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In recent years, cell and gene therapies have been generating highly promising results in clinical studies, advancing them toward the market. However, the small number of products launched to date have not been proven commercial successes, with a number of advanced therapies being withdrawn from the EU market and limited sales of CAR-T therapies in the U.S.
Developing a continuous manufacturing (CM) process for a new drug or implementing CM for an existing batch process demands significant time, effort, and money. Adapting any manufacturing process to CM requires in-depth chemical and mechanical engineering understanding as well as the right technologies.
In the United States, a national debate on drug pricing is taking place, with questions being raised about why U.S. patients pay some of the highest fees in the world to access prescription medicines. One drug class in the spotlight more than others is the insulins, as U.S. politicians put their pricing and the manufacturers that market them under scrutiny.
Why does “Quality” seem like such a slippery, elusive term? The answer is easy: It’s because the people who claim to know it really don’t. And everyone else is exhibiting a form of the psychological bias known as the bandwagon effect, in which they go along with the rhetoric because everyone else is.
Not only must new IoMT patents make it through the typical granting process, the market’s size suggests that post-grant challenges may become increasingly common.
Looking forward, it will be increasingly important for pharma companies to employ ingenious strategies to access data already existing in the healthcare environment, moving away from solely building and owning data sets.
Thanks to our relationship with LSTI and an outstanding team here at Accelovance, we have built a training program that is able to be leveraged moving forward to address an industry need.
My main reason for taking the course was to re-evaluate quality agreements and how to improve our current template. Coming out of this, I would like to compare a few of our supplier quality agreements against the structure and checklist given in the course to see how they align.
Cook Pharmica LLC
All parts of the training were useful, including the topics of Documentation, Change Control and Revisions. I will now review our current Quality Agreement to make sure the requirements are included, and if not, add them.
I took the course to get a better understanding of FDA requirements. As an ISO 9001 registered organization, we need to control and cooperate with suppliers and this gave me some ideas on more formal ways to do that. The webinar was easy to attend with clear audio.