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.
American Pharmaceutical Review
International Council for Harmonisation of Technical Requirements (ICH) is updating the M10 guidance, focusing on bioanalytical method development, validation, application and documentation of drugs. The guidance aims to harmonize global standards, including those on reporting and the submission process.
The article dives into how reporting requirements may change and what that means for drug development programs. WuXi AppTec subject matter experts featured:
- Dr. Tom Zhang, senior director for large molecule bioanalysis
- Dr. Colton Wong, senior director for small molecule bioanalysis & head of method development
2. “Winning the drug development relay”
Drug development can be similar to a relay race, as each runner tries to coordinate the baton handoff precisely. Though, when unexpected challenges and delays arise, timelines can falter. The article explains six ways companies can combat these challenges and complete handoffs that get you to the developmental finish line. WuXi AppTec subject matter expert featured:
- Xiaoxia Li, executive technical director
Drug Discovery & Development
3. “Analyzing FDA guidance on DDI studies for therapeutic proteins”
Co-administering drugs are common, but without a proper strategy for drug-drug interaction (DDI) studies, developers may face delays when preparing for clinical trials. The U.S Food and Drug Administration (FDA) recently releases new guidance on DDI studies for therapeutic proteins. This article breaks down the guidance and provides insights to better position developers. WuXi AppTec subject matter expert featured:
- Peter Wang, senior director of drug metabolism and niotransformation
4. “Manging critical reagents through drug development”
Proper critical reagent management strategy is imperative to large molecule bioanalytics, though critical reagents prove to be a challenging aspect due to their inherent variability and necessary validation from lot to lot.
This article explains the nuances that drug developers should be aware of, as well as pertinent regulatory aspects to managing critical reagents. Readers can learn more about implementing a proper critical reagent strategy and where best practices come in for managing and characterizing. WuXi AppTec subject matter expert featured:
- Xuesong Chen, Ph.D., technical director for large molecule bioanalytics
Life Science Leader
5. “Improving Submission Quality: Preparing For Regulatory Differences”
Filing clinical trial applications to multiple regulatory bodies complicates product development, with varying requirements making it difficult for teams to navigate exactly what standards apply to testing. This article provides executives with advice on approaching different regulatory pathways and increasing efficiencies. WuXi AppTec subject matter expert featured:
- Xiaoxia Li, Ph.D., DABT, executive technical director toxicology
6. “Preparing for Preclinical Testing: A Readiness Checklist”
Forward-thinking in drug development is imperative, and organizations need to look ahead to preclinical testing and what they can do now to set themselves up for success. But where can you start?
This article provides a checklist approach to start the right conversations and prepare your team for successful preclinical development. Check out these five tools to keep your team on track and well prepared. WuXi AppTec subject matter expert featured:
- Mark Walker, DMV, senior technical director of toxicology
7. “The Transition to ICH M10 and its Impact on Global Submissions”
Shifting testing expectations is nothing new in the drug development industry, and teams must be proactive in adjusting to ICH M10 bioanalytical evaluation guidelines to give their submissions the best chance to progress towards clinical trials.
In this article, experts break down the draft guidance and explain what developers can expect with the implementation of ICH M10. WuXi AppTec subject matter expert featured:
- Tom Zhang, Ph.D, senior director large molecule bioanalysis
- Colton Wong, Ph.D, senior director small molecule bioanalysis and head of method development
Our experts are passionate about the development and forward progression of therapies to solve some of healthcare’s most significant challenges. Whether providing a point of view as a thought leader or giving customers tangible advice, WuXi AppTec experts continue to weigh in and support the industry.
Interested in speaking to an expert from WuXi AppTec’s Laboratory Testing Division? Contact us today
WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. As an innovation-driven and customer-focused company, WuXi AppTec helps our partners improve the productivity of advancing healthcare products through cost-effective and efficient, socially responsible and sustainable solutions. With industry-leading capabilities such as R&D and manufacturing for small molecule drugs, cell and gene therapies, and testing for medical devices, WuXi AppTec’s open-access platform is enabling more than 5,200 collaborators from over 30 countries to improve the health of those in need – and to realize our vision that “every drug can be made and every disease can be treated.”