Dr. Thomas Moss, Founder & Chief Medical Officer
When the United States Marine William A. Foster wrote, “Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution,” he could have been penning an epigram about the importance of quality in translational research.
Take the example of biospecimen-driven research, where it truly is “garbage in, garbage out.”When a scientist spends weeks laboring to isolate an unusual cell in a rare patient sample only to later learn that the target cells aren’t present due to inadequate pre-analytic parameters, it is not only the research team that suffers but also society at large. Biospecimens are not the same as laboratory reagents and beware of those that treat them that way.
Quality iscentral and the difference between a project’s success and failure can come down to one of the dozens of choices a biospecimen provider makes in patient identification, collection, shipping, and storage
Dr. Thomas Moss couldn’t agree more. For Dr. Moss—a board-certified oncologist and stem cell transplanter with an MD from UCLA Medical School—quality in biospecimens has always been a pillar of clinical research. “Quality is central,” he says. “And the difference between a new drug reaching patients or not can come down to one of the dozens of choices a biospecimen provider makes in patient identification, collection, shipping, and storage.”
Early on, Dr. Moss knew the importance of quality. What he saw that others missed, however, was the importance of providing comprehensive clinical annotation with each sample. As a practicing physician and a rare cell researcher, he knew that without this metadata, bench scientists would not be able to truly understand each sample’s clinical context. What co-morbidities affected the patient’s outcome? How did the patient respond to first line therapy? How did the disease track over time? With this information, researchers can bridge the scientific and clinical worlds for tremendous patient impact.
It was only a matter of time before Dr. Moss and his longtime business partner, Mr. Marc Siegel, converted this epiphany into reality by founding the MT Group—a leading biospecimen CRO. Over the past 20 years, the Los Angeles-area CRO has proven itself as the go-to-source for high quality, comprehensively annotated, and difficult-to-source biospecimens, including fresh, frozen, and FFPE tissue as well as blood, serum, and plasma.
What Makes the MT Group Your Go-To Biospecimen CRO?
One answer is medical expertise and many years “in the industry trenches.” Having worked together for over 30 years and analyzing tens of thousands of specimens, Dr. Thomas Moss and Mr. Marc Siegel know what a good specimen looks like and how to consistently deliver one. Their firm has translated its know-how into robust collection, processing, and logistic protocols that ensure quality while minimizing sample variations, together providing pharma scientists with biologics they can trust.
Effective management of multi-time point studies, i.e., longitudinal studies, is another key point of differentiation. These projects, which may include measuring response over time to a new therapeutic regimen, studying week-to-week variation in a disease process, and comparing antibody response pre- and post-vaccination, are logistically challenging to organize and manage. After many dozens of longitudinal collections over the past two decades, however, the MT Group has established systems and protocols that provide effective oversight, resulting in infrequent missed collections.
Collaboration on study design ensures the right patients and right biologics are collected in the right way to achieve translational research goals
MT Group’s extensive and geographically diverse site network—spanning almost 200community clinics, hospitals, and academic sites primarily in the US but also internationally—allows it to support studies across many disciplines. Historically focused on oncology, the CRO has expanded its offering into cardiology, autoimmune (e.g., IBD, diabetes, rheumatoid arthritis, lupus), Non-Alcoholic Steatohepatitis (NASH), and infectious disease (COVID-19). As its network has grown, niche capabilities at its sites have also been identified, which enable the collection of rare, high value patient populations for translational research.
Partnering and Collaborating for Success
Central to MT Group’s business ethosis one powerful word: collaboration. The organization discovered early on that close collaboration with its customers as well as its sites was the winning recipe for successful collections.
With every project, MT sets this tone with its customers from the very beginning. “We have a collaborative approach, which begins with the first customer discussions on study design. Together, we ensure the right patients and right biologics are collected the right way to achieve translational research goals,” underscores Mr. John Kibler, VP of Business Development. “We get to the core of our customer’s project specific requirements and the results they hope to achieve with the biospecimens.”
MT Group views its collection sites as partners as well and after a preliminary study design is complete, MT quickly and efficiently consults with them to clarify regional medical practice and project feasibility. During this phase, MT secures “boots on the ground” clinical insight such as at what stage of disease an immuno-oncology drug is typically provided and whether it is given solo or as part of a combination therapy. This information is shared with MT’s customers and together the customer and MT may choose to refine the study design; flexibility and customization being a central part of MT’s service.
Study-specific site feedback helps MT accurately project patient enrollment rates as well as optimize collection parameters. “The dynamic feedback process helps pharma clients understand clinical practice and answers questions like, ‘Is this the best way to do the study? If not, how might we change it to improve results?’” states Dr. Moss. “It also allows scientists a window into what is actually happening in clinical practice rather than solely relying upon guesswork or what’s found in academic papers.”
Project initiation is handled like a mini clinical trial, with study-specific SOPs, biospecimen collection kits, and site initiation meetings that ensure site staff understand all of the patient inclusions and exclusions, the biologic collection and processing processes, data requirements, and sample storage and logistics. Once the study begins, MT Group monitors enrollment progress, adding new sites as required with progress transparently communicated to sponsors. And before samples and data are provided to sponsors, they are screened and quality checked, ensuring that they meet the stringent standards set by MT. Adds Mr. Siegel, “On top of this, we have an incredibly talented and detail-oriented team. Great people coupled with robust processes ensure the fast and on-target subject enrollment that our customers have grown to rely upon.”
The Tailwind behind Client Success
Illustrating the efficacy of its unique approach and strategies, Dr. Moss shared an anecdote in which MT helped a new client after an unsatisfactory engagement with another provider. In that study, the client was looking for circulating tumor cells (CTCs) collected from metastatic prostate cancer patients.
Mr. Marc Siegel, Founder & President
The customer had reviewed dozens of specimens from the other firm but had not received a single specimen with detectable CTCs, leading the customer to halt its study.
Months later during an introductory meeting, the customer shared this story with MT as an example of its frustration securing biospecimens for some of its more complicated projects. His years in the trenches were quickly put to use as Dr. Moss identified several problems with the study design, particularly around the pre-analytics and patient profiling. He and Mr. Siegel convinced the customer to try again.
“Leveraging our long experience in liquid biopsy, we constructed pre-analytic parameters around prostate specific antigen (PSA) values and disease metastasis,” shares Dr. Moss. Ultimately, these and a few other criteria drove MT’s delivery of samples with a60%+ positivity hit rate for CTCs. “Defining more selective patient inclusion criteria delivered a tremendous win for the new client, which set the foundation for a long-standing partnership.” Adds Mr. Siegel, “We apply a similar approach in circulating tumor DNA (ctDNA) projects as well as in our other prospective and longitudinal studies.”
Metadata is King
Core to all of MT Group’s projects is patient-linked metadata, the comprehensive clinical and laboratory information that provides actionable context through which biospecimen experimental results can be evaluated. MT Group’s metadata includes both single time point details as well as collection follow ups such as therapeutic response or disease progression. Customers have leveraged this data to drive biomarker research, refine clinical trial eligibility criteria, support FDA submissions, and anchor publications.
A related element is the MT Group’s ability to use its metadata to enroll patients under identical eligibility criteria to those used in a customer’s clinical trial. With biospecimens from these “clinical trial mimic” studies, customers can refine their trial’s inclusion criteria, reduce costs, and increase the probability of success.
“When we started MT Group back in 2003, we were the first in the industry to offer biospecimens with comprehensive clinical annotation,” shares Dr. Moss. “Since then, we have extended our metadata offering by following client interests and incorporating the clinical practice knowledge derived from our broad site network. We receive more positive customer feedback about our metadata than any other element of our service.”
The Unflinching Tenacity during Turbulence
When the COVID-19 pandemic struck, Mr. Siegel and Dr. Moss realized that they needed to do something to help. They knew that the MT Group network included many multi-specialty centers but they didn’t know whether collecting COVID-19 patients was feasible. A quick survey led to an enthusiastic “yes” from many sites. MT then turned to its customers, many of which were already developing COVID-19 vaccines, therapeutics, and diagnostics, and the interest was immediate.
A first few collections rapidly multiplied into dozens enrolling both active disease and convalescent subjects. One study longitudinally collected blood products to study progressive immune response while others secured matched saliva and nasopharyngeal swabs to support new diagnostic regulatory filings. One of the most exciting projects was a sera collection of recovered subjects to support Pfizer’s Phase 1-2 vaccine benchmarking work. “Seeing the real and tangible impact of our contribution to such a globally important project reaffirmed for Tom and me why we started this business. We are proud of our customers and our team,” states Mr. Siegel.