Aligos Therapeutics’ Post

N=1: Redefining Clinical Pathways for Ultra-Rare Disease Treatment This represents perhaps the greatest opportunity to revolutionize how we think about drug development, regulatory approval, and patient care. By Rob Freishtat, MD, MPH and Marshall Summar, M.D. https://lnkd.in/e5cJU9uu

Same-Day Re-Draw/Re-Dose Loops: The Fastest Way to Protect Patients and Payment In home infusion, waiting until tomorrow is often too late. When drug levels shift, delaying a dose adjustment means three bad things: ❌ Higher risk of kidney injury (nephrotoxicity) ❌ Greater chance of treatment failure ❌ Claims that get denied for lack of clinical necessity. The fix? Build a same-day re-draw/re-dose loop: if a lab result shows levels are off, redraw the level, recalc the dose, and re-dose the same calendar day. This isn’t just best practice—it’s standard of care for vancomycin (AUC-guided) and aminoglycosides, where therapeutic drug monitoring (TDM) is everything. Read more at https://lnkd.in/e42u4QmA

“When we do a clinical study for an originator product, we’re saying: does that drug cure that disease, and is it safe? That does not apply to a biosimilar, because we already know from the originator that we are referencing that that drug cures that disease and it’s safe.” Gillian Woollett, our VP and Head of Regulatory Strategy and Policy, highlights that routine clinical efficacy trials don’t add any new information to what science-based analytics already provide for biosimilars. 📘 Read the full interview with Korea Biomedical Review here: https://lnkd.in/gwKMDzk2

Even when the clinical data is strong, adoption can stall when human drivers are overlooked. In the cardiometabolic space, a client approached us with a challenge: they had developed a drug that had the potential to be a game-changer for cardiovascular patients; however, the product was facing slower-than-expected adoption. Our Hidden Depths methodology helped surface the emotional dynamics that shape medication prescription and adoption. What we uncovered: - Perceived risk and a “fixer” mindset made adding a new therapy feel high‑stakes. - Longstanding patient relationships made benefit conversations sensitive. - Product‑as‑hero narratives conflicted with clinicians’ identity as the advocate in the room. We aided the brand in revamping its communication to be more empathetic, recognizing the emotional complexity of discussing cardiovascular conditions with patients. This reframed the story to support clinicians and align with real-world practice. Read more on this case study: https://lnkd.in/eif5PGCH #IntegroInnovation #MarketResearch #HealthcareIndustry #HealthcareMarketing #PharmaResearch #MRX #pharma #insights

MDMA-Assisted Therapy Coverage Decisions Require Real Comparators & Sane Pricing We critique the Lykos cost-effectiveness analysis on two policy-critical points: 1) Comparator: Benchmarking against placebo therapy is not a payer-relevant alternative; standard of care is. 2) Price: Modeling $36,000 for MDMA drug cost undermines value and access. At $10.5k, MDMA-Assisted Therapy is highly cost-effective—and even cost-saving below ~$10,320. For coverage adoption, payers need relevant comparators and sustainable pricing. Read the full text here, https://lnkd.in/gDnV4ceY Jennifer Mitchell

Primary cells are directly isolated from living tissues and retain the physiological characteristics of their origin, making them highly valuable in drug development. They offer realistic models for studying drug efficacy, toxicity, and disease mechanisms, helping bridge the gap between lab research and clinical outcomes. Learn more at www.kosheeka.com. #labresearch #Primarycells #drugdevelopment #cellculture #kosheeka

𝗙𝗗𝗔 𝗗𝗿𝗮𝗳𝘁 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲: 𝗘𝘅𝗽𝗮𝗻𝗱𝗶𝗻𝗴 𝗡𝗼𝗻-𝗢𝗽𝗶𝗼𝗶𝗱 𝗢𝗽𝘁𝗶𝗼𝗻𝘀 𝗳𝗼𝗿 𝗖𝗵𝗿𝗼𝗻𝗶𝗰 𝗣𝗮𝗶𝗻  We are sharing this review from Lynn Webster, MD, Executive Vice President, Scientific Affairs, Dr. Vince Clinical Research: The FDA has released draft guidance to accelerate the development of non-opioid treatments for chronic pain. Unlike the 2019 version, which focused narrowly on condition-specific trials, the new approach allows broader indications when science supports shared pain pathways. It also encourages adaptive and pragmatic trial designs, digital health tools, and biomarkers—while setting clear standards for demonstrating opioid avoidance, elimination, or reduction. This is a patient-centered step toward safer, more effective therapies and a reduced reliance on opioids. 𝗥𝗲𝗮𝗱 𝘁𝗵𝗲 𝗳𝘂𝗹𝗹 𝗿𝗲𝘃𝗶𝗲𝘄 𝗵𝗲𝗿𝗲: https://bit.ly/4nSdQD3 #FDA #ChronicPain #DrugDevelopment #OpioidCrisis #NonOpioid 

Adverse Drug Events are a $30–100 Billion Dollar Problem We Can Actually Solve. Every year in the U.S.: • 1 in 5 patients takes 5+ medications — often with little personalized oversight • Up to 50% experience a clinically significant drug–drug or drug–gene interaction • 1.3 million ED visits are caused by ADEs annually • ADE-related costs exceed $30–100 billion per year What’s worse? Most of these events are preventable with better medication management, pharmacogenomic (PGx) testing, and smarter follow-up. At MedMind, we’re helping health plans and providers identify risks early, personalize therapy, and prevent avoidable hospitalizations, starting with PGx-guided polypharmacy reviews for complex patients. Partner with us to reduce ADEs and improve outcomes.

🔬 Regeneron’s Phase 2 COURAGE trial is turning the spotlight to quality of weight loss, not just quantity. Regeneron’s latest trial results highlight an important step forward: combining therapies that not only drive greater fat reduction, but also help preserve lean muscle mass. This approach has the potential to set a new standard in obesity treatment and patient outcomes. At Luminary Group, we continue to follow innovations that shape the future of healthcare and bring meaningful impact to patients’ lives. #ClinicalResearch #DrugInnovation #HealthcareLeadership #DrugDevelopment #ClinicalResearch #MuscleHealth #Innovation #LuminaryInsights https://lnkd.in/exRcMFG7

When patients hesitate to seek vital treatment, diving deeper to understand the "why" becomes essential. Using our Hidden Depths methodology, a major pharmaceutical client uncovered the underlying reasons for their patients' reluctance to address neurological side effects of antipsychotic drugs. The Hidden Depths approach was able to reveal unspoken fears, anxieties, and internal conflicts that patients dealing with mental health conditions were facing. And through this method, we identified three emotional barriers: fear of uncomfortable truths, feelings of being diminished, and the sensation of being controlled by medication. These insights enabled us to craft a campaign that resonated deeply with patients, reframing treatment as a path to reclaim autonomy over health. Explore how we transformed patient hesitation into empowerment: https://lnkd.in/egXY6TgM #IntegroInnovation #MarketResearch #HealthcareIndustry #HealthcareMarketing #PharmaResearch #MRX #pharma #insights