The Importance of Sample Processing for Clinical Trials

Cambridge Biomedical frequently works with clients on the optimum methodology for the collection of clinical samples. For many clinical trials this  involves collection sites situated in different countries with varying levels of expertise and understanding of the correct processes to follow.

One of the critical areas we investigate when we develop an assay for a client, is the sample collection process and particularly the stability of the sample. For example, assays may involve the collection of PBMC’s, if these are not processed, correctly, within 24 hours of collection then the resulting data obtained from the assay can be seriously affected.

We identified this issue several years ago and introduced a video service for our clients. These videos are specifically tailored to the study requirements and  detail the complete process,from venipuncture through to sample shipment.

The result of using these training videos has been a resounding success and we have seen a dramatic decrease in the quality of the resulting data.

If you would like to learn more about how Cambridge Biomedical can help with your sample collection process and bioanalytical analysis please visit our website and we will be delighted to assist.

 

Could Alzheimer’s Stem From Infections? It Makes Sense, Experts Say

Could it be that Alzheimer’s disease stems from the toxic remnants of the brain’s attempt to fight off infection?

Provocative new research by a team of investigators at Harvard leads to this startling hypothesis, which could explain the origins of plaque, the mysterious hard little balls that pockmark the brains of people with Alzheimer’s.

It is still early days, but Alzheimer’s experts not associated with the work are captivated by the idea that infections, including ones that are too mild to elicit symptoms, may produce a fierce reaction that leaves debris in the brain, causing Alzheimer’s. The idea is surprising, but it makes sense, and the Harvard group’s data, published Wednesday in the journal Science Translational Medicine, supports it. If it holds up, the hypothesis has major implications for preventing and treating this degenerative brain disease.

The Harvard researchers report a scenario seemingly out of science fiction. A virus, fungus or bacterium gets into the brain, passing through a membrane — the blood-brain barrier — that becomes leaky as people age. The brain’s defense system rushes in to stop the invader by making a sticky cage out of proteins, called beta amyloid. The microbe, like a fly in a spider web, becomes trapped in the cage and dies. What is left behind is the cage — a plaque that is the hallmark of Alzheimer’s.

Read at New York Times

The MIT lab flushing out a city’s secrets

Researchers in Massachusetts are looking at ways to tackle public health issues by delving into the sewers. Luckily, a robot does all the dirty work…

 

Here in this small room within the Massachusetts Institute of Technology in Cambridge, MA, I am making the acquaintance of Luigi. As explorers go, he lacks charisma – not for him a winning smile, witty catchphrase and firm handshake. But then, Luigi isn’t your typical pioneer. He’s a robot. And it isn’t curios he collects. It’s sewage.

At first take, it seems an unlikely subject for Luigi’s creators – the Senseable City Lab – to embrace. Along twisting corridors, sleek black panels showcase the group’s off-the-wall ideas: LED-clad micro helicopters, location-tracked trash, theCopenhagen wheel – a motorised hub for bicycles that won a James Dyson prize. I am almost surprised to find the lab didn’t invent the flat white. “We usually say our top projects should be both in Nature and in MoMA [Museum of Modern Art],” admits the lab’s director, Professor Carlo Ratti, when we meet in his office, a room dominated by a vast table covered with piles of paper.

 

Read article at The Guardian

Cambridge Biomedical announces that Tim Smith has been appointed Chief Financial Officer, effective Feb 1st, 2016.

Cambridge Biomedical announces that Tim Smith has been appointed Chief Financial Officer reporting to Brad Yount, President and Chief Operating Officer, effective Feb 1st, 2016.

“Tim has extensive experience in bringing operational improvements and financial acumen to developing companies. I have worked with Tim in previous organizations and have tremendous confidence that he will help to further strengthen Cambridge Biomedical’s capabilities” said Brad Yount, President and Chief Operating Officer Officer.

Smith will assume responsibility for financial operations in Cambridge Biomedical and is focused on improving operational efficiencies within the company as it positions itself for continuing double-digit growth.

“Cambridge Biomedical’s strength in bioanalytical assays and diagnostic testing is well known in the industry” Smith commented “and I am excited by this opportunity to help develop the infrastructure within the company with its team of highly experienced staff through its next phase of growth”

Prior to this appointment, Smith was responsible for the the financial operations of several different companies in Maine, Massachusetts, New Jersey and Europe. Mr. Smith received a BS in Management from Susquehanna University and an MBA from Lehigh University and is also a certified CPA.

About Cambridge Biomedical

Cambridge Biomedical, based in Boston, Massachusetts, supports sponsors by developing customized assays for small and large molecules, biomarkers, and other critical analytes, along with validation and sample testing in our CLIA certified and CAP accredited, GLP/GCLP compliant facilities,

The Company has extensive expertise in technology transfer, assay development, optimization and validation. It also offers specific services in analytical support for PK/PD studies, biomarker development, clinical assay development, assay validation, specimen analysis, and testing services in support of clinical trial and drug or device development.

Our personalized project methodology, along with a focus on delivering quality results and regulatory submission ready documentation and rapid turnaround times, ensures we meet our client’s product development timelines.

Freeze-dried pills being tested for obesity treatment Trial will offer some of the first human data on microbe transplants and weight.

‘The freeze-dried poop method’ might not sound like a weight-loss strategy that would catch on, but—as some researchers are now testing—it may be an effective way to slim down.

In a randomized, controlled clinical trial starting this year, researchers will test out such a fecal formula for the treatment of obesity. They’ll also try to glean critical details about the human microbiome and its role in our health and metabolism. The trial, led by Elaine Yu, an assistant professor and clinical researchers at Massachusetts General Hospital, will involve taking fecal samples from lean, healthy donors then freeze-drying the stool, putting a gram or two into capsules, and giving them to 20 obese patients.

Such poop-packed pills, which are designed to replace a person’s intestinal microbes with those from a donor via their feces, have proven effective at treating tenacious gut infections. This has led researchers to ponder whether the transplants could remedy other health problems, including obesity and metabolic disorders. A few animal studies and some anecdotal data in humans suggests the answer is yes—and Yu hopes to get a final answer with the upcoming trial.

 

Link to full article