From The Stage

CMC Requirements for Cell and Gene Therapy for IND Applications

Posted by BioAgilytix / / Regulatory Considerations

The U.S. Food and Drug Administration (FDA) has issued Chemistry, Manufacturing, and Control (CMC) recommendations for Investigational New Drug (IND) applications for human investigational gene therapies. The focus of the guidance is on SISPQ (safety, identity, strength, purity and quality), critical quality attributes (CQAs) and risk assessment. These apply to new cell/gene therapy products that have been developed in recent years. The FDA’s requirements, updated in January 2020, cover critical factors such as: Specification/characterization of manufacturing materials Filing and submission practices (i.e. eCTD or not) Manufacturing processes/procedures Product testing considerations…

FDA RACE for Children Act: What You Should Know

Posted by BioAgilytix / / Industry Update

Short for Research to Accelerate Cures and Equity, the RACE Act went into effect on August 18, 2020, and significantly increased the number of required studies devoted to pediatric cancer research, drugs, and therapies. Originally enacted in August 2017, as a part of the Food and Drug Administration (FDA) Reauthorization Act (FDARA), the RACE Act is an amendment to the Federal Food, Drug, and Cosmetic Act (FFDCA) which was created to extend user-fee programs for drugs, medical devices, and biosimilars, as well as other biological products. Key Factors of the…

The Benefits of Outsourcing R&D Processes to CROs

Posted by BioAgilytix / / CRO Selection

As a leading contract research organization (CRO), BioAgilytix helps companies around the world with research and development, leveraging expertise in cell-based assays, immunogenicity, biomarkers and pharmacokinetics. We perform assay development and validation as well as sample analysis, lot release testing and ongoing data surveillance after drug products are introduced to market. Committed to helping reduce drug development timelines and costs, we are not alone in this growing industry. In fact, our work represents the larger-scale trend of pharma companies outsourcing R&D to CROs specializing in state-of-the-art technologies and expertise. The…

Noninvasive Liquid Biopsy Assays Integrating Tumor and Immune Biomarkers Prove to Be Promising Tools in Immuno-Oncology

Posted by BioAgilytix / / Immuno-oncology

Tumor tissue biopsies have been the traditional method of identifying and analyzing cancer cells. But in addition to being invasive and risky, they have many limitations. Tumor accessibility is often problematic as are issues with monitoring the progression of disease. Tissue samples from a single location don’t always provide a full picture of a tumor’s genetic heterogeneity, limiting accuracy. The more data oncologists have about a patient’s cancer, including genetic information, the more precisely it can be diagnosed, treated, and monitored. Immunotherapy has quickly evolved as a promising treatment modality…

The Benefits of Hiring the Right CRO

Posted by BioAgilytix / / Industry Update

Short for Contract Research Organization, a CRO is a company that provides clinical research support to the pharmaceutical, biotech and medical industries on a contract basis. Contract Research Organizations are hired to offer research support and conduct clinical trials to safely and efficiently bring life-saving drugs and vaccines to market. Lasting partnerships between CROs and pharmaceutical companies are vital to the long-term success of ongoing programs and clinical trials. When a CRO fails to meet certain criteria relating to safety protocols or deadlines it can leave some companies questioning whether…