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Implementing Pre-qualified Shippers into Ambient and Controlled Room Temperature Operations

Whether you are working with cell therapies, biologics, drug product, or biospecimens, temperature is an omnipresent concern that requires your attention. From a logistics standpoint, maintaining appropriate temperature conditions is of utmost importance to ensure your material arrives at its final destination with its integrity intact. Therefore, it is no surprise that within our industry the definition of cold chain is expanding beyond cold temperatures to include both ambient and controlled room temperature (CRT) shipments.

Topic: Cold-Chain Logistics, Topic: Qualification ..........

The 21st Century Cures Act and the Glacial Pace of Drug Development

Since the mapping of the genome, there has been a growing expectation that a flood of transformative therapies would re-define medical practice and patient care. But this flood is still a small trickle, and the Federal government is attempting to craft legislation to speed development and eliminate some logjams. Where are the logjams? Not at the FDA or NIH.

The much-discussed 21st Century Cures Act (introduced in the House of Representatives last May, passed on July 10, and now in the Senate), is intended to encourage innovation, give the FDA greater leeway to consider non-traditional sources of data and clinical studies, and shorten the time between application to the FDA and approval.  The consensus among some industry experts is that the Act is a “mixed blessing.” This list juxtaposes some elements of the Act (in no particular order) with some recent commentary.

Topic: Biobanking and Biorepository, Topic: Clinic..........

Researchers Propose a Validated Phenotyping Algorithm for Genetic Association Studies in Age-related Macular Degeneration

Age-related macular degeneration (AMD) is a leading cause of vision loss among people aged 50 and older. This multifactorial neurodegenerative disease damages the macula, responsible for sharp central vision. Rapid advancement of DNA sequencing technologies has allowed researchers to identify many AMD-associated genetic polymorphisms. However, phenotyping and patient recruitment are currently the most time-consuming steps facing researchers performing this work. Patient identification and DNA collection are often the rate-limiting steps in genetic association studies.

Facilitated by the rapid growth of electronic medical record (EMR)-linked DNA biorepositories, patient selection algorithms can improve efficiency in genetic association studies.

In this blog, we'll discuss a new study, published in Nature, where researchers show that using stepwise validation of such an algorithm could provide reliable cohort selection outcomes and, when networked with an EMR-linked DNA biorepository, replicate previously published AMD-associated single nucleotide polymorphisms (SNPs).

Topic: Biobanking and Biorepository, Topic: Clinic..........

Eliminating Public Health Threats: How scalable is your vaccine distribution strategy?

In the last two years, the Center for Disease Control and Prevention (CDC) has sent scientists and doctors into the field over 750 times to respond to health threats. Middle East Respiratory Syndrome (MERS), Ebola, and Avian flu are just a few of the diseases that have recently infiltrated large populations and required a global response to mitigate the risk.  

In the event that there is a widespread public health outbreak, it's the responsibility of various government agencies, including the Department of Defense (DoD) and CDC, and commercial entities to sponsor research that will protect populations; ranging from the warfighter to the general public. Oftentimes these collaborations between government and industry facilitate vaccine development and distribution so that when an emergency arises they are prepared and can respond quickly.

In this blog we'll discuss three considerations when carrying out a large-scale vaccine distribution operation and the importance of a qualified deployment strategy.

Topic: Biobanking and Biorepository, Topic: Clinic..........

Explore the Virtual Biobank

Sample integrity is essential to the success of every biobanking project. So is the ability to easily share information designed to accelerate lifesaving discoveries. Various types of unwanted pre-analytical variables can be introduced at numerous points in the life of a sample, beginning at the time it is collected from the donor, through shipping, receiving/inventory, laboratory processing, during storage and subsequent retrieval for analysis.

On the Thermo Scientific's biobanking community we recently introduced a virtual biobank which allows users to explore critical points in the biobank workflow from collection through distribution. This tool offers a hands-on way to gain a better understanding of each aspect of the workflow, and ultimately conveys the importance of a valued partner that can preserve your samples, track your inventory, streamline your productivity, and help you meet laboratory challenges.

This blog discusses some fun facts about biobanking as well as additional information about each step in the workflow. Let's explore the virtual biobank!

Topic: Biobanking and Biorepository, Topic: Clinic..........

Two and a Half Degrees of Separation: Clinical Trial Finds Moderate Cooling Improves Transplant Results

This is not about a chain of six acquaintances that (in theory) connect all the inhabitants of the world, but rather how a very small reduction in temperature can make a tremendous difference in the outcome of an organ transplant. A recently published clinical trial1 found that establishing mild hypothermia in an organ donor resulted in a significant benefit to recipients of transplanted kidneys! So here is a question to consider: if 2.5°C has a significant effect on outcomes in living patients, what effect may it have on biospecimen-based research?

Topic: Biobanking and Biorepository, Topic: Clinic..........

From Point A to B in the USA: Transporting Dangerous Goods

There are many things to consider when shipping dangerous goods; the type of material, how it's being transported, and the governing body all play an integral role in getting your material from Point A to Point B.

At Fisher BioServices, we are well versed in the management of dangerous goods; ranging from kit production to transportation. In this blog, we'll touch on some of the important information associated with dangerous goods, how they are transported, and the importance of personnel training.

Topic: Cold-Chain Logistics, Topic: Clinical Trial..........

Innovation in Biobanking: Pushing the Boundaries

Though biobanking has been a unique niche for many years, a 2009 article by Time Magazine helped solidify its importance as one of the 10 Ideas Changing the World. For librarians of specimens, also known as biorepository technicians, Standard Operating Procedures (SOPs) and work instructions provide necessary order and structure, but oftentimes make daily activities a bit routine. In some instances this can diminish the spark that’s necessary to push boundaries and insert innovation. 

As the Assistant Project Director of a busy central biorepository where 1.4 million transactions occur annually, I believe that innovation is of critical importance to the wide variety of tasks involved in a biobanking environment, ranging from shipping and receiving, to laboratory processing and data analysis. In this blog I’d like to discuss how to create a culture of innovation and some boundary-pushing ideas that have improved our daily processes.

Topic: Biobanking and Biorepository, Topic: Clinic..........

Clinical Trial Identifies New CAR T-Cell Therapy to Fight Leukemia

Two of our previous blogs, Viral Cell Therapies Fighting Cancer and Researchers Learn How to Turn Cancer Cells into Macrophages, discussed the challenges associated with Acute Lymphoblastic Leukemia (ALL) and some of the medical breakthroughs being used to fight this difficult disease. A recent article in Blood Journal explains how recurrent ALL is very difficult to treat, but suggests there is real hope for finding a lasting curative therapy for refractory patients. Let's explore the studies findings and uncover additional information on the research into potential ALL cell therapy treatment modalities.

Topic: Clinical Trial Sample Management, Topic: Ce..........

Amazing Samples: Spit, Spat, Sputum

The word “phlegm” itself dates back to the ancient Greek humoralist theory of medicine. At the time, it was believed that just as all matter was made up of combinations of the four elements, so were all body parts made up of specific mixes humors: the heart was primarily blood and air, the liver yellow bile (kholé) and fire, the spleen black bile (melaina kholé) and earth, and the brain was phlegm and water. Many health conditions were attributed to an imbalance of the humors, both physiological and psychological, and such words have remained in the English language since, such as cholera (yellow bile) and melancholy (black bile), and sanguine or phlegmatic personalities.

Topic: Biobanking and Biorepository, Topic: Clinic..........

Curing Crohn's Disease: How Data and the Gut Microbiota Proteome Are Working Together

As previously discussed on Thermo Fisher Scientific's Accelerating Proteomic's blog, research into the debilitating inflammatory bowel condition called Crohn’s disease has identified the gut bacterial community as a key factor in the disease’s pathogenesis and continuation. Despite this, there is still no reliable clinical biomarker to speed investigation, monitoring and diagnosis for patients. Because the symptoms of Crohn’s disease are not unique and are shared among many inflammatory bowel diseases, diagnosis frequently requires many different and invasive clinical tests.

In this blog, let's explore how Juste et al. (2014) used the gut microbiota as a starting point in their study exploring the intestinal microbiome for prospective biomarkers1 and how a new platform established by The Crohn's & Colitis Foundation of America (CCFA) may help speed the process towards a potential cure to this disease.

Topic: Biobanking and Biorepository, Topic: Labora..........

Transporting Critical Bio-Material: How do you safely move an irreplaceable biospecimen collection?

Are you faced with the task of relocating a biospecimen collection? Moving a substantial inventory of samples is a logistical challenge, and requires managing temperature, equipment, regulatory, and personnel safety issues. The choice of vehicle used for transport may be low on the list, but the right truck can be critical to success.

The best mode of transportation for moving your irreplaceable sample collection from Point A to Point B may not be one you are familiar with. This InfoPoster explores the pros and cons associated with the well-known (standard) option vs. specialized transport services and associated ancillary equipment. Getting familiar with all of your options will lead to a better decision.

Topic: Cold-Chain Logistics, Content: Poster, Topi..........