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An Expert’s Perspective on Accelerated Pathways for Cell Therapy Approvals

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Yaron Ramati, Director of Regulatory Affairs at Pluristem Therapeutics
Yaron Ramati, Director of Regulatory Affairs at Pluristem Therapeutics

Over the past few years, the regulatory landscape for cell therapy development has grown increasingly complex. There are now accelerated pathways for advanced therapy medicinal products (ATMPs) in several countries worldwide, including the U.S., Japan, and South Korea. While the possibility for accelerated commercialization has resulted from these changes, substantial complexity has also been introduced, making it a more elaborate process to move cell therapy products from “bench to bedside.”

In the interview with Yaron Ramati, Director of Regulatory Affairs at Pluristem Therapeutics, we get an expert’s perspective on how the regulatory environment has changed and new opportunities that exist for bringing cell therapy products through the clinical trial process and into the global marketplace. [Read more…]

Pluristem Therapeutics, Interview with Yaky Yanay, President and Co-CEO

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Pluristem TherapeuticsPluristem Therapeutics (PSTI) is a clinical-stage company that is a proprietary 3D manufacturing technology to develop placental cell therapies for conditions that include ischemia, muscle injury, and exposure to radiation. I had the honor of interviewing Mr. Yaky Yanay, President and Co-CEO of Pluristem Therapeutics.

In this interview, we discuss the history of Pluristem Therapeutics, its clinical-stage products, intellectual property (IP) portfolio, marketing strategy and future directions.

Enjoy these insights into Pluristem Therapeutics, a world-class leader in cell therapy manufacturing and placental-derived products. [Read more…]

Global Radiation Threats Require Cutting-Edge Counter-Measures

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Many governments, including the U.S. and Japan, are well aware of the dangers to their populations of exposure to high levels of radiation from nuclear accidents or dirty bomb attacks. Whereas Japan’s population was recently exposed at Fukushima following the tsunami of 2011, the U.S. Department of Defense has been stockpiling acute radiation syndrome (ARS) countermeasures as a precaution for many years. [Read more…]

Pluristem’s PLX Cells Significantly Inhibit Cancer Cell Growth in Newly Published Study

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  • PLX cells exhibit anti-proliferative effect on a wide range of human cancer cell types
  • Pre-clinical study results show statistically significant reduction in tumor size as well as complete tumor remission in 30% of treated recipients

HAIFA, Israel, Jan. 12, 2018 — Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, today announced the publication of a peer-reviewed article in the journal Scientific Reports, from the publisher of Nature, titled, “Human Placental-Derived Adherent Stromal Cells Co-Induced with TNF‑α and IFN‑γ Inhibit Triple-Negative Breast Cancer in Nude Mouse Xenograft Models.”

The article is based on studies which examined the effect of PLX cells that had been induced with tumor necrosis factor alpha (TNF-α) and interferon-gamma (IFN-γ), on the proliferation of over 50 lines of human cancerous cells. The induction of the cells was carried out by adjusting their manufacturing process in order to transiently alter their secretion profile. [Read more…]

Pluristem Gets Accelerated Approval Pathways in Top 3 Healthcare Markets – U.S., Europe, Japan

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Cell therapy was recently described as “One of the most promising new fields of science and medicine,” by FDA Commissioner Scott Gottlieb. He went on to state that cell therapy and regenerative medicine “…hold significant promise for transformative and potentially curative treatments for some of humanity’s most troubling and intractable maladies.” In the FDA statement issued August 28th, Gottlieb also revealed that the U.S. regulator is looking improve upon its approval process for cell therapies. [Read more…]

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