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  8. NCTR Participation at 2023 FDA Science Forum
  1. Science & Research (NCTR)

NCTR Participation at 2023 FDA Science Forum

FDA Science Forum: Advancing Regulatory Science Through Innovation, June 13-14, 2023

View recordings of full event

Concurrent Session 2 — Product Development Tools and Manufacturing

  • “Opportunities and Challenges in Using Liver Microphysiological Systems to Study Drug Metabolism and Hepatotoxicity” (Dr. Qiang Shi)

Concurrent Session 4 — Tools to Effectively Use Big Data

  • Panel Discussion (Dr. Joshua Xu)

Concurrent Session 5 — Food and Cosmetic Safety
Chair/Moderator (Dr. Raj Nayak)

  • “Studies to Assess the Virulence of Enteric Foodborne Pathogens” (Dr. Steven Foley)
  • “An Update on NCTR and Office of Cosmetics and Colors’ Collaborative Efforts to Support Cosmetics Safety Evaluation” (Dr. Luísa Camacho)
  • Panel Discussion and Q&A

Concurrent Session 6 — Medical Countermeasures, Infectious Disease, and Pathogen Reduction Technologies
Chair/Moderator (Dr. Mugimane Manjanatha)

  • Introduction (Dr. Mugimane Manjanatha)
  • “Evaluation of Testicular Organoids as a Model for Zika Virus Infection” (Dr. Dayton Petibone)
  • Panel Discussion and Q&A

Concurrent Session 7 — Advancing Products Based on Novel Technologies
Chair/Moderator (Dr. Mugimane Manjanatha)

  • “Host-Microbiome Crosstalk: Disruption of Gastrointestinal Barrier as Toxicity Assessment Tool” (Dr. Sangeeta Khare)
  • Panel Discussion and Q&A

2023 FDA Science Forum Poster Sessions

NCTR Authors

A Droplet Digital PCR (ddPCR) and Recombinase Polymerase Amplification (RPA) with Propidium Monoazide (PMAxx) for the Detection of Viable Burkholderia cepacia Complex in Nuclease Free Water and Antiseptics S. Daddy Gaoh, O. Kweon, and Y. Ahn.
A Modified Approach of Fluoro-Jade C Labeling for Neurotoxicity Assessments Q. Gu, S. Sarkar, J. Raymick, and J. Kanungo
Assessing the Developmental Effects of Fentanyl (Anesthetics/Analgesics) Using Neural Stem Cell Models C. Wang, L. Latham, S. Liu, and F. Liu
Assessing the Developmental Neurotoxicity of Perinatal Exposure to Cannabidiol in Sprague Dawley Rats W.D. Gill, A. Shen, C. Law, S. Burks, B. Robinson, and T. Flanigan
Assessment of a Modified Sandwich Estimator for Generalized Estimating Equations with Application to Opioid Poisoning in MIMIC-IV ICU Patients P. Rogers
CANcer Variant Allele Sequencing (CANVAS): A computational pipeline for the quantitation of ultra-low frequency hotspot mutations in myeloid neoplasm-associated genes via targeted error-corrected sequencing of human peripheral blood DNA P. McKinzie, J. Faske, L. Lyn-Cook Jr., and M. Myers
CarcSeq detection of a dose- and time-dependent induction of a cancer driver mutation in the mammary DNA of lorcaserin-treated rats J. Faske, M. Bryant, M. Myers, X. He, F McLellen, and B. Parsons
Cardiotoxicity Assessment of HESI Reference Compounds Using HiP-SC-CMs P. Bagam and L. Pang
Comparative pharmacokinetics of Zileuton’s active pharmaceutical ingredient, nanocrystal-drug, and physical mixture in male and female Sprague Dawley rats C. Mohan Reddy Muthumula, B. Wickramaratne, S. Khare, and G. Kuppan
Concentration-dependent proteome response of a strong biofilm producer S. epidermidis RP62A to subinhibitory tigecycline K. Sung, M. Park, S. Khan, A. Shen, and A. Paredes
Cytokine Mediated Chemotherapy Induced Cognitive Impairment in Cisplatin and Methotrexate Treated Sprague-Dawley Rats J. Yeary, M.C. Fogle, S. Burks, J. Talpos, and
X. Zhang
DeepAmes: Deep learning-powered Ames test predictive models for regulatory application by harnessing a comprehensive and consistent dataset T. Li, Z. Liu, and W. Tong
Detection of SARS-CoV-2 Variants in Wastewater in Two Metropolitan Areas of Arkansas C. Silva, V. Tryndyak, L. Camacho, L. Mullis, and M. Azevedo
Direct Detection and Identification of Viruses in Saliva in Real-Time Using a SpecID™ Mass Spectrometer D. Buzatu and M. Azevedo
Evaluation of plasma proteome and miRNA changes related to COVID-19 patient severity response R. Beger, L.-R. Yu, T. Han, V. Vijay, L. Pence, J. Sun, M. Bidarimath, T. Schmitt, K. Mercer, E. Masters, and J. Hawes
Examination of the Effect of Black Cohosh on the Efficacy of Risedronate on Bone Mineral Density in an Ovariectomized Rat Model E. Masters, A. Inselman, J. Moore, R. Beger,
B. Delclos, L. Camacho, M. Vanlandingham, D. Sloper, N. Nakamura, G. Gamboa Da Costa, K. Woodling, M. Bryant, R. Trbojevich, Q. Wu, F. McLellan, and D. Hansen
Gene expression changes predict the severity of NAFLD-like liver injury in male Collaborative Cross mice V. Tryndyak, R. Willett, S. Nagumalli, F. Beland, and I. Pogribny
Genotoxicity assessment of eight nitrosamine impurities using 2D and 3D in vitro human HepaRG models J.-E. Seo, J. Yu, N. Mei, R. Heflich, and X. Guo
Inorganic arsenic alters the development of dopaminergic neurons but not  serotonergic neurons and induces motor neuron development via Sonic hedgehog pathway in zebrafish J. Kanungo, N. Twaddle, C. Silva, B. Robinson, Q. Gu, and F. Beland
Lessons learnt in establishing a reliable and low-cost assay for urea production in human primary hepatocytes cultured in a Liver-Chip for the study of drug hepatotoxicity Q. Shi, L. Ren, K. Papineau, D. Mendrick, J. Hawes, and L. Schnackenberg
MALDI imaging mass spectrometry of mouse fetuses to assess markers of neural tube defects after maternal opioid exposure D. Barnette, E.E. Jones, R.D. Beger, P.R. Kaldhone, and A. Inselman
MALDI IMS identified changes in lipids and metabolites in rat brains following arsenic exposure E.E. Jones, L. Schnackenberg, D. Barnette, R.D. Beger, A. Shen, and T. Flanigan
Metabolomics Evaluation of the Impact of Violet-Blue Light (405 nm) on Platelet Concentrate J. Sun, T. Schmitt, and R. Beger
Seroprevalence of a novel human canine coronavirus in Arkansas M. Azevedo, L. Mullis, S. Nho, and B. Erickson
Sex-based differences in inflammasome activation due to silver nanoparticles B. Canup, P. Rogers, B. Lyn-Cook, and T. Fahmi
T2-MRI mapping as a minimally-invasive correlate of central nervous system (CNS) toxicity in a cuprizone-model: A biomarker study S. Imam, K. Ball, N. Sadovova, J. Raymick, B. Robinson, T. Patterson, and S. Liachenko
The development of an in vitro qPCR assay to detect and quantify HCoV-NL-63 M. Rumman, S. Nho, S. Johnson, M. Azevedo, L., D. Wagner, and K. Feye
The Neurotoxic Potential of a Single Dose of Ketamine in Adolescent and Adult Rats S. Sarkar, G. Gamboa de Costa, M. Vanlandingham, K. Woodling, and J. Talpos
The plasmid puzzle: challenges for Salmonella monitoring K. Feye, D. Sopovski, J. Revollo, J. Miranda- Colon, D. Gudeta, J. Han, and S. Foley
Toxicity of three antisense oligonucleotide drugs and eighteen of their impurities in primary human hepatocytes J. Hawes, Q. Shi, L. Ren, and L. Schnackenberg
Using Various Machine Learning Algorithms to Determine the Best Method for Predicting Population Physiologically Based Pharmacokinetic Model Plasma Profiles K. Fairman, M.-K. Choi, P. Gonnabathula, and M. Li


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