<span class="archive__title-prefix>Posts Categorized:</span> Conference Spotlight

Early-phase cell and gene therapy (CGT) product development focuses primarily on product safety issues. However, it is also critical to demonstrate the firm’s capability to consistently and reproducibly manufacture its investigational product. At the ISPE Annual Meeting held in Orlando, Florida, in early November 2022, Center for Biologics Evaluation and Research (CBER) Office of Tissues […]

Cell and gene therapy (CGT) is an emerging and promising field of medicine that offers cures for rare and debilitating diseases, though often at exorbitant costs. The science supporting CGT is complex, and serious side effects are possible. The complexity and variability of these technologies, their novelty, the assays required, and the excitement of the […]

Which GMP quality system was most often linked to FDA drug recalls since 2012?  Redica’s Jerry Chapman asked the audience that question at the February Pharma Hot Topics Conference in San Diego during his presentation, “A Deep Dive Into Industry-Wide Recall Data: Leveraging an Expert Ontology and AI to Uncover Patterns and Insights.” A senior […]

Cell and Gene Therapy (CGT) is one of the fastest-growing areas of research and development in the healthcare sector internationally. Some of the resulting products have been touted as miracle cures and demonstrated to provide transformative results for some patients. CGT products have been developed to treat a wide range of rare and debilitating diseases […]

How does FDA decide whether to conduct a biologics manufacturing inspection in person or perform a remote assessment? At the GMP by the Sea annual conference in Cambridge, Md. in August 2022, FDA Office of Pharmaceutical Manufacturing Assessments (OPMA) deputy director Derek Smith explained that the agency makes decisions based on a variety of risk […]

Insights from Peter Baker at the 46th International GMP Conference An investigation into data integrity (DI) issues is “almost inevitable” for every company in the industry within about two years, says Peter Baker, former FDA investigator and president of Live Oak Quality Assurance.  Speaking at the 46th International GMP Conference in March, Baker painstakingly detailed […]

What are the current and future anticipated states of biologics inspections regulated by CDER? At the annual GMP by the Sea conference in Cambridge, Md. in August, FDA Office of Pharmaceutical Manufacturing Assessments (OPMA) deputy director Derek Smith provided insight into the inspection landscape of biologics regulated by CDER. [Related: Download our latest report that […]

During the recent pandemic, conducting in-person biologics manufacturing facility inspections has been a challenge and has forced FDA to look for innovative ways to maintain the quality of its oversight of drug manufacturing. In addition to remote assessments and other non-traditional methods to ascertain the quality and compliance of manufacturing facilities, the agency further explored […]

New and Hybrid Clinical Trial Approaches Under Review Companies and physicians planning and executing clinical trials have been challenged by the special circumstances and constraints brought about by the recent pandemic. The need to conduct the trials has accelerated the creation and adoption of new and hybrid clinical study designs, operational approaches, and data sources. […]

Persistent: (adj): existing for a long or longer than usual time or continuously Non-compliance (noun): failure or refusal to comply with something (such as a rule or regulation): a state of not being in compliance (Both definitions are taken from Merriam-Webster.com.) Put these two words together in the pharma world and the combination creates a […]