WuXi AppTec Laboratory Testing Division experts continually weigh in on emerging trends and stay updated on salient drug development topics. These experts routinely contribute to industry publications. Here’s where they’ve been featured in the first half of 2021....
For both large and small drug development companies, good communication displayed throughout the preclinical testing process is essential to success. Project leaders who exhibit great awareness, flexibility and communication skills can’t be undervalued in the timely...
There are many factors involved in designing a preclinical drug safety assessment program, but among the priorities is having a good understanding of the different requirements from the various regulatory agencies in which the Investigative New Drug (IND) will be...
In the design of a preclinical program, identifying and understanding the broad classification of the molecule is the priority. Is it a small molecule, a chemical, a manufactured drug? Or is it a biologic or a large molecule, a construct of amino acids, providing a...
Having the full spectrum of information about the early investigative work completed, as well as safety assessment goals and expectations for the successful development of a new drug, is essential in order to create the most effective preclinical strategies. Dr. Mark...
The Nanjing Branch of the DMPK Business Unit Begins Operation Grand Opening On May 24, 2021, the Nanjing Branch of the DMPK business unit of WuXi AppTec’s Laboratory Testing Division opened for business in a grand fashion. The event attracted many presenters,...
Lead optimization in the world of drug development is a multifaceted process. It is a crucial part of discovery pharmacology and toxicology, as such, is used to identify and advance the most promising drug compounds. First and foremost, lead optimization aims to...
Navigating the Investigational New Drug (IND) submission process for your drug development program can be a complex process, especially when filing with various regulatory agencies and pursuing multiple markets. However, dual, or globally filing an IND package can...
Immunogenicity assessment helps drug developers understand the possible immune responses that can occur when humans are exposed to a potential therapeutic protein. Recently, the FDA has updated its guidance for immunogenicity risk assessment for developing and...
In 2019, the U.S. Food and Drug Administration (FDA) revised its guidance for immunogenicity risk assessment (IRA) of biological therapies. IRA is required to help drug developers and regulatory agencies better understand the potential impact an immune response will...