Externally sponsored scientific research

Forxiga/Farxiga
(dapagliflozin)

Make a submission

SGLT2 inhibitor

Exploring the Renal and Heart Failure benefits of Dapagliflozin

• Observational / RWE research about disease burden, patient reported outcome, treatment patterns, disease risk prediction and clinical management of kidney disease or heart failure, if study could be completed within a two-year timeframe defined as Start of Project -> FSR/Draft Publication.
• Please contact your local market medical representative before submission to ensure funding and alignment to strategy.

Lokelma
(Sodium Zirconium Cyclosilicate)

Make a submission

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.

Unbranded Data generation:

• HK prevalence and HK treatment patterns based on local need
• Practice change initiatives to bridge the gap between guidelines (GDMT use/RAASi optimization also after hyperkalemia) and clinical practice

SZC-specific Data Generation:

• RAASi use, with SZC to manage HK as needed
• Long-term treatment with SZC
• SZC as part of in-hospital treatment pathway (acute – inpatient – discharge)
• Real world descriptive analysis
• Real world comparative analysis will be considered

Wainua / Wainzua
(Eplontersen)

Make a submission

Antisense oligonucleotide

• Health system approaches to implement imaging or biomarker strategies for early diagnosis and prompt treatment initiation
• Real-world outcomes of quality standards in reducing disease burden, lowering healthcare utilization, and supporting early therapeutic interventions
• Evaluating quality of life (QoL) as an indicator of disease burden and a key goal for future treatment approaches
• Implementation of risk prediction models to optimize the timing of treatment initiation (early vs. late) and enhance clinical outcomes
• Establish evidence for the benefits of early versus late treatment interventions on patient outcomes
• Innovative methodologies to reduce disparities in disease management and improve sustainability, with a focus on equitable diagnostic and care access
• Role of Silencers in improving patient-centric outcomes and defining best practices for its use in clinical care

Baxdrostat

Make a submission

Aldosterone synthase inhibitor

• Mechanistic differences with MRA vs ASI
• Role of non-MR mediated effects of aldosterone
• Other physiological effects of aldosterone (including inflammation and fibrosis)

Fluenz /

FluMist
 

(LAIV)

Make a submission

Live Attenuated Influenza Vaccine

Areas of interest (but considered on a case-by-case basis):

• Role of children in the transmission of influenza:
  • Within households, schools and to older adults
  • Disruption of transmission via use of LAIV
  • Reduction of antibiotic misuse
     

• LAIV use in healthy adults (18 – up to 59 years of age):
  • Effectiveness
  • Broader benefits of vaccinating young adults
  • Self-administration
  • Mucosal and systemic Immune response
     

• Caregiver-/Selfadministration
  • Ease of use
  • Uptake, change in Demographics of uses
     

• Impact of different delivery mechanisms for LAIV (e.g. via school-based program, pharmacy program, etc.) on:
  • Vaccine uptake
  • Indirect benefits of LAIV
  • Value to broader society
     

• All other submissions considered on a case-by-case basis.
• Please contact the V&I medical team before submitting any study proposal.

IVX-A12
Make a submission

RSV and hMPV Bivalent Virus-like Particle
Protein Subunit Vaccine

Priority 1:

Work with researchers who can leverage existing data sets or platforms for sample collection and testing or archived samples to address the below in adults 18yrs or over for hMPV and or RSV: 

• Incidence rates
  • Hospitalised patients
  • Community infection
• Prevalence and disease including severity/characterisation hMPV and or RSV:
  • In an Outpatient setting
  • In an Emergency Department setting

Data on the above for populations of special interest infected with hMPV and or RSV:

• High risk
  • Chronic Lung disease COPD, asthma
  • Degenerative neurological disease
  • frailty status (according to a frailty score index)(14, 15)
  • cardiovascular diseases (e.g., CHD), Diabetes Mellitus,
  • Chronic Renal Disease
  • Chronic Liver Disease
  • Long term facility residents
• Oncology
  • All haematological oncology patients, including HCT
  • Solid tumor patients with cytotoxic chemotherapy
• Immunosuppressive therapy
  • Including transplant recipients:
  • B-cell targeting, S1P Receptor Modulators, Calcineurin Inhibitors, Chronic HD Corticosteroids ≥20mg/day, Immunosuppressive Antimetabolites, including SOT
• Immunology
  • Primary immunodeficiencies (patients on IVIG)
  • Advanced/uncontrolled HIV (CD4 < 200 cells/mm3)

Priority 2:

Work with researchers and modellers to assess in adults 18 years and over:

• Financial impact of hMPV and the combination of RSV and hMPV on healthcare systems
• Health care resource utilisation data for both outpatients, emergency department and inpatients for both hMPV, RSV and the combination of RSV and hMPV

Sipavibart

COVID-19 Antibody

• Not accepting Externally Sponsored Research Proposals

Synagis
Make a submission

Monoclonal antibody for prevention of severe disease in children caused by RSV infections

• Please contact medical team before submitting a study proposal

Accepting limited Externally Sponsored Clinical Research Proposals

Hematologic Malignancies

iNHL: 

• Surovatamig combinations and sequencing strategies with novel non-chemotherapy molecules or mechanisms of action in other types of indolent NHL such as WM/LPL
• Surovatamig combinations and response adapted strategies with novel non-chemotherapy molecules or mechanisms of action in TN FL patients
• Surovatamig combinations and sequencing strategies with novel non-chemotherapy molecules or mechanisms of action in R/R FL, including those with high-risk disease, POD24, and elderly and frail patients

LBCL: 

• 1L LBCL: Response-adapted and/or, chemo-free/ chemo-lite novel combinations with AZ-developed and/or external molecules
• 2L+ LBCL: Novel combinations with other molecules in relapsed/refractory LBCL patients
• Unmet medical needs in special populations 

Independent of LOT above:

• Innovative Technologies: Exploration/development of innovative technologies for early AE detection or prediction (e.g., digital wearables) 
• Optimal administration: Study and optimize administration and clinical management of Surovatamig
• Understanding mechanism of resistance to CD19 expression in relationship to clinical outcome

ALL:

• 1L B-ALL (adult): Response/MRD-adapted and/or, chemo-free/chemo-lite novel combinations with AZ-developed and/or external molecules
• Pediatric B-ALL: novel/SOC combinations and sequencing strategies
• Vulnerable and/or rare patient populations
• CD19+ acute leukemias, other than B-cell ALL

CLDN18.2 GC/GEJC:

• Explorations of biomarker (CLAUDIN18.2) expression
• Considerations for multi-modal combinations, leveraging novel technologies
• Alternative applications beyond those currently under Ph3 investigation

• Areas of interest include exploration of monotherapy or combination treatment in indications where there is a strong scientific, translational, or clinical rationale to target ATM inhibition
• Proposals in combination with radiotherapy, other double strand break inducing agents or other novel combinations for solid tumour indications
• Proposals will be prioritzed accordingly based on scientific merit and fit with the core development program.

Not accepting externally sponsored studies at this time.

Not accepting Externally Sponsored Clinical Research Proposals.

Not accepting externally sponsored studies at this time.

Not accepting Externally Sponsored Clinical Research Proposals.

Central Nervous System tumors; PARPi based imaging Biomarkers, Solid tumors

• Safety and efficacy of AZD9574 in combinations with anti-cancer agents in solid tumors
• Development of PARPi based Imaging Biomarkers
• Safety and efficacy of AZD9574 in Central Nervous System tumors
• Other areas may be considered based on strong scientific rationale and supported by preclinical and/or clinical data
• As AZD9574 is still in Early Development,, discussions on proposed dose levels should be entered into at an early stage.

CLL/SLL

• Acalabrutinib combinations with novel non-chemotherapy molecules or MOA (including ADCs) in CLL/SLL
• Drivers of resistance with acalabrutinib treatment in CLL/SLL
• RWE and observational CLL/SLL studies addressing sequencing, key clinical outcomes including tolerability, quality of life, reimbursement, or country-specific needs with acalabrutinib and/or acalabrutinib combinations

MCL (and iNHL)

• Acalabrutinib combinations with AZ or external novel molecules (MOA) with potential to disrupt SOC in both MCL and iNHL regardless of line of therapy
• Understand contribution of A as maintenance therapy in MCL as an alternative to Autologous SCT
• RWE and observational studies with BTKis addressing specific needs in TN or R/R MCL
• Retrospective drug-resistance analyses (not limited to C481S) with clinical correlates in post-1L and 2L (TTP and finite combo)

DLBCL

• Novel combinations with AZ-developed or new external molecules, with potential to disrupt SoC (e.g., anti-CD19 mAbs and CAR T-cell therapies, TCE, or ADCs) in earlier lines of DLBCL, ideally chemo-free

HR+ aBC

Pre- and post-launch:

• Camizestrant in fast progressing patients
• Novel combinations for launched compounds
• Clinical benefit in patients underrepresented or not represented in Phase III trials: i.e. black, men, frail, elderly
• Treatment sequencing (after SERENA-4 and/or SERENA-6)
• Characterisation of HR-positive, HER2-negative patient outcomes in a RW setting
• Understanding predictive biomarkers
• ESR1m prevalence in 1L and biomarker optimal testing patterns in 1L*
• Patient and physician experiences & preference on testing*
• Early adopter site evaluations on introducing molecular monitoring *
• Camizestrant monotherapy in select patient populations

• CDK4/6i combinations with camizestrant in RW setting
• Characterising RW experience with Camizestrant
• Safety/efficacy of camizestrant as indirect comparisons with other ET in aBC, including ngSERDs
• Camizestrant in different BC disease subtype
• Analysis of long-term benefit and ESR1m monitoring impact on health care resource utilisation*
• Defining optimal clinical cut-offs and MAF (mutational allele frequency) for ESR1m testing*

• Combination with ribociclib (via NVS partnership)
• Definitions of intermediate-/high-risk populations
• Use of innovative technologies (e.g. AI-driven approaches etc)
• Role of clinical criteria (e.g. tumour size, lymph nodes etc.), Ki67 and genomic assays
• Unmet need in special patient groups (e.g. premenopausal)
• Treatment patterns and adherence
• Burden of AI on eBC patients' quality of life (e.g. gynaecological disturbances, arthralgia, vasomotor symptoms, sleeping disorders)
• Unmet need and treatment outcomes in the evolving RWE landscape
• ctDNA testing in late adjuvant setting (e.g. MRD)

• RW experience with camizestrant

NSCLC

• Identify/validate predictive biomarkers for ceralasertib regimen
• Patient populations of special interest (e.g., excluded from registrational trial, PS2, brain mets, 1L poor responders, etc.)​
• Explore ceralasertib combinations following progression after surgery plus neoadjuvant/perioperative IO or after CRT+IO
• Understand sequencing of ceralasertib + durvalumab after novel 1L mNSCLC regimens

Breast Cancer

• Identifying risk factors and optimal management of Dato-DXd adverse events
• Efficacy and safety in patient populations including underserved populations not represented/underrepresented in registrational studies
• Optimal incorporation of Dato-DXd within the evolving breast cancer treatment landscape (including early, advanced, and metastatic settings, and inclusive of real-world or clinical studies)
• *Prevention or delaying the emergence of CNS metastasis
• Novel combinations with targeted agents supported by strong rationale/data
  
• Understanding biomarkers and association with clinical outcomes and/or mechanisms of acquired resistance

* Indicates AOIs where company has already received multiple proposals

Lung Cancer

NSCLC

• Complement ongoing Phase 3 trials with efficacy/safety in patient populations not reflected/under-represented
• Combinations with approved agents that complement Dato-DXd clinical program
• Exploring biomarkers that may inform drivers of resistance or response
• Identifying mechanisms, risk/predictive factors and optimal management of key AESIs (e.g., stomatitis, ocular surface events, ILD) that complement ongoing activities
• Understanding MoA/MoR of Dato DXd in EGFRm setting

HER2+ Breast Cancer

• Optimal treatment approaches to maximize patient experience and outcomes with T-DXd in mBC
• Rechallenge strategies with T-DXd within different LoT
• Exploration of benefit of T-DXd in broadening the patient population in eBC
• Combination treatment strategies in patients with suboptimal response to T-DXd

HER2low Breast Cancer

• Exploration of benefit of T-DXd in subpopulations with high unmet need
• Clinical applicability of technologies (AI / Digital / Computational path) to approach patient ID, spanning the HER2 spectrum
• Explore approaches to maximize patient response

Breast Indication Non-specific

• Novel combinations translational or clinical approaches to delay resistance and optimize outcomes
• Characterizing treatment patterns and benefit risk profile in BC using large scale RWE
• Identify population at risk for high-grade AEs and strategies for prophylaxis & management and optimize patient's experience

HER2-expressing Gastric Cancer

• Real-world testing, treatment patterns and sequencing such as following IO and/or other regimens; in earlier lines/early disease: unmet need, outcomes by geographic location, and HER2 expression
• Clinical activity and safety in HER2-expressing disease, incl. novel combinations with T-DXd
• HER2 dynamics and prevalence over time in response to different Tx combinations/monotherapy (including overlapping biomarkers)

HER2-targetable Non-Small Cell Lung Cancer (NSCLC)

• Long term follow up efficacy of T-DXd in metastatic 2L HER2m in the real-world setting
• T-DXd combinations in HER2m including safety, dosing in 1L setting
• T-DXd efficacy and safety in HER2 IHC 2+ NSCLC population in 2L+
• T-DXd MoA/MoR in HER2 IHC 2+/3+ NSCLC
• T-DXd CNS brain metastasis efficacy in HER2 (OE, Mutant) NSCLC

HER2-expressing Tumor Agnostic

• T-DXd efficacy/safety in HER2 expressing malignancies with limited data including real-world evidence, including novel combinations
• Novel technologies and methods to support patient ID
• Exploring biomarkers and patient characteristics contributing to clinical outcomes

HER2-expressing Gynecological Tumors

• Signal seeking studies of T-DXd efficacy/safety in combinations, including HER2 IHC 1+ in earlier lines, complementing CDP
• HER2 diagnostic workup optimization including pre-analytics, detection, and reporting (e.g. IHC scoring algorithm & correlation with response to T-DXd)
• Monotherapy T-DXd studies to support/complement CDP
• HER2 expression dynamics, heterogeneity, and overlap with other biomarkers in GYN cancers

Bladder cancer

• Accepting limited Externally Sponsored Clinical Research Proposals at this time. For more details, please contact the AstraZeneca medical team.

rNSCLC

• Patient Identification (Biomarker & Clinical Features): Identification of risk-based populations more likely to derive benefit from durvalumab-based regimens (perioperative vs neoadjuvant vs adjuvant), or mechanisms of IO resistance
• New MoAs: Explore activity of new molecules and/or novel combinations with durvalumab in rNSCLC

urNSCLC

• Novel combination approaches in urNSCLC pts with prior IO exposure
• Data informing optimal IO maintenance treatment duration following SBRT (biomarkers, PD patterns, etc.)

SCLC

• Outcomes & safety profile of durvalumab in LS-SCLC in real-world practice
• Durvalumab in patients excluded from ADRIATIC or in conjunction with alternative CRT approaches (e.g. sCRT, other RT modalities etc.)
• Novel methods of screening and IPN management for earlier detection of SCLC (e.g. blood-based screening initiatives)
• Durvalumab-based combinations at progression on or following durvalumab treatment in LS-SCLC
• Biomarker-driven combinations of durvalumab with novel agents (LS-SCLC and ES-SCLC)

Biliary Tract Cancer (BTC)

• Real world use of Durvalumab in 1L BTC (e.g. for populations excluded in the registration program)
• Data supporting clinical decision making for durvalumab in 1L BTC
• BTC downstaging approaches with durvalumab for locally advanced unresectable patients

Unresectable Hepatocellular Carcinoma (uHCC)

• Data for STRIDE (T300+ Durvalumab) or Durvalumab mono in unresectable HCC special populations not included in registration program
• Data on the optimal sequencing of other unresectable HCC systemic therapies after STRIDE (T300+ Durvalumab)
• Real World Evidence (RWE) to understand treatment practices, regional differences, and therapeutic decision-making in unresectable HCC
• Optimal management of imAEs in unresectable HCC special populations (e.g., cirrhosis)
• Well-defined correlative science studies to identify biomarkers for long term survival and resistance

Earlier Stages of HCC (Intermediate-stage HCC and early-stage HCC)

• Safety and efficacy of durvalumab / STRIDE-based regimens with LRT in higher risk patients w
• Response-based sequencing strategy for durvalumab / STRIDE-based combinations with LRT
  
• Efficacy of durvalumab / STRIDE-based regimens on proportion of patients downstaged to curative therapies Other indications supported by robust preclinical data may be considered
• Pre-clinical studies will be considered through the AstraZeneca Open Innovation portal.
• Studies that overlap or compete with AstraZeneca development program or where there is compromised or excessive safety risk will not be accepted

Resectable Gastric/GEJC

• Novel peri-operative regimens or strategies to identify IO responders/candidates for longer adjuvant course

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.

Not accepting Externally Sponsored Clinical Research Proposals at this time. Externally Sponsored ‘Non-Clinical’ Research proposals might still be considered but only where sponsors require supply of drug and not funding support.

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

Accepting limited Externally Sponsored Clinical Research Proposals for drug-only support. Proposals should be supported by a strong scientific rationale, preclinical data package and specific hypotheses to address.

Accepting Externally Sponsored Clinical Research Proposals for drug only in allogenic stem cell transplantation

Accepting limited Externally Sponsored Clinical Research Proposals

• Savolitinib efficacy in CNS metastases
• Mechanisms of acquired resistance to MET targeted therapies
• Patient preference and adherence to MET inhibitors
• Enhanced MET detection with advanced and less invasive methods
• Identify optimal novel combination sequencing post EGFR MET progression

• The reproductive toxicology package indicates a risk of foetal 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.
• AZD0530 is a moderately potent CYP3A4 inhibitor; concomitant administration of medicines that are metabolised by this route should be avoided.
• We are not currently seeking proposals in oncology indications

HR- BC

HER2-negative BC:*

• Testing and biomarkers: Identification of novel testing modalities / biomarkers to predict clinical outcomes of interest
• Novel predictive biomarkers: Investigations / new technologies supporting characterisation of HR+ BRCAm/PALB2m to better identify which patients to test
• Advances in BC treatment settings: Trials investigating new treatment strategies to broaden/expand the evidence base for saruparib whilst addressing important unmet medical needs:
• (Neo)adjuvant: ‘Low’/’intermediate’ risk; ‘high’ risk – in combination with IO
• Metastatic: Improve outcomes; overcoming resistance after prior therapies (through improved PARP1-selectivity); through combination approaches, preventing/delaying resistance, extending platinum-based ChT
• Novel combination strategies (early or late): Trials investigating new combination partners/strategies for saruparib and support understanding of the MoA of PARPi-combinations:
• Notable interest in IO combinations in HR+ BC and TNBC and combinations with non-DNA-damaging payload ADCs
• Other combination strategies addressing area of high unmet need may also be considered
• Breast Cancer prevention strategies: Studies investigating viability for, and early indication of, effectiveness of PARPi as an alternative to elective surgery
• Novel study design concepts: ctDNA endpoint / translational analysis: analyses supporting as composite endpoint for accelerated timelines/decision-making Diversity considerations and health equity; mechanisms to address these within ongoing/planned studies

EvoPAR-Breast01:*

• Analysis of appropriate sequencing: 1L PARPi + camizestrant followed by CDK4/6i + ET vs. CDK4/6i + ET followed by PARPi
• Evidence for PARPi rechallenge: Adjuvant PARPi, then 1L PARPi
• Rationale of combining PARPi with camizestrant: Evidence to further understand the MoA of the combination

Resectable NSCLC

• Novel approaches for detecting EGFRm earlier (Dx, radiomics, AI, non-smoker screening)
• Prognostic and predictive factors in relation to recurrence (MRD, co-mutations, clinical factors)
• Optimizing staging and tissue acquisition including impact on MDT decisions
• Optimal patient selection for perioperative treatment with osimertinib +/- chemotherapy
• Optimizing adjuvant osimertinib treatment adherence and duration

Unresectable NSCLC

Prognostic factors

• Clinical prognostic factors for low and high risk of recurrence in stIII EGFRm unresectable NSCLC
• Novel approaches with osimertinib and radiation (chemotherapy free) in stIII EGFRm NSCLC
• Co-mutations at baseline expressed with EGFRm and impact on clinical outcomes (RWE)
• Treatment sequencing strategies post-progression on LAURA regimen

Combos

• Combos of osimertinib and other treatment modalities in stIII unresectable NSCLC
• Efficacy in special populations, including uncommon mutations

Clinical considerations

• Impact of EGFRm results on MDT decisions
• Predictive clinical and radiological characteristics of ILDs: radiation induced vs. drug induced ILDs

Resistance/recurrence

• Patterns of recurrence following LAURA regimen
• Paired tissue and plasma analyses at baseline and recurrence to assess resistance mechanisms
• Treatment strategies for early progressors in unresectable stIII EGFRm

Metastatic NSCLC

• Novel combinations that enhance patient outcomes based on preclinical / translational data
• Reducing risk of CNS progression    
• Treatment strategies to overcome 1L innate resistance and persister mechanisms and/or residual disease  
• Sequencing of emerging therapies following osimertinib +/-chemotherapy
• Efficacy in patients with symptomatic CNS disease at baseline
• Outcomes in patients with uncommon EGFRm mutations using osimertinib in combination with chemotherapy

Screening and Detection

• Diagnostic approaches for early identification (RWE)
• New technologies to improve identification of EGFRm
• Radiomic/imaging studies for screening, prognosis and progression
• Optimize mutation testing strategies (tissue, liquid) to maximize patient identification (RWE)
• Screening algorithms to identify EGFRm NSCLC patients

Metastatic HR-positive BC

• Proposals investigating current PIK3CA/AKT1/PTEN testing pathways and methods of improving adoption
• Proposals investigating methods to improve patient adherence and/or AE management
• Capivasertib effectiveness; in particular, in patients with primary or secondary ET resistance Triplet inhibition approaches for different 1L high-risk populations

Across BC

• Capivasertib combination with Dato, Enhertu, Imfinzi and focus on late-stage development AZ molecules to align with LCM strategy*

Accepting limited Externally Sponsored Clinical Research Proposals

NSCLC

• Novel IO approaches in patients with mts PD post-IO in early stages
• Novel IO approaches in certain patient populations: e.g. oligometastatic disease/brain metastases​
• Predictive factors beyond PD-L1 expression to select patients to IO treatments

HNSCC

• Real world treatment patterns and unmet need across HNSCC
• Translation research to further understand: - the mode of action of volrustomig in HNSCC - ctDNA as a biomarker for treatment escalation

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

Airsupra
(Budesonide + Albuterol)

Make a submission

Inhaled steroid/short acting Beta2 agonist

Areas of Priority, all submissions considered on a case-by-case basis

• Evaluation of safety and efficacy in in use of inhaled steroid/short acting Beta2 agonist
• How does the use of inhaled steroid/short acting Beta2 agonist affect maintenance medication management, examining factors such as adherence and the intensification of maintenance treatment
• Efficacy and safety of anti-inflammatory reliever with ICS-Albuterol maintenance in different populations (demographics), including in patients with exercise induced bronchoconstriction
• Evaluation of interventions designed to improve the implementation of anti-inflammatory rescue therapy and the quality of asthma management in clinical practice

Please contact company staff before submitting a study proposal

Breztri
(Budesonide/Glycopyrronium/ Formoterol)

Make a submission

ICS, LAMA, LABA

• Mechanistic studies on the benefits of triple therapy (or synergistic effects of the components) on factors associated with cardiopulmonary outcomes including exacerbations, CV events and mortality – high priority
• Studies highlighting the disease burden (including clinical outcomes and HCRU) associated with increased cardiopulmonary risk in COPD patients
• The role and value of pMDIs in the management of respiratory conditions
• Quality Improvement Programmes and studies supporting the earlier/ prompt optimization of therapy in patients with COPD and on cardiopulmonary risk

Fasenra
(Benralizumab)

Make a submission

Anti-IL-5Rα monoclonal antibody

Studies in patients with eosinophilic asthma to:

• Investigate and identify predictors of enhanced response to Benralizumab
• Understand the overlap between different T2 biomarkers and the effects of Benralizumab
• Investigate early onset and long term patient-centric and clinical benefits of Benralizumab

Mechanistic studies in relevant disease-state models to:

• Study the effect of eosinophil depletion by Benralizumab on airway structure/function and cellular/molecular pathology
• Characterize the role and effect of Benralizumab on other IL-5R expressing cells beyond eosinophils

Benralizumab lifecycle management:

• Mechanistic or Real-World studies in eosinophil-driven diseases other than asthma that provide information about patient characteristics and disease burden. 
• Mechanistic or clinical studies in eosinophil-driven diseases other than asthma that are not addressed by currently sponsored development programs 

Oscillometry  -
Submit under Symbicort

Make a submission

Oscillometry

High Priority:

• Build Evidence: Establish evidence supporting Oscillometry as an alternative diagnostic device for respiratory diseases, particularly in settings with limited access to spirometry.
• Guideline Impact: Provide data to inform clinical guidelines on Oscillometry usage for asthma/COPD diagnosis.
• Real-World Impact: Evaluate the implementation of oscillometry in clinical practice, assessing its role in early diagnosis and the benefits of timely initiation of guideline directed medical therapy (GDMT) on patient outcomes and disease monitoring

Medium/Low Priority

• Screening Tool: Explore Oscillometry as a screening modality to facilitate early diagnosis.
• Payer Evidence: Generate data to support reimbursement and coverage.
• Environmental Impact: Examine GHG/CO2 burden and sustainability aspects.
• Registries: Establish and analyse registry data to track outcomes.
• Technology Advancements: Enhance technology to improve basic oscillometry
• New Cut-off Values: Further creation of thresholds in healthy subjects.

Off-Strategy Topics

• Mechanistic and Proof of Concept Studies: Basic research without direct clinical application.

Pulmicort
(Budesonide)

Make a submission

ICS

• Please contact company staff before submitting a study proposal

Saphnelo
(Anifrolumab)

Make a submission

Monoclonal antibody to the type I IFN receptor subunit 1

Studies in patients with SLE focus, including:

• Assessments of organ disease responses in lupus (e.g. skin, joint, other)
• Innovative patient-centric modalities to measure symptoms of disease and response to treatments, including QOL measures
• High unmet need in SLE & associated comorbidity related to SLE
• Mechanistic or clinical studies regarding the role of IFN in other diseases
• Diseases related to SLE
• Role of interferon in other immunology diseases
• IFN driven disease beyond rheumatologic disease

Symbicort
(Budesonide + Formoterol)

Make a submission

ICS/LABA combination

All submissions considered on a case by case basis - Priority is given to studies with clear potential to accelerate clinical adoption

• Accelerate the implementation of AIR/MART (Anti-Inflammatory Reliever/Maintenance and Reliever Therapy) in clinical practice through alignment with treatment guidelines.
• Real-World Evidence Generation: Address gaps in understanding the burden of asthma, treatment patterns, levels of control, and drivers of exacerbation across diverse populations.
• Anti inflammatory relievers in emergency settings, including discharge protocols and impact on readmission rates.
• Anti inflammatory reliever therapy in LMICs (Low and Middle Income Countries), including implementation research, health system strengthening, and local data generation to inform policy and reimbursement.

Tezspire
(Tezepelumab)

Make a submission

Anti-TSLP monoclonal antibody

Areas of priority, considered on a case-by-case basis

• New mechanistic insights on the role of TSLP in epithelial driven diseases including EoE, CRSwNP, COPD (can be tezepelumab treatment related)
• New mechanistic insights into the role of blocking TSLP on epithelial immune responses to environmental exposures and insults or epithelial integrity and function
• Utilize tezepelumab to study epithelial immune responses and/or repair to the epithelium related to clinical disease stability, disease modification and/or remission in epithelial driven diseases
• Mechanistic or proof-of-concept studies using TSLP/blocking TSLP to support diseases with emerging biologic evidence

Tozorakimab

Make a submission

Inhibition of IL-33

• Studies evaluating tozorakimab mechanism of action in COPD and severe viral lower respiratory tract disease (LRTD) including downstream effects of IL-33^red and IL-33^ox inhibition
• Studies that provide information about the role of IL-33 as a driver of dysregulated inflammation and epithelial and endothelial dysfunction in COPD and severe viral LRTD
• Studies that provide information on tozorakimab efficacy and safety profile in COPD and LRTD sub-populations currently not included in the clinical development plan
• Mechanistic and interventional studies on the role of IL-33 and tozorakimab to inform future development plans

Cross-TA AI/Digital 

Make a submission

AI/Digital health solutions

Patient awareness:​

• Use of digital solutions for improved awareness of disease, treatment options, and disease management. ​
• Leveraging AI/ML to mitigate bias/discrimination risks and ensure privacy and security of patient data. ​
• Utilization of digital solutions for enhanced patient recruitment in clinical studies, decentralized clinical trial designs, and data collection (EMR into CRF) and incorporation of Patient-Reported Outcomes (PROs) into electronic medical records. ​
• Patient screening (mass, early including newborn, early cancer detection, detect progression using novel methods including ctDNA, radiomics, digital pathology) and at-risk identification (case finding). ​

Early Diagnosis:​

• Utilization of digital solutions to support early diagnosis and at-risk identification (case finding) in therapeutic areas in the community and primary care and increasing capacity for specialist testing (e.g. amyloidosis, biomarker). ​
• Development of digital/digitally enabled endpoints for diagnostic purposes. ​

Treatment, adherence to treatment and AE management:​

• AI/ML algorithm development and assessment to support diagnosis, monitoring, and management of disease symptoms or medicinal adverse events including causality assessment. ​
• Leveraging digital health solutions for medication adherence and patient safety monitoring & management and monitoring the impact on outcomes. ​
• Initiatives that develop innovative measures quality of life (Qol) and digital biomarkers that when utilized, will support regulatory approval of therapies. and digital therapies. ​
• Use of AI/ML as part of disease and product benefit-risk characterization, such as minimization or mitigation of a risk that is part of disease understudy or a known medicinal product adverse reaction.   ​
• Deployment strategies to drive healthcare professionals (HCPs) and obtain regulatory approvals (e.g., CE marking) for successful treatment and reimbursement of the digital/AI solution. ​
• Clinical decision support tools to encourage guideline concordant care. ​

Post-Treatment/ Wellness:​

• Use of AI/ML to study treatment effect and impact heterogeneity by patient profile to personalize post-treatment care. ​
• Remote Patient Monitoring for identified risks that form part of post market commitments or high-risk patients (prevent readmission, deterioration post-hospital discharge).​

Wellbeing:​

• Digital health solutions for improving patient experience, quality of life, communication of product information, and interactions with HCPs/patients for informed decisions. ​