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, Clinical Trials, Embyonic Stem Cells, FDA, Geron, Novocell, Regenerative Medicine, cell delivery, regulatory, stem cells | 1 Comment »
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 »
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 [...]
Filed under: Angiotech, Athersys, Biomaterials, Clinical Trials, Joint Ventures, Regenerative Medicine, cardiac regeneration, cell delivery | Tagged: Angiotech, Athersys, cardiac cell therapy, cell delivery, IND | No Comments »
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 experience. [...]
Filed under: Job search, Regenerative Medicine | Tagged: advice, industry, Job search | No Comments »
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: BioTime, Bioprocessing, Embryome Sciences, Regenerative Medicine, business models | Tagged: bioprocess supply, BioTime, business model, Embryome Sciences, Michael West, spinnout | No Comments »
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 [...]
Filed under: Bioprocessing, Joint Ventures, Manufacturing, Regenerative Medicine, business models | Tagged: china, China's National Tissue Engineering Center, joint venture, Organogenesis, Regenerative Medicine | 1 Comment »
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: Bioprocessing, cell manufacturing, Job search, quality control, Regenerative Medicine | 1 Comment »
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, Regenerative Medicine, business models | Tagged: biomaterials as therapeutics, business models, Regenerative Medicine | 1 Comment »
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: convergent technologies, Innovation, Patent Reform Act, patent thicket, Regenerative Medicine | No Comments »
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 [...]
Filed under: Bioprocessing | No Comments »
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 [...]
Filed under: Big Pharma, Innovation, stem cells | Tagged: Big Pharma, Innovation | 1 Comment »
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 [...]
Filed under: Biomaterials, Clinical Trials, Osiris, Regenerative Medicine, adult stem cell, cartilage, orthopedics, stem cells | 1 Comment »
