Q: iSpecimen recently announced the launch of the iSpecimen Marketplace for human biospecimens. Can you tell us more about this marketplace?

A: The iSpecimen Marketplace is the first-of-its-kind, self-service platform for researchers to search for and obtain human biospecimens. Through the Marketplace, researchers across the globe gain instant access to millions of specimens anytime, anywhere, while participating provider organizations gain an opportunity to contribute compliantly to medical research as well as their bottom line. To date, there has never been a technology platform like this to connect researchers who need human biospecimens with the healthcare providers that have them.

The full potential of this platform is tremendous. Whether researchers need banked samples or prospectively-collected samples, the efficiencies and scalability of a self-service platform that can search across thousands of hospitals, practices, biorepositories, clinical labs, pathology labs, and other healthcare organizations is unprecedented and game changing. At the same time, it gives provider sites a broad-reaching, streamlined opportunity to move specimens into research programs.

Q: What problem is this Marketplace solving and who is the audience / customer for it? What is the technology behind it?

A: The iSpecimen Marketplace solves one of the life science industry’s biggest challenges – how to more efficiently find and obtain annotated human biospecimens required for diagnostic and therapeutic discovery research.It’s the only platform that allows researchers and scientists to search a truly federated network of healthcare providers and biobanks to find the specific specimens and data sets required for their research. It was initially developed to address the growing need for biospecimen access by scientists across the biopharmaceutical and in vitro diagnostic (IVD) industries, as well as those with government and academic institutions, driving biomarker discovery and validation efforts. Coincidentally, it also provides a tremendous service to the healthcare provider organizations that take part – such as hospitals system, commercial laboratories, biobanks, and private practice groups – that desire to contribute more broadly to biomedical research and offer research participation opportunities to their patients/donors.

Regarding the technology, the iSpecimen Marketplace has been developed on a proprietary, cloud-based platform. At the heart of the platform is technology that securely and compliantly receives de-identified data from electronic medical records, laboratory information systems, and other data sources about available specimens and patients and harmonizes the data across all participating organizations for one standardized view into the federated specimen pool.

This data is then easily searchable by researchers using our intuitive, web-based user interface, which bears similar ease-of-use and faceted-search functionality found in other marketplace/search platforms. Additionally, the iSpecimen Marketplace simplifies administrative tasks associated with specimen procurement and handles all compliance management and financial transactions on behalf of both provider partners and researchers.

Q: What biospecimens are made available via the Marketplace?

A: iSpecimen’s Marketplace provides access to a wide range of biofluids (blood, plasma, serum, urine, etc.), solid tissues, and viable hematopoietic cells (PBMCs, bone marrow, cord blood, etc.) collected for research use under approved IRB protocols with the informed consent of the patients and donors. The Marketplace also provides near real-time access to tens of millions of remnant biofluids and solid tissues that are flowing through the clinical labs and pathology labs of the healthcare provider organizations in our network. These are biofluids and solid tissues that were collected and tested for clinical purposes, have exhausted their “clinical lifespan”, and are scheduled to be discarded. Many of these samples are useful to a variety of research endeavors.

Q: What makes the iSpecimen Marketplace different from a regular biobank? What are some of the advantages?

A: Two things primarily – our technology and our business model, both of which allow us to minimize internal inventory and rely on the distributed inventories across the globe. iSpecimen runs the only true, technology-driven marketplace for biospecimen procurement, which makes it possible to for us to source samples and data sets without the need to build internal inventory (i.e., bank samples). We are the only company using technology to essentially watch the healthcare grid and biobanking world in near real time to provide access to the samples. We do not need to house any specimens ourselves to satisfy researcher needs. Individual healthcare providers and biobanks in our network each maintain their own inventory from which samples are provided – inventory that we monitor virtually in near real-time to broadcast availability.

Q: How do you ensure the protection of patient/donor privacy and compliance with regulations that govern the use of healthcare data and biospecimens for research?

A: iSpecimen has made numerous and substantial investments into the security and compliance features of the platform. First, all of our processes, whether manual or technology-enabled, have been designed in accordance with the appropriate section of the Department of Health & Human Services (HHS) Common Rule and HIPAA. As a rule, iSpecimen does not ever take in Protected Health Information (PHI) from its healthcare providers sites. All data transmitted to iSpecimen have had any PHI removed by our proprietary software, iSpecimen Guardian®, for secure storage behind the firewall of the institution from which the data came. Only non-identifying data elements are sent to iSpecimen to provide a general description of the specimens and patients that are available (specimen type, test results, diagnoses, medications, etc.). When a specimen within the Marketplace is selected by a researcher, a secure message is sent back to the source institution where it is reunited with the respective PHI to allow staff there to select that specimen and send it to the researcher in an anonymized format.

As an added level of protection, iSpecimen restricts any researcher from ordering specimens until they have executed iSpecimen’s Material & Data Use Agreement. This Agreement prohibits the researcher from ever using de-identified data sets that iSpecimen provides, or any data sets that the researcher may generate from analysis of the specimen, to attempt to re-identify a sample or patient/donor.

Q: What are some of the key applications and studies that will benefit from the Marketplace?

A: There are many applications across both basic and translational research that benefit from the Marketplace – applications ranging from biomarker discovery/validation to IVD analytical/clinical validation to assay development/refinement to correlation studies to instrument calibration. A sampling of the projects we’ve helped accelerate can be found here: ispecimen.com/blog/category/specimen-spotlight

Q: If we understand this right, access to samples is free. Who pays for the Marketplace or in other words how do you create revenue?

A: Access to the iSpecimen Marketplace is free, meaning that there is no charge for researchers/scientists to create an account and search for the samples that they need. There is a modest charge for the service of procuring the samples, should the researcher wish to obtain them following their search, with pricing determined by each sourcing institution. iSpecimen derives its revenue through a variety of revenue-sharing agreements that we manage with the numerous healthcare providers and biobanks in our partner network.

Interview with Gabriel Bien-Willner of Palmetto GBA

Q: What does your role entail as the director of the MolDX program at Palmetto GBA?

A: The job directing MolDX is multifaceted; first and foremost the MolDX program is responsible for assessing molecular diagnostic tests on the market and makes coverage and pricing determinations for such tests and technology. This is usually done through local coverage determination policies or technical assessments.

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Interview with Peter Marks of FDA

Q: The CBER’s Regenerative Medicine Advanced Therapy Designation program has been very successful, with about 100 requests for designation in the two years of its existence. Can you please tell us about the program and how it was put together?

A: The Regenerative Medicine Advanced Therapy (RMAT) Designation program came into being as part of the 21st Century Cures Act that was signed into law on December 13, 2016.

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Interview with Calum MacRae of Harvard Medical School

Q: What patient data do we need to better understand the underlying cause of disease and how to prevent it?

A: Medicine at present is highly underdetermined and data poor. To be precise, one must be comprehensive, so medicine (with our consent) will use not only what we currently conceive of as biomedical information, but also data from across our lives.

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Headlines from PMWC 2019 Silicon Valley

A big ‘Thank You’ to all of our presenters and attendees for celebrating 10 years of precision medicine progress with us! PMWC 2019 Silicon Valley was attended by 2000 participants from 35 countries, which included over 400 speakers in 5 parallel tracks!

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Interview with Ken Bloom of Ambry Genetics

Q: Tell us more about your organization/company. What patient population are you serving and which services are you specializing in?

A: Ambry Genetics is a recognized leader in high quality complex genetic testing. We seek to find the genomic cause or contributors to rare diseases, abnormal phenotypes and hereditary disorders.

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Interview with Lee Pierce of Sirius Computer Solutions

Q: What is the state of big data and analytics in healthcare, and how to best use the reams of data available?

A: More than ever, Healthcare organizations are achieving measurable value through use of their data and analytics assets. There is more raw material available than ever to create value. This raw material is the data flowing from internal systems and applications and also from devices and systems external to healthcare organizations.

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Interview with Anita Nelsen of PAREXEL

Q: There are various new, emerging technologies that bring us closer towards a cure for life-threatening disorders such as cancer, HIV, or Huntington’s disease. Prominent examples include the popular gene editing tool CRISPR or new and improved cell and gene therapies. By when can we expect these new technologies being part of routine clinical care?

A: Today’s emerging technologies are making the promise of individualized treatment a reality.

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Interview with Ilan Kirsch of Adaptive Biotechnologies

Q: The Nobel Prize in Medicine was awarded recently to James Allison and Tasuku Honjo for their work on unleashing the body’s immune system to attack cancer, a breakthrough that has led to an entirely new class of drugs and brought lasting remissions to many patients who had run out of options. The Nobel committee hailed their accomplishments as establishing “an entirely new principle for cancer therapy.” What is your first-hand experience the impact that those new drugs had on patients?

A: For decades cancer was viewed as solely a cell-autonomous condition.

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BMS buys Celgene | Lilly buys Loxo Oncology – Does this Signal a Return to Strong Deal-Making Activities in 2019?

Bristol-Myers Squibb’s blockbuster $74B deal to buy Celgene creates an oncology powerhouse amid industrywide excitement about the rapidly evolving science and explosive growth of the sector. The agreement could signal a return to deal-making for the pharmaceutical industry in the $133B global oncology therapeutics market.

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Interview with Gini Deshpande of NuMedii

Q: What need is NuMedii addressing?

A: NuMedii, has been pioneering the use of Big Data, artificial intelligence (AI) and systems biology since 2010 to accelerate the discovery of precision therapies to address high unmet medical needs. Artificial Intelligence approaches are a natural fit to harness Big Data as they provide a framework to ‘train’ computers to recognize patterns and sift through vast amounts of new and existing genomic

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Interview with Minnie Sarwal of UCSF

Q: Genomic medicine is entering more hospitals and bringing with it non-invasive technology that can be used to better target and treat diseases. What are some key milestones that contributed to this trend?

A: Completion of complete sequence data from the human genome project, and the advances in proteomic, microRNA and epigenetic assays added a layer of pathway biology to the understanding of human diseases.

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Interview with Shidong Jia of Predicine

Q: Once sequencing has been validated as a clinical solution via trusted workflows, and coinciding with the technological developments driving costs lower, we can expect accelerated human genome profiling for clinical Dx. How soon, do you think, will we see accelerated growth and what can we expect?

A: We will see accelerated human genome profiling for clinical Dx in 2019 and the coming years as more biomarker-based cancer drugs are gaining approval.

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Interview with Iya Khalil of GNS Healthcare

Q: Artificial intelligence (AI) techniques have sent vast waves across healthcare, even fueling an active discussion of whether AI doctors will eventually replace human physicians in the future. Do you believe that human physicians will be replaced by machines in the foreseeable future? What are your thoughts?

A: I think that there’s a lot of speculation and uncertainty around AI, but I don’t foresee a time when we won’t need physicians.

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Interview with Ilya Michael Rachman of Immix Biopharma Inc.

Q: The Nobel Price in Medicine was awarded recently to James Allison and Tasuku for their work on unleashing the body’s immune system to attack cancer, a breakthrough that has led to an entirely new class of drugs and brought lasting remissions to many patients who had run out of options. The Nobel committee hailed their accomplishments as establishing “an entirely new principle for cancer therapy.” Besides CAR T-cell therapy what do you think next generation immunotherapies will look like to successfully combat cancer?

A: The next generation of immunotherapies will build on the insights discovered by immunologists like James Allison and Tasuku Honjo and extend them to modify the body’s response to tumors.

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Join me to Kick off PMWC Silicon Valley in the Santa Clara Convention Center, Focusing on Every Element of Precision Medicine

My team worked in collaboration with Bill Dalton, Kim Blackwell, Atul Butte / India Hook Barnard, Nancy Davidson and Sharon Terry to create a program that touches every component of precision medicine while bringing together all of its key stakeholders. Leading participating institutions including Stanford Health Care, UCSF, Duke Health, Duke University, John Hopkins University, University of Michigan and more will share their learnings and experiences and their successes and challenges, as they make precision medicine the new standard of care for all.

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Johns Hopkins
University Of Michigan

The Precision Medicine World Conference (PMWC), in its 17th installment, will take place in the Santa Clara Convention Center (Silicon Valley) on January 21-24, 2020. The program will traverse innovative technologies, thriving initiatives, and clinical case studies that enable the translation of precision medicine into direct improvements in health care. Conference attendees will have an opportunity to learn first-hand about the latest developments and advancements in precision medicine and cutting-edge new strategies and solutions that are changing how patients are treated.

See 2019 Agenda highlights:

  • Five tracks will showcase sessions on the latest advancements in precision medicine which include, but are not limited to:
    • AI & Data Science Showcase
    • Clinical & Research Tools Showcase
    • Clinical Dx Showcase
    • Creating Clinical Value with Liquid Biopsy ctDNA, etc.
    • Digital Health/Health and Wellness
    • Digital Phenotyping
    • Diversity in Precision Medicine
    • Drug Development (PPPs)
    • Early Days of Life Sequencing
    • Emerging Technologies in PM
    • Emerging Therapeutic Showcase
    • FDA Efforts to Accelerate PM
    • Gene Editing
    • Genomic Profiling Showcase
    • Immunotherapy Sessions & Showcase
    • Implementation into Health Care Delivery
    • Large Scale Bio-data Resources to Support Drug Development (PPPs)
    • Microbial Profiling Showcase
    • Microbiome
    • Neoantigens
    • Next-Gen. Workforce of PM
    • Non-Clinical Services Showcase
    • Pharmacogenomics
    • Point-of Care Dx Platform
    • Precision Public Health
    • Rare Disease Diagnosis
    • Resilience
    • Robust Clinical Decision Support Tools
    • Wellness and Aging Showcase

See 2019 Agenda highlights:

    • Five tracks will showcase sessions on the latest advancements in precision medicine which include, but are not limited to:
      • AI & Data Science Showcase
      • Clinical & Research Tools Showcase
      • Clinical Dx Showcase
      • Creating Clinical Value with Liquid Biopsy ctDNA, etc.
      • Digital Health/Health and Wellness
      • Digital Phenotyping
      • Diversity in Precision Medicine
      • Drug Development (PPPs)
      • Early Days of Life Sequencing
      • Emerging Technologies in PM
      • Emerging Therapeutic Showcase
      • FDA Efforts to Accelerate PM
      • Gene Editing / CRISPR
      • Genomic Profiling Showcase
      • Immunotherapy Sessions & Showcase
      • Implementation into Health Care Delivery
      • Large Scale Bio-data Resources to Support Drug Development (PPPs)
      • Microbial Profiling Showcase
      • Microbiome
      • Neoantigens
      • Next-Gen. Workforce of PM
      • Non-Clinical Services Showcase
      • Pharmacogenomics
      • Point-of Care Dx Platform
      • Precision Public Health
      • Rare Disease Diagnosis
      • Resilience
      • Robust Clinical Decision Support Tools
      • Wellness and Aging Showcase
  • Luminary and Pioneer Awards, honoring individuals who contributed, and continue to contribute, to the field of Precision Medicine
  • 2000+ multidisciplinary attendees, from across the entire spectrum of healthcare, representing different types of companies, technologies, and medical centers with leadership roles in precision medicine
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