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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.

[Read more…]

Cytori Completes Enrollment for Habeo™ Cell Therapy for Scleroderma and Impaired Hand Function

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  • Cytori developing cell therapies that harness the unique attributes of adipose-derived regenerative cells (ADRCs)

  • 40 patients enrolled among 5 French centers: Marseille, Montpelier, Rouen, Lyon, and Paris

SAN DIEGO, Jan. 22, 2018 — Cytori Therapeutics, Inc. (NASDAQ:CYTX) announces completion of patient enrollment in SCLERADEC II (NCT02558543), a randomized, double-blind, placebo-controlled, parallel group, multi-center clinical trial intended to study the safety and efficacy of Habeo™ Cell Therapy in up to 40 subjects with impaired hand function due to scleroderma (systemic sclerosis). [Read more…]

Veritas Genetics Launches Collaboration with Mayo Clinic to Integrate Whole Genome Sequencing into Clinical Care

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Goal is to empower physicians and patients through making whole genome sequencing broadly available

BOSTON, Jan. 8, 2018— Veritas Genetics, The Genome Company, and Mayo Clinic are entering into an agreement to make whole genome sequencing broadly available to healthy individuals.

As part of this collaboration:

  1. The team at Mayo Clinic’s Center for Individualized Medicine will provide medical and clinical expertise to the Veritas team.
  2. Veritas will integrate Mayo Clinic’s know-how into its flagship product myGenome.
  3. Patients who qualify for a Mayo Clinic research study of healthy adults will be offered Veritas myGenome screening test for whole genome sequencing.
  4. Mayo Clinic will become a shareholder of Veritas.

Veritas, Genome Company“The Center for Individualized Medicine at Mayo Clinic is the gold standard in personalized medicine and we are proud and honored to collaborate with such a professional and dedicated team. This is a great step to further realize the promise of the human genome,” expressed Mirza Cifric, Founder, CEO Veritas Genetics. [Read more…]

2017 Marks the 1st Year That Regenerative Medicine Disrupted Healthcare

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The regenerative medicine industry has been rapidly expanding over the past few years, making it a high-value, fast-growth market. Key drivers for the market include high rates of clinical trials, accelerated pathways for product approvals, new technologies to support cell and gene therapy manufacturing, and the potential for cell therapies to revolutionize healthcare.

The regenerative medicine market gained major momentum when the Swiss pharmaceutical giant Novartis made history as the first company to win FDA approval for a CAR-T cell therapy in the U.S. in August 2017 (Kymriah). In October 2017, Kite Pharma became the second company to get FDA approval of a CAR-T cell therapy (Yescarta).

With swelling momentum to support the CAR-T technology, there are now close to 40 companies developing redirected T cells or NK cells for therapeutic use. [Read more…]

Gilead Sciences and Kite Expand CAR-T Domination with Acquisition of Cell Design Labs

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— Adds Two Technology Platforms that May be Broadly Applicable in Cellular Therapy —

— Enables Research and Development of Potential Future Generations of CAR T and TCR T-cell Therapies for Solid Tumors —

Cell Design LabsFOSTER CITY, Calif. & SANTA MONICA, Calif.–Dec. 7, 2017–Gilead Sciences, Inc. (Nasdaq: GILD) and its cell therapy subsidiary Kite announced that they have entered into a definitive agreement under which they have agreed to acquire Cell Design Labs, Inc., gaining new technology platforms that will enhance research and development efforts in cellular therapy.

Under the terms of the agreement, Gilead will acquire all of the outstanding shares of Cell Design Labs, which includes the approximately 12.2 percent of shares of Cell Design Labs that are currently held by Kite, for up to approximately $567 million. The agreement includes an initial upfront payment of approximately $175 million, subject to certain adjustments, and additional payments of up to $322 million that will be paid to the shareholders of Cell Design Labs other than Kite upon the occurrence of certain events, including the achievement of development and approval milestones. The acquisition is subject to customary closing conditions, and is expected to close shortly. [Read more…]

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