Externally sponsored scientific research

AstraZeneca and MedImmune recognise the important role that Externally Sponsored Scientific Research can play in expanding the knowledge related to a company product and/or its associated disease area(s). This research can advance science and contribute to the development of better medicines for patients consistent with the company’s overall research and global development strategies.

Externally Sponsored Scientific Research

Externally Sponsored Scientific Research (ESR) is research that is initiated and managed by a Non-Company 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) - Clinical, Observational Research, and/or Methodology research involving authorized, unauthorized or discontinued Company compounds no longer being developed.
Observational Research (i.e. Real World Evidence (RWE)) - 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 (pre-clinical research) - in vitro, in vivo or ex vivo biomedical research not performed on human subjects such as:pharmacodynamic, pharmacokinetic, animal, microbiologic, human biological samples (biomarker, diagnostic assay).

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 - ES²ROS. Access to ES²ROS, 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

AZD1656

Brand / Substance	Mechanism of action	ESR - Areas of interest
Arimidex (anastrozole)	Aromatase-inhibiting	Not accepting Externally Sponsored Research Proposals at this time
AZD1775 Make a submission	Wee-kinase Inhibitor	Proposals will be prioritised accordingly based on scientific merit and fit with the core development programme Collaborators may need to generate additional preclinical work to support clinical settings of interest
AZD4547 Make a submission	FGFR1, 2, 3 Inhibitor	Accepting Externally Sponsored Research Proposals on a drug only basis at this time
AZD5363 Make a submission	AKT Inhibitor	Accepting Externally Sponsored Research Proposals on a drug only basis at this time
AZD6738 Make a submission	ATR Inhibitor	Head & neck cancer Gastric cancer Colorectal cancer Chemotherapy combinations Combinations with other novel agents Proposals should be supported by a strong scientific rationale and preclinical data package, or proposals to generate such data
AZD8186 Make a submission	Lipid kinase PI3Kß /d	Proposals will be prioritised accordingly based on scientific merit and fit with the core development programme Collaborators may need to generate additional preclinical work to support clinical settings of interest
AZD9150 Make a submission	STAT3rx antisense oligonucleotide	Proposals will be prioritised accordingly based on scientific merit and fit with the core development programme Collaborators may need to generate additional preclinical work to support clinical settings of interest
Cediranib / AZD2171 Make a submission	Oral VEGF receptor -1-2-3 kinase inhibitor	As a combination with novel agents for which there is a strong scientific rationale and demonstrable pre-clinical evidence or translational science, with a preference to combining with existing AZ marketed or pipeline products. Monotherapy proposals must have an exceptionally strong rationale to be supported by AZ.
Durvalumab / MEDI4736 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 +/- tremelimumab in NSCLC patients excluded from the registration program (un-resectable Stage IIIA / IIIB and Stage IV) Durvalumab-based combinations in immunotherapy pre-treated patients Durvalumab +/- tremelimumab combinations with chemotherapy, radiotherapy or other agents (immunotherapy / targeted therapies) Enhance biomarker knowledge to support 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 +/- tremelimumab in NSCLC Urothelial Cancer Durvalumab +/- tremelimumab combined with SoC chemotherapy in front-line metastatic urothelial cancer Durvalumab +/- tremelimumab combined with novel agents or radiotherapy in front-line or relapsed bladder cancer Optimal utilization of Durvalumab +/- tremelimumab in non-muscle invasive bladder cancer Durvalumab +/- tremelimumab combined with SoC chemotherapy, novel agents, or radiotherapy in patients with stage II– IV non-metastatic disease Real-world evidence (RWE) on treatment patterns and outcomes with introduction of checkpoint inhibitors in bladder cancer Prognostic value of PD-L1 expression in patients with bladder cancer treated with the SOC Patient reported outcomes and patient experience of patients receiving durvalumab +/- tremelimumab in bladder cancer Head & Neck Cancer Durvalumab +/- tremelimumab in HNSCC patients excluded from the registration programs Durvalumab +/- tremelimumab in locally advanced HNSCC sub-populations Durvalumab +/- tremelimumab combined with targeted agents (e.g. cetuximab, AZ targeted small molecules etc.), radiotherapy and/or chemotherapy Patient reported outcomes and patient experience of patients receiving durvalumab +/- tremelimumab in HNSCC Generate data in historical recurrent/metastatic HNSCC cohorts based on biomarkers and current SoCs Other indications (e.g. SCLC, GI tumours) supported by robust preclinical data may be considered Priority will be given to proposals that advance understanding of core development programs in NSCLC, Bladder and HNSCC Pre-Clinical studies will be considered through the ESR program 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
Faslodex (fulvestrant) Make a submission	Selective Estrogen Receptor Downregulator	Opportunities for development in Breast cancer: Monotherapy studies: In early stage breast cancer First-line for patients with advanced breast cancer after adjuvant AI Combinations studies with targeted biological agents: In early breast cancer Adding novel targeted agents after progression on Faslodex ER+ subgroups: Peri- and pre-menopausal women as monotherapy or in combination (e.g. with GNRH agonists, novel targeted agents) Patients with ER mutations Patients with visceral disease Patients with different molecular pheonotypes (e.g Luminal B breast cancer)
Iressa (gefitinib) Make a submission	EGFR Inhibitor	1st line EGFR mutation positive advanced NSCLC, e.g. combinations 2nd line onward EGFR mutation positive NSCLC, e.g. re-challenge therapy Neo-adjuvant & Adjuvant EGFR mutation positive early and locally advanced NSCLC All lines NSCLC diagnostic research Non-NSCLC tumour settings which are EGFR M+ve
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 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
MEDI551 Make a submission	MAb Anti-CD19 B cell depleting agent	Accepting proposals for drug only in allogenic stem cell transplantation
Osimertinib / AZD9291 Make a submission	EGFR sensitising and T790M Resistance Mutations Inhibitor	2^nd Line post-TKI T790M osimertinib segment and 3L post-osimertinib progression Improving benefit for patients refractory to osimertinib e.g. understanding innate resistance biology, prognostic strategies, treatment approaches Extending benefit to patients who progress post osimertinib treatment e.g. understanding genomic and non-genomic acquired resistance biology, treatment strategies Use of combination strategies to prolong benefit of osimertinib e.g. strategies to intervene at asymptomatic progression, excluding anti-VEGFR related combinations Building biology of T790M disease heterogeneity e.g. complex EGFR mutant context, co-existing genetic drivers Increasing our understanding of intracranial resistance 2^nd line post-TKI treatment of T790M unknown/negative patients Understanding molecular characterisation of T790M-ve segment and treatment opportunities (excluding cMET-targeted treatment) 1^st line Treatment with Osimertinib Defining future landscape of 1L acquired resistance to osimertinib and treatment options e.g. genomic and non-genomic mechanisms, CNS resistance Identifying combination strategies to improve benefit in refractory population Use of combination approaches to intervene at asymptomatic progression Characterising sub-populations e.g. rare activating mutations, sensitive detection of T790M Understanding CNS disease e.g. treatment outcomes, combination options to treat refractory disease, impact of dose, mandated brain scan studies Real world experience of EGFRm patient journey to inform TKI treatment strategy Use of Diagnostics Evaluating other prognostic biomarkers of osimertinib response and/or outcome with TAGRISSO Improving efficiency, implementation, and interpretation of testing workflows and pathways in the context of disease management for lung cancer patients, including (but not limited to) EGFR mutation testing Better understand the tumor biology and heterogeneity of T790M and EGFRm disease, especially at resistance Treatment of CNS Disease: Brain Metastasis and Leptomeningeal Disease Treatment of T790M+ and T790M- patients Brain Metastasis and/or Leptomeningeal Disease (asymptomatic and symptomatic) 1^st line Treatment of CNS Disease including dose escalation strategies to treat refractory pre-existing lesions or on CNS progression Use of Osimertinib in combination with Radiation Therapy (SRS and WBRT), Including: Time to cranial Radiation therapy endpoints and sequencing of local cranial RT (SRS or WBRT) and systemic osimertinib treatment (including combinations) 3^rd Line CNS disease e.g. Treatment Beyond Progression, refractory CNS disease Mechanisms of CNS resistant disease (across lines of treatment) Other CNS tumors (e.g. GBM) Immunotherapy areas of focus Building translational biological understanding across disease segments Exclude any IO treatment approaches Pre-clinical activities Use of pre-clinical derived mechanisms of resistance to inform clinical hypotheses and translational strategies, in particular non-genomic mechanisms. Use of patient derived xenograft models representing key areas of interest across EGFRm disease Studies to build evidence generation to support clinical opportunities in tumour-targeted or immune-therapy treatment areas Special populations of interest Tx of patients with rare mutations (excluding Exon20Ins) and early stages of disease e.g. pre-surgical window studies, neoadjuvant studies, un-resectable stage 3 Retrospective Real World Treatment data sets
Saracatanib / AZD0530 Make a submission	Src kinase Inhibitor
Savolitinib Make a submission	cMET Inhibitor	Renal cell carcinoma Colorectal cancer SCLC Hepatocellular Carcinoma Esophageal adenocarcinoma Triple Negative Breast Cancer Other indications supported by robust preclinical data
Selumetinib / AZD6244 Make a submission	MEK 1/2 Inhibitor	Not accepting Externally Sponsored Clinical Research Proposals at this time. Externally Sponsored ‘Non-Clinical’ Research proposals are still being considered but only where sponsors require supply of drug and not funding support.
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.
Vistusertib / AZD2014 Make a submission	mTOR (TORC1/2) Inhibitor	Not accepting Externally Sponsored Clinical Research Proposals
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
Zoladex (goserelin) Make a submission	LHRH agonist	Not accepting non-clinical Externally Sponsored Research Proposals at this time Accepting the following clinical Externally Sponsored Research Proposals: No new proposals are being considered for the US and Japan Prostate Cancer early or locally advanced disease: combination with novel targeted agents Prostate Cancer Metastatic disease: in combination with chemotherapy, other therapies or novel targeted agents. Sequencing strategies and response after progression on anti-androgens Benign Gynaecology Breast cancer: comparison of Zoladex + Tamoxifen with modern chemo regimens in HR+ pre-menopausal patients in early BC

Brand/Substance	Mechanism of action	ESR - Areas of interest
AZD1236 Make a submission	Matrix metalloproteinase 9 & 12 (MMP9,12) inhibitor	The reproductive toxicology package indicates a risk of fetal 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 The risk of muscular skeletal syndrome (MSS; joint fibrodysplasia), while reversible, has been seen after chronic administration with other MPP inhibitors in humans and fibrodyplasia in the subcutis has been seen at high doses in the 12 month preclinical safety study with AZD1236. This risk must be considered when proposing a new indication and associated treatment regimen
AZD1981 Make a submission	CRTh2 Inhibitor	Preclinical reprotoxicology data is available and has not identified any specific risks. Women of child-bearing potential using highly effective contraception can be included Given the potential for DDI and LFT effects, dosing regimen (level and duration) as well as inclusion/exclusion criteria should be selected carefully to support a favourable risk-benefit There is currently no clinical data to support use in pediatric populations below 12 years of age, although existing preclinical data would support clinical studies in a pediatric population of > 5 years
AZD5904 Make a submission	Myeloperoxidase (MPO) inhibitor	The reproductive toxicology package indicates a risk of fetal 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 AZD5904 is renally cleared, thus, requiring caution and PK monitoring if dosed to subjects with impaired renal function
AZD9668 Make a submission	Neutrophil elastase (NE) inhibitor	Preclinical reprotoxicology data is available and has not identified any specific risks. Women of child-bearing potential using highly effective contraception can be included Due to elevations in liver enzymes noted in Ph2 studies, LFTs should be monitored and a careful benefit/risk assessment as well as exclusion criteria considered for any future clinical study
Benralizumab Make a submission	Anti-IL-5Rα monoclonal antibody	Studies in Asthma and COPD which address the following: Role of eosinophils and basophils in inflammation and asthma /COPD exacerbations Data generation in uncontrolled asthma across the severity spectrum Efficacy in Benralizumab responsive eosinophilic phenotypes Concepts understanding airway remodeling and/or disease remission. Rapid and effective eosinophil and basophil depletion in tissue compartments Imaging to understand eosinophil trafficking and migration in tissue compartments
Budesonide / Glycopyrronium / Formoterol (PT010) Make a submission	ICS, LAMA, LABA	1. COPD: Understand the treatment journey of exacerbating patients in need of step-up Explore the extent of underdiagnosis of COPD and under-/un-reporting of AECOPD by patients. Explore novel biomarkers / treatable traits and pheno- and endotypes associated with differential outcomes in COPD. 2. Asthma: Establish the benefits of LAMAs beyond bronchodilation in asthma Explore the role Acetylcholine (Ach) plays in a) bronchial reactivity and remodelling; b) inflammatory cell chemotaxis and activation and c) rhinovirus (RV) infections. 3. Device: Importance of pMDI device Establish the benefits of using a single device platform (pMDI a.n. + maintenance) in more severe patients.
Duaklir (aclidinum/formoterol) Make a submission	Long Acting Muscarinic Antagonist (LAMA)/Long Acting Beta Agonist (LABA)	Studies assessing the impact of sleep, nocturnal symptoms, early morning symptoms, day-time symptoms, breathlessness and cough in COPD patients Studies investigating the combination of aclidinum and formoterol with ICS (e.g. Pulmicort) Studies assessing Patient Reported Outcome (PROs) Studies assessing physical activity and symptoms in COPD patients Studies assessing Quality of Life (QoL) Studies investigating muscle endurance Studies investigating Duaklir’s impact on the sexual life in COPD patients
Eklira (aclidinum) Make a submission	Long Acting Muscarinic Antagonist (LAMA)	Studies assessing the impact of sleep, nocturnal symptoms, early morning symptoms, day-time symptoms, breathlessness and cough in COPD patients Studies investigating Asthma COPD Overlap Syndrome Studies investigating the combination of aclidinum with a fixed dose LABA/ICS (e.g. Symbicort) Studies assessing Patient Reported Outcome (PROs) Studies assessing physical activity and symptoms in COPD patients Studies assessing Quality of Life (QoL) Studies investigating muscle endurance
Glycopyrronium / Formoterol (PT003 (Bevespi)) Make a submission	LAMA, LABA	Studies that increase the knowledge about: Symptom control Impact in patients’ activities of daily living and quality of life Early morning symptoms, including impact on QoL, disease progression and cost of care prevalence in general COPD population subsets of patients that most experience these symptoms tool and mechanisms of detection/evaluation Treatment pathways according to disease progression Current drivers of choice for COPD treatment (device and drug) ACOS identification and treatment pathways Optimization of device choice and training Impact of 24 hour symptoms (DT, NT/EM) and sleep quality post dual bronchodilators/PT003 (Bevespi) Beneficial treatment effects of dual bronchodilation/PT003 (Bevespi), on physiological, neuropsychiatric, or patient reported outcomes (including common COPD comorbid conditions such as: cardiac disease, depression & sleep disorders)
MEDI551 Make a submission	MAb Anti-CD19 B cell depleting agent	Autoimmune diseases that have B cell etiology. Of particular interest are autoimmune disease in the areas of neuro-inflammatory, rheumatoid and dermatology The Company will supply drug only (no funding is available at this time)
None	N/A	Biomarkers of response to inhaled corticosteroid-containing therapies in COPD Biomarkers to characterize COPD pheno and/or endotypes that benefit from non-ICS-containing therapies Understand inflammation in COPD vs. non-inflammatory features of the disease (e.g. structural changes) Differentiation of COPD exacerbation types (e.g. infectious vs. non-infectious) ICS-containing therapy in early (vs. mild or severe) COPD, in order to prevent disease progression Role of PDE4 inhibition in COPD-related inflammation
Pulmicort (budesonide) Make a submission	Anti-inflammatory corticosteroid	Budesonide’s contribution in preventing COPD exacerbations Device – adherence, consequences of switching device Budesonide differentiation vs. other ICS Biomarkers or other novel intermediate endpoints both asthma and COPD Niche patient populations; exploratory studies Asia – treatment patterns Early intervention in very young asthma patients as disease modification factor
Symbicort (budesonide / formoterol) Make a submission	Inhaled steroid/long acting Beta2 agonist	Symbicort preventing COPD Exacerbations Symbicort SMART in Asthma Adolescents – behavior and treatment adherence Device – adherence, consequences of switching device Budesonide differentiation vs. other ICS Biomarkers or other novel intermediate endpoints Niche patient populations; exploratory studies Asia – treatment patterns COPD/Asthma overlap diagnostic markers COPD/Asthma overlap markers for ICS benefit Early intervention in young asthma patients as disease modification factor
Tralokinumab Make a submission	Anti-IL-13 monoclonal antibody	Accepting the following clinical Externally Sponsored Research Proposals: Studies relating to understanding of IL-13 attenuation in response to pathogen challenge Longitudinal studies relating to increasing understanding of biomarker modulation in patients with uncontrolled asthma Studies that contribute to the understanding of the pathophysiology and impact of uncontrolled asthma on individuals or healthcare systems Studies exploring the potential for patient benefit in other indications including but not limited to chronic rhinosinusitis with nasal polyposis and eosinophilic esophagitis Accepting the following non-clinical Externally Sponsored Research Proposals: Any aspect of interleukin-13 (IL-13) or T helper 2 (Th2) driven (i.e. IL-4) biology that pertains to cellular responses in isolated cell or co-culture systems relevant to human asthma or any human disease for which IL-13 may play a role Of specific interest are studies that may relate to epithelial and or smooth muscle function, repair and remodeling, attenuation of the IL-13 signaling pathway in response to standard of care treatment in patients with uncontrolled asthma and co-administration studies with standard of care treatment Translational studies relating to the identification of novel biomarkers relevant to patients with uncontrolled asthma or other allergic disease such as atopic dermatitis Translational studies relating to attenuation of biomarkers relevant to the type 2 cytokine axis by standard of care treatment and/or novel drugs in clinical development, understanding of biomarkers relevant to the type 2 axis throughout childhood and adolescence

Externally sponsored scientific research