As biosimilars to treat rheumatic diseases begin get approval from the FDA, biosimilar development remains a hot topic in drug development. Sponsors estimate a 35% growth of biosimilars in their development pipelines by 2020, but face a wide variety of regional and global markets along with shifting guidelines and recommendations, stressing the need to understand this rapidly changing landscape. What is the real potential for clinical and health-economic benefits offered by these agents? Continue reading
Covance is proud to announce that Xcellerate® Trial Design has been selected as the winner of the Fierce Innovation Awards: Life Sciences Edition in the Data Analytics/Business Intelligence category. The Fierce Innovation Awards: Life Sciences Edition recognizes outstanding innovations that are driving improvements and transforming the life sciences industry. Xcellerate Trial Design was recognized for its innovative approach to improving site selection, forecasting resource demand and optimizing of clinical trial design. Continue reading
When developing a biologic, great science does not always translate into a great product. Doing the rights studies, the right way, is paramount to realizing the product’s potential. Knowing which studies to conduct, when to conduct them and interpreting the data in the context of the product’s development, can make the difference between success and failure.
For Biologics, “The Product is the Process”
Biological medicines, including therapeutic proteins, DNA vaccines, monoclonal antibodies, and fusion proteins are large, complex molecules that cannot be fully defined by physicochemical analytical methods. They are manufactured from genetically modified living cells using processes that are usually complex. Biological medicines are often 200 to 1,000 times the size of small molecule drugs, and because of the biological nature of the starting materials, the manufacturing processes have inherent variability and product heterogeneity. Continue reading