Pharmaceutical companies face a number of challenges when sourcing comparator compounds for clinical trials, including addressing product lead times, availability, expiry limitations, safety or cost. Learn how clinical trial sponsors can determine the best strategy to meet these challenges.
An important measure of success of any clinical supply chain strategy is whether or not clinical sites have the necessary study medications at the ready when needed to avoid delays in new patient starts or continuance of therapy. Forecasting and demand simulations are useful for anticipating when and where stock is likely to be needed to formulate a kit production and distribution strategy.
Clinical trial protocol template can help investigators create high quality protocols that are consistent, well organized and contain all pertinent information needed to be properly reviewed. Read more!
The growth in outsourcing is one strategy life science innovators are pursuing to address the evolving pharma landscape; however, should a sponsor company seek the traditional route of utilizing multiple partners across the supply chain or does an integrated CDMO offer a more efficient and faster path to commercialization?
Despite their potential to increase the efficiency healthcare, autologous cell therapy treatments present significant challenges to most companies when it comes to development and manufacturing.
The ability to link key pieces of data and mine experiments captured in BIOVIA Workbook moves a top pharmaceutical organization toward true scientific knowledge management.
At the end of the day (or several years), sponsors and the FDA ideally work collaboratively during the drug development process, having a shared public health goal of making safe, effective, and high-quality drugs available to the American public as quickly as possible.
About a month ago, I was offered a tremendous opportunity: to attend a media trip to Thailand to learn about the country’s burgeoning life sciences industry. Like many people in the life sciences industry, I had no idea just how much has been going on within the country in terms of life sciences.
Alvotech's facility features a high-yield disposable fermentation and downstream process, with a fill-and-finish line for vials and prefilled syringes,and end-to-end upstream/downstream automation.
While existing cGMP processes are likely to continue using stainless steel infrastructure, many new products are going directly into single-use production equipment.
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