Some Steps Toward Fit-For-Purpose, Future-Proof Specimens
We spill a good bit of virtual ink in our blogs and eBooks discussing biospecimen integrity, but the emerging term that is being used more and more often, is “fit–for-purpose.” Identifying a sample as fit-for-purpose implies molecular integrity, but goes beyond this to encompass all the variables that make a biological sample useful for research. Sample integrity focuses on the quality of individual samples, while the term fit-for-purpose can be interpreted as addressing entire collections.
Topic: Biobanking and Biorepository, Topic: Labora..........
Storing Biologics at Non-Traditional Temperatures
Maintaining the appropriate storage temperature of biological material is critical for downstream use. However, due to the complexity of this material and its sensitivity to temperature we are seeing an increase in non-traditional storage temperature requests. In this blog we’ll explore some of the reasons why this is occurring and the associated challenges.
Topic: GMP Biologics Management, Content: Blog, To..........
INSIGHTS Europe: Addressing the Challenges of Supply Chain Management for Clinical Trials
Clinical supply professionals face many challenges in today’s world of clinical supply chain management. Tracking systems, temperature monitoring devices, courier capabilities, and regulations are all changing to accommodate both the increasing numbers of biotherapeutic products moving through the supply chain and the increasingly stringent criteria for temperature compliance. In partnership with Fisher Clinical Services, we invite you to INSIGHTS Europe; a complimentary forum with guest speakers and roundtable discussions on key issues impacting clinical supply management today.
Content: Blog, Topic: Cold-Chain Logistics
Cut It Out: The Role of Gene Editing Technologies in Combating HIV
HIV has been one of the largest public health challenges facing the world in the past few decades. Approximately 36.7 million people were infected with HIV, as reported by the World Health Organization, at the end of 2015. Despite the public attention and large population impacted by this virus, developing a cure for HIV has been particularly difficult. To successfully cure an infected individual the virus would need to be fully eradicated from their body, which is difficult because HIV is extraordinarily good at hiding in a person’s cells. In fact, part of the virus’ replication cycle is to insert itself into the host’s DNA. Once there, HIV appears to be undetectable and it can stay in the cells for the lifetime of the cell. In this state, the virus is termed “latent.”
Topic: Cell Therapy Solutions, Content: Blog, Topi..........
"Validation" or "Qualification" – What’s the difference?
What is the difference between qualification and validation? This question comes up frequently with both internal and external clients.
Topic: Qualification / Validation, Content: Blog, ..........
The Evolution of Public Health Research: The Next Frontier
Topic: Public Health Research, Content: Blog
Proposed Changes to Biospecimen Consent Requirements Dropped from the Revised Common Rule
If you are conducting biospecimen-based research, you are probably aware that on January 18, the long-anticipated revised Common Rule (Title 45 of the CFR, part 46, Federal Policy for the Protection of Human Subjects) was posted to the Federal Register (for some background on the nature of these revisions, see my blog post).
Topic: Biobanking and Biorepository, Topic: Public..........
A Perspective on "Expanded Access" to Experimental (Cell) Therapies
“Expanded Access,” is a regulatory pathway for physicians to gain access to experimental therapies for patients who usually do not qualify for the clinical trial. This pathway often represents one final chance against a condition that is severely debilitating and/or fatal. Often called “Compassionate Use,” the number of patients and physicians requesting access to experimental therapies has been growing steadily over the past three decades.
Content: Blog, Topic: Cell Therapy Solutions, Topi..........
Entrusting Your Biologics with a Service Provider? Important Factors to Consider
Over the past decade, a wave of scientific advances and new technologies have made significant impacts on how medicines are discovered. The drive towards personalized medicine has led to an increased understanding of the molecular and genetic bases of disease. As a result of this increased knowledge, the life sciences industry is shifting its focus from small molecule medicine to biologic medicine, resulting in increased use of biologics in clinical trials and R&D efforts.
Topic: GMP Biologics Management, Content: Blog
Phacilitate Cell and Gene Therapy World 2017: Streamline the path from discovery to cure
The advancements in cell and gene therapy are increasing at a rapid pace and are transforming the way we think about medicine. Whether in research or in the clinic, scientific innovators are acutely aware that every moment counts when working with these valuable therapies. To facilitate knowledge sharing and collaboration, Thermo Fisher Scientific is proud to support Phacilitate Cell & Gene Therapy World 2017 as the Platinum Sponsor.
Topic: Cell Therapy Solutions, Content: Blog
The Evolution of Public Health Research: Malaria, Part 2
Malaria Elimination vs. Eradication, and Genetic Diversity vs. “Freezer Epidemiology”
It is because of its historic mission to eliminate malaria that the CDC is in Atlanta, Georgia. The agency is still deeply involved with the control of malaria, by providing technical assistance around the world, and continuing to protect the US population from the parasite. The CDC estimates that 1,500 people in the USA annually are infected with malaria while traveling, and the CDC tracks these cases and advises the medical community on accurate diagnosis and treatment.
Topic: Public Health Research, Content: Blog, The ..........
Fisher BioServices Top Five Most Popular Blogs of 2016