About

Terry David Church, DRSc, MA, MS, is an Associate Professor of Regulatory and Quality Sciences at the University of Southern California's Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences. His academic focus includes the application of pharmaceutical regulations, patterns of addiction, disaster management, and education and training. Dr. Church's areas of expertise encompass the history and geography of drugs, biorepository regulation and ethics, regulation of controlled substances, regulatory practices for continuity and disaster planning, and policies and ethics of academic research. He received his Doctor of Science and Master of Science in Regulatory Sciences from USC, with his doctoral thesis evaluating regulatory practices for continuity and disaster planning for biobanks in the United States. Dr. Church is a faculty fellow of the USC Center for Excellence in Teaching and serves as the Associate Director of the educational committee of the Institute for Addiction Sciences. He is also the Director of the STAR science educational program with BRAVO Medical Magnet High School of Los Angeles and USC. His professional background includes working at the University of Pennsylvania’s Office of Human Research as Operations Director, where he helped implement human subjects research protections and monitored clinical trial activity, and at USC Norris Comprehensive Cancer Center as Program Manager, overseeing research, clinical, and community activities for various cancer research initiatives. His research interests include continuity planning, adolescent and young adult cancer supportive care, drug addiction, biorepository regulation and ethics, and the regulation of controlled substances. Dr. Church is actively involved in teaching courses related to the history and geography of drugs, substances of abuse and addiction, and ethics, drugs, and society.

Research topics

• Medicine
• Psychology
• Medical education
• Family medicine
• Radiology

Selected publications

• 550 An international comparison of the efficacy of regulatory mechanisms regarding traditional medicines (TM)

  Journal of Clinical and Translational Science · 2025-03-25

  articleOpen accessSenior author

  Objectives/Goals: To identify the most impactful regulations regarding the approval and marketing of TMs in the U.S., E.U., Japan, Australia, China, and India enacted between the years 2000 and 2022. To explore TM-related regulations in new countries, Japan and Australia, for their novel regulatory approaches in intersecting Western and Eastern medical practices. Methods/Study Population: International regulatory bodies included in this study were chosen based on the country’s long history with TM and/or the existence of review processes specific to TM. TM-related regulatory changes that were enacted between the years 2000 and 2022 were identified and categorized into special departments, changes in clinical trials, or specialized tracks. The impact of these TM policies was measured via the number of TM-related INDs, approved applications, marketed drugs, and rejected applications per decade since 2000. This data was then organized alongside policies to draw conclusions about the influence of these regulatory changes. All data was collected using official government websites and journals published by independent, external research institutions accessed via USC’s library services. Results/Anticipated Results: Previous research revealed each country made efforts to integrate TMs into existing drug practices, such as clinical trials and safety requirements, although the extent and methods for the integration differed. Countries with a longer history with TMs are predicted to have regulatory systems that are more accommodating to the unconventional nature of TMs, making the approval and marketing of TMs much easier in these countries. As TM-related policies are more refined and increase in number in a given country, the number of TM-related applications and TMs marketed as legitimate, prescribable medications will also increase. Discussion/Significance of Impact: Timelines and charts displaying the impact of new TM-related regulatory changes will help identify a successful model for increasing TM IND submissions, approvals, and marketed TM drugs.

  PublisherDOI

• 314 Mapping preeclampsia inequalities in medical treatment: Converging medicare/medicaid and clinical trial availability

  Journal of Clinical and Translational Science · 2025-03-25

  articleOpen accessSenior author

  Objectives/Goals: This study looks to better understand and call attention to the inequalities found within medical treatment options for individuals suffering from preeclampsia during pregnancy in the USA. The goal is to map the terrain of clinical trials and evaluating existing medicare/medicaid covered services on a both national and state levels. Methods/Study Population: The study population for this research was limited to: pregnant women, ages 18–45, both pregnant and postpartum suffering from preeclampsia. We began looking at clinical trials targeting preeclampsia treatment conducted within the United States between 2019 and 2024. Using our study population parameters, we searched clinicaltrials.gov. These trials’ inclusionary and exclusionary factors were noted, along with participant race. The drug intervention medication used during these clinical trials was compared to those prescribed by doctors via the current national standard of care. We then looked at Medicaid coverage provided to expecting mothers on a state-to-state basis and nationally regulated level. These factors included coverage on ultrasounds, low-dose aspirin, blood pressure monitors, and more. Results/Anticipated Results: Preliminary findings demonstrate the need for more federally regulated policies and programs set in place to help combat the lack of resources faced by expecting mothers across the nation. This research will expose factors contributing to a lack of successful and completed clinical trials and lack of drug intervention innovations taking place to combat the rise in maternal deaths. This study will also focus on the importance of more education and awareness for communities such as African American mothers and those facing multiple gestational pregnancies who are at much higher risk of complications during their pregnancies. We also anticipate a large correlation between a lack of proper childbirth education and mothers who experience complications during birth. Discussion/Significance of Impact: Within the past two decades, rates of preeclampsia have grown 25% within the USA. It affects 5–8% of all pregnancies, and with maternal death rates rising, it is crucial to highlight the alarming lack of government regulation. It is imperative to provide awareness to mothers from disadvantaged backgrounds to treat this preventable condition.

  PublisherOA PDFDOI

• 143 Assessing gender literacy: A novel methodology for evaluating eligibility criteria in clinical research

  Journal of Clinical and Translational Science · 2025-03-25

  articleOpen accessSenior author

  Objectives/Goals: The objective of this project is to develop a tool for evaluating clinical trial (CT) eligibility criteria for demonstrated “gender literacy,” defined as the recognition that biologically assigned “sex” is distinct from personally defined “gender identity,” as a way to quantify the inclusion of gender minority populations. Methods/Study Population: The study is validating an assessment scale that evaluates gender literacy based on CT eligibility criteria (EC). Two health professionals will serve as “coders,” tasked with grading 15 CTs. EC for all CTs will be exported from clinicaltrials.gov. Once trained with using the scale, each coder will give a score for each trial. After this first scoring period, coders will share their scores and experiences using the scale. Coders will be tasked again with grading 15 new CTs. This second scoring period will yield final scores to calculate the inter-rater reliability (IRR), or the extent to which qualitative measurements are consistent and not due to random chance. IRR will be quantified by Cohen’s kappa to validate the scale. Results/Anticipated Results: Cohen’s kappa is on a continuous interval from 0 to 1, where 0 means no agreement and 1 means perfect agreement. It is expected that the Cohen’s kappa for this assessment scale will exceed 0.80. Such validation is necessary to ensure the scale is robust and dynamic for multiple use-cases and consistent across any coder. By having a discussion after the initial scoring period, we can identify confusions or challenges with the scale early on and correct them before the secondary scoring period. In comparing these two coders’ performance, it is expected that the second scores will be more similar, thus a kappa closer to 1. However, if the kappa is low, this may be because gender literacy is a learned skill, through the internalized recognition that gender is truly different from sex. Discussion/Significance of Impact: Systemic barriers and exclusionary language have excluded gender minorities from CT spaces for too long. Tools such as these, paired with standardized language for sex and gender eligibility criteria, will greatly bolster the representation of this population and spark change for a more inclusive future.

  PublisherOA PDFDOI

• Learning Outcomes from Project Design: A Model for Integration in Pharmacy Education

  American Journal of Pharmaceutical Education · 2025-11-01

  articleOpen access
  PublisherDOI

• From traits to puffs: The interplay of personality, pandemic stress, and smoking behaviors

  PLoS ONE · 2025-07-07

  articleOpen accessSenior authorCorresponding

  Smoking, a leading cause of chronic diseases, is often used to cope with stress, which has been heightened by the pandemic due to health and economic concerns. Studies have shown that the Big Five personality traits are linked to smoking behavior, suggesting that different personality traits influence nicotine use in varying ways. However, there remains a significant gap in understanding how individuals with different personalities respond to nicotine use under stress. This study aims to investigate how nicotine dependence changes for different Big Five personalities under the pandemic stress and whether other stress-related factors influence nicotine dependence during COVID-19. This cross-sectional study collect data from randomly selected adults aged 18-30 in the US. The Big Five Personality Model assessed personality traits, and nicotine dependence was measured with the Hooked-on Nicotine Checklist. Stress was evaluated using the Perceived Stress Scale, while demographics and other pandemic-related stressors were gathered through structured questions. Correlation and multiple logistic regression models were used for data analysis. The main findings showed that both before (r = -.25, p < .001) and during (r = -.19, p < .001) the pandemic, agreeableness was significantly negatively associated with nicotine dependence, indicating that higher agreeableness was linked to lower nicotine dependence. Similarly, conscientiousness was negatively correlated with nicotine dependence both before (r = -.123, p < .001) and during COVID-19 (r = -.19, p < .001). Although no direct association was found between perceived stress, personality traits, and smoking behavior, the analysis identified that external stressors played a moderating role. These findings emphasize the importance of understanding how different personality traits influence young people's dependence on nicotine under stress. The outcome can guide the design of targeted nicotine withdrawal interventions and inform effective public health strategies.

  PublisherDOI

• Pioneering Computational Culture Within Pharmacy Schools by Empowering Students With Data Science and Bioinformatics Skills

  American Journal of Pharmaceutical Education · 2024-12-13 · 1 citations

  articleOpen access

  As advancements in digital health lead to the generation of increasingly diverse and voluminous pharmaceutical data, it is increasingly critical that we teach trainee pharmaceutical scientists how to leverage this data to lead future innovations in health care and pharmaceutical research. To address this need, the University of Southern California Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences is incorporating data science and bioinformatics into the graduate and undergraduate curricula through introductory courses tailored for students without prior programming experience. These courses feature a teaching framework designed to make the fundamentals of data science and bioinformatics accessible to pharmacy students through step-by-step, Jupyter-based coding assignments with examples relevant to the pharmaceutical sciences. The framework supports Doctor of Pharmacy students by focusing on the practical applications of data science in clinical settings, while for Doctor of Philosophy (PhD) and Master's (MS) students, the emphasis is on research methodologies and advanced data analysis techniques. Here, we outline the design of this framework, highlighting the strategies we developed and the opportunities it provides to cultivate a computational culture within our institution and beyond.

  PublisherDOI

• 105 Gender-Diverse Inclusion: The Language of Sex and Gender in PrEP Clinical Trials

  Journal of Clinical and Translational Science · 2024-04-01

  articleOpen accessSenior author

  OBJECTIVES/GOALS: To construct an assessment scale capable of evaluating a trial’s gender literacy or the extent to which biologically assigned “sex” is understood as separate from culturally defined and personally embodied “gender”. This scale in tandem with a policy brief will outline recommendations for inclusive medical nomenclature in the clinical space. METHODS/STUDY POPULATION: Using clinicaltrials.gov, inclusion/exclusion criteria was recorded for PrEP interventional trials (i.e., Truvada, Descovy). To evaluate these trials, an assessment scale for “gender literacy” is necessary. This scale relies on the fact that sex and gender are distinct elements to one’s identity and ought to be reported as such. As a form of content analysis, where literary information (eligibility criteria) is evaluated based on set rubric, this scale will require validation through inter-coder agreement. Evaluated in a group of 5 college-age students, this scale was used on selected PrEP clinical trials to verify if there was high agreement in the scores given. After validation, the dataset from clinicaltrials.gov underwent evaluation using the proposed assessment scale for gender literacy. RESULTS/ANTICIPATED RESULTS: The student coders had a Kalpha of 0.4 in the first round of grading. After retraining, their Kalpha increased to 0.68. The grading involved a subjective language rating (LIR), evaluating the usage of inclusive language, and a numerical score (GR) for the demographics of inclusion in a trial. After this inter-coder agreement validation, 216 active PrEP clinical trials (as of March 2023) were downloaded from clinicaltrials.gov. Grading of these trials showed that cisgender males represented 40% of participants, while 28% represented both transgender men and women, and less than 1% represented non-binary individuals. Moreover, more than half of the trials (52%) exhibited cisgender-oriented language or made no reference to gender identity. DISCUSSION/SIGNIFICANCE: It is a scientific imperative for clinical trials to have representative participant bases in order to derive data that is generalizable to afflicted populations. Especially for PrEP clinical trials, where gender-diverse individuals need visibility, trial design must be carefully crafted so as not to exclude through dated or exclusionary language.

  PublisherOA PDFDOI

• Beyond Juul: The New Face of Underage Nicotine Addiction - A Survey of College Students

  Therapeutic Innovation & Regulatory Science · 2024-12-28

  articleOpen accessSenior author

  BACKGROUND: Youth nicotine addiction is a major public health concern in the United States. Disposable Electronic Nicotine Delivery Systems (ENDS), or disposable vapes, are commonly sought out by youth despite not having received premarket authorization from the FDA. The objective of this study was to identify factors contributing to underage consumption of disposable ENDS. METHODS: An anonymous survey was deployed to college students to understand young adults' perceptions and patterns of use of disposable ENDS. RESULTS: Disposable ENDS are very popular among youth. The results of this study revealed the popular brands, flavors, modes of access, and attractive aspects of disposable ENDS. Survey results combined with information from the literature reveal that disposable ENDS gained popularity in the years following the decline in the popularity of pod-based ENDS, such as JUUL, following strict regulatory action from the FDA. CONCLUSION: To ultimately address underage nicotine addiction, the FDA must hold disposable ENDS to the same regulatory standards as other tobacco products and produce regulations specifically targeted at disposable ENDS. The results of this study emphasize the importance of making effective regulatory reform and functional educational resources to prevent young people from initiating the use of disposable ENDS.

  PublisherOA PDFDOI

• 507 A Comparison of Regulatory Mechanisms for the Approval of Herbal Medicines

  Journal of Clinical and Translational Science · 2024-04-01

  articleOpen accessSenior author

  OBJECTIVES/GOALS: To compare the herbal medicine (HM) programs of the U.S. to those of different countries–including the European Union, South Korea, China, and India–and to examine each regulatory body’s process for obtaining market approval for HM drugs. METHODS/STUDY POPULATION: The European Union, South Korea, China, and India’s respective HM regulatory programs were examined and compared to the U.S. FDA’s HM process. These specific regulatory bodies were chosen based on the country’s long history with HM and/or the robustness of their existing HM review processes. International HM programs were researched using official government websites and journals published by independent, external research institutions that were accessed via USC’s library services. Data regarding the efficacy of HM policies such as HM IND approval rates, number of marketed HM drugs, and establishment of unique HM sectors will be collected. RESULTS/ANTICIPATED RESULTS: Investigational New Drug (INDs) applications regarding HM from each country will be categorized and displayed according to their approval status in order to provide insight on a HM program’s efficiency. Results also included a table displaying common challenges for approval for HM drugs across federal regulatory bodies. If applicable, effective solutions implemented to address some of these obstacles that proved to be effective will also be displayed in the form of a table. DISCUSSION/SIGNIFICANCE: Tables displaying the collective flaws of international HM programs and the resulting regulatory solutions can provide clearer guidance for companies seeking to submit HM INDs and for the U.S. FDA seeking to develop improved HM regulations.

  PublisherOA PDFDOI

• From Traits to Puffs: The Interplay of Personality, Pandemic Stress, and Smoking Behaviors

  medRxiv · 2024-12-12

  preprintOpen accessSenior authorCorresponding

  Abstract Smoking, a leading cause of chronic diseases, is often used to cope with stress, which has been heightened by the pandemic due to health and economic concerns. Studies have shown that the Big Five personality traits are linked to smoking behavior, suggesting that different personality traits influence nicotine use in varying ways. However, there remains a significant gap in understanding how individuals with different personalities respond to nicotine use under stress. This study aims to investigate how nicotine dependence changes for different Big Five personalities under the pandemic stress and whether other stress-related factors influence nicotine dependence during COVID-19. This cross-sectional study collect data from randomly selected adults aged 18-30 in the US. The Big Five Personality Model assessed personality traits, and nicotine dependence was measured with the Hooked-on Nicotine Checklist. Stress was evaluated using the Perceived Stress Scale, while demographics and other pandemic-related stressors were gathered through structured questions. Correlation and multiple logistic regression models were used for data analysis. The main findings showed that both before (r = −.25, p &lt; .001) and during (r = −.19, p &lt; .001) the pandemic, agreeableness was significantly negatively associated with nicotine dependence, indicating that higher agreeableness was linked to lower nicotine dependence. Similarly, conscientiousness was negatively correlated with nicotine dependence both before (r = −.123, p &lt; .001) and during COVID-19 (r = −.19, p &lt; .001). Although no direct association was found between perceived stress, personality traits, and smoking behavior, the analysis identified that external stressors played a moderating role. These findings emphasize the importance of understanding how different personality traits influence young people’s dependence on nicotine under stress. The outcome can guide the design of targeted nicotine withdrawal interventions and inform effective public health strategies.

  PublisherOA PDFDOI

Frequent coauthors

• Richard Sposto

  Radiation Effects Research Foundation

  19 shared

• Debu Tripathy

  The University of Texas MD Anderson Cancer Center

  18 shared

• Linda Hovanessian‐Larsen

  University of Southern California

  14 shared

• Griffin Riggs

  Southern California University for Professional Studies

  13 shared

• Akshara Singareeka Raghavendra

  The University of Texas MD Anderson Cancer Center

  12 shared

• Lingyun Ji

  University of Southern California

  9 shared

• CN Ricker

  University of Southern California

  9 shared

• Shiwen Tang

  Guangzhou Medical University

  9 shared

Education

• DRSc - Doctorate of Regulatory Science, Pharmacy

  University of Southern California

  2017

• MS Regulatory Science, Pharmacy

  University of Southern California

  2015

• MA - Cultural Anthropology, Humanities

  Temple University

  2005

• BA - Social Sciences, Social Sciences

  University of Pittsburgh

  2000

Awards & honors

• faculty fellow of the USC Center for Excellence in Teaching
• Associate Director of the educational committee of the Insti…
• Director of the STAR science educational program with BRAVO…