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Informed Consent for Use of De-Identified Biospecimens?

The Federal Government is revising the rules governing use of humans in research, specifically, Title 45 of the Code of Federal Regulations (CFR) part 46, Protection of Human Subjects. A Notice of Proposed Rulemaking (NPRM) was issued September 5, and comments are being accepted until December 7, 2015.

Changes in the rulings include new requirements for informed consent, including consent for the use of de-identified patient biospecimens, and the duties of Institutional Review Boards.

Topic: Biobanking and Biorepository, Topic: Clinic..........

Top Translational Researchers of 2014

Nature recently released its list of the top 20 translational researchers for 2014, highlighting scientists whose work and patents facilitate new discoveries and advances in medicine and healthcare. The publication ranked biotech's top translational researchers according to patenting activity, using information supplied by the patent analytics firm, IP Checkups. This research directly impacts the role of personalized medicine and will help to identify the future wave of biotherapeutics and diagnostic tools in our industry. In this blog we'll review some of the research from five of these top researchers, and learn how their research is shaping our future.

Topic: Biobanking and Biorepository, Topic: Clinic..........

Tackling Global Health Initiatives and HIV/AIDS at the PEPFAR Roundtable

Global health initiatives work to assess, monitor, and ultimately effect positive improvements in the well-being of citizens around the world. The battle against the spread of HIV/AIDs is one that has been in the news for decades and with organizations like the US President’s Emergency Plan for AIDS Relief (PEPFAR), global leaders are working together to combat this disease.

Recently, Thermo Fisher Scientific teamed up with the Business Council for International Understanding (BCIU) to host a roundtable discussion between leaders in the Global Health industry and Ambassador Deborah Birx, the US Global AIDS Coordinator in charge of overseeing and leading PEPFAR. PEPFAR is widely cited as the largest commitment by any nation to combat a single disease in history and is one of the most successful global health programs in the world.

In this blog I’ll give some insight into the roundtable discussion and review some of the key points global health leaders are addressing for those affected by HIV/AIDS.

Topic: Biobanking and Biorepository, Topic: Clinic..........

A New Class of Immunotherapeutics: Using Oncolytic Viruses to Treat Cancer

Scientists have noted the ability of viruses to kill tumor cells for almost a century but have been unable to document the therapeutic use of these viruses in patients with cancer. Interest in this approach is growing, supported by advancing knowledge of viral biology, molecular genetics and tumor immunology. Oncolytic virus immunotherapy is a type of cancer treatment that uses viruses to replicate within cancer cells.

In this blog, we’ll briefly explore how viruses, specifically oncolytic viruses, are being used to treat cancer.

Topic: Biobanking and Biorepository, Topic: Cell T..........

Developing Immunotherapies for Cell-Based vs. Non Cell-Based Therapies

Immunotherapies harness the power of the body's own defense mechanism, the immune system, to combat disease. They were initially introduced in the form of non cell-based biologics and vaccines, such as the splurge of products known as the check-point inhibitors designed to target the PD1/PD-L1 immune pathway. An individual would be injected with a weakened form of a virus, exposing the body to the disease and prompting the immune system to produce antibodies to fight the infection from the live virus. In recent years, immunotherapies are expanding into the realm of cell and gene therapy. Cell therapy includes re-engineering the T-cell or immune cells and re-delivering these cells back the patient to treat the cancer.

Both cell-based therapies and non cell-based therapies are developed as immunotherapies and therefore they share some similar challenges in development. However, due to the nature of cell-based therapies manufacturing complexities, there are several additional challenges that must be considered. In this blog we'll take a closer look as some of the challenges that cell-based and non-cell based therapies face, and why cell-based therapies are so complex.

Topic: Biobanking and Biorepository, Topic: Cold-C..........

Amazing Samples: Bone Marrow

When I was young, my father tried to teach me to eat everything put on my plate (though it was an uphill battle, since I was quite the finicky child). One of the few “bizarre” foods that I took a liking to, though, was sucking the marrow out of goat, lamb, or beef curries (my father was clearly not a devout Hindu). Even now, it’s one of my favorite parts of such dishes, and I recently added San Diego to my travel wish list if just to eat swordfish marrow (thanks for the tip, Andrew Zimmern).

But that’s clearly not what we’re going to talk about right now. Everyone knows that human bone marrow is rich in stem cells, specifically hematopoietic. In fact, without research on bone marrow, stem cells might not be as well understood, and accordingly we might not have reached the current burgeoning development in the cell therapy field. Last time in our Amazing Samples blog series, we discussed the value of adipose tissue cells. This time, let’s savor the rich history of bone marrow research.

… Man, I should cook some curry.

Topic: Biobanking and Biorepository, Topic: Cell T..........

Why GMP? An explanation of Good Manufacturing Practice

GMP refers to the Good Manufacturing Practice Regulations published by the FDA under the Federal Food, Drug, and Cosmetic Act. As a response to concerns about substandard drug manufacturing practices occurring at the time, Congress enacted the 1962 Drug Amendments. These amendments instructed the FDA to require all drugs to be made according to Good Manufacturing Practice (GMP) as defined under FDA 21 CFR Part 210-211.

The first set of Good Manufacturing Practices (GMP) regulations were published in 1963. These regulations are meant to guide companies in the production of safe and effective drugs. The regulations outlined in the GMPs are the minimum requirements necessary to ensure safe and effective products.

In this blog we'll discuss the definition of GMP, various regulatory components, and why it's important for companies in the life sciences space.

Topic: Biobanking and Biorepository, Topic: Qualif..........

The Other Glass Ceiling: Maintaining Cell Therapies at -135°C

Maintaining biological materials used in cell therapies at temperatures lower than -135°C is much more complicated than simply freezing samples.

The goal of cryopreservation is to prepare stocks of cells for preservation and storage, which prevents the need to maintain all cell lines in culture all the time. Cryogenic storage is especially valuable when dealing with cells presenting a limited lifespan. Even though the technique keeps cells and tissues at very low temperatures, advanced cryopreservation strategies are required to keep these cells viable after thawing. Cryopreservation techniques and equipment focus on bringing samples to very low temperatures without causing additional damage from the formation of ice and other effects of storing living matter at sub-zero temperatures. 

Topic: Biobanking and Biorepository, Topic: Cell T..........

Biobanking for Biologics and Cell Therapies: All Biobanks Are Not the Same

Until recently, most biorepositories were primarily used for archival sample storage. Researchers would generate large sample collections for research with a broad idea of how they would or could be used.  Although this required expert temperature monitoring while in storage at biorepositories, it did not demand a lot of transactional activity, debits and credits from the inventory, as there was no defined use for the sample.

However, in the last ten years the industry landscape has evolved. With the introduction of advanced biotherapeutics and personalized medicine, biorepositories have transformed from archival storage facilities into true biobanks where the overall workflow now includes numerous complex transactions. Many of these transactions are associated with adding value through an integrated workflow that seamlessly connects the sponsor, bio-manufacturer, clinical center, and patient into a tandem, well-coordinated process chain. Additionally, in some instances sample collections are developed with a more targeted end-use in mind, resulting in smaller inventories.

Let’s explore the expanded focus across our industry from biorepositories for traditional research (biospecimens) to biobanking for therapeutic components (biologics and cell therapies).

Topic: Biobanking and Biorepository, Topic: Cell T..........

Amazing Samples: Adipose Tissue

Fat - its popularity depends hugely on context, and varies from person to person. On our own bodies, some cultures stigmatize it while others embrace it. In food, some people think well-marbled ribeyes are the best steak, while others prefer the lean filet mignon (and still others don’t like steak, I guess?). Traditionally, candles and soap has been made of tallow, and some still make it that way (ignoring Fight Club fans), while most people today use some sort of substitute wax or surfactant.

The cells in adipose tissue, however, are not as controversial. In fact, adipocytes are valuable for a number of research applications, from understanding the tissue itself to harnessing the power of stem cells and progenitor cells hidden within the tissue. Last time in our Amazing Samples blog series, we concentrated on the value of progenitor cells. This time, let’s discuss how adipose tissue can be an Amazing Sample.

Topic: Biobanking and Biorepository, Topic: Cell T..........

The 21st Century Cures Act and the Glacial Pace of Drug Development

Since the mapping of the genome, there has been a growing expectation that a flood of transformative therapies would re-define medical practice and patient care. But this flood is still a small trickle, and the Federal government is attempting to craft legislation to speed development and eliminate some logjams. Where are the logjams? Not at the FDA or NIH.

The much-discussed 21st Century Cures Act (introduced in the House of Representatives last May, passed on July 10, and now in the Senate), is intended to encourage innovation, give the FDA greater leeway to consider non-traditional sources of data and clinical studies, and shorten the time between application to the FDA and approval.  The consensus among some industry experts is that the Act is a “mixed blessing.” This list juxtaposes some elements of the Act (in no particular order) with some recent commentary.

Topic: Biobanking and Biorepository, Topic: Clinic..........

Latest Cell Therapy and Biobanking Discoveries to be Discussed at Key Events

We are excited to share our participation at four upcoming industry conferences that will focus on the latest cell therapy and biobanking discoveries.

Topic: Biobanking and Biorepository, Topic: Cell T..........