Innovation in gene therapy brings the potential for transforming patient care and obviating the need for chronic therapy through single-dose cures. Despite the potential long-term benefits of this new therapeutic modality, gene therapy companies face a number of underappreciated challenges.
It is certainly no surprise that risk management continues to hold the spotlight as a hot topic within the biotechnology/pharmaceutical industry. With the increased focus by regulatory authorities on an organization’s ability to identify, mitigate, and control risks, the industry remains in a state of growth, developing and evolving practices to ensure proper alignment with industry best practices and regulators’ expectations. Many organizations are finding it difficult to establish and embed risk management practices, as doing so requires a paradigm shift from a traditional risk-averse industry culture.
Not only must new IoMT patents make it through the typical granting process, the market’s size suggests that post-grant challenges may become increasingly common.
Since the introduction of similar biological medicinal products in the EU in 2004, biosimilars markets and their regulation have been evolving with the rise of two powerhouses: Europe and the United States. How does the rise of the China biosimilars market fit into this established picture?
Looking forward, it will be increasingly important for pharma companies to employ ingenious strategies to access data already existing in the healthcare environment, moving away from solely building and owning data sets.
CARVER + Shock is a vulnerability assessment tool that can help manufacturers of medicinal products protect their products from deliberate contamination. Originally developed by the U.S. military, the technique can also be applied to raw/starting materials, production, distribution, and commercial and retail sales.
The latest version of ISO 13485 already contains several requirements that do not exist in 21 CFR 820. In advance of the new proposed rule’s release, this article presents a summary of the potential changes’ impacts on medical device manufacturers once the proposed rule becomes final.
ASTM standard E2500, Specification, Design, and Verification of Pharma and Biopharma Manufacturing Systems and Equipment, elevates risk-based validation as a critical aspect of GMP manufacturing. This article explores validation’s role in efficiency and cost management, in an approach to ASTM E2500 from a scientific, value-added perspective
Over the past four decades, and especially in recent years, progress in the development of cell and gene therapies has reached unprecedented levels. In gene therapy alone, between 1989 and 2015 there were more than 2,330 clinical research programs targeting almost 50 different indications.1,2 As more cell and gene therapies reach commercial stage, industry insiders expect research in the sector to continue to expand in the coming years. For patients, clinicians, and health systems, new cell and gene therapies bring the promise of historic and transformative advances in the treatment of many serious diseases.
Despite the best efforts of those directly responsible for data integrity, human error will still find its way into the equation and undermine the efforts. The potential for human error is directly and indirectly impacted by the corporate culture, the national/regional culture, and the quality culture of an organization.
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