John Lin, EVP & Global Head, Bioanalytical and Biologics ServicesA full-service contract research organization (CRO) with a next-generation central lab can provide comprehensive, scientifically based analytical research and development services from drug discovery to development. Transformative approaches to drug development can improve the efficiency of R&D, bring new therapies to market earlier, and improve patient experience during clinical trials.
Frontage Labs is an all-around integrated pharmaceutical R&D CRO with central laboratory services collaborating with pharmaceutical and biotech companies to help them bring drug candidates to market.
The organization assists pharmaceutical companies with drug discovery and development processes through integrated, science-driven product development services. With over 70 percent of its scientific staff having advanced degrees in life sciences, it offers a comprehensive suite of solutions in small molecules, biologics, genomics, and biomarkers with end-to-end support. Its quality standards are globally aligned throughout the organization, including streamlined communication, data management systems, and analytical platforms.
“Our clients choose us because of our scientific expertise and adherence to quality standards specific to their study needs. Our project directors have extensive scientific knowledge in various therapeutic areas and methodologies, offering custom solutions for complex studies,” says John Lin, EVP and global head, Bioanalytical and Biologics Services.
The Frontage Labs’ team closely communicates with clients to understand study objectives and timelines and develop a unique approach to overcome challenges while maximizing efficiency and minimizing risk. Frontage provides a comprehensive service delivery model focusing on quality, efficiency, and best-in-class laboratory science.
Frontage Labs used drug removal techniques and careful titrations to achieve accurate signal readings. Working closely with them to understand the roadblocks provided a custom solution to deliver the request methods with high sensitivity and reproducibility.
Choosing the right partner during the early phase can be critical to the product’s journey. That’s not all.
Recently, Frontage Labs supported Phase I and II studies with its bioanalytical services and through its global infrastructure and centralized data processes, delivering highquality data for its sponsor’s compound, leading to positive outcomes for the drug.
Based in the U.S., the studies were for a first-in-class, orally administered, highly selective non-competitive AMPA glutamate receptor antagonist developed for treating epilepsy. The sponsor required sample analysis in China to support one of the sites involved in the global Phase III clinical study. However, shipping clinical study samples out of China was a challenge. The sponsor decided to transfer the validated bioanalytical method from the U.S. to the lab in China and chose to analyze the study samples from different hospitals in China.
Our clients choose us because of our scientific expertise and adherence to quality standards specific to their study needs. Our project directors have extensive scientific knowledge in various therapeutic areas and methodologies, offering custom solutions for complex studies.
The global bioanalytical team of Frontage Labs transferred the bioanalytical method from the U.S. to the China lab and cross-validated the technique using the study samples. The project management team in the US oversaw communication with the sponsor and closely worked with the project management team in China. Data was centralized and stored in less than one study design at the U.S. site using a validated Watson LIMS system.
A robust project management infrastructure and central data management solution facilitated a smooth study and high-quality data delivery. The sponsor achieved positive outcomes, and the drug was effective in treating the disorder in pivotal (Phase III) clinical trials and has been approved by various global authorities.
Due to the contributions of companies like Frontage Labs, the growing role of solving complex drug discovery and development challenges is shaping the contours of the market. In the future, Frontage Labs will continue helping clients advance hundreds of compounds from the product development stage to commercialization.
