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.
01.21.21 Using Production And Postmarket Data To Validate FMEA Assumptions
Acepodia s Dr. Sony Hsiao, CEO, and Dr. Mark Gilbert, SVP of R&D, join
Business of Biotech for a discussion on the company s approach to dramatically reducing the cost of cell therapy development, manufacturing, and administration via its oNK, CAR, and ACC candidates. Listen now and subscribe so you never miss an episode.
Featured Editorial
By Mark Durivage, Quality Systems Compliance LLC
One common issue with regulatory agencies and certification bodies regarding failure mode and effects analysis (FMEA) is that organizations are not utilizing production and post-market surveillance data to validate the probability of occurrence and probability of detection assumptions, which leads to inspectional observations and audit findings.