First-to-market: Leveraging PMDx Integrated Solutions
You qualified a biomarker that will benefit the healthcare of patients worldwide. Do you have the resources to validate and move to market before your competitors do?
A growing biotech was struggling to meet resource and logistical requirements for an upcoming Premarketing Application (PMA) for FDA submission. While raw materials and resources were available, the organization lacked the time, capital, and infrastructure required to meet their goals.
ProMedDx engineered a suite of bioservices, customizing its proprietary systems into a fully-integrated solution for the client. This enabled the organization to maintain their focus on collecting data and preparing for submission. As a result, they ultimately gained FDA approval 12 months ahead of schedule and achieved first-to-market status. Furthermore, they avoided the capital burden of additional staff, process development, equipment, and software.
Download the full case study here to learn how one company completed its PMA 12 months ahead of schedule by leveraging ProMedDx Biospecimen Solutions.
Best Practices for Managing Multi-site Biotech Research Studies
Clinical Operations Managers can minimize unforeseen challenges by instituting a few key operational standards in their biologistics program.
Every Biotech research study poses an array of challenges. However, the pace and complexity of today’s multi-site studies, which can span 2-3+ years, creates unique biologistics challenges, including:
- Timing, frequency and distribution of supply shipments
- Expiration and lot-to-lot accountability/tracking
- Managing supply shipments to minimize budgetary impacts
- Monitoring the movement of temperature-sensitive shipments
Here are 3 ways Clinical Operations Managers can address these challenges and minimize biologistics surprises that can derail or invalidate important research:
1) Utilizing Technology-Driven Specimen and Supply Management Programs
Sophisticated inventory management and scheduling programs provide the benefits of real-time accountability and just-in-time delivery of specimens and clinical supplies. Clinical Operations Directors who have the ability to monitor enrollment velocity and the timing of future study visits can wisely plan for and schedule distribution, thereby minimizing unplanned shipments and related surcharges that can cripple a study budget.
At ProMedDx we utilize a next-generation inventory management system that closely monitors usage and dependent supply requirements and schedules just-in-time distribution of supplies and specimens to their destination. One of the key features of our program is a tracking tool that allows us to identify and recall assets and compliantly manage the return and replenishment in real time. This is helpful for those conducting studies involving biospecimen collection in which tube expiration may vary between lots and by tube type. These types of variations can create an array of tracking challenges if they are not accurately managed and can even invalidate a study.
You don’t have to partner with us, but be sure whichever vendor system you do choose enables proper tracking and efficient distribution of supplies—the foundation of your current and future research.
2) Accurately Tracking Biospecimens from Site to Storage
A reliable chain of custody is critical for ensuring the integrity of valuable biospecimens and other study materials at every stage, from the point of collection through transport and into storage.
Technology enhancements that can accurately track the movement of biospecimens while minimizing risk to your assets include barcoding, electronic requisition forms and GPS tracking. Employing all of these technologies in an integrated biologistics platform as we do at ProMedDx results in a solid chain of custody and maximum visibility of the biospecimen journey.
3) Maintaining Direct Communication With Your Biologistics Team
Using technology to track the location and condition of your specimens is only part of the solution. It is also invaluable to have a team of dedicated logistics specialists who are trained to use the technology and experienced with temperature-critical shipments. When necessary, a properly trained logistics team can triage a shipment in real-time by adjusting its itinerary and/or re-icing the shipment at its connection.
Clinical Operations Managers who proactively address these three areas will have more confidence in their biologistics programs and, ultimately, in their ability to support important research.
Trying to manage all of these biologistics tasks in-house can be expensive and risky—especially if your team does not have the technology or experience needed. Partnering with a team of trusted experts can free you from worrying about and managing complex details and unpleasant surprises that cost money and research time.
At ProMedDx, we have more than 20 years of experience in Biologistics management. Contact us to learn more about how we can support you with on-demand retrieval and shipment while maintaining a reliable chain of custody.
Over the last year and a half, academic and government researchers have joined to voice their opposition to proposed updates to the Common Rule regarding biomedical and behavioral research involving human subjects in the United States. Specifically, they opposed consent changes that would stifle the progress of science. It seems the U.S. Department of Health and Human Services listened.
Whether it was a rush to announce prior to the administration transition or serendipity, on the eve of Inauguration Day, the Feds published the Final Rule, minus the biospecimen provisions.
The spark that ignited 17 months of debate, angst, and uncertainty was a proposal that would have required researchers to obtain written consent before using biospecimens such as DNA, cells, blood, and tumor samples obtained during clinical care or a specific research study. This proposal would have required consent even if the biospecimens were de-identified (stripped of personally identifiable information). As of today, and for the indefinite future, those biospecimens can now be used for government-funded research without the donor’s consent, provided they are de-identified.
While academic and government researchers may collectively exhale in response to the recently published Final Rule, privately funded programs cannot. Lobbyists and patient advocates were unsuccessful in their efforts to convince HHS to expand the regulations on human subjects to include Industry (Biotech and Pharmaceutical). The procedures and regulation of industry-sponsored human subject research are more stringent and remain unchanged.
The key takeaway for any researcher: It is your responsibility to ensure that all biospecimens intended or used in the course of your research were obtained in compliance with the appropriate Federal Regulation.
If you (or your research team) are spending too much time on tasks unrelated to actual research, consider my Top 10 list of research management tasks you can outsource to a bioservices organization.
Over the last 18 years, I’ve witnessed firsthand how managing the non-scientific details of biomarker development—from enrollment strategies to assembling collection kits to building cold storage facilities—can be unnecessarily distracting to biomedical research teams. Often, researchers take on such tasks without realizing that they can easily outsource them and remain focused on their research. Here are the top 10 bioservices to consider outsourcing:
- Building and Distributing Study Kits
If you’ve ever scrambled to assemble study kits, you know how time-consuming it can be. A reliable bioservices partner can provide sample collection kits that are customized to meet the protocols of your specific program and distribute them to your sites on-demand. Outsourcing this function can save hours or even days of lost time and needless complications.
- Providing Kit Training Materials for Study Staff
Inconsistencies in the most basic details of research can impact the viability of your targeted biomarker and, ultimately, the quality of your research. Some of these details may include the order in which collection tubes are drawn, the handling times and temperatures, processing and storage.A good way to protect the quality of your study is to outsource for study-specific training materials that will educate site personnel on proper collection, labeling, and shipping methods. Having easy-to-reference instruction documents, detailed collection and processing logs, as well as proper training and monitoring can ensure the biospecimens you receive are as consistent as the research you are conducting.
- Defining Appropriate Cohort Profiles
You know your research objectives, but you may not realize the availability or the accessibility of the intended patient cohort. A team of bioservice specialists who are experienced in the clinical diagnosis and treatment pathway of diseased and healthy cohorts can help you define the precise cohort. They may also suggest productive strategies to successfully approach and enroll subjects. Making decisions with the benefit of proven experience can help your team avoid pitfalls and eliminate potential bottlenecks in the research pipeline.
- Study Recruitment
Research shows that 80 percent of all clinical trials fail to meet their enrollment goals. Nearly half of those are the result of poor site selection and ineffective recruitment techniques. Outsourcing to a bioservices company that is experienced in study recruitment can help ensure the progress of your research.
- Managing Regulatory Compliance
Outsourcing the protocol and consent development ensures compliance with regulation and provides valuable insight to current focus points of Institutional Review Boards (IRB).By selecting an external partner with appropriate experience, you can prevent avoidable delays in the review process. Doing so can deliver significant savings while decreasing frustration.
- Collecting Biospecimens
The right biomaterials for your specific research are not always readily available and can present a research-ending bottleneck. Whether it’s a specific disease or treatment status or the need for freshly collected cells and tissues, Outsourcing to a bioservices company that is directly connected to patients and caregivers can simplify this process—and your path to research success. Working with the right partner can also give you the confidence of knowing that proper collection procedures were followed and that the quality and integrity of your biospecimens remain intact.
- Providing Biostorage
Many biopharmaceutical companies lack access to adequate facilities, resources, and expertise necessary to manage the variety of biospecimens and cell-lines that today’s research requires. Outsourcing to a qualified biostorage provider can ensure state-of-the-art technology, round-the-clock security, and the temperature-controlled environment necessary to protect invaluable biospecimens, while still giving your team full, on-demand access.
- Bioprocessing Services
A bioservices partner can format your biologics to your exact specifications so that they easily integrate into your research and clinical studies. Some of the bioprocessing services that can be outsourced include reference testing, formatting, coding, and custom labeling, to name a few.
- Directing Biologistics
Handling and distributing biospecimens throughout the discovery process can pose significant challenges. They must be stored under precise conditions, transported in a timely manner, consistently monitored, tracked and documented to ensure their integrity. Imagine the hours you could reallocate to hands-on research by outsourcing this process to trusted biologistics experts.
- Procuring Precision Biospecimens
In response to the evolution towards Precision Medicine, the demand for translational research has risen. Research teams are requesting a higher pedigree biospecimen among greater competition on an already limited supply. Aligning your research program with an experienced procurement partner ensures your research teams have on-demand access to the critical biospecimens necessary to support their programs.
At ProMedDx, we recently opened the doors to our first Clinical Collection Center. This new addition to our suite of innovative bioservices offers us the agility to collect and deliver precise biologics, fresh to your lab, to accelerate the pace of your biomedical research.
Whether you outsource to us or to another trusted bioservices company, I think you’ll agree – speeding the pace of your research is our collective goal.
Are there particular research tasks that are stalling your team’s progress? Email our Bioservices team directly or find us on Facebook, Twitter or Linked-in and tell us about your issue. We’ll offer our insight and possible solutions.
The proof is $142 million dollars recently awarded to Mayo Clinic from National Institutes of Health (NIH)
When President Obama introduced his Precision Medicine Initiative® (PMI) during the 2015 State of the Union address, his vision was to empower medical professionals with the information and resources they need to tailor treatments to the individual patient based on his or her unique characteristics.
Simplified, if you are sick, your doctor takes your blood and sends it to a lab for testing. He or she will then compare the results of that test along with your medical history to those of other patients who have had the same illness. If a match is found, your doctor can more easily identify treatments that “worked” for other patients and create an individualized treatment plan with the expectation that it will also work for you.
The idea of Individualized Medicine sounds straightforward, but implementing it will require cooperation at all levels of government and from those doing clinical research. It will also require the availability of precise biospecimens.
The Precision Medicine Initiative is a major step towards developing that cooperation, and over the last two years it has started taking form, as recently demonstrated by the large sum awarded to Mayo Clinic by National Institutes of Health. The $142 million dollar award will help Mayo Clinic build the world’s largest research-cohort biobank for the PMI Cohort Program. This award also signifies the “all of government” commitment that has been made to PMI, and it highlights the importance of Biobanking and other Bioservices in executing the program.
An Idea That’s Time Has Come
Over a decade ago, my friend (and now business partner), Jim Sperzel, and I drew up a business plan on a piece of notebook paper as we traveled from Munich to Tutzing, Germany. What we were envisioning was a first of its kind biobank that could provide the Diagnostic Industry with IRB-approved, patient biospecimens to help expedite the pace of research. Our company, ProMedDx, grew out of that business plan, and today it is a small-scale version of what the PMI Cohort Program aims to become.
As our company grew and our capabilities expanded, we realized we were in possession of a very large, very rare collection of precision biospecimens. We also knew that as medicine became more individualized the research community would show greater demand for a reliable resource of precise biospecimens from large cohorts of diagnosed patients. That is exactly what has happened.
We weren’t as prophetic as we would like to believe. The need for a program such as the PMI is not new, but it has become more critical to the future of human health worldwide. At ProMedDx, we know there are quantifiable benefits to understanding the individual behind the illness. In depth information allows healthcare professionals to practice more precise care more efficiently and with improved patient outcomes. Ultimately, Precision Medicine will reduce the time and expense of healthcare. It all begins with quality biospecimens.
Precise Biospecimens are the Key to More Precise Medicine
For Precision Medicine to work, doctors and nurses engage a process of analyzing patient medical history and genomic testing to guide them in making diagnosis and treatment decisions. This interpretive analysis of large-scale patient data and analytical tools is a dynamic process that becomes more precise each day as the assay of patient data and technology progresses. Precise biospecimens are the “fuel” that continuously feeds this process.
Biopharmaceutical companies also play an important role in the success of Precision Medicine, as they focus on the development of drugs that target specific genetic differences/changes. To achieve this, they must analyze large volumes of biospecimens in their research labs to study the effects of singular and combination compounds at a cellular level. Accessibility to biospecimens from diverse cohorts of diseased and treatment naive individuals makes their work possible.
Furthermore, laboratories that provide genomic insight use proprietary panels of next-generation sequencing tests. Such tests require precise processing & handling of the specimens prior to analysis. The technology is meticulous, and slight variations in handling of the biospecimen can limit—and in some cases prevent—an accurate analysis.
As you can see from these examples, today’s science cannot be optimized using legacy biologics whose source or handling is not known.. Just as precision automobiles require premium grade gasoline to fuel their performance engines, researchers need precision biosamples to fuel their investigation. Ultimately, this is the goal of the Precision Medicine Initiative: The government wants to build a biobank of “premium” biospecimens and information.
The Future of the Precision Medicine Initiative
The National Institutes of Health will award $142 million to the Mayo Clinic over a five-year period to establish the world’s largest research-cohort biobank for the PMI Cohort Program. The PMI Cohort Program aims to extend precision medicine to all diseases by building a national research cohort of one million or more U.S. participants. The award will support the collection, storage and distribution of biological samples known as biospecimens for use in research.
According to a Press Release from NIH, laboratory analyses of the biospecimens, including chemical and genetic tests, will be a key component of the core PMI Cohort Program data set. These data, combined with other information provided by volunteers such as lifestyle and health questionnaires, medication history, electronic health records, physical exams, environmental exposures, and real-time physiology tracked through mobile health technologies will give researchers a more efficient way to study individual differences in health and disease.
“This range of information at the scale of 1 million people will be an unprecedented resource for researchers working to understand all the factors that influence health and disease,” said NIH Director Francis S. Collins, M.D., Ph.D. “The more we understand about individual differences, the better able we will be to tailor the prevention and treatment of illness.”
Mayo Clinic was chosen for its size, expertise and capabilities to provide the infrastructure to store, analyze and make available to researchers more than 35 million biospecimens and associated data. Mayo Clinic will be using state-of-the-art laboratory automation and robotics for efficient processing and retrieval, and its Biobank staff will follow a detailed set of policies to safeguard the collection against contamination or loss and to protect participant confidentiality.
Here at at ProMedDx, we have a long, defined history of supporting Precision Medicine, so we are anxiously watching to see how the PMI program evolves. In fact, Jim and I are once again putting pen to paper to see how we can expand our own services to support the initiative and provide our clients with innovative solutions. Meanwhile, our portfolio of services is already growing to provide immediate support to researchers in the fields of Lung, Colorectal, Breast, Prostate, Ovarian, Metabolic and Neurological disease studies.
Clinical trial therapeutics and biospecimens are temperature-sensitive, so transporting and storing them locally and/or globally can be complex. Every day, frozen biospecimens are shipped and received, creating new logistics and storage challenges for even the most experienced supply chain and clinical operations managers.
By identifying a trusted Biostorage Service Provider early in the product development life cycle, Clinical Op’s Managers can ensure proper planning, validation, mitigation and reporting.
Whether that provider is an in-house solution, or outsourced partner, there are specific controls and safety measures that require careful consideration in order to mitigate risk of damage or delay.
Here are the top 4 considerations to include in your biostorage partner search:
Biostorage and Biologistics are increasingly important for maintaining product quality and accommodating the moving timelines of stakeholders such as sponsors, investigators, and researchers. Having a solid plan in place will help eliminate potential biostorage issues that could prevent your biopharma from delivering key discoveries and innovations.
A Biostorage or Biologistics plan should address whether you will accommodate biostorage onsite or outsource, the level of security you plan to provide, and how you will scale up if your inventory or demand suddenly increases.
Onsite vs. Outsourced Biostorage
Carefully consider the Capital Requirements for onsite storage, including the cost of freezers, Dewars, specimen management & temperature monitoring, and back-up power systems. Staffing is also important, as you will need skilled personnel with the proper Certifications & Accreditations, capable of operating with precision within temperature controlled environments.. Lastly, you will need to plan for security, back-up security and 24/7/365 monitoring to protect the biospecimens you are storing. If you can’t confidently manage all of these issues in-house, it’s time to consider outsourcing.
If you choose to outsource, look for a Biostorage Service Provider with experience in cold chain logistics, not just storage. Providers should offer proven strategic expertise in planning, packaging, and transporting temperature sensitive materials.
Certification and expertise is a must. Check to see that a potential Biostorage Service Provider has:
- Documented experience
- IATA Certification
- Specialized personnel
- Documented Quality Assurance System that includes SOP’s for hiring, training, and auditing
- Proven adherence to HIPAA, GCP, GMP, GTPGLP
- 21 CFR Part 11 compliant Inventory Management System
- A Secure Access Web Portal
Make it a priority to choose Biostorage facilities & systems designed to support changing needs. You may not currently foresee an expansion, but it is always a possibility, so you should know how you will accommodate a larger inventory.
Undocumented biospecimen storage practices can lead to a lack of confidence in the reliability of generated data. That’s why it is critically important that Biostorage Service Providers use robust, validated processes and controls. Standards to measure by include:
- cGMP compliant facilities
- Controlled access & reporting of assets
- Environmental controls, such as facility temperature & humidity
- 21 CFR Part 11 compliant monitoring
Mitigating risk with documented controls gives you the assurance that your organization’s biologics are secure in the event of an incident at your facility. Whether you are storing biospecimens onsite or off, they should be properly monitored and protected with:
- A 24/7/365 alarm response
- “at- temperature” redundant storage units
- Back-up power
- Regularly scheduled equipment maintenance
- Calibration in compliance with manufacturer’s specifications
- Inventory tracking from receipt to distribution
- Audit-ready processes
Your organization is responsible for upholding all regulatory mandates related to the procurement of human biospecimens, and should be prepared to address reporting requirements and audits. Be sure your chosen Biostorage Service Provider can give you the proper data access and frequency of reporting to successfully monitor:
- Inventory activity
- Access activity
ProMedDx delivers nearly 20 years of biologistics, biostorage, and biospecimen distribution expertise, providing complete control and transparency to biomaterial control and fulfillment. Our team of experts can assist you in your planning with an end-to-end solution and cGMP compliant workflows that protect biomaterials and research participants while providing the documented source to validate clinical trial data. To learn more, contact us or simply call 800.785.7808.
Key factors Clinical Ops and Researchers should consider when seeking a source for biospecimens
President Obama’s Precision Medicine Initiative (PMI) is gaining traction, and here’s the proof: National Institutes of Health recently awarded $142 million dollars to Mayo Clinic to help establish the world’s largest research-cohort biobank for the Precision Medicine Initiative Cohort Program. Clinical Operations Managers and Researchers in biopharm firms should feel encouraged by the promise of increased access to precision biospecimens.
But what about today? Biopharm can’t wait 5 years to begin to see the fruits of the PMI Cohort Program. Clinical Researchers need a trusted bioservice partner and source of precise biospecimens to fuel their research now.
Here are 4 factors Clinical Operations Managers and Researchers should consider when sourcing precision biospecimens:
1) Exact Regulatory Compliance
A reliable source for biospecimens will uphold all regulatory and other mandates related to the procurement of human biospecimens, such as complying with HIPAA, IRB approval & consent standards.
2) Controlled Sourcing and Storage
Precision Science means being as precise as possible at every stage of discovery. That includes the use of precise samples of blood, tissue, and saliva. Human biospecimens should be treated like gold throughout the entire discovery cycle—from collection and prep to transport and storage. Any fluctuation or variation in a sample will affect the research, and can result in less than optimum results and/or a loss of credibility.
3) Verification of Source Documentation
Poor biospecimen collection practices can bring the reliability of research data into question, which is why it is critical for organizations to have a strong bioservice partner that follows high standards. A reliable source will provide biospecimens of known quality—meaning those that are well characterized, properly consented, sourced and appropriately prepared—and they will be able to provide evidence in advance to support your biospecimen annotation.
4) Proper Data and Specimen Management Systems
Human biospecimens and accompanying data are like money in the bank, and they must be guarded as such. Make sure your biospecimen source offers 21 CFR part 11 compliant Data and Specimen Management Systems with state-of-the-art security, 24/7/365 temperature monitoring, video surveillance and private 24-hour security patrol. Data should also be protected by layered network firewalls, anti-virus gateways and daily backup with redundancy at an off-site secure data center.
Aligning future clinical programs to trusted, reliable resources for precise human biospecimens and solutions enables a more efficient delivery of targeted therapies. That’s the idea behind the Mayo Clinic Precision Medicine Initiative Cohort Program, and one my company, ProMedDx, whole-heartedly supports.
In fact, ProMedDx was founded on this basic idea that quality biospecimens = quality research, and today we are putting pen to paper to see how we can evolve our services to support the PMI. We’ve been collecting biospecimens for nearly two decades, and we are in a unique position to offer a broad representation of blood and tissue from patients with genetic mutations or other alterations that can indicate the likelihood patients will respond to certain medicines and/or specific treatments.
Currently, biospecimens from our repository are being included in the development of several CDx tests that can aid in making better treatment choices for cancer patients. We are passionate about what we do, because we recognize the tremendous potential that Precision Medicine has for improving patient care and reducing healthcare cost.
If you would like more information about our biospecimen collections and support services please contact our Bioservices Team by email or at 800.785.7808.