Teresa Hines

RWE is now CORE, not optional. The FDA is reducing pre-approval trials. What does this mean for RWE? • Less randomized evidence → more uncertainty at launch • Regulators lean on post-market data • RWE demand = 🚀 Let’s break this down: 1️⃣ Post-approval RWE needs explode: safety, effectiveness, label expansions, confirmatory commitments 2️⃣ Earlier RWE pre-approval is needed: external controls, natural history cohorts, single-arm trial context 3️⃣ Quality is king: regulator-grade, protocolized, fit-for-purpose. Low-quality RWE won’t cut it Where it matters most: • Regulatory ✅ • HTA & payers 💰 • Lifecycle & commercial strategy 📈 💡 Bottom line: Fewer trials = RWE is now core, not optional. #RWE #Pharma #DrugDevelopment #RegulatoryScience #MarketAccess

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Could #science one day warn us about disease years before symptoms appear? In a new collaborative episode of Regeneron’s The Nucleus podcast and STAT Brand Studio, Dr. John Overton, VP & Chief Sequencing Officer at the Regeneron Genetics Center (RGC), joins host Jesse McQuarters to explore how #proteomics — the large-scale study of proteins and their activity in the body — is being integrated with other multi-omics data to open the door to earlier and more precise disease detection. Watch: https://lnkd.in/e7sAGAai

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William Soliman breaks down his outlook on the weight loss drug industry, talking to Eli Lilly (LLY) and other names in the space. He explains why he thinks Amgen (AMGN) and Structure Therapeutics (GPCR) are potential names to watch.

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If the press release OS claim is borne out by the full dataset, this is a major result: an adjuvant CDK4/6 inhibitor (abemaciclib) would have demonstrated not only disease-free but also overall survival benefit after only 2 years of therapy in a high-risk, node-positive HR+/HER2− population. This would strengthen the rationale for using abemaciclib in eligible patients and support its current regulatory approvals / guideline recommendations . The previously reported absolute IDFS benefit at 5 years (~7.6%) is clinically meaningful in the adjuvant setting; an OS improvement would confirm that the IDFS gain translates into lives saved rather than just delayed recurrences. There are some importantly aspects to consider however: Full numerical OS results, subgroup analyses, Kaplan-Meier curves, and statistical details (HR, CI, p-value, pre-specified alpha allocation / multiplicity handling) are not yet publicly available. monarchE was open-label and while IDFS and OS are objective, open labeling can influence management and post-recurrence treatments and we will need full details on subsequent theapies. in terms of the design I note the OS analysis plan was amended and we will need clarity on how this was handled. It will be of interest also to see how the difference , if any between. cohort 1 = classic clinical high risk; and cohort 2 = Ki-67 high) play out in the analysis as approvals and guideline statements focused mainly on cohort-1–type patients. Something to watch indeed

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Delaware-based CorriXR Therapeutics secured a $1 million investment from Delaware as it prepares to launch the first-in-human clinical trials of its cancer-focused gene-editing therapy. #netde #cancer #clinicaltrials #CRISPR https://lnkd.in/g5a8cgtT

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When French pharmaceutical giant Sanofi decided to place its new U.S. headquarters in a $130 million redevelopment project in Morristown, N.J., the company cited access to a highly skilled workforce and proximity to sustainable transportation options as critical #siteselection factors. Kelly Barraza of Site Selection Magazine chronicles this major site location project that is resulting in a 375,000SF HQ with 2,000 workers. And that is just the beginning of what's happening in the Garden State. New Jersey Economic Development Authority (NJEDA) Conway Data, Inc. Industrial Asset Management Council (IAMC) Paul Hudson Ellavoz Impact Capital #economicdevelopment #workforce #jobs https://lnkd.in/d-Htcik5

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🎙️ Join #IPCPresident Bruce Strober and #IPCCouncilor Linda Stein Gold on this ReachMD podcast as they break down the new #IPC consensus on reclassifying psoriasis severity and redefining failure of topical therapies. From high-impact disease sites and BSA >10% to inadequate response to topicals, this discussion clarifies which patients may benefit from earlier systemic therapy, including IL-23 and IL-17 inhibitors, and how to apply the framework confidently in practice. Listen to the full podcast: https://lnkd.in/gHxm9tPi #Psoriasis #Dermatology #SystemicTherapy #IL23 #IL17 #ClinicalGuidance #MedicalEducation

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Thanks to proteomics and multi-omics, we’re entering an era that expands how we can detect disease before symptoms even start. Hear more on our podcast, The Nucleus, where in the collaborative episode with STAT we discuss how these insights are helping advance more predictive and preventative healthcare.     https://bit.ly/44Bo3wz 

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The results are in. Last week we asked, “Which factor most influences investor confidence in cell and gene therapy companies?” Our followers voted: -62% Strong clinical data -25% Clear commercialization plan -8% Stable leadership -4% Compelling investor narrative While strong data led the poll, our latest Insights Hub article explores why financial stability depends on more than clinical results — from leadership continuity to compelling storytelling. Read more: https://lnkd.in/g-yPhuur #SyneosHealth #CellAndGeneTherapy #CGT #InvestorConfidence #Biopharma

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Leaders from Merck KGaA, Darmstadt, Germany — including CEO Belén Garijo, Healthcare CEO Danny Bar-Zohar, and EMD Serono President Miguel Fernández Alcalde—were in Connecticut this week to meet with team members from SpringWorks Therapeutics to discuss how we’ll co-create an inclusive and successful integration of SpringWorks in to our global parent company’s Healthcare sector. Thanks to the #SpringWorkers for their engagement—and enthusiasm—as we build what’s next, #AsOneForPatients.

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3SBio has built a decade-deep bispecific pipeline. We often talk about the $6B out-licensing deal of 707 (PD1/VEGF) to Pfizer. But that's just the tip of the iceberg. Explore the innovative bispecific antibodies transforming cancer and autoimmune treatments! 🚀💉 Exciting advances in clinical pipelines with strong safety profiles await. This is long-term accumulation, not overnight hype. 🎥 Watch the video for the full picture. Share by Tingting Fan, the Senior Business Consultant of DXY Insight Database. #BispecificAntibodies #3SBio #DrugDevelopment #Innovation #Biotech #Pfizer #DXYInsightDatabase

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Good news for patients and their families: Regeneron’s gene therapy treatment has been approved by the FDA. Regeneron launched a clinical trial (called CHORD) in 2023 for its treatment of this form of hearing loss, which targets the OTOF gene, which encodes the otoferlin protein. This approval marks a major breakthrough in the treatment of hearing loss. This is the first time a gene therapy for this type of condition has been approved for marketing. Otarmeni and the administration kit are a one time biologic-device combination product. It includes a dual adeno-associated virus serotype 1 (AAV1) vector gene therapy administered as a single dose per ear surgically into the cochlea via a syringe and catheter provided in the Administration Kit and connected to an infusion pump. https://lnkd.in/eE6mt_9S

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Six smart ways to speed up clinical trials and reduce risk Clinical trials are complex and even the most well-resourced sponsors and CROs can face unexpected challenges. Here are six strategic ways to augment your trial with the right CRO support: ✅ Site list augmentation – Expand reach and accelerate enrollment ✅ Clinical staffing augmentation – Fill gaps quickly without compromising quality ✅ Regulatory & quality consulting – Navigate evolving compliance with confidence ✅ Protocol optimization & feasibility – Reduce amendments and improve retention ✅ Technology integration & data management – Enable clean, timely data delivery ✅ Risk-based monitoring & oversight – Detect issues early and enhance compliance 👉 Read the full article: https://gag.gl/Jj5irk #RescueStudy #CROTransition #ClinicalTrials #ClinicalResearch #RiskManagement

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PharmaDS 2026 | March 23–25 | Edison, NJ PharmaDS 2026 is designed for teams who want to apply what they learn the moment they’re back at work. This year’s program centers on real-world use cases, not concepts in isolation, showing how AI is being deployed today across pharmaceutical development, from predictive modeling and digital twins to pharmacovigilance and more. You’ll hear directly from industry leaders who are building, validating, and scaling these approaches in practice, with clear lessons learned and implementation insights. Expect: • Concrete use cases you can operationalize • Regulatory-aware AI strategies • High-value short courses with immediate ROI ⭐ Early registration closes February 14 Register via the QR code in the image or link: https://lnkd.in/gEf9YwKK In-person or virtual Short Courses (abbreviated): * AI-Enabled Trial Design * LLM + REGEX for Information Redaction * Causal Generalist Medical AI * AI Governance & Regulatory Readiness * Python for Clinical Development Thank you to our 2026 sponsors BeOne Medicines, Merck, AbbVie, Bristol Myers Squibb, ASA Biopharmaceutical Section, HopeAI, INSTAT, and waterworksAI for supporting an applied, practitioner-focused conference and helping advance responsible AI adoption across the industry. #PharmaDS2026 #AIinPharma #DrugDevelopment 

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In biopharma, approval isn’t the finish line. It’s the starting gun. The first six months of launch can define long-term commercial performance. Prescriber perceptions form quickly. Access assumptions solidify. Messaging either earns credibility or gets filtered out. That’s why launch readiness can’t be measured by training completion alone. True readiness means field teams can translate complex clinical evidence into confident, compliant, real-world HCP conversations from day one. For emerging biopharma companies, the launch window is too important to leave execution consistency to chance. Get the eBook from ACTO to read more on why early execution determines long-term performance: https://lnkd.in/eBZrs5Pc #Biopharma #ProductLaunch #FieldExcellence #Commercialization #LifeSciences

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Rare disease regulation is becoming more complex and more strategic, redefining how sponsors plan, generate evidence, and engage regulators. Explore five key regulatory shifts shaping rare disease development: https://hubs.ly/Q03VRqvG0 Seth D. DePuy, Ph.D. Angi Robinson M. Kenneth Ndugga-Kabuye, MD, FACMG #PremierResearch #RareDisease #RegulatoryStrategy

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Op-Ed: Tariffs on Medicines Threaten Patients, Innovation & NJ's Biopharma Leadership Written by Debbie Hart, President & CEO, BioNJ Read full Op-Ed: https://ow.ly/kNYN50X5Ia3 #BioNJ #Biopharma #InnovationMatters #NJLeadership #PatientAccess #PharmaNews #TariffsImpact #LifeSciences #HealthcarePolicy

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