Monthly Archives: December 2007

FDA Proactively Addresses Embryonic Stem Cell Safety Testing

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 … Continue reading

Posted in 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

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 … Continue reading

Posted in Regenerative Medicine | 1 Comment

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

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 … Continue reading

Posted in 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

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. … Continue reading

Posted in Job search, Regenerative Medicine | Tagged , , | 1 Comment

BioTime Births Embryome Sciences

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 … Continue reading

Posted in Bioprocessing, BioTime, business models, Embryome Sciences, Regenerative Medicine | Tagged , , , , , | Leave a comment

Organogenesis Expands into China

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 … Continue reading

Posted in Bioprocessing, business models, Joint Ventures, Manufacturing, Regenerative Medicine | Tagged , , , , | 1 Comment

Jobs in Regenerative Medicine: Part I

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, … Continue reading

Posted in Bioprocessing, Job search, Regenerative Medicine | Tagged , , , , | 5 Comments

Biomaterials as Therapies

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 – … Continue reading

Posted in Biomaterials, business models, Regenerative Medicine | Tagged , , | 1 Comment

Patent Reform Act of 2007 – Impact on Regenerative Medicine

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 … Continue reading

Posted in Big Pharma, Innovation, Intellectual Property, Regenerative Medicine | Tagged , , , , | 1 Comment

Progenitor Cell Therapy, LLC: Acquisition Target

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 … Continue reading

Posted in Bioprocessing | Leave a comment

Pfizer Launches Independent BioInnovation Center

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 … Continue reading

Posted in Big Pharma, Innovation, stem cells | Tagged , | 1 Comment

Osiris Releases 1 Year Data from Chrondrogen Trial

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 … Continue reading

Posted in adult stem cell, Biomaterials, cartilage, Clinical Trials, orthopedics, Osiris, Regenerative Medicine, stem cells | 1 Comment