FDA Proactively Addresses Embryonic Stem Cell Safety Testing

Posted on December 31, 2007 by jrowley

The FDA has scheduled an April 10, 2008 meeting to “discuss scientific considerations for safety testing for cellular therapy products derived from human embryonic stem cells.” This meeting will be followed by another meeting on April 11 that will “discuss updates on 1) research management related to the September 29, 2005 review of research programs [...]

Filed under: Advanced Cell Technology, cell delivery, Clinical Trials, Embyonic Stem Cells, FDA, Geron, Novocell, Regenerative Medicine, regulatory, stem cells | 1 Comment »

Top Ten Events in the Regenerative Medicine Industry in 2007

Posted on December 26, 2007 by jrowley

Top Ten Events in the Regenerative Medicine Industry in 2007 (according to Jon Rowley, and in no particular order): Embyronic stem cells were primed for human trials. Both Advanced Cell Technology and Geron are gearing up for INDs in early 2008.

Filed under: Regenerative Medicine | 1 Comment »

Athersys’ Adult Stem Cell Product IND Approved for Acute MI Phase I Trial

Posted on December 23, 2007 by jrowley

Athersys and their cardiac parter, Angiotech, announced today that they got the ok from the FDA to begin a Phase I clinical study using Athersys’ Multistem adult stem cell product in acute myocardial infarction (MI). This is the second IND approval for Athersys in just over a month (and a welcome Christmas present for the [...]

Filed under: Angiotech, Athersys, Biomaterials, cardiac regeneration, cell delivery, Clinical Trials, Joint Ventures, Regenerative Medicine | Tagged: , , , , | Leave a Comment »

The Regenerative Medicine Industry Job Search – Resources and Advice

Posted on December 21, 2007 by shsiong

A guest post by Susan Hsiong, PhD You worked hard as a lab rat for the past several years and you’re eager to move on to the next step. However, the transition from academia to industry is a tricky one. Companies are often wary of hiring someone fresh out of grad school without any industrial [...]

Filed under: Job search, Regenerative Medicine | Tagged: , , | 1 Comment »

BioTime Births Embryome Sciences

Posted on December 19, 2007 by jrowley

There have been some interesting news releases this week, including Osiris’ fast track designation, Cytori obtaining a 510k for their fat cleaner (not their stem cell isolation device, just a clinical fat cleaner), and the angiogenesis and liver regeneration capabilities of Aldagen’s aldehyde dehydrogenase positive sorted cells. However, the press release that really caught my [...]

Filed under: Bioprocessing, BioTime, business models, Embryome Sciences, Regenerative Medicine | Tagged: , , , , , | Leave a Comment »

Organogenesis Expands into China

Posted on December 13, 2007 by jrowley

Organogenesis, one of the pioneering tissue engineering companies, is partnering with China’s National Tissue Engineering Center (NTEC) to bring Organogenesis’ regenerative therapies to the Chinese marketplace. NTEC is a Shanghai-based private company that is funded by the Chinese government, and it was launched by a Harvard/MIT-trained plastic surgeon, Dr. Yiling Cao. The two companies look [...]

Filed under: Bioprocessing, business models, Joint Ventures, Manufacturing, Regenerative Medicine | Tagged: , , , , | 1 Comment »

Jobs in Regenerative Medicine: Part I

Posted on December 13, 2007 by jrowley

One of the aspects of my science career that I really enjoy is the career coaching that I provide, and receive. I actually spend a lot of time telling students that are graduating, whether it is at the Bachelors, Masters, or PhD level, about industry, and helping them get a feel for what the job [...]

Filed under: Bioprocessing, Job search, Regenerative Medicine | Tagged: , , , , | 2 Comments »

Biomaterials as Therapies

Posted on December 9, 2007 by jrowley

The regenerative medicine industry is banking on cellular therapy to help regenerate tissues and restore function in clinical indications with high unmet needs. The mechanism of action, or how stem cells actually drive tissue regeneration, is still hotly debated – but it is likely a mixture of several actions (see item #6 in this post) [...]

Filed under: Biomaterials, business models, Regenerative Medicine | Tagged: , , | 1 Comment »

Patent Reform Act of 2007 – Impact on Regenerative Medicine

Posted on December 7, 2007 by jrowley

The author of CELLWISE, one of the newer bio-Blogs out there, asked a question related to the Patent Reform Act of 2007 in a comment on the Pfizer post. He asked: The article that is cited is right; our patent system is not optimized for today’s innovations or our different industries. The patent office is [...]

Filed under: Big Pharma, Innovation, Intellectual Property, Regenerative Medicine | Tagged: , , , , | 1 Comment »

Progenitor Cell Therapy, LLC: Acquisition Target

Posted on December 4, 2007 by jrowley

I have been playing with the idea of a post related to the area of therapeutic cell bioprocessing, and today one of the leaders in the field became an acquisition target. Progenitor Cell Therapy (PCT) provides process development and manufacturing support for institutions and cell therapy companies, and has over 30,000 cell procedures under it’s [...]

Filed under: Bioprocessing | Leave a Comment »

Pfizer Launches Independent BioInnovation Center

Posted on December 1, 2007 by jrowley

Pfizer Global Research and Development (PGRD) has been going through some major restructuring, and in an effort to spur innovation has opened an independent research center in the Bay Area. This “biotherapeutics and bioinnovation center” will be headed up by experienced bioentrepreneur Corey Goodman. Is it possible that this could lead to some cell therapeutic-based [...]

Filed under: Big Pharma, Innovation, stem cells | Tagged: , | 1 Comment »

Osiris Releases 1 Year Data from Chrondrogen Trial

Posted on December 1, 2007 by jrowley

Osiris Therapeutics last week announced positive data that came out of their Phase I/II double blinded Chondrogen trial. They demonstrated statistically significant improvements in joint pain in patients with osteoarthritis, however this seems to be an about face compared to when they announced their “disappointing” (the CEO’s words) interim 6 month data from this trial. [...]

Filed under: adult stem cell, Biomaterials, cartilage, Clinical Trials, orthopedics, Osiris, Regenerative Medicine, stem cells | 1 Comment »

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