To help address the unmet needs of the drug development industry, he founded Frontage Labs, a global CRO dedicated to providing integrated, science-driven, product development services.In the two decades since, Frontage has become a recognized leader in every sector of drug development.  Speaking about the company’s continuing success, Dr Li said, “I am immensely proud that our team of scientific leaders has successfully assisted our clients to advance hundreds of molecules through development to commercial launch in the global market.”

Today, Frontage Labs stands as a value-added partner with a focus on solvingour customer’smost significant and complex drug discovery and development challenges. In doing so, the company has enabled innovator, generic, and consumer health companies of all sizes to file IND, NDA, ANDA, BLA, and 505(b)(2) submissions in global markets, therebycontributing to the successful development of important therapies and products for patients worldwide. Dr Lialso highlightedFrontage Labs’ operations in both the United States and China, two of the largest markets for CRO services in the worldexplaining that, “Our ‘Two Countries, One System’ approach assures the same quality standards, operating procedures, and systems in both China and the US, while also providing customers with a detailed and highly experienced understanding of the regulations and requirements for drug discovery and development in both countries.”

Frontage’s scientific knowledge base, technical expertise, and reputation for high-quality services have been integral to its ability to enter into strong long-term strategic relationships and partnerships with key customers.The company’s arsenal of comprehensive services includes drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment, and early phase clinical studies.

Showcasing Frontage’s prowess in the CRO market, Dr Li shared an interesting case study of a client that had gone through an unsuccessful attempt in developingbioanalytical assays that were needed to support development of an Antibody Drug Conjugate (ADC) drug. Frontageaccepted the challenge of delivering the project with alimited total sample volume (< 100 μl) for the multiple assays needed (3 PK and 1 ADA). Our highly skilled scientific team was able to overcome the technical issues that our client’s former CRO wasnot able to solve.To do so, Frontage consolidated multiple 1-in-1 methods into  the new platform LC-MS/MS based 2-in-1 methods – an innovative approach that addressed the critical constraint of minimal sample volume.  Our team was also able to develop and fully validate all the assays within six months of contracting the project, which enabled us to analyze over 700 samples in one month. In total, the three assays utilized ~30 μL of the sample while maintaining the acceptance criteria of maintaining an adequate sample volume for ISR. Based on the study datawe were able to produce within this tighttimeline, the sponsor was able to successfully advance their ADC drug from pre-clinical stage to clinical development.As Frontage growsinto a leading player in the CRO market, we continue to broaden ourservice offeringsacross drug discovery and development. Over the past several years, Frontage has made several key acquisitions to expandourportfolio of services and provide clients with anintegrated end-to-end service offering. These acquisitions include expansion into medicinal and organic chemistry, metabolite identification, transporters, microbiome, xenograft, safety and toxicology, QWBA, and mass balance studies.Dr Li adds, “Our broad service offering also includes biological, chemical, and regulatory support in a GLP-compliant facilities. We offer both in vitro and in vivo studies in support of compound registration including residual chemistry, plant and animal metabolism, and environmental fate.”As a part of the growth strategy, Frontage continues to invest in facilities and state of the art instrumentation and software. Frontage has recently increased its bioanalytical/biologics space to 60,000 sqftwhile adding 7000 sqft in its Exton Laboratories, and 300,000 sqftto support its preclinical, CMC and, central lab services in China. “In addition to delivering better sample management and increased laboratory space, this has allowed us to enhance our instrumentation, robotics automation, software, and personnel capacity too,”says Dr Li. In addition, Frontage has established acenterof excellence supporting cell and gene therapy, which includes dedicated laboratories in DNA/RNA sample preparation, PCR, flow cytometry, and cell culture. The expansion provides greater biomarker, PK, and immunogenicity bioanalytical capacity to support large Clinical Phase II-IV studies.Frontage sees these investments as important demonstrations of our commitment to supporting clients’ drug development programs for biologics and small molecules, including cell and gene therapies, as well as biomarker testing.

“Frontage’s“Two Countries, One System” approach assures the same quality standards, operating procedures and systems in both China and the US”

Dr Song Li
Management
Founder andCEO
Website
frontagelab.com