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) – 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):
- Oncology – requests for non-clinical research involving compounds across all phases of development can be made via the AstraZeneca Open Innovation portal.
- Non-Oncology Therapy Areas – requests for non-clinical research involving compounds in phase III development or beyond can be made via Evidence Connect portal.
- Non-Oncology 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
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 / |
Mechanism |
ESR - Areas of interest |
AZD1656 |
Glucokinase (GK; hexokinase 4) activator |
cre |
AZD4017
|
11-beta-hydroxysteroid dehydrogenase type 1 (11ß-HSD1) inhibitor |
|
Brilinta / |
ADP receptor antagonist |
|
Forxiga / Farxiga
|
SGLT2 inhibitor
|
Exploring the Effects of Dapagliflozin on the Cardiovascular System
Exploring the Effects of Dapagliflozin on the Renal System
Other research focus areas will be considered so as not to restrict scientific creativity |
Plendil (Felodipine) |
calcium antagonist |
Accepting proposals in China only (previous confirmation with Xi Zang Kang Zhe Pharmaceutical development Co., Ltd.) |
Sodium Zirconium Cyclosilicate (SZC) |
Oral, non-absorbed potassium binder |
|
Renal disease (no substance or brand involved) |
NA |
|
Roxadustat |
Oral, hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) |
Real World Evidence: local data generation to describe anaemia and its management, CKD. Active drug trials with Roxadustat: will only be considered after Roxadustat is authorised in the country of the applicant. Areas of interest will be:
Other research focus areas will be considered as to not restrict scientific creativity |
Gastrointestinal
Brand /Substance | Mechanism of action |
ESR - Areas of interest |
Lesogaberan / |
Gamma-aminobutyric |
|
Nexium (esomeprazole) |
PPI inhibitor |
|
Infection
Brand / |
Mechanism |
ESR - Areas of interest |
AZD1222 |
COVID-19 Vaccine |
We are currently not accepting any ESRs related to Long Acting Antibodies research |
Fluenz Tetra /
|
Live attenuated influenza vaccine |
|
Neuroscience
Brand / |
Mechanism |
ESR - Areas of interest |
AZD0328 |
Nicotinic acetylcholine
|
|
AZD7325 |
Gamma-aminobutyric
|
|
Cabocaine |
Mechanism of action not fully understood |
|
Citanest |
Mechanism of action not fully understood |
|
Diprivan |
Mechanism of action not fully understood |
|
EMLA |
Mechanism of action not fully understood |
|
Marcaine |
Mechanism of action not fully understood |
|
Movantik/Moventig (Naloxegol/NKTR-118) |
Oral peripherally-acting mu opioid receptor antagonist |
|
Naropin |
Mechanism of action not fully understood |
|
Seroquel / |
Mechanism of action not fully understood |
|
Vimovo |
NSAID/ |
|
Xylocaine |
Mechanism of action not fully understood |
|
Zomig |
Serotonin receptor (1b,1d) agonist |
|
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 |
AZD4635 |
Oral inhibitor of adenosine 2a receptor (A2aR) |
|
Acalabrutinib |
Highly selective, potent BTK inhibitor |
Proposals evaluating the use of acalabrutinib in B-cell hematological malignancies
|
AZD5153 |
BRD4/BET bromodomain inhibitor |
|
Capivasertib / AZD5363 |
AKT Inhibitor |
Accepting Externally Sponsored Research Proposals on a drug only basis at this time |
AZD6738 |
ATR Inhibitor |
|
AZD8186 |
Lipid kinase PI3Kß /d |
Not accepting Externally Sponsored Clinical Research Proposals. |
Cediranib / AZD2171 |
Oral VEGF receptor -1-2-3 kinase inhibitor |
|
Durvalumab / MEDI4736 |
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 |
|
Faslodex (fulvestrant) |
Selective Estrogen Receptor Downregulator |
Opportunities for development in Breast cancer: Monotherapy studies:
Combinations studies with targeted biological agents:
ER+ subgroups:
|
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
|
MEDI9197 |
TLR 7agonist |
Accepting limited number of Externally Sponsored Clinical Research Proposals |
MEDI0457 |
HPV vaccine |
Accepting limited Externally Sponsored Clinical Research Proposals in combination with durvalumab in H&N”. |
MEDI0562 |
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 |
NKG2A |
Accepting limited Externally Sponsored Clinical Research Proposals |
Saracatinib / AZD0530 |
Src tyrosine kinase family inhibitor |
|
Savolitinib |
c-Met receptor tyrosine kinase inhibitor (TKI) |
|
Selumetinib / |
MEK 1/2 Inhibitor |
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.
Paediatric NF1-PN
Studies exploring re-treatment with selumetinib in patients who have come off therapy (for reasons other than toxicity or progression) for >3 months Adjuvant/Neo adjuvant use in combination with debulking surgery Country-specific real world evidence studies Adult NF1-PN Real world evidence in adult population
Studies exploring combinations to deepen the response in adult patients
Country-specific studies real world evidence studies NF1 – associated disease Treatment of MPNST
NF1-NSCLC
Pathway related paediatric tumours
Pathway related adult solid tumours
|
Trastuzumab deruxtecan (DS-8201/T-DXd) |
HER2-targeting Antibody Drug Conjugate (ADC) |
|
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 |
Zoladex (goserelin) |
LHRH agonist |
|
Respiratory & Immunology
Brand/Substance |
Mechanism of action |
ESR - Areas of interest |
anifrolumab |
Monoclonal antibody to the type I IFN receptor subunit 1 |
|
Benralizumab |
|
|
budesonide / glycopyrronium / formoterol FDC in COPD |
ICS, LAMA, LABA |
|
budesonide / |
Inhaled steroid/long acting Beta2 agonist |
|
Tezepelumab |
Anti-TSLP monoclonal antibody |
|
None |
N/A |
|
AZD1236 |
Matrix metalloproteinase 9 & 12 (MMP9,12) inhibitor |
|
AZD1981 |
CRTh2 Inhibitor |
|
AZD5904 |
Myeloperoxidase (MPO) inhibitor |
|
MEDI551 |
MAb
|
|
AZD1222 |
COVID-19 vaccine |
We are currently not accepting any ESRs related to Long Acting Antibodies research (LAAB) |
PT027 - Budesonide/Albuterol | Inhaled steroid/short acting |
|