U19AI171292

Rapidly Emerging Antiviral Drug Development Initiative- AVIDD Center (READDI-AC) - Program Summary/Abstract

Emerging viruses arise suddenly and cause considerable morbidity and mortality worldwide. To prepare for current and future threats, public-private partnerships are needed to change the current reactive response platform into one that is proactive.

In response to RFA-AI-21-050, the Rapidly Emerging Antiviral Drug Development Initiatives AVIDD Center (READDI-AC) is an integrated public-private partnership with a renowned, interdisciplinary research team of experts. They apply cutting-edge innovative technologies in virology, biochemistry, structural biology, medicinal chemistry, computational biology, structure-guided drug design, and genomics to develop oral, potent, broad-spectrum family-specific antivirals for coronaviruses, flaviviruses, alphaviruses, and filoviruses.

To achieve these goals, the READDI-AC program includes academic leaders in basic and applied antiviral research and chemistry, as well as industry leaders Janssen Pharmaceuticals N.V. (JPNV), Takeda, Chimerix Inc., and Pardes Biosciences. Our commercial partners provide an enviable track record in drug discovery and product development, as well as leadership in medicinal chemistry, pharmacology, drug formulation, toxicity studies, and pharmacokinetics, especially critical for driving optimized leads through preind enabling studies toward the clinic. Importantly, our industry partners also provide in-kind matching contributions, access to high-quality commercial chemical libraries, early hits, optimized leads, and state-of-the-art high-throughput screens.

The immediate and long-term goals of READDI-AC are to:

A) Validate druggable targets in conserved viral proteins,
B) Identify hits and leads using SAR and state-of-the-art biochemical and enzymatic assays,
C) Optimize/formulate chemical probes and lead compounds as broadly acting oral compounds with activity against multiple relevant members of each emerging virus family,
D) Provide critical late-stage preclinical development and IND-enabling in vivo studies for two broadly active, oral drug candidates,
E) Promote open science sharing of unused chemical assets, chemical probes, methods, reagents, and assays for innovations by crowdsourcing,
F) Build capacity and training in 21st-century viral drug discovery and development by coupling innovative approaches in target discovery and validation with state-of-the-art techniques, integrated workflows, and novel discovery platforms for hit to lead progression and SAR optimization.

READDI-AC has five research projects and four highly interactive cores that establish a cooperative landscape. This landscape builds leadership, expertise, response capacity, and partnerships that invigorate 21st-century drug development.

University Of North Carolina At Chapel Hill

TO ASSIST PUBLIC AND PRIVATE NONPROFIT INSTITUTIONS AND INDIVIDUALS TO ESTABLISH, EXPAND AND IMPROVE BIOMEDICAL RESEARCH AND RESEARCH TRAINING IN INFECTIOUS DISEASES AND RELATED AREAS, TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS. TO ASSIST PUBLIC, PRIVATE AND COMMERCIAL INSTITUTIONS TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS, TO PROVIDE RESEARCH SERVICES AS REQUIRED BY THE AGENCY FOR PROGRAMS IN INFECTIOUS DISEASES, AND CONTROLLING DISEASE CAUSED BY INFECTIOUS OR PARASITIC AGENTS, ALLERGIC AND IMMUNOLOGIC DISEASES AND RELATED AREAS. PROJECTS RANGE FROM STUDIES OF MICROBIAL PHYSIOLOGY AND ANTIGENIC STRUCTURE TO COLLABORATIVE TRIALS OF EXPERIMENTAL DRUGS AND VACCINES, MECHANISMS OF RESISTANCE TO ANTIBIOTICS AS WELL AS RESEARCH DEALING WITH EPIDEMIOLOGICAL OBSERVATIONS IN HOSPITALIZED PATIENTS OR COMMUNITY POPULATIONS AND PROGRESS IN ALLERGIC AND IMMUNOLOGIC DISEASES. BECAUSE OF THIS DUAL FOCUS, THE PROGRAM ENCOMPASSES BOTH BASIC RESEARCH AND CLINICAL RESEARCH. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM EXPANDS AND IMPROVES PRIVATE SECTOR PARTICIPATION IN BIOMEDICAL RESEARCH. THE SBIR PROGRAM INTENDS TO INCREASE AND FACILITATE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM STIMULATES AND FOSTERS SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. RESEARCH CAREER DEVELOPMENT AWARDS SUPPORT THE DEVELOPMENT OF SCIENTISTS DURING THE FORMATIVE STAGES OF THEIR CAREERS. INDIVIDUAL NATIONAL RESEARCH SERVICE AWARDS (NRSAS) ARE MADE DIRECTLY TO APPROVE APPLICANTS FOR RESEARCH TRAINING IN SPECIFIED BIOMEDICAL SHORTAGE AREAS. IN ADDITION, INSTITUTIONAL NATIONAL RESEARCH SERVICE AWARDS ARE MADE TO ENABLE INSTITUTIONS TO SELECT AND MAKE AWARDS TO INDIVIDUALS TO RECEIVE TRAINING UNDER THE AEGIS OF THEIR INSTITUTIONAL PROGRAM.

93.855 - Allergy and Infectious Diseases Research

National Institute of Allergy and Infectious Diseases (NIAID) [HHS - NIH]

North Carolina United States

State-Wide

Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern (U19 Clinical Trial Not Allowed) (RFA-AI-21-050)

COVID-19 $65,483,194 (100%) percent of this Cooperative Agreement was funded by COVID-19 emergency acts including the American Rescue Plan Act of 2021.