# Core A: Program Management and Biostatistics Core

> **NIH NIH P01** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2020 · $213,434

## Abstract

Abstract – Core A
The Program Management and Biostatistics Core is designed to function as a drug development Project Team
decision-making body. Thus, it will oversee all aspects of the drug development paradigm. This activity will
involve two integrated and overlapping functions: (1) Oversight/Assessment of new directions of the scientific
topics that form the basis of the tPPG target/drug development paradigm; and (2) Oversight of the drug
development process. The oversight of scientific paradigms will focus on delineation of the ideal profile for
mucolytics, need for mucus hydrating agents for co-formulation with mucolytics, selection of mucolytic clinical
candidates, and identification and validation of biomarkers for use throughout the tPPG development program.
Oversight of the drug development process will include oversight of the composition of the DSMB and DSMB
Charter, flow of data to the DSMB, and the role of DSMB in clinical development decision making. Core A will
also provide biostatistical assistance to the pre-clinical projects and extensive services for the clinical projects
in the context of the creation of REDCap databases for clinical data collection, oversight of clinical database
management , and creation of tables and listings for analyses of all studies. Note, an external biostatistician
will be named by Core A for overall final review of safety and efficacy data. The external statistician will also be
part of the External Advisory Board. Finally, Core A will provide administrative functions to the tPPG, including
budgetary and programmatic support, oversight of human subjects, protocols, and oversight of conflict of
interest reviews. These activities should provide for an effective Project Management in Biostatistics Core
support function for the tPPG.

## Key facts

- **NIH application ID:** 10001594
- **Project number:** 5P01HL108808-09
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** Richard Charles Boucher
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $213,434
- **Award type:** 5
- **Project period:** 2017-09-07 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10001594

## Citation

> US National Institutes of Health, RePORTER application 10001594, Core A: Program Management and Biostatistics Core (5P01HL108808-09). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10001594. Licensed CC0.

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