Investigator Sponsored Research


Astellas and its alliance partners are committed to supporting investigator sponsored research studies that promote the advancement of medical and scientific knowledge and innovation involving Astellas products and therapeutic areas of interest.

What is Investigator Sponsored Research?
Investigator Sponsored Research (ISR) is proposed by a Sponsor-Investigator or institution for which support is requested to obtain an Astellas compound, and/or funding to perform specific research. The Investigator assumes full responsibilities for the research/study as the Sponsor.

Investigator Sponsored Research Overview:
Sponsor-Investigator or institution proposing the research can be an investigator, physician, non-clinical researcher, clinical research group, consortia and/or Cooperative Group. ISRs include, but are not limited to, non-clinical or clinical research, including epidemiological, non-interventional (e.g., registries) and interventional studies. Requests for support for a specific independent study with treatment and/or analysis according to a protocol must be classified as an ISR.

ISR proposals must be submitted independently (no influence by Astellas) through the ISR submission portal and reviewed by Astellas medical and scientific committees. The decisions of the committees are based upon scientific merit, alignment with research areas of interest, and availability of resources.

The areas of interest may provide Investigators with additional knowledge about open ISR programs to see whether their research proposal and expertise fits with recognized priorities. Astellas is interested in supporting studies that are innovative and contribute to scientific knowledge of a product, a disease state, medical condition or advancing technology. The areas of interest are to serve as a guidance for submission of a proposal and does not guarantee Astellas support.

Please refer to the table below for the areas of interest supported by Astellas.

Please click here to access the Astellas submission portal https://globalisrportal.force.com
 

Compound Area of Interest and Areas of Non-Interest
enzalutamide
  • New approaches for treatment of prostate cancer, including drug and non-drug (modality) combinations
  • Research in early stages of prostate cancer
  • Adverse event management under standard enzalutamide dosing
  • Biomarkers to inform response, resistance and treatment decisions
  • Patient reported outcomes and quality of life in prostate cancer
  • New screening, artificial intelligence, & diagnosis technology in conjunction with prostate cancer treatment
  • Understanding mechanisms of androgen receptor inhibitor action and resistance
  • Treatment of oligometastatic disease
The following proposal types will not be considered at this time:
All tumor types other than prostate cancer
 
gilteritinib
  • FLT3 mutation positive (FLT3 m+) malignancies, acute myeloid leukemia (AML) and other
  • Targeted drug combinations with gilteritinib in FLT3 mutation positive (FLT3 m+) acute myeloid leukemia (AML)
  • Maintenance therapy in FLT3 mutation positive (FLT3 m+) acute myeloid leukemia (AML)
  • Minimal residual disease and impact on treatment outcomes in gilteritinib treated acute myeloid leukemia (AML) patients
The following proposal types will not be considered at this time:
Wild type FLT3 acute myeloid leukemia (AML) or any other malignancy
 
enfortumab vedotin Practice Informing – EV monotherapy:
  • Retreatments
    • In patients who previously responded to EV (MIBC, la/mUC)
    • Biology of retreatment (e.g. changes in nectin-4 expression)
  • AE prevention, treatment /mitigation (aligned to labeled recommendations)
  • Optimizing initiation of treatment and sequencing
Proof of Concept:
  • la/mUC
    • Combinations/ sequences with targeted therapies
  • Nectin-4*** expressing tumors with scientific rationale/ unmet need
    • Of interest but not limited to: Gyn tumors, Thyroid, GI not included in EV-202 Trial**, others as appropriate^
Biomarkers/HEOR:
  • Biology of Resistance pathway/ overcoming resistance pathways
  • Biology of Nectin-4: expression dynamics***
  • HEOR
    • NMIBC claims data Identification of high risk/low risk patients
    • Uptake of novel therapies and impact on NMIBC treatment patterns
    • Support new innovative modeling methods for combination therapy
    • Patterns and outcomes of cycling (reuse) of treatment 

The following proposal types will not be considered at this time:
Duplicative with development program/ISRs, Evaluation of altered route, dose or schedule, Combinations with unapproved therapies*, RCT (may be exceptions) , 1L maintenance in la/mUC, Tumors in EV-202 trial**, NMIBC (clinical investigation), PD markers/response predictors, Economic modeling, Health resource, cost  and outcomes with EV.

* For evaluation by business development. 
**Any stage, all tumor associated subtypes and combination until tumor development plan is implemented. Tumors included in EV-202 Trial are: HR+/HER2- Breast Cancer, Triple Negative Breast Cancer (TNBC), Squamous Non-Small Cell Lung Cancer (SNSCLC), Non-Squamous Non-Small Cell Lung Cancer (NSNSCLC), Head and Neck Cancer and Gastric, Gastroesophageal Junction or Esophageal Cancer.
*** all nectin-4 testing to be done by Q2;
^ For tumors without Nectin-4 expression data, evaluation of Nectin-4 should be done.

 

isavuconazonium sulfate
  • Real world experience, including pharmacokinetic data, regarding the use of isavuconazonium sulfate with new molecules used in oncology and immunology
  • Real-world evidence/experience, including incidence and outcome, of invasive pulmonary aspergillosis and other invasive fungal infections in non-traditional hosts, such as post-severe influenza/ARDS, COVID-associated secondary infections, etc.
  • Real-world evidence/experience regarding management of complicated/serious invasive fungal infections with combination antifungal therapy
  • Use of isavuconazonium sulfate for prophylaxis
  • Use of isavuconazonium sulfate in the treatment of endemic fungi
mirabegron

Real World Evidence research to confirm clinical trial results (Databases, registries, networks of care analysis for treatment patterns, clinical outcomes, non-interventional and retrospective data analysis)

  • Studies to support personalized medicine in overactive bladder (OAB), including clinical phenotyping, biomarkers, prediction tool, etc.
  • Mirabegron in patients with comorbidities (e.g. subgroups of patients in regular practice, overweight overactive bladder patients (OAB), male patients with benign prostatic hyperplasia (BPH), male or female overactive bladder OAB patients with impaired sexual function)
  • Patient’s self-administered overactive bladder (OAB) management tool
  • New Patient Reported Outcomes
  • Impact of the timing of mirabegron dose on nocturia (e.g. morning vs. evening dosing)
  • Epidemiological studies in the evolution of overactive bladder (OAB) prior to diagnosis and treatment
The following proposal types are not being considered at this time:
Clinical trials in the current indication including pediatric overactive bladder and neurogenic detrusor over-activity.
 
ipragliflozin
  • Clinical and mechanistic studies regarding effects of sodium-glucose co-transporter 2 inhibition with ipragliflozin focusing on micro- and macro-vascular function, heart failure, cardiovascular risks in type 2 diabetes mellitus and type 1 diabetes mellitus.
  • Clinical and mechanistic studies regarding the effects of sodium-glucose co-transporter 2 inhibition with ipragliflozin on renal function in patients with type 2 diabetes mellitus and type 1 diabetes mellitus.
  • Clinical and mechanistic studies regarding the effects of sodium-glucose co-transporter 2 inhibition with ipragliflozin on other comorbidities frequently associated with type 2 diabetes mellitus and type 1 diabetes mellitus.
  • Clinical and mechanistic studies regarding the effects of sodium-glucose co-transporter 2 inhibition with ipragliflozin on metabolic control and the cardio-renal axis in type 2 diabetes mellitus and type 1 diabetes mellitus.
  • Observational research regarding the effects of sodium-glucose co-transporter 2 inhibition on micro / macro vascular complications in patients with type 2 diabetes mellitus and type 1 diabetes mellitus.
The following proposal types are not being considered at this time:
Safety studies of ipragliflozin, comparator studies with other sodium-glucose co-transporter 2 inhibitors
 
tacrolimus ADVAGRAF: Real World Evidence research including:
  • Database, registries, networks of treatment pattern of long-term clinical outcomes in liver/kidney transplantation (non-interventional and retrospective data)
  • Conversion from Prograf to Advagraf, de novo use of Advagraf (e.g. dose, trough level, renal function)
  • Risk factors evaluation related to treatment outcomes, (e.g. intrapatient variability, adherence)
  • COVID-19 related
PROGRAF:
  • Epidemiological studies in those countries who have launched/pre-launch autoimmune disease indication
  • Efficacy and safety outcome of Prograf treatment on auto-immune patients.
The following proposal types are not being considered at this time:
Very low dose tacrolimus regimens (e.g. <3ng/ml), comparison study between generics with Prograf or Advagraf in terms of purity, pharmcokinetic or bioequivelance analysis, comparison studies between Prograf & Advagraf.
 

Please note: Studies proposing very low dose tacrolimus regimens (e.g. targeting levels <3ng/ml) or studies with switch to Advagraf when tacrolimus levels are already low (e.g. <5ng/ml), would not be supported due to the potential risk of immunological injury.
 

roxadustat
  • Clinical outcomes
  • Special populations (e.g. inflamed patients, diabetes, chronic kidney disease stage 3a/b, HIV nephropathy, African descent, renal transplant, etc)
  • Iron metabolism
  • Treatment patterns
  • Patient reported outcomes
  • Mechanistic and biomarker studies
  • Renal anaemia epidemiology
  • Real world use of roxadustat in dialysis dependent and not-dialysis dependent chronic kidney disease anaemia (efficacy and safety)
  • Long term renal effects of roxadustat (estimated glomerular filtration rate (eGFR) preservation)
The following proposal types are not being considered at this time:
Off-label use studies, and safety-related studies with roxadustat (primary endpoint: safety)
 


Please click here to access the Astellas submission portal https://globalisrportal.force.com/