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..........
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.
Topic: Public Health Research, Content: eBook, The..........
"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..........
Collaboration in Biopharma: Harnessing the Power of Cloud-based Technologies
From banking to e-commerce, cloud computing has transformed the landscape of the world economy. It is also gradually changing the face of the biopharma industry. In the scientific world, effective communication and collaboration are essential to successful outcomes. Although biopharma has been slower than some other industries to adopt cloud-based technologies, the field is increasingly relying on the cloud to advance scientific knowledge.
Topic: Public Health Research, Topic: Biobanking a..........
Biospecimen-Based Research and the 21st Century Cures Act
“God Willing, This Bill Will Save Lives.” So said Vice President Joe Biden, in sharing his thoughts on the potential ramifications of the passing of the 21st Century Cures Act (H.R.6), made possible by the bipartisan leadership of Republicans and Democrats in the Senate and the House on December 13th 2016.
Topic: Public Health Research, Topic: Cell Therapy..........
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