WuXi AppTec Laboratory Testing Division experts continually weigh in on emerging trends and stay updated on salient drug development topics. Here is a rundown of the industry publications featuring WuXi AppTec experts in the second half of 2021.
1. Genetic Engineering and Biotechnology News
“Using In Vitro-In Vivo Extrapolation to Predict Human Clearance”
Drug developers must fully understand the structural transformation a compound undergoes in the body when estimating dosage and optimizing compounds in clinical research. By providing a pathway to predict in vivo data through in vitro methods, IVIVE can deliver precise, highly relevant preclinical data. This data can facilitate future drug discovery, reduce the time and cost of developing new products, and inform chemical risk assessments.
This article provides a step-by-step approach to creating the correct equation to predict human clearance in In Vitro-In Vivo extrapolation. It details the best way to build an IVIVE model to achieve accurate clearance data to optimize in vitro metabolic assay protocols. WuXi AppTec subject matter experts featured include:
- Dr. Xiangling Wang, director & head of drug metabolism and distribution
2. Drug Discovery & Development
“The Opportunities & Challenges Inherent in Using Protein Biomarkers for New Drug Development“
Protein biomarkers can bring clarity to invisible illnesses, improve prediction capabilities and quell the spread of a disease before it starts. They can also streamline clinical trials by helping identify populations, monitor therapeutic responses and document a drug’s side effects.
A better understanding of the opportunities and inherent challenges in protein biomarkers can help set expectations for drug developers pursuing them for regulatory submissions, eventually increasing their drug approval rate. WuXi AppTec subject matter experts featured include:
- Xuesong Chen, Ph.D., technical director for large molecule bioanalytics
- Clara Brando, Ph.D., assistant director for large molecule bioanalytics
3. American Pharmaceutical Review
“Improving Preclinical Outcomes: De-Risking Your Drug Development Program“
Every drug candidate must demonstrate safety and efficacy to gain U.S. Food and Drug Administration (FDA) approval, but not all drugs are created equally. A drug’s therapeutic area will often determine the length of time and financial investment needed for development.
Product reformulation, safety/efficacy concerns and unforeseen ADME characteristics can derail a program during early-phase development. But one of the most overlooked, and perhaps most dangerous, risks to any drug development program is poor team management and ineffective partnership. WuXi AppTec subject matter experts featured include:
- Mark Walker, senior technical director
Looking Ahead
Our experts are passionate about advancing therapies to solve some of healthcare’s most significant challenges. WuXi AppTec subject matter experts continue to shape and support the drug development industry through thought leadership and actionable advice.
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As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable global pharmaceutical and healthcare industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec’s integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, cell and gene therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received AA ESG rating from MSCI in 2021 and its open-access platform is enabling more than 5,600 collaborators from over 30 countries to improve the health of those in need – and to realize the vision that “every drug can be made and every disease can be treated.”
