The Senotherapeutics Biomarker Consortium (SBC) is a precompetitive, international initiative to harmonize senescence biomarkers and accelerate the clinical translation of senotherapeutics.
The Senotherapeutics Biomarker Consortium is a multistakeholder initiative spanning academia, biotechnology, pharmaceutical companies, and regulatory agencies. It was announced at the 2nd SenoTherapeutics Summit and the 10th Annual Meeting of the International Cell Senescence Association (ICSA) — a 4-day event co-organized by the Phaedon Institute and ICSA in Rome, September 2025.
The SBC is coordinated under the umbrella of the Phaedon Institute and operates through a shared governance structure of topic-specific working groups, ensuring tridirectional exchange between discovery science, translational development, and regulatory considerations.
Guiding Principles
Phaedon Institute is also pleased to announce the inaugural Senotherapeutics Biomarker Consortium Summit on December 7th, 2026 at Stanford University.
The science of cellular senescence has advanced rapidly. Senescent cells — characterized by stable proliferative arrest, unresolved DNA damage, and a complex secretory phenotype — accumulate with age and drive chronic inflammation, tissue dysfunction, and a wide range of age-related diseases.
Senotherapeutics, interventions that eliminate, modulate, or prevent the detrimental effects of senescent cells, represent a compelling class of therapies. Yet clinical translation remains limited. Assays differ across laboratories and disease contexts. No universally validated biomarkers exist. Regulatory consensus on acceptable endpoints is absent.
Therapeutic concepts are being proposed faster than the tools to measure, compare, and regulate senescence in humans are being developed. The SBC was founded to close that gap.
Four interconnected objectives span discovery, validation, and clinical translation.
1. Biomarker Development & Harmonization: Establish and validate a multimodal panel of senescence biomarkers — molecular, histological, imaging, and functional — through multicenter cross-validation and standardized protocols.
2. Data Sharing & Integration: Develop a FAIR (findable, accessible, interoperable, reusable) data infrastructure enabling comparison of senescence-associated signatures across models, tissues, diseases, and technologies. AI-assisted platforms will support harmonization, meta-analysis, and predictive modeling.
3. Regulatory Science Engagement: Coordinate structured interactions with the FDA and EMA to define acceptable biomarkers, surrogate endpoints, and clinical trial templates for senescence-targeting interventions.
4. Capacity Building, Standards & Best Practices: Produce community-endorsed white papers, assay standards, and training modules to support reproducibility and disseminate evolving consensus guidelines field-wide.
| Year | Milestones |
|---|---|
| 2026 |
Consortium launch and governance establishment
Selection of initial biomarkers and assays
Creation of working groups
|
| 2027 |
Multicenter validation studies
Establishment of a shared biorepository
Initial FDA & EMA workshops on assay qualification
|
| 2028 |
Biomarker qualification packages
Draft adaptive clinical trial templates
Integration of multiomics datasets across participating centers
|
| 2029 |
Surrogate endpoint proposals submitted to regulators
Initiation of harmonized early-phase clinical trials
Field-wide dissemination of new senescence detection standards
|
The SBC pursues eight interconnected mission areas that define the scientific scope, collaborative culture, and long-term ambitions of the consortium.
Define the molecular, functional, and microenvironmental diversity of senescent cells across tissues, disease contexts, and interventions.
Identify and validate biomarkers capturing cellular heterogeneity and context dependence, progressing them toward clinical and regulatory relevance.
Develop standardized protocols and assay guidelines to improve reproducibility and cross-study comparability.
Foster multiomics, imaging, and clinical data integration across institutions to support comparative analyses and hypothesis generation.
Refine and cross-validate in vitro, ex vivo, and in vivo models that better capture senescence dynamics in human disease.
Engage early and continuously with regulatory agencies to define acceptable endpoints, trial templates, and qualification pathways.
Stimulate precompetitive partnerships across academic groups, biotechs, pharmaceutical companies, technology developers, and regulators.
Provide training, workshops, and white papers to empower the next generation of senescence researchers and translational scientists.
The SBC is designed to complement, not replace, existing international efforts.
Shared governance and co-organization of scientific meetings
Alignment with published senescence detection guidelines developed through the NIH Common Fund.
Engagement with the fundamental senescence research community and early-career scientists across Europe.
Bidirectional exchange on biomarker discovery, validation, and regulatory science — acknowledging that senescence is one of multiple mechanisms driving biological aging.
The SBC builds on existing published guidelines from SenNet and the Biomarkers of Aging Consortium, extending them toward regulatory qualification and clinical implementation.
Participation is open to academic laboratories, biotechnology companies, pharmaceutical partners, technology providers, and regulatory scientists who contribute assays, datasets, computational tools, or domain expertise — or who are interested in collaborative validation and regulatory science.
The SBC is led by committee of leading scientists spanning academia, biotechnology, and pharmaceutical research — united by a shared commitment to advancing the clinical translation of senescence biology.
The SBC was formally announced in Nature Aging (2026) by Marco Quarta, Nicola Neretti, Heinrich Jasper, and Marco Demaria — outlining the consortium’s mission, structure, and strategic roadmap for senescence biomarker harmonization.
