The pace of change in the Life Sciences industry is both exciting and extraordinary, resulting in core paradigm shifts in both strategies and processes for key industry stakeholders. Leading Life Sciences organizations understand that in order to meet these challenges they must excel in scientific leadership and innovation for processes […]
Ensuring better-managed stocks of high-quality vaccines is the key to addressing large-scale outbreaks. Image Source: Flickr User CDC Global Health Over the last couple of years, there have been massive outbreaks of nightmarish illnesses such as Zika virus, Ebola, Yellow Fever and the resurgence of both measles and mumps. Many […]
As concerns about the drug manufacturing process grow, pharmaceutical companies must adopt digital solutions that reduce quality variability. Image source: Flickr CC user Michael Chen Last year, the FDA proposed standards for quality metrics and followed that up with guidelines covering data integrity and cGMP compliance. The latter, in particular, […]
Restructuring and streamlining operations have been a core strategy for many pharmaceutical companies in recent years. But while small molecule and solid dosage efforts are often the target of such cost-cutting measures, life sciences firms have been concentrating on increasing biologics manufacturing efforts.
“Personalized medicine” is an increasingly popular catchphrase in modern health care and advocates of this approach argue that doctors should not assume that one treatment will work for every patient with a certain disease or condition. Instead, it’s believed that doctors should prescribe individualized medical treatments based on an evaluation […]
Today’s shifting regulatory environment continues to exert mounting pressure upon the pharmaceutical industry. In a recent meeting with Congress, the FDA presented draft guidance seeking to modernize drug manufacturing. The suggestions encourage life sciences firms to adopt emerging technologies to improve drug quality. Poor quality can lead to costly recalls stemming from a variety of failures such as compromised sterility, mold in manufacturing areas and contaminated containers. It can even result in delayed product launches. In addition to the potential health risks, these delays and recalls contribute to shortages, which can prevent life-saving drugs from reaching the patients who need them.
After seven years of intensive negotiations, terms of the Trans-Pacific Partnership (TPP) were finally reached in early October. A trade agreement between twelve Pacific Rim countries, the TPP seeks to promote economic growth and covers all industries, including those dealing with the life sciences. While intended for collective gain, the deal has caused some consternation within the innovative field of biologics. In fact, it’s been speculated that reaching accord on the provisions governing the intellectual property protection of biopharmaceuticals contributed to delays in reaching a final agreement. But now that a compromise has been reached, what does this mean for the nations involved—and in particular, the United States?