Newsletter | June 13, 2025

06.13.25 -- The Hidden Risk In Cell & Gene Therapy Commercialization

FOCUS ON CLINICAL TRIALS

The Hidden Risk In Cell & Gene Therapy Commercialization

Of the root causes of new product launch failure, insufficient relative advantage is by far the most important. Let's take a closer look at lessons we can learn from two key (approved) cell therapies.

Enabling Market Access As CGTs Reach More Patients

Bringing potentially curative cell and gene therapies to more patients requires a focused approach to market access. Discover essential insights into payer dynamics and treatment evolution.

The Rescue Option: Course Correcting Struggling Clinical Trials

The willingness to seek expert support from Rescue CROs when clinical trials face critical challenges is not a sign of weakness but a demonstration of accountability and commitment to excellence.

Bladder Cancer: Challenges And Innovations

Bladder cancer ranks ninth in incidence and 13th in mortality among cancers. Recent advancements in treatment are transforming the management of advanced bladder cancer cases.

Harnessing RWE For Effective External Control Arms In Clinical Trials

Real-world evidence (RWE) is transforming clinical trials by enabling the use of external control arms (ECAs), which serve as an alternative to traditional randomized control groups.

U.S. Oncologists See Promise In CGTs, But Barriers Loom

Explore the findings of a survey of 124 U.S. oncologists focused on better understanding the current use of cell and gene therapies (CGTs) and possible barriers to future adoption.

CLINICAL TRIALS SOLUTIONS

Dermatological Assessments - CHDR

End-To-End Data Management Services - Avance Clinical

EHR-To-EDC Success In A Complex, Adaptive Platform Trial - OpenClinica

FOCUS ON SUPPLY CHAIN

A Road Map For Transitioning From A Research-Focused To Commercialization Mindset

As the timeline for commercialization closes in, it’s necessary to best position the organization for a successful launch. Where to start?

Safe Storage And Handling Of Viral Vectors

In order to advance viral vectors like AAVs, there's a growing need for technologies and platforms that facilitate reliable and safe handling all the way from production to shipping and storage.

Biopharmaceutical Packaging Solution Advancements And Considerations

Explore how to develop a strong packaging system, and learn more about why a reliable supply chain is critical for drug substance and drug product transport.

SUPPLY CHAIN SOLUTIONS

Safely Transport ATMPs In Single-Use Bags - Single Use Support

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