The evolution and complexities of drug development have prompted biopharmaceutical organizations to seek collaboration much earlier in their research and development (R&D) programs and better appreciate the value of collaboration in areas such as study planning and start-up. These arrangements are becoming critical to business strategies for many in the industry hoping to create greater efficiencies and advance the R&D of innovative medicines. One key factor that is driving the success of these collaborations is the willingness and commitment to share information such as study materials and training documentation.
A recently published article examining recent GMP inspection data from CDER (FDA’s Center for Drug Evaluation and Research) and MHRA (Medicines and Healthcare products Regulatory Agency) notes that “Deficiencies in investigations remains at the top of this list [of the most frequently cited observations] over the past four years. We as an industry cannot seem to get this quite right.” I agree.
This article presents a totality of evidence approach to show superior sterility performance of a well-designed closed system compared to conventional aseptic processing, and to design the control strategy.
Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. In order to properly prevent, destroy, and monitor microbial contamination in cleanrooms, several aspects of cleanroom microbiology must be understood. This four-part article provides a foundational introduction to some of those aspects.
To some extent, the Integrated Addendum to ICH E6(R1): Guideline For Good Clinical Practice E6(R2) has come and gone without much fanfare. Perhaps that’s because prior guidance documents surrounding risk-based quality management practices stole its thunder, and sponsors, CROs, and investigators were already well on their way to finding ways to “encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results,” as advocated by ICH E6 (R2).
It seems blockchain technology is following the hype path the cloud did a few years ago. The most talked-about example of blockchain is Bitcoin, a digital currency that does not rely on a central authority (such as the Federal Reserve) to clear financial transactions. A few short months ago, the word “blockchain” was seldom mentioned in supply chain circles. Now, it’s not uncommon to be asked what your blockchain strategy is within those same circles. What has changed is its successful use and blockchain platforms adding functionality.
Today Life Science Connect (LSC), a leading B2B marketing services and engagement company, announced the acquisition of Industry Standard Research (ISR), also known as ISR Reports.
The U.S. biosimilar market is relatively new. It took another two years for the FDA to issue the first draft guidelines for developing and registering a biosimilar in the United States, and another three years until the first biosimilar was approved.
In the last decade, the healthcare industry has witnessed significant changes, some of which present important challenges to how pharmaceutical companies develop drugs. One such challenge is the shift in influence from the physician to the payer in the adoption of new interventions. This article discusses threats to the traditional model of drug development posed by the increasing influence of payers and considers ways for industry to embrace “value-focused development” to simultaneously adapt to the evolving market and de-risk drug development.
Cleaning manufacturing equipment to prevent cross contamination of pharmaceutical products is a fundamental aspect of GMPs. Validation of cleaning processes has been required within cGMP industries for a long time and is recognized as an important activity to establish that product cross contamination is controlled to ensure patient safety and product quality.