RKS helps move USC and CHLA discoveries from research to commercialization. Because of the long timeline, heavy resource burden, and high regulatory hurdle of bringing new products to market, RKS works closely with investigators to identify critical steps in the go/no-go decision-making process. The team has assisted with Small Business Innovative Research (SBIR) and other grants; regulatory agency meeting requests and briefing packages; filings for investigational new drugs (INDs), investigational device exemptions (IDEs), dietary supplements, and combination products; abbreviated new drug applications (ANDAs); marketing submissions; monitoring and auditing; competitive analysis; and general regulatory intelligence, knowledge, and strategy. RKS has aided in 16 investigational new drugs (INDs) and investigational devise exception (IDEs) and three abbreviated new drug applications (ANDAs); provided monitoring and auditing support for nine investigator-initiated clinical trials; and helped secure a Small Business Innovative Research (SBIR) award.

One of SC CTSI’s unique strengths is its long-standing partnership with the D.K. Kim International Center for Regulatory Science within the Department of Regulatory and Quality Science, a world-class training ground for professionals involved in the development and commercialization of regulated products. Three of the center’s faculty leaders form the SC CTSI RKS core, with the mandate to promote efficient, safe, compliant, and high-quality clinical studies. RKS collaborates with other cores to facilitate regulatory planning and clinical trial conduct by providing expert consultation, offering educational programs, and performing research to foster innovation in regulatory policies and practice. Its contributions have been recognized by its designation in 2019 as a Center of Excellence in Medical Device Priority Work Area.

Objective: Promote a culture of quality and streamline translation by leveraging unique USC strengths in regulatory and quality sciences to develop and disseminate best practices, conduct research, and provide direct service to clinical researchers.

Specific Aim 1. Service: Provide high-touch support throughout the life cycle of clinical protocols through a combination of consultation and establishment of standard best practices.

Specific Aim 2. Education: Expand expertise in regulatory and quality sciences in the clinical research workforce through on-site education and self-study online training modules.

Specific Aim 3. Innovation: Conduct research to address regulatory challenges in clinical research.

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Eunjoo Pacifici Eunjoo Pacifici, PharmD, PhD Chair and Associate Professor of Regulatory and Quality Sciences Associate Director, D. K. Kim International Center for Regulatory Science Details about Eunjoo Pacifici, PharmD, PhD

Team Members

Benson Kuo Benson Kuo, PhD Associate Director, Regulatory Knowledge and Support Details about Benson Kuo, PhD
Karen Manrique Karen Manrique, MS Project Administrator, Regulatory Knowledge Support Details about Karen Manrique, MS
Nancy Pire-Smerkanich Nancy Pire-Smerkanich, DRSc, MS Assistant Professor of Regulatory and Quality Sciences; Associate Director, Regulatory Knowledge and Support Details about Nancy Pire-Smerkanich, DRSc, MS
Rushaanaaz Sokeechand Rushaanaaz "Rusha" Sokeechand Student Worker Details about Rushaanaaz "Rusha" Sokeechand
Roxy Terteryan Roxy Terteryan, MPH Project Administrator, Regulatory Science Research and Co-Curricular Program Details about Roxy Terteryan, MPH
Gordon Wimpress Gordon D Wimpress, BS, BA Project Administrator, Media Content and Production Details about Gordon D Wimpress, BS, BA

Core Groups

Biostatistics, Epidemiology and Research Design logo Biostatistics, Epidemiology and Research Design Details about Biostatistics, Epidemiology and Research Design
Central Administration logo Central Administration Details about Central Administration
Clinical Research Informatics logo Clinical Research Informatics Details about Clinical Research Informatics
Clinical Research Support logo Clinical Research Support Details about Clinical Research Support
Community Engagement logo Community Engagement Details about Community Engagement
Evaluation & Improvement logo Evaluation & Improvement Details about Evaluation & Improvement
Healthcare Delivery Science Healthcare Delivery Science Details about Healthcare Delivery Science
Regulatory Knowledge & Support logo Regulatory Knowledge & Support Details about Regulatory Knowledge & Support
Research Development logo Research Development Details about Research Development
Workforce Development logo Workforce Development Details about Workforce Development

NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.