By Anna Rose Welch, editor, Biosimilar Development
Here, I’ll discuss some of the current physician knowledge gaps in the different therapeutic areas. Similarly, I’ll delve into the discussions surrounding what educational strategies and guidelines may be needed on the hospital or national level to improve physicians’ and patients’ relationships with biosimilars.
While continuous manufacturing (CM) approvals to date are for small molecule solid dosage forms, the trend toward CM also compliments the increasingly popular use of single-use process equipment, particularly in biotherapy production, as manufacturers attempt to integrate single-use systems into continuous production platforms.
By Kristen Slawinski and Laura Moriarty,Bio-Rad Laboratories, Inc.
The typical success rate of a clinical trial is less than ten percent. While a single trial can cost upwards of $50 million, there is a strong sense of urgency to implement methods that reduce costs and increase a drug’s likelihood of approval (LOA).
This e-book offers insights and advice from some of the industry’s top experts about current trends in biomanufacturing, modern process intensification techniques, and the outlook for digital automation.
Back and better than ever! Join us November 4 to 6, 2019, in North Bethesda, MD, for GRx+Biosims 2019. GRx+Biosims is the premier scientific and regulatory event for the U.S. generics and biosimilars industries, featuring timely programming relevant to technical, regulatory, policy, and legal professionals. Hear from top-in-their-field officials and subject matter experts, share knowledge and best practices, and gain insights on navigating the regulatory process approvals and the evolving policy landscape. Register Today!