Amendment 35: DRIVe EZ Broad Agency Announcement

EZBAA-22-100-SOL-00003

Amendment #035

Office of Biomedical Advanced Research and Development Authority Division of Research, Innovation & Ventures (DRIVe)

Easy Broad Agency Announcement EZBAA-22-100-SOL-00003

The purpose of Amendment #035 is the following:
1) Reopen the following Area of Interest (AOI):
AOI #16: Lab at Home
2) Open the following Area of Interest (AOI):
AOI #29: Type to Treat

EZBAA-22-100-SOL-00003

Amendment #035

INTRODUCTION AND OVERVIEW INFORMATION

A. Development Opportunity Objective:

Under this Amendment, DRIVe is doing the following:
1)

Reopening the following research Area of Interest (AOI): AOI #16: Lab at Home

2)

Open the following research Area of Interest (AOI):
AOI #29: Type to Treat

We are now seeking abstract submissions for the following AOI:

DRIVe Type to Treat EZ-BAA AOI # 29
Type to Treat: Patient Stratification for Improved Therapeutic Efficacy The development of efficacious therapeutics for PHE preparedness and response is hampered by heterogeneity of treatment effect, as there is an inability to identify and treat patient populations most likely to respond to particular interventions. BARDA DRIVe has launched the “Type to Treat” program focused on development and validation of platform technologies for endotyping or patient stratification to enhance the efficacy of therapeutic intervention for injuries, insults, infection, or severe disease relevant to BARDA’s mission space. "Type to Treat" aims to transform the "Test to Treat" paradigm, by now discerning via a test, not just who is positively infected, but also determining what treatment options would most benefit an individual.
The program goal is to advance development of commercially sustainable platform technologies that could be used to improve therapeutic efficacy in specific populations. This AOI is seeking development and validation of stratification technologies for either a FDA-approved (in BARDA’s mission space) or BARDA-supported therapeutic. BARDA is primarily interested in partnering with the stratification tool developer versus the therapeutic developer, to enable primary focus on the platform capability and not the therapeutic investigational product, thereby enabling the potential to expand development of the stratification approach to other therapeutic use cases (beyond the scope of this AOI). The goal is to advance the technology towards FDA approval (e.g., as a complementary or companion diagnostic). Selection of the therapeutic use case should take into consideration what clinical trial and