The success of every clinical trial hinges on recruiting and enrolling a statistically significant set of patients who meet specific enrollment criteria. The goal is to keep these people engaged through the end of the study to produce the quality data necessary to gain approval to market the drug or medical device being studied. However, patient recruitment and retention is widely recognized as the single biggest bottleneck of the clinical trials process.
Through the implementation of automation, data management, and analytical technologies, pharma has the opportunity to breathe new life into a number of areas of the biologics drug development process.
The Supply Chain Information Sharing and Analysis Center’s (SC-ISAC) primary mission is to facilitate communication among supply chain dependent industry stakeholders in order to help secure the global supply chain.
Santosh Vetticaden, Ph.D., M.D. is a drug development professional with over 20 years of experience spanning large pharma and biotech across multiple therapeutic areas. He has been involved in trials from Phase I-Phase IV and has been extensively involved in the design, planning, and implementation of global trials. By Rob Wright, Chief Editor, Life Science Leader magazine
As Pfizer began its pursuit of delivering two biosimilar monoclonal antibodies (mAbs) in China, it sought a partner that could mitigate the risks of expanding into this region while also significantly reducing the development timeline. By leveraging the expertise of an experienced partner and the benefits of single-use technology (SUT), Pfizer was able to quickly establish a global footprint while also gaining a competitive advantage in an emerging market.
Partnering with a specialist CRO is an ideal way to quickly and cost-effectively manage development. Biopharmaceutical manufacturing is increasingly focused on productivity and efficiency. A changing economic climate, together with the patent cliff of many major products, has resulted in drastic changes in the business models of a whole industry. It’s no longer simply the repetitive, simple tasks, that are outsourced, but increasingly complex specialized tasks including research and development, when pursuing the identification of new chemical and biochemical entities. By Dr. Laura Ciccolini
Comparative human in-vivo study of an immediate release tablet over-encapsulated by gelatin and hydroxypropyl methyl cellulose capsules – impact of dissolution rate on bioequivalence.
To meet therapy production demands, the industry needs to have the right capacity, in the right locations. Increasingly, single-use technologies are being seen as flexible and cost-effective solutions.
At Charles River, three complementary approaches are offered to ensure the viral clearance of a biotechnology product.
|
|
|
|
|
|
|
|
|