Scientists today are increasingly focused on delivering medical innovations tailored to real-world patients. Developing these therapies can be costly, however, and part of the cost can be connected to identifying the right patient sub-population too late in the development process. At Novaseek Research, we aim to drastically reduce the time required to identify the right patient cohorts with well-categorized and detailed clinical phenotypes and help clinical researchers prospectively obtain biospecimens
enriched with EMR-sourced, fully consented patient data. Identifying the right patient cohorts early on increases clinical researchers’ success and saves a lot of time and money in the process.

When our Novaseek team came together, obtaining biospecimens prospectively was key to our innovative approach. We knew that our biggest impact would be made by getting the right biospecimens to clinical researchers with as much information about the patients as possible. Rather than looking through freezers of existing biospecimens to meet researchers’ needs, we enable
researchers to identify the types of patients from whom they would need to collect biospecimens. Based upon criteria set by the researchers, our Clinical Data Network for Research (CDNR) platform would then identify patients who met those criteria within our network of hospital partners, and further identify biospecimens remaining from the patients’ clinical testing, allowing those specimens to be repurposed for research, rather than being discarded by the hospitals’ labs. Of course, the patients’ information is coded within CDNR, fully consented and HIPAA-compliant.

CDNR enables biomedical and clinical researchers to define criteria for patients and biospecimens based on detailed clinical needs, including primary disease, co-morbidities, medications prescribed, and medical events within a certain timeframe and more. This data is accessible via a user-friendly interface and allows researchers to request highly specialized biospecimens, as well as to follow patients over time and collect medical data updates and biospecimens as disease or treatment progresses. There are several advantages to this approach:

• Identifying specific groups of patients early in the development process allows clinical researchers to test and tweak responses in different patient sub-populations through observational studies, helping inform the next steps. It’s an extremely flexible approach that can accommodate the latest scientific and medical needs.
• We can track patients longitudinally and prospectively. For example, one Novaseek customer needed to evaluate the performance of a novel biomarker in patients with life-threatening acute conditions, such as heart attack, stroke and organ failure, requiring the collection of biospecimens shortly after an acute event and at multiple timepoints during patient recovery. We were able to set up the project within a few days and provide consented biospecimens and data at the right points in time, from shortly after the acute event and over the course of patient recovery.

The system we’ve built and our approach fills an unmet need by researchers and hospitals alike. While CDNR allows clinical researchers to easily identify patient cohorts and obtain biospecimens in a speedy manner, CDNR also enables hospitals and large practices to easily participate in research. Most of all, we are thrilled to play a role in getting better medicines to patients faster.

Last Thursday Novaseek Research had the chance to listen in on the Harvard Business School Kraft Precision Medicine Accelerator Oncology Data Landscape Update call. The Kraft Accelerator was established last year to speed breakthroughs in precision medicine. The Accelerator aims to enable faster commercialization of high-impact innovations by addressing challenges that slow the advancement of precision medicine and disseminating best practices and models to overcome them.

Last week’s talk focused on the data landscape and its importance in driving precision medicine forward. The need is recognized across the industry, and the Kraft Accelerator is working to collate many databases that have been created by industry and outside organizations into a single, powerful resource for oncology. They are populating the database through crowdsourcing and taking a number of innovative approaches to build the database further. Scientists will access the database to create synthetic cohorts of patients and draw insights based upon vast amounts of real world patient data searchable to the most minute genomic sequence. It’s an incredible project, and one that will advance oncology research significantly.

However, there is a missing link. The phenomenal insights we would be able to gain need to be tied to real world patients. It underscores the importance of the Novaseek offering. As scientists define even more precisely the type of patient they are seeking for research, and later for linking the right treatment to the right patient, access to those patients and human biospecimens matching those specific criteria becomes even more critical to successful research and clinical studies. Using the CDNR platform from Novaseek, scientists can procure clinical data and human biospecimens that match exactly the characteristics identified in the cohort of interest and continue to follow those patients prospectively as they continue their research.
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Novaseek has a place at this precision medicine accelerator table. By offering an end-to-end solution for researchers, Novaseek’s CDNR provides real world clinical data and clinical data-enriched biospecimens for translational medicine, clinical feasibility and observational studies. It is encouraging to be part of an industry where so many are working tirelessly toward the same goal of getting better medicines to patients faster, leveraging technological advances not only for data analytics, but also for machine learning and crowdsourcing. We have an exciting new era of healthcare ahead.

Last month I had the opportunity to present Novaseek’s CDNR platform at the second annual Digital Medicine Showcase. This event is a part of the Biotech Showcase event that takes place during the J.P. Morgan Annual Healthcare Conference. Digital Medicine Showcase brings together innovative companies and gives them a forum to present their clinically impactful digital technologies to an audience of venture capital and private equity investors, pharmaceutical executives and professional advisors. I was so thrilled to share our approach to providing real world data-enriched biospecimens for translational medicine, clinical feasibility and observational studies. It was Novaseek’s second year at Digital Medicine Showcase, and we were able to detail updates to our CDNR technology that we recently announced. We also were excited to share some of the use cases and examples of studies that Novaseek currently is enabling for our pharmaceutical, biotechnology and diagnostic customers. 

Even over the past year, digital medicine has gained a lot of traction. It was evident in the expansion of Digital Medicine Showcase conference, from an afternoon in a single room last year, to a two-day event this year. Thirty companies presented, with offerings ranging from live coaching, to virtual reality, to digital treatments for enhanced outcomes, to gaming apps, in areas as diverse as smoking cessation, to mental health, to diabetes. The industry has advanced rapidly in the past five years, but the feeling is that the next five years will be even more critical in determining the collaborations and partnerships that will shift medical care from a position of reaction to one of proactive health management.

Advances in technology have been a driving force in this evolution, particularly with the transition to EHRs and the technological ability to integrate records from multiple sources and to manipulate and analyze large volumes of data. Such advances in technology make our CDNR offering possible, enabling us to connect researchers with real world data and patients in an entirely new way. CDNR offers researchers the ability to procure human biospecimens enriched with data from EHRs, including lab test results, medical history, medication information – and to follow patients prospectively during the course of the disease or treatment. CDNR also offers population analytics features that facilitate insights into the effect of various co-morbidities or drug classes on the progression of disease. Armed with this extensive data and the ability to incorporate these data-laden human biospecimens into their work, researchers can develop more effective and precise options for patients in need.
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We are only beginning to tap the power of real world clinical data for research. As we continue this trend, patients will be the true beneficiaries of these advances as scientists are able to develop better medicines sooner, ultimately improving the lives of patients and their families.

Last month, Foundation Medicine and Flatiron Health announced an initiative to assemble large genomic databases built around the electronic health records (EHRs), of 20,000 cancer patients. The purpose of this initiative would be to provide a real world data-based tool for oncology reseachers.

It’s exciting to think about the possibilities that this type of database holds, from understanding and identifying mutations that may be affected by certain types of drugs, to enrolling specific patient cohorts into clinical trials based upon genetic similarities. And this is only the tip of the iceberg. Considering that currently only 4 percent of cancer patients participate in clinical trials, there are vast amounts of data held in these health records of the other 96 percent of cancer patients that could be a treasure trove of information.

Yet the Foundation-Flatiron partnership is just one example of how health information technology companies are leveraging EHRs to accelerate research. Large numbers of health IT companies are emerging to develop diverse and powerful tools that make better use of available healthcare information, from drawing insights into treatment practices, to improving prescription practices, to understanding large populations of patients. We are at a point where the power of information is just beginning to be tapped, holding great promise for the future of medical development.

Although the Foundation-Flatiron structure will be anonymized and HIPAA-compliant, there is some concern that patients haven’t directly consented to participate. This is a point where Novaseek strongly differentiates. When we founded Novaseek, we put together a seasoned management team from both the life science research and hospital operations sides of the equation. Collectively, we have implemented clinical data programs in 600+ hospitals and launched 20+ life sciences products in the US. We understand the potential and challenges from a variety of perspectives.

Based on all of this experience, from the beginning we felt it was important to put patient consent front and center. We designed a process for patient consent and data-sharing authorizations in ways that are highly aligned to current hospital workflows.

The goal was to make it transparent and convenient for patients. We also wanted to make it easy and convenient for hospital personnel whose main focus is patient care. We designed Novaseek’s CDNR platform to interface with hospital data sources seamlessly and to scale easily.

Our consent process covers not only the patient’s medical history and prospective medical data but also the human biospecimens obtained via the regular course of patient care. This is convenient for patients, sustainable for the hospital, and provides researchers access to important longitudinal information, such as disease progression. It also allows researchers to have access to biospecimens and associated data at various points of the disease progression so that clinical phenotype can be matched to the underlying biology.
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As our industry continues its path forward in leveraging technology to provide better care for patients, it’s important to streamline processes so that patients and healthcare providers can partake in research and medical advances. The results will advance the science, resulting in better treatments to patients sooner.

With the advance of precision medicine, ensuring that clinical studies more accurately reflect real-world patients needs to be at the heart of drug discovery and development. Historically, one of the reasons that so many studies fail is because patient cohorts are often not defined optimally for the treatment being investigated. Step one in changing this process is access to highly annotated and relevant biospecimens. The critical role of biospecimens was underscored when the Precision Medicine Initiative (PMI) announced by the White House in January 2015 was funded to include recruitment and follow-up of one million or more patients whose lifestyle, medical data and biospecimen samples will be collected for research.

For years even before PMI, the life sciences industry, academic institutions and the National Institutes of Health invested heavily in biospecimen resources through federal grants and contracts. In fact, the Collaborative Human Tissue Network, funded by the National Cancer Institute, brought together over 20 years more than 100 hospitals to make specimens available to researchers.

All of these steps have been instrumental in advancing science and the field of medicine. However, until now, up-to-date and relevant patient clinical data was the missing link between the biospecimens received by researchers and the practice of medicine in the real world. Biospecimens, whether procured through the Collaborative Human Tissue Network or even some private companies, generally include a pathology report and general demographic information, such as age, race, gender, surgical pathology and quality control diagnoses. What these samples don’t include, however, is the clinical history of the disease progression, co-morbidities that the patient might have or follow-up information.1

At the same time, PMI highlighted a broader call across the industry for increased participation in clinical trials. Clinical trials often experience delays, early termination or other impediments due to failure to meet recruitment goals.2 One reason participation historically has been low is that hospitals, with the exception of academic medical centers, and other healthcare settings frequently struggle to manage immense workloads and typically do not have human resources to support research despite interest in doing so. Many healthcare organizations find it challenging to incorporate research engagement alongside their core mission of providing patient care.

Novaseek aims to bridge the gap between patients (and their real-world clinical data), providers across a variety of healthcare settings and researchers. By automating critical parts of research and clinical studies, less effort is required to identify exactly the right patients who can participate and to collect their clinical data and biospecimens. Through our cloud-based Clinical Data Network for Research (CDNR) platform, we are helping researchers access real-world data reflective of patients who may benefit from the drugs in development.
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CDNR connects researchers with highly annotated human biospecimens and clinical history and prospective longitudinal clinical data from consented patients, helping them to achieve more precise segmentation, identify patterns of greater efficacy and analyze a fuller spectrum of data, more reflective of real-world patients. We are transforming how researchers access and interact with clinical patient data and biospecimens, allowing for the assembly of cohorts of patients for tracking in a turn-key way for translational medicine, clinical feasibility and observational studies, positioning them for a greater probability of success and bringing them a step closer to getting better medicine to patients faster.

1. https://www.chtn.org/faqs.html
2. http://www.appliedclinicaltrialsonline.com/barriers-clinical-trial-recruitment-and-possible-solutions-stakeholder-survey

Precision medicine is an exciting area of innovation for researchers in academia and industry. It holds the promise of better outcomes for patients, and it is changing the way patients experience disease and treatment.

By definition, the patient population for a targeted medicine is smaller than that of the disease category as a whole. Medicines affect patients differently.1 Even in a condition as widespread as diabetes, diagnosed in 21 million people in the US2, 43 percent of patients do not respond to initial treatment.1 In conditions with smaller patient populations, the subset of one phenotype of patient versus another can be small indeed.

The burden of precision medicine researchers is to design clinical studies targeting the specific clinical patient phenotype for which the treatment is expected to be most effective. Due to the current clinical research infrastructure, most patients are recruited into studies from a pool of academic centers. But the current system often may not provide researchers with enough diversity for the study.

Importantly, even earlier in the R&D process, researchers may not have access to enough data to identify all of the correct clinical phenotypes of patients who should be benefiting the most from the new medical developments. Currently, such information and data are hard to get.

At the same time, a 2013 Research!America poll showed that 72 percent of Americans said they would likely participate in research if recommended by their doctor. The same survey showed that 74 percent are willing to share privacy-protected personal health information to help researchers better understand disease and develop new ways to prevent, treat and cure them.3

Novaseek bridges this gap by connecting researchers with real-world clinical data for much improved discovery or study design as well as observational studies. The process is intuitive and straightforward using Novaseek’s cloud-based Clinical Data Network for Research (CDNR) platform.

CDNR interfaces easily with hospital data sources, enabling researchers to define patients and patient cohorts based on detailed clinical criteria and request biospecimens highly annotated with clinical data from consented patients. Researchers gain access to health insights and the biospecimens necessary for research and clinical studies success, based on better understanding of patient populations. CDNR is an important tool in the quest to make more effective therapies available to patients sooner.


1. http://www.personalizedmedicinecoalition.org/Userfiles/PMC-Corporate/file/pmc_the_case_for_personalized_medicine.pdf
2. http://www.cdc.gov/diabetes/data/statistics/2014statisticsreport.html
3. https://www.elsevier.com/connect/poll-majority-of-americans-would-participate-in-clinical-trials-if-recommended-by-doctor

We have received many emails about a recent Op-Ed in the New York Times – “Your Cells. Their Research. Your Permission?”
By Rebecca Skloot (Dec. 30, 2015). In her piece, Ms. Sloot correctly points out that patient consent is a significant issue regarding the use of biospecimens in research: “Tissues from millions of Americans are used in research without their knowledge. These “clinical biospecimens” are leftovers from blood tests, biopsies and surgeries. If your identity is removed, scientists don’t have to ask your permission to use them. How people feel about this varies depending on everything from their relationship to their DNA to how they define life and death. Many bioethicists aren’t bothered by the research being done with those samples — without it we wouldn’t have some of our most important medical advances. What concerns them is that people don’t know they’re participating, or have a choice.”

Indeed, we at Novaseek agree with this basic premise. This is why transparency in the consent process has been a primary objective in the Novaseek model from the very beginning, reflecting a commitment to respect for the rights of patients to decide how their specimens and data will be used.  Novaseek’s IRB-approved consent form appears to have anticipated the changes proposed to the Common Rule – not surprising given the fact that Novaseek’s approach to consent and privacy was developed in collaboration with thought leaders in the fields of biospecimen science and research ethics. As recommended by the Common Rule Notice of Proposed Rulemaking, patients are provided with clear information about everything from compensation to genetic research use. Ultimately the vast majority of patients are happy to donate their left over specimens and data for use in research – ​but the key is that they are given the choice, preserving the relationship of trust between hospitals and patients.

Importantly, the Novaseek approach is also pragmatic, recognizing that the ultimate goal of participating patients, hospitals, and researchers is to ensure that important research advances rather than becoming stalled in onerous administrative requirements.  So Novaseek provides turnkey consent materials along with expert support to help hospitals create an effective research consent process that does not burden patients or staff.
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With or without changes in legislation, Novaseek and our partners are committed to respectful partnerships between hospitals, patients, and biomedical researchers as we work toward the common goal of a healthier future for all.

Illinois-based NorthShore University HealthSystem, along with Dartmouth, University of Pennsylvania, Wake Forest Baptist Health System, Medical University of South Carolina, Ochsner Health System, University of Arkansas, and the University of Nebraska are collaborating on “to precision medicine at the point of care, through the EMR.”

Focused on neurological disease, this consortium of leading hospitals is working to showcase how biobanking (in this case patient DNA) tied to specialized longitudinal EHR data derived from a neurological office visits can eventually be analyzed to conduct practice-based research, to make discoveries and ultimately to improve quality of care.

Precision medicine at the point of care is also a fundamental goal of Novaseek. Our core mission is to tie together biosamples and EHR data to create a more holistic, personalized picture of a patient’s disease.

In today’ age of personalized medicine, getting “fit for purpose” biosamples is crucial for pharmaceutical industry. Creating solutions that meet this objective was the topic of a webinar recently put on by the Pistoia Alliance. Dr. Kate Torchilin, CEO of Novaseek, moderated the discussion: http://www.pistoiaalliance.org/slides-available-from-biosample-exchanges-webinar/

According the expert panel, the biobank industry today is facing the challenge of too many specimens being collected without proper quality controls and without consistent patient consent processes, as well as the absence of complementary patient data. Interestingly, 100% of participants responded in the poll conducted during the webinar that it is very important for them to have access to patient clinical data in addition to the biospecimen. One of the panelists, Dr. Philip Quinlan of the University of Nottingham, noted that the problem for the industry is not in finding a biobank, but finding the right specimen.
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The panelists discussed how to solve this problem and create a resource for pharma industry to procure the biospecimens along with the data that they need. Fortunately, this is exactly what Novaseek is doing with our Clinical Data Network for Research (CDNR) platform.

On October 29, Dr. Kate Torchilin, CEO of Novaseek Research, will lead the webinar “Biosample  Exchanges – the Past, the Current and the Future – How Do We Make It Work?”   Dr. Torchilin will be joined by John Spall from GSK and Dr. Philip Quinlan from University of Nottingham, UK.

This is part of the webinar series organized by Pistoia Alliance, a global, not-for-profit alliance of life science companies, vendors, publishers, and academic groups that work together to lower barriers to innovation in R&D.

Access to biosamples remains one of the main bottlenecks in pharma R&D.  Researchers need access to the right biosamples from the right patient and the right time. Millions of dollars have been invested both in creating biosample repositories as well as the collection infrastructures, by government, academia and industry; millions in budget approvals continue to be requested each year for acquiring biosamples for research.  Thousands of biobanks and sample collections have been created within various for-profit and non-for-profit entities.  This panel of experts will discuss approaches that can be pursued to increase transparency of information and streamlined approaches to acquiring biosamples.

In a recently released 100-page report, a working group of experts from academia, government, and industry for the Precision Medicine Initiative (PMI) announced by President Obama earlier this year, recommended to the NIH that anyone in the US willing to share their health data, a blood sample, and be recontacted for research purposes should be allowed to join the PMI. The PMI initiative has an ambitious goal 1 million participants, and this massive cohort would be used to gain insights into a range of important healthcare questions.

Throughout the report, the working group emphasized that the 1 million-participant cohort should reflect the diversity of the US. The PMI must be designed from the start to “ensure that people historically underrepresented in biomedical research are included in sufficient numbers to allow robust inferences in these groups.” Additionally, in order to conduct such queries using data from so many people, the PMI must use up-to-date technologies to analyze the data, while protecting participants’ privacy and containing costs. Importantly, the working group also suggested that the NIH collaborate with healthcare provider organizations (i.e. hospitals, physician groups, etc.) as a means to enroll patients cost-effectively. This is where Novaseek’s Clinical Data Network for Research (CDNR) platform can play a critical role.
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The Novaseek CDNR platform is in strong alignment with the objectives presented by the PMI working group. Novaseek’s CDNR platform can support greater diversity in the cohort building process by tapping into large numbers of patients at geographically diverse locations, and by allowing inclusion of community hospitals and physician groups. While Novaseek can work with any hospital and medical center, its CDNR platform was developed to plug into the daily operations and workflows of community hospitals, and has both the cost structure and the features to allow community hospitals and large physician groups to provide data and biospecimens for research purposes without disruption to existing workflows. Ultimately, Novaseek’s approach will allow more patients at more hospitals to choose to participate in research, even if they are not being treated at a major academic research center.

Quintiles and Quest Diagnostics combine to deliver Q2 Solutions, highlighting biopharma’s need for patient data in the era of precision medicine. This is exactly why Novaseek developed the platform to make clinical data and biospecimens readily available to the industry and that would be an important complement to services provided by CROs and Clinical labs.

Foundation Medicine and IMS Health recently announced a collaboration to leverage IMS’s Real-World Evidence platform and Foundation Medicine’s knowledgebase of comprehensive cancer genomic profiles to improve cancer care by better connecting patients to the right targeted therapies at the right time. Once valuable insights are generated, platforms like Novaseek will help to put the actionable data at the fingertips of community oncologists.

More efforts are underway to bring relevant patient data into research. The Reagan-Udall Foundation’s Big Data for Patients (BD4P) initiative will make clinical patient data more relatable and less intimidating for patients, while ensuring that patients are better equipped to actively engage in precision medicine research and healthcare.

The need and demand in research for large clinical patient datasets is powerful, as seen by “Apple ResearchKit” new mobile platform. Our Novaseek platform is also addressing this demand by enabling hospitals and patients to provide biospecimens and clinical data for research without deviating from established hospital workflows in patient care. “The incentive is to bring many more thousands of participants to human research. And with greater numbers of participants will come greater power to the results,” and we could not agree more.