Utilizing NGS for Proteomics - Olink® to Accelerate Drug Discovery and Optimize Clinical Trials Outcome

Individuals take for granted everyday interactions with well-designed products and devices that save both time and aggravation. Well-designed products can eliminate overall confusion for the user. Every day, more medical devices are designed for portability and at home monitoring. A major initiative in the medical device industry is to reduce the workload on our already overworked medical professionals. Medical device manufacturers must consider countless items when designing and manufacturing their final product, but unfortunately, connectors usually take a back seat to other more engaging topics. Nicomatic has relationships with many of the top medical device manufacturers to help them determine the best connector solution for their specific application. In the medical market, connectors are unique to their specific application and one solution does not work across the board.

We are entering a new era in which real-world evidence is transforming how drugs are developed, approved, and commercialized. As FDA leads the change with a 3-year strategy—the Framework for FDA’s Real-World Evidence Program—the industry is launched on a shared learning process to understand where and when RWE can support regulatory decision-making. This webcast brings together industry experts in research and pharma to explore how forward-thinking pharmaceutical organizations are adopting new approaches for the use of RWE in drug development and approval.

Developing and bringing a new drug to market is a long, expensive, and uncertain process. It’s even more complicated when it comes to complex products such as modified-release products and biologics. Bio/pharma companies can adopt proven strategies to increase the success of a product launch: cross-functional team collaboration, risk understanding and mitigation, a dedicated team, and the right project management tools. In this webcast, experts will share insights gained from decades of experience launching new products and discuss case studies demonstrating how to reliably bring products to market quickly without sacrificing compliance.

The analysis of Host Cell Proteins (HCPs) has historically been performed using ELISA-based tests. A number of off-the-shelf products (e.g. Cygnus kits) are available and the testing is relatively straightforward. However, it been recognized for some time that these kits generally allow detection of a maximum of ~70% of the HCPs present in biopharmaceutical products. This is due to the fact that in any anti-HCP antibody pool, there won’t be antibodies available to cover the entire spectrum of HCP species present.