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) - 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) - for compounds in Phase III development or beyond 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). Compounds in pre phase III development are open for externally sponsored research submissions 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

Immuno-Oncology Areas of Key Scientific Interest – Submission Window Open

AstraZeneca Oncology is particularly interested in receiving proposals for clinical studies with Durvalumab in the following settings:

We are interested in understanding the optimal subsequent treatment for NSCLC patients who progressed after the durvalumab regimen used in the PACIFIC study¹ and a) have a local recurrence, or b) who have distant progression.
In loco-regional Hepatocellular Carcinoma, trans-arterial chemoembolization (TACE) is the most commonly recommended treatment method^2,3. In clinical practice, TACE is highly individualized. Therefore, it is important to investigate safety and efficacy of durvalumab combination with various TACE practice, which are commonly used in real world clinical setting. In addition, how to measure efficacy of durvalumab combination with TACE is another key topic of interest.

AstraZeneca is welcoming proposals for academic-sponsored clinical research studies addressing these areas of interest and requests that submissions are made between 19^th November 2018 through to 13^thJanuary 2019. When completing your submission, please enter the code RFP TACE or RFP PACIFIC at the beginning of the Study Title field.

^{1. Antonia SJ, et al. Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC. NEJM; Sep 2018.}

^{2. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Hepatobiliary Cancers Version 1.2018}

^{3. Verslype C, Rosmorduc O, Rougier P. ESMO Guidelines Working Group. Hepatocellular carcinoma: ESMO-ESDO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2012;23(7): vii 41–8.}

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

Make a submission

Glucokinase (GK; hexokinase 4) activator

Preclinical reprotoxicology data are available and have not identified any specific risks. Women of child-bearing potential using highly effective contraception can be included
Proposed indications should be evaluated against the risk of hypoglycaemia in non-diabetic subjects

AZD4017

Make a submission

11-beta-hydroxysteroid dehydrogenase type 1 (11ß-HSD1) inhibitor

Preclinical reprotoxicology data is not available for this compound. The inclusion of women of child-bearing potential using highly effective contraception in trials of modest size and duration could be considered based on the risk benefit and in accordance with territory specific requirements
Preclinical safety studies support future clinical studies of up to 3 months duration with the need for monitoring liver enzymes, thyroid, and adrenal function

Brilinta /
Brilique’s (ticagrelor)

Make a submission

ADP receptor antagonist

Brilinta/Brilique in CAD-PMI, CAD-T2DM and AIS (acute ischemic stroke).

Bydureon
(exenatide)

Make a submission

GLP-1 receptor agonist

Study proposals with Bydureon intended to investigate:

Comparison with basal insulin or delay of insulin initiation
Bydureon autoinjector device ease-of-use and patient acceptability (not placebo-controlled)
Administration in sequential combination with SGLT-2 inhibitors
Effects on cardiometabolic parameters

Crestor (rosuvastatin)

Make a submission

Selective and competitive inhibitor of HMG-CoA reductase

Pilot studies in novel indications
Studies of lipid efficacy biomarkers or other novel intermediate endpoints
Atherosclerosis studies of niche patient populations; exploratory studies of plaque stability and composition
Studies of pleiotropic effects, including studies of patients with a non-CV disease state

Forxiga / Farxiga
(dapagliflozin))

Make a submission

SGLT2 inhibitor

Original studies, involving Dapagliflozin, aimed to:

Define its clinical benefit within different therapeutic strategies, alone or in combinations with other medications, addressing multiple populations in type 2 diabetes mellitus, including other comorbidities or disease areas (e.g. overweight/obesity, heart failure, chronic kidney disease)
Better understand the mechanism of action on different target organs
Effects on cardiovascular risk factors and on renal impairment

Research proposals can be non-clinical, clinical interventional and observational

Investigators should justify the innovative contribution of their research proposal and avoid repetition of previous well-established research.

Plendil

(Felodipine)

calcium antagonist

Medical areas related to hypertension

Accepting proposals in China only (previous confirmation with Xi Zang Kang Zhe Pharmaceutical development Co., Ltd.)

Sodium Zirconium Cyclosilicate (SZC)

Make a submission

Oral, non-absorbed potassium binder

Real World Evidence, with local data generation on SZC use, Quality of Life studies and resource utilization impact
Until Lokelma is authorised in the country of the applicant, we need to defer the endorsement of any clinical proposals. Areas of interest will be:
- SZC in Chronic Kidney disease (CKD): Efficacy >28d in CKD; enabling RAASi use in CKD; SZC use in dialysis; impact on nutrition; patient reported outcomes; use to facilitate fistula maturation in dialysis.
- SZC in Heart Failure (HF): Efficacy >28d in HF; SZC enabling RAASi/Entresto/MRA use in HF;
- SZC in ER setting and resistant HT
- Other: Adherence and persistence; Frequency and K monitoring and treatment protocol; Endpoints other than K; Impact on blood pressure.
HiK management: Association between Hyperkalemia (HK) and CKD progression; readmission rates in HK; K variability; HK in the ER setting; arrhythmias in CKD.
Profile/Mechanism of Action: Benefits of selective K trapping; benefits of increased bicarbonate with SZC.

Renal disease (no substance or brand involved)

Make a submission

Research to further development of regulatory endpoints in renal trials
Research to support understanding of early disease progression, and how it relates to progression of disease
Research to support understanding of fast progressors versus patients with slower prognoses
Mechanistic and biomarker studies to further novel segmentation of chronic kidney disease, which is not biopsy dependent

Brand /Substance

Mechanism
of action

ESR - Areas of interest

Lesogaberan /
AZD3355

Make a submission

Gamma-aminobutyric
acid receptor B (GABAB) agonist

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 the previously observed increases in liver enzymes, proposals should be for diseases that require short term dosing regimens with appropriate liver monitoring and exclusion of patients or volunteers with liver abnormalities, or alternatively for diseases of severe unmet medical need where a case for tolerating potential adverse events can be made

Nexium (esomeprazole)

Make a submission

PPI inhibitor

Proposals for ESR will not be endorsed, unless if a major data gap has been identified
Accepting proposals in Japan and China only

Brand /
Substance

Mechanism
of action

ESR - Areas of interest

Fluenz Tetra /

FluMist

Quadrivalent

(LAIV/QLAIV)

Make a submission

Live attenuated influenza vaccine

Sustainability of school-located influenza vaccination programs
Novel approaches to evaluating LAIV-induced immune responses

Synagis
(palivizumab)

Make a submission

IgG1κ

Burden of RSV disease due to comorbidities and/or socioeconomic status
Healthcare utilization following RSV LRI
Exploring challenges in compliance and adherence associated with dosing of RSV prophylaxis
Cost of premature birth hospitalizations
Long-term consequences in preterm infants, children with CLDP and children with hemodynamically significant CHD

Brand / Substance	Mechanism of action	ESR - Areas of interest
AZD0328 Make a submission	Nicotinic acetylcholine receptor alpha 7 (a7 nAChR) agonist	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 AZD0328 is renally cleared and, therefore, future studies will require an assessment of the risk-benefit for subjects with renal impairment
AZD6765 (Lanicemine) Make a submission	N-methyl-D-aspartate (NMDA) receptor, low-trapping, open-channel blocker	Preclinical 3, 6 and 9 month intermittent i.v. infusion studies have been performed to support > 45 infusions in humans. NMDA-class associated neurotoxicity findings have been observed in rats at supra-therapeutic doses 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 Proposals for indications, other than the original target indication of Depressive Disorders are welcomed. Proposals should be supported by a strong scientific rationale and/or supporting preclinical data
AZD7325 Make a submission	Gamma-aminobutyric acid receptor A alpha 2 & 3 (GABAAa2,3) positive modulator ;	Preclinical reprotoxicology data is available and has not identified any specific risks. Women of child-bearing potential using highly effective contraception can be included Subjects with past or present symptoms of alcohol or drug abuse/dependence and/or subjects suspected of abusing alcohol or illicit or prescription medications should probably be excluded
Cabocaine (mepivacaine) Make a submission	Mechanism of action not fully understood	No additional indications are being sought for Cabocaine Proposals for safe and appropriate use of Cabocaine within currently approved indications may still be supported, if a major data gap has been identified
Citanest (prilocaine) Make a submission	Mechanism of action not fully understood	No additional indications are being sought for Citanest Proposals for safe and appropriate use of Citanest within currently approved indications may still be supported, if a major data gap has been identified
Diprivan (propofol) Make a submission	Mechanism of action not fully understood	No additional indications are being sought for Diprivan Proposals for safe and appropriate use of Diprivan within currently approved indications may still be supported, if a major data gap has been identified
EMLA (lidocaine / prilocaine) Make a submission	Mechanism of action not fully understood	No additional indications are being sought for EMLA Proposals for safe and appropriate use of EMLA within currently approved indications may still be supported, if a major data gap has been identified
Marcaine (bupivacaine) Make a submission	Mechanism of action not fully understood	No additional indications are being sought for Marcaine Proposals for safe and appropriate use of Marcaine within currently approved indications may still be supported, if a major data gap has been identified
Movantik/Moventig (Naloxegol/NKTR-118) Make a submission	Oral peripherally-acting mu opioid receptor antagonist	Proposals that increase the knowledge of Movantik’s/Moventig’s efficacy and safety in OIC patients with chronic pain (non-cancer and cancer) Proposals that assess efficacy and safety of Movantik/Moventig in novel areas: eg OIC in acute pain, prophylaxis of OIC, other GI disorders Proposals that contribute to the understanding of Movantik’s/Moventig’s mechanism of action
Naropin (ropivacaine) Make a submission	Mechanism of action not fully understood	No additional indications are being sought for Naropin Proposals for safe and appropriate use of Naropin within currently approved indications may still be supported, if a major data gap has been identified
Seroquel / Seroquel XR (quetiapine fumarate) Make a submission	Mechanism of action not fully understood	No additional indications are being sought for Seroquel/Seroquel XR Proposals for safe and appropriate use of Seroquel/Seroquel XR within currently approved indications may still be supported, if a major data gap has been identified
Vimovo (naproxen / esomeprazole) Make a submission	NSAID/ PPI	No additional indications are being sought for Vimovo Proposals for safe and appropriate use of Vimovo within currently approved indications may still be supported, if a major data gap has been identified
Xylocaine (lidocaine) Make a submission	Mechanism of action not fully understood	No additional indications are being sought for Xylocaine Proposals for safe and appropriate use of Xylocaine within currently approved indications may still be supported, if a major data gap has been identified
Zomig (zolmitriptan) Make a submission	Serotonin receptor (1b,1d) agonist	No additional indications are being sought for Zomig Proposals for safe and appropriate use of Zomig within currently approved indications may still be supported, if a major data gap has been identified

Brand / Substance	Mechanism of action	ESR - Areas of interest
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.
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	Not accepting Externally Sponsored Clinical Research Proposals.
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 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
MEDI9197 Make a submission	TLR 7agonist	Accepting limited number of Externally Sponsored Clinical Research Proposals
MEDI0457 Make a submission	HPV vaccine	Accepting limited Externally Sponsored Clinical Research Proposals in combination with durvalumab in H&N”.
MEDI0562 Make a submission	Humanized immunoglobulin G1 kappa (IgG1κ) monoclonal antibody (mAb) that specifically binds to and triggers signaling of human OX40	Accepting limited Externally Sponsored Clinical Research Proposals
Monalizumab Make a submission	NKG2A	Accepting limited Externally Sponsored Clinical Research Proposals
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 papillary renal cell carcinoma (pRCC), gastric cancer, castration resistant prostate cancer (CRPC) and paediatric brain tumours. Only proposals requesting study drug alone can be considered at this juncture.
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.
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 other biomarkers in the lung and in systemic inflammation in COPD Role of eosinophils in different triggers of asthma and COPD exacerbations (e.g. infectious, allergic) Characterization and burden of eosinophilic COPD Understanding the effect of benralizumab on airway remodeling in asthma and COPD, and disease progression in COPD Mechanistic study of EOS or BASO tissue depletion by benralizumab in relevant human setting/model in asthma and COPD
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

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