# Development of a multifunctional interventional device for biopsy and optical imaging-based phase-0 drug response measurements

> **NIH EB R01** · BRIGHAM AND WOMEN'S HOSPITAL · 2026 · $749,901

## Abstract

PROJECT SUMMARY:
Background. Traditional drug development is slow, costly, and inefficient, with over 90% of drugs failing in clinical
trials. Personalized medicine also faces challenges in accurately matching patients with optimal treatments.
"Phase-0" microdosing, involving the delivery of tiny drug doses directly into target tissues, has the potential to
transform both drug development and personalized drug selection by directly evaluating drug effects in patients
without systemic toxicity and rapidly identifying the best treatment for each individual. Our team is leading the
clinical translation of an implantable microdevice (IMD) that provides Phase-0 microdose readouts of multiple
drugs in a single patient. IMDs are placed into diseased tissue (most commonly tumors) and subsequently
release drugs into spatially discrete microscopic regions. The devices and surrounding tissue are then removed
surgically and drug effects are characterized and compared using a multi-omic spatial analysis pipeline.
Preclinical and first-in-human IMD trials have been highly promising with unprecedented drug insights. However,
surgical resection required for IMD analysis is not feasible or safe in most deep anatomic locations. This has
prevented IMD validation and use in most settings where they are needed, including neoadjuvant and aggressive
metastatic cancer. A less invasive and safer approach is needed to enable broad clinical application. More
specifically, there is a critical and currently unmet need for a nonsurgical interventional device to deliver drug
microdoses and subsequently biopsy drug-containing tissues for Phase-0 measurements.
Proposal and impact. In Aim 1, we will develop an interventional drug response assay (IDRA) device that will
broadly enable biopsy-based Phase-0 measurements from any percutaneously accessible site similar to routine
percutaneous biopsies, with similar outpatient workflow and low risk. In Aim 2, we will validate IDRA safety and
feasibility in

## Key facts

- **NIH application ID:** 11294842
- **Project number:** 1R01EB037010-01A1
- **Recipient organization:** BRIGHAM AND WOMEN'S HOSPITAL
- **Principal Investigator:** Sharath  Bhagavatula
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** EB
- **Fiscal year:** 2026
- **Award amount:** $749,901
- **Award type:** 1
- **Project period:** 2026-05-01T00:00:00 → 2030-04-30T00:00:00

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11294842

## Citation

> US National Institutes of Health, RePORTER application 11294842, Development of a multifunctional interventional device for biopsy and optical imaging-based phase-0 drug response measurements (1R01EB037010-01A1). Retrieved via AI Analytics 2026-05-20 from https://api.ai-analytics.org/grant/nih/11294842. Licensed CC0.

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