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
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
gilteritinib
  • FLT3 mutation positive (FLT3 m+) malignancies, AML and other
  • Targeted drug combinations with gilteritinib in FLT3 mutation positive (FLT3 m+) AML
  • Maintenance therapy in FLT3 mutation positive (FLT3 m+) AML
  • Minimal residual disease  and impact on treatment outcomes in gilteritinib treated AML patients
enfortumab vedotin Practice Informing – EV monotherapy
  • Special populations
    • UTUC (upper tract urothelial carcinoma)
    • Rare histology
    • Platinum ineligible
    • Elderly
  • Earlier use in mUC
    • Platinum ineligible
  • Patient management and disease burden evaluation (inclusive of HEOR concepts)

Proof of Concept

  • mUC
    • Combinations/ sequences with approved therapies and sound rationale
    • Targeted therapies
  • Muscle invasive (BC and UTUC)
    • UTUC (upper tract urothelial carcinoma)
    • Bladder sparing
    • LN+ (Lymph node) disease
    • Neo-Adjuvant
  • Nectin-4 expressing tumors not in basket (multi-cohort) trial
Biomarkers Pre-clinical
  • Nectin-4 expression
    • adenocarcinoma, squamous cell carcinoma
  • Resistance pathway/ overcoming resistance
  • Predictors of efficacy / toxicity
The following proposal types will not be considered at this time:
Dosing, route of administration or scheduling changes, NMIBC (non-muscle invasive bladder cancer) or MIBC (muscle invasive  bladder cancer), combinations with unapproved drugs, duplicative with development program or other ISRs
 
isavuconazonium sulfate
  • Use of isavuconazonium sulfate sulfate in the treatment of endemic fungi
  • Real world experience, including pharmacokinetic data, regarding the use of isavuconazonium sulfate with newer molecules used in oncologyand immunology
  • Real world experience regarding the use of isavuconazonium sulfate in adult patients with cystic fibrosis
  • Real world experience regarding the use of isavuconazonium sulfate in adult patients in burn units/ICU
The following proposal types are not being considered at this time:
Paediatric studies
 
mirabegron
  • Real World Evidence Research, including:
    • Databases, registries, networks of care analysis for treatment pattern clinical outcomes non-interventional and retrospective data
    • Studies to support personalized medicine in over active bladder, including clinical phenotyping, biomarkers, prediction tool, etc.
    • Mirabegron in patients with comorbidities (e.g. subgroups of patients in regular practice, overweight over-active bladder patients, male patients with benign prostatic hyperplasia, male or female over active bladder patients with impaired sexual function)
    • Patient’s self-administered screening tool
    • Patient Reported Outcomes
    • Combination treatment with mirabegron e.g. with botulinumtoxinA (Botox), percutaneous tibial nerve stimulation (PTNS) and sacral nerve stimulation (SNS)
    • Impact of the timing of mirabegron dose on nocturia (e.g., morning vs. evening dosing)
  • Epidemiological studies in countries and regions where data is missing
The following proposal types are not being considered at this time:
Clinical Trials:  further studies assessing cognition in the elderly, pediatric neurogenic detrusor over-activity and idiopathic detrusor over activity studies using mirabegron, weight loss, brown fat, diabetes and related topics
 
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:
Comparator studies with other sodium-glucose co-transporter 2 inhibitors
 


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