David Lansky, the founder and president of Precision Bioassay Inc. in Burlington doesn’t expect to ever have many customers in Vermont. That’s okay with him, “We work for biotechnology and pharmaceutical companies all over the world.” he says. The demand for Precision Bioassays’ help is high because they offer a unique set of skills that includes bioassay expertise, sophisticated statistical analysis skills, and software development capabilities. They are a “statistical consulting and software development company” that helps companies develop, design, and run biological assays (or bioassays)—and use best-practice statistical methods to evaluate and present the data. Also driving customer demand is the fact that regulatory agencies around the world require bioassays as part of quality control testing for most biotechnology products.
Bioassays have traditionally used living organisms, such as mice or rats, to test pharmaceutical agents for biological activity; most modern bioassays use cultured cells, some use fresh blood cells. Even with the move to cell-based systems, however, bioassays have a well deserved reputation for being hard to develop, laborious, expensive, and low precision. Precision Bioassay strives to change that. Through years of developing bioassays and analyzing the resulting data, David has identified several key factors that can have a profound impact on bioassay precision. This understanding forms the basis for Precision Bioassay’s newest tool, called Xymp® Bioassay Analysis Software. There is a great description on the Precision Bioassay website, but in a nutshell, the software directs pipetting robots to provide robotically-randomized assay layouts and performs sophisticated statistical analysis on experimental data that, together, help researchers “attain higher precision from existing bioassays.”
When asked which of his recent endeavors make him most proud, however, David cites his work with other volunteers for the United States Pharmacopeial Convention (USP). The USP is “a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements…USP’s drug standards are enforceable in the United States by the Food and Drug Administration.” Approximately 9 years ago, the group set out to rewrite chapter 111 of the organization’s standards covering bioassay design and analysis—a chapter that had not been revised since the 1950’s. That effort has resulted in 5 chapters that were published in spring of this year and will be included in the official US Pharmacopeia (USP) later this summer. Some of the changes to the guidelines were controversial when the first drafts of these chapters were presented. The group advocates a major paradigm shift in some of the statistical analysis methods used for bioassay and they encountered enormous resistance.,That resistance has largely melted away over the last 5 years and their suggestions are now broadly recognized as best practice—this has been an extremely gratifying result for David and his fellow volunteers. David readily recognizes that the group, working together, made far more progress than any of them could have made alone.
This spirit of working together drew David Lansky to the group that formed the Vermont Biosciences Alliance (VBSA); Precision Bioassay is a founding company in the alliance. Headquartering his company here in Vermont affords him and his employees the many benefits of living in this physically beautiful and culturally unique corner of the United States, but also presents the challenge faced by many in our fledging bioscience industry of attracting and retaining high-caliber employees. He supports the efforts of the VBSA to draw attention to the progress and potential for biological science advancement here in Vermont, in the hope that by combining our efforts, we can accelerate opportunity in the Vermont bioscience sector.
Written by Lori Martin