The American College of Rheumatology (ACR) Convergence 2025, the world’s premier rheumatology experience, will take place October 24–29 in Chicago, Illinois. This year’s program offers a unique opportunity for clinical trial professionals and CRO teams to gain insights into protocol design, operational execution, and regulatory strategy in autoimmune research. Below is a curated list of sessions selected for their clinical development relevance, scientific depth, and potential to shape the future of autoimmune trial execution.
Designing and Executing Clinical Trials: irAEs and CAR-T for Autoimmunity
📅Saturday, October 25, 2025
Drs. Laura Cappelli, Xavier Mariette, and Marcela Maus will share insights on the evolving role of CAR-T cell therapy in autoimmune diseases and the challenges posed by immune-related adverse events (irAEs) in clinical trial design.
2025 ACR Guideline for the Treatment of Systemic Lupus Erythematosus
📅Sunday, October 26, 2025
Drs. Bonnie Bermas, Jennifer Grossman, Maria Dall’Era, Mary Beth Son, Grant Louie, Anca Askanase, May Choi, Lisa Sammaritano, Ali Duarte-Garcia, Victoria Werth, and Linda Hiraki will present the 2025 ACR extrarenal systemic lupus erythematosus (SLE) guideline, developed through a structured review of key clinical questions and a systematic literature analysis. The session will explain how the guideline was developed, outline the ACR’s recommendations for treating lupus based on specific organ systems, and demonstrate how to apply these recommendations in clinical practice. Through case-based examples, the speakers will also address childhood-onset lupus.
The New Rules of the Road: An Update on CAR-T-Mediated Immune Reset for SLE
📅Sunday, October 26, 2025
Drs. Saira Sheikh, Sarfaraz Hasni, DeAnna Baker Frost, Anca Askanase, Joan Merrill, and Maximilian Konig will discuss the biology behind CAR-T-mediated B cell immune reset and recent developments in the field. The session will cover different CAR-T approaches, autologous, allogeneic, and various B cell targets, and share interim results from ongoing trials in diseases like SLE, scleroderma, myositis, and ANCA-associated vasculitis.
Sponsoring Women and Underrepresented Minorities in Team Science and Clinical Practice
📅Sunday, October 26, 2025
Drs. DeAnna Baker Frost, Karen Kruzer, Elizabeth Volkmann, Sheetal Desai, Edith Williams, and Paula Ramos will explore ongoing disparities in research and academic medicine, focusing on women and underrepresented minorities. The session will offer practical strategies to improve representation in clinical trials and support career advancement, with an emphasis on designing studies that address gender and racial/ethnic disparities in autoimmune diseases.
Designing Stronger Clinical Trials: Choosing the Best Comparator for Impactful Results
📅Sunday, October 26, 2025
Drs. Daniel White, Joshua Stefanik, Rana Hinman and Elena Losina will explore how to choose the right comparator in behavioral intervention trials, especially in rheumatology. The session will look at the pros and cons of placebo vs. active treatment comparators and offer practical guidance using real-world examples to help improve trial design and relevance.
BiTE the Dust: T Cell-Engaging Antibody Therapies to Eliminate Autoreactive Immune Compartments in Rheumatic Diseases
📅Monday, October 27, 2025
Drs. Roberto Caricchio, Anca Askanase and Lorenzo Falchi will review emerging data on T-cell engagers (TCEs) in systemic autoimmune diseases. The session will cover the rationale behind these therapies, current trial designs, and what evidence is still needed before broader clinical adoption.
The Great AI Debate: Unlocking Potential or Unleashing Chaos?
📅Monday, October 27, 2025
Drs. Alvin Wells, Priya Reddy, Jeffrey Curtis and Jinoos Yazdany will introduce how large language models (LLMs) and AI tools are being used in clinical practice. The session will cover techniques to improve LLM outputs and present both the benefits and challenges of using AI in rheumatology through a debate format.
FDA Update
📅Tuesday, October 28, 2025
Drs. Raj Nair, Michael Weisman, Gregory Gardner and Anam Tariq will provide updates on newly approved therapies and indications in rheumatology, including CAR-T and multi-specific treatments. The session will also address emerging safety concerns and the U.S. Food and Drug Administration (FDA) considerations around newer immune therapies.
Pediatric Rheumatology FDA Updates
📅Wednesday, October 29, 2025
Drs. Pui Lee, Jessica Neely and Emily Gotschlich will discuss the FDA’s role in ensuring safe and effective treatments for pediatric rheumatic diseases. The session will highlight recent drug approvals, the growing presence of biosimilars and interchangeables, and the challenges in developing new therapies for children.
About the Author
Dr. Ovalles is the Senior Director of Rheumatology at Indero, providing medical leadership and strategic guidance in rheumatology research. He collaborates with business development, supports operational and regulatory teams, and builds relationships with key stakeholders. With over 12 years of clinical development experience, he began his career as an investigator in 2012 and transitioned to the CRO industry in 2021. A board-certified rheumatologist with a PhD in biomedical sciences, he specializes in innovative therapies for immune-mediated inflammatory diseases.
