From Lab to Patients: How an Integrated Testing Platform Can Accelerate Novel Drug R&D

R&D for new drugs is like a relay race and winning the race can make a difference in the lives of patients and their families.

WuXi Testing, a business segment of WuXi AppTec, provides "end-to-end" testing services for novel drug developers and medical device manufacturers. With expertise in safety assessment, DMPK, bioanalytical, and clinical trial services all in-house, WuXi Testing supports the entire development cycle, from preclinical to clinical and beyond.

Dr. Steve Yang, Co-CEO of WuXi AppTec, said, “Our integrated testing platform combines diverse expertise at every stage of development. This holistic approach allows us to break down silos, offer customers insights from extensive research data analytics needed for the R&D process, and advance their endeavors to bring life-saving healthcare products to patients in need.”

Innovative Integration: “Seamless” Transition from Preclinical to Clinical

One of the most significant steps in a drug development timeline is filing an Investigational New Drug (IND) application and progressing a drug candidate into the pivotal clinical trial stage. Working with a partner offering the entire range of testing services can minimize the risks of delay during handoffs and even boost the efficiency of new drug R&D.

When it comes to an IND submission, time is of the essence. That is why we have expert project management and dossier preparation to support our testing services. Our services combined together can support an efficient 6-12 months’ process from testing through IND submission. All of this happens with one centralized project manager to provide a single point of contact as an extension of the customer’s team. We call this platform WuXi AppTec IND (WIND).

To support the needs of customers across additional essential stages of drug development, we have extended our coordinated offering to include CMC and clinical trial services. Our dedicated project management team and coordinated services provide the insights drug developers need from early insights into drug characteristics through late-stage refinement of project design to maximize operational efficiency to support clinical trials.

WuXi Testing, WuXi Clinical and WuXi SMO actively work with our other departments and leverage their comprehensive capabilities to provide customers with high-quality Phase I to Phase IV clinical services, supporting the "last mile" of drug development. Our goal is to support global customers with expert resources and the comprehensive services throughout the drug development journey.

Meeting the Evolving Needs of New Modalities Testing

Emerging new modalities lead us to pursue targets long considered undruggable. While they open new avenues to transform disease treatment and address unmet medical needs, the development of these novel modalities presents unique challenges, such as efficient drug delivery and the risk of off-target effects. Identifying potential adverse effects for safety assessments of these innovative therapies is also intricate.

To meet these evolving needs, and consistent with the principle of “following the science”, WuXi Testing started early and established capabilities in a wide range of molecular modalities, with an increasing proportion dedicated to new modalities over time, including peptides, oligonucleotides, ADCs (antibody drug conjugates), cell and gene therapies and more. Currently, WuXi Testing has supported thousands of projects and conducted extensive testing on thousands of innovative modalities.

Consider our Bioanalytical Services Department (BAS) as an example. In anticipation of the emerging development of oligonucleotides, BAS proactively established a R&D team dedicated to exploring, refining and optimizing testing methods. Through the optimization of LCMS methods, the BAS team successfully circumvented the need for solid-phase extraction, a costly step in oligonucleotide testing. This breakthrough streamlines the bioanalytical process, significantly reducing costs and ensuring greater efficiency.

WuXi Testing’s commitment to quality and innovation extends beyond BAS to other departments like Drug Metabolism and Pharmacokinetics (DMPK) and safety evaluation. Operating under comprehensive quality management systems, these teams bring extensive experience to new drug R&D and robust testing capabilities. Together, these combined skills and expertise enable customers to navigate the journey from preclinical phases to clinical trials, ultimately delivering innovative drugs to patients globally.

Driving Efficiency Through Automation, Digitalization and Intelligence

Today, WuXi Testing’s pursuit is not only to provide full support to customers but to do so with optimal efficiency. By fostering cross-function collaboration, researchers from DMPK, BAS and many other departments are actively contributing to a future with higher efficiency, driven by automation, digitalization, and intelligence.

The DMPK department has pioneered the use of automation at WuXi Testing. Since the first automated liquid handling workstation was set up in 2014, the in vitro ADME group has consistently upgraded the automation level of the workstation to improve work efficiency and research data quality. Compared to the uni-functional workstation, the fully automated workstation can perform tasks other than liquid handling, including constant temperature and uniform oscillation incubation, centrifugation and solid-liquid separation, sealing and peeling, and cryopreservation of sample plates.

BAS also boasts diverse types of automation systems, including liquid handling workstations, biological sample analysis systems, as well as nucleic acid extraction systems. These cutting-edge platforms enable researchers to achieve increased throughput, minimizing human error and ensuring accurate, reliable results.

"We are honored to enable customers with integrated preclinical testing and clinical trial services to help bring more innovative therapies to the market," said Dr. Steve Yang. "In the future, WuXi Testing will stay at the forefront of innovation, proactively deploying new capabilities and technologies to better meet customers' growing innovation needs, and to make a meaningful impact for patients around the world."