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The Architectural Turn in Depression Why Network Topology Will Redefine CNS Strategy

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  By Denis Katz, MD, MHA Founder, Salience Clinical For decades, psychiatry has framed major depressive disorder (MDD) as a disorder of chemistry, an imbalance of serotonin, norepinephrine, or dopamine. That model produced meaningful therapeutic advances, yet it has not consistently delivered durable remission for a substantial proportion of patients. Roughly one-third remain treatment resistant, and among responders, relapse is common. Incremental modulation of synaptic signaling alone appears to have reached a ceiling in its ability to transform long-term outcomes at scale. The next shift in neuropsychiatry will not be chemical. It will be architectural. By “architectural,” we mean the topology, coupling, and switching behavior of large-scale brain networks that shape how information is processed. From neurotransmitters to networks Advances in high-resolution functional MRI, multimodal imaging, and computational modeling over the past decade have transformed our unde...
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The Architectural Turn in Depression Why Network Topology Will Redefine CNS Strategy

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The Architectural Turn in Depression Why Network Topology Will Redefine CNS Strategy By Denis Katz, MD, MHA Founder, Salience Clinical, LLC For decades, psychiatry has framed major depressive disorder (MDD) as a  disorder of chemistry , an imbalance of serotonin, norepinephrine, or dopamine. That model produced meaningful therapeutic advances, yet it has not consistently delivered durable remission for a substantial proportion of patients. Roughly one-third remain treatment resistant, and among responders, relapse is common. Incremental modulation of synaptic signaling alone appears to have reached a ceiling in its ability to transform long-term outcomes at scale. The next shift in neuropsychiatry will not be chemical. It will be architectural. By “architectural,” we mean the topology, coupling, and switching behavior of large-scale brain networks that shape how information is processed. From neurotransmitters to networks Advances in high-resolution functional MRI, multimodal imagi...
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Biomarker Strategy for Musculoskeletal Regenerative Medicine

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Biomarker Strategy for Musculoskeletal Regenerative Medicine A Market on the Brink of Transformation Musculoskeletal regenerative medicine is approaching a commercial inflection point. What was once a speculative frontier cell therapies, bioengineered scaffolds,  gene-modified constructs  is now advancing first-generation clinical programs. But clinical promise alone doesn’t win regulatory approval or payer adoption. Success depends on demonstrating early, mechanistically meaningful, and durable signals of efficacy. That’s why a fit-for-purpose biomarker strategy is rapidly becoming the strategic backbone of competitive development programs. As Denis Katz, MD, Founder of Salience Clinical, LLC, puts it: “In regenerative medicine, biomarkers aren’t just endpoints they’re accelerators. They determine which programs reach the market first, which get funded, and which fall behind.” Biomarkers: From Data Points to Strategic Advantage For musculoskeletal regenerative medicine t...
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Post-Market Surveillance Best Practices for Advanced Wound Care Devices: Expert Insights

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Post-Market Surveillance Best Practices for Advanced Wound Care Devices: Expert Insights By Denis Katz, MD — Founder & Principal, Katz Medical Affairs Consulting | Specialist in Medical Device Compliance & Post-Market Surveillance In today’s MedTech landscape, post-market surveillance (PMS) has evolved from a regulatory checkbox to a strategic driver of patient safety, clinical evidence, and market success. Advanced wound care devices, given their complex patient populations and diverse  surgical applications , demand tailored  PMS approaches  that address unique clinical and regulatory challenges. Drawing on extensive experience in medical affairs and compliance, this analysis outlines practical strategies for effective PMS implementation, illustrated through the case study of Solventum’s Prevena Restor Incision Management System the first negative pressure wound therapy device to receive FDA clearance to aid in reducing superficial surgical site infections ...
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