Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system is the integration of risk-based thinking. While the concept of risk management is not new, previous practice was more reactionary, primarily focusing on detection after the fact, root cause analysis, corrective actions, and preventing recurrence of the failure. Contemporary thinking places the emphasis on considering risks up front (prevention) and having a solid approach to address risk in planning, managing, and driving actions.
New York City has long aspired to become a life sciences hub, but while the city seems to have all the elements necessary to foster such industry growth, it has continually fallen short of this goal. New York currently ranks a distant third behind both Greater Boston and the San Francisco Bay Area, and there’s some work to do if it hopes to catch up.
Adopting a life cycle management approach will assist in identifying risk factors and constraints and provide structure and control, with a clearly defined methodology to identify and mitigate risk.
Clinical research is becoming more and more complex due to many factors, including increased regulations, competition for patients, and cost of conducting clinical trials. Most of the smaller pharmaceutical and biotech companies (sponsors) do not have the workforce to provide proper oversight of a clinical trial. This forces companies to outsource much, if not all, of the trial oversight to contract research organizations (CROs) and service providers (vendors).
Our discussion continues with the physical application of GMP design practices as influenced by the CDC and NIH regulations. The first part of our design discussion covers various processes and their applicable BSL levels, to understand the risk levels and what types of processes must be contained.
Serialization in the pharmaceutical sector is a direct response to the problems of counterfeit, stolen, and gray-market drugs. There’s been a huge incentive for counterfeiters to duplicate high-profit-margin products. According to the 2016 Brand Protection and Product Traceability Market Research Report from PMMI, the black market for counterfeit drugs is about $75 billion annually.
In today’s world of ever-increasing regulatory scrutiny on pharmaceutical quality we have all witnessed first-hand the public relations nightmare of adverse events, drug recalls, and even company closures. In response, pharma companies have set stricter rules and regulations for their employees to follow, to ensure they remain in compliance with regulators and avoid negative inspection results.
There have been considerable updates in the Brexit situation since April 2017, including, the surprising result of the U.K. general election. If anything, news regarding Brexit and the biopharma industry has started to heat up in recent months, and there have been a number of relevant developments that manufacturers must keep their eye on.
Wall Street is wondering what’s next on Amazon’s shopping list, and pharmaceuticals may be a leading contender. Here are four patient touch points where Amazon can leverage its existing capabilities in conducting clinical trials and pharmaceutical development.
Real-world evidence is a hot topic in clinical research right now. But too often, the massive amounts of data now available from electronic medical records used in routine medical practice are being considered to be clinical evidence to support medical decision making. However, the process of transforming these large data sources into actionable evidence that can change clinical practice is a complicated but important endeavor.