This article explains why having the right and option to seek declaratory relief is still important to a biosimilar applicant despite the patent resolution mechanism provided by BPCIA, examines the limitations on declaratory judgment actions imposed by BPCIA, and discusses recent court cases addressing biosimilar applicants’ rights to declaratory relief.
When weighing the operational and product constraints — batch size, container throughput, cost per unit, equipment utilization, facility footprint, cost per square foot, etc. — it is important to consider all of the options available to provide the most effective processing approach for the product manufacturer and, importantly, the best quality product for patients.
Cell and gene therapies are finally becoming a reality, with hundreds of clinical trials underway and some major therapeutic breakthroughs already reaching the market. In the past year alone, the FDA approved its first gene therapy, Spark’s Luxturna for the treatment of a rare form of vision loss, as well as the first two CAR T-cell therapies, Novartis’s Kymriah and Gilead’s Yescarta, for certain forms of blood cancer. While this certainly marks the beginning of an exciting period in the development of cell and gene therapies — the culmination of decades of development — the future impact of cell and gene therapies is uncertain.
I had been working with a large CMO on a commercial injectable product for a couple of years; the CMO had a terrific support structure, including a fully functioning laboratory. Its quality systems met my team’s needs and its regulatory team provided appropriate support for our program. However, when we tried to bring in a clinical trial drug product, we found several limitations in using the CMO: there was not agility in meeting rapid timelines; also, process losses were acceptable for large-scale batches but represented significant issues for small batches. We needed some preclinical batches as well, so GLP manufacturing was part of our base needs.
As the minimally invasive approach continues to become standard procedure, demand for surgical visualization equipment will continue to rise. Continued adoption of 4k technology is bolstering growth in the total U.S. video and integrated operating room equipment market, which currently is valued at almost $2.3 billion.
When looking at most job descriptions in GMP companies, they now require a college degree. This leads to the question: Are we overvaluing educational degrees and undervaluing experience in our hiring practices and position expectations?
Medical devices released into the market are part of an evolving software and security ecosystem in which new vulnerabilities are discovered or introduced all the time. The FDA's Medical Device Safety Action Plan outlines evolving expectations for the medical device industry, including expectations for secure updates.
The FDA recently issued six draft guidance documents intended to serve as part of a modern, comprehensive framework for how CBER will help advance the field of gene therapy. This is the final article in a six-part series summarizing each of the draft guidance documents. It will discuss the guidance Human Gene Therapy for Hemophilia.
Proposals for the use of visual inspection (VI) as an analytical method for cleaning validation have been rising for several years now.1 This article discusses regulatory views on the use of VI as a sole criterion in cleaning validation, presents a case study on how inspectors can be qualified for VI, recommends the use of statistical techniques, and suggests how VI could be implemented as part of a control strategy in a cleaning validation program based on the level of risk.
The FDA recently issued six draft guidance documents intended to serve as part of a modern, comprehensive framework for how CBER will help advance the field of gene therapy. This is the fifth article in a six-part series summarizing each of the draft guidance documents. It will discuss the draft guidance Human Gene Therapy for Retinal Disorders.
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