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Immediate access to targeted, annotated, and enriched biospecimens empowers the rapid pace of discovery to commercialization found throughout the medical and life science industries. “Precision for Medicine respects the value of the biospecimen and understands its importance in fueling the translational medicine engine,” says Jim Boushell, Vice President, Biospecimen Solutions at Precision for Medicine. “Our team has built a resource for scientists that brings together expertise and infrastructure that enables ‘next-day discoveries’ leveraging our biorepository with strategic patient access to interrogate and validate their targeted biomarkers.” In short, using biospecimens that have deep data annotation makes research and development work.
In addition to a biorepository that consists of millions of samples (See “A Data-Rich Biorepository Supporting Science”), Precision for Medicine can collect biospecimens from a network of clinics. “Our biorepository, investigator network, and specialty laboratories are what differentiate us from your traditional CRO,” Boushell says. “Our clinical and biomarker expertise informs every protocol and procedure—ensuring that scientists have the required medical information to enable the discovery and use of biomarkers, which enhances the drug-development process.”
Relying on wisdom
The value of a biospecimen to a research study increases exponentially when deeper analytical and medical history data are paired. As an example, a scientist may approach Precision for Medicine interested in evaluating a potential biomarker, but with limited guidance on which study cohorts to target. “Whether it’s a novel biomarker or it’s a new virus, our ability to leverage prior experience enables us to efficiently and effectively solve a scientist’s dilemma,” says Boushell. “We are unique in the life science industry, having been at this for over 30 years provides a lot of wisdom.” As he adds: “It’s that intangible element that helps you solve challenges that might otherwise dead-end programs.”
When the COVID-19 pandemic gained attention in January 2020, for example, Boushell and his colleagues realized the impending need for biospecimens, which were key ingredients in developing assays and tests to diagnose COVID. “We immediately shifted our infrastructure to focus on COVID,” Boushell explains. But the pandemic created additional challenges, including people sheltering in place and healthcare transitioning to telemedicine. Consequently, “interacting with patients in their doctor’s office was no longer an option,” Boushell says. “So, our clinical operations and regulatory teams huddled up, developed a strategy that we could deploy directly to patients, and we were able to provide nearly uninterrupted resources to scientists challenged with developing tests and vaccines to COVID-19.”
Research did not stop during the pandemic—it shifted. Precision for Medicine is continuously enrolling subjects and collecting biospecimens to enable current and future science. “Keeping the biorepository well stocked with relevant diseased and non-diseased specimens is a 24/7 commitment,” Boushell says. “We are very good at what we do, and standardize our processes to mitigate preanalytical variation.” But that’s an ongoing challenge. “The scientists we support have a curious nature—one that requires us to continuously evolve.”
Beyond real-time patient access, Precision for Medicine’s clients can use its specialty labs to process the biospecimens in myriad ways: isolate cells, extract nucleic acid, perform analysis using technologies such as Next Generation Sequencing, and finally organizing and digesting the vast quantity of resulting data. “Our long history as an outsource partner to biotech and pharma has provided us a front-seat position when a new technology or new disease emerges,” Boushell says. “It’s both fascinating and challenging, and it’s what drives my team and I to keep innovating.”
The Precision Biospecimen Collection Center provides one example of Precision for Medicine’s ongoing innovation. “Recognizing the increasing demand for cellular products to support the cell and gene therapy industry in nearby Cambridge, MA, we expanded our collection center and laboratory in Mansfield, MA to include the capability of collecting mobilized and non-mobilized leukopaks, which involves a 4-hour procedure called leukopheresis,” Boushell says.
Logging into a legacy
Beyond keeping track of millions of biospecimens and their locations, Precision for Medicine also collects large quantities of information surrounding the specimens. That information goes in the company’s laboratory information management system (LIMS). “We need to maintain an accountability trail, a chain of custody so that, should an unexpected result arise in a scientist’s research, we are able to review step-by-step, record-by-record the history of the biospecimen and the individual from which it came, which provides scientists with confidence and assurance in their work,” Boushell says. “We still get calls from clients about biospecimens delivered decades ago, and with a couple of clicks we can access the history of the sample and answer many of the client’s questions.”
Such an information legacy works just as well for pulling information from the past or preparing for future work. “Scientists frequently reach out to us for advice on the design of a study or how to connect with a specific cohort of subjects,” Boushell says. “Many times, we have biospecimens from the cohorts in the biorepository, but when we don’t, we offer clients the service of using our network to operationalize the study.”
Looking at the long term
“We aim to be partners with our clients,” Boushell says. “Our industry is modest in size, and the scientists we supported 5–10 years ago are often today’s CEOs or CSOs of a biotech with a blockbuster therapy.” He adds: “We see that frequently enough to know and value each and every interaction as a future opportunity.”
Overall, Precision for Medicine’s network of clinical specialists and labs makes data generation easy and reliable. Those are unique capabilities in the increasingly complex world of collecting and creating value from biospecimens.