2025 SAPA-NE Symposium Spotlights Human-Relevant Models Transforming Drug Discovery

Cambridge, MA — SAPA-NE convened its 2025 scientific symposium, “Advancing Translational Sciences via Human-Relevant Models in Drug Discovery & Development,” at Sanofi’s Cambridge campus (450 Water St.) on Oct 4th, 2025. The program assembled leaders from pharma and academia for a deep dive into new approach methodologies - including organoids, microphysiological systems (MPS), and ex vivo platforms designed to bridge the translation gap from lab to clinic while reducing reliance on animal models.

On October 27, 2025, a Fierce Biotech report described what it calls the first FDA IND approval in oncology based solely on efficacy data from human vascularized organoids—an inflection point for human-relevant preclinical testing under FDA Modernization Act 2.0. Fierce Biotech This milestone squarely reinforces our symposium’s theme that organoids, MPS, and ex vivo platforms are moving from promise to regulatory impact.

Organizers reported close to 150 attendees, with full Saturday support from Sanofi’s External Innovation Global R&D team, and Operations and Security team.  Their exceptional weekend support ensured seamless registration, logistics, and site access. SAPA-NE also acknowledged ABclonal as the event sponsor.

Leadership and conveners

SAPA-NE President Yue-Mei Zhang opened the meeting and set the stage with a focus on human-relevant approaches to accelerate patient impact.  SAPA-NE Secretary General Hong Liu moderated the first session and the capstone panel discussion. After the break, SAPA-NE President-Elect Kejie Li kicked off the second half. SAPA-NE EC member Tracy Zhang (Sanofi) and former SAPA-NE President James Cao (Sanofi) moderated the second session. The symposium concluded with closing remarks from Immediate Past President Huijuan Li.

What the experts said

Sanofi’s translational priorities

Srinivas (Srini) Rao, Ph.D., MBA (Sanofi R&D US Lead; Global Head, Translational Models Research Platform). In his opening remarks, Srini delivered a compelling presentation on the transformative role of human organoids and advanced in vitro models in biopharma innovation. He addressed a key industry challenge: the limited clinical translatability of traditional animal-based research, which often fails to predict human outcomes accurately.  To overcome this, he introduced cutting-edge alternatives such as organoids, MPS, and other NAMs, emphasizing their superior human relevance for mechanistic insights, pharmacological profiling, and toxicological evaluation.  Srini also highlighted the ethical advantages of reducing animal testing, alongside growing regulatory support for these methodologies. His talk concluded with an inspiring call to action: urging the scientific community to collaborate, standardize protocols, and build regulatory confidence to fully unlock the potential of these models in accelerating drug R&D for patients worldwide.

MPS adoption and regulatory engagement

Jason Ekert, Ph.D., MBA (Head of US Neuromuscular Translational Biology, UCB) detailed internal adoption of MPS and the IQ MPS affiliate’s regulatory work, including efforts to align on performance standards. He showcased a neuromuscular junction model and a muscular dystrophy muscle on a chip model used to interrogate disease mechanisms and assess therapeutic interventions—illustrating where well-characterized in vitro systems can complement or replace animal studies.

A “mini-brain” with a functional BBB

Alice Stanton, Ph.D. (Harvard Medical School) presented an integrated human mini-brain that combines neurons, astrocytes, oligodendroglia, microglia, endothelial cells, and pericytes within a defined Neuromatrix hydrogel. Data showed mature neuronal activity/connectivity (MEA, calcium, optogenetics), myelination, homeostatic microglia, and a lumenized, functional BBB on a GelChip with tunable flow and size-dependent permeability. The team modeled genotype-specific disease features (e.g., APOE4 amyloid/tau, astrocytosis, oxidative stress) and demonstrated neurovascular coupling. Use cases span efficacy, safety, delivery, neurotoxicity, inflammation, BBB transport, and remyelination—paired with a call to scale throughput, standardize QC, and link readouts to clinical outcomes.

Precision-cut lung slices to de-risk lung-disease targets

Hae Jin Kim, Ph.D. (Eli Lilly) introduced the ex vivo Precision-Cut Lung Slice (PCLS) platform across animal and human tissues. By preserving native architecture and multicellular interactions, PCLS enables controlled perturbations and translational readouts in airway and parenchymal biology. Forthcoming expansions include immune co-cultures, live imaging, and 3D modeling to sharpen mechanistic insight and de-risk targets earlier.

Lymphatics-on-chip for subcutaneous mAb absorption

Adriana Martinez Ledo, Ph.D. (Novartis) discussed a lymphatic absorption model designed to rank-order subcutaneous absorption of monoclonal antibodies. She compared the % transport on-chip versus SC bioavailability in human across 9 mAbs. The good in vitro-in vivo correlation underscored the model’s potential as a predictive discovery tool, with implications for de-risking late-stage formulation development. Adriana highlighted the technical complexity of the model and the opportunities for future refinement.

Organoids: promise and remaining problems

Dinesh Bangari, Ph.D. (Head of Global Discovery Pathology & Multimodal Imaging, Sanofi) reviewed Sanofi’s organoid research, with particular emphasis on chronic respiratory diseases (e.g., asthma, COPD). Case examples included air-liquid interface cultures and AI-assisted analysis. He noted the rapidly expanding vendor landscape and underscored the need for rigorous quality, standards, and collaboration to translate organoid insights into earlier, better decisions.

Panel: from standards to culture change

Moderated by Hong Liu, the panel brought together Rao, Ekert, Xiao Shelley Hu, Stanton, Martinez Ledo, Kim, and Bangari. Discussion centered on the limits of animal models, the growing role of validated non-animal alternatives, regulatory expectations, and the culture shift needed to integrate AI/digital twins with traditional and emerging platforms. Participants stressed that cross-sector collaboration and shared benchmarks are essential to earn regulatory trust and clinical relevance.

Why it matters

Across talks and Q&A, three messages dominated:

1. Human-relevant platforms are maturing—organoids, MPS, and ex vivo systems now produce richer, clinically meaningful readouts and are increasingly part of regulatory conversations.

2. AI and digital tools amplify signal—but make standardization, QC, and reproducibility non-negotiable.

3. Alignment beats silos—industry, academia, and consortia must converge on performance standards to speed safer, more predictive medicines.

Acknowledgments: SAPA-NE thanked ABclonal for its sponsorship, Sanofi for hosting the event, Special thanks were extended to External Innovation Global R&D team, and Operations and Security team, for their exceptional weekend support. With strong turnout and substantive discussions, the symposium underscored accelerating momentum for human-relevant science on the path to patients.