Agendas

August 31, 1:00 p.m. – 5:00 p.m. EDT
September 10, 11:45 a.m. – 4:30 p.m. EDT
September 18, 12:00 noon – 4:30 p.m. EDT

Mini-Symposium #1: Igniting the Pipeline: Preclinical Advances in NAMs for HIV

This virtual symposium brings together leading experts to discuss advances, challenges, and future directions in utilizing 3D models, lymphoid organoids, and other new approach methodologies (NAMs) to study HIV pathogenesis, persistence, and cure across the life span.

1:00 p.m. – 5:00 p.m. EDT	Monday, August 31, 2026
Virtual meeting – link will be sent to all registrants.
Chairs: Lis Caler, PhD, MPhil (OAR, NIH); Tania Lombo, PhD (NIAID, NIH); Vasundhara Varthakavi, PhD, DVM (NIDA, NIH); and Dwight Yin, MD, PhD (NIAID, NIH)
1:00 p.m. – 1:10 p.m.	Welcome and Introduction to the Goals, Format, and Schedule of the Symposium Series	Lis Caler, PhD, MPhil (OAR, NIH)
1:10 p.m. – 1:35 p.m.	Opening Remarks	Nicole Kleinstreuer, PhD (DPCPSI, NIH) Warren Casey, PhD (ORIVA, NIH)
Keynote Presentation
1:35 p.m. – 2:00 p.m.	Characterizing, Validating, and Standardizing 3D Models for Studies of HIV Pathogenesis and Persistence	Mary Kearney, PhD (NCI, NIH)
Session I: Where Are We?
2:00 p.m. – 2:08 p.m.	NIH landscape of NAMs in HIV Research	Tania Lombo, PhD (NIAID, NIH)
2:08 p.m. – 2:15 p.m.	Break	All
Session II: Current Developments, Gaps, and Opportunities
Chairs: Vasundhara Varthakavi DVM, PhD (NIDA, NIH) and Dwight Yin, MD, PhD (NIAID, NIH)
2:15 p.m. – 2:35 p.m.	NeuroHIV on a Chip: A Human-Relevant New Approach Methodology	Michael Corley, PhD, MA (UCSD)
2:35 p.m. – 2:55 p.m.	Engineering Immunocompetent Neural Spheroids for Viral Infection Research	Emily Lee, PhD (NCATS, NIH)
2:55 p.m. – 3:15 p.m.	Modeling HIV Persistence and Cure in Human Lymphoid Organoids	Catherine Blish, MD, PhD (Stanford University)
3:15 p.m. – 3:35 p.m.	New Methodological Approaches for HIV Research: A Stage-Specific 3D Feto-Maternal Interface Model for Viral Infection and Its Challenges and Future Horizons in Pathology and Therapeutics	Cristina Antich Acedo, PhD (NCATS, NIH)
3:35 p.m. – 3:55 p.m.	Developing an Immunocompetent Lymph-Node-on-a-Chip Model for Cure Purpose	Guido Ferrari, MD (Duke University)
3:55 p.m. – 4:15 p.m.	Building Partnerships for HIV NAMs: Opportunities with the Multiscale Immune System Modeling Center of Excellence	Keith Reeves, PhD (Duke University)
4:15 p.m. – 4:20 p.m.	Break	All
Session III: Expert Panel Discussion and Closing Remarks
4:20 p.m. – 4:50 p.m.	Expert Panel Discussion	Mary Kearney, PhD (NCI, NIH); all speakers; and Invited Experts: Sara Gianella Weibel, MD (UCSD), Brandon Keele, PhD (NCI, NIH), and Frank Malderalli, MD, PhD (NCI, NIH)
4:50 p.m. – 5:00 p.m.	Closing Remarks & Future Directions	Dwight Yin, MD, PhD

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Mini-Symposium #2: Modeling Immunity to HIV: Bridging Preclinical Discovery to Clinical Evaluation

This virtual symposium will share emerging evidence and insights, present existing capabilities, and address the key challenges and opportunities in new approach methodologies (NAMs) applicability for modeling immunity to HIV infection, pathogenesis, comorbidities, and biomedical interventions for HIV prevention and cure strategies across ages, biological sex, and vulnerable populations.

11:45 a.m. – 4:30 p.m. EDT	Thursday, September 10, 2026
Virtual meeting – link will be sent to all registrants.
Chairs: Vasudev Rao, MBBS, MS (NIMH, NIH); Uday Shankar, PhD (NIAID, NIH); and Anjali Singh, PhD (NIAID, NIH)
Welcome and Opening Remarks
11:45 a.m. – 12:00 p.m.	Opening Remarks and Brief Recap of NAMs Mini-Symposium #1	Anjali Singh, PhD (NIAID, NIH) Uday Shankar, PhD (NIAID, NIH) Vasudev Rao, MBBS, MS (NIMH, NIH)
Keynote Presentation
12:00 p.m. – 12:20 p.m.	Advancing HIV Research with NAMs	Melanie Ott, MD, PhD (Gladstone Infectious Disease Institute)
Session I: Modeling Immunity, Developmental Safety, Immune Pathways, and Comorbidities
12:20 p.m. – 1:20 p.m.	Deciphering Human Immunology Through Immune Organoids and Functional Microphysiological Systems	Ankur Singh, PhD (Georgia Institute of Technology)
	In Vitro Modeling of Lymphoid Function in Spatially Organized Organs-on-Chip	Rebecca R. Pompano, PhD (University of Virginia)
	A NAM Model of the Cervix Recapitulates Microbial, Immunologic, and Pathogenic Properties of Sexually Transmitted Infections	Jason P. Gleghorn, PhD (University of Delaware)
1:20 p.m. – 2:00 p.m.	Insights Into Viral Infection and Immunity From Human Immune Organoids	Lisa E. Wagar, PhD (University of California)
	Hi-DEF, a Unified Framework for Quantifying and Evaluating Immune Dysregulation at System Level	Purvesh Khatri, PhD (Stanford University)
2:00 p.m. – 2:10 p.m.	Break	All
Session II: Modeling Disease Pathogenesis, Tissue Reservoirs, and Sanctuary Sites
2:10 p.m. – 3:00 p.m.	Enhanced Human Antigen-Specific B Cell Responses Using In Vitro 3D Tonsil Cultures Containing Stromal Cells	Marit van Gils, PhD (University of Amsterdam)
	Modeling Genome-edited B Cell Responses to Vaccination	James E. Voss, PhD (The Scripps Research Institute)
	Human Multi-organ on a Chip System to Evaluate Drug-drug Safety for HIV Therapeutics	James Hickman (Hesperos Inc)
3:00 p.m. – 3:50 p.m.	NAMs as Drug Development Tools in Reproductive Medicine	Ramkumar Menon, PhD (University of Texas Medical Branch Galveston)
	Modeling HIV Infection in 3-D Cerebral Organoids: Opportunities and Considerations	Kelly L. Jordan-Sciutto, PhD (University of Pennsylvania)
	Neuroimmunity in Motion: A Human 3D Neurovascular Model for Tracking Neuroinflammation in Real Time	Lishomwa C. Ndhlovu, MD, PhD (Weill Cornell Medical College)
3:50 p.m. – 4:00 p.m.	Break	All
Session III: Expert Panel Discussion and Closing Remarks
4:00 p.m. – 4:30 p.m.	Key Takeaways, Gaps in Current NAMs Landscape, and Actionable Recommendations for Future Collaborative Research and Development Opportunities	James Hickman, PhD (Hesperos Inc.) Lorna Ewart, PhD (Emulate)

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Mini-Symposium #3: Preclinical Models and NAMs in HIV Research: Priority Use Models, Platform Readiness, and Validation Pathways

This virtual symposium will examine priority contexts in which human-based new approach methodologies (NAMs) and established preclinical models can be integrated to advance HIV research and clinical product safety and development, define platform-level features needed for credible HIV applications, and review regulatory and validation expectations through concrete HIV-relevant contexts of use.

12:00 noon – 4:30 p.m. EDT	Friday, September 18, 2026
Virtual meeting – link will be sent to all registrants.
Chairs: David Chang, PhD (OAR, NIH); Sai Majji, PhD (NICHD, NIH); and Youngjun Sui, PhD (ORIP, NIH)
Welcome and Opening Remarks
12:00 noon – 12:10 p.m.	Goals for Mini-Symposium #3 and framing around adoption-ready HIV NAMs	Yongjun Sui, PhD (ORIP, NIH)
12:10 p.m. – 12:20 p.m.	Brief Recap of Mini-Symposia #1 and #2: Key Gaps, Model Systems, and Unresolved Translational Questions	David Chang, PhD (OAR, NIH)
Session I: Priority Use Models for HIV NAM Adoption and Preclinical Integration
Moderator: David Chang, PhD (OAR, NIH)
12:20 p.m. – 12:45 p.m.	Modeling Mucosal HIV: Integrating Clinical Cohorts, Organoids, and Preclinical Models	Douglas S. Kwon, MD, PhD (Ragon Institute of MGH, MIT and Harvard; Harvard Medical School)
12:45 p.m. – 1:10 p.m.	New Approaches to HIV Cure	Robert F. Siliciano, MD, PhD (Johns Hopkins University School of Medicine)
1:10 p.m. – 1:20 p.m.	Break	All
Session II: Human-Relevant Platforms and Cross-Model Translation in HIV Research
Moderator: Sai Majji, PhD (NICHD, NIH)
1:20 p.m. – 1:45 p.m.	Dissecting Human Inflammatory Diseases: Lessons from HIV-1	Lishan Su, PhD (University of Maryland School of Medicine)
1:45 p.m. – 2:10 p.m.	From Patient to Pipette to Predicting Clinical Outcomes: How NAMs Can be Harnessed to Advance HIV Research	J. Zachary Porterfield, MD, PhD (University of South Florida/USF Health)
2:10 p.m. - 2:35 p.m.	Beyond Replacement: Integrating NHP Models and NAMs to Advance HIV Research	Mirko Paiardini, Ph.D. (Emory University)
2:35 p.m. – 2:45 p.m.	Break	All
Session III: Validation and Context of Use for HIV NAMs
Moderator: Yongjun Sui, PhD (ORIP, NIH)
2:45 p.m. – 3:10 p.m.	Resource Development and Validation Landscape for NAMs	Oleg Mirochnitchenko, PhD (ORIP, NIH)
3:10 p.m. – 3:35 p.m.	From Models to Mothers: New Approach Methodologies to Advance Antiretroviral Safety in Pregnancy	Mackenzie L. Cottrell, PharmD (University of Oklahoma College of Pharmacy)
Extended Expert Panel Discussion and Closing Remarks
Moderator: Sai Majji, PhD (NICHD, NIH)
3:35 p.m. – 4:25 p.m.	Integrating Preclinical Models with NAMs for HIV Research and Product Development	All Speakers
4:25 p.m. – 4:30 p.m.	Closing Remarks and Next Steps	Stephanie Murphy, VMD, PhD (ORIP, NIH)