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Decentralized Manufacture: The Drivers and Barriers

The emergence of advanced therapeutics, including cell and gene-based therapies (CGTs), presents significant opportunities for treating unmet clinical needs, and specifically, has demonstrated the potential to provide personalized therapies. Amidst the exciting science and clinical opportunities however, there are unique challenges that arise from manufacturing and delivering patient-specific CGTs.

Topic: Cell Therapy Solutions, Content: Blog

An Alternative Model for Clinical Trial Product Management: Exploring Distribution and Dispensing

Managing limited supplies of an investigational agent in a clinical trial can present challenges. The typical practice is to ship inventory to the research pharmacy or the principal investigator’s office at clinical a site in anticipation of enrollment. One challenge is that the amount needed at study sites can only be estimated, and inadequate inventory may delay the study while providing extra is expensive and wasteful. In the meantime, the agent(s) and clinical supplies sit in storage until enrollment proceeds and dispensing begins. This ties up inventory and can create additional challenges with expiration dates. However, there is an alternative model of clinical trial support for consideration.

Topic: Clinical Trial Sample Management, Content: ..........

The Evolution of Public Health Research: Heart Disease, Part 2

Smoking, Salt and the Downside of Success

In the past 55 years, death rates from cardiovascular disease have declined by 68 percent—a two thirds reduction in mortality. Over the same period of time, death from stroke has declined by more than three fourths.

Topic: Public Health Research, The Evolution of Pu..........

Chemical Storage in the Contract Environment

When we think of chemical storage we tend to think of large warehouses or factories designed to store chemicals in large quantities. However, the standards and regulatory requirements required of large chemical facilities still have to be met by smaller facilities. In smaller facilities and laboratories, chemical storage is often secondary to other tasks and functions. There are still a number of things you must do even if your primary business is not managing chemicals. In this blog, we’ll explore some of the necessary steps to properly manage chemicals as well as protect employee well-being. 

Topic: Biobanking and Biorepository, Topic: GMP Bi..........

The Evolution of Public Health Research: Heart Disease, Part 1

How a Radio Game Show and a Town in Massachusetts Invented Biobanking and Redefined Public Health Research

Topic: Public Health Research, The Evolution of Pu..........

Expanding our Global Footprint: Supporting Cell and Gene Therapy in Japan

As I mentioned in my previous blog, favorable regulations in Japan are impacting cell therapy clinical trials conducted by the biopharmaceutical industry on a global scale.  To meet this increasing demand Fisher BioServices has expanded our cryogenic service capabilities in Tokyo, Japan.  This expansion enables our customers to seamlessly conduct clinical trials across multiple geographies and provide patients around the world with access to life changing therapies. 

Topic: Cell Therapy Solutions, Content: Blog

Cell Therapy Clinical Trials and the Mad Dash to Japan

When Shinzo Abe was re-elected as Japan's Prime Minister he aggressively embarked on a challenge to revive Japan's struggling economy. With the introduction of Abenomics, an economic policy that includes "three arrows" of fiscal stimulus, monetary easing, and structural reforms, the ball was set in motion to redefine Japan's standings within the global market.

Topic: Cell Therapy Solutions, Content: Blog

CAR T-Cell Therapy: High Risk, High Reward Part 2

As discussed in Part 1 of this blog series, Chimeric Antigen Receptor (CAR) T-cells are having an incredible impact on the cell therapy industry.  However, despite the many success stories, there are also several items that require consideration if we are to truly harness the potential of this type of therapy.  Let’s begin by exploring some of the unresolved questions and issues surrounding CAR T-cell therapy.

Topic: Cell Therapy Solutions, Content: Blog

CAR T-Cell Therapy: High Risk, High Reward Part 1

Of all the advances in medicine recently, cellular therapy is perhaps the most intriguing. It is a fast-paced, ever changing market that tests the boundaries of innovation and has forever changed the way we approach certain diseases. However, this type of medical discovery comes with its fair share of risk, but when all goes according to plan, the rewards can be great.

Topic: Cell Therapy Solutions, Content: Blog

European Biobank Week: Biobanking for health innovation

Biobanks serve a common goal: to improve understanding of patients, diseases and health; and to deliver the best individualized care. Sample quality is paramount to achieving that goal. Without confidence in the integrity of biosamples, there can be no confidence in the results.  To support this effort, we are pleased to announce our participation at the upcoming European Biobank Week (EBW) in Vienna, Austria.

Topic: Biobanking and Biorepository, Content: Blog

Shooting for the Moon: A New Cancer Immunotherapy Initiative

In 1962, President John F. Kennedy electrified the nation when he declared our intent to send a man to the moon. This year, President Obama declared a new “shoot for the moon” endeavor: to find an effective immunotherapy treatment for cancer by the year 2020.

Topic: Cell Therapy Solutions, Content: Blog

Expansion Cohort Clinical Trials and Your Cryogenic Supply Chain

One advantage to the traditional phase 1, 2, and 3 format of clinical trials is that it allows reasonable forecasting with regard to the clinical supply chain. This phase 1-2-3 format is rapidly changing, however, especially with regard to biological therapies, as more and more clinical trials include expansion cohorts. If you are planning clinical trials for a cell-based therapy that must be maintained in liquid nitrogen, and may potentially take the expansion cohort route, you should consider the impact on your distribution capabilities as soon as possible.

Topic: Cold-Chain Logistics, Topic: Cell Therapy S..........