Newsletter | June 5, 2026

06.05.26 -- FDA Now A Supply-Chain Complication

INDUSTRY INSIGHTS

Patient-Centric Formulations In Pediatric Adherence

Improving pediatric adherence requires age-appropriate formulations, taste-masking, and swallowability strategies. Regulatory, clinical, and technological insights help support more effective therapies.

Risk Isn't Inevitable: How The Right CDMO Protects Your Programme

Risk in outsourced drug development is often created, not inherent. Learn how CDMO structure, continuity, and communication directly affect programme risk, timelines, and outcomes.

Accelerating Small Molecule Protein Degrader Development

High‑content imaging enables discovery and optimization of small‑molecule protein degraders by delivering multiparametric, single‑cell insights that accelerate identification and development.

FEATURED EDITORIAL

FDA Now A Supply-Chain Complication

Crossing the Rubicon to regulatory-leadership discontinuity; suffering a disunity at the FDA impacting our supply chains. When sponsors begin altering outsourcing relationships and clinical-trial strategies because of uncertainty at the FDA, more supply-chain challenges are created than corrected for. That suggests all of us should take a deep breath. Vigilance and concern are always part of the drug industry. But we need to address the question: How is the FDA impacting development and manufacturing outsourcing?

The Hidden Operational Cost Contained In Every Small Molecule Portfolio

The volume of post-approval changes is rising and the manual approaches that have worked until now are no longer adequate. Get ahead of this to spend less and execute faster.

INDUSTRY INSIGHTS CONTINUED

An Integrated Model For Faster PFS Development

Discover how integrated, end-to-end development for prefilled syringes can streamline timelines, enhance patient-centric delivery, and scale efficiently from early development to global launch.

How To Increase Success In Topical Drug Development With Automation

Explore how automation can enhance topical drug development — from pre-formulation studies to performance testing — ultimately supporting more efficient, reliable, and patient-friendly therapies.

The Power Of AI And Route Scouting To Navigate API Complexity

Using AI tools for retrosynthesis can help you investigate molecules interactively to build a complex API manufacturing process that maintains your timeline and saves you money.

Overcome Common Pre-Filled Syringe Challenges Through Partnership

The pre-filled syringe space is one of the fastest growing pharma sectors, offering patient safety and lower manufacturing costs. But there are particular obstacles to overcome.

SOLUTIONS

Predictive Platform For Solubility And Bioavailability Enhancement

Protecting Your Drug Product

South Haven cGMP Manufacturing Services And APIs

OUTSOURCED PHARMA CAPABILITIES UPDATE

Find Your New CDMO At Outsourced Pharma Capabilities Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capabilities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

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