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 surprised at the non-cardiac cells (MNCs, CD133s, and MSCs) for cardiac disease/repair being designated TEPs. I’m also surprised at the islets not being [...]
Read the Rest...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 investors, researchers, and executives recognize that there will almost certainly be room for both to succeed and that the winner in any particular indication will be [...]
Read the Rest...Tweet Following is a list of cell therapy products approved recently (2010-11): Dendreon Provenge US FCB-Pharmicell Hearticellgram-AMI Korea Fibrocell Sciences Laviv US Living Cell Technologies DIABECELL Russia Honorable mention goes to TiGenix’ ChondroCelect approved in late [...]
Read the Rest...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 formal regulatory market approval in some jurisdiction. In the course of doing that work, I came across the following industry-sponsored phase [...]
Read the Rest...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 At the very least it will almost imminently be out-of-date in a fast-moving sector like cell therapy. Nonetheless, because there is no other reliable repository of this information, I am daring to put this out [...]
Read the Rest...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 would be so delighted to have you join me in supporting Sabrina Cohen and her efforts. You can start by buying next year’s calendar! [...]
Read the Rest...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 product for patient use. In this QandA interview by Pharma IQ, William Fodor, Director of Translational Sciences, Cell Therapy Group, gives some teasers into a few [...]
Read the Rest...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 cell therapy and regenerative medicine and thought this might be the easiest way to get the word out. Let me know if you are [...]
Read the Rest...Below is sample list of companies with cell therapy products* on the market in Europe, USA, or Japan. Company Product Advanced BioHealing (now part [...]
Read the Rest...Tweet Cell Therapy Group and BioBusiness.TV are pleased to announce they are collaborating to build a “cell therapy” video channel focused on the cell therapy industry. The initiative is part of BioBusiness.TVs “Best of the Web” initiative intended to bring together publicly available video content that complements their original content. The Cell Therapy channel will focus [...]
Read the Rest...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™ Osteoprogenitor Cell Allograft intended for the “repair, replacement, reconstruction of musculoskeletal defects”. The letter stated: “The PureGen™ Osteoprogenitor Cell Allograft is not the subject of an approved biologics license [...]
Read the Rest...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 last week which I have no doubt will one day be considered an unfortunate pothole on their road to eventual success. [...]
Read the Rest...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 (see full article here) Average per-patient trial costs across all therapeutic areas: Phase I: $21,883 Phase II: $36,070 Phase IIIa: $47,523 Phase IIIb: $47,095 Phase [...]
Read the Rest...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 announce the introduction of the “Technology Showcase” session and award to be held in conjunction with Informa’s Cell Therapy Manufacturing conference to be held 30 November to [...]
Read the Rest...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 cell caccine to treat colorectal cancer patients. This is the first FDA authorization of the use of Cell Sense in [...]
Read the Rest...{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 medicine. Check it out here and let us know if you believe any should be added. www.celltherapyblog.com hosted by www.celltherapygroup.com
Read the Rest...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 interconnectivity of the LinkedIn/Twitter combo to be more seductive of my limited time than the more laborious and seemingly [...]
Read the Rest...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 cell therapy. Certainly it is the Cell Therapy Group‘s view, that this is both timely and much-needed as more cell therapies [...]
Read the Rest...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 little useful commentary along the way. I won’t have to convince “regular” readers of this “irregular” blog [...]
Read the Rest...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 NEWS RELEASE For Immediate Release: August 6, 2010 Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA FDA Seeks Injunction Against Colorado Manufacturer of Cultured Cell Product Violations of [...]
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