Clinical trials are an increasingly global endeavor. Collaborations between pharmaceutical companies, academic bodies, healthcare institutions, CROs, and CDMOs require a robust, highly regulated infrastructure for storing and distributing IMPs to international sites. Such infrastructure must ensure the safety and security of sensitive materials, achieve timely delivery, and maintain adaptive regulatory compliance.

Companies must partner with a MIA (IMP) licensed provider to meet these demands for import into the UK. This accreditation enables the storage and distribution of IMPs and facilitates the exchange of IMPs with other licensed entities through a Qualified Person. Finding an MHRA-certified partner who meets the highest standards of trust and quality is essential. Choosing the wrong partner can put clinical trials at risk through diminished IMP quality and regulatory non-compliance.

The recent MIA (IMP) license renewal and MHRA certification reinforce Sampled as a trusted, world-class partner for the storage and transport of IMPs. Our scalable storage and distribution solutions are built to support the evolving needs of organizations running global clinical trials, offering a safe, cost-effective, and fully compliant way to store and ship investigational materials through the UK.

“Sampled’s MHRA certification under our renewed MIA (IMP) license cements our global reputation for maintaining the highest standards of quality and control in handling clinical trial materials. On the back of our recent WDA licensing, this accreditation reinforces Sampled as a safe pair of hands for regulated storage and distribution at any scale, vindicating the trust leading pharmaceutical companies place in our capabilities.”

Mike Whatmough

General Manager UK, Europe & Global Technical Services, Sampled

View the press release on PRNewswire

About Sampled

Sampled is a fully integrated laboratory and biorepository with industry-leading storage, sample management, multiomics, cellular services, and custom clinical kitting. Founded in 1999 as RUCDR at Rutgers University, Sampled operates facilities in the US and UK and is CAP accredited and CLIA licensed. Sampled is committed to providing the highest quality sample storage, processing, and analysis services that enable researchers to make new discoveries and advance human health. When combined with state-of-the-art biobanking facilities, these capabilities provide comprehensive scientific solutions that speed time to quality data.

Media Contact

Caroline Mitchell, PhD

Director, Content & Creative Strategy, Sampled

communications@sampled.com

Safe and scalable product storage is essential for pharmaceutical and medtech companies to consistently meet market demand. However, building and maintaining large storage facilities for drugs, biologics, medical devices, and therapeutic products can drive up operational costs. Many products, such as flu vaccines, are only needed seasonally, leading to underused storage space and unnecessary expenditure. This makes outsourcing a cost-effective alternative to reduce CapEx. However, finding a reliable, WDA-licensed partner with the capacity to manage and store large volumes of inventory can be a significant hurdle.

WDA licensing, regulated by the MHRA, is mandatory for any organisation that stores or distributes human or veterinary medicines in the UK. This license ensures compliance with strict regulations, requiring that medicinal products are handled safely and maintained to high quality standards. WDA ensures customer protection by safeguarding end users from counterfeit products. It also mandates thorough documentation, which must be accurately maintained and stored for a minimum of ten years.

By obtaining WDA licensing, Sampled now offers a powerful new service covering distribution, returns, recalls, and secure long-term storage of medicinal products in two specialised warehouses (Cold 2–8 °C and Controlled Ambient 15–25 °C). This solution is ideal for large pharmaceutical manufacturers and is capable of handling substantial volumes while offering flexibility and reliability. Located on Scotland’s central M8 corridor, Sampled streamlines logistics across the UK and beyond, with key advantages for pharmaceutical and life science companies, including:

• Eliminating CapEx and maintenance costs for new storage facilities
• Scaling with demand so you only pay for what you need
• Remaining up to date with technological advancements and regulatory requirements to ensure enduring quality and compliance

“I am delighted to announce that Sampled has obtained WDA licensing, allowing us to offer extensive outsourced storage and distribution services for pharmaceutical companies operating within the UK. This marks a significant expansion of our storage and logistics offerings, further strengthening our support for life sciences organisations with flexible, compliant, and scalable solutions.”

Mike Whatmough

General Manager UK, Europe & Global Technical Services, Sampled

About Sampled

Sampled is a fully integrated laboratory and biorepository with industry-leading storage, sample management, multiomics, cellular services, and custom clinical kitting. Founded in 1999 as RUCDR at Rutgers University, Sampled operates facilities in the US and UK and is CAP accredited and CLIA licensed. Sampled is committed to providing the highest quality sample storage, processing, and analysis services that enable researchers to make new discoveries and advance human health. When combined with state-of-the-art biobanking facilities, these capabilities provide comprehensive scientific solutions that speed time to quality data.

Media Contact

Caroline Mitchell, PhD

Director, Content & Creative Strategy, Sampled

communications@sampled.com

Piscataway, NJ – Sampled, an integrated analytical biorepository and multiomics company, is proud to announce its selection as a Genomic Characterization Center for the Genome Characterization program of the National Cancer Institute (NCI), part of the National Institutes of Health. This prestigious Indefinite Delivery, Indefinite Quantity (IDIQ) contract has a funding ceiling of $150 million, positioning Sampled as a key contributor to supporting the advancement of cutting-edge cancer research and genomic discovery.

Under the award, Sampled will participate in all four contract pools, leveraging its state-of-the-art technologies and expertise to deliver comprehensive genomic solutions:

Pool 1 – DNA Sequencing

Whole Genome Sequencing and Whole Exome Sequencing using DNA extracted from FFPE or fresh frozen samples to support researchers comprehensive understanding of cancer biology by identifying mutations, structural variations, and genetic abnormalities that drive tumor progression critical for advancing precision oncology, uncovering novel therapeutic targets, and supporting large-scale cancer genomic studies.

Pool 2 – RNA Sequencing

RNAseq and microRNAseq using RNA extracted from FFPE or fresh frozen samples for transcriptomic analysis which will support researchers to analyze gene expression and regulatory pathways, revealing how genetic changes affect tumor development and behavior, essential for to identify biomarkers, study tumor microenvironment interactions, and potentially monitor responses to cancer therapies.

Pool 3 – Epigenome Characterization

Methylation and Chromatin Accessibility Characterization with array and sequencing based assays using DNA extracted from FFPE or fresh frozen samples to support NCI researchers to investigate critical changes, such as methylation patterns and chromatin remodeling, that drive cancer progression and therapeutic resistance.

Pool 4 – Single Cell/Spatial Characterization

Single-cell RNA, ATAC-seq, Spatial, and In Situ Analyses from FFPE or fresh frozen samples allowing a detailed understanding of tumor heterogeneity and the tumor microenvironment by analyzing individual cells and their interactions, for studying treatment resistance, advancing immunotherapy, and personalizing cancer care.

“Being part of the NCI Genome Characterization contract is a testament to Sampled’s unwavering commitment to delivering innovative and reliable solutions for cancer research,” said Greg Morrissey, Sr Director Government / Public Sector at Sampled. “Our participation across all four contract pools underscores our diverse capabilities in supporting the scientific community to uncover the complexities of cancer and drive precision medicine forward.”

“Sampled’s selection for this contract is an significant milestone in our mission to support cancer researchers with cutting-edge multiomics tools,” said Shareef Nahas, Chief Scientific Officer of Sampled. “Our team is deeply committed to advancing human health and medicine. This partnership with the NCI allows us to contribute directly to advancing oncology research, accelerating the discovery of novel cancer therapies, and improving patient outcomes through comprehensive genomic and molecular insights.”  

As a trusted partner to the NCI and the broader research community, Sampled’s contributions will enable groundbreaking discoveries in cancer genomics and epigenetics. The company’s integrated approach, combining cutting-edge technologies, robust infrastructure, and unparalleled expertise, ensures that researchers have access to the highest quality data and insights.

View the Press Release at PR Newswire Here

About Sampled

Sampled is a fully integrated laboratory and biorepository with industry-leading storage, sample management, multiomics, cellular services, and custom clinical kitting. Founded in 1999 as RUCDR at Rutgers University, Sampled operates facilities in the US and UK and is CAP accredited and CLIA licensed. Sampled is committed to providing the highest quality sample storage, processing, and analysis services that enable researchers to make new discoveries and advance human health. When combined with state-of-the-art biobanking facilities, these capabilities provide comprehensive scientific solutions that speed time to quality data.

Media Contact

Caroline Mitchell

Director, Content & Creative Strategy

communications@sampled.com

Olink’s state-of-the-art proteomics technology enables understanding of complex biological pathways and disease markers. Proteomics technology is an important tool for studying diseases, providing crucial insights into their underlying molecular mechanisms. The consistent and highly accurate results produced by Olink’s Proximity Extension Assay (PEA) technology have made it widely recognized and extensively cited in various research fields for protein profiling and biomarker development.

Olink® Certified Service Providers are recognized for their commitment to delivering the highest quality standards, undergoing rigorous training and annual certification using concordance samples.

 “We are proud to be one of the first Olink® Certified Service Providers and believe it highlights our dedication to pioneering health innovations. With this technology we can empower our clients with cutting-edge proteomics research capabilities,” says John DelliSanti, Sampled’s CEO.

 “We are excited that Sampled has joined the Olink® Certified Service Provider Network as it underscores our shared goal of giving customers the highest quality tools for their biomarker discovery research. Sampled has established themselves as a company committed to maintaining the highest standards of data quality and is well-equipped to support their customers with Olink technology” said Mike Irwin, Vice President of Global Sales, Support and Marketing at Olink.

About Sampled, Olink Certified Service Provider

Sampled enable clients to advance human health by leveraging active biological samples through; preservation, immortalization and utilization in comprehensive Multiomics research in the only Global Integrated Analytical Biorepository. Our vision is a world where we make health innovation easier, with a mission for Sampled to be behind every transformative health innovation. Sampled is headquartered in Piscataway, N.J. with labs across the US and the UK and partner labs in the Netherlands, China and Australia.

Infinity BiologiX LLC, Roylance Stability Storage Limited and Roylance Scientific Limited are doing business as Sampled. For more information, please visit www.sampled.com

Noel Figueroa Appointed Interim CFO

Positioned to Accelerate Mission to Support Every Transformative Health Innovation

Piscataway, NJ, 4/26/24 – Sampled, the next-generation laboratory that unlocks the valuable data in any biological sample, today announced the appointment of John DelliSanti as CEO, effective immediately. He succeeds Robin Grimwood, who will serve as an advisor to Sampled to help ensure a seamless transition.

“I am thrilled to join Sampled as its next leader, having been drawn to its unique mission and compelling commercial position,” said Mr. DelliSanti. “With labs and partners around the world, Sampled is at an inflection point and I am energized to help it realize its next phase of growth. I look forward to applying my experience, alongside the many talented Sampled employees, to allow health innovators to make breakthroughs faster and easier.”

“It has been a privilege and an honor to be part of this journey, as we’ve transitioned from RUCDR to Infinity BiologiX, to Sampled,” said Mr. Grimwood. “Sampled has realized many achievements, while successfully navigating through the COVID pandemic, and I’ve been honored to work alongside the incredible Sampled team. I am confident John is the right leader to further Sampled’s mission and strategy and look forward to the team’s continued success.”

“This leadership transition positions Sampled to accelerate its strategy of delivering exceptional services to its clients across the healthcare landscape,” said Sarah Hersey, Independent Director. “We thank Robin for his unwavering commitment and are excited to benefit from John’s considerable experience and expertise. The Board and I are confident that with these changes Sampled will remain at the forefront of this industry.”

Additionally, Amit Bhalla, Chief Financial Officer, has decided to leave the company to pursue other opportunities. Sampled is conducting a thorough search to identify its next CFO. Noel Figueroa, Vice President and Corporate Controller, will serve as interim CFO.

Mr. DelliSanti brings extensive experience to this new role. He was most recently Chief Commercial Officer for Taconic Biosciences. John has a proven track record of commercial success in the healthcare industry, having previously held leadership positions at ArisGlobal, Carestream Health, and Caliper Life Sciences. Mr. DelliSanti holds an B.S. and MBA from Fordham University.

About Sampled

Sampled enable clients to advance human health by leveraging active biological samples through; preservation, immortalization and utilization in comprehensive multiomics research in the only Global Integrated Analytical Biorepository. Our vision is a world where we make health innovation easier, with a mission for Sampled to be behind every transformative health innovation. Sampled is headquartered in Piscataway, N.J. with labs across the US and the UK and partner labs in the Netherlands, China and Australia.

Infinity BiologiX LLC, Roylance Stability Storage Limited and Roylance Scientific Limited are doing business as Sampled. For more information, please visit www.sampled.com

Piscataway, NJ, July 11, 2023 – Sampled¹ today announced that it has been named a Certified Service Provider for PacBio, a leading developer of high-quality, highly accurate sequencing solutions, equipping Sampled to deliver the highest quality advanced sequencing technology services on PacBio’s technology.

To achieve this certification, providers must undergo a rigorous process including training on PacBio sample processing and data analysis workflows. Sampled has added long-read sequencing technologies to its already industry-leading, advanced integrated analytical-biorepository suite of capabilities to Store, Manage, Analyze, Research and Transport biosamples for its clients.

“We are very proud to have been named a Certified Service Provider for PacBio, one of the leading providers of sophisticated sequencing technologies,” stated Shareef Nahas, Ph.D., Sampled’s Chief Scientific Officer. “Through this partnership, we can provide our clients with some of the world’s most advanced technologies and capabilities, enabling them to make important breakthroughs in their discovery and development programs.”

“We are delighted to announce Sampled as a Certified Service Provider,” said Jeff Eidel, Chief Commercial Officer at PacBio. “The robust certification process requires companies to meet very strict training and quality standards. Sampled and PacBio are both dedicated to supporting the scientific community in their genomic research projects, and we look forward to continuing to grow our partnership as Sampled scales on Revio and adopts future technologies developed by PacBio.”

“At Sampled, we are always striving to innovate and bring the most cutting-edge services to our clients, so we are delighted to now offer the PacBio long-read sequencing technology,” said Robin Grimwood, Chief Executive Officer at Sampled. “Our thanks to the PacBio team for their partnership and collaboration as we work together for the benefit of our clients.”

About Sampled

Sampled is a next-generation laboratory that unlocks the valuable data in any biological sample. Through our integrated lab services, we can Store, Manage, Analyze, Research and Transport biological materials, offering partners a seamless solution for all research samples. Our vision is a world where we make it faster and easier for health innovators to improve human health, with a mission for Sampled Labs to be behind every transformative health innovation. Sampled is headquartered in Piscataway, N.J. with labs across the US and Europe and partner labs in the Netherlands, China and Australia.

Infinity BiologiX LLC, Roylance Stability Storage Limited and Roylance Scientific Limited are doing business as Sampled. For more information, please visit www.sampled.com

Glasgow lab will manage blood samples for the Guardant Health SHIELD lung cancer screening study in the EU.

February 1, 2023 – Piscataway, NJ – Sampled¹ today announced that the new genomics Sampled Lab in Glasgow, UK, has initiated a project with Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, to manage blood samples for a large-scale lung cancer screening study. The SHIELD Lung registrational study is designed to evaluate the performance of a Guardant blood-based screening test to detect lung cancer in high-risk individuals aged 50-80. Sampled has already begun receiving blood samples for the study, which is expected to enroll nearly 10,000 patients and will be conducted across approximately 100 centers in the U.S. and Europe. Sampled will manage receipt of the study’s blood samples from these test sites, prepare them for analysis, and store them until they are ready to be shipped to Guardant Health’s U.S. laboratories for test processing.

“This project is a major milestone towards making Sampled’s world-class capabilities available around the world. Guardant Health is a leader in precision oncology testing and we are delighted to partner with them to manage and prepare the blood samples from this important clinical study,” said Robin Grimwood, Sampled CEO. “Our Glasgow lab is located in the heart of BioCity, Scotland’s life science innovation incubator, and as a result we’ve been able to attract a deeply experienced team of scientific professionals to become part of our team.”

Sampled’s Glasgow facility has the ability to store and manage large quantities of blood samples throughout the course of the two-year study. The state-of-the-art, 3,000 square foot biosample research and analysis lab was created to bring Sampled Labs service offerings to European clients. The lab is equipped with leading technologies from a number of providers including: Illumina sequencing platforms, PacBio long read sequencing, microarray capability from ThermoFisher, and microfluidic-based molecular sample identification from Standard BioTools. The lab also offers an extensive range of automated liquid handling from Hamilton, PerkinElmer, and SPT Labtech.

About Sampled

Sampled is a next-generation laboratory that unlocks the valuable data in any biological sample. Through our integrated Sampled Lab services, we can Store, Manage, Analyze, Research and Transport biological materials, offering partners a seamless solution for all research samples. Our vision is a world where we make it faster and easier for health innovators to improve human health, with a mission for Sampled Labs to be behind every transformative health innovation. Sampled is headquartered in Piscataway, N.J. with labs across the US and Europe and partner labs in the Netherlands, China and Australia.

Infinity BiologiX LLC, Roylance Stability Storage Limited and Roylance Scientific Limited are doing business as Sampled. For more information, please visit www.sampled.com

November 15, 2022 – Piscataway, NJ – The Chief Scientific Officer at Sampled¹ issued a call to action for greater diversity in clinical trial recruitment and the collection of biosamples in a letter in the current issue of Biopreservation and Biobanking.

The letter by Sheldon et al, “Biobanks and International Initiatives Are Playing a Critical Role in Redressing Historic Inadequacies in Biosample and Data Access from Underrepresented Minority Populations,” states that the development of effective precision medicine tests must have broad representation from Underrepresented Minority (URM) populations in sample collection, processing and analysis.

“Genomic testing is revolutionizing the development of medicines, and Sampled is at the forefront of helping companies and academic institutions to unlock the genetic information that will lead to new treatments and cures,” said, Shareef Nahas, Ph.D., Chief Scientific Officer at Sampled. “However, the basis for these advancements lies in the ability of researchers to identify patterns and characteristics from many kinds of genetic profiles. Greater diversity in the collection of biomaterials and biosamples will speed our ability to develop and implement cutting-edge analytical approaches.”

“Biobanks such as Sampled play a critical role in helping to address the historic lack of representation of minority communities in medical research,” said Robin Grimwood, Founder and CEO of Sampled. “For instance, our Minnesota laboratory collaborated with state public health officials to offer free COVID testing to local minority communities. Our focus on public outreach and communication about the importance of testing, along with our ability to combine storage, management, and analytical approaches in one facility made this joint effort with the state health officials a great success.”

Traditionally, as many as 86% of participants in clinical trials have been characterized as being of European descent². Contributors to these racial and ethnic disparities include inadequate clinical trial recruitment programs and mistrust of the medical community by those in minority communities. Dr. Nahaas calls on the biopharma industry to increase outreach to URM communities, and to implement studies and testing in strict compliance with regulations over protected health information, adherence to validated standard operating procedures for processing genomic data and a storage infrastructure designed to safeguard specimen integrity.

You can access the paper here temporarily, after the 8th of decembet please get in touch to receive a copy: Biobanking Diversity Article

About Sampled

Sampled is a next-generation laboratory that unlocks the valuable data in any biological sample. Through our integrated Sampled Lab services, we can Store, Manage, Analyze, Research and Transport biological materials, offering partners a seamless solution for all research samples. Our vision is a world where we make it faster and easier for health innovators to improve human health, with a mission for Sampled Labs to be behind every transformative health innovation. Sampled is headquartered in Piscataway, N.J. with labs across the US and Europe and partner labs in the Netherlands, China and Australia.

Infinity BiologiX LLC, Roylance Stability Storage Limited and Roylance Scientific Limited are doing business as Sampled. For more information, please visit www.sampled.com

October 11, 2022 – Piscataway, NJ: Sampled¹ launch new informatics platform, SampledSphere.

SampledSphere is a new informatics platform built from the ground up to provide a 360-degree view of a biosample managed by a Sampled Labs. SampledSphere, is a next generation informatics platform that allows researchers to leverage the data around their samples including everything from simple LIMS tasks such as registering and searching for samples to track location and storage condition, through to accessing research results and harnessing big data.

SampledSphere will have 5 pillars that match our unique Sampled Labs service. The first pillar to launch is focussed on replacing pre-existing systems focussed on storage with ‘SampledSphere – Store’.

“We are excited to be bringing innovation into the informatics space with our new SampledSphere platform. We strongly believe that the power of big data will be the key to success for health innovators, and as a solution provider we need to give our clients the tools needed to leveraging that power.” Said Robin Grimwood, Sampled Chief Executive Officer.

“I’m very proud of the solution that our informatics experts have built, SampledSphere represents a step change in how our clients can access not just the data on individual samples but how they can harness wider data sets, manage consent, examine sample condition, review chain of custody and in future gain access to test results and research data.” Said Stephen Wang, Sampled Chief Information Officer.

As the first ‘SampledSphere’ pillar to launch ‘SampledSphere – Store’ will allow clients to register, search and exchange data on samples hosted on a secure, serverless AWS architecture. The databases that store all of this information is HIPAA, and CFR Part 11 compliant and is stringently guarded. All communication between user browser and databases are conducted through private subnets, so only pre-authorised IP addresses can exchange information.

About Sampled:

Sampled is a next-generation laboratory that unlocks the valuable data in any biological sample. Through our integrated Sampled Lab services, we can Store, Manage, Analyze, Research and Transport biological materials, offering partners a seamless solution for all research samples. Our vision is a world where we make it faster and easier for health innovators to improve human health, with a mission to be the lab behind every transformative health innovation. Sampled is headquartered in Piscataway, N.J. with labs across the US and Europe and partner labs in the Netherlands, China and Australia.

¹Infinity BiologiX LLC, Roylance Stability Storage Limited and Roylance Scientific Limited are doing business as Sampled.

Sarah brings a wealth of experience in precision medicine and biopharmaceutical research and development gained from leadership positions throughout the pharmaceutical industry.  Sarah joins current Board members Robin Grimwood, Co-Founder and CEO and Brian Rose, Managing Director, Viking Global.

“Appointing Sarah to our board adds a wealth of experience to our business as we continue with our growth strategy,” said Robin Grimwood, Sampled’s CEO.  “We are particularly excited to have Sarah bring her insights in precision medicine, to help guide our expanding service offerings.  We welcome Sarah and are very excited to have her on our Board of Directors.”

“I am thrilled to be joining Sampled’s Board of Directors at such a significant time for the company,” said Sarah Hersey.  “Sampled’s vision of making it faster and easier for health innovators to improve human health guides the company in its future growth, and I look forward to applying my experience in precision medicine and translational science in helping Sampled realize this vision.”

Sarah is an accomplished leader and is responsible for leading a world-class research and development team of over one hundred scientists including MDs and PhDs supporting translational sciences and diagnostics.  Sarah is currently at Bristol Myers Squibb serving as Vice President, Head of Translational Sciences and Diagnostics, where she leads a team that supported more than twenty drug approvals, top-line results and other key regulatory milestones in a single year during the Pandemic. Prior to Bristol Myers she was Head of Precision Medicine, Vice President at Celgene (which was acquired by Bristol Myers Squibb in 2019) where she built and led a world-class precision medicine team. Prior to Celgene, Sarah was the Global Head of Future Precision Medicine at Novartis where she developed innovative solutions to support accurate and precise use of advanced diagnostic platforms, such as NGS.  Prior to Novartis, Sarah held multiple positions at Johnson & Johnson, Ortho Clinical Diagnostics, and Charles River Laboratories. Sarah received an MS, Biology, Biochemistry from Northern Illinois University and an MBA from California State University, Dominguez Hills. She received a BS in Chemistry from Northern Illinois University.

About Sampled:

Sampled is a next-generation laboratory that unlocks the valuable data in any biological sample. Through our integrated Sampled Lab services, we can Store, Manage, Analyze, Research and Transport biological materials, offering partners a seamless solution for all research samples. Our vision is a world where we make it faster and easier for health innovators to improve human health, with a mission to be behind every transformative health innovation. Sampled is headquartered in Piscataway, N.J. with labs across the US and Europe and partner labs in the Netherlands, China and Australia.

Infinity BiologiX LLC, Roylance Stability Storage Limited and Roylance Scientific Limited are doing business as Sampled.

For more information, please visit www.sampled.com 

Media Contact: Mike Thurogood Mike.Thurogood@sampled.com