05.20.21 Making Sense Of Antibody Epitope Claims
A novel drug path to market is complex. Drug developers must navigate the journey, under growing pressure of regulation and competition while managing technical and financial risks. Challenges of gaining regulatory approval and transitioning production add to this complexity. Attend this webinar to understand the challenges when moving a bioconjugate candidate from clinic to market. Click here to learn more.
Featured Editorial
By Benjamin Pelletier, Haynes and Boone
Obtaining certain types of patent rights to antibodies has become increasingly challenging in the U.S. To comprehend this evolution, we must first take a careful look at what antibodies are, and then understand how they are claimed in a patent.
Understanding Multinational Regulatory Filings: New Chemical Entity
By Jim Springer, Steve Halpin, and Megan Kuikstra, Albemarle FCS
Finding the right long-term CDMO partner for development and commercial launch of a new chemical entity (NCE) presents sponsors with a uniquely challenging scenario. First, “right” must be defined in quantifiable metrics, then the search begins for a CDMO exhibiting those qualities. The challenge is magnified when a multinational launch is planned.
For many sponsors, the search for a CDMO partner begins in earnest during phase two of clinical trials: the new chemical compound, chemical structure, or mechanism of action (MOA) is producing positive results, and the sponsor is actively evaluating the patient population and dose. They are trying to estimate volumes for launch and predict where growth might take the product in five or ten years.