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Human Induced Pluripotent Stem Cell (iPSC) Derived Tissues – Present & Future Outlook

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In this article, the present and future outlook for human iPSC derived tissues is explored. Induced pluripotent stem cells (iPSCs) are differentiated cells that are reprogrammed into a pluripotent state, allowing a wide range of cell and tissue types to be derived from them.

Key findings include:

  • iPSC technology is moving from a boutique phenomenon to industrialized cellular models.
  • Increasing recognition by industry and regulatory bodies for detecting a variety of toxicities.
  • Emerging utility for predicting cardio and neuro-related oncology adverse effects.

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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…]

What is the 21st Century Cures Act? | 21st Century Cures Act Summary

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Passed December 13, 2016, the 21st Century Cures Act authorizes $6.3 billion in funding. It will support the development of innovative regenerative medicines, by providing substantial funding to the U.S. NIH and the FDA, among other groups.

21st Century Cures Act

In this article:

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How does the U.S. FDA regulate cell therapies? (351 vs 361 Products)

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In the United States, cellular therapies are regulated by the FDA’s Office of Cellular, Tissue, and Gene Therapies (OCTGT) within the FDA Center for Biologics Evaluation and Research (CBER).

According to the FDA, the Center for Biologics Evaluation and Research (CBER) regulates:

  • Cellular therapy products
  • Human gene therapy products
  • Certain devices related to cell and gene therapy

CBER uses both the Public Health Service Act and the Federal Food Drug and Cosmetic Act as enabling statutes for oversight.

In the U.S., human tissues intended for transplantation are regulated by the FDA as “Human cells, tissues and cellular and tissue-based products” or “HCT/Ps.” Under U.S. law, any company that engages in the collection, processing, storage, screening/testing, packaging, or distribution of HCT/Ps must register with the FDA.

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Japan’s Laws Supporting Accelerated Pathways for Cell Therapies

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In late 2014, Japan passed two new laws that revolutionized the commercialization of cell therapies within the country by providing an accelerated pathway for product approvals. While there has been much discussion about these laws, few people have a clear understanding of the implications of these regulations on a global scale.

Below, we summarize the laws, identify their importance, and most importantly, speak to how Japan has become a “gateway country” for regenerative medicines. [Read more…]

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