The Evolution of Public Health Research—A Summary of the Blog Series

Over the past year, we presented a series of blog posts on The Evolution of Public Health Research, our salute to a profession and area of study that has not only saved many, many millions of lives, but also dramatically improved the length and quality of life as well.

Content: eBook, Topic: Public Health Research, The..........

Amazing Samples: A Compilation of Stories in Our Cells

Though small, biological samples hold a wealth of information. They are the foundation for the development of new therapies as well as research into the cause of disease.  

Content: eBook, Topic: Amazing Samples

Controlling Preanalytical Variability in Biospecimen Collections

Large, well-designed population studies and the interrelationships they reveal are the backbone of public health and serve as a foundation for medical research. The health and lifestyle information of participants, collected via questionnaire and linked to their biospecimen samples, allow investigators to examine the intricate relationships between genetics, physiology, behavior, environment, and disease.

Content: eBook, Topic: Public Health Research

Cell Therapy Logistics: Beyond the Basics

My previous eBook, Commercially Successful Cell Therapies: Navigating the Ultra Cold Chain Distribution Minefield, and several of my blogs, have discussed the basics of building a successful logistics strategy for the management of cell-based material. If you read these, then you are aware of the better-known and important factors to consider, such as:

Content: eBook, Topic: Cell Therapy Solutions

Standardizing Biosample Management: Why Use Collection Kits?

Whether you are conducting a phase 3 clinical trial of a new therapy or looking for biomarkers, you will need to collect samples, and that leads to a number of questions. How do you collect the biosamples in such a way as to preserve their usefulness—maintain molecular integrity—for your specific (or unknown) downstream analyses and assays? How many samples will be needed, how many “collectors” will be involved, and how many locations? How long do the samples have to be preserved, and how will they be stored? And how will you manage the data?

Content: eBook, Topic: Kit Production

Smart Biobanking: From Samples to Predictive Algorithms for Detecting Cancer

The recently released World Cancer Report 2014, a global analysis by the World Health Organization, noted both the increase in cancer cases worldwide, as well as the burden represented by the spiraling cost of treating late stage disease. The report, as stated in the preface, makes it clear that we cannot “treat our way out of cancer.”

The most effective approach to addressing cancer is prevention, and if treatment is necessary, it is best at an early stage, which is associated with much higher survival rates as well as lesser side effects. Ovarian cancer is a case in point: Five-year survival among women diagnosed with stage 4 disease is 5.6 percent, while those diagnosed and treated at stage 1 is as high as 92 percent. However, early treatment depends on early diagnosis, and in spite of major investments of both resources and effort, there are still few biomarkers available for the diagnosis of cancer at a very early stage, when the disease is far more treatable.


Topic: Biobanking and Biorepository, Content: eBoo..........

Extreme Biobanking: How to Build and Operate a -80°C Walk-In Freezer

Opening a door and walking into the equivalent of Antarctica takes preparation. Scientists studying climate can use instruments to measure extremely cold temperatures: NASA documented the lowest temperature on record, -93.2°C, in 2010 from a high ridge on the East Arctic ice sheet, using satellite data. But what if instruments won’t do the job? What if your employees have to work in such an environment?

Topic: Biobanking and Biorepository, Content: eBoo..........

Protecting Your Protocol: Operating a Flawless Clinical Agent Repository

Managing the distribution of clinical agents for large, multi-site, multi-country clinical trials requires a spectrum of expertise and infrastructure, specifically designed to ensure accuracy in order processing and preservation of the integrity of the product from initial receipt into inventory through delivery to the clinical site. 

Content: eBook, Topic: Chemical Compound and Mater..........

Automating Your Sample Collection for Biobanking: 10 Things to Consider

How do you determine if your inventory is automation-friendly?  Chances are, if you didn’t launch your biobank with automation in mind, or if a large percentage of your inventory is legacy collections, you’ve got some serious challenges ahead of you. If your focus is managing labor costs, automation may or may not be all or part of the answer.  As a starting point, give considerable thought to the issues presented here.

Topic: Biobanking and Biorepository, Content: eBoo..........

Biobanking for Animal Health: Morris Animal Foundation is Taking Veterinary Research to a New Level

The Morris Animal Foundation is working with Fisher BioServices and several other partners to take veterinary research—specifically, research into canine cancer—beyond the laboratory. Called the Golden Retriever Lifetime Study, the project is the first study to go into operation under the administrative umbrella of the Foundation’s Canine Lifetime Health Project (CLHP). The Golden Retriever Lifetime Study will enroll 3,000 dogs before age two, and collect environmental and other data as well as biospecimens, throughout the dogs’ life.

Topic: Biobanking and Biorepository, Content: eBoo..........

Cold Chain Qualification : 5 Questions You Must Ask When Shipping Biologics

“Cold Chain” refers to the uninterrupted series of logistical activities (packaging, shipping, storage, distribution, handling) of products that must be maintained within a given temperature range. And as those of us in the bio-pharmaceutical industry know well, maintaining cold chain is critical to the integrity of biologically derived therapeutic products.

Topic: Qualification / Validation, Content: eBook

QP Essentials : Your EU Gateway to Clinical and Commercial Distribution of Cell Therapeutics

QPs—Qualified Persons–serve as the eyes and ears of the UK Medicines and Healthcare product Regulatory Agency (MHRA). Their primary focus is to protect patients by ensuring that medicinal products have been manufactured and handled according to GMP and European Union regulations. By protecting the patient, QPs also serve to help and protect the manufacturer.

Content: eBook, Topic: GMP Biologics Management