Externally sponsored scientific research

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AstraZeneca recognises the important role that Externally Sponsored Scientific Research can play in expanding the knowledge related to a medicine and/or its associated disease area(s). This research can advance science and contribute to the development of better medicines for patients.

Externally Sponsored Scientific Research

Externally Sponsored Scientific Research is research that is initiated and managed by an external researcher who assumes the legal and regulatory responsibility for the conduct and management of the research as defined by applicable regulations and laws of the country involved.

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.

Research proposals are evaluated strictly on their scientific merit and alignment with the Company´s overall research and global development strategy
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

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

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.

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: Initiatives directed at monitoring and improving patient outcomes in individuals with all types of life-threatening or uncontrolled FXa inhibitor-related bleeds 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.	Characterization of local practices in managing the persistent threat of hyperkalaemia (including RAASi downtitration / discontinuation, low K+ diet, SPS/CPS, or wait and see approach [no intervention]) and associated impact on patient outcomes Use of SZC for the management of hyperkalaemia and enablement of RAASi in patients with CKD/DKD and/or HF and associated impact on HCRU (including cost) and patient outcomes RWE data characterizing the long-term treatment of hyperkalaemia with SZC RWE/Registry data demonstrating SZC enablement of guideline-directed RAASi therapy in patients with CKD and/or HF
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)

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 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 Perioperative durvalumab +/- neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer not represented in the NIAGARA or VOLGA trials 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. Studies that overlap or compete with AstraZeneca development program or where there is compromised or excessive safety risk will not be accepted 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. Externally Sponsored ‘Non-Clinical’ Research proposals might still be considered but only where sponsors require supply of drug and not funding support.
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 1^st and 2^nd 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. The inclusion of women of child-bearing potential would need to be assessed for any proposal based on the risk benefit and the use of appropriate highly effective contraception. 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. Proposals with a supporting translational / exploratory mechanistic research package to understand the role and interplay of MET and the immune-microenvironment will be prioritised. 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. Investigators interested in submitting a proposal for consideration will first have to register on the web-based system iEnvision with their profile, 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	Proposals for Oncology indications using tremelimumab alone or in combination with other products (with the exception of durvalumab-based combinations - see the durvalumab areas of interest for further information), 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

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

The link will provide further information about Areas of Interest for the Rare Disease brands as well as direction on how to submit your ESR proposal.

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

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	Mechanistic studies on the benefits of triple therapy (or synergistic effects of the components) on factors associated with cardiopulmonary outcomes including exacerbations, CV events and mortality – high priority Studies highlighting the disease burden (including clinical outcomes and HCRU) associated with increased cardiopulmonary risk in COPD patients The role and value of pMDIs in the management of respiratory conditions Quality Improvement Programmes and studies supporting the earlier/ prompt optimization of therapy in patients with COPD and on cardiopulmonary risk
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: Mechanistic or Real-World studies in eosinophil-driven diseases other than asthma that provide information about patient characteristics and disease burden. Mechanistic or clinical studies in eosinophil-driven diseases other than asthma that are not addressed by currently sponsored development programs
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	Studies evaluating tozorakimab mechanism of action in COPD and severe viral lower respiratory tract disease (LRTD) including downstream effects of IL-33^red and IL-33^ox inhibition Studies that provide information about the role of IL-33 as a driver of dysregulated inflammation and epithelial and endothelial dysfunction in COPD and severe viral LRTD Studies that provide information on tozorakimab efficacy and safety profile in COPD and LRTD sub-populations currently not included in the clinical development plan Mechanistic and interventional studies on the role of IL-33 and tozorakimab to inform future development plans

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

AstraZeneca is proud to introduce a new initiative, the AI/Digital ESR Governance team. This initiative represents our ongoing commitment to leveraging artificial intelligence and digital technology in our research and development efforts. 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. They are dedicated to ensuring our collaborations are successful and align with the AI/Digital ESR strategy and AstraZeneca's vision and values.

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.

Guidelines on creating cross-TA AI/Digital ESR submission in Veeva Clinical Vault (General Information section):

To ensure that your submission ends up with the correct AstraZeneca review team, please follow the steps below.

Step 1: Therapeutic Area - "Across TAs [AT]"

Step 2: Indication - "Other Diseases"

Step 3: Primary Product - "None"

Step 4: Direct to AI/Digital Team? - "Yes" (this field will only be available when the above 3 options are selected together)

For all other steps please follow the general ERS submission guidelines.

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: Utilization of digital solutions to support early diagnosis and at-risk identification (case finding) in therapeutic areas in the community and primary care and increasing capacity for specialist testing (e.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.

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:

Utilization of digital solutions to support early diagnosis and at-risk identification (case finding) in therapeutic areas in the community and primary care and increasing capacity for specialist testing (e.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.

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Relevant information for partners thinking about submitting an ESR application

Resources to support the submission and management of your research proposal

Externally sponsored scientific research

AstraZeneca recognises the important role that Externally Sponsored Scientific Research can play in expanding the knowledge related to a medicine and/or its associated disease area(s). This research can advance science and contribute to the development of better medicines for patients.