Allucent

𝗣𝗿𝗼𝗮𝗰𝘁𝗶𝘃𝗲 𝗰𝗼𝗵𝗼𝗿𝘁 𝗺𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗽𝗹𝗮𝘆𝘀 𝗮 𝗰𝗿𝗶𝘁𝗶𝗰𝗮𝗹 𝗿𝗼𝗹𝗲 𝗶𝗻 𝘀𝘂𝗰𝗰𝗲𝘀𝘀𝗳𝘂𝗹 𝗲𝗮𝗿𝗹𝘆-𝗽𝗵𝗮𝘀𝗲 𝗼𝗻𝗰𝗼𝗹𝗼𝗴𝘆 𝗱𝗼𝘀𝗲-𝗲𝘀𝗰𝗮𝗹𝗮𝘁𝗶𝗼𝗻 𝘁𝗿𝗶𝗮𝗹𝘀. By coordinating project management, medical, and clinical pharmacology from the start, biopharma teams can keep studies moving efficiently while supporting timely decisions, data integrity, and patient safety. Our recent infographic highlights practical strategies for proactively managing dose-escalation cohorts to support operational efficiency, data quality, and timely decision-making throughout early-phase oncology trials. Learn how a proactive approach can help you: • Keep dose-escalation timelines on track through coordinated cohort management • Strengthen real-time data review to support faster, more informed decisions • Anticipate potential challenges early and build contingencies before they impact the study Download here: https://lnkd.in/ezKjQyMu #Allucent #BringingNewTherapiesToLigh #EarlyPhaseOncology #CohortManagement #DoseEscalation #OncologyCRO

The FDA's 2025 draft biosimilar guidance, "Scientific Considerations in Demonstrating Biosimilarity to a Reference Product", could change how biosimilars are developed by clarifying when a Comparative Efficacy Study (CES) may no longer be needed. What does this mean for biosimilar development programs? In our recent blog, Allucent regulatory experts examine: 🔸 When a dedicated CES may not be expected 🔸 The scientific framework supporting that determination 🔸 The limited circumstances in which a CES could still be required 🔸 How the guidance aligns with EMA Read the full blog here: https://lnkd.in/eWf7BGBP #Allucent #BringingNewTherapiesToLight #Biosimilars #BiosimilarDevelopment #FDA #FDAGuidance #EMA #HealthCanada #RegulatoryAffairs

From Alzheimer's to Parkinson's and multiple sclerosis, Model-Informed Drug Development (MIDD) is helping sponsors accelerate smarter, more informed decisions. In a recent blog, Allucent expert, Martin Johnson, PhD, explores how MIDD and adaptive approaches are helping sponsors navigate the complex landscape of neuroscience programs. Key takeaways include: 🔸 Why MIDD is becoming a cornerstone of neuroscience drug development 🔸 How adaptive trial designs and digital biomarkers are improving decision-making 🔸 Why integrating these capabilities early is a competitive advantage Read the full blog to learn how these strategies are shaping the future of neuroscience development: https://lnkd.in/efzcAr9p #Allucent #BringingNewTherapiesToLight #MIDD #MIDDinNeuroscience #NeuroscienceCRO

We're excited to spotlight Gene Williams, PhD, Vice President, Clinical Pharmacology. With more than 25 years of industry experience, including serving as a Team Leader and Primary Reviewer at the FDA, Dr. Williams brings a depth of expertise in clinical pharmacology and regulatory science to Allucent's A-Team. Dr. Williams and our Clinical Pharmacology experts partner with sponsors across drug development, applying clinical pharmacology, model-informed drug development (MIDD), and quantitative approaches to inform dose selection, study design, and other critical development decisions. By integrating scientific expertise with advanced modeling and analysis, our team helps sponsors reduce uncertainty and move programs forward with greater confidence. Learn how our Clinical Pharmacology team can support your next program: https://lnkd.in/gqEHZbfz #Allucent #BringingNewTherapiesToLight #ATeam #ClinicalPharmacology #ModelInformedDrugDevelopment #MIDD #SpecialtyCRO

𝗬𝗼𝘂𝗿 𝗽𝗿𝗶𝗺𝗮𝗿𝘆 𝗲𝗻𝗱𝗽𝗼𝗶𝗻𝘁 𝗶𝘀 𝗼𝗻𝗹𝘆 𝗮𝘀 𝘀𝘁𝗿𝗼𝗻𝗴 𝗮𝘀 𝘆𝗼𝘂𝗿 𝗼𝗽𝗲𝗿𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝘀𝘁𝗿𝗮𝘁𝗲𝗴𝘆. In immunology clinical trials, a well-designed endpoint strategy that minimizes variability, standardizes assessments, and protects data integrity is critical to generating reliable, clinically meaningful efficacy data. In our latest blog, our Immunology & Inflammation ACE head, Mila Grieg, MD, PhD explores what it takes to build an endpoint strategy that protects your primary endpoint, from selecting clinically meaningful measures and planning for variability to implementing operational safeguards that help preserve data integrity throughout the study. Read the blog: https://lnkd.in/e7gBDcf7 #Allucent #BringingNewTherapiesToLight #EndpointStrategy #ProtectTheEndpoint #ImmunologyCRO #ImmunologyClinicalTrials

In oncology drug development, FDA's Project Optimus emphasizes identifying and justifying the optimal dose using a robust body of clinical and scientific evidence. This represents a shift away from dose selection strategies centered on the maximum tolerated dose (MTD). That means incorporating approaches such as PK/PD analyses, exposure-response modeling, biomarkers, and dose expansion cohorts early in development to better understand the relationship between dose, efficacy, and safety. Our recent blog explores practical strategies for designing oncology trials that support dose optimization, including: ▪️ The expanding role of dose expansion cohorts in oncology development ▪️ Why model-informed approaches support dose selection ▪️ Key elements of a robust dose optimization strategy ▪️ Practical considerations for aligning early-phase trial design with FDA expectations Read more: https://lnkd.in/etEXP66g #Allucent #BringingNewTherapiesToLight #ProjectOptimus #Oncology #ClinicalTrials #DoseOptimization #DrugDevelopment

Great teams are built by great people. Welcome to the team, Faysal Yildirmaz. We're excited to have you join our Data Management team, with a focus on delivering high-quality clinical data and making a meaningful impact for our clients. Interested in joining the Allucent A-Team? Check out our open roles: https://lnkd.in/epXrH2RT #Allucent #BringingNewTherapiesToLight #JoinTheATeam #CareersAtAllucent #GlobalCRO #SpecialtyCRO

Last week, Brad Loncar of BiotechTV sat down with Allucent COO Patrick Phillips BSc(Hons) D.Phil. at our U.S. headquarters in Cary, NC, to discuss the launch of Allucent's IGNITE™ Global Site Network. IGNITE was designed to improve predictability by accelerating study start-up, supporting more consistent enrollment, and reducing execution variability. With more than 250 pre-qualified, therapeutically aligned research sites, access to 50M+ patients across 17 countries, and defined operational commitments around feasibility and site activation, IGNITE is built to help sponsors move faster without compromising quality.   For more information on IGNITE, listen to the full interview below and visit our website: https://lnkd.in/eEWpCwyS #Allucent #BringingNewTherapiesToLight #IGNITEGlobalSiteNetwork #PredictableStudyStartUp #GlobalCRO

Less than three weeks. More than 90 documents. One successful EU CTR submission. When an emerging biotech faced a critical timeline for an oncology trial, Allucent helped achieve a successful EU Clinical Trials Regulation (EU CTR) submission in under three weeks without compromising quality or compliance. Check out our case study to learn how shared ownership, close collaboration, and regulatory expertise helped deliver: ▪️ An accelerated submission timeline ▪️ Streamlined document readiness and review cycles ▪️ Full compliance with EU CTR requirements Read the full case study: https://lnkd.in/eyR_x85F #Allucent #BringingNewTherapiesToLight #EUCTR #RegulatorySubmission #OncologyClinicalTrials #OncologyCRO

Thanks to Brad Loncar and BiotechTV for stopping by Allucent's North Carolina office to meet with our A-team! We loved the opportunity to share what makes Allucent special: our people, our passion, and our commitment to helping small to mid-size biopharma companies bring new therapies to patients. #Allucent #BringingNewTherapiesToLight #ATeam #ResearchTrianglePark #GlobalCRO #SpecialityCRO Tiffany W. Andrew DeMaine Sheila Plant, PhD, MHS, RAC Donna Crabtree, PhD Patrick Phillips BSc(Hons) D.Phil. Nathan Thompson Sarah DiVito