A Data-Rich Biorepository Supporting Science

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Much of healthcare and basic biological research depends on access to data-rich biospecimens. To learn about one of the larger biorepositories involved in multi-omic research, we spoke with Precision for Medicine’s Scientific Director, Anuj Kalsy, and Associate Director of Genomics, Robert Snyder, PhD.

“In 1998,” says Kalsy, “We identified a disconnect between the scientists who were committed to understanding and solving human disease and the patients who were impacted by those medical conditions.” So, Precision for Medicine developed a business plan that connected its specimens with medical records and other health-related information. The resulting biorepository now includes more than 30 million biospecimens. “We are therapeutic area agnostic, research area agnostic, technology agnostic, and assay type agnostic,” Kalsy says.

In the beginning, Precision for Medicine created its biorepository for its own purposes. “We developed the biorepository to supply our own laboratories—for their research and needs going forward—and over time it grew into something great,” says Dr. Snyder. “Once we realized the value of these specimens and data, we were compelled to make these available commercially through the launch of Precision for Medicine, Biospecimens Solutions.”

In addition to a data-packed collection of specimens, Precision for Medicine provides deeply-integrated services. “We have all of the downstream lab services and research expertise available to generate novel data or support R&D with the specimens,” Dr. Snyder says. “That’s a big differentiator from other biospecimen suppliers.” (See “Applying Immunohistochemistry to Diagnostics Development”)

Putting the biorepository into practice

Although the Precision for Medicine biorepository is used by many types of researchers, one of the fastest growing uses is development of assays to support drug development. “When a company has a new drug and they need to start enrolling patients for clinical trials, they first need a test to make sure that the patient is eligible for the trial,” Dr. Snyder says.

Based on years of experience working in the pharmaceutical industry, Kalsy adds, “I think about our biorepository as a big toolbox that’s able to support discovery and translational scientific research.” He goes on to say “this can be applied across the board including early discovery, target identification and validation, startup development and manufacturing, and FDA submissions.”

Precision for Medicine’s biorepository also plays a key role in discovering new biomarkers. As an example, Dr. Snyder describes a customer that used artificial intelligence to develop novel proteins to test against targets. “They came to us with some in silico-derived candidates, and we have this big wall, so to speak, of samples that they can just throw these candidates at and see what sticks.” As a result, previously unknown proteins might be turned into targets for health-related biomarkers.

In many ways, the healthcare industry depends on a well-curated biorepository. As Kalsy says, “The biorepositories are really fierce research tools that fuel innovation in the biopharmaceutical industry to get early R&D going or serving the purpose of developing and building first-in-class or best-in-class therapies for clients.”

To give customers even more access to information, Precision for Medicine created QuartzBio, which Dr. Snyder describes as a “database that combines all of the disparate kinds of information—pathology records, genetic components, and so on—together in one place with a value-added interface.” Customers can use this tool for trial-consent tracking and biomarker monitoring through analytics and reporting.

Cataloging cancer mutations

As healthcare experts aim to make cancer treatments more personalized, that work relies on finding the right targets. Precision for Medicine supports that endeavor through its Precision Oncology Sequencing Initiative (Project P.O.S.I.). “The aim is to genetically characterize as much of our inventory as possible,” Dr. Snyder explains.

Through a collaboration with other companies, Precision for Medicine supplies the samples for next-generation sequencing. “In diagnostic development, one of the difficult things is finding samples that have the genetic variants that you’re looking for,” Dr. Snyder says. “Sometimes, the variants that you’re looking for are in the realm of 1% of patients or fewer, and there might be cancer drugs that are being targeted towards patients with these specific variants.”

Consequently, only a large biorepository is likely to contain the necessary samples. “When you’re submitting an assay to the FDA, you require enough positive examples where your assay worked to prove that it’s accurate,” Dr. Snyder says. “Statistically, just finding those is really hard.” To enhance diagnostic and treatment development, Project P.O.S.I catalogs a sample’s genetic characteristics: single nucleotide variants, insertions and deletions, structural variants like copy-number variation or gene fusions, microsatellite instability, and more. Dr. Snyder summarizes these characteristics as the “kinds of variants our customers are looking for that might really signal a good candidate for immunotherapy.”

Stretching the services

To ensure the biorepository continues to meet the needs of researchers, Precision for Medicine ensures its labs and offerings stay up-to-date with the most advanced technologies available.

For example, Precision for Medicine tracks new sequencing technologies to better characterize its biorepository. As one example, Dr. Snyder says, “We’re currently looking into using long-read sequencing to reveal structural variants that might not appear in short-read sequencing.”

In addition, the biorepository keeps expanding. As Kalsy says, “We’re always on the lookout for increasing the breadth of cases and sample types for all human diseases, including the parallel cohorts of non-diseased and at-risk sample types.”

Furthermore, Precision for Medicine has expanded beyond research-use specimens to now include a GMP platform to support clinical manufacturing for various therapies, including cell and gene therapies.

The overall goal of the biorepository will remain the same, which Kalsy describes as “providing meaningful partnerships and fueling research in order to help our customers deliver on our shared goal of serving patients.”

Anuj Kalsy
Scientific Director, Clinical Science
Precision for Medicine
Pharmaceutical industry veteran with specialized scientific experience in academia and R&D. Holder of patents. Author of high-impact papers. Subject matter expert in oncology, angiogenesis, immune-oncology, targeted therapies, immunology, and vaccine design. Deep focus on translational medicine, including development of antibody drug conjugates.

Robert Snyder
Associate Director, Genomics
Precision for Medicine
Respected authority in genomic research. Specialized expertise in in vitro diagnostic assay development for cancer mutations and recombinant protein expression modeling. Peerless focus on analytical accuracy, study design specificity, execution management, protocol and report writing.

Learn more about Precision for Medicine and its Biospecimens Solutions offerings.

The post A Data-Rich Biorepository Supporting Science appeared first on Inside Precision Medicine.

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