# Biomarker Analytic and Regulatory Core

> **NIH NIH U54** · UNIVERSITY OF PENNSYLVANIA · 2020 · $246,989

## Abstract

PROJECT SUMMARY
Tobacco regulatory science (TRS) is a rapidly evolving field driven by numerous regulatory changes since the
inception of the 2009 Family Smoking Prevention and Tobacco Control Act. Because regulatory actions must
be based on empirical evidence that demonstrate public health benefits, data are needed to inform potential
tobacco control policies.
Based on our previous TRS experience, we recognize the need for strong supporting infrastructure within the
UP-RU TCORS to take advantage of future opportunities to further TRS. Specifically, projects may benefit
greatly from having an existing infrastructure to support: 1) novel analytic approaches, data measures, and
data management; 2) biosample collection, analysis, and storage; and 3) regulatory filing and reporting
structure. To address this need, we propose a dedicated Biosample, Analytic and Regulatory (BAR) Core to
establish this infrastructure and provide support from established investigators in these respective fields who
also have strong knowledge in the emerging field of TRS.
The overall goal of the BAR Core is to maximize the contributions of projects conducted within the UP-RU
TCORS to TRS. The first aim of the BAR Core is to support within-center primary projects with
harmonized measures, data collection, and analytic resources. This includes using similar measures
across our proposed studies, aligning with PATH, PhenX and other large scale initiatives, study recruitment
logistics and centralized data quality check and assurance activities. The second aim of the BAR Core is to
support pilot projects with biosample, analytic and regulatory expertise, in order to better align them with
center projects and have a greater impact in the TRS research community. We will assemble experts in
tobacco-related biosample work, tobacco research-specific statistical approaches and data collection
requirements. The final aim of the BAR Core is to support RRPs with biosample, analytic and regulatory
expertise. At the formative stages of RRP planning, we will bring in experts in biostatistics, biosample
collection and analysis, and regulatory filing, in order to enhance our proposed projects.
BAR Core investigators are experts in each of the Core's domains (Biosamples, Analytics, and Regulatory),
and have an established history of conducting TRS-relevant research. It is this critical intersection of specific
domain knowledge and the understanding of TRS research that is needed to advance the science. This core
will be a cost-efficient approach to harmonizing measures and procedures of the primary projects and
supporting innovation and creativity in the pilot projects and RRP Program.

## Key facts

- **NIH application ID:** 9999502
- **Project number:** 5U54CA229973-03
- **Recipient organization:** UNIVERSITY OF PENNSYLVANIA
- **Principal Investigator:** Andrew A Strasser
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $246,989
- **Award type:** 5
- **Project period:** 2018-09-14 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9999502

## Citation

> US National Institutes of Health, RePORTER application 9999502, Biomarker Analytic and Regulatory Core (5U54CA229973-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9999502. Licensed CC0.

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