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 conduct 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

How to participate

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

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

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

The Company accepts ESR submissions via our submission tool -  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 and areas of interest for Externally Sponsored Research

Cardiovascular and Metabolic diseases

Brand /
Substance

Mechanism
of action

ESR - Areas of interest

Atacand (candesartan)

Angiotensin II inhibitor

Not accepting Externally Sponsored Research Proposals at this time

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, PAD and stroke
  • Studies that contribute to the understanding of Brilinta/Brilique’s mechanism of action

Byetta /
Bydureon
(exenatide)

Make a submission

 

 

GLP-1 receptor agonist

 

  • Islet Function / Glucose Control: Preservation of  β cell function and transplanted islets, Glycemic control in specific patient subgroups, EQW plus/versus insulin
  • CV: Mechanistic studies of EQW with Dapagliflozin  (Cardiovascular/ Renal/Other - hemodynamics, risk factors, etc.)
  • Real World Evidence: Device attributes, acceptability, use, T2DM data vs. other injectables (GLP, Insulin), and Combination use with Dapagliflozin

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

Epanova
(omega-3 free
fatty acids)

 

Omega-3 free fatty acids

Not accepting Externally Sponsored Research Proposals at this time

Forxiga / Farxiga
(dapagliflozin) /
Xigduo
(dapagliflozin
& metformin)

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, including diabetes and other comorbidities or disease areas, such as IGT, overweight/obesity, heart failure, chronic kidney disease, chronic arrhythmias (e.g. atrial fibrillation/flutter)
  • Better understand the mechanism of action on different target organs, the protective effects on beta-cell function, the role of the insulin/glucagon ratio and on glucose fluctuations and variability (i.e. CGM)
  • To elucidate the beneficial effect on cardiovascular risk factors and on renal impairment (i.e. renoprotection)

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

 

Studies should not aim for outcomes or design already addressed in previous studies, including Externally Sponsored Research or the phase 2b/3 clinical programme

Onglyza
(saxagliptin) /
Komboglyze /
Kombiglyze XR (saxagliptin
& Metformin)

Make a submission

DPP4 inhibitor

 

  • Mechanistic studies of the potential effects of saxagliptin on the progression of kidney disease
  • Studies of saxagliptin in special populations of patients with high unmet medical needs, including type 1 diabetes
  • Glycemic control in understudied ethnic populations

 For Studies using saxagliptin and Dapagliflozin in combination, please refer to the saxagliptin and dapagliflozin combination section for further details on areas of interest

 

 

Roxadustat
(FG-4592)

Hypoxia-inducible factor inhibitor

Not accepting Externally Sponsored Research Proposals at this time

Saxagliptin & Dapagliflozin

Make a submission

DDP4 inhibitor/ SGLT2 inhibitor

  • Studies to further understand the combination of Saxagliptin and Dapagliflozin on Islet function, insulin resistance and glucose homeostasis.
  • Studies to explore the combination mechanisms of saxagliptin and Dapagliflozin on microvascular complications of T2DM
  • Studies to further understand the clinical effectiveness of the combination of Saxagliptin and Dapagliflozin in T2DM.
  • Studies to further understand the benefits of concomitant initiation of Saxagliptin and Dapagliflozin in combination as a new therapeutic strategy in T2DM

Symlin
(pramlintide)

Make a submission

Amylin analogue
  • Support research that explores pramlintide dose ranges and physiologic effects in combination with other treatments in patients with diabetes, emphasis T1D
  • Support research evaluating novel combinations of pramlintide with other treatments and delivery systems in patients with diabetes, emphasis in T1D

Gastrointestinal

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

 

Prilosec/Losec (omeprazole)

PPI inhibitor

Not accepting Externally Sponsored Clinical Research Proposals at this time

Infection

Brand /
Substance

Mechanism
of action

ESR - Areas of interest

ATM AVI


(aztreonam / avibactam)

monobactam/beta lactamase inhibitor

BL/BLI

Accepting Non Clinical Externally Sponsored Research Proposals only

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

Zavicefta

(Ceftazidime / Avibactam)

Make a submission

Cephalosporin/betalactamase inhibitor

  • Pharmacokinetic proposals in special populations such as obese patients, immunocompromised patients, patients with renal insufficiency, patients with severe sepsis and tissue penetration studies (e.g. CSF) 
  • Proposals in patients with resistant pathogens like CPE, KPC, pseudomonas, MDR pathogens  
  • Clinical efficacy proposals in patients with gram negative infections beyond the target indications like bronchopulmonary infections in cystic fibrosis, pancreatic infections, febrile neutropenia, blood stream infections

Zinforo (ceftaroline)

Make a submission

Extended spectrum cephalosporin

  • Open to proposals from countries outside of North America and Japan
  • Proposals that increase the understanding of the use of Zinforo™ in the target indications of Complicated Skin and Soft Tissue Infections (cSSTIs) and Community Acquired Pneumonia (CAP)
  • Proposals that expand into other areas of potential clinical interest consistent with the target indications, including MRSA pneumonia and staphylococcal bacteraemia

Neuroscience

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

Oncology

Brand / Substance

Mechanism of action

ESR - Areas of interest

Arimidex (anastrozole)

Aromatase-inhibiting

Not accepting Externally Sponsored Research Proposals at this time

AZD1152

Aurora Kinase Inhibitor

Not accepting Externally Sponsored Research Proposals at this time

AZD1208

PIM Inhibitor

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

AZD8931

Pan-Erb Inhibitor

Not accepting Externally Sponsored Research Proposals at this time

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

Casodex / Cosudex (bicalutamide)

Anti-androgen

Not accepting Externally Sponsored Research Proposals at this time

Cediranib / AZD2171

Make a submission

Oral VEGF receptor -1-2-3 kinase inhibitor

As a monotherapy with a focus on Ovarian Cancer:

  • to identify subgroups
  • as a treatment to sequence with other standard of care treatments
  • explore dosing schedules for fixed and patient directed dosing that will manage tolerability

 As a combination:

  • With novel agents with demonstrable pre-clinical evidence or translational science with a preference to combining existing AZ pipeline products

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

  • Clinical studies that investigate Durvalumab in combination with other Immunotherapy agents or with other anticancer agents in all indications and all lines of therapy where there is good scientific rationale to support the combination

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

  • Head and Neck cancer
  • Identification of broader homologous recombinant deficient breast population responsive to Lynparza
  • Lynparza re-challenge following progression
  • New novel/novel combinations in HRD tumours
  • Chemotherapy combinations in breast and ovarian (including sequencing and scheduling)
  • BRCA breast and other tumours
  • Gastric cancer outside of Asia

MEDI551

Make a submission

MAb
Anti-CD19 B cell depleting agent

Accepting proposals for drug only in allogenic stem cell transplantation

MEDI0562

Humanized anti-OX40 monoclonal antibody that selectively binds and activates the OX40 (CD134) receptor in the tumour necrosis factor family of receptors

Not accepting Externally Sponsored Research Proposals at this time

MEDI6383

Human OX40 ligand fusion protein, a potent agonist of the receptor OX40 in the tumour necrosis factor receptor family

Not accepting Externally Sponsored Research Proposals at this time

Nolvadex / Istubal /
Valodex (tamoxifen)

Oestrogen Receptor Antagonist

Not accepting Externally Sponsored Research Proposals at this time

Osimertinib / AZD9291

Make a submission


EGFR sensitising and T790M Resistance Mutations Inhibitor

  • Combination with other anti-cancer therapy, especially immunotherapy or other novel anticancer agents, in advanced NSCLC
  • Diagnostic/Biomarker Research in EGFRm+ve NSCLC, all lines (single mutant EGFRM+ve or double mutant EGFRm+ve and T790M+ve NSCLC)
  • Monotherapy and combination studies in EGFRm+ve tumours other than NSCLC
  • In addition monotherapy or combination therapy in adjuvant/neoadjuvant setting may be considered

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

Vistusertib / AZD2014

Make a submission

mTOR (TORC1/2) Inhibitor

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

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

 

Respiratory, Inflammation & Autoimmunity

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:

  • Rapid and effective eosinophil and basophil depletion in tissue compartments
  • Role of eosinophils and basophils in inflammation and exacerbations
  • Efficacy of benralizumab in specific patient populations
  • Imaging to understand eosinophil trafficking and migration in tissue compartments

Studies assessing the role of benralizumab in other eosinophil and basophil driven diseases, including:

  • Signal generation for further indication seeking development
  • Non-indication seeking data generation

Budesonide / Glycopyrronium / Formoterol (PT010)

Make a submission

ICS, 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 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

Daliresp, Daxas (Roflumilast)

Oral PDE4 inhibitor

  • Not accepting Externally Sponsored Research Proposals at this time

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 (PT001)

Make a submission

LAMA

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

Glycopyrronium / Formoterol (PT003)

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

MEDI2338

Interleukin-18 neutralizing monoclonal antibody (αIL-18 mAb)

Not accepting Externally Sponsored Research Proposals at this time

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
  • Niche patient populations; exploratory studies
  • Asia – treatment patterns

Symbicort
(budesonide /
formoterol)

Make a submission

Inhaled steroid/long acting Beta2 agonist

  • Symbicort preventing COPD Exacerbations
  • Symbicort SMART in Asthma
  • 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

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

Zurampic (Lesinurad)

Selective Uric Acid Reabsorption Inhibitor (SURI) that inhibits URAT1

Not accepting Externally Sponsored Research Proposals at this time