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Flawed Study Design—the Other “Pre-Analytical Variable” in Biomarker Research

Why are we failing to find biomarkers for early detection of disease?  Throughout our blog we write a great deal about biospecimen integrity and emphasize the control of pre-analytical variability in biospecimens. However, the highest quality biospecimens are wasted in the search for biomarkers if the study design is flawed. And the literature on biomarker discovery studies is filled with examples of poor study design, creating an overabundance of false positives that cannot be validated.

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

Gut Bacteria Rivals Immunotherapies in Cancer Treatment

The human gut contains more than 100 trillion bacteria from perhaps 500 or more different species. In fact, gut bacteria outnumber the cells in the human body. The vast number of these bacteria has caused researchers to take a closer look at how they are related to health and disease. Now, breaking scientific research suggests that gut bacteria may be more important than anyone previously realized: they appear to be effective cancer treatments.

Topic: Laboratory Processing, Topic: Cell Therapy ..........

[Video] Semi-Automated Biobanking: Delivering quality samples in less time

The holy grail in the biobanking industry is all about maximizing the value of biospecimens to deliver new therapies. Thus, there's now more pressure on biobanks to deliver samples that are in better condition, with better annotation, and with a more rapid turnaround time. In order to support our clients in achieving their aims in maximizing the value of their sample collections, we have installed a LiCONiC Semi-Automated Biobank (SAB) to manage the increased demands on sample utilization. To learn more and see the LiCONiC system in action, check out our video below!

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

Amazing Samples: Water

Water – the universal solvent. The all known life on our planet requires it to function, not directly because of water itself, as much as its ability to transport other compounds and ions, and facilitate metabolic reactions. That’s why human civilization itself is based on water, both in determining where people settled, as well as whether they live.

Topic: Biobanking and Biorepository, Topic: Amazin..........

The Importance of Early Planning for Clinical Supplies: Part II

In Part I of this blog series, I identified some of the challenges in supporting clinical trials and a few reasons why early planning for clinical supplies is very important. In Part II, let’s look at three areas of clinical supply support that can greatly benefit from having the support team involved from the start and given ample time to design and contribute to the protocol:

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

The Link Between Epigenetics and CRISPR-Cas9

When it was first released in 2012, the CRISPR-Cas system stunned scientists with its potential for revolutionizing biological research. Researchers initially noticed that bacterial genomes often contain “clustered regularly interspaced short palindromic repeats,” now dubbed CRISPR sequences. When scientists provide the Cas enzyme with a guide RNA sequence, they can tell it precisely where to slice the DNA. This allows unprecedented control over DNA slicing and insertion of new genetic code.

Topic: Laboratory Processing, Topic: Cell Therapy ..........

The Evolution of Public Health: Virchow, DOTS-plus, and the Economics of Tuberculosis (Part 2)

After the discovery of Streptomycin in the 1940s, followed by isoniazid in the 1950s and later rifampin in the 1970s, the incidence of TB in the developed world dropped dramatically. Sanatoria closed and research into new antibiotics and vaccines likewise diminished. TB was no longer considered a significant threat in the US and much of Europe. So when multiple drug-resistant strains of TB (MDR-TB) appeared in the 1980s, the concern within the infectious disease community was perhaps understated. Besides, all but a small number of cases were in underdeveloped countries where the very high cost and difficulty of treating MDR-TB was considered beyond reach.

Topic: Public Health Research, The Evolution of Pu..........

Safeguarding Data Across Biotech Global Boundaries

In an era of “big data,” companies across all industries are collecting consumer information to provide effective solutions to problems or better market their products. Industry watchdog groups have long been concerned about the implications of data collection on consumer privacy. These issues become even more complex when conducting transactions across international borders. A recently drafted European Union-United States Privacy Shield agreement is intended to clarify the privacy principles U.S. organizations must meet to comply with EU privacy laws.

Topic: Biobanking and Biorepository, Content: Blog

The Evolution of Public Health: Virchow, DOTS-plus, and the Economics of Tuberculosis (Part 1)

In all of human history, tuberculosis has killed more people than any other disease. Discovered in 1882 by Robert Koch, the M. tuberculosis bacterium was responsible for the Great White Plague that began in the 1600s and has not yet truly ended. It was the primary cause of death in Europe in the mid-1600s, and even in the 1800s, the high mortality from TB among young adults earned it the nickname of “the romantic disease,” which glosses over the symptoms that earned TB other nicknames such as “consumption", “phthisis" (bless you), and "scrofula".

Topic: Public Health Research, The Evolution of Pu..........

The Importance of Early Planning for Clinical Supplies: Part I

Beating other investors to an offer or getting ample time to support a clinical trial can yield big benefits and returns. The advantages from the financial perspective can be fairly evident but the gains from having plenty of time to plan, design and implement support functions for clinical supplies may not be so obvious. In this two part blog series, I will discuss the challenge of supporting clinical trials and the importance of early planning for clinical supplies.

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

Cooling Valley Fever: Unique Kits for a Unique Clinical Trial

Fisher BioServices supports clinical trials in numerous ways, including acquiring and distributing clinical agents and the design and assembly of biospecimen collection kits. Recently, the staff members at the Clinical Agent and Specimen Repository (CASR), which Fisher BioServices operates for the National Institute of Allergy and Infectious Disease (NIAID) at the National Institutes of Health (NIH), were challenged to support a particularly unique clinical trial: The efficacy of fluconazole in the treatment of Valley Fever.

Content: Case Study, Topic: Kit Production

Increasing Global Cell Therapy Awareness: ISCT 2016

We are pleased to announce our participation as a platinum sponsor at next week's International Society for Cellular Therapy (ISCT) 22nd Annual Meeting in Singapore. This will be the first time that the ISCT Annual Meeting will be held in Asia and is a reflection of the increasing global awareness of the importance of Asia in the field of Cellular Therapies. With over 1000 international delegates registered to attend, ISCT 2016 is a great opportunity to network with experts within the global cell therapy arena. We are honored to showcase our global integrated solution for cell therapy clinical and commercial development in conjunction with our parent company, Thermo Fisher Scientific.

Topic: Cell Therapy Solutions, Content: Blog