Immunogenicity Assessment: As FDA Guidance Shifts, How Can You Reduce Clinical Hold Risks?

By Jing Shi, Ph.D., Global Head of Large Molecule Bioanalysis, WuXi AppTec

Biotechnology entrepreneurs face many challenges as they push to bring potential new drugs into the clinic, whether that means raising the necessary funds for a clinical trial or conducting adequate assessments that ensure drug safety and efficacy. One main concern is often challenging: keeping up with an ever-evolving regulatory guidance.

As science and understanding of drug development continue to advance, the Food and Drug Administration (FDA) and other regulatory agencies are continually evolving their guidance for various aspects of preclinical and clinical drug development. Delays in safety assessment and development of the drug can put companies at risk of missing milestones, resulting in loss of credibility with investors and potential partners, thereby lowering value of their molecule. However, for many companies, staying abreast of those changes can be difficult, especially when the information is a vital part of their drug development program and any oversight can result in a costly clinical hold.