Newsletter | April 29, 2026

04.29.26 -- The Impact Of FDA Risk On Biotech Rewards With CFO And Board Director Allan Shaw

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FEATURED ARTICLE

The Impact Of FDA Risk On Biotech Rewards With Allan Shaw

On this week's episode of the Business of Biotech, five-time public company CFO and seven-time public company board member Allan Shaw talks about why FDA decision-making feels less predictable, and how that uncertainty is reshaping clinical trial strategy, investor behavior, and the innovation ecosystem.

INDUSTRY INSIGHTS

Best Practices In Rare Disease Patient Recruitment

Recruiting for rare disease clinical trials is daunting, and making patients aware of clinical trials, involving them in trial design, and building trust are a few ways sponsors can boost recruitment.

Phase 1 Trial In Painful Diabetic Peripheral Neuropathy

A complex Phase 1 neuropathy study with overnight stays achieved full enrollment and retention through careful planning, strong participant engagement, and disciplined operational execution.

Gene Therapies For Rare Diseases: Platforms, Modalities, And Delivery Systems

Examine the treatment landscape for rare diseases and the rapid evolution of gene therapy across three key dimensions: editing platforms, delivery modalities, and delivery vehicles.

Building The Plant Of Tomorrow With Modular Automation

Modular automation with MTP enables plants to adapt quickly and scale efficiently. See how standardized, plug-and-produce modules reduce complexity and accelerate time-to-market.

SMB Technology: Optimizing API Purification

Explore how Simulated Moving Bed (SMB) technology can enhance API production while overcoming common misconceptions about chromatographic purification.

Patented Process For Intermediates Useful For Etrasimod Arginine

See how rethinking the synthetic strategy for Etrasimod can overcome the limitations of legacy routes, enabling more efficient chirality control, improved scalability, and more practical industrial API production.

Clinical Trial Matching With AI And Large Language Models

Unlock more accurate clinical trial matching by using AI to interpret complex patient notes, reducing the manual screening burden and identifying eligible candidates with higher precision.

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