Category: Industry Insights

  • The Industrial Internet of Things and the Life Sciences Industry – Part II

    Checkout Part 1 of this Blog: The Industrial Internet of Things and the Life Sciences Industry – Part I When discussing the Internet of Things (IoT), it is important to contextualize the technology. With as nondescript a term as the “Internet of Things,” it can be difficult to understand the implications of this technology upon initial […]

  • The Industrial Internet of Things and the Life Sciences Industry – Part I

    Over the years, maintenance operations – as defined by standard plant accounting procedures – have been recognized as major expenses for manufacturing plants. Since 1981, the industry has seen a significant increase in overall maintenance costs for manufacturing companies. In 2000, costs had reached over $1 Trillion. It was during these years that the saying […]

  • The M&A Roller Coaster

    Following 2015’s significant rise of mergers and acquisitions (M&A) in the Pharmaceutical industry, Price Waterhouse Coopers’ Health Research Institute’s 2015 annual report suggested that the year of 2016 would be “the year of merger mania” for the Pharmaceutical and Life Sciences industries. Although 2016 had started out to be exactly that, the second half of […]

  • The Impact of Quality Standards on Compounding Pharmacies

    Pharmaceutical compounding as we know today has grown exponentially since its origin – creating greater complexities than ever before. Drug compounding was once the job of local community pharmacists – preparing personalized medications based on patient-specific needs. More recently, the industry experienced a growth in mass production of compounded drugs due an increase in cost. […]

  • The Brexit’s Impact on Global M&A

    The Brexit vote, which occurred back in June 2016, left the world wondering what would happen to the United Kingdom’s economy, as well as the impact it would have on their own country. Many people predicted that the vote would have a negative impact on the Life Sciences industry – effecting the future of funding […]

  • The Cancer Moonshot Summit

    In my previous blog, I discussed the announcement of Vice President’s, Joe Biden, cancer “moonshot.” After six months from the launch of the government’s moonshot, the United States has not yet doubled the rate of progress toward finding a cure as had hoped yet, there have been many efforts made with reference to the end goal. Since the announcement of the […]

  • A Race for CAR-T Cell Manufacturing

    The process of developing novel cancer therapies is complex. As a result, the industry is seeing a growth in in-house manufacturing for companies with a focus on cancer treatments. Companies need to move fast and efficiently, as they are facing fierce competition. Companies in the Spotlight Kite Pharma recently opened a new CAR-T cell manufacturing […]

  • The FDA’s New Draft Guidance

    More recently, the FDA has begun seeing data integrity as a major concern to the violations discovered during audits. As a result, the FDA published its new draft guidance, Data Integrity and Compliance with cGMP, in April 2016 with the purpose to provide organizations with recommendations to ensure reliable and precise data documentation; which will […]

  • Could The United Kingdom Be The Next Life Sciences Hub?

    Implications of the Historic Brexit Verdict Since the final votes of the Brexit were counted, a majority of the UK’s decision to leave the EU has appeared pessimistic for the Biotech and Pharmaceuticals industries. As a result, there has been very little talk about any positive outcomes for the Life Sciences. Yet, can we truly […]

  • Departmental Roles of Data Integrity

    Adherence to cGMPs is vital to all Life Sciences manufacturers and data integrity is one component that impacts cGMP. A corporation’s data integrity is influenced by everyone at an organization. As a result, it is essential that employees at all levels understand their roles and responsibilities with data integrity. Let’s take a look at a […]