Developing products in the life sciences industries is complex. Basic quality tools can be used to bring the complexity into focus and help streamline the development strategy. These tools can help identify your primary goals and assess potential risks and failure modes to enable agile thinking early in development, where experimental outcomes often indicate the need to alter your development strategy.
Previous articles on Clinical Leader have discussed the potential benefits of wearable devices for remote patient monitoring in clinical trials. In addition to possible increases in trial efficiency and reduction of costs, “wearables” have the potential to collect data better reflecting patient functioning and response in the real-world setting. According to the Clinical Trials Transformation Initiative’s Mobile Clinical Trials (MCT) Program, mobile devices, including wearables, offer the opportunity to collect more complete and informative data than ever before. Mobile devices may also reduce the patient burden in clinical trials, thus enhancing the patient experience. Companies are exploring the use of wearable devices in the post-marketing setting as well, as a component of patient care.
Your manufacturing CMO has just announced that it is preparing to implement a new technology that will improve quality and save time and money. Now, you just need to figure out if you are able to align the needs of your product or products and get on board with the change. Innovation and improvement efforts need to consider all aspects of the impact, including quality and regulatory considerations, supply constraints, market constraints, and cost.
To be entitled to a patent, an invention must satisfy a number of patentability requirements, including the “patent eligibility” requirement under 35 U.S.C. § 101. In this three-part series, we will look at how the U.S. Supreme Court’s jurisprudence on patent eligibility has evolved, examine the impact of its March 2012 decision in Mayo Collaborative Services v. Prometheus Labs, Inc. on life sciences patent litigation in lower courts, and discuss what it means for patent eligibility of biologic and biosimilar patents.
Modeling and simulation (M&S) in the drug development process is an industry-proven scientific approach used to inform crucial drug development decisions such as dosing, drug-drug interaction (DDI), and other critical safety and efficacy questions. The FDA has shown a strong commitment to utilizing M&S in the drug development process.
The recent announcement that the watchdog group Center for Responsible Science (CRS) has filed a lawsuit against the FDA has raised some concerns in the clinical research community. The lawsuit is regarding the denial of the group’s citizen petition, which was originally submitted in June 2014.
Part 1 of this two-part article addressed FDA warning letter enforcement actions and discussed things that can go awry in these relationships related to data governance and data integrity. In Part 2, we turn our attention to health authority GMP guidance on contractual relationships and best practices that should be considered in this area.
A holistic view of the value of blockchain to the pharmaceutical supply chain takes into account the magnitude of the global counterfeit drug problem; the financial, economic, and social costs of counterfeit drugs; and the positive financial and economic benefits of moving beyond compliance to tackling the issue of counterfeit drugs head-on.
While presenting a webinar on the CMO selection process not long ago, I had a moment of clarity. Even though I didn’t include the following words in 36-point block letters on any slide, I suddenly discovered the essence of the lecture
In this article I will present five often ignored elements of a solid statistical analysis plan that help to address those “what-ifs” and will make troubleshooting the inevitable deviations easier. As you will see, a little thoughtful consideration of what could go awry up front will keep you from pulling out the duct tape and hammer to jerry-rig after the fact.