American Innovation Meets Japanese Vision with a Global Outlook
American Innovation Meets Japanese Vision with a Global Outlook
10 years ago Sekisui Chemical Company acquired XenoTech and the future of the groundbreaking, innovative CRO was assured. The combination of the already successful XenoTech and the vast and ever-growing reach and resources of Sekisui combined to make a partner for pharmaceutical companies and other product developers that needed quality test systems and services to facilitate the development of safe medicines and products.
In 1994, Andrew Parkinson founded XenoTech when he saw that development teams needed a partner to conduct drug metabolism studies. As a professor studying xenobiotic metabolism at the University of Kansas Medical Center, he’d been receiving more industry requests to study drug metabolism and drug-drug interactions (DDI) than his lab could handle. His solution was to form XenoTech, which brought exactly the right core competencies to help a growing number of drug makers obtain in vitro preclinical safety data before moving to the clinical phase.
Xenobiotic n. or adj. A substance not normally found in the body, such as a drug or other chemical compound. First used in 1965 by H.S. Mason, et al, in Federation Proc XXIV. 1172 “Microsomal mixed-function oxidations: the metabolism of xenobiotics.” 1
Small molecule compounds comprise the majority of therapeutic agents (drugs) in development today, and metabolism usually plays a crucial role in the therapeutic function of these xenobiotics.
Drug metabolism is the process
Today the study of xenobiotic metabolism is an important part of nonclinical studies for drug development.
Thousands of compounds are evaluated in the discovery and development process, but only a few will receive approval. In fact, with an estimated $2.7 billion spent on development of a new drug, only 12% of candidates are eventually approved.2 Drug Metabolism and Pharmacokinetics (DMPK) has long been a discipline that evaluates the safety of a lead compound, but today is also a primary tool in drug discovery and development. Sub-optimal DMPK properties are a prime contributor to the failure of potential drugs and minimizing potential drug-drug interactions (DDIs) will improve the chances a drug candidate will survive the development process and become a successful therapy.
The FDA mission states, “The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.”3 Sekisui XenoTech embodies this mission and over the last 20 plus years has contributed with its mission “to lead collaborations with the world’s principal researchers and scientific experts, advancing life-enhancing therapies with unparalleled insight and interpretation through high value products and bespoke services.” Less formally, the goal is to make the world a safer, healthier place by generating high-quality, reliable and reproducible data. In the process, they’re also helping their clients reduce costs and better understand risks inherent within the drug development life-cycle.
Today Sekisui XenoTech is also improving scientific techniques for the betterment of its customers. In his 2018 FDA Strategic Policy Roadmap, the FDA Commissioner, Dr. Scott Gottlieb, states a main priority as “[to] Leverage innovation and competition to improve healthcare, broaden access, and advance public health goals.”4 As new methods of therapeutic creation and development are introduced, so must the techniques to screenand evaluate these compounds be made available. Sekisui XenoTech is doing just that by evaluating new methods to improve submission data and identify compound risks earlier.
Sekisui XenoTech is a global leader in drug metabolism, partnering with development teams in the drug, nutraceutical, food additives and cosmetics industries to conduct numerous different types of assays. “The drugs we’re working on are the future of healthcare,” says Dr. Joanna Barbara, Vice President of Scientific Operations at Sekisui XenoTech. “Ultimately, we are affecting people’s lives through studies conducted at Sekisui XenoTech.”
As new technology is introduced, regulatory agencies and drug makers are pushing to get safety answers even earlier in the process. It is important to understand metabolism and potential drug-drug interactions as early as possible to avoid costly delays further down the development pipeline. Sekisui XenoTech is nimbly adapting to these changes and ready to provide the latest technologies and services for its clients. For example, as assays move from only using subcellular fractions and microsomal proteins to including cell-based test systems, Sekisui XenoTech has redeveloped many of its assays, and even created new ones. The Sekisui XenoTech team is constantly exploring and innovating to provide clients with the most informative data possible.
Regulatory requirements are also changing. In October of 2017, the FDA published two new draft guidance documents on drug-drug interactions, including updates to numerous study designs. Sekisui XenoTech has been leading the education on these changes and implementing new procedures in its laboratories. For more information, please see our recent webinar, Essential Considerations on the New FDA In Vitro DDI Guidance (the What, the Why, and the Wow).
Sekisui XenoTech: All About Quality
“The data we gather is used by our clients to decide where to go next in their discovery and development programs and navigate the regulatory process, so it’s imperative that the data we produce are accurate and reliable,” says Dr. Barbara.
The greater the quality of the non-clinical studies performed the less the risk for a costly failure. Because of this emphasis on quality and realization of this importance for drug developers, 98% of top pharmaceutical customers choose to work with Sekisui XenoTech.
Sekisui XenoTech: In Conclusion
Drug metabolism studies and products are an integral part of any successfully developed drug. From its inception Sekisui XenoTech has been the partner drug developers trust to effectively move their drug through the development process.
One of the constant challenges developers face is keeping up with the rapid pace of change in the industry and regulatory requirements. Sekisui XenoTech maintains state-of-the-art laboratories and expertise, offering latest technologies that comply with updated regulatory requirements.
At the end of the day, the Sekisui XenoTech team needs to deliver quality data in a timely fashion. With the throughput and timelines they need to meet, there’s typically no time for repeating a study or a set of samples—everything has to run correctly the first time. Starting with rigorous maintenance and attention to instrument performance and continuing with careful assay design, execution and data analysis, Sekisui XenoTech is able to deliver unparalleled data that helps drug developers make critical decisions. They go home satisfied that they are doing their part to make the world safer one drug at a time.
References:
- xeno-, comb. form. OED Online. http://www.oed.com/view/Entry/
230989 - “Biopharmaceutical Research & Development Overview.” PhRMA. www.phrma-docs.phrma.org
- “What We Do – FDA.” US Food and Drug Administration. https://www.fda.gov/aboutfda/
whatwedo/default.htm - “FDA’s 2018 Strategic Policy Roadmap.” US Food and Drug Administration. https://www.fda.gov/aboutfda/
reportsmanualsforms/reports/ ucm591993.htm
About Sekisui XenoTech
Sekisui XenoTech, LLC is a global Contract Research Organization utilized by 98% of top pharma companies and numerous other organizations. For almost 25 years, the company has offered proven expertise for drug development, providing an ever-evolving selection of cell and tissue-based products, screening, radiolabeling, API manufacturing, in vitro ADME Tox and pharmacology, in vivo ADME Tox and QWBA, metabolite ID andproduction, bioanalytical services and consulting. Sekisui XenoTech’s product selection includes a wide range of high-quality unique and standard reagents, including subcellular fractions, hepatocytes, media, tissue samples, cell lines, recombinant enzymes, substrates, metabolites and more. The company also regularly prepares and delivers custom-designed products and services in response to client requests. For additional information, please refer to the company’s website at www.xenotech.com.
