Advancing Immune Safety: HESI ITC Drives Innovation from Bench to Translation at SOT and IMMUNOLOGY2026

The HESI Global Immunosafety Technical Committee (ITC) maintained a strong and visible presence across two major scientific meetings this spring, reinforcing its leadership in advancing immune safety science and fostering cross-sector collaboration.

At the Society of Toxicology (SOT) Annual Meeting in San Diego, CA (March 2026), the ITC delivered two high-impact scientific sessions that addressed critical challenges in immunosafety assessment.

The Continuing Education course, “Lost in Translation? Navigating Species Selection for Immunotoxicological Assessment in Preclinical Studies,” co-chaired by Drs. Marie-Soleil Piche (CRL) and Shermaine Mitchell-Ryan (HESI Global), tackled one of the field’s most persistent translational hurdles: selecting appropriate preclinical species. Through a comparative analysis of immunological similarities and differences across species (speakers: Prakash Nagarkatti, University of South Carolina; Ana Goyos, J&J; Lars Madsen, Ellegaard Göttingen Minipigs; Ingrid Cornax, Altos Labs; Morteza Roogdar, Sanford University; Wendy Freebern, J&J), the course provided attendees with a more rigorous framework for interpreting immunotoxicology data and improving its relevance to human outcomes. The session underscored the importance of mechanistic understanding in bridging preclinical findings with clinical risk.

Complementing this, the symposium session “Rebuilding Immunity in the Lab,” co-chaired by Drs. Mark Collinge (Pfizer) and Chrissy Crute (HESI Global), highlighted the rapidly expanding role of complex in vitro models (CIVMs). The speakers (Emmanuela Corsini, University of Milan; Rebecca Pompano, University of Virginia; Lenie van den Broek, Mimetas; Lynn O’Donnell, Pfizer; Ronald Wange, Aclairo Pharmaceutical Development Group) demonstrated how these advanced platforms are reshaping immune function assessment and enabling more predictive, human-relevant approaches to immunosafety evaluation. Together, the two sessions reflected the ITC’s commitment to modernizing methodologies and addressing translational gaps in drug development.

 

 

The ITC continued its engagement at IMMUNOLOGY2026 in Boston, MA (April 2026), with a series of activities spanning scientific programming, knowledge exchange, and community outreach.

A central highlight was the HESI Global-sponsored symposium, “Bridging Immunology and Drug Safety: A New Paradigm,” chaired by Nikki Marshall (GSK) and Birgit Fogal (Sanofi), with contributions from Christina Sakellariou (Lund University) and Lizzie Geerling (FNIH). This session explored the evolution of immune safety as a cornerstone of public health and pharmaceutical development, tracing its roots from early immunotoxicology frameworks to its formalization through ICH S8 guidance. Speakers addressed how emerging therapeutic modalities, including immunotherapies and gene therapies, are introducing new complexities that challenge traditional safety paradigms.

 

The discussion emphasized the need for innovative approaches, including alternative methodologies and integrated strategies that bridge immunology and toxicology in regulatory submissions. Importantly, the session highlighted opportunities for harmonization and underscored the value of cross-functional collaboration and public–private partnerships in advancing immune safety science.

Further extending its impact, the ITC hosted an exhibitor session titled “One Target, Many Risks: Immunosafety Challenges from Mechanism to Medicine.” Featuring presenters Nikki Marshall (GSK), Danice Wilkins (CRL), and Tracey Papenfuss (StageBio), the session examined how a single immunotherapy can exhibit divergent safety profiles depending on disease context, mechanism of action, and patient population. Through real-world case studies, speakers illustrated how mechanistic immunology can be leveraged to identify immune “tipping points,” predict adverse responses, and inform safer therapeutic design. The session also highlighted opportunities for basic scientists to contribute directly to translational immune safety.

 

Throughout the meeting, Drs. Chrissy Crute and Shermaine Mitchell-Ryan hosted a HESI Global ITC booth in the exhibitor hall, which served as a hub for engagement, promoted ITC initiatives, and fostered potential new collaborations.

Across both conferences, a consistent theme emerged: immune safety is entering a new phase defined by increasing biological complexity, evolving regulatory expectations, and the need for integrative, mechanistically informed approaches. The HESI Global Immunosafety Technical Committee continues to play a pivotal role in shaping this landscape, driving innovation, enabling collaboration, and advancing science to better protect human health.

 

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