Currently, I am in the middle of moving my family to Frederick, Maryland. I am starting a new position at Lonza, and it may take a couple weeks to figure out how the blog fits with the new position/company. Please stay tuned, and I should be able to start back up in one form or [...]
Filed under: Regenerative Medicine | Tagged: intermission, twitter experimentation | 1 Comment »
Q Therapeutics, a cell therapy company focusing on neural applications, recently announced a $15M series B financing that included funding from multiple venture capital (VC) groups as well as biotech tools provider Invitrogen. Q’s lead product, Q-Cells™, is an allogeneic product intended to restore function to damaged neurons by providing trophic (e.g. cytokines, growth factors) [...]
Filed under: adult stem cell, Bioprocessing, Clinical Trials, Company Profiles, Manufacturing, MS, Neural Repair, Q Therapeutics, Regenerative Medicine, stem cells | Tagged: cell therapy development, cell therapy tools, GMP-grade kits and reagents, symbiotic business relationships | 2 Comments »
ES cell biopsy from blastocyst.
Filed under: adult stem cell, Advanced Cell Technology, Athersys, Clinical Trials, Cytori, Embyonic Stem Cells, FDA, Geron, JNJ, Novocell, Osiris, Regenerative Medicine, spinal cord injury, stem cells | Tagged: Clinical Trials, embryonic vs adult stem cell, embyryonic stem cell 2008, evolving clinical landscape, safety issues | Leave a Comment »
Geron yesterday announced the issuance of US patent #7,326,572, helping to extend their patent protection around their embryonic stem (ES) cell platform technology in the area of treating type 1 diabetes. Currently, Geron owns an exclusive license from the Wisconsin Alumni Research Foundation (WARF) for James Tomson’s original ES patents. This license allows Geron the [...]
Filed under: Embyonic Stem Cells, Geron, Intellectual Property, Novocell, Regenerative Medicine, Type 1 diabetes | Tagged: culture conditions, embryonic germ cells, endoderm, patent protection | Leave a Comment »
Cytori Therapeutics announced that they have enrolled their first two patients in an acute myocardial infarction clinical trial using adipose-derived cells prepared using their Celution™ device. The Celution™ device is an automated, tissue processing unit that isolates cells from adipose tissue derived via liposuction.
Filed under: adult stem cell, autologous, Bioprocessing, cardiac regeneration, cell delivery, Clinical Trials, Company Profiles, Cytori, Device-centric cell therapies, patient specific cell therapy, personalized medicine, Regenerative Medicine, stem cells | Leave a Comment »
by Susan Hsiong, PhD You’ve been submitting resumes like nobody’s business. And contacted everyone you know asking if they know of any job opportunities. You’ve attended all the local networking events and career fairs. After what seems like forever, you get called in for an interview. Congrats!
Filed under: Job search, Regenerative Medicine | Tagged: interview questions, interviewing, job hunting, Job search | 1 Comment »
You have to hand it to Tengion, they are trying to tackle one of the largest challenges I can think of: producing tissue engineered organs and tissues from a patients own cells in unrelated indications (bladder, blood vessel, and kidney). While moving through clinical trials Tengion will surely be transforming patients lives with these technologies. [...]
Filed under: autologous, Biomaterials, Bioprocessing, Clinical Trials, combination products, Company Profiles, JNJ, patient specific cell therapy, personalized medicine, Regenerative Medicine, Tengion, tissue engineered product, vascular regeneration | Tagged: autologous therapies, company prifile, tissue engineering company | 3 Comments »
Here is another take on working in a big company from ScienceMag (http://sciencecareers.sciencemag.org/career_development/tools_resources/forum/view?id=3845)
Filed under: Job search, Regenerative Medicine | Tagged: big vs small companies, Job search, pros and cons | 6 Comments »
Pervasis Therapeutics announced that they have raised $9.75M to further develop their allogenic tissue engineered endothelial cell (EC) product for vascular health indications. Their Vascugel product is comprised of ECs grown in 3D collagen sponges that are implanted externally on blood vessels to prevent them from occluding. Pervasis has proven safety in a Phase I [...]
Filed under: Biomaterials, Bioprocessing, cell delivery, Clinical Trials, combination products, Company Profiles, Manufacturing, Pervasis, Regenerative Medicine, tissue engineered product, vascular regeneration | Tagged: end stage renal disease, endothelial cells, ESRD, gelfoam, tissue engineering, vascular health | 1 Comment »
When we have a cold or a headache, we pop a pill. We get sick, we go to the doctor and get a shot. Taking medication orally via a pill or getting drugs injected via a syringe are some of the oldest forms of delivering therapeutic molecules. In the past, “drug delivery” simply meant getting [...]
Filed under: Biomaterials, biomimetics therapeutics, combination products, controlled release, diabetes, Mimetic Solutions, Regenerative Medicine, Smart materials | Tagged: controlled release, diabetes, drug delivery, mimetics, Mimetics Solutions | Leave a Comment »
Osiris Therapeutics announced that they won a DoD contract worth up to $224.7 million for developing their adult mesenchymal stem cell (MSC)-based therapeutic for treating acute radiation exposure. The contract allows for reimbursement of up to $24.7 million for continued development of their Prochymal product, and then, once the product is FDA approved for acute [...]
Filed under: adult stem cell, business models, Clinical Trials, DoD, MSCs, Osiris, Regenerative Medicine, stem cells | Tagged: Acute Radiation Therapy, DoD contract, Mesenchymal Stem Cell product, near term revenue, Prochymal, Type 1 diabetes | 1 Comment »
Just a quick note on a topic that keeps catching my attention: China. Three interesting things have come up in the last month: Organogenesis signs a distribution deal with China’s National Tissue Engineering Center, with the potential to expand into manufacturing and joint product development activities. WuXi Pharmatech purchases contract organization Apptec to gain a [...]
Filed under: Regenerative Medicine | 1 Comment »
The WuXi acquisition of Apptec (posted last week) is continuing the trend of consolidation in the cell manufacturing sector. It is similar to Lonza’s (a Swiss company) purchase of Cambrex’s biologics division in 2006, and GE’s purchase of Wave Biotech in mid-2007. Lonza is currently the largest manufacturer of cells for therapy, and has process [...]
Filed under: Apptec, BD, Bioprocessing, Invitrogen, JNJ, Lonza, Manufacturing, Progenitor Cell Therapy, Regenerative Medicine, Stem Cells Inc, WuXi Pharmatech | 1 Comment »
by Susan Hsiong, PhD Biomimetics Therapeutics, Inc. (Franklin, TN), a company which develops drug-device combination products for orthopedic applications, recently announced positive results from its Canadian clinical study evaluating its GEM OS®1 Bone Graft for the open surgical treatment of foot and ankle fusions. The GEM OS®1 is a combination product comprised of a β-tricalcium [...]
Filed under: Biomaterials, biomimetics therapeutics, bone regeneration, combination products, Company Profiles, controlled release, Medtronic, Regenerative Medicine | Tagged: biomimetics therapeutics, bone graft substitutes, bone healing, combination products, controlled release, GEM OS1, Infuse, orthopedics, recombinant protein products | 3 Comments »
WuXi (pronounced Woo-See) Pharmatech, a contract research organization (CRO) based in China, announced the acquisition of MN-based Apptec Laboratory Services. WuXi acquired Apptec to gain an immediate US footprint, better access to the US market, and important biologics expertise to expand outside the world of small molecules. This biologics expertise includes Apptec’s cell therapy bioproduction [...]
Filed under: Apptec, BD, Bioprocessing, business models, Company Profiles, Invitrogen, JNJ, Lonza, Manufacturing, Regenerative Medicine, WuXi Pharmatech | 1 Comment »
I have recently signed up for the StemCellPatents.com weekly newsletter, and it is great to keep updated on all the patents that get issued in regenerative medicine. In the most recent newletter, they reported on two patents that issued last week that strengthen Celgene’s patent estate in adult stem cells. Celgene got into the stem [...]
Filed under: adult stem cell, Biomaterials, Celgene, Intellectual Property, placenta stem cells, Regenerative Medicine, stem cells | Tagged: acquisition, Anthrogenesis, Celgene, patent strategy, placenta stem cells | 1 Comment »
With the New Year upon us, I thought it would be good to make a set of New Year’s Resolutions for the regenerative medicine industry. This set of resolutions is not company specific, but things that will be required to build long term value for this nascent industry. Get those marketing people working: Any way [...]
Filed under: business models, Innovation, Regenerative Medicine | Tagged: business models, convergent biological technologies, new year's resolutions, strategic marketing | 2 Comments »
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 (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 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: Angiotech, Athersys, cardiac cell therapy, cell delivery, IND | Leave a Comment »
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: advice, industry, Job search | 1 Comment »
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: bioprocess supply, BioTime, business model, Embryome Sciences, Michael West, spinnout | Leave a Comment »
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: china, China's National Tissue Engineering Center, joint venture, Organogenesis, Regenerative Medicine | 1 Comment »
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 | 2 Comments »
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: biomaterials as therapeutics, business models, Regenerative Medicine | 1 Comment »
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 | 1 Comment »
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 »
CellCyte Genetics Corporation recently announced that US Patent No 7,282,222 was issued, a patent which they have exclusive rights to. The press release states that the patent covers unique methods and compositions “to deliver and direct stem cells to target organs in the body”, including cardiac tissue. The focus of the patent addresses cell retention [...]
Filed under: cardiac regeneration, cell delivery, Clinical Trials, Intellectual Property, Regenerative Medicine, stem cells | 1 Comment »
I do not want to undermine the importance of the great work that was done in generating pluripotent stem cells from adult skin cells, but the only thing I think about when hearing this news is TIME and MONEY. I know I will be fielding questions from my friends and relatives over Thanksgiving weekend on [...]
Filed under: Regenerative Medicine, stem cells | 2 Comments »
On November 15, 2007, Athersys announced in a press release that they had received a letter from the FDA giving the green light to start a Phase I safety study of MultiStem, their adult, allogeneic stem cell product. Athersys will start an open label, dose escalation trial to test their cells after bone marrow transplantation. [...]
Filed under: adult stem cell, Athersys, Clinical Trials, FDA, MSCs, Osiris, Regenerative Medicine, stem cells | Tagged: adult stem cells, Athersys, business model, stem cells clinical trials | 1 Comment »
An interesting study was published this week in the Journal of Neuroimmunology spurring a press release from Geron that stated “GERON’S HUMAN EMBRYONIC STEM (ES) CELL-BASED THERAPEUTIC FOR SPINAL CORD INJURY EVADES DIRECT ATTACK BY THE HUMAN IMMUNE SYSTEM”. The title is a little misleading since the cells really only evade immune cells in an [...]
Filed under: Advanced Cell Technology, Clinical Trials, Embyonic Stem Cells, Geron, Regenerative Medicine, regulatory, spinal cord injury, stem cells | Tagged: Clinical Trials, embryonic stem cells, immune response, spinal cord injury | Leave a Comment »
I am not sure if you noticed, but the stem cell stocks haven’t been performing all that great in 2007, especially compared to technology companies like Apple or Google. So now seems as good a time as any to start a blog that will help to demystify the area of regenerative medicine and cell-based therapies [...]
Filed under: Regenerative Medicine, Uncategorized | Tagged: regenerative medicine 2.0, stem cells | 1 Comment »
