Hanie Yousefi, PhD, MSc

Bold solutions for complex health problems: ARPA-H is transforming biomedical research through its high-risk, high-reward approach and industry partnerships   The Advanced Research Projects Agency for Health (ARPA-H) is redefining how our country tackles some of the toughest health challenges by: • Implementing unique and beneficial R&D processes for industry • Proactively reaching out to industry to identify possible partners and tech required   Modeled after DARPA, ARPA-H was established in 2022 to accelerate biomedical breakthroughs through bold, high-risk, high-reward research initiatives.   𝗪𝗵𝗮𝘁 𝗠𝗮𝗸𝗲𝘀 𝗔𝗥𝗣𝗔-𝗛 𝗨𝗻𝗶𝗾𝘂𝗲? • Streamlined application process • Milestone-driven funding • Partnerships with non-traditional vendors to rapidly catalyze innovation • Investments also extend into biomanufacturing (to increase access, reduce costs, strengthen supply chains)   𝗔𝗥𝗣𝗔-𝗛’𝘀 𝗠𝗶𝘀𝘀𝗶𝗼𝗻 𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀 • 𝗣𝗶𝗼𝗻𝗲𝗲𝗿𝗶𝗻𝗴 𝗥𝗲𝘀𝗲𝗮𝗿𝗰𝗵: From molecular advancements to societal health solutions, ARPA-H invests in cutting-edge tech that push boundaries and remove barriers to healthcare innovation. • 𝗦𝘁𝗿𝗲𝗮𝗺𝗹𝗶𝗻𝗲𝗱 𝗙𝘂𝗻𝗱𝗶𝗻𝗴: Flexible contracts and milestone-driven funding ensure efficient use of resources while fostering collaboration with non-traditional vendors (e.g., small companies). • 𝗘𝗾𝘂𝗶𝘁𝘆 𝗶𝗻 𝗔𝗰𝗰𝗲𝘀𝘀: Initiatives like Advancing Clinical Trial Readiness aim to bring clinical trials within reach of 90% of eligible Americans, ensuring equitable access to life-saving treatments. • 𝗙𝗼𝗰𝘂𝘀 𝗼𝗻 𝗨𝗻𝗱𝗲𝗿𝘀𝗲𝗿𝘃𝗲𝗱 𝗔𝗿𝗲𝗮𝘀: Programs such as the "Sprint for Women’s Health" address critical gaps in funding and research for women’s health conditions.   𝗣𝗿𝗼𝗮𝗰𝘁𝗶𝘃𝗲 𝗢𝘂𝘁𝗿𝗲𝗮𝗰𝗵 𝗘𝘅𝗮𝗺𝗽𝗹𝗲 An ARPA-H Program Manager recently reached out to the CEO of one of our Clients to discuss use cases for their MedTech platform.  in-depth discussion focused on the platform and potential partnership opportunities if a program is implemented. This exemplifies ARPA-H's approach reaching out to industry to discover the teams and tech that pushes the bold, high-risk and high reward outcomes forward.   The agency’s focus on solving urgent health problems — chronic diseases, antimicrobial resistance, mental health crises, pandemic preparedness, and others — has the potential to transform lives. I am excited to see how ARPA-H continues to build.   To stay up to date on all things MILMED R&D, join our MILMED Connect Funding Insider newsletter >> Link in the comments

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Postdoctoral scholar Bibekananda Sahoo’s research on Ninjurin proteins was recently published in the journal Cell. His work uses cryo-electron microscopy to investigate protein structures central to many human diseases and to advance structure-based drug discovery. https://lnkd.in/gJbqHsKv

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This new review in Nature Communications shows how advances in #biomonitoring could help close some of the most persistent evidence gaps in #women’s #healthresearch. Authored by Shaghayegh Moghimi, Lubna Najm, MASc, PMP, Wei Gao, Tohid Didar and colleagues, the paper offers one of the most comprehensive looks at how #biosensing, #wearables, and #digitaldiagnostics can transform women’s health research. For decades, most health technologies have been designed and validated primarily in men. As a result, conditions that affect women—ranging from menstrual and fertility disorders to menopause and chronic diseases—remain understudied and underdiagnosed. This review highlights how new technologies can help close that gap. 💡 ⌚ Wearable and biosensing devices. New generations of sensors are smaller, softer, and better aligned with female physiology. Examples include ovulation-tracking wristbands, sensor-enabled “smart bras” that can detect early breast tissue changes, and noninvasive patches that monitor uterine contractions or fetal health. Some emerging prototypes even track bone density or hormone fluctuations through skin-mounted sensors, allowing for continuous, participant-driven data collection. 🧪Point-of-care and home diagnostics. Portable, low-cost tests using colorimetric or molecular detection (such as loop-mediated isothermal amplification, or LAMP) are expanding access to screening for infections and reproductive conditions. These rapid tests could enable earlier and more equitable diagnosis in both clinical and community settings. Limitations and next steps. The authors note that progress will depend on standardization, validation, and thoughtful integration into healthcare systems. Data quality remains a major barrier. Many devices and algorithms still rely on incomplete or biased datasets that fail to capture the biological and environmental variability across women’s lives. Ensuring that digital health tools are developed with representative, sex-specific data is essential if they are to improve outcomes rather than reproduce existing inequities. Open Access Paper 🔗 https://lnkd.in/dA5GHXua At GSD Health Research, we see this as the central challenge and opportunity for the field. Capturing high-quality, real-world data that reflect the full spectrum of female biology is how we can move from promising prototypes to meaningful clinical impact. #womenshealth #digitalhealth #clinicalresearch

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NAMs catalyst - NIH Establishes Standardized Organoid Modeling Center On September 25, NIH announced the award of contracts for launching the Standardized Organoid Modeling (SOM) Center, a national resource that will be dedicated to using cutting-edge technologies to develop standardized organoid-based NAMs that deliver robust, reproducible, and patient-centered research findings. With contracts totaling $87 million for the first three years, the center will be housed at the Frederick National Laboratory for Cancer Research, a facility supported by NIH’s National Cancer Institute. The center’s goal will be to leverage the latest technologies to enable real-time optimization of organoid protocols. The complete NIH announcement is available at https://lnkd.in/eSjTYWeA. The NIH SOM Center is designed to support a wide array of users, including scientists and researchers from academic institutions, industry, and government; clinicians in need of patient-specific models; and the broader scientific community, including industry partners and educators. It will provide open access to protocols, data, and organoids, promoting global collaboration. The center will also work with regulatory bodies, including FDA, to develop models that meet preclinical testing standards, accelerating development of new disease treatments and safety assessments. The center will initially focus on organoid models of the liver, lung, heart, and intestine, with plans to expand to additional organ systems and disease-specific models.

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FDA's Makary and Prasad have acknowledged America's lagging early clinical trial ecosystem, as Australia and China make advances. The recognition most recently came at the agency's listening tour stop in Boston this week. Industry execs proposed a number of ways the US could make up for lost ground. Those details and more in in our Endpoints News exclusive: https://lnkd.in/efYrHYjK #Biotech #FDA #DrugDevelopment #Innovation #ClinicalTrials #China

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Department of Biotechnology notifies User Access policy for DBT-BIRAC Biofoundries & Biomanufacturing Hubs established at academia/research institutions/industries under the #BioE3 Policy to provide pilot and pre-commercial scale-up support to researchers, start-ups and innovators across the country for bio-product development. This is expected to strengthen the Make-in-India in the biotech sector. Read policy: https://lnkd.in/eHnDSAk8 #Biomanufacturing #GreenGrowth #DBTIndia Dr Jitendra Singh Rajesh Gokhale

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Our CSO, Timothy rolph, has co-authored a new article in the Journal of Hepatology , highlighting the impact of FGF21 on a novel signaling pathway implicated in MASH. The original research by Liu, Wei, Jiang and colleagues reveals how FGF21 inhibits mTORC1, a key regulator of metabolism, to help clear liver fat by stimulating autophagy, a vital cellular clean-up process. FGF21 is also known to enhance insulin sensitivity which would be expected to inhibit autophagy. The novel signaling pathway described by Liu et al could explain the conundrum of how FGF21 is simultaneously able to increase autophagy and insulin sensitivity. Our investigational therapy, efruxifermin (EFX), and other FGF21 analogs have shown clinically significant reductions in liver fat and resolution of steatohepatitis. The work described in this editorial expands our understanding of FGF21's direct actions on hepatocytes, offers valuable insights into the therapeutic mechanisms of these emerging MASH treatments, and paves the way for further investigation into these pathways. Learn more: https://lnkd.in/gEpnHYuP #MASH #FGF21 #Hepatology #EFX #DrugDevelopment

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CLS' President and CEO Mike Guerra testified in the most recent Select Committee on Biotechnology and Medical Technology regarding the impact of NIH funding cuts to California's dynamic life sciences ecosystem. The immediate and long-term impacts of proposed NIH cuts to our academic research institutions will cause irreparable harm to life-saving biomedical research and the world-renown talent pipeline that makes California's life sciences ecosystem the most productive innovation hubs in the world. While the life sciences industry is a resilient and robust sector, especially in California, slashing NIH funding cuts compromises the very foundations of biomedical research that is the lifeblood of the entire ecosystem.   “If one link in the biomedical innovation chain breaks as a result of funding cuts we are in serious trouble, we do not have the infrastructure and ability to continue the cycle without stable funding,” Mike shared yesterday.

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🥰😍WOMEN ON A MISSION TO CURE ARTHERITIS WOW! Stanford Medicine researchers led by Dr. Helen Blau and Dr. Nidhi Bhutani have identified a method to reverse cartilage loss in arthritis by targeting a protein called a "gerozyme". Their 2025 research suggests that blocking this protein can regenerate cartilage in both mouse and human tissues. Recent breakthroughs by researchers, particularly at Stanford Medicine and in studies from Australia, have shown that inhibiting specific "gerozyme" proteins can reverse cartilage loss and regenerate joint tissue in mice and human tissue. These findings, including new injectable cell therapies and "smart gels," offer potential for reversing osteoarthritis, rather than just managing symptoms, with human trials for some methods either planned or underway. https://lnkd.in/eet9PPqS

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Wei Yang joins SMART after a postdoc with David Baker University of Washington - School of Medicine Institute for Protein Design, University of Washington. He develops computational protein-design methods to create next generation binders for immune checkpoint receptors and therapeutics with reduced systemic toxicity. At SMART, his team integrates algorithm development with high-throughput experimental validation to deliver more selective protein therapeutics.

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🧪 Causal mediation remains my favorite tool to uncover hidden mechanisms. In our latest study, using the Bangladesh Vitamin E and Selenium Trial cohort in rural Bangladesh, we combined weighted quantile regression (WQS) with the parametric mediational g-formula to understand how socioeconomic status (SES) influences the risk of elevated blood pressure through metal mixture exposures. 📊 Our earlier research showed higher SES groups face more hypertension & diabetes in Bangladesh. This study explored why: 📚 Higher education ➡️ ↑ BP 🌾 Land ownership (SEP) ➡️ ↓ BP ⚠️ Both lowered toxic metals (lead, selenium, arsenic), which mediated up to 89% of the SEP effect on BP measures. 🌍 Key message: SES–BP disparities in LMICs are not just social, they’re environmental. Reducing disparities in metal exposures may mitigate the SES-related burden of high BP in LMICS. You can read our preprint version: https://lnkd.in/eTn4EmPU #Epidemiology #CausalInference #MediationAnalysis #PublicHealth #EnvironmentalHealth #Bangladesh #HealthEquity

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Lightfinder (Diana Mojahed, PhD), an MIT spinout, is transforming pathology diagnostics by developing a silicon chip–based imaging system capable of fast, accurate, cellular-level resolution. This next-generation platform aims to dramatically improve diagnostic accuracy while reducing turnaround times, costs, and workload in pathology labs. By addressing the limitations of traditional diagnostic tools, Lightfinder’s innovation offers a powerful solution for improving patient care and expanding access to high-quality diagnostics across healthcare systems. This breakthrough is supported by the National Science Foundation (NSF) through its SBIR Phase I program (seedfund.nsf.gov), helping to de-risk the core technology and accelerate its path to market. The project focuses on refining the chip-based imaging architecture, validating its performance across real-world pathology use cases, and building a foundation for scalable manufacturing. With pathology laboratories identified as the first market segment, Lightfinder’s approach is positioned to deliver measurable commercial impact, while advancing the NSF’s mission to promote scientific innovation and improve national health outcomes. #SeedtheFuture #SBIR #STTR #innovation https://lnkd.in/gphQPts3 https://lnkd.in/gupvds77.

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