Frontage Laboratories, is a value-added partner with a focus on solving its customers’ most signiﬁcant and complex drug discovery and development challenges. The organization’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 its key customers.
The company immensely gets beneﬁted from having operations in both the United States and China (the two largest markets for CRO services in the world) and are well placed to capture growth opportunities in both markets. Frontage’s “Two Countries, One System” approach is integral to its commitment to high quality standards. This approach assures the company’s customers the same quality standards, operating procedures and systems in both China and the United States, whilst also providing its customers with a detailed and highly experienced understanding of the regulations and requirements for drug discovery and development in both countries. This approach enables Frontage Laboratories to be a partner of choice for companies with multinational requirements or companies that need support for parallel submissions with the US FDA and China FDA.
In an Interview with Insights Success, Frontage Laboratories’ spokesperson has shared many details, which has made the organization a true global leader.
“We believe this approach—where we are positioned as a value-add partner—differs from standard CROs, who focus on offering a variable-cost alternative to their customers’ internal product development functions and support their customers on their routine work.” – Song Li
Below are the highlights of the interview;
What led to the inception of Frontage Laboratories, Inc?
Our origins date back to 2001 when our founder, Dr Song Li, set up a testing laboratory in Thorofare, New Jersey with an ambition to build a customer-focused organization to help pharmaceutical companies overcome their complex drug development challenges through an outsourced solution. Over the past 19 years Frontage Laboratories, Inc, has grown to one of the leading CRO’s with over 850 employees in both North America and China.
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”), drugdrug 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
Give a detailed description of the featured person’s inﬂuence over Frontage Laboratories, Inc. and the industry.
Dr. Song Li founded Frontage Laboratories in 2001 with the ambition of building a client-focused organization to help solve the most complex drug development challenges. 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. 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, Dr. Li 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.
What measures are you taking to prevent the outbreak of COVID-19, amongst your workforce?
Frontage is closely monitoring the outbreak of COVID19 and following guidance from the Centers for Disease Control and Prevention (CDC), the World Health Organization (WHO) and other public health and government agencies. We are committed to ensuring the health, welfare and safety of our employees and to the best of our ability continue to the delivery of our services.
Given the rapid spread of COVID-19 and its proximity to our communities, we have implemented the following measures, in which we believe are in the best interest of our workforce and operations, to minimize, as best as we can, the risk of our employees’ exposure to COVID-19, and the likelihood of its spread to the members of our community while striving to maintain the continuity of our business operations.
- We have established an internal situation management committee and dedicated resources to help our organization to navigate through the immediate challenges presented by the evolving COVID-19 outbreak.
- We have continuity plans in place to prepare for events as they occur and to meet the needs of employees and clients.
- We have instituted business travel restrictions that apply to our employees, contractors, suppliers and vendors.
- We have worked with our facilities teams to employ additional disinfecting and cleaning procedures in all facilities.
- Frontage has donated RMB 1M to Wuhan through Red Cross Society of Shanghai in order to support the prevention and control of novel coronavirus epidemic. This donation helped to purchase urgent medical supplies such as protective clothing, respirators, goggles and disinfectants, as well as supporting the construction of hospitals that used for the treatment of patients infected by novel coronavirus pneumonia in Wuhan and surrounding areas
To enable our delivery of services during this dynamic situation, we emphasize the need for open lines of communication about potential challenges as a result of the current COVID-19 outbreak. We encourage you to regularly connect with your respective contacts at Frontage.
Is it possible to ﬁnd a cure of COVID-19 virus by the end of the year?
Many of our leading Pharmaceutical partners are committed to proactively developing anti-COVID-19 virus products. Frontage is honorably supporting several of these programs and clinical trials. We have seen extraordinary commitment from the industry as a whole and as a result we believe it is very possible to have new therapeutics available by the end of the year.
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.
What is your idea of Corporate Social Responsibility?
Frontage engages in local community activities in order to promote its community commitment and value to the community. Our strategy is to establish partnerships with local non-proﬁt organizations (Autism, Breast cancer, any other signiﬁcant charity).
“Our commitment to investing in highly trained and experienced scientists, stateof-the-art facilities and instrumentations, and a strong commitment to operational excellence will allow us to deliver results that meet or exceed our customers’ needs.” – Song Li
How are you solving your customers’ complex drug discovery challenges?
Integrated CRO operating in a large and growing market and well positioned to capitalize on strong industry growth drivers, especially in China
We provide integrated, scientiﬁcally-driven research, analytical and development services in the United States and China – the two largest pharmaceutical markets in the world. Our “Two Countries, One System” approach enables us to be a partner of choice for pharmaceutical companies with multinational requirements, which we believe could uniquely position us for the outsourcing demands from foreign companies entering China as well as Chinese pharmaceutical companies expanding into the United States.
Proven ability to deliver value-add technical expertise because of our deep pool of talented scientists and world-class facilities and equipment
We believe that we deliver high quality services through our focus on technical excellence, which enables us to understand and solve complex scientiﬁc challenges (such as challenges in drug formulation, data interpretation and bioanalysis).
Our facilities and equipment enable us to deliver results that meet our customers’ needs. Each of our facilities is equipped with state-of-the-art equipment, which includes over 80 mass spectrometers across our facilities and high-performance chromatography systems. We aim for our facilities and equipment to remain at the forefront of the global pharmaceutical research, analytical and development standards.
Effective quality management systems and strong track record of regulatory inspections
We have a strong track record of successful regulatory inspections. Our facilities have successfully undergone inspections by the US FDA, NMPA and Health Canada on numerous occasions. In addition, our facilities have also been inspected by the US EPA, the US Drug Enforcement Agency (“DEA”), the World Health Organization (“WHO”) and the US Nuclear Regulatory Commission (“NRC”). None of these inspections have resulted in any materially adverse issues being identiﬁed.
Highly experienced and professional management team Our highly skilled and experienced management team possesses extensive knowledge of the markets in which we operate. Most of our senior management team have experience with leading global pharmaceutical companies and an in-depth understanding of our markets and the requirements of our customers. Almost all members of our senior management team possess a scientiﬁc background with a PhD and/or MD in their relevant ﬁeld. They also regularly contribute to peerreviewed industry publications and journals as well as present at national and international scientiﬁc conferences.
Our deep pool of talented and highly qualiﬁed scientists is integral to our business. The majority of our scientists held advanced degrees, including PhDs, MDs or Master’s degrees. In addition to being highly qualiﬁed, our scientists are regularly trained on new scientiﬁc and regulatory developments and frequently participate in academic activities. A number of our scientists have expertise across a range of disciplines, that enables them to perform and manage a wide variety of tasks across our various business units. This helps us provide ﬂexibility in allocating resources to our customers and maximizes our productivity. We believe that the depth of our scientiﬁc knowledge base is a key strength and the foundation of our reputation and competitive position in our markets.