Newsletter | September 2, 2026

09.02.26 -- When Timelines Trump Science In Neuropsychiatric Trials

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How can life sciences companies developing new medicines engage the FDA successfully during a period of rapid changes in agency personnel and policies?  Register for 9-15-26 Crossing The Valley Of Death: New Funding Options For Preclinical And Early-Stage Drug Development for free and learn from an experienced panel of experts about key changes at the FDA, how companies can get the most out of agency interactions, and strategies to lower risks and avoid regulatory surprises.

FEATURED ARTICLE

Nasdaq's New MVLS Rule: Rethinking Exchange Choice For Micro-Caps

Nasdaq’s new $5 million MVLS rule raises delisting risk for micro-cap life sciences companies, making exchange choice an ongoing board governance issue.

 

INDUSTRY INSIGHTS

 

Traditional, Hybrid Or Decentralized: What Actually Works?

Learn how traditional, decentralized, and community-based approaches address different study challenges and support more effective, patient-centered research.

 

Speed Kills: When Timelines Trump Science In Neuropsychiatric Trials

This Bold Conversation brings together experts helping to define the next chapter of psychedelic clinical research to unpack lessons from recent regulatory reviews and explore what clinical teams need now.

 

Advancing Lentiviral Vector Manufacturing For CAR-T Therapies

Discover how scalable, cost-effective, and high-quality lentiviral vector manufacturing can accelerate both ex vivo and emerging in vivo CAR-T therapies.

 

A Platform Approach To Better Bispecific Antibodies

Novel bispecific antibody engineering overcomes assembly and manufacturability challenges, enabling scalable production while preserving therapeutic function, stability, purity, and product quality.

 

Five Key Factors For Sustained Post‑Launch Success

From payer negotiations and formulary expansion to real-time uptake analytics and global distribution, post-launch success depends on a commercialization partner that adapts as market conditions shift.

 

Flexibility And Capability In Pre-Filled Syringes: The Future Of PFS

Explore the benefits of prefilled syringes (PFS), their role in biologic and vaccine delivery, rising demand following COVID-19, and the value of partnering with a flexible CDMO.

 

Nurturing The Next Generation Of Life Science Innovators

A strong life sciences ecosystem offers organizations a deep talent pool, an extensive R&D presence, and dedicated backing through local government investment.

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