Newsletter | June 18, 2024

06.18.24 -- ISPE Offers Best Practices For Making Allogeneic Cell Therapies

SPONSOR

Clinical Research As A Delicate Ecosystem

Making the right outsourcing decision can significantly contribute to the success and growth of your program, providing essential support and resources that empower it to thrive in its objectives and endeavors. Entrust that your program is in hands you can rely on, where integrity is paramount, and excellence is the standard.

FEATURED EDITORIAL

New Guide Tackles Best Practices For Making Allogeneic Cell Therapies

The ISPE sought to accelerate guideline development for allogeneic cell therapy. This discussion digs into some of the bigger themes in its recent guide.

INDUSTRY INSIGHTS

Selecting Container Closure Systems With Confidence: Lyophilization

Experts take you through the entire selection process for primary packaging components for lyophilization and provide aspects to consider for all relevant attributes.

Faster From Formulation To Fill/Finish

Optimize your speed to clinic by securing a development and aseptic fill/finish partner to support your applications with the right manufacturing equipment, communications, and SOPs.

My Worst Nightmare In RSTM: Accidental Unblinding

Learn how collaborative efforts from study managers, supply managers, biostatisticians, designers, and clinicians can better protect the blind in clinical trials and prevent accidental unblinding.

Cell And Gene Therapy Logistics Management: A Holistic Approach

Learn to recognize essential logistics requirements to create a holistic and comprehensive approach to logistics management that successfully addresses the spectrum of complexity across all CAGT assets.

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Proactive Strategies To Evaluate And Mitigate Clinical Supply Risk

Successful clinical trials are crucial for advancing a novel therapeutic to market and maintaining a competitive edge. Clinical trials face risks such as supply shortages which can cause costly delays and impact the safety and well-being of the patients involved in the trial. Learn about strategies that can help build an understanding of risk assessment when developing a clinical supply plan with this on demand webinar.

SOLUTIONS

Direct-to-Patient Supply Management

Navigating The Use Of Controlled Substances In Clinical Trials Using IRT