Newsletter | February 21, 2025

02.21.25 -- Inside Interius' Global Regulatory Strategy

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Join Cell & Gene Live for an exclusive look at cutting-edge manufacturing technologies revolutionizing cell therapy production. Our expert panel will explore organoids, 3D cultures, automation, and scalable solutions to streamline processes and enhance efficiency. Gain insights into the latest innovations driving the future of cell therapy. Registration is free thanks to the support of CPC and MaxCyte.

FOCUS ON CLINICAL TRIALS

Inside Interius' Global Regulatory Strategy

Interius BioTherapeutics' lentiviral gene therapy INT2104, which creates CAR T and CAR NK cells in vivo, headed to clinical trials in Australia where the company dosed a first patient with a B-cell malignancy. CEO Phil Johnson, M.D. gave us a look inside the company's global regulatory strategy.

The Sponsor's Clinical Development Handbook For Gene Therapy Trials

Gene therapy has existed for decades, but the field is not as mature as it may seem. Here, the author provides essential insights and strategies for overcoming gene therapy development challenges.

Overview Of Parkinson's Disease: Global Clinical Trials Landscape

Parkinson's disease affects over 8.5 million globally. Explore how advances in gene therapy, Deep Brain Stimulation, and innovative drugs are transforming treatment and improving patient outcomes.

Transition Clinical Cell Therapy Manufacturing To A Commercial Scale

If you're a CGT manufacturing company transitioning to automation, consider the strategies and manufacturing roadmap provided herein and how they can improve efficiencies in development.

Advancing Gene Therapy For Rare Diseases

Delve into key considerations when conducting clinical trials for gene therapies, including collaboration between stakeholders, site management, and patient-centric strategies.

The Key To Clinical Trial Success In 2025

As the landscape of clinical trials continues to evolve, point-of-need care and the integration of mobile clinics present a scalable approach to improve retention, compliance, and patient satisfaction.

Defining The Necessary Steps In Antibody Development

Explore antibody development and production, the processes and steps involved, and the screening and selection of antibody candidates.

Marketing Application Publishing Best Practices

Explore how effectively managing the publishing of documents required for a marketing application submission can help accelerate the time it takes to bring your product to market.  

CLINICAL TRIALS SOLUTIONS

Avance Clinical North America: Proven Expertise With Global Solutions For U.S. Biotechs - Avance Clinical

Bridging The Gap Between Research & Healthcare - OpenClinica

FOCUS ON SUPPLY CHAIN

Digital Certificates Of Analysis: A Vision For The Transfer Of Quality Data

The pharma/biotech industry must ramp up adoption of digital certificates of analysis, which are transforming the way quality data is transferred between organizations in the supply chain.

Keep It Cool: Cellular Cryopreservation For Clinical Applications

Cryopreservation is essential for storing stem and T cells for therapy but poses challenges like low survival and function loss. Watch to explore optimization strategies and solutions.

SUPPLY CHAIN SOLUTIONS

Flexible Freeze Containers - W.L. Gore & Associates

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