Pharma Focus America

𝐏𝐡𝐚𝐫𝐦𝐚 𝐅𝐨𝐜𝐮𝐬 𝐀𝐦𝐞𝐫𝐢𝐜𝐚 𝐈𝐬𝐬𝐮𝐞 𝟎𝟓 𝐢𝐬 𝐎𝐮𝐭 𝐍𝐨𝐰! We are thrilled to announce the release of 𝐏𝐡𝐚𝐫𝐦𝐚 𝐅𝐨𝐜𝐮𝐬 𝐀𝐦𝐞𝐫𝐢𝐜𝐚 𝐌𝐚𝐠𝐚𝐳𝐢𝐧𝐞 – 𝐈𝐬𝐬𝐮𝐞 𝟎𝟓! In this edition, we explore the transformation of virtual clinical trials, along with other innovations reshaping the biopharmaceutical industry. From cutting-edge advancements to industry insights, this issue is packed with valuable knowledge for pharma. A heartfelt thank you to our incredible contributors—your expertise and insights are essential in shaping the future of the pharmaceutical sector! We invite you to engage with us through 𝐚𝐫𝐭𝐢𝐜𝐥𝐞𝐬, 𝐢𝐧𝐭𝐞𝐫𝐯𝐢𝐞𝐰𝐬, and thought 𝐥𝐞𝐚𝐝𝐞𝐫𝐬𝐡𝐢𝐩 𝐜𝐨𝐧𝐭𝐫𝐢𝐛𝐮𝐭𝐢𝐨𝐧𝐬 as we continue to explore groundbreaking developments. 𝐑𝐞𝐚𝐝 𝐭𝐡𝐞 𝐥𝐚𝐭𝐞𝐬𝐭 𝐢𝐬𝐬𝐮𝐞 𝐧𝐨𝐰: https://lnkd.in/gdXUhnQ4 𝐖𝐞 𝐰𝐨𝐮𝐥𝐝 𝐥𝐨𝐯𝐞 𝐲𝐨𝐮𝐫 𝐟𝐞𝐞𝐝𝐛𝐚𝐜𝐤! 𝐒𝐡𝐚𝐫𝐞 𝐲𝐨𝐮𝐫 𝐭𝐡𝐨𝐮𝐠𝐡𝐭𝐬 ◾[email protected], ◾[email protected] ◾[email protected], ◾[email protected] 𝐊𝐄𝐘 𝐇𝐈𝐆𝐇𝐋𝐈𝐆𝐇𝐓𝐒 ◾Long-acting Drug Delivery Systems: Present and Future Eneko Larrañeta Queen's University Belfast, and Juan Domínguez Robles Universidad de Sevilla, ◾Tailoring Drug Delivery for Biomarker-Driven therapy Dr.Jnanadeva Bhat and Manali Dalvi, ACG World, ◾Virtual Clinical Trials: Hurdles and Promises Kelly FitzGerald, WCG IRB ◾Catalyzing a Greener Future: Innovations in Sustainable Green Pharmaceutical Manufacturing Nithya Karakala, MS, PG PM Veranova, ◾Transformative Convergence of AI in Pharmaceutical Manufacturing Cetin Cetinkaya, Clarkson University ◾Transformative Impact of Artificial Intelligence on Clinical Trials John Praveen, Accenture ◾The Transformative Role of Artificial Intelligence in Pharmacovigilance Vasudev Bhupathi, Moderna ◾The Evolving Landscape of Biosimilars: Challenges, Opportunities, and the Future of Biopharmaceutical Access Gillian Woollett, Samsung Bioepis ◾Integrating Artificial Intelligence into Pharma R&D Michael N. Liebman, IPQ Analytics ◾Visual Inspection of Parenteral Products: Critical Aspects for Setting up Robust Operations and Current Trends Satish Singh, Astria Therapeutics, Inc., and Atanas Koulov Clear Solutions Laboratories ◾Strategic Positioning for M&A: Optimising Value for Small Biotech through Clinical Development Joab Williamson of Faron ◾Biochemical and Molecular Pharmacology in Drug Discovery Vidya Niranjan, Mithun Rudrapal ◾Targeted Therapies for Cancer María de Miguel The START Center for Cancer Research, Brant Nicks WCG, and Gilles Besin Orbital Therapeutics ◾Characterizing AAV Capsids with Label-Free Biosensor Technology Yoann Saucereau, ExcellGene SA ◾Biosimilars and Biobetters: Navigating the Future of Biopharmaceuticals Emina Karahmet Sher, International Society of Engineering Science and Technology

𝐓𝐡𝐞 𝐑𝐨𝐥𝐞 𝐨𝐟 𝐂𝐡𝐫𝐨𝐦𝐚𝐭𝐨𝐠𝐫𝐚𝐩𝐡𝐲 𝐢𝐧 𝐅𝐨𝐫𝐞𝐧𝐬𝐢𝐜 𝐈𝐧𝐯𝐞𝐬𝐭𝐢𝐠𝐚𝐭𝐢𝐨𝐧𝐬 Chromatography isn’t just a pharmaceutical powerhouse—it’s a forensic game-changer. From detecting counterfeit drugs to uncovering hidden toxins in biological samples, advanced techniques like 𝐇𝐏𝐋𝐂 and 𝐆𝐂-𝐌𝐒 are pivotal in criminal investigations. By separating and identifying compounds in complex mixtures, forensic scientists can reveal crucial evidence—whether it’s tracing illicit substances, analyzing explosives, or linking arson accelerants to a crime scene. Chromatography’s speed, sensitivity, and accuracy ensure that justice is backed by science, transforming how we solve crimes and protect public health. Explore how this intersection of pharma and forensics is driving innovation and collaboration across disciplines. 🔗 𝐋𝐞𝐚𝐫𝐧 𝐌𝐨𝐫𝐞: https://lnkd.in/gJub37Tu #forensicscience #chromatography #pharmaceuticals #druganalysis #toxicology #crimesceneinvestigation #innovation #qualitycontrol #evidenceanalysis #pharmainnovation #forensictesting #HPLC #GCMS

𝐔𝐧𝐥𝐨𝐜𝐤 𝐭𝐡𝐞 𝐅𝐮𝐭𝐮𝐫𝐞 𝐨𝐟 𝐏𝐡𝐚𝐫𝐦𝐚 𝐰𝐢𝐭𝐡 𝐭𝐡𝐞 𝐏𝐡𝐚𝐫𝐦𝐚 𝐅𝐨𝐜𝐮𝐬 𝐀𝐦𝐞𝐫𝐢𝐜𝐚 𝐋𝐢𝐧𝐤𝐞𝐝𝐈𝐧 𝐍𝐞𝐰𝐬𝐥𝐞𝐭𝐭𝐞𝐫 Stay ahead in the dynamic world of pharmaceuticals! 🚀 Pharma Focus America has just launched its exclusive LinkedIn Newsletter, designed for industry leaders, innovators, and professionals who crave insights that matter. 𝐄𝐚𝐜𝐡 𝐞𝐝𝐢𝐭𝐢𝐨𝐧 𝐢𝐬 𝐩𝐚𝐜𝐤𝐞𝐝 𝐰𝐢𝐭𝐡 ✔️ In-depth ARTICLES and EXPERT INTERVIEWS ✔️The latest NEWS and PRESS RELEASES ✔️Cutting-edge TECHNO TRENDS ✔️Project spotlights and major EVENTS Why subscribe? You’ll receive curated, actionable content straight to your inbox—no more missing out on the trends shaping pharma’s future. Whether you’re a researcher, executive, or passionate about healthcare innovation, this newsletter is your gateway to staying informed and connected. 🔗 𝐒𝐮𝐛𝐬𝐜𝐫𝐢𝐛𝐞 𝐧𝐨𝐰 𝐚𝐧𝐝 𝐬𝐡𝐚𝐫𝐞 𝐰𝐢𝐭𝐡 𝐲𝐨𝐮𝐫 𝐧𝐞𝐭𝐰𝐨𝐫𝐤 𝐭𝐨 𝐞𝐦𝐩𝐨𝐰𝐞𝐫 𝐲𝐨𝐮𝐫 𝐜𝐨𝐧𝐧𝐞𝐜𝐭𝐢𝐨𝐧𝐬 𝐰𝐢𝐭𝐡 𝐤𝐧𝐨𝐰𝐥𝐞𝐝𝐠𝐞! https://lnkd.in/g-vRY4tr #pharmafocusamerica #pharmanewsletter #pharmatrends #pharmaleaders #pharmaceuticalindustry #pharmanews #expertinsights #industryupdates #subscribenow #pharmaceuticalindustry #pharmafocus #pharmamagazine #pharmanews #pharmaevents

𝐇𝐨𝐰 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐂𝐡𝐚𝐧𝐠𝐞𝐬 𝐀𝐫𝐞 𝐒𝐡𝐚𝐩𝐢𝐧𝐠 𝐭𝐡𝐞 𝐅𝐮𝐭𝐮𝐫𝐞 𝐨𝐟 𝐭𝐡𝐞 𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥 𝐈𝐧𝐝𝐮𝐬𝐭𝐫𝐲 The pharmaceutical industry is experiencing a regulatory revolution! From Europe’s CEP 2.0 to Brazil’s CADIFA Framework, global compliance standards are evolving rapidly. These changes are not just about paperwork—they’re transforming how pharma companies innovate, access markets, and ensure the highest quality for patients worldwide. Digital transformation and regulatory harmonization are now essential for safe, efficient, and timely drug distribution. Are you ready to navigate this new landscape? 🔗 𝐋𝐞𝐚𝐫𝐧 𝐡𝐨𝐰 𝐲𝐨𝐮𝐫 𝐨𝐫𝐠𝐚𝐧𝐢𝐳𝐚𝐭𝐢𝐨𝐧 𝐜𝐚𝐧 𝐬𝐭𝐚𝐲 𝐚𝐡𝐞𝐚𝐝 𝐨𝐟 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐜𝐡𝐚𝐧𝐠𝐞𝐬! https://lnkd.in/gFaSSs4K #pharmaregulations #compliance #pharmaceuticalindustry #pharmafocusamerica #digitaltransformation #drugsafety #marketaccess #pharmainnovation #qualityassurance #regulatoryaffairs #futureofpharma #CEP2 #CADIFA

𝐇𝐚𝐫𝐦𝐨𝐧𝐢𝐳𝐢𝐧𝐠 𝐁𝐢𝐨𝐬𝐢𝐦𝐢𝐥𝐚𝐫 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧𝐬 𝐭𝐨 𝐈𝐦𝐩𝐫𝐨𝐯𝐞 𝐏𝐚𝐭𝐢𝐞𝐧𝐭 𝐀𝐜𝐜𝐞𝐬𝐬 The global biosimilar landscape is evolving, but inconsistent regulations are still holding back patient access and healthcare savings. Harmonizing biosimilar regulations isn’t just a policy goal—it’s a patient-centric necessity! Europe’s success story shows us what’s possible with clear guidelines, while other regions face hurdles due to fragmented requirements. By aligning global regulatory standards, we can streamline approvals, reduce costs, and accelerate access to life-changing therapies for millions. Let’s champion international collaboration, education, and innovation to unlock the full potential of biosimilars. Ready to join the movement for better healthcare? 👉 𝐋𝐞𝐚𝐫𝐧 𝐦𝐨𝐫𝐞 𝐚𝐛𝐨𝐮𝐭 𝐛𝐢𝐨𝐬𝐢𝐦𝐢𝐥𝐚𝐫 𝐡𝐚𝐫𝐦𝐨𝐧𝐢𝐳𝐚𝐭𝐢𝐨𝐧:  https://lnkd.in/gumyZ7fU #Biosimilars #HealthcareInnovation #PatientAccess #RegulatoryAffairs #PharmaLeadership #GlobalHealth #Biologics #MarketAccess #HealthEquity #PharmaTrends #PolicyMatters #MedTech #LifeSciences #DrugDevelopment #FutureOfHealthcare

🚨 𝐇𝐮𝐠𝐞 𝐝𝐢𝐬𝐜𝐨𝐮𝐧𝐭𝐬 𝐚𝐡𝐞𝐚𝐝! 🚨 Bundle the Incucyte® and CellCelector platforms to save up to $150,000. Elevate your organoid and spheroid studies by merging the power of live-cell analysis with the precision and ease of automated cell imaging and selection. Get all the details here! 𝐃𝐢𝐬𝐜𝐨𝐯𝐞𝐫 𝐦𝐨𝐫𝐞: https://lnkd.in/gJDaz3mv #cellbiology #organoids #spheroids #livecellimaging #cellanalysis #automatedcellimaging #lifescienceresearch #labinnovation #biomedicalresearch #celltherapy #pharmadeals #researchtools #labtech #stemcellresearch #biotechsolutions

🚀 𝐖𝐚𝐧𝐭 𝐭𝐨 𝐦𝐚𝐱𝐢𝐦𝐢𝐳𝐞 𝐭𝐡𝐞 𝐢𝐦𝐩𝐚𝐜𝐭 𝐨𝐟 𝐲𝐨𝐮𝐫 𝐩𝐡𝐚𝐫𝐦𝐚 𝐞𝐯𝐞𝐧𝐭? Submit your event with us and gain unparalleled visibility in the industry! Our platform connects you with a targeted audience of industry leaders, researchers, and healthcare professionals eager to discover new innovations, partnerships, and breakthroughs. By posting your event, you'll not only increase attendance but also position your brand as a key player in the pharma landscape. We offer a seamless submission process, broad exposure, and analytics to track your reach. Don’t miss this opportunity to showcase your industry’s latest advancements! Launch your event into the spotlight today. 🔗 𝐏𝐨𝐬𝐭 𝐲𝐨𝐮𝐫 𝐞𝐯𝐞𝐧𝐭 𝐧𝐨𝐰: https://lnkd.in/gnjJgyHX #pharmaevents #pharmaconference #medicalresearch #pharmafocus #pharmaindustry #pharmanetworking #medicalevents #pharmamarketing #industryconnect #eventpromotion #pharmafocusamerica

Eton Pharmaceuticals Achieves FDA Approval for KHINDIVI™: A New Era in Pediatric Adrenocortical Insufficiency Care We’re proud to announce the FDA approval of KHINDIVI™, the first and only oral hydrocortisone solution for pediatric patients (5+ years) with adrenocortical insufficiency! KHINDIVI™ offers a game-changing, ready-to-use 1 mg/ml liquid formulation, eliminating the need to split or crush tablets. This innovation ensures precise dosing and simplifies administration for children who struggle with traditional tablets or require special care, such as gastric tubes. KHINDIVI™ will be available exclusively through Anovo specialty pharmacy, supported by the Eton Cares Program, which provides prescription support and $0 co-pays for eligible patients. This milestone expands Eton’s rare disease portfolio and marks a pivotal step forward in treatment accessibility and patient-centric care. 👉 Learn more about KHINDIVI™ and how we’re advancing rare disease therapies! https://lnkd.in/gctvhziZ #FDAApproval #PediatricCare #RareDiseases #PharmaInnovation #KHINDIVI #EtonPharma #AdrenocorticalInsufficiency #PatientCare #HealthcareInnovation #Pediatrics #SpecialtyPharmacy #PrecisionMedicine #PharmaNews #PatientSupport #NewLaunch

𝐄𝐯𝐨𝐥𝐯𝐢𝐧𝐠 𝐑𝐨𝐥𝐞 𝐨𝐟 𝐍𝐨𝐯𝐞𝐥 𝐄𝐱𝐜𝐢𝐩𝐢𝐞𝐧𝐭𝐬 𝐢𝐧 𝐌𝐨𝐝𝐞𝐫𝐧 𝐃𝐫𝐮𝐠 𝐃𝐞𝐥𝐢𝐯𝐞𝐫𝐲 𝐒𝐲𝐬𝐭𝐞𝐦𝐬 As we move into 2025, the pharmaceutical industry is witnessing a revolution in drug delivery systems—driven by the innovation of novel excipients. These advanced ingredients are crucial for overcoming formulation challenges and enabling targeted, stable, and highly bioavailable medicines. From nanotechnology-based carriers to multifunctional excipients, the possibilities are endless: enhanced solubility, improved stability, and tailored release profiles are now within reach for even the most complex therapeutics. Despite regulatory hurdles, the demand for high-purity, sustainable, and patient-centric excipients is fueling R&D and market growth.  Successful examples include nanoparticle-enabled cancer therapies and 3D-printed personalized medicines, both of which rely on cutting-edge excipient science. 𝐑𝐞𝐚𝐝𝐲 𝐭𝐨 𝐥𝐞𝐚𝐫𝐧 𝐡𝐨𝐰 𝐞𝐱𝐜𝐢𝐩𝐢𝐞𝐧𝐭 𝐢𝐧𝐧𝐨𝐯𝐚𝐭𝐢𝐨𝐧 𝐢𝐬 𝐬𝐡𝐚𝐩𝐢𝐧𝐠 𝐭𝐡𝐞 𝐟𝐮𝐭𝐮𝐫𝐞 𝐨𝐟 𝐡𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞? https://lnkd.in/gJ69zUrx #pharmainnovation #drugdelivery #excipients #nanotechnology #personalizedmedicine #pharmaceuticals #futureofmedicine #bioavailability #pharma2025 #drugdevelopment #patientcare #sustainability #3dprinting #healthcaretrends

Teva Pharmaceuticals is proud to announce a major milestone: our investigational anti-IL-15 antibody, TEV-53408, has received Fast Track designation from the US FDA for the treatment of celiac disease in patients on a gluten-free diet. Celiac disease affects nearly 1% of the global population, and many patients continue to experience debilitating symptoms despite strict dietary adherence. TEV-53408, now in Phase 2a trials, is designed to inhibit interleukin-15 (IL-15), aiming to reduce immune response and prevent intestinal damage caused by gluten exposure. This recognition by the FDA underscores both the urgent unmet needs in celiac disease and the innovative potential of our pipeline. At Teva, we remain committed to advancing treatments that transform lives for those living with chronic autoimmune conditions. Discover more about our commitment to innovation: https://lnkd.in/gxgTtzzr #CeliacDisease #FDA #FastTrack #TevaPharma #Innovation #AutoimmuneDisease #ClinicalTrials #Biotech #Healthcare #PatientCare #MedicalInnovation #Immunology #GlutenFree #R&D #PharmaNews