Precision oncology has transformed who receives treatment and what biology we target. The next frontier is designing where therapeutic activity occurs.
- Crossing The Uncrossable: Skin Biology For The Delivery Of Peptide And Protein Therapeutics
- When The Adhesive Becomes The Drug Delivery System
- Antibody–Oligonucleotide Conjugates, Part 1: Approaching Your AOC Development Plan
- Drug–Device Combination Products: Bridging Formulation, Device, And Manufacturing Decisions
- Rethinking Drug Delivery To Combat Antibiotic Resistance
- The Resurgence Of Fervor For Oral Delivery
- Advancing Multi-Pathology Disease-Modifying Therapy For Neurodegenerative Diseases
- Container Closure Systems For Biosimilars: Is There Regulatory Difference?
ON-DEMAND WEBINARS
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.
Gain valuable insights into key considerations when selecting lipid excipients for LNP formulations and the process development steps necessary to advance them to GMP manufacturing and clinical trials.
Discover how an integrated ADC strategy addresses containment, analytics, fill-finish, and inspection challenges to improve product protection, process reliability, and delivery performance.
Explore how bioavailability of poorly soluble APIs can be improved and patient compliance enhanced by reducing the size or number of tablets that a patient must take to achieve the required dose.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Artificial Intelligence, Technology, Robot, Futuristic, Data Science, Data Analytics, AI-GettyImages-1480912336]( "AI: The New Partner In Medical Device Development")
AI: The New Partner In Medical Device DevelopmentInvolving users in the development process and staying informed about regulatory policies can help ensure AI-powered devices meet the needs of patients and healthcare professionals.
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![iStock-1191001266-tablet-pill]( "How Approved Drugs Have Evolved Since The '70s")
How Approved Drugs Have Evolved Since The '70sDrugs have become more lipophilic and complex in structure over time. Innovative strategies are needed to improve the bioavailability of these new drugs.
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![GettyImages-1543830891-direct-to-patient-cell-medicine-order-medication]( "PHI And Medical Devices: What Device Manufacturers Need To Know")
PHI And Medical Devices: What Device Manufacturers Need To KnowConnected medical devices must treat Protected Health Information (PHI) protection as integral to patient safety and compliance. Understand the data flows and HIPAA requirements to design security.
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![GettyImages-1299873218-lab]( "Improve Solubility And Spray Drying Throughput For Brick Dust Compounds")
Improve Solubility And Spray Drying Throughput For Brick Dust CompoundsThis paper presents three approaches to address poor solubility in organic solvents for spray drying as well as case studies outlining their successful application during development.
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![Female researcher analyzing scientific samples-GettyImages-2231025177]( "Navigating The Analytical Challenges Of Complex ADCs")
Navigating The Analytical Challenges Of Complex ADCsAntibody drug conjugates are expanding to deliver diverse therapeutic payloads. Advanced analytical strategies are required to characterize these evolving platforms.
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![Regulatory]( "The Challenges And Opportunities Of Real-World Evidence")
The Challenges And Opportunities Of Real-World EvidenceThe FDA's Real-World Evidence framework addresses challenges in using Real-World Data for regulatory decisions, emphasizing data reliability, bias management, and successful case studies.
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![capture1]( "Responding To Trends In Prefilled Delivery: Component Assessment And Selection")
Responding To Trends In Prefilled Delivery: Component Assessment And SelectionExisting plunger technology for PFS was developed for manual injection and does not meet the evolving requirements for drug delivery especially for consistency of injection rate.
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![04 West]( "Delivering Market Success For Pharma Partners From Concept To Patient")
Delivering Market Success For Pharma Partners From Concept To PatientThe development of drug delivery devices that are innovative, intuitive, patient friendly, and patient safe must address certain areas of concern that are particular to both biologic and biosimilar therapies.
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![Patent Trolls]( "The Largest LOE Event In US Pharma History")
The Largest LOE Event In US Pharma HistoryAhead of the first biosimilar Humira product set to launch in 365 days, this article provides a comprehensive run-down of where biosimilar sponsors stand and the key issues ahead of market formation.
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![Solving The Silicone Challenge]( "Solving The Silicone Challenge In Pre-Fillable Syringes")
Solving The Silicone Challenge In Pre-Fillable SyringesDiscover a technology platform that is revolutionizing the pre-fillable syringe market by solving the challenge of silicone sensitivity, ensuring stability for sensitive drugs.
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]( "Container Closure Systems For Biosimilars: Is There Regulatory Difference?")
Container Closure Systems For Biosimilars: Is There Regulatory Difference?In this article, Fran DeGrazio discusses the FDA’s draft guidance on container closure systems for biosimilar products. She highlights key takeaways and offers recommendations on implications that developers of biosimilar pharmaceutical products should consider in areas such as quality, testing, and documentation.
EDITORIAL COLLECTIONS KNOWLEDGE CENTER
Our Editorial Collections examine today’s biggest scientific, operational, and patient-centered drug delivery issues. These collections help companies navigate complex development decisions with in-depth analysis, real-world examples, and guidance from industry experts.
