With an ambition to build a customer-focused organization to help pharmaceutical companies overcome their complex drug development challenges through an outsourced solution, Dr. Song Li formed Frontage Laboratories, Inc. Today, Frontage Laboratories has grown to one of the leading CRO’s with over 850 employees in both North America and China.
Prior to Frontage, Dr. Li held management positions at Great Valley Pharmaceuticals and Wyeth. During this time, he led numerous projects related to the development of pharmaceutical products. Besides, Dr. Li has authored more than 15 scientific publications spanning a wide range of topics, including chiral separations, drug-protein interactions, pharmacokinetics, and analytical chemistry. Importantly, he has been the recipient of numerous awards, most recently Healthcare CEO award from Philadelphia Alliance for Capital and Technologies, Ernst & Young Entrepreneur of the Year Award, the “Realizing the American Dream” award from the Pennsylvania Welcoming Society, and the Outstanding 50 Asian Americans in Business Award from the AABDC.
Dr. Li earned a Doctor of Philosophy degree in analytical chemistry from McGill University and a Bachelor of Science degree in chemistry from Zhengzhou University in China.
In our endeavor to find “The 10 Most Eminent Leaders in Pharmaceutical Industry, 2021” we crossed our paths with Dr. Li to know more about his leadership journey and how Frontage Laboratories is addressing the most significant and complex drug discovery and development challenges of pharmaceutical companies.
Below are the highlights of the interview:
Describe Frontage Laboratories, Inc. and its cutting-edge services which address all the needs of its customers.
Frontage Laboratories, Inc. is a CRO that provides integrated, science-driven, product development services throughout the drug discovery and development process to enable pharmaceutical and biotechnology companies to achieve their development goals. Comprehensive services include 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.
Drug Metabolism and Pharmacokinetics (“DMPK”)
We offer standard and customized in vivo and in vitro DMPK services. This includes pharmacokinetic (“PK”) and pharmacodynamics (“PD”) studies throughout the development process. We also offer ADME studies. For the discovery phase, we also offer PK screening and characterization to enable structure optimization. We also offer metabolite identification in different animal species, Metabolites in Safety Testing (“MIST”), drug-drug interaction, and radiolabeling studies.
Safety and toxicology
We offer clients and extensive range of safety and toxicology services, including large animal testing, to our customers for the first time. These services include non-GLP and GLP toxicology studies to support regulatory submissions such as INDs. Additional toxicological assessments include pathology, ophthalmology and cardiovascular studies. We also offer chronic toxicity and investigative toxicology studies, carcinogenicity studies and support for additional indications. We also assist with the development of safety and toxicology testing plans, mainly for the pre-clinical stage, with the goal of identifying the pharmacological and toxicological effects of drug candidates.
Our bioanalytical services include non-GLP research based and GLP assays (both in vivo and in vitro) for small and large molecule drugs and biomarkers throughout the drug development process as well as immunogenicity and neutralizing antibody assessments. These assays support first-in-human dose justifications and Investigational New Drug (“IND”) packages for pharmaceutical therapeutics. We provide method development and validation services in addition to sample analysis services to assess pharmacokinetics, immunogenicity and pharmacodynamics effect.
Chemistry, manufacturing and controls (CMC)
Our portfolio of CMC services spans drug discovery to the post approval phase, including lead compound quantification and analytical testing for the discovery phase, formulation development, GLP toxicology batch studies, release and product testing, stability testing, CTM and Good Manufacturing Practice (“GMP”) manufacturing, extractability and leachability studies and commercial product release following approval of an application.
With over 20 years’ experience in the execution of comprehensive Phase I-IIa studies, the Frontage Clinical team collaborates closely with our clients to develop a unique approach to overcome the challenges of each study, while maximizing efficiency and mitigating risk. We leverage our best practices in study design and execution to advance investigative compounds to drug candidates. Located near NYC, we have access to one of the most diverse study populations and acclaimed medical professionals and facilities to help support each study.
We provide bioequivalence (“BE”) and related services (such as medical writing and regulatory support) in China. Bioequivalence is the term used to assess the expected in vivo biological equivalence of two preparations of a drug. Bioequivalence is generally defined as the absence of a significant difference in the rate and extent of which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administrated at the same molar dose under similar conditions in an appropriately designed study. These services are currently provided by us in China from our facility in Zhengzhou, Henan, and 17 clinical research centers in our collaborating hospitals in China. Focus on product development on clients’ needs then the services are one stop shop – list services in product development
As a leading laboratory and agrochemical services provider, what contribution has been made by you?
We are a value-add partner with a focus on solving our customers’ most significant and complex drug discovery and development challenges. Our scientific knowledge base, technical expertise and reputation for high quality services have been integral to our ability to enter into strong long-term strategic relationships and partnerships with our key customers.
Over the years, Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of molecules through development and file regulatory submissions globally.
Describe in detail about the work culture and the values that drive Frontage Laboratories, Inc.
Our Purpose: To improve quality of life
Our Vision: To be the preferred partner of life science leaders in product development
Our Core Values
Quality: We are committed to excellence in the results we achieve, and how we achieve them.
Integrity: We believe in honesty, reliability and accountability in our words and behavior.
Innovation: We employ new scientific approaches, technologies and processes to provide innovative solutions to challenging problems.
What are the future aspirations of Frontage Laboratories, Inc.? What strategies are you undertaking to achieve those goals?
Frontage Laboratories will continue to grow its capacity and capabilities both organically and through mergers and acquisitions as appropriate. In just the last six months, the company has expanded its footprint in both North America and China, acquiring a majority share position of a CMC group in China and setting up new labs in both China and North America to accommodate growth in the CMC and Bioanalytical areas. Along the same lines, Frontage Laboratories will continue to look for opportunities that will enhance its end-to-end discovery and drug development services.
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