What does the Cures Act mean for regulation of cell therapy in US

December 18, 2016

New law, called “21st Century Cures Act”, has been signed this week in US. This is huge legislation, which covers new developments and initiatives, aimed to improve healthcare system. Few sections of the Cures Act specifically dedicated to regenerative medicine. These sections were proposed by industry lobby organization Alliance of Regenerative Medicine (ARM) as the […]

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Presentation: CELL THERAPY – Definitions, Classifications and Trends

October 14, 2016

Here is my talk that I gave on August 15 this year during annual BioProcessing Summit in Boston. Cell Therapy – Definitions and Classifications from nanog Link Transcript: 2. Cell therapy is mostly experimental field right now. So, one of the best ways to track activities in this field is to look at number of […]

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Historic FDA public hearing on regulation of cell therapy in US

September 18, 2016

On September 12 and 13 of 2016, FDA conducted public hearing on clarification of regulatory guidances for cell therapy. In my view, it was historic event, because it was the first-of-its-kind public hearing for cell therapy field. The reason for the hearing was unexpectedly high number of controversial comments about 4 guidances that FDA released […]

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Whom should we blame for the absence of approved stem cell products in US?

September 14, 2016

Few months ago I was watching presentations from Bipartisan Policy Center on support of REGROW Act as alternative regulation for cell therapy, proposed to FDA. I was especially intrigued by presentation of Randal Mills – President and CEO of California Institute for Regenerative Medicine (CIRM). Here is a quote that I’d like to discuss today […]

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Why price for cell/ gene therapy products is so high?

September 6, 2016

The topic of pricing cell and gene therapies is very hot right now. The price tags for the most approved cell/gene therapy products are high and there is no one simple solution to address their reimbursement and adoption. The world’s most expensive drug is gene therapy drug Glybera, has captured a lot of attention in […]

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Is cell therapy failing commercialization in Europe?

August 19, 2016

Christopher Bravery – a consultant on advanced biologicals, has opened Cell Therapy Stream of the annual Bioprocessing Summit with worrisome note: “Half of approved cell and gene therapy products on European market eventually failed commercialization and were withdrawn“. Let’s look at it in details. Since introduction of regulation cell/ gene therapy as Advanced Therapy Medicinal […]

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FDA calls for collaboration on CAR T-cell therapies database

March 16, 2016

CAR T-cell therapy is disruptive technology on many levels. One of such levels is regulation. On the one hand regulators have not seen such impressive efficacy data for long time and it is very inspiring (FDA keeps awarding CAR T-cell developers with “Breakthrough Therapy” designation). On the other hand, high efficacy “comes with a high […]

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Spinal mass formation after auto- transplantation of olfactory cells in patients with spinal cord injury

February 13, 2016

The recent report, published in Acta Neuropathologica, describes 2 cases of spinal tissue mass formation after local transplantation of autologous olfactory mucosa in patients with spinal cord injury. Both patients underwent cell translplantation 7- and 5 years ago in Portugal as part of clinical trial. Patients were evaluated at University of Michigan Medical Center for […]

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Brain tumor after infusion of fetal liver-derived cells in patient with diabetes

January 24, 2016

I’m continuing to document of all clinical cases reports on complications of cell therapy with focus on regenerative medicine. I’m trying to capture all published autopsy or pathology reports. I believe, such database will equip professionals with a knowledge and allow to avoid mistakes in future translation of cell therapies. Today, I’m going to highlight […]

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On conditional approval of cell therapy products

December 20, 2015

As you may know, about 2 years ago Japan has passed a new law for regulation of Regenerative Medicine. Under this law, the regulatory pathway for commercial cellular products is significantly accelerated by skipping of typical “Phase 3 trial” and allowance of marketing authorization after demonstration of safety and some (minimal) signs of efficacy (Phases […]

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