8:30-10:00am: Breakout Session 1

Generative AI for Drug Safety and Toxicology

Co-Chairs: Weida Tong and Leihong Wu, Division of Bioinformatics and Biostatistics, FDA/NCTR

Speakers:

• Leihong Wu, Division of Bioinformatics and Biostatistics, FDA/NCTR
  • Adverse Event (AE) classification with GenAI
• Hadi Salman, Division of Bioinformatics and Biostatistics, FDA/NCTR
  • GANomics
• Xi Chen, Division of Bioinformatics and Biostatistics, FDA/NCTR
  • AnimalGAN vs QSARs
• Dongying Li, Division of Bioinformatics and Biostatistics, FDA/NCTR
  • QKAR vs QSARs in Drug-induced Cardiotoxicity
    

Session Description: AI encompasses two main application categories: predictive and generative. Predictive algorithms utilize existing data to forecast future outcomes, whereas generative algorithms generate new data through AI-driven learning. Generative Artificial Intelligence (AI), exemplified by technologies like ChatGPT, has captured public attention with its vast potential across various fields. The wide range of Generative AI (GenAI) approaches offers unprecedented opportunities for enhancing strategies to predict toxicity. This session will showcase examples from FDA/NCTR projects in GenAI using the wide range of GenAI approaches to evaluate drug safety and toxicology. The topics will include: (1) using LLMs for toxicity classification; (2) learning from existing animal study data to generate animal study results without conducting actual experiments; (3) developing knowledge-based prediction with GenAI; and (4) Translate findings from one organ to another.

8:30-10:00am: Breakout Session 2

From Hogs to Algorithms: AI’s Impact on Teaching in the Land of Opportunity

Co-Chairs: Samantha Robinson (UAF) and David Ussery (UAMS)

Speakers:

• David Ussery (Professor, UAMS)
• Brian Delevan (Ark. Dept. Health; Ph.D. student in the UALR/UAMS bioinformatics program)
• Samantha Robinson (Associate Professor, UAF/UADA)
• Don Johnson (UAF)

Session Description: In this session, we will discuss the use of artificial intelligence and machine learning in university education in Arkansas. There will be three professors discussing how they use AI in teaching, and three students giving brief talks about their experiences in using AI in the classroom and their work.  David Ussery (UAMS) will talk about how machines learn, and what we can learn from this, with examples from more than 40 years of machine learning in bioinformatics; Brian Delevan (Arkansas Department of Health) will discuss how he’s using machine learning to map outbreaks in Arkansas. Samantha Robinson (UAF/UADA) will discuss the use of machine learning and AI in teaching statistics and data science to undergraduates, followed by one of her students.  Don Jonson (UA) will discuss using AI tools in Agricultural Education, followed by one of his students.

10:00-10:30am: Break

10:30am-12:00pm: Breakout Session 3

Advancing Regulatory Science with Digital Innovations

Chair: Shraddha Thakkar, FDA/CDER

Speakers: 

• Sridhar (Sri) Mantha, M.B.A., M.S., B.Tech., Director, Office of Strategic Programs, Center for Drug Evaluation and Research (CDER), FDA
  • Challenges and Opportunities for Implementing Data-Centric Approaches”
• Lilliam Rosario, Ph.D., Director, Office of Computational Science (OCS), Office of Translational Science (OTS), Center for Drug Evaluation and Research (CDER), FDA
  • Fueling the Digital Innovative Pipeline for Drug Review”
• Shraddha Thakkar, Ph.D., Senior Research Scientist, Office of Computational Sciences (OCS), Division of Regulatory Review & Research (DRRR)
  • Translation to Regulatory applications from Innovation”
• Emma Marczylo, FBTS CMgr MCMI, Principal Toxicologist & Toxicology Talent Partner, Toxicology Department, UK Health Security Agency
  • Innovation in Safety Assessments at UK Health Security Agency”

Session Description: The integration of digital technologies into regulatory science is transforming compliance processes and decision-making in the life sciences and healthcare sectors. This paradigm shift is driven by data-centric approaches enabling real-time analysis and improved compliance monitoring, while Regulatory Technology and cloud solutions automate tasks, enhance risk management, and facilitate global collaboration. This session highlights how Artificial Intelligence (AI), machine learning, and digital health technologies are reshaping real-world data validation, pharmacovigilance, and regulatory frameworks. A key focus is the critical transition from proof of concept to enterprise solutions, crucial for validating innovations, mitigating risks, and achieving scalable implementations that transform regulatory processes organization-wide. The session will explore how collaboration plays a pivotal role in this transformation by integrating regulatory science into interdisciplinary research. Participants will gain insights into creating a responsive and efficient regulatory landscape, equipping them with knowledge to navigate the evolving environment in life sciences and healthcare. Researchers will learn strategies for incorporating regulatory considerations.

10:30am-12:00pm: Breakout Session 4

Applications of Micro-Computed Tomography and Spatial Technologies in Anatomical Sciences, Biomedical Research, and Beyond

Chair: Claire Terhune, Associate Professor of (ARSC)-Arts & Sciences, Director of Graduate Studies, University of Arkansas

Speakers:

• Claire Terhune
• Kathleen Paul
• Sam Stephens and Morten Jensen
• Parker Taylor
• Carla Klehm

Session Description: Since 2018, the University of Arkansas MicroCT Imaging Consortium for Research and Outreach (MICRO), which is nested within the Center for Advanced Spatial Technologies (CAST), has been providing researchers with the ability to non-destructively document the structure of a range of natural and engineered materials in extremely fine three-dimensional detail. This imaging enables the systematic evaluation of composition, form, and functional properties of a wide variety of objects, leading to breakthroughs in anatomical, biomedical, and engineering sciences. This session will provide an overview of microCT imaging applications and highlight ongoing research using microCT data as well as spatial data more broadly.

12:00-1:00pm: Lunch Provided

1:00-2:30pm: Breakout Session 5

Next Generation Sequencing Approaches Across the Biological Spectrum

Chair: Steven Foley, FDA/NCTR

Speakers:

• Christopher Nelson, University of Arkansas
  • Third generation sequencing methods for examining CRISPR therapy safety
• David Ussery, University of Arkansas for Medical Sciences
  • The democratization of NGS via nanopore sequencing and its portability
• Javier Revollo, FDA National Center for Toxicological Research
  • Approaches for error-corrected NGS to assess genetic mutations
• Kristina Feye, FDA National Center for Toxicological Research
  • Cross-platform comparisons for plasmids/bacterial genomes
    

Session Description: The proposed session will explore next generation sequencing (NGS) technologies and their applications across the biological spectrum.  Session speakers have extensive experience using a range of sequencing platforms for different uses including the study of microbial organisms as well as understanding the role of genetic mutations in human diseases including cancer and genetic disorders.  The session’s featured speaker from the University of Arkansas, Dr. Christopher Nelson, utilizes long-read sequencing approaches to evaluate approaches for the development of cures for genetic diseases such as muscular dystrophy.  Other session speakers including Dr. Javier Revollo from the FDA-NCTR will discuss the evaluation of NGS approaches to assess rare genetic mutations that can lead to cancer development.  Dr. David Ussery from UAMS will discuss the use of accessible NGS approaches to assess the genetics of microbial pathogens.  The final presentation by Dr. Kristina Feye will focus on cross-NGS platform comparisons describing their utility for different plasmid and bacterial genomic applications.  Each of the available NGS technologies have strengths and weaknesses for different applications across the biological spectrum and their developments have led to a paramount shift in moving our understanding of genetics forward with the promise of limiting and/or curing diseases that impact humanity.

1:00-2:30pm: Breakout Session 6

Transformative Technologies for Integrative Health

Speakers:

• Meredith Adkins, PhD, I³R, UA Fayetteville
  • Transformative technologies for food systems
• Prashant Ravishankar, PhD, and Philip Sambol, I³R, UA Fayetteville
  • Transformative technologies for agrifood biotech
• Alejandro Martin Gomez, PhD, I³R and Department of Electrical Engineering and Computer Science (EECS), UA Fayetteville
  • Machine learning and extended reality for surgical procedures
• James Abbas, PhD, I³R and Department of Biomedical Engineering, UA Fayetteville
  • Data-driven approaches to personalizing neurostimulation

Session Description: The University of Arkansas in Fayetteville has launched the Institute for Integrative and Innovative Research (I³R, pronounced:  “I-cubed-R”), which is designed to pioneer solutions to wicked problems through innovation and convergence across sectors. Its initial focus is to take on the Grand Challenge of Integrative Health with an approach that recognizes the multiple physiological, social, and environmental factors at play and an approach that utilizes a holistic and integrative strategy to produce impactful solutions that are deployable at scale. This session will describe some of the on-going and planned research and development at I³R, with an emphasis on the role of data-driven approaches, AI and machine learning, and biotechnology. With I³R’s commitment to convergence, the session will also seek to connect with innovators from across the state to form partnerships that will enable healthier living and improve health for all Arkansans.

2:30-3:00pm: Award Announcements and Concluding Remarks