With attention shifting to data integrity, companies must increasingly be able to guarantee the reliability and accuracy of their quality data. To do otherwise could leave companies vulnerable to data integrity and quality risks that increase their chances of noncompliance.
Following the explosion of biomedical understanding over the last few decades, researchers have begun to develop biologic therapies for diseases. Understanding the biologics regulatory pathway will help researchers utilize emerging technology while ensuring that their new therapies meet necessary standards at every step of the process.
Attention to detail is par for the course within most modern industries and fields, including scientific research. In addition to finding ways to remain competitive in today’s crowded market and maintaining margins in the face of rising R&D costs, life science organizations now have to take into consideration more regulatory […]
The announcement of regulatory changes can fill life sciences companies with trepidation. More often than not, the implementation of such updates would require resources and manpower that organizations cannot provide without significant investment or reallocation. However, it seems like tightening guidelines are becoming the norm in the life sciences industries.
Quality management remains a top concern of many life sciences companies. How do they streamline quality processes to minimize bottlenecks and speed up the release cycle to gain advantage in today’s competitive pharmaceutical market? Even more importantly, how do they achieve these goals while keeping costs down in order to […]
While much of the United States may still be experiencing the harsh temperatures of winter, spring is only a few weeks away. Unfortunately, warmer days also mark the coming of something else: seasonal allergies. Many people suffer from this condition—something that drug companies are well aware of, if the number of allergy relief products lining drugstore shelves is any indication. Recent events, however, may alter what medications will be available over the counter in the near future. Earlier this year, a major pharmaceutical company had to recall its OTC versions of two popular allergy medications. One of the drugs was found to potentially contain an impurity while the other may have incorrect dosing markings. The recalled medications aren’t actually suspected of any harmful contamination, but no one wants to risk administering a potential overdose.
Most famous for its juggernaut cell phone business, Samsung entered the life sciences arena in 2011 with the intention to become an expert in manufacturing biologics. The actions it’s taken in the time since definitely support that proclamation. From investing $2 billion to building multiple production plants, it is now the largest for-hire biologics manufacturer in the world. In addition to its contract manufacturing plans, Samsung has a division devoted to making its own biosimilars of biologics whose exclusivity periods are expired or close to expiring. This aim, in itself, would not be especially noteworthy. Other companies have adopted the same strategy. What’s particularly striking about Samsung’s biosimilar initiative is the company’s claims that it can manufacture the copycat drugs at half the cost of Western drug-makers. A stunning declaration to make in a time when many people remain uncertain about the quality, safety, and efficacy of biosimilar products despite the purported cost savings due to increased competition.
The biotherapeutics market has seen marked growth in recent years, a trend that isn’t likely to change anytime soon. If anything, as more innovative drugs gain regulatory approval, the field is guaranteed to become increasingly crowded. In order to remain competitive, life sciences companies will need to find ways to speed up their product release cycle. In fact, estimates claim that delays occurring during the discovery and preclinical development of a new drug can value a loss of $1 million per day. Indeed, in the current climate, organizations must adopt strategies that support efficient operational excellence in the hopes of not only recouping their investment, but to also maintain their advantage over rival firms.
Are we finally about to see a change in the U.S. gene therapy sector? Stark Therapeutics would certainly like us to think so. The company recently announced that one of its drugs has succeeded in late-stage clinical trials. The medicine in question treats patients with rare, inherited retinal dystrophies that […]
For modern life sciences companies, quality management efforts often top the list of challenges they face when working to bring new products to market. Today’s highly competitive environment favors fast release cycles, while mergers and acquisitions have resulted in large organizations that span the globe and that are more difficult to oversee. […]