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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: Cell Therapy Solutions, Topic: GMP Biologic..........

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.

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

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

Radiation Therapy for Cancer Treatment is Undergoing a Personalized Medicine Transformation

Personalized medicine, sometimes called precision medicine, has become a major buzzword in the pharmaceutical industry. For decades, scientists and physicians have puzzled over why some treatments are very successful for one patient, while other seemingly similar patients given the same treatment fail to get better. The idea behind personalized medicine is that by characterizing genetic factors, epigenetic information, levels of RNA expression, and other individual factors, we can better target our treatments to the people most likely to respond to them.

Topic: Cell Therapy Solutions

Cell Therapy Manufacturing & Gene Therapy Congress

We are pleased to announce our participation as a sponsor at the upcoming Cell Therapy Manufacturing & Gene Therapy Congress in Amsterdam. The event will focus on connecting cell and gene therapy leads to drive manufacturing and commercialization through direct access to innovative discovery, product development and regulatory know-how. We are honored to showcase our global integrated solution for cell therapy clinical and commercial development in conjunction with our parent company, Thermo Fisher Scientific.

Topic: Cell Therapy Solutions, Content: Blog

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

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

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..........