Next-generation drug delivery pairs science with usability, solving adherence by simplifying treatment, aligning patient behavior, and improving poorly tolerated therapies.
- Expanding The IV → SC Framework: What Reformulation Really Means
- AI: The Inflection Point In Retinal Drug Discovery, Development, And Delivery
- Reformulating An In-Clinic IV To At-Home Injection Puts Patients At The Center
- AI, Digitalization, And In Vivo Programming Redefine Cell And Gene Therapy
- Minding The Gap: Submission Strategies For Combined Use Combination Products
- Advances In Precision Delivery In CNS Oncology
- Drug-Device Combination Products: 4 Evolving Platforms For 2026
- A Case Study: Control Strategies For A Multi-Dose Pen Injector
ON-DEMAND WEBINARS
Discover how to advance new compounds with complex chemistry through each stage of development by refining processes to give fit-for-purpose manufacturability and yields.
Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.
Explore insights on extractables, focusing on how they relate to the revised EU GMP Annex 1, new and evolved expectations under USP <382>, and the use of VHP decontamination in aseptic environments.
Discover how revolutionary and environmentally sustainable nanoparticle technologies coupled with innovative formulation approaches can address drug solubility issues and add value for patients.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![AST- Fill-Finish Automation And Robotics]( "Small-Scale Aseptic Filling Technology Considerations")
Small-Scale Aseptic Filling Technology ConsiderationsSmall-scale aseptic filling presents a unique set of challenges. Learn what to look for when evaluating small-scale aseptic filling technology.
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![West]( "The Dynamic Regulatory Environment Of Drug-Device Combination Products")
The Dynamic Regulatory Environment Of Drug-Device Combination ProductsExamine the dynamic regulatory environment of drug-device combination products as well as concrete steps to take to navigate regulatory complexities and decrease time to market.
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![Multicolored pills-GettyImages-1370358685]( "Solid Form Strategies For Increasing Oral Bioavailability")
Solid Form Strategies For Increasing Oral BioavailabilityOptimizing a drug’s solid form can improve its solubility and bioavailability when further molecular modifications are prohibitive.
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![GettyImages-1333253892-doctor-legal-regulatory]( "The Challenges And Opportunities Of Real-World Evidence: Part I")
The Challenges And Opportunities Of Real-World Evidence: Part IExplore how the FDA's Real-World Evidence framework helps integrate real-world data into drug approval, improving efficiency, while ensuring data reliability and regulatory compliance.
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![Compliance GettyImages-1348548209]( "Annex 1 – The Brave New World Of Regulatory Compliance")
Annex 1 – The Brave New World Of Regulatory ComplianceThe revision to Annex 1 will become effective in August 2023. Explore the major changes and considerations along with the next steps to achieve Annex 1 Regulatory compliance.
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![Getty Images-823447656-vector-viral-lab-AAV-cell-development]( "Sophisticated Formulation Approaches For Insoluble Drug Candidates")
Sophisticated Formulation Approaches For Insoluble Drug CandidatesA sophisticated drug delivery approach involves collaboration, technical experience, and years of working knowledge in drug development at different stages of the process.
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![GettyImages-1145121597-knee-arthritis-pain]( "Development Of Next Gen Sustained Release Solutions For Pain Management")
Development Of Next Gen Sustained Release Solutions For Pain ManagementA TheraPEA™ polymer based injectable formulation designed to deliver the same dose of Triamcinolone Acetonide (TAA) as in Zilretta® has shown promising results in a series of pre-clinical studies.
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![Telehealth virtual ipad elderly]( "Hospital To Home: What It Means For Patients, Providers And Medical Devices")
Hospital To Home: What It Means For Patients, Providers And Medical DevicesHealthcare is shifting homeward. With telehealth, connected devices, and user-friendly design, patients and caregivers now deliver hospital-level care safely and effectively outside clinical settings.
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![GettyImages-1346675513 lab materials]( "Early Solid Form Screening To Guide Drug Development")
Early Solid Form Screening To Guide Drug DevelopmentConducting solid form screening early can help your team select and isolate the ideal lead polymorph to ensure manufacturability and stability while avoiding costs and hiccups down the road.
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![Cleanroom Scientists Using Tablet GettyImages-1341292153]( "High-Throughput Platform Propels Gene Editing Therapy Research")
High-Throughput Platform Propels Gene Editing Therapy ResearchExplore the potential of polymeric nanoparticles (PNPs) as an alternative to viral vectors. PNPs offer design flexibility, enabling larger payloads, targeted release, and minimized side effects.
TOM'S TAKES ON DRUG DELIVERY
TALKING WITH TOM VIDEOCASTS
Fran offers keen industry and technical insights exclusively on Drug Delivery Leader.
DELIVERED BY DEGRAZIO
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![Delivered _by _DeGrazio_Logo_Color_2]( "6 Packaging And Delivery Challenges For Biologic Therapies")
6 Packaging And Delivery Challenges For Biologic TherapiesIn this article, Fran DeGrazio identifies six aspects of biologics-based therapy packaging and delivery that, if addressed, may help to ensure successful product development and lifecycle management. They include 1) chemical compatibility with device functionality, 2) long-acting formulations, 3) product stability, 4) primary packaging and device integration, 5) cold storage, and 6) higher concentrations and viscosities.
FREE EBOOK: COMBINATION PRODUCTS
Combination products provide significant avenues for increasing patient adherence and overall efficacy. This collection outlines the opportunity and identifies strategies for gaining regulatory approval.
