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Cell and Gene Therapy, Industrial Impact

Benefit-Risk Considerations for Product Quality Assessments; Guidance for Industry; DRAFT GUIDANCE

May 10, 2022

Benefit-Risk Considerations

This guidance describes the benefit-risk principles applied by FDA when conducting product quality-related assessments of chemistry, manufacturing, and controls (CMC)2 19 information 20 submitted for FDA assessment as part of original new drug applications (NDAs) under section

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Advanced therapy medicinal products cell and gene therapies offer tremendous hope for patients either by actually curing serious diseases or by alleviating suffering.

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whitePaper | September 27, 2022

Cell and Gene Therapy (CAGT) activity has increased dramatically in recent decades, especially in Chimeric Antigen Receptor T-Cell (CAR-T) clinical trials and therapy registrations. The IQVIA CAGT Hot Buttons series covers basic concepts in CAGT for newcomers to this field.

Read More

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Advanced therapy medicinal products cell and gene therapies offer tremendous hope for patients either by actually curing serious diseases or by alleviating suffering.

Read More

BLOCKCHAIN ENABLED GENOME SECURITY FROM THE MOMENT IT IS SEQUENCED

whitePaper | June 8, 2022

Sequencing of human genomes is fast becoming an affordable technology for general consumer.

Read More

BIOPHARMACEUTICAL INDUSTRY AND INTERRELATED BIOTECHNOLOGY ORGANIZATIONS

whitePaper | November 21, 2019

Our Accounting and Finance team has published an overview of the accounting and finance challenges facing the Biopharmaceutical industry and interrelated Biotechnology organizations.

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whitePaper | December 16, 2022

Bispecific antibodies (bsAbs) are genetically engineered, recombinant antibodies that consist of two distinct binding domains.

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Cardinal Health is fortunate to sit at the crossroads of the United States (U.S.) healthcare system, engaging with stakeholders from across the industry including healthcare

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