Externally sponsored scientific research
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AstraZeneca recognises the important role that Externally Sponsored Scientific Research can play in expanding the knowledge related to a medicine and/or its associated disease area(s). This research can advance science and contribute to the development of better medicines for patients.
Externally Sponsored Scientific Research
Externally Sponsored Scientific Research is research that is initiated and managed by an external researcher who assumes the legal and regulatory responsibility for the conduct and management of the research as defined by applicable regulations and laws of the country involved.
We support:
- Interventional Clinical Research (Phase I - IV), involving authorised, unauthorised or discontinued AstraZeneca compounds no longer being developed.
- Observational Research (i.e. Real World Evidence) - the product of interventional or non-interventional research, utilising data collected through observation of current clinical practice and/or patient-reported experience.
- Non-clinical research involving compounds across all Disease Areas and phases of development. This includes in vitro, in vivo or ex vivo biomedical research across pharmacodynamics, pharmacokinetics, animal studies, microbiologic and human biological samples (biomarkers, diagnostic assays). Requests for non-clinical research can be made via the AstraZeneca Open Innovation portal.
Transparency and Integrity
We are committed to maintaining Transparency and Integrity in all of our interactions with healthcare professionals. We follow a strict code of ethics which ensures we are compliant with regulations and ethical standards.
- Research proposals are evaluated strictly on their scientific merit and alignment with the Company´s overall research and global development strategy
- As required by law, we disclose financial support provided to researchers and their institutions
- Funding of research must not exceed local fair market value, nor be used for expenses not associated with the conduct of the research
How to participate
What does the Company require from Investigators who request support for ESR?
- Submit a well-written proposal supported by pre-clinical or clinical data with strong scientific rationale
- Have the scientific, technical and operational capabilities to conduct the study
- Be able to submit an Investigational New Drug Application (IND)/Clinical Trial Application (CTA), if necessary
- Deliver to agreed timelines
- Write final report or manuscript
- Provide contractual agreed-upon study status updates
- Have expert statistical support available for data analysis
What is the submission review process? How and when are decisions made?
The Company accepts ESR submissions via our submission tool. Access to this tool, information on the available products/compounds, and the associated areas of interest for ESR can be found on this page. Please follow the instructions to register a user name and password to access the tool.
The non-Company researcher should submit either a clinical ESR proposal or a non-clinical ESR protocol. Research proposals and protocols are reviewed on a regular basis by Company Review & Evaluation Groups, which include members from Medical, Biostatistics, and Regulatory functions. Decisions are typically communicated within 45 days of receipt of a complete submission.
Once a clinical ESR proposal is reviewed and approved, the non-Company researcher will be invited to submit a full protocol for review. Please note, approval of a proposal does not imply or guarantee approval of a protocol.
Compounds with areas of interest for Externally Sponsored Research are listed below. We aren’t accepting proposals at this time for the non-listed compounds.
Cardiovascular, Metabolic and Renal diseases
Brand / Substance |
Mechanism of action |
ESR - Areas of interest |
---|---|---|
Andexxa / Ondexxya |
Modified recombinant inactive factor Xa (FXa) designed to reverse FXa inhibitors |
Epidemiology:
Impact of locally implemented treatment algorithms across all types of life-threatening or uncontrolled FXa inhibitor-related bleeds:
Quality measurements and/or process improvement initiatives:
FXa inhibitor-related Trauma bleeds: Characterization of life-threatening or uncontrolled FXa inhibitor-related bleeds following traumatic injury.
FXa inhibitor-related Gastrointestinal bleeds: Characterization of life-threatening or uncontrolled FXa inhibitor-related GI bleeds.
Urgent Surgery:
|
Forxiga / Farxiga
|
SGLT2 inhibitor
|
|
Lokelma |
An oral non-absorbed potassium binder that selectively captures potassium ions locally in the gastrointestinal tract, thereby reducing serum potassium (S-K) concentration and removing potassium from the body through increased faecal excretion. |
|
Wainua |
Antisense oligonucleotide |
|
Vaccines & Immune Therapies
Substance |
Mechanism of action |
ESR - Areas of interest |
---|---|---|
AZD1222 |
COVID-19 Vaccine |
|
AZD7442 |
COVID-19 Antibody |
|
AZD3152 |
COVID-19 Antibody |
|
Fluenz Tetra /
FluMist
Quadrivalent
(LAIV/QLAIV) |
Live Attenuated Influenza Vaccine |
|
Oncology
Oncology Externally Sponsored Research Handbook – guidance on how to work successfully with AstraZeneca and advice on key challenges encountered during ESR. Please click here to download the Handbook.
Brand / Substance |
Mechanism of action |
ESR - Areas of interest |
---|---|---|
AZD0171 |
humanized monoclonal antibody (mAb), immunoglobulin G subclass 1 (IgG1) |
Accepting limited Externally Sponsored Clinical Research Proposals |
AZD4635
|
Oral inhibitor of adenosine 2a receptor (A2aR) |
Not accepting Externally Sponsored Clinical Research Proposals. |
Acalabrutinib |
Highly selective, potent BTK inhibitor |
Proposals evaluating the use of acalabrutinib in B-cell hematological malignancies
|
AZD1390 |
Potent and Selective Brain Penetrant ATM inhibitor |
|
AZD2811 | Potent and Selective AURKB nanoparticle inhibitor | Not accepting externally sponsored studies at this time. |
AZD5153
|
BRD4/BET bromodomain inhibitor |
Not accepting externally sponsored studies at this time. |
Capivasertib / AZD5363 |
AKT Inhibitor |
Accepting Externally Sponsored Research Proposals on a drug only basis at this time |
AZD6738 Ceralasertib |
ATR Inhibitor |
|
AZD8186 | Lipid kinase PI3Kß /d |
Not accepting Externally Sponsored Clinical Research Proposals. |
Dato-DXd |
TROP2-directed Antibody Drug Conjugate (ADC) |
Dato-DXd in NSCLC
Dato-DXd in Breast Cancer
Pre-clinical studies will be considered through the AstraZeneca Open Innovation portal.
|
Imfinzi (Durvalumab) |
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
SCLC
Urothelial Cancer
GI Cancers Biliary Tract Cancer (BTC)
Hepatocellular Carcinoma
Intermediate stage HCC
Early-stage HCC
Other indications supported by robust preclinical data may be considered
|
Iressa (gefitinib) |
EGFR Inhibitor |
|
Lynparza |
PARP Inhibitor |
|
MEDI551 |
MAb |
Accepting Externally Sponsored Clinical Research Proposals for drug only in allogenic stem cell transplantation |
Osimertinib / AZD9291 |
|
EGFRm NSCLC Resistance/What next?
Real World Evidence
CNS
Early Disease
EGFR Testing
|
Volrustomig (MEDI5752) |
monovalent bispecific humanized immunoglobulin G1 (IgG1) monoclonal antibody (mAb) |
Accepting limited Externally Sponsored Clinical Research Proposals |
MEDI9197 |
TLR 7agonist |
Accepting limited number of Externally Sponsored Clinical Research Proposals |
Monalizumab |
NKG2A |
Accepting limited Externally Sponsored Clinical Research Proposals |
Saracatinib / AZD0530 |
Src tyrosine kinase family inhibitor |
|
Savolitinib |
c-Met receptor tyrosine kinase inhibitor (TKI) |
|
Selumetinib / AZD6244 |
MEK 1/2 Inhibitor |
NF1 PN Accepting limited Externally Sponsored Clinical Research Proposals. Proposals should be supported by a strong scientific rationale, preclinical data package and specific hypotheses to address. Proposals shall be prioritized accordingly based on scientific merit and fit with the core development program. We will be prioritising drug-only requests. Investigators interested in submitting a proposal for consideration will first have to register on the web-based system iEnvision with their profile, link attached below. Once you have registered in the system, you can submit a concept proposal electronically. Email submissions are not accepted http://alexion.com/our-research/research-partnerships/externally-sponsored-research |
Trastuzumab deruxtecan (DS-8201/T-DXd) |
HER2-targeting Antibody Drug Conjugate (ADC) |
HER2+ Breast Cancer
HER2-low Breast Cancer
Breast Indication Non-specific
HER2-expressing Gastric Cancer
HER2-targetable non-small cell lung cancer (NSCLC)
Additional Areas of Interest
Pre-clinical studies will be considered through the AstraZeneca Open Innovation portal. |
Tremelimumab |
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 / |
Endothelin receptor A (ETA) antagonist |
Proposals for Oncology indications are not sought at this time. Proposals for non-oncological indications may be of interest |
Rare Diseases
For submission of ESRs related to Rare Diseases you will be directed to an Alexion domain by clicking the below link.
The link will provide further information about Areas of Interest for the Rare Disease brands as well as direction on how to submit your ESR proposal.
http://alexion.com/our-research/research-partnerships/externally-sponsored-research
Respiratory & Immunology
Brand / Substance |
Mechanism of action |
ESR - Areas of interest |
---|---|---|
Airsupra |
Inhaled steroid/short acting Beta2 agonist |
Areas of Priority, all submissions considered on a case by case basis
Please contact company staff before submitting a study proposal |
Breztri |
ICS, LAMA, LABA |
|
Fasenra |
Anti-IL-5Rα monoclonal antibody |
Studies in patients with eosinophilic asthma to:
Mechanistic studies in relevant disease-state models to:
Benralizumab lifecycle management:
|
Pulmicort |
ICS |
|
Saphnelo |
Monoclonal antibody to the type I IFN receptor subunit 1 |
Studies in patients with SLE focus, including:
|
Symbicort |
ICS/LABA combination |
|
Tezspire |
Anti-TSLP monoclonal antibody |
Areas of High Priority but considered on a case by case basis
Medium Priority, but considered on a case by case basis
All other submissions considered on a case by case basis |
Tozorakimab |
Inhibition of IL-33 |
|