Newsletter | October 30, 2026

10.30.26 -- Escape The Biotech's Valley Of Death

SPONSOR

Can CDMOs Keep Up With the Next Generation of Medicine? Join us November 11, 2026, at 11 AM ET for Outsourcing the Uncharted: Manufacturing Complex and Emerging Therapies, a free expert panel exploring the challenges of outsourcing complex, personalized, and live-cell products—and how innovators are finding specialized CDMO partners to bring breakthrough therapies to patients. Register today!

INDUSTRY INSIGHTS

From Molecule To Milestone: Fast Track Formulation

Fast‑track, data‑driven formulation strategies align early decisions with long‑term goals, enabling First‑in‑Human progress while reducing risk, avoiding rework, and supporting manufacturing.

A Roadmap To Expedited Review Pathways

Accelerated development and manufacturing timelines provide developers with paths to move new therapies to market quickly while still maintaining a balance of risk/benefit assessment. 

Chemoenzymatic ADC Conjugation For Higher Efficacy

A chemoenzymatic process creates uniform DAR2 ADCs from native mAbs through glycan remodeling and click chemistry, delivering stronger in vivo efficacy than a comparable marketed ADC.

FEATURED EDITORIAL

Escape The Biotech's Valley Of Death

The biopharmaceutical's “Valley of Death” is entered through a desert of dwindling funding. Chief Editor Louis Garguilo talks with two consultants on avoiding financial failure when outsourcing development and manufacturing. The many contributing factors for failure may have a common denominator: Project Management is an overlooked financial savior.

AI Doesn't Sit Still. Validation Must Adapt

The computer system validation playbook was written for software that holds its shape. AI doesn't. Validating it has to become an act of governance.

INDUSTRY INSIGHTS CONTINUED

Rapid, Material-Sparing Feasibility Screening For Hot Melt Extrusion

Discover a screening process to quickly assess HME feasibility that yields more accurate predictions for API loading and degradation while saving material and time compared to traditional approaches.

Advancing Precision Dosing In Oral Solid Drug Delivery

Combining a precision dosing device with multiparticulate drug delivery enables accurate, repeatable oral dosing, supporting personalized treatment and improved patient outcomes.

The Delicate Dance: When Phase-Appropriate Decisions Carry More Risk

 Early drug development demands speed, but some decisions carry long-term consequences. Learn which process and analytical choices require teams to look beyond the next milestone.

Navigating The New USP Chapter <382> For Elastomeric Closures

Dive into the scope of <382> for pharmaceutical closures and the regulatory landscape, which includes new required tests, instrumentation for compliance, and recommendations on implementation.

The Most Important Team In Pharma Manufacturing That Nobody Talks About

Pharmaceutical manufacturing facilities require active management and engineering expertise to balance costs, plan long-term infrastructure, and minimize production downtime.

SOLUTIONS

Performance Starts With Better Delivery

Experience That Drives Drug Delivery Innovation

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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