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    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?


    The challenge

    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.

    The solution

    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.

    Read how PMDx Biospecimen Solutions helped one company excel.

    See how ProMedDx can help streamline your research and accelerate your program.

     

     

    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:

    1. 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.
    2. 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.
    3. 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.
    4. 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.
    5. 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.
    6. 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.
    7. 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.
    8. 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.
    9. 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.
    10. 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.

    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:

    1) Planning

    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

    Scaling Up

    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.

    2) Validation

    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

    3) Mitigation

    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

    4) Reporting

    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:

    • Temperature
    • 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.

     

     

     

    NORTON, Mass., June 9, 2016 /PRNewswire/ — The rising cost and scarcity of lab space is putting small and midsize biotech firms in a bind. Often, they face a choice of using lab space to perform critical research or using it to house freezers to store the biologics that fuel their work. While some Biostorage companies may see this as an opportunity to raise revenue, Boston-area company, ProMedDx is focused on raising the bar.

    ProMedDx founder, Jim Boushell says, “We are located in the hub of biotech innovation, where the demand and supply of laboratory space are out of sync. Emerging biotechs must maximize the revenue potential of each square foot of lab space by keeping more researchers researching. By taking the management of their biologics offsite, we create lab space and empower biotechs to do more discovery work in their current footprint.”

    Currently, large pharmaceutical companies offsite their biologics to large “freezer farms” for cost-control and risk mitigation. Small to midsize biotechs are less aggressive due to the expense of one-size-fits-all solutions.

    “It takes more than square-footage to support the life-altering discoveries of these biotechs,” Jim says. “This is what has driven us to grow our bioservices and become a single source provider of all phases of biospecimen management; from recruitment and consent through collection, and storage. Our bioservices empower these small to midsize biotechs with nearly everything but the research.”

    Biospecimen management and information management share many characteristics. Both require local, centralized and offsite/cloud storage. They must provide security and follow best practices with dedicated resources to support them. Ultimately, the realized benefit from outsourcing these processes is better allocation of resources. 

    For Large pharma, this expertise may be found in-house, but for burgeoning biotechs—some of which are virtual—those resources aren’t there. So, after nearly 20 years in the biologics industry, ProMedDx is expanding its own services to enable biotechs to focus on science and spend less time on biologics management. These services include; a new Class 1000 bioprocessing suite that ensures the integrity and sterility of manufacturing control products, an on-site research blood collection center delivering custom and same-day collections, and a cold chain logistics team managing the entire discovery cycle.

    “For years, Chief Scientific Officers and Bioresearchers have been reinventing the wheel, introducing unnecessary risk and slowing the progress of research,” says Jim. “By aligning with a proven bioservices organization such as ours, the entire bioresearch process becomes more efficient, higher quality, and keeps research on plan.”

    Small to midsize biotech firms are where game-changing discoveries are being made. They need a partner that understands the discovery cycle and can help them bring new innovations to market faster. ProMedDx believes bioservices that provide this support will expedite the discoveries of the future, and they are focused on being that partner now.

    Learn more about ProMedDx Bioservices at www.promeddx.com.
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    Have you noticed that each year the importance of your research increases, yet available space in your research lab decreases? The culprit, your success! You see, the more research you do, the more biospecimens you gather – the more biomaterials you produce, the more freezers you need to store them.  Like an athlete sitting in a room full of trophies/medals, there comes a time to delegate history to a safe place, and create more functional space for your next success.  A secure off-site biostorage facility may be that safe space.

     

    Signs that it might be time to consider off-site biostorage:

    Rents are increasing, and available Lab Space is decreasing.

    In a recent report by the Boston Business Journal, laboratory space, in greater Boston averages $47.40 …in Cambridge it exceeds $51 /sq. ft.  At rates this expensive, you need to maximize your investment by making every square foot cost-effective. While very important, the storage of legacy specimens, mirror supplies, and reagents, are likely consuming expensive lab space better suited for current research. An economical off-site storage solution, will open up working lab space providing immediate on-site access to your time sensitive materials.

    Are your researchers Researching? … Or managing inventories of specimens?

    If you’re working in Finance, chances are your answer is “of course”.  If you’re managing a Lab, the likely answer is both.  Overcrowding of labs by Freezers – Refrigerators – and Files creates an operational maze…and increases the risk of misplaced or damaged research specimens.  In most labs, each lab tech must protect and manage their own research assets…resulting in operations that are both inefficient and unfamiliar to employees who are accustomed to operation according to protocol.  Organizing and protecting your research materials today and having them available tomorrow, is one of many the many benefits of an off-site biostorage partner.

    Are you being challenged to provide a range of storage conditions?

    Today’s precision research calls for precise-stable storage environments.  No single chamber can accommodate the range of temperature thresholds your research teams demand.  So while you are focused on maximizing the impact of each square foot of laboratory, you now have to account for additional capital expenditures to support your team’s research protocols (and the required monitoring, maintenance, and security procedures…and the very thing you cannot create, SPACE).

    The greatest of plans can easily be interrupted and redirected by a simple protocol revision, but it doesn’t have to result in full redesign of your lab.  Careful consideration and evaluation of off-site biostorage providers, can result in a real-time, cost effective partner for your short and long term temperature sensitive laboratory materials.

    Through outsourcing your storage needs you recapture valuable on-site lab space to expand your research, development and production.   Off-site storage provides you unlimited additional storage space, at a wide array of temperature thresholds, quickly, securely, and cost-effectively…enabling your researchers to research.

    ProMedDx’s continuously monitored biostorage facility securely manages clinical study samples, research biomaterials, master cell banks, drug compounds, production stock, and other medical products in precisely-controlled temperature chambers. Our proprietary 21CFR part 11 inventory and order management system, enables you to have your specimens in your lab when you need them. Same day or Next day. You can count on the efficiency, security, adaptability, and professionalism of ProMedDx BioStorage.

    Contact us today to learn how ProMedDx can help you take back control of your lab.