Newsletter | September 15, 2025

09.15.25 -- Crossing The Blood-Brain Barrier To Target Tumors

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Join Chief Editor Tom von Gunden and Drug Delivery experts to explore innovations in delivering complex and combination therapies, including drugs, biologics, and personalized medicines. Topics include nanoparticles, platform approaches, and delivery challenges for cell and gene therapies. Free registration—sign up today!

FEATURED EDITORIAL

Crossing The Blood-Brain Barrier To Target Tumors

In this episode of Sit and Deliver, host Tom von Gunden talks with CEO John Climaco and Chief Medical Officer Dr. Sandra Silberman from CNS Pharmaceuticals about intravenously crossing the BBB to deliver classes of drugs, such as taxanes, proven in treating solid tumors in other locations. 

Understanding Annex 1 For Sterile Medicinal Products

Fran DeGrazio outlines key concepts from the EU Annex 1 guidance for sterile medicinal products. She highlights considerations for manufacturing and offers recommendations for contamination control, facilities upgrades, quality risk management, and inspections

INDUSTRY INSIGHTS

GLP-1 Analog Formulations: Overcoming Oral Delivery Challenges

Oral GLP-1 formulations represent a groundbreaking advance in obesity treatment to offer improved patient comfort and adherence while expanding the therapeutic market.

Combination Product Regulatory In The EU: Transitioning To MDR

If devices are integral to positive patient outcomes, device partners must play an integral role to ensure regulatory compliance is achieved in the most effective way.

Successful Manufacturing Strategies For Highly Potent Oral Solids

Industry experts explore some of the key challenges in HPAPI drug product manufacturing and highlight essential factors sponsors should consider when evaluating a CDMO partner.

Ophthalmic Drug Delivery

Explore the challenges to effective delivery of drugs to the eye, intricacies of ophthalmic drug delivery, and advantages of nanoparticles as an enabling technology for ocular drug-delivery systems.

A Blueprint For Breakthroughs: Accelerating Rare Disease Therapies

To manufacture your rare disease therapy cost effectively, partner with an experienced CDMO from the outset. The right partner will offer development, manufacturing, quality, and regulatory expertise.

Micronization Technology For HPAPI Drug Products

Learn how to classify HPAPIs in early development and recommendations for safe product handling, from clinical manufacturing to commercialization.

De-Risking FDA Abbreviated New Drug Application (ANDA) Submissions

By conducting early task analysis, physical comparisons and formative CUHF studies, drug delivery device developers can identify and mitigate potential design differences and use errors.

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The PDA Pharmaceutical Microbiology Conference 2025 marks two decades of advancing microbiological science and practice. This milestone event brings together the global microbiology community, including experts from industry, academia, and regulatory agencies, to explore the evolving landscape of pharmaceutical microbiology. This year's theme, Microbial Resilience: Today's Response, Tomorrow's Plan, reflects our focus on navigating present-day challenges while building robust strategies for the future.

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