Externally sponsored scientific research

Andexxa / Ondexxya
(Andexanet Alfa) 

Make a submission

Modified recombinant inactive factor Xa (FXa) designed to reverse FXa inhibitors

Quality measurements and/or process improvement initiatives across all bleeds:

• Initiatives directed at monitoring and improving patient outcomes; impact of early administration of reversal; impact of care bundles
• Characterisation of barriers to optimal management

Gastrointestinal (GI) and non-ICH trauma bleeds:

• Characterization of life-threatening or uncontrolled FXa inhibitor-related GI and non-ICH trauma bleeds
• Real World characteristics of current management and outcomes

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)

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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)

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Antisense oligonucleotide

• Improve diagnosis and optimize treatment in transthyretin amyloidosis (ATTR) (mixed phenotypes, under recognized populations, etc.)
• Biomarkers for early detection of ATTR amyloidosis
• Patients with ATTR Amyloidosis can be identified via artificial intelligence (AI)/machine learning (ML) predictive models
• Understand link between serum ATTR amyloidosis to patient reported outcomes (PROs) and/or clinical outcomes
• New tools for ATTR amyloidosis patient monitoring (define and monitor disease progression (with/without treatments)

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

Mechanism of action:

• Identification of immunological components and mechanisms associated with protection after LAIV immunisation

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

LAIV use in healthy adults (18 – up to 59 years of age):

• Effectiveness
• Broader benefits of vaccinating young adults
• Self-administration

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

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.

AZD1390

Make a submission

Potent and Selective Brain Penetrant ATM inhibitor

• 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.

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.

AZD8186

Lipid kinase PI3Kß /d

Not accepting Externally Sponsored Clinical Research Proposals.

Calquence (acalabrutinib)

Make a submission

Highly selective, potent BTK inhibitor

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

Ceralasertib (AZD6738)

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ATR Inhibitor

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 with other novel 2L mNSCLC regimen

Dato-DXd / Datopotamab deruxtecan (DS-1062)

Make a submission

TROP2-directed Antibody Drug Conjugate (ADC)

 NSCLC

• Identifying mechanisms, risk/predictive factors and optimal management of key AEs (stomatitis, ocular surface events, ILD) that complement ongoing activities
• Clinical benefit in patients not represented (or underrepresented) in PH3 trials (e.g., IO ineligible)
• Mechanism of action in brain metastases
• Understanding TROP2 biology (e.g. co-expression & expression dynamics associated with clinical efficacy/safety outcomes and disease settings)
• Understanding differentiated activity in nonsquamous NSCLC
• Defining mechanisms of resistance
• 2L+ combinations with approved agents (e.g. VEGFRi, KRASi)

Breast Cancer

• Elucidate risk factors, Dato-DXd pathophysiology, and understand ways to improve AE management
  • Improve knowledge of the pathophysiology and clinical management of stomatitis, ILD, and OSE
  • Identify risks factors/biomarkers correlating with AEs
• Clinical benefit in patients underrepresented or not represented in phase 3 trials
  • Clinical data in patients as it relates to age, renal impairment, ECOG PS > 1, ethnicities, etc.
• Define mechanisms of (primary and secondary) Dato-DXd resistance
  • Preclinical/translational studies to identify pathways mediating resistance involving TROP2, DXd, or other cellular processes that may be supported with clinical studies
• Novel combinations where one or more agent is an approved SoC in the proposed settings
• Understand mechanism associated with clinical activity in CNS metastases
• Understanding biomarkers of response
  • Identification of potential biomarkers that may be associated with the response to therapy

Pre-clinical studies will be considered through the AstraZeneca Open Innovation portal.

Enhertu / Trastuzumab deruxtecan (DS-8201/T-DXd)

Make a submission

HER2-targeting Antibody Drug Conjugate (ADC)

HER2+ Breast Cancer

• Exploration of T-DXd concepts to cure HER2+ metastatic breast cancer (mBC)
• Rechallenge strategies within different lines of therapy (LoT)
• Exploration of benefit of T-DXd in broadening the patient population in early breast cancer (eBC)
• Combination treatment escalation strategies in patients with suboptimal response to T-DXd

HER2-low Breast Cancer

• Exploration of benefit of T-DXd in subpopulations with high unmet need
• Clinical applicability of technologies to approach patient ID, spanning across the HER2 spectrum, patient responses, and molecular relapses

Breast Indication Non-specific

• Novel combinations, translational or clinical approaches to delay resistance and optimize patient experience
• Identify population at risk for high-grade AEs and strategies for prophylaxis

HER2-expressing Gastric Cancer

• Real-world treatment patterns and outcomes by geographic location, histology and HER2 expression, including unmet need and disease biology
• Clinical activity and safety in HER2-expressing disease, including novel combinations with T-DXd
• HER2 dynamics and prevalence over time in response to different treatment combinations/monotherapy (including overlapping biomarkers)

HER2-targetable non-small cell lung cancer (NSCLC)

• T-DXd monotherapy in non-metastatic HER2m NSCLC:
  • T-DXd as adjuvant in resectable disease
  • T-DXd as consolidation in unresectable stage III disease
  • T-DXd efficacy and safety in HER2 amplified NSCLC population 
  • T-DXd as a treatment strategy after disease progression on TKIs in oncogene driven NSCLC

HER2-expressing Tumor Agnostic

• T-DXd efficacy/safety in HER2-positive 2L+ solid tumors with limited data including real-world evidence
• T-DXd efficacy/safety in earlier lines of therapy (1L, adjuvant/neoadjuvant), HER2-Low, and combinations with other agents in select tumors
• T-DXd efficacy/safety in HER2 amplified population

HER2-expressing Gynecological Tumors

• T-DXd efficacy/safety in rare histologies
• Signal seeking studies of T-DXd efficacy/safety in combinations, including HER2 IHC 1+, 2+ (per gastric ASCO-CAP guidelines) and earlier lines
• HER2 testing methods to support patient identification and treatment, including IHC scoring algorithms & correlation with response and T-DXd efficacy/safety in HER2 amplified population
• Real-world outcomes of HER2-expressing patient populations in 1L

Pre-clinical studies will be considered through the AstraZeneca Open Innovation portal.

Imfinzi (Durvalumab)

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

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

• RWE in select patient segments such as fast progressors, IO experienced
• Patient identification: Predictors of efficacy, long-term survivorship, early progressors and imAE incidence
• Intensified regimens: Explore novel combinations or sequencing of durvalumab-based treatments with novel agents in PACIFIC progressors, in previous IO experienced patients newly diagnosed with UR STIII, in PD-L1 negative, in medical inoperable in Stage I/II, and as a consolidation option

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)
• New molecules and/or novel combinations with durvalumab at progression on or following durvalumab treatment in LS-SCLC
• New molecules and/or novel combinations with durvalumab in biomarker-selected populations (limited-stage or extensive-stage disease)

Urothelial Cancer

• Durvalumab + BCG in patients with non-muscle-invasive bladder cancer not represented in the POTOMAC trial
• Perioperative durvalumab +/- neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer not represented in the NIAGARA or VOLGA trials
• Durvalumab +/- tremelimumab combined with novel agents in front-line bladder cancer or after progression on immunotherapy
• Real-world evidence (RWE) on treatment patterns and outcomes with BCG treatment in non-muscle-invasive bladder cancer
• Durvalumab in combination with novel agents for patients with non-muscle-invasive or muscle-invasive bladder cancer
• Biomarkers to predict clinical outcome following durvalumab treatment for bladder cancer
• Patient reported outcomes and patient experience receiving durvalumab +/- tremelimumab as treatment for bladder cancer

GI Cancers

 Biliary Tract Cancer (BTC)

• Expand data for Durvalumab in 1L BTC special populations not included in registration program
• Durvalumab + alternative gem/platinum chemotherapy & regimens in 1L BTC
• Data on the impact of common BTC palliative therapies, (antibiotics or biliary stents) on Durvalumab efficacy in 1L BTC
• Patient-centric studies; QoL, patient preference
• Real World Effectiveness for Durvalumab
• Real World Evidence (RWE) to understand diagnosis, treatment practices and outcomes across BTC
• Addition of T300 to Durvalumab + Gemcitabine/Cisplatin
• Durvalumab in combination with Locoregional (TACE/TARE/Ablation/Radiotherapy) Therapies

Hepatocellular Carcinoma

• 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)
• Response data for STRIDE (T300+ Durvalumab) in pts with fully characterized non-viral aetiology
• 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 response, non-response, and resistance

 Intermediate stage HCC

• Replace TACE / TARE with Durvalumab-based therapy
• Durvalumab-based treatment in combination with alternative embolization regimens (TARE, TAE)
• Effect of Durvalumab-based regimens on % of patients moving to curative therapies (downstaging)
• Durvalumab-based therapy + SBRT
• Predictors of efficacy & early progression (e.g., role of MRD, ctDNA) as potential markers of progression
• Real World Evidence (RWE) to understand treatment practices and outcomes across Intra-hepatic cholangiocarcinoma
• TACE + Durvalumab (+ bev / other combo / STRIDE) + in special populations (pre-transplant setting)

 Early-stage HCC

• Durvalumab -based therapy in low-risk adjuvant setting
• Identification of low, intermediate and high-risk patients
• RWE to understand treatment practices and outcomes across early HCC (early/intermediate/high risk)
• Durvalumab -based regimens as neoadjuvant therapy
• IO & Surrogate endpoints
• Durvalumab -based regimens in special populations
• Predictors of efficacy & early progression (e.g., role of MRD, ctDNA) as potential markers of progression

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
• Non-oncology indications will not be supported at this time

Imjudo (tremelimumab)

Make a submission

Anti-CTLA4 Mab

Proposals for Oncology indications using tremelimumab alone or in combination with other products (with the exception of durvalumab-based combinations - see the durvalumab areas of interest for further information), are not sought at this time. Proposals for non-oncological indications may be of interest.

Iressa (gefitinib)

Make a submission

EGFR Inhibitor

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.

Koselugo (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

Lynparza
(olaparib)

Make a submission

PARP Inhibitor

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.

MEDI551

Make a submission

MAb
Anti-CD19 B cell depleting agent

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

Monalizumab

Make a submission

NKG2A

Accepting limited Externally Sponsored Clinical Research Proposals

Orpathys (savolitinib, AZD6094)

Make a submission

c-Met receptor tyrosine kinase inhibitor (TKI)

• Identify optimal treatment at progression
• Characterize resistance mechanisms and biology of MET mediated resistance.
• Patient Preference and Adherence
• MET detection with liquid biopsy and concordance

Saracatinib (AZD0530)

Make a submission

Src tyrosine kinase family inhibitor

• 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

Tagrisso (osimertinib, AZD9291)

Make a submission

EGFR sensitising and T790M Resistance Mutations Inhibitor

EGFRm NSCLC

• Treatment strategies to overcome innate resistance &/or residual disease
• Osimertinib-based combination treatments and associated biomarkers for patient selection
• Outcomes in patients with uncommon EGFRm mutations
• Build prospective evidence for CNS risk reduction.

Early-Stage Disease

• Diagnostic and prognostic factors
• Prognostic and predictive factors in relation to recurrence (MRD/ctDNA, co-mutations, clinical factors)
• Optimizing staging and tissue acquisition including impact on MDT decision
• Clinical prognostic factors for low & high risk of recurrence
• Screening algorithms to identify EGFRm NSCLC patients.
• Radiomic/imaging studies for screening, prognosis & progression in NSCLC

Treatment and outcomes

• Strategies to identify and assess resistance mechanisms
• Treatment at recurrence
• Efficacy in special populations
• Treatment strategies for early progressors
• Combinations of osimertinib and other treatment modalities

Truqap (capivasertib / AZD5363)

Make a submission

AKT Inhibitor

HR+ mBC

• Proposals investigating current PIK3CA/AKT1/PTEN testing pathways & methods of improving adoption
• Proposals investigating methods to improve adherence and/or AE management
• Patient identification in 2L HR+ mBC by PTEN with IHC

Volrustomig (MEDI5752)

monovalent bispecific humanized immunoglobulin G1 (IgG1)

monoclonal antibody (mAb)

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

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

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 in relation to varying maintenance treatment
• 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

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 

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

• Please contact company staff before submitting a study proposal

Tezspire
(Tezepelumab)

Make a submission

Anti-TSLP monoclonal antibody

Areas of High Priority but considered on a case by case basis

• Novel studies to position tezepelumab as a paradigm shift in treatment for severe asthma including disease stability, disease modification and remission 
• New mechanistic insights on the role of TSLP activation and downstream inflammatory effects in diseases other than asthma including EoE, CRSwNP, COPD, allergy and CSU (can be tezepelumab treatment related)
• Utilize tezepelumab clinical effect on airway pathophysiology, eosinophil biology, mast cell or epithelial function and asthma unexplored patient populations
• Mechanistic or proof of concept studies using tezepelumab to support diseases with emerging biologic evidence

Medium Priority, but considered on a case by case basis

• Focused studies looking at the role of the epithelium in upper and lower airway diseases delivered through the EpiCentral platform
• Develop innovative tools to measure patients reported outcomes that capture holistic effects (e.g. emotional) of tezepelumab in upper and lower airways
• Novel studies to investigate the effect of tezepelumab on airway hyperresponsiveness
• Registry and real-world evidence experience of tezepelumab in clinical practice (locally funded)

All other submissions considered on a case by case basis

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. ​