediate and high-risk patientss
  •  RWE to understand treatment practices and outcomes across early HCC (early/intermediate/high risk)
  •  Durvalumab -based regimens as neoadjuvant therapy
  •  IO & Surrogate endpoints
  •  Durvalumab -based regimens in special populations
  •  Predictors of efficacy & early progression (e.g., role of MRD, ctDNA as potential markers of progression

 Other indications supported by robust preclinical data may be considered

  •  Pre-clinical studies will be considered through the AstraZeneca Open Innovation portal.
  •  不接受与澳门葡京网赌游戏开发计划重叠或竞争的研究,或存在妥协或过度安全风险的研究
  •  Non-oncology indications will not be supported at this time

Iressa (gefitinib)

Make a submission

EGFR Inhibitor

  • Not accepting Externally Sponsored Clinical Research Proposals at this time. 外部资助的“非临床”研究提案可能仍会被考虑,但只有在赞助商要求提供药物而不是资金支持的情况下.

Lynparza
(olaparib)

Make a submission

PARP Inhibitor

  • Studies in ovarian cancer patients with sBRCA or non-BRCA HRD mutations, examining prevalence, diagnostics, molecular profiles; or clinical outcomes following treatment with Lynparza
  • Pre-clinical to proof of concept scale clinical studies of combination of Lynparza with targeted small molecules or Immunotherapy, in BRCA+ve patients will be considered through the AstraZeneca Open Innovation portal.
  • gBRCAm, sBRCAm & HRRm studies as monotherapy or in combination with other products in breast cancer patients
  • Exploring effective diagnostic screening strategies to identify BRCAm & HRRm/HRD patient cohorts
  • Studies in prostate cancer patients with BRCAm/HRRm, examining prevalence, diagnostics, molecular profiles; or clinical outcomes following treatment with Lynparza
  • Combination studies with currently approved therapies in prostate cancer, including targeting of specific patient groups by molecular signature
  • Patient reported outcomes and patient preference studies
  • Studies examining switching from or substituting olaparib for bevacizumab in ovarian cancer patients
  • Studies in other tumours with DDR involvement
  • Other studies for which a strong scientific rationale and/or supporting pre-clinical data can be provided
  • PLEASE NOTE THAT ASTRAZENECA IS UNABLE TO REVIEW PROPOSALS FOR STUDIES INVOLVING PEMBROLIZUMAB AND LYNPARZA. IF YOUR IDEA INVOLVES THE USE OF PEMROLIZUMAB, THEN PLEASE SUBMIT YOUR APPLICATION TO MERCK, WHO ARE RESPONSIBLE FOR THIS COMBINATION.

MEDI551

Make a submission

MAb
Anti-CD19 B cell depleting agent

Accepting Externally Sponsored Clinical Research Proposals  for drug only in allogenic stem cell transplantation

Osimertinib / AZD9291

Make a submission


EGFR sensitising and T790M Resistance Mutations Inhibitor

EGFRm NSCLC

Resistance/What next?

  • Rapid identification of 1L resistance mechanisms using tissue, to accelerate new combination options
  • Benefit/risk of treatment beyond progression
  • Understand biomarkers of poor initial response to 1L TAGRISSO
  • Extend survival benefit using TAGRISSO in combination with  targeted and non-targeted approach’s
  • Establish evidence to support appropriate position of IO agents in EGFRm patients (advanced and early disease)

Real World Evidence

  • Generate RWE data on 1L TAGRISSO including patient preference 
  •  Develop insights into the 1L treatment journey to reinforce the benefits of starting with the best EGFR TKI first
  • Assess the risk of CNS disease progression with 1st and 2nd generation TKIs, including in Leptomeningeal patients
  • Develop treatment insights into the early disease setting, including EGFR prevalence through early screening

CNS

  • Build prospective evidence for CNS risk reduction
  • Build efficacy in leptomeningeal metastases, and symptomatic CNS patients using the 80mg dose
  • Use of TAGRISSO in combination with Stereotactic radiotherapy, and in combinations with other systemic agents

Early Disease

  • Translational assessment of tumour micro-environment post-surgery in the neoadjuvant setting
  • Address optimal treatment strategy for downstaging tumors (e.g. unresectable to resectable)
  • Optimize treatment in unresectable patients (e.g. in non-CRT eligible EGFRm patients)
  • Explore ctDNA and other biomarkers to help guide treatment decisions in the early disease setting (E.g. optimal duration of therapy)

EGFR Testing

  • Optimization of 1L testing to improve turnaround times
  • Identify new testing approaches to improve the quality and speed of treatment decisions in metastatic and early disease
  • Understand the prevalence and impact of other biomarkers e.g. uncommon, PD-L1, emerging IO related biomarkers, and impact on outcomes

Volrustomig (MEDI5752)

monovalent bispecific humanized immunoglobulin G1 (IgG1)

monoclonal antibody (mAb)

Accepting limited Externally Sponsored Clinical Research Proposals

MEDI9197

Make a submission

TLR 7agonist

Accepting limited number of Externally Sponsored Clinical Research Proposals

Monalizumab

Make a submission

NKG2A

Accepting limited Externally Sponsored Clinical Research Proposals

Saracatinib / AZD0530

Make a submission

Src tyrosine kinase family inhibitor

  • The reproductive toxicology package indicates a risk of foetal toxicity. 任何建议都需要根据风险效益和使用适当的高效避孕措施来评估是否包括有生育能力的妇女.
  • AZD0530 is a moderately potent CYP3A4 inhibitor; concomitant administration of medicines that are metabolised by this route should be avoided.
  • We are not currently seeking proposals in oncology indications

Savolitinib

Make a submission

c-Met receptor tyrosine kinase inhibitor (TKI)

  • Savolitinib monotherapy proposals in MET-driven solid tumours (ie tumours with MET gene amplification, activating MET mutations, MET fusions or HGF amplifications) will be considered in tumour types other than NSCLC, papillary renal cell carcinoma (pRCC), gastric cancer, castration resistant prostate cancer (CRPC) and paediatric brain tumours.
  • Combinations with durvalumab in tumour types other than renal cell carcinoma and NSCLC. 将优先考虑具有支持翻译/探索性机制研究包的提案,以了解MET和免疫微环境的作用和相互作用.
  • Resistance profiling - alternative combination studies where MET+ is a resistance mechanism. Proposals should be supported by a strong scientific rationale and preclinical data package (or proposals to generate such data)
Selumetinib /
AZD6244

MEK 1/2 Inhibitor
 

NF1 PN

Accepting limited Externally Sponsored Clinical Research Proposals. Proposals should be supported by a strong scientific rationale, preclinical data package and specific hypotheses to address. Proposals shall be prioritized accordingly based on scientific merit and fit with the core development program. We will be prioritising drug-only requests.

有兴趣提交提案供考虑的研究人员首先必须在基于网络的iEnvision系统上注册他们的个人资料, link attached below. Once you have registered in the system, you can submit a concept proposal electronically. Email submissions are not accepted

http://alexion.com/our-research/research-partnerships/externally-sponsored-research
 

Trastuzumab deruxtecan (DS-8201/T-DXd)

Make a submission

HER2-targeting Antibody Drug Conjugate (ADC)

HER2+ Breast Cancer

  • Novel approaches to minimize resistance and optimize patient experience within different lines of therapy
  • Exploration of predictors of response to T-DXd (Complete Response/Partial Response)
  • Rechallenge strategies within different lines of therapy
  • Exploration of benefit of T-DXd in sub-populations with high un-met need

HER2-low Breast Cancer

  • Exploration of benefit of T-DXd in sub-populations with high un-met need
  • Indicators of endocrine therapy [ET] resistance and/or non-endocrine receptor (ER) driven disease in HR+ breast cancer
  • Enhance accuracy of identification of HER2-Low patients, including use of novel technologies

Breast Indication Non-specific

  • Novel combinations or approaches to minimize resistance and optimize patient experience
  • Identify population at risk for high grade adverse events and strategies for prophylaxis
  • Ability to detect molecular relapse and clinical applicability of technology

HER2-expressing Gastric Cancer

  • Real world treatment patterns and outcomes by geographic location, histology and HER2 expression, including HER2-Low prevalence, unmet need, and disease biology
  • Clinical activity and safety in HER2+ and HER2-Low disease:
    • First line (1L) disease setting (including multimodality therapies)
    • Novel combinations with T-DXd
  • HER2 dynamics and prevalence over time in response to different treatment combinations/monotherapy (including HER2-Low expression)

HER2-targetable non-small cell lung cancer (NSCLC)

  • T-DXd monotherapy in non-metastatic HER2m NSCLC
    • As adjuvant in resectable disease
    • As consolidation in unresectable stage III disease
  • Approaches to optimize adverse event (AE) management in NSCLC including interstitial lung disease (ILD)
  • T-DXd mechanism of action and resistance mechanisms explored via liquid and or tumor biopsies

Additional Areas of Interest

  • Exploration of monotherapy or combination treatment in indications where there is a strong scientific, translational, or clinical rationale to target HER2, including pediatric malignancies
  • Assessing the frequency and intensity of HER2 expression/amplification in solid tumors where information is limited, including pediatric malignancies

Pre-clinical studies will be considered through the AstraZeneca Open Innovation portal.

Tremelimumab

Make a submission

Anti-CTLA4 Mab

关于单独使用tremelimumab或与其他产品联合使用的肿瘤学适应症的建议(基于durvalumab的组合除外-参见durvalumab感兴趣的领域以获取更多信息), are not sought at this time. Proposals for non-oncological indications may be of interest.

Zibotentan /
ZD4054

Make a submission

Endothelin receptor A (ETA) antagonist

Proposals for Oncology indications are not sought at this time. Proposals for non-oncological indications may be of interest

 

Rare Diseases

For submission of ESRs related to Rare Diseases you will be directed to an Alexion domain by clicking the below link.

该链接将提供有关罕见病品牌感兴趣领域的进一步信息,以及如何提交ESR提案的指导.

http://alexion.com/our-research/research-partnerships/externally-sponsored-research

Respiratory & Immunology

Brand / Substance

Mechanism of action

ESR - Areas of interest

Airsupra
(Budesonide + Albuterol)

Make a submission

Inhaled steroid/short acting Beta2 agonist

Areas of Priority, all submissions considered on a case by case basis

  • Evaluation of safety and efficacy in in use of inhaled steroid/short acting Beta2 agonist in relation to varying maintenance treatment
  • How does the use of Inhaled steroid/short acting Beta2 agonist affect maintenance medication management, examining factors such as adherence and the intensification of maintenance treatment
  • Efficacy and safety of anti-inflammatory reliever with ICS-Albuterol maintenance in different populations (demographics), including in patients with exercise induced bronchoconstriction

Please contact company staff before submitting a study proposal

Breztri
(Budesonide/Glycopyrronium/ Formoterol)

Make a submission

ICS, LAMA, LABA

  • 三联疗法(或各成分的协同作用)对包括急性加重在内的心肺预后相关因素的益处的机制研究, CV events and mortality – high priority
  • 研究强调疾病负担(包括临床结果和HCRU)与COPD患者心肺风险增加相关
  • The role and value of pMDIs in the management of respiratory conditions
  • 质量改进方案和研究支持COPD患者早期/及时优化治疗和心肺风险

Fasenra
(Benralizumab)

Make a submission

Anti-IL-5Rα monoclonal antibody

Studies in patients with eosinophilic asthma to:

  • Investigate and identify predictors of enhanced response to Benralizumab
  • Understand the overlap between different T2 biomarkers and the effects of Benralizumab
  • Investigate early onset and long term patient-centric and clinical benefits of Benralizumab

Mechanistic studies in relevant disease-state models to:

  • Study the effect of eosinophil depletion by Benralizumab on airway structure/function and cellular/molecular pathology
  • Characterize the role and effect of Benralizumab on other IL-5R expressing cells beyond eosinophils

Benralizumab lifecycle management:

  • 除哮喘外嗜酸性粒细胞驱动疾病的机制或现实世界研究,提供有关患者特征和疾病负担的信息. 
  • 除哮喘以外的嗜酸性粒细胞驱动疾病的机制或临床研究,目前资助的发展计划尚未解决 

Pulmicort
(Budesonide)

Make a submission

ICS

  • Please contact company staff before submitting a study proposal

Saphnelo
(Anifrolumab)

Make a submission

Monoclonal antibody to the type I IFN receptor subunit 1

Studies in patients with SLE focus, including:

  • Assessments of organ disease responses in lupus (e.g. skin, joint, other)
  • Innovative patient-centric modalities to measure symptoms of disease and response to treatments, including QOL measures
  • High unmet need in SLE & associated comorbidity related to SLE
  • Mechanistic or clinical studies regarding the role of IFN in other diseases
  • Diseases related to SLE
  • Role of interferon in other immunology diseases
  • IFN driven disease beyond rheumatologic disease

Symbicort
(Budesonide + Formoterol)

Make a submission

ICS/LABA combination

  • Please contact company staff before submitting a study proposal

Tezspire
(Tezepelumab)

Make a submission

Anti-TSLP monoclonal antibody

Areas of High Priority but considered on a case by case basis

  • Novel studies to position tezepelumab as a paradigm shift in treatment for severe asthma including disease stability, disease modification and remission 
  • New mechanistic insights on the role of TSLP activation and downstream inflammatory effects in diseases other than asthma including EoE, CRSwNP, COPD, allergy and CSU (can be tezepelumab treatment related)
  • Utilize tezepelumab clinical effect on airway pathophysiology, eosinophil biology, mast cell or epithelial function and asthma unexplored patient populations
  • Mechanistic or proof of concept studies using tezepelumab to support diseases with emerging biologic evidence

Medium Priority, but considered on a case by case basis

  • Focused studies looking at the role of the epithelium in upper and lower airway diseases delivered through the EpiCentral platform
  • Develop innovative tools to measure patients reported outcomes that capture holistic effects (e.g. emotional) of tezepelumab in upper and lower airways
  • Novel studies to investigate the effect of tezepelumab on airway hyperresponsiveness
  • Registry and real-world evidence experience of tezepelumab in clinical practice (locally funded)

All other submissions considered on a case by case basis

Tozorakimab

Make a submission

Inhibition of IL-33

  • 研究评估托zorakimab在COPD和严重病毒性下呼吸道疾病(LRTD)中的作用机制,包括IL-33的下游作用red and IL-33ox inhibition
  • 研究提供了IL-33作为COPD和严重病毒性LRTD中炎症失调、上皮和内皮功能障碍驱动因素的信息
  • 提供tozorakimab在COPD和LRTD亚群中的有效性和安全性信息的研究目前未包括在临床开发计划中
  • Mechanistic and interventional studies on the role of IL-33 and tozorakimab to inform future development plans

Cross-TA AI/Digital

The Cross-TA AI/Digital Externally Sponsored Research (ESR):

AstraZeneca is proud to introduce a new initiative, the AI/Digital ESR Governance team. 这一举措体现了澳门葡京赌博游戏在研发工作中利用人工智能和数字技术的持续承诺. Our goal is to foster innovation, improve efficiency, and ultimately, enhance patient outcomes.

At the heart of this initiative is a global cross-functional team, operating across various therapeutic areas (TAs) and brands. This team, with its strong expertise in AI, digital technology, and medical research, is at the forefront of this initiative. They are tasked with overseeing and guiding the review and evaluation of AI and digital proposals that are not compound specific. 他们致力于确保澳门葡京赌博游戏的合作取得成功,并与人工智能/数字ESR战略和澳门葡京网赌游戏的愿景和价值观保持一致.

Our AI/Digital ESR strategy is a comprehensive approach to leveraging AI, machine learning (ML), and digital health solutions to address patient needs from patient awareness to wellbeing. It aligns with both technical considerations and our business goals, and is structured around five key focus areas, crucial for delivering impactful AI/Digital ESRs consistently across disease areas and markets.

By aligning digital health solutions with the company business needs, we believe this strategy will drive significant impact and positive change in healthcare.

Please review the AI/Digital Area of Interest below before submitting your ESR proposal.


Cross-TA AI/Digital Externally Sponsored Research Handbook – guidance on how to work successfully with AstraZeneca and advice on key challenges encountered during ESR. Please click here to download the Handbook.


Crosss-TA AI/Digital Area of Interest:

This comprehensive strategy is structured around five key focus areas, aiming to deliver impactful AI/Digital ESRs consistently across our disease areas and markets.
 

Brand / Substance

Mechanism of action

ESR - Areas of interest

Cross-TA AI/Digital 

Make a submission

AI/Digital health solutions

Patient awareness:

  • Use of digital solutions for improved awareness of disease, treatment options, and disease management. ​
  • Leveraging AI/ML to mitigate bias/discrimination risks and ensure privacy and security of patient data. ​
  • Utilization of digital solutions for enhanced patient recruitment in clinical studies, decentralized clinical trial designs, and data collection (EMR into CRF) and incorporation of Patient-Reported Outcomes (PROs) into electronic medical records. ​
  • Patient screening (mass, early including newborn, early cancer detection, detect progression using novel methods including ctDNA, radiomics, digital pathology) and at-risk identification (case finding). ​

Early Diagnosis:

  • 利用数字解决方案,支持社区和初级保健治疗领域的早期诊断和风险识别(病例发现),并提高专家检测的能力.g. amyloidosis, biomarker). ​
  • Development of digital/digitally enabled endpoints for diagnostic purposes. ​

Treatment, adherence to treatment and AE management:

  • AI/ML algorithm development and assessment to support diagnosis, monitoring, and management of disease symptoms or medicinal adverse events including causality assessment. ​
  • Leveraging digital health solutions for medication adherence and patient safety monitoring & management and monitoring the impact on outcomes. ​
  • Initiatives that develop innovative measures quality of life (Qol) and digital biomarkers that when utilized, will support regulatory approval of therapies. and digital therapies. ​
  • Use of AI/ML as part of disease and product benefit-risk characterization, such as minimization or mitigation of a risk that is part of disease understudy or a known medicinal product adverse reaction.   ​
  • Deployment strategies to drive healthcare professionals (HCPs) and obtain regulatory approvals (e.g., CE marking) for successful treatment and reimbursement of the digital/AI solution. ​
  • Clinical decision support tools to encourage guideline concordant care. ​

Post-Treatment/ Wellness:

  • Use of AI/ML to study treatment effect and impact heterogeneity by patient profile to personalize post-treatment care. ​
  • Remote Patient Monitoring for identified risks that form part of post market commitments or high-risk patients (prevent readmission, deterioration post-hospital discharge).​

Wellbeing:

  • Digital health solutions for improving patient experience, quality of life, communication of product information, and interactions with HCPs/patients for informed decisions. ​