2011 EMA Committee for Advanced Therapies (CAT) classification record. What can be learned?
Tweet What follows is the record of "classifications" done by the ATMP CAT in 2011 related to anything I would call "cell therapies". In my opinion there are a couple surprises. I'm Continue Reading
Washing cryopreserved cells. An emerging need or disappearing process?
Tweet I’m not a fan of the allogeneic vs autologous business model debate because I don’t believe it’s a debate that rages other than at conference panel sessions. Most Continue Reading
Recently approved cell therapy products
Tweet Following is a list of cell therapy products approved recently (2010-11): Dendreon Continue Reading
Inactive and recently failed or terminated phase III or II/III cell therapy trials
Tweet In the two previous posts I have outlined what I believe to be the active phase III and II/III cell therapy trials, as well as the cell therapy products to have 'recently' obtained Continue Reading
Active phase III or II/III cell therapy trials
Tweet I know that the moment I publish anything that purports to be comprehensive there will be errors and omissions. At the very least it will almost imminently be out-of-date in a Continue Reading
Sabrina Cohen Foundation Thanks Stem Cell Researchers
Tweet I'm proud to use every available resource at our disposal, including this blog, to highlight the efforts of the charity we support - especially during this holiday season. I Continue Reading
Commercializing Cell-based Regenerative Medicines
Tweet When introducing a regenerative medicine cell based product to a commercial setting, there are a host of things to take into consideration to ensure a commercially viable and safe Continue Reading
Cell Therapy & Regenerative Medicine Domains Available
Tweet Please pardon the crass commercial nature of this post. I try to keep self-promotion to a minimum here but I'm looking to unload a number of domains I have the related to Continue Reading
Commercial-stage Cell Therapy Companies and Products
Below is sample list of companies with cell therapy products* on the market in Europe, USA, or Japan. Company Continue Reading
Potential far-reaching implications of the ongoing fight over point-of-care autologous cell therapy
Tweet The FDA recently issued an untitled letter to Parcell Laboratories and its contract manufacturing organization, New England Cryogenic Center (NECC), pertaining to the product PureGen™ Continue Reading
Good Data? $100. Good Product Development? $100. Good Commercialization Strategy? Priceless.
I'm not going to fool anyone into believing I'm a therapeutic product development expert but that's not going to stop me from making a few humble observations in light of the Dendreon "fiasco" of Continue Reading
Clinical trial costs
Based on a survey* of 21 drug makers, 12 biotechs, nine device makers and 23 contract research organizations, PharmaLot has recently published the following metrics for current clinical trial costs Continue Reading
Cell Therapy’s Got Talent Technology Showcase – A Call for Cell Therapy Manufacturing Technology Presentations
in collaboration with: In an effort to showcase the latest technologies driving the production of cell therapies, the Cell Therapy Group and Informa Life Sciences are proud to Continue Reading
In vivo cell trafficking just took a leap forward
Today Celsense, Inc. and the University of Pittsburgh Cancer Center announced that the FDA has authorized the use of the Cell Sense imaging reagent for use in a phase I clinical trial of a dendritic Continue Reading
Cell Therapy Conferences
{EAV_BLOG_VER:16f07422b56ae667}For those of you have been asking, we've now created what we hope is the most comprehensive and current listing of conferences in cell therapy and regenerative Continue Reading
The LinkedIn Cell Therapy Industry Group – 1,000 members strong
As some of you may know, much of my recent social media energy has been spent on LinkedIn rather than blogging. This was not a conscious decision but I will admit to finding the immediacy and Continue Reading
Cell Therapies: Commercializing a New Class of Biopharmaceuticals
Over the past six months I have been honored and pleased to have seen and been part of an increasing focus and attention being paid to the unique manufacturing and bioproduction issues related to Continue Reading
Careers in cell therapy & regenerative medicine
As you will see just below, this post falls under the category of a thinly veiled and somewhat shameless plug which I hope you'll tolerate if I'm transparent about it upfront and I add what may be a Continue Reading
FDA files injunction again Regenerative Sciences citing Regenexx violates regulations
For those of you who follow this blog, you'll imagine my surprise to wake up the morning to the following announcement from the FDA:_____________________________________________________________FDA Continue Reading
Money for regenerative medicine
This is simple. You can give real money to regenerative medicine without it costing you a dime. JPMorgan Chase & Co's Chase Community Giving program is giving away $5 million to the charities Continue Reading
