About

Paul Watkins is the Howard Q. Ferguson Distinguished Professor at the University of North Carolina School of Medicine. His research focuses on mechanistic toxicology, hepatic toxicology, research translation, and biomarkers. He is associated with the Institute for Drug Safety Sciences at the Research Triangle Park campus. His work involves understanding the mechanisms underlying toxicological effects, particularly in the liver, and translating these findings into practical applications for drug safety and environmental health. Watkins has contributed to the field through his leadership and research in toxicology, with a focus on improving safety assessments and biomarker development.

Research topics

• Pharmacology
• Medicine
• Internal medicine
• Computer Science
• Computer Security
• Gastroenterology
• Environmental health
• Intensive care medicine
• Genetics
• Risk analysis (engineering)
• Biology
• Geography

Selected publications

• A Missense Variant in PTPN22 is a Risk Factor for Drug-induced Liver Injury

  Repository@Nottingham (University of Nottingham) · 2026-02-18

  book-chapterOpen access
  PublisherDOI

• ERAP-1 and ERAP-2 Variants in Liver Injury After COVID-19 mRNA Vaccination: A US Multicenter Study

  UNC Libraries · 2025-03-26

  articleOpen access1st authorCorresponding

  INTRODUCTION: The aim of this study is to describe the presenting features, genetic factors, and outcomes of 23 adults who developed liver injury after coronavirus disease 2019 (COVID-19) mRNA vaccination. METHODS: Patients with suspected COVID-19 vaccine hepatitis were enrolled into the Drug-Induced Liver Injury Network. Causality was assessed using the Drug-Induced Liver Injury Network expert opinion score. High-resolution HLA sequencing was undertaken using Illumina platform. RESULTS: Amongst the 16 high causality cases, median time to onset was 16 days, median age was 63 years, and 75% were female. The injury was hepatocellular in 75% with a median alanine aminotransferase of 497 U/L, and 37% had jaundice. An antinuclear antibody and smooth muscle antibody were detectable in 27% and 36%, but only 12% had an elevated immunoglobulin G level. During follow-up, 37% received a short course of corticosteroids, and 88% fully recovered by 6 months with no deaths observed. HLA alleles associated with autoimmune hepatitis were not overrepresented compared with controls, but an ERAP-2 variant (rs1263907) and the ERAP-1 Hap6 haplotype were significantly overrepresented in the high causality cases vs controls ( P = 0.026 and 5 × 10 -5 , respectively). DISCUSSION: Acute liver injury may arise within 8 weeks of COVID-19 mRNA vaccination that is generally mild and self-limited in most patients. The absence of an association with the AIH HLA alleles combined with the significant ERAP-2 and ERAP-1 Hap6 haplotype associations implicates a unique but very rare host immune response to vaccine-derived antigens in the pathogenesis of COVID-19 vaccine hepatotoxicity.

  PublisherDOI

• Engineering inclusive and interdisciplinary research excellence: the DiveIn approach to diversity in postgraduate research

  2025-05-19

  articleOpen access

  We present DiveIn CDT’s model for engineering inclusive, interdisciplinary research excellence. It outlines evidence-based recruitment, anonymised shortlisting, and holistic support systems that dismantle structural barriers in postgraduate research. Our aim is to improve diversity, equity, and learning practices to address mission-driven challenges across the STEM landscape.

  PublisherOA PDFDOI

• A Clinical Review of Psoriasis and Its Association with Systemic Inflammation

  Preprints.org · 2025-07-21

  reviewOpen accessSenior author

  Psoriasis is a prevalent chronic inflammatory skin condition characterized by hyperproliferation of keratinocytes and a dysregulated immune response, resulting in the formation of plaques and systemic manifestations. This clinical review aims to elucidate the intricate relationship between psoriasis and systemic inflammation, emphasizing the pathophysiological mechanisms, clinical implications, and potential therapeutic strategies. Recent studies have demonstrated that psoriasis is not merely a localized skin disorder but a systemic condition with significant associations with comorbidities such as cardiovascular disease, metabolic syndrome, and psoriatic arthritis. The underlying pathogenesis involves an interplay of genetic predisposition and environmental triggers that activate innate and adaptive immune pathways, leading to the overproduction of pro-inflammatory cytokines, such as tumor necrosis factor-alpha (TNF-α), interleukin-17 (IL-17), and interleukin-23 (IL-23). These cytokines contribute to both the local inflammation within psoriatic plaques and systemic inflammation, influencing the development of associated comorbidities. The review highlights the role of systemic inflammation in exacerbating the severity of psoriasis and its comorbid conditions. Evidence suggests that patients with moderate to severe psoriasis exhibit elevated levels of systemic inflammatory markers, including C-reactive protein (CRP) and interleukin-6 (IL-6), which correlate with disease severity and the risk of cardiovascular events. Furthermore, the review discusses the implications of systemic inflammation on treatment outcomes, particularly in the context of biologic therapies that target specific inflammatory pathways. In conclusion, this clinical review underscores the necessity of a holistic approach to managing psoriasis, considering its systemic implications. Future research should focus on elucidating the bidirectional relationship between psoriasis and systemic inflammation, aiming to improve patient outcomes through integrated management strategies that address both skin and systemic health. This comprehensive understanding is vital for healthcare professionals in tailoring individualized treatment plans that mitigate not only the dermatological aspects of psoriasis but also its associated systemic effects, ultimately enhancing the quality of life for affected individuals.

  PublisherOA PDFDOI

• Liver Safety of Fasiglifam (TAK-875) in Patients with Type 2 Diabetes: Review of the Global Clinical Trial Experience

  UNC Libraries · 2025-09-06

  articleOpen access
  PublisherDOI

• Engineering inclusive and interdisciplinary research excellence: the DiveIn approach to diversity in postgraduate research

  2025-07-07

  article

  We present DiveIn CDT’s model for engineering inclusive, interdisciplinary research excellence. It outlines evidence-based recruitment, anonymised shortlisting, and holistic support systems that dismantle structural barriers in postgraduate research. Our aim is to improve diversity, equity, and learning practices to address mission-driven challenges across the STEM landscape.

  PublisherDOI

• Correction to: Liver Safety of Fasiglifam (TAK-875) in Patients with Type 2 Diabetes: Review of the Global Clinical Trial Experience

  UNC Libraries · 2025-09-06

  articleOpen access
  PublisherDOI

• ERAP-1 and ERAP-2 Variants in Liver Injury After COVID-19 mRNA Vaccination: A US Multicenter Study

  The American Journal of Gastroenterology · 2024-02-05 · 7 citations

  articleOpen access

  INTRODUCTION: The aim of this study is to describe the presenting features, genetic factors, and outcomes of 23 adults who developed liver injury after coronavirus disease 2019 (COVID-19) mRNA vaccination. METHODS: Patients with suspected COVID-19 vaccine hepatitis were enrolled into the Drug-Induced Liver Injury Network. Causality was assessed using the Drug-Induced Liver Injury Network expert opinion score. High-resolution HLA sequencing was undertaken using Illumina platform. RESULTS: Amongst the 16 high causality cases, median time to onset was 16 days, median age was 63 years, and 75% were female. The injury was hepatocellular in 75% with a median alanine aminotransferase of 497 U/L, and 37% had jaundice. An antinuclear antibody and smooth muscle antibody were detectable in 27% and 36%, but only 12% had an elevated immunoglobulin G level. During follow-up, 37% received a short course of corticosteroids, and 88% fully recovered by 6 months with no deaths observed. HLA alleles associated with autoimmune hepatitis were not overrepresented compared with controls, but an ERAP-2 variant (rs1263907) and the ERAP-1 Hap6 haplotype were significantly overrepresented in the high causality cases vs controls ( P = 0.026 and 5 × 10 -5 , respectively). DISCUSSION: Acute liver injury may arise within 8 weeks of COVID-19 mRNA vaccination that is generally mild and self-limited in most patients. The absence of an association with the AIH HLA alleles combined with the significant ERAP-2 and ERAP-1 Hap6 haplotype associations implicates a unique but very rare host immune response to vaccine-derived antigens in the pathogenesis of COVID-19 vaccine hepatotoxicity.

  PublisherOA PDFDOI

• ALTEX Proceedings TIERethik Corrigendum to Incorporating new approach methodologies into regulatory nonclinical pharmaceutical safety assessment

  ALTEX · 2024-01-01

  erratumOpen access

  This corrects the article DOI: 10.14573/altex.2212081.

  PublisherOA PDFDOI

• An approach for collaborative development of a federated biomedical knowledge graph-based question-answering system: Question-of-the-Month challenges

  UNC Libraries · 2024-06-29

  articleOpen access

  Knowledge graphs have become a common approach for knowledge representation. Yet, the application of graph methodology is elusive due to the sheer number and complexity of knowledge sources. In addition, semantic incompatibilities hinder efforts to harmonize and integrate across these diverse sources. As part of The Biomedical Translator Consortium, we have developed a knowledge graph-based question-answering system designed to augment human reasoning and accelerate translational scientific discovery: the Translator system. We have applied the Translator system to answer biomedical questions in the context of a broad array of diseases and syndromes, including Fanconi anemia, primary ciliary dyskinesia, multiple sclerosis, and others. A variety of collaborative approaches have been used to research and develop the Translator system. One recent approach involved the establishment of a monthly "Question-of-the-Month (QotM) Challenge" series. Herein, we describe the structure of the QotM Challenge; the six challenges that have been conducted to date on drug-induced liver injury, cannabidiol toxicity, coronavirus infection, diabetes, psoriatic arthritis, and ATP1A3-related phenotypes; the scientific insights that have been gleaned during the challenges; and the technical issues that were identified over the course of the challenges and that can now be addressed to foster further development of the prototype Translator system. We close with a discussion on Large Language Models such as ChatGPT and highlight differences between those models and the Translator system.

  PublisherDOI

Recent grants

• NIH Grant M01RR000046

  NIH · $3.5M · 2008

• NIH Grant P01ES004238

  NIH · $4.8M · 1999

• NIH Grant R55ES005770

  NIH · $100k · 1993

• UNC-Duke Collaborative Clinical Pharmacology Postdoctoral Training Program

  NIH · $7.8M · 2011–2026

• University of North Carolina Clinical Center for DILIN

  NIH · $6.9M · 2003–2028

Frequent coauthors

• Robert J. Fontana

  University of Michigan–Ann Arbor

  142 shared

• Naga Chalasani

  127 shared

• Herbert L. Bonkovsky

  Atrium Health Wake Forest Baptist

  103 shared

• José Serrano

  98 shared

• Erin G. Schuetz

  90 shared

• Timothy J. Davern

  88 shared

• James Rochon

  86 shared

• Brett A. Howell

  Simulations Plus (United States)

  83 shared

Labs

• Curriculum in Toxicology & Environmental MedicinePI

Education

• Ph.D., Toxicology

  University of North Carolina at Chapel Hill

  1995

• M.S., Toxicology

  University of North Carolina at Chapel Hill

  1992

• B.S., Toxicology

  University of North Carolina at Chapel Hill

  1989

Awards & honors

• Howard Q. Ferguson Distinguished Professor