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英矽智能 · 官方新闻与管线·· 5 天前AI 评分22

ARDD 2026在哈佛举行:前沿AI、大型药企与科学先驱汇聚,长寿生物技术进入新阶段

ARDD 2026 Signals a New Era for Longevity Biotechnology as Frontier AI, Big Pharma, and Scientific Pioneers Converge at Harvard

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第13届衰老研究与药物发现(ARDD)会议于10月1—3日在哈佛大学David Rubenstein Treehouse举行,由Insilico Medicine创始人兼联合CEO Alex Zhavoronkov于2014年创办,此次为北美首秀。

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ARDD 2026 Signals a New Era for Longevity Biotechnology as Frontier AI, Big Pharma, and Scientific Pioneers Converge at Harvard

The convergence of frontier artificial intelligence, large-scale biological data, and pharmaceutical innovation is opening new possibilities for understanding human aging, predicting disease, and developing interventions that could extend healthy human lifespan. At the 13th Aging Research and Drug Discovery (ARDD) meeting, held October 1–3 at Harvard University’s David Rubenstein Treehouse, leaders from across biotechnology, global pharmaceutical companies, academia, and investment gathered to explore how these rapidly advancing capabilities are reshaping the future of longevity science.

Founded in 2014 by Alex Zhavoronkov, PhD, Founder and Co-CEO of Insilico Medicine, ARDD made its North American debut in Boston following years of growth in Europe. What began as an academically focused scientific gathering has evolved into a global forum connecting fundamental aging biology with the computational power, industrial capabilities, and investment needed to advance a new generation of longevity technologies.

This year’s discussions highlighted an emerging inflection point for the field: the ability to integrate high-dimensional biological data, generative AI, virtual cell models, and increasingly sophisticated experimental systems to investigate aging at a scale and level of complexity previously beyond reach. Rather than treating aging solely as a collection of individual diseases and biological mechanisms, researchers are developing new approaches to model interconnected biological processes, identify opportunities for intervention, and ultimately translate these insights into measurable improvements in human health.

“The convergence we witnessed at ARDD 2026 represents a remarkable moment for longevity biotechnology,” said Alex Zhavoronkov, PhD, Founder and Co-CEO of Insilico Medicine and Co-Chair of ARDD. “We are seeing frontier AI, increasingly sophisticated biological models, and unprecedented volumes of human data begin to converge with the scientific and industrial capabilities needed to act on these insights. From virtual cells and biological world models to next-generation therapeutics, we are moving toward a future where aging can be studied and potentially intervened upon with far greater precision. The opportunity extends well beyond any single drug or technology. We are witnessing the emergence of an entirely new scientific and industrial frontier.”

Regulatory Spotlight: From HHS Health Policy Shifts to FDA Function-Based Approvals

Longevity therapeutics have long moved beyond the lab, yet the market faces a stark reality: peptides, supplements, and biological age tests are marketed directly to consumers, most without passing rigorous clinical validation. In a landmark milestone for the conference, senior officials from the US regulatory took the stage for the first time, delivering high-level keynotes and leading panel discussions to map out an actionable regulatory framework for longevity therapeutics.

According to Admiral Brian Christine, Assistant Secretary for Health at the U.S. Department of Health and Human Services (HHS), health policy must shift from reactively treating individual diseases to proactively preserving health and extending healthspan. He emphasized that targeting the biology of aging provides a unique opportunity to delay multiple age-related conditions at once. Under the HHS "Make America Healthy Again" framework, the government aims to break down agency silos among the NIH, FDA, and CDC, fund rigorous clinical trials, develop predictive biomarkers for functional outcomes, and rapidly translate research into clinical practice.

Addressing the central challenge of measuring endpoints for therapeutics targeting multiple age-related declines at once, the FDA sent a delegation of four representatives, presenting a pragmatic stance that progress in longevity therapeutics does not hinge on defining aging as a disease; rather, validated, function-based endpoints and shared data are the true path forward. CDER drug evaluation leaders revealed that the FDA's upcoming Regulatory Science Priority Areas document will officially include "aging and longevity," which formally incorporates longevity into the agency's strategic priorities even though the timeline remains unannounced.

During the policy panel moderated by ARPA-H, CDER officials outlined two viable approval pathways: demonstrating efficacy across two or three distinct age-related diseases, or targeting a broad aging indication measured by composite endpoints across functional domains like cognition, frailty, and vision. Crucially, regulators emphasized a strict "evidence ladder" for biomarkers, clarifying that predictive markers are not surrogates until proven to respond to treatment, map to risk reduction, and reproduce across interventional trials. While fully validated surrogates support traditional approval, "reasonably likely" surrogates can unlock accelerated approval pathways backed by confirmatory trials.

As Steven Kozlowski, FDA Chief Scientist noted, identifying shared underlying mechanisms across multiple chronic diseases remains the primary goal, offering a roadmap built on robust, longitudinal human data rather than theoretical claims.

Big Pharma Leans In: Bridging Geroscience and Disease Indications Through Hard Clinical Data

Pharmaceutical executives and R&D leaders from the world's top global biopharmaceutical companies outlined a pragmatic entry point for longevity therapeutics: securing initial regulatory approval in a defined age-related indication while systematically gathering aging biomarker data along the way.

Fiona Marshall and Sophie Lemire-Brachat from Novartis noted that in addressing the clinical limitations of single-target regenerative therapies, Novartis is shifting its R&D strategy toward a systems-based approach centered on longitudinal human data (e.g., Data42, Our Future Health) and resilience biology, backed by a newly established Diseases of Aging and Regenerative Medicine department. Novartis emphasizes that its goal is not an "aging" approval, but rather to target specific aging-driven diseases and incorporate aging-relevant secondary or exploratory endpoints, while utilizing AI predictive models to balance efficacy against safety risks.

Parallel clinical and biomarker advances from Eli Lilly, Novo Nordisk, and AstraZeneca further illustrated how large-scale datasets are validating geroscience-derived interventions.

Eli Lilly’s Kevin Duffin and Ruth Gimeno highlighted sub-study data from the SURMOUNT-5 trial, where 72 weeks of the GLP-1/GIP dual agonist Tirzepatide favorably decelerated 26 epigenetic clocks alongside organ-specific biological ages across the heart, kidney, liver, and immune system. They distinguished targeted diseases with isolated risk factors from systemic conditions like obesity and idiopathic pulmonary fibrosis (IPF), which serve as living models of accelerated aging.

Novo Nordisk’s Alejandro Aguayo-Orozco and Maria Dermit presented pooled data from approximately 32,000 patients, showing semaglutide reduced major adverse cardiovascular events by 20%, kidney composite outcomes by 24%, and all-cause mortality by 18%, while significantly reducing proteomic organ-age scores. Dermit emphasized that legitimate longevity claims must remain anchored in hard functional outcomes, mortality, and validated clocks.

On the cell therapy front, Mark Cobbold of AstraZeneca introduced a novel genetic approach to defeat T- and NK-cell senescence by knocking out CDKN2A, CDKN2B, and MTAP on chromosome 9p. This triple knockout enables up to a 1020-fold donor-cell expansion without compromising safety or efficacy, paving the way for scalable, off-the-shelf allogeneic CAR-T therapies in autoimmune and age-related indications.

Broader contributions from Pfizer, GSK, Boehringer Ingelheim, and Moderna further reinforced a unified industry focus on the cardiometabolic-renal-neuro axis, immune aging, and genomic healthstacks.

Pioneering Geroscience: Harvard, Stanford, and Leading longevity institution Redefine Aging Therapeutics

Academic researchers from leading institutions presented pioneering modalities spanning transcriptomics, systemic organ crosstalk, single-cell clocks, and multi-gene interventions. Vadim Gladyshev of Harvard Medical School introduced cross-species transcriptomic clocks predicting biological age and time-to-death. His heterochronic heart transplant studies demonstrated that young hearts in old hosts age faster while old hearts in young hosts rejuvenate, offering a rationale for utilizing older donor organs and modeling aging as systemic biological states. George Church of Harvard highlighted multiplex gene therapies, machine-learning-engineered viral vectors featuring 280-fold enhanced brain delivery, late-life OSK administration, and 69-edit pig organ xenotransplantation currently in FDA-cleared trials. Meanwhile, David Sinclair of Harvard detailed newly identified NAD-consuming cellular structures driven by PARP14, OSK gene therapy trials in ocular diseases, OSK-mediated cancer re-differentiation, and the chemical cocktail SL100, which extended mean lifespan by 25% in progeroid mouse models.

Parallel scientific sessions underscored the diagnostic and therapeutic potential of cellular, spatial, and companion animal models. Morten Scheibye-Knudsen of the University of Copenhagen demonstrated that facial photography and cell-morphology classifiers predict survival and disease risk, while introducing "Drug F"—a small molecule that triggers DNA-damage signaling without inducing genetic damage, reversing senescence and rescuing cognitive and motor deficits in Alzheimer’s mouse models. Tony Wyss-Coray of Stanford University showed that cell-type-specific plasma proteomics can forecast disease, identifying astrocyte age as the strongest cellular predictor of Alzheimer’s risk and skeletal muscle cell age as the top predictor of overall mortality. Furthermore, Dan Promislow of Tufts University and Steve Horvath of UCLA presented companion animal cohorts and veterinary methylation clocks as accelerated translational proving grounds, while Harvard’s Omar Abudayyeh and MIT’s Eric Sun leveraged AI co-scientists and spatial transcriptomic clocks to identify non-pluripotent rejuvenation factors and spatial cell-cell signaling dynamics.

Capital & Ecosystem Convergence: VC Insights and Cross-Industry Coalitions Accelerating the Longevity Market

During the investor panel moderated by the Financial Times, leading venture capitalists agreed that AI is driving a "golden age" of biotech innovation, but investors increasingly favor proprietary data and practical applications over pure software, amid rising low-cost competition. Jim Flynn, Managing Partner at Deerfield, emphasized a "data-first strategy empowered by software," identifying proprietary data as the true competitive moat. Alfredo Viegas, Managing Director at Oaktree Capital, noted that China is becoming the "Costco of biotech," licensing molecules at a fraction of U.S. costs, while Flynn added that U.S. biotechs can combine university-sourced targets with licensed Chinese assets. Kan Chen, Partner at Qiming Venture Partners, called GLP-1 drugs the "first longevity medicine" that is clinically legitimate, adding that longevity investments are increasingly anchored in acute or orphan indications.

Meanwhile, the lineup of sponsors and partners at ARDD 2026 highlights an unprecedented global cross-industry convergence around the longevity theme. On one front, the heavy presence of top-tier global biopharma leaders—including Eli Lilly, AstraZeneca, AbbVie, and Novo Nordisk—demonstrates mainstream pharma's deep commitment and strategic leap into geroscience and longevity therapeutics. Concurrently, pioneering longevity-focused companies like BioAge continue to reinforce the domain with robust mechanistic research and innovative pipeline development. Equally striking is the active participation of cross-industry giants such as Nestlé, Dior, and Estée Lauder, who are expanding the boundaries of geroscience into specialized nutrition, skin longevity, and holistic health management. By bridging the gaps between big pharma, longevity biotechs, and consumer wellness leaders, this powerhouse ecosystem is redefining the future of healthcare and accelerating a multi-trillion-dollar longevity market.

From Bench to AI Virtual Cells: How Insilico Medicine Is Bridging Clinical Success with Next-Gen Biological Simulation

Insilico Medicine featured prominently across both the main stage and the AI in Drug Discovery and Virtual Cell forums, showcasing a robust pipeline running from AI theory to clinical validation. During his mainstage presentation, Alex Zhavoronkov framed longevity therapeutics as a multi-trillion-dollar industry and advocated for a dual-purpose commercial strategy: selecting targets shared by aging biology and severe age-related diseases, securing regulatory approval in a defined indication where standard-of-care can be beaten, and subsequently expanding into broader longevity applications. He highlighted Rentosertib (currently advancing to Phase 3 in idiopathic pulmonary fibrosis), which yielded a 98 mL increase in forced vital capacity over 12 weeks in a Phase 2 high-dose cohort, reversed 758 aging-associated protein trajectories in UK Biobank data, and produced a 3 to 6 year reduction in biological age after 4 weeks of dosing according to independent clock evaluations. Zhavoronkov also noted that Insilico reached profitability in H1 2026 with 34 developmental candidates nominated to date, emphasizing that fine-tuned domain-specific models like PreciousGPT consistently outperform broad frontier LLMs on biological tasks.

In the Virtual Cell forum, Petrina Kamya, Global Head of AI Platforms at Insilico Medicine, presented the company's Virtual Aging Cell simulation framework. Built upon 12 years of proprietary data and benchmarking, the Virtual Aging Cell operates as a multi-agent system spanning five biological scales, including molecular, intracellular, intercellular, tissue/organ, and organism levels. The system utilizes approximately 43 specialized AI agents per biological layer to simulate post-intervention cell state transitions against patient-seeded baseline graphs. Kamya emphasized that prospective validation in Insilico’s fully automated robotic laboratory—testing novel molecules with unknown mechanisms—is currently being executed to rigorously validate predictions and rule out literature memorization.

来源:英矽智能 · 官方新闻与管线 · insilico.com