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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..........

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..........

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.

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

[Video] Biorepository Services Help Discover Correlation Between DDT and Breast Cancer

DDT, once hailed as the miracle pesticide, was sprayed on crops, trees, and even inside houses throughout the United States in the 1950s and 60s. Though banned in 1972 and not used in the US for more than four decades, DDT has long been a suspect in the risk of breast cancer. New research shows that exposure, even from a long time ago, could be a contributing factor in the development of breast cancer; a connection scientists have been unable to make convincingly until now.

Courtesy of NBC Nightly News

Content: Video, Topic: Biobanking and Biorepositor..........

First Pass Yield or Quality Yield, Wait… What’s the Difference?

Manufacturing-related quality statistics aren’t normally associated with biorepositories, but the world of statistical process improvement tools can be very useful for biobanking. One such case is the difference between two basic statistical metrics — Quality Yield and First Pass Yield.  I'd like to shed some light on both metrics starting with their definition, then propose a recommendation of which to use in a biorepository setting, and conclude with a proposed performance target level.

First Pass Yield vs. Quality Yield

Quality Yield (QY), also known as Final Yield (FY)1 represents the acceptable pieces at the very end of a process divided by the original number of pieces fed into the process. In a manufacturing setting, this tells you the overall proportion of acceptable results; if the number of units of acceptable quality at the end of the process is the same as what can be expected given what is fed into the process, then you have achieved a 100% Quality Yield.1

Topic: Biobanking and Biorepository, Topic: Qualif..........

Whole Blood Basics: How to maintain a stable sample

Like any other fluid or tissue sample, whole blood can be most effectively analyzed when its integrity is maintained throughout collection, processing and storage. But how do you maintain the quality of a whole blood sample when considering long term storage? What happens when a sample is not handled properly?

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