Cell Therapy's Got Talent Technology Showcase – A Call for Cell Therapy Manufacturing Technology Presentations

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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 1 December 2011 in Brussels Belgium.

Having held the same conference last year in London, Informa is committed to building on the success of last year's event by continuing to create a meaningful European forum for the issues related to the clinical and particularly commercial-scale production of cell-based therapies.

The Technology Showcase session, taking place on the main agenda, will feature 6 x 10 minute presentations from innovative companies developing cutting-edge technologies in the field of cell therapy manufacturing, and is particularly relevant to SME and academic groups with limited marketing resources.

All presentations will be reviewed by the Scientific Advisory Board with the winner announced at the end of the session. Exposure on BioProcess International's website is also included.

Technologies we'd like to promote include:

  • Manufacturing systems including bioreactor technologies
  • Cell harvest/collection technologies
  • Cell storage/logistics technologies
  • Clinical cell delivery and/or other point-of-care technologies
  • Automation technologies
  • Cell separation system
  • Cell process devices
  • Innovative reagents, scaffolds, matrices, and other “ancillary” tools
  • Technologies to close currently open systems
  • Suspension-based production systems
  • Disposable technologies

How to apply:

To apply to present companies must submit an abstract (<300 words) to daniel.barry@informa.com and lbuckler@celltherapygroup.com outlining the product or service to be presented and why it is a critical technology related to cell therapy manufacturing.

The deadline for applications is SEPTEMBER 15 2011 - Priority given to early submissions

    The cost of taking part in the Technology Showcase is £2,700 which includes the following benefits:

    • 1 x 2-day conference pass (normal price £1,599)
    • 10-minute podium presentation within main conference room
    • 1 poster display in the Exhibition Hall
    • Marketing - company logo displayed on website and event guide
    • Exposure in BPI Magazine

    Terms and conditions:

    To be eligible the product or service to be presented must be:

    • On the market for no less than 2 years or expected to be on the market no later than Q4 2012
    • Appropriate for, applicable to, and compliant with clinical-grade manufacturing requirements (technologies only available for research use will not be considered)

    Plus...

    • The company must have no more than 15 employees
    • The company has been running for no more than 5 years, and
    • The company generates annual revenue of no more than $5m

    For further information please contact: daniel.barry@informa.com or lbuckler@celltherapygroup.com

    Industry-sponsored cardiovascular cell therapies. Some metrics.

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    Cell therapies for cardiovascular-related conditions is a closely watched, much studied, oft-discussed, and hotly contested segment of the cell therapy industry.


    The data to-date are admittedly confusing.  From a clinical perspective, the studies for which we have data have been relatively small involving a mish-mash of indications, endpoints, eligibility criterion, methods and/or route of administration, as well as the time of administration relative to event or disease progression.


    Further compounding any interpretation of the data, from a technical perspective, is the fact the products have been widely varied in terms of being autologous vs allogeneic, expanded and not, genetically modified and not, from a plethora of different sources, and utilizing a wide variety of cell types from skelatal myoblasts, cardiomyocytes, mesenchymal stromal cells, mononuclear cells, etc. 


    All this makes it extremely difficult to draw any conclusions with respect to what's working and what's not.  We will not attempt to do so.


    All we do below is attempt to give a snapshot of the industry-sponsored cell therapy trials currently ongoing for cardiovascular-related conditions.  So here it is:


    Commercial:
    Pharmicell's Heartcelligram is the only cell therapy to have received regulatory approval for commercial distribution for the treatment of a cardiac-related indication.  Heartcelligram is an autologous cell therapy approved in 2011 by the Korean Food and Drug Administration (KFDA) for the treatment of Acute Mycardial Infarction (AMI).  The price is reportedly $19,000 and the trial data behind the approval has not yet been published in a peer-reviewed journal.


    Phase III or II/III:
    There are currently only 3 active and recruiting cardiac-related, industry-sponsored cell therapy trials.  Interestingly they all involve autologous products, two involve devices, two involve centralized manufacturing, two involve bone marrow cells as a source, two are only in European clinical sites, and two are targeting ischemic-related conditions.

    • Baxter Therapeutics' Auto-CD34+ cells
    • Cytori
    Two companies warrant particular mention at this stage as they appear to be in transition between phases II and III.

    Cardio3 Biosciences initially designed a trial of their autologous C-Cure in heart failure secondary to ischemic cardiomyopathy to be a phase II/III trial enrolling 240 patients.  While the trial began in late 2008 and is still registered as active but no longer recruiting on ClinicalTrials.gov the entry has not been updated for almost a year.  

    In 2010 the company announced that after enrolling 45 patients - of which 21 were in the treatment arm (24 in the control arm) - they decided to close the study to future enrollment and prepare for a phase III trial.  This decision was reportedly based on "very encouraging data". 

    Dr. Christian Homsy, CEO of Cardio3 BioSciences provided the following guidance: “The highly promising data we report today build on the favourable safety profile we have observed through this Phase II trial and documents in patients our belief that we have with  C-Cure a product candidate with the potential to make a real difference in the treatment of heart failure... As noted in the company’s press release of 29 June 2010, with the Phase II stage completed and to allow for potential modifications to the trial protocol, Cardio3 BioSciences has not proceeded to Phase III recruitment into the trial but has continued to gather all data for the six month analysis. Through the Phase II trial, we gained significant  experience in working with a highly innovative stem cell therapy in a clinical setting, and we are using this acquired knowledge in the design of our planned Phase III programme."  The phase III trial of C-Cure is expected to commence in the second half of 2012.

    Mesoblast has also announced with its strategic partner, Teva, that they are proceeding with plans to conduct a phase III study of its allogeneic cell therapy product, Revascor, in chronic heart failure.  Most anticipate this clinical trial application to be filed sometime in late 2012.


    Phase I or II:
    There are over 20 active, industry-sponsored earlier-stage trials (phase I, I/II or II) for cardiovascular-related conditions.  At least 5 of these are expected to have clinical readouts this year.   



    Hope this is useful.

    --

    This post has been brought to you by your friends at CTG.  All cell therapy. All the time. ðŸ™‚  

    -- Lee @celltherapy

    p.s.  As always we welcome your feedback, comments, and corrections.  
























































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    GEN's "Cellular Therapy Wave Finally Cresting". An overview and data set.

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    We first provided a listing (with very few details) of industry-sponsored late-stage (pivotal, phase 3 and 2/3) cell therapy clinical trials on this blog late last year (see the posting here).

    We are now pleased to we have worked with Genetic Engineering and Biotechnology News and Enal Razvi of Select Biosciences to provide an updated (as of June 2012) and more detailed listing of industry-sponsored late-stage (pivotal, phase 3 and 2/3) cell therapy clinical trials (excluding cell-based immunotherapies which we intend to cover in a follow-up article).

    A link to the listing can be found in an article published today entitled "Cellular Therapy Wave Finally Cresting" found in the November 1, 2012 issue of GEN.  

    While not my favorite title, the article is a brief - but we hope useful - overview of the sector and its pipeline.  It also provides a snapshot of the cell therapy products already in commercial distribution. 
    Some will quibble about the numbers. Certainly others have published larger revenue numbers, for instance, but in our view these have almost always included revenue from cord blood banking which we have excluded.
    We encourage you to read the article but for convenience here is a direct link to the spreadsheet.  Of course it's already out-dated but we'll do an update again soon here on this blog.


    Hope this is useful.
    --Lee


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    http://feedproxy.google.com/~r/CellTherapyBlog/~3/ctijFXeY01M/gens-cellular-therapy-wave-finally.html

    Cell Therapy Industry Group Welcomes its 4,000th member

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    I'm pleased to point out that today the LinkedIn Cell Therapy Industry Group welcomed its 4,000th member today. 


    The Cell Therapy Industry group was created to serve as a network of those in the cell therapy industry. The group acts as a vehicle for referrals, networking, information, and facilitating collaboration.  The group's focus is on the activities of companies in and serving the space.


    The group began in July 2008. It took 2.5 years to reach the first 1000 members, 9 mos to reach 2,0000, 6 months to reach 3,000, and 6 months to meet today's 4,000 member mark. 


    As is typical, there is a very high percentage of passive participants but the group benefits from an avid group of participants who post, share, exchange, and debate on a range of topics ranging from regulatory, clinical, commercial, scientific, manufacturing, financial, and other topics of interest to the group.


    As the group has grown I've noted two trends pertaining to the composition of the membership:  (a) having tapped out the c-level suite, growth is increasingly coming from down the hierarchy of the corporate food chain and including those in the operational trenches, and (b) a much higher ratio of new members of late is from outside the US, presumably as LinkedIn increasingly penetrates OUS markets.


    We strive hard to maintain the quality of the participation by screening each applicant, deleting off-topic posts, moving promotional posts to the "promotions" tab" and encouraging a balance of news-sharing with useful discussion threads.


    I'm proud to say the group has become a vibrant and valuable part of the sector due to the hard work and contributions of all involved.    


    As these kind of virtual networks become exponentially larger and provide different value than the professional societies representing the sector, I will be fascinated to watch if and how this affects how sectors like our interact and how this will impact the traditional value proposition of member-based professional societies.


    If you are not a member of the LinkedIn Cell Therapy Industry Group, check it out.


    --Lee

    Source:
    http://feedproxy.google.com/~r/CellTherapyBlog/~3/EOlUEgJGsTQ/cell-therapy-industry-group-welcomes.html

    Anticipated short-term cell therapy industry clinical milestones

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    What follows is an interesting but not exhaustive list of cell therapy industry clinical milestones we anticipate in the next 3-9 months as selected from the list of cell therapy products we are tracking in late-stage or post-commercial development.  


    There are other commercial milestones we are monitoring as well as other clinical milestones we expect to see related to cell therapy products in earlier stages of the development pipeline that are not included below.


    CellCoTec (http://www.cellcotec.com)
    • Having completed a trial in Europe of their device to enable POC production of an autologous chondrocyte cellular product in/with a biodegradable, load-bearing scaffold for the treatment of articular cartilage defects, they have now submitted their CE market application.  The CE mark application is under review and they anticipate a response in October.  
    • This device and the potential emergence of Sanofi's MACI in the European market next year may have an impact on Tigenix (EBR:TIG) most directly.



    ERYtech Parma (http://www.erytech.com)

    • Their 'pivotal' phase 2/3 trial in Europe of lead product, GRASPA, for the treatment of Acute Lymphoblastic Leukemia (ALL) is scheduled for completion 2H 2012. 


    GamidaCell (http://www.gamidacell.com)

    • Their 'pivotal' phase 2/3 trial in the US, Israel, and Europe of lead product, StemEx, for the treatment of leukemia and lymphoma, in joint development with Teva, completed enrollment in February and is scheduled for completion 2H 2012.  They have not been shy about the fact they expect to be in the market in 2013.


    Innovacell (http://www.innovacell.com)

    • They raised over 8m Euro in April for a phase 3 trial in Europe for their lead product, ICES13, for the treatment of stress-urinary incontinence which was scheduled for a preliminary clinical data readout in Q4 2012 and be ready for market authorization in 2013. Since announcing the capital raise the company has been stone silent and no clinical trial registry has been filed.  Status unknown.


    Miltenyi Biotec (www.miltenyibiotec.com)

    • Their phase 3 trial in Germany of CD133+ cells as an adjunct to CABG surgery for myocardial ischemia or coronary artery disease is scheduled for completion in January.


    NovaRx (http://www.novarx.com)

    • Their phase 3 trial in US, Europe, and India of their lead product, Lucanix, for the treatment of advanced Non-small Cell Lung Cancer (NSCLC) following front-line chemotherapy is scheduled in clnicaltrials.gov for completion in October but we have learned they expect their next 'interim analysis' in February.


    NuVasive (http://www.nuvasive.com)

    • They have a series of trials scheduled to complete 2H 2012 intended to provide additional clinical data to support its marketing of Osteocel Plus for the treatment of a growing number of orthopedic applications.


    Sanofi's Genzyme (http://www.genzyme.com)

    • Having completed their phase 3 trial in Europe of MACI for knee repair (symptomatic articular cartilage defects of the femoral condyle including the trochlea), they expect to file their market authorization application (MAA) in 1H 2013.


    Hope that's helpful and gives you a sense some of the late-stage things to watch for in the coming weeks and months.  



    --Lee

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    http://feeds.feedburner.com/CellTherapyBlog

    Cell therapy portfolio outperforms major indices year-to-date

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    On August 10 we created a model portfolio in Google Finance of 29 public companies in the cell therapy sector then we compared how that portfolio was doing against the major indices year-to-date (Since 1 January 2012).  See that post here.  Bottom line: even though we are still in a relatively bullish market, the CT portfolio was doing better.  Significantly better.
    So how is the sector portfolio doing now that we've been through three quarters?
    CT model portfolio compared to 3 major indices YTD
    In case you can't read the image above, the blue line represents the cell therapy portfolio and here are the stats on performance since 1 January 2012:
    • Cell Therapy Portfolio:  +24.44%
    • Dow Jones:  +4.5%
    • S+P 500:  +6.78%
    • Nasdaq:  +10.26%
    The only change I've made to the portfolio of 29 companies listed in our August 10 post is to add Thermogenesis (KOOL).  Today its stock is at .968 up from .7 at the beginning of the year.
    You do or should know, I'm no financial analyst.  I'm not entirely sure what assumptions are behind this 'model portfolio' or precisely what one should take from this snapshot but what is clear to me is that at least from one perspective the sector is treating investors fairly well.
    I certainly welcome comments from more sophisticated investors or analysts.  In fact, if anyone with that kind of experience or expertise wants to write a guest post on this blog providing a more sophisticated commentary on what this all means, I would very much welcome the contribution.
    In the meantime, I hope this helps.
    _________________
    Post-publication addition:
    Carter Gould, Associate Biotech Analyst at Dawson James Securities emailed me to point out that the cell therapy portfolio is simply riding the bull wave of biotech in general and and the portfolio has not done even half as well as the broader biotech (BTK) index which is up 45% YTD.  All very true.  Here is a YahooFinance snapshot of the BTK performance vs the three major indices.















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    The cost of clinical trial data bias/loss, FDA's new job and the need for bold leadership.

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    The scandal of clinical trial data loss is eroding the fundamentals of evidence-based research and clinical medicine.


    Before you right this post off as the stuff of conspiracy theories, fear-mongering, and 'alternative world views' consider that this view is shared by the likes of the FDA, the International Committee of Medical Journal Editors, the Cochrane Collaboration, and researchers at institutions like Johns Hopkins School of Medicine.


    Here's the underlying premise as succinctly described by author Ben Goldacre:

    "Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer.

    When trials throw up results that companies don't like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug's true effects. Regulators see most of the trial data, but only from early on in a drug's life, and even then they don't give this data to doctors or patients, or even to other parts of government. This distorted evidence is then communicated and applied in a distorted fashion."

    Authors M. Todwin and J. Abramson summarize it thusly:

    "Trials with positive results generally are published more frequently than studies that conclude that a new drug poses greater risks or is no more effective than standard therapy or a placebo. Furthermore, some articles may distort trial findings by omitting important data or by modifying prespecified outcome measures. Lack of access to detailed information about clinical trials can undermine the integrity of medical knowledge."

    Here is a great list of very recent resources that may convince you of the merits of this concern:

    Yesterday, the US Secretary of Health and Human Services announced (in an FR notice) that the FDA was now charged with ensuring all organizations comply with the heretofore enacted but relatively unenforced  requirement to submit all relevant clinical trial data to http://www.clinicaltrials.gov. 

    For further commentary on this move see the following reports from:
    What is abundantly clear to me is that the FDA is left almost powerless - and if not powerless than certainly without sufficient resources - to successfully enforce its new power.  This requires collective industry leadership.  Bold, industry-initiated standards, infrastructure and old-fashioned peer pressure.

    Here's what I wish.  

    I wish that as a cell therapy industry we - through organizations like ISSCR, ARM, ISCT, etc and leading publishers of some of our leading journals like Regenerative Medicine, Cytotherapy, Cell Stem Cell, Stem Cells, etc - would take a leadership position on an issue like this.

    I believe that as a relatively small and nascent sector of the biopharma industry we are more likely capable of collaborating on something important like this than larger, more established [entrenched] and diverse sectors.  Of course it requires the political will and cajones.

    The payoff from our sector in taking a leadership role on this issue could potentially be enormous in terms of providing our sector with truly transparent and useful data.  Perhaps even more important would be the public profile such leadership would provide the sector.  Such a move requires bold leadership, pain, and cost but this is the kind of stuff that moves the needle and goes down as critical pivot points in history. 

    Just my thought for the day...

    --Lee

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    Two lessons I learned this week.

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    I learned two valuable things this week I thought I'd pass on in a Friday afternoon post.  Actually strictly speaking these are likely things I've learned before but needed to re-learn or to be 'reminded' of their importance.
    Please pardon a little stroll away from the typically strict focus on cell therapy -- but in a way that's the theme of today's post.
    1.  Take time each week to read something from outside your specific profession or job focus.  
    I'm not talking here about the importance of escaping in the evening with a fiction novel (also very important) but rather reading something professional but from well outside your area of focus.  Here are my examples.

    I always read WIRED magazine.  Aside from GEN it's the only magazine I read.  Just reading something outside of cell therapy or biotech often infuses me with an idea that otherwise would have never occurred to me like the need for a cell therapy X Prize or cellular aggregates as microcarriers or tissue-engineered memory and processing devices or even just the conviction to better represent cell therapy to the broader world out there of scientists, engineers, journalists, policy-makers, or perhaps people with too much money looking to be inspired and wanting to make a difference.

    Similarly, on a flight this week I reached into the seat pocket in front of me and discovered a recent copy of the Journal of the American Medical Association.  I read a fascinating article that has me excited about an idea for how we as a cell therapy industry might lead the way in addressing clinical trial and data transparency that would put our sector in a leadership position, lend the industry a much-needed spotlight, and has the potential to facilitate the kind of meta-analysis and data-mining that could only be done through data aggregation.  I believe the concept has the potential to be disproportionately significant for a sector defined by so many small, under-powered trials.
    The idea may never see the light of day but the point is the source of the inspiration.  In order to 'think' outside the box one typically has to 'be' outside the box.  Lesson?  Spend some time outside your box.
    2. It often takes something very small to make a disproportionately significant impact on someone.  
    I was reminded recently through an exchange of simple kindnesses just how little it sometimes takes to make a big difference in someone's life.  For you what might be so easy to give might be of unparalleled value to someone for whom that is so unattainable.  
    Lesson?  When the opportunity knocks for you to give something small or simple, take it.  This kind of charity almost always has the potential to be mre impactful than you might ever imagine.

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    Is the cell therapy sector outperforming the major indices?

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    So here's what I did today.  I built a portfolio of public companies focused exclusively or predominately in the cell therapy space.  I excluded any companies that are in the sector but their products/services constitute less than a significant majority of their revenue and/or expenses.  The portfolio sits at 29 companies.  Here's the list:


    Here's how the portfolio performs against the Dow Jones, Standard and Poor's, and NASDAQ indices so far this year.


    When looking at the period 1 January 2012 to 10 August 2012, the cell therapy portfolio is up 42%, Dow Jones up 8%, Standard and Poor's up 12% and NASDAQ up 16%.

    In the context of how much we hear about how harsh this sector is or has been on investors, I found today's analysis interesting and, honestly, pleasantly surprising.

    This snapshot is useful but has its limitations. I'm relying on Google Finance for accuracy of the information provided.  Do your own due diligence. Invest accordingly.  I hope this helps.

    --Lee

    This snapshot has been brought to you by Cell Therapy Group: all cell therapy, all the time! 🙂

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    Cell-based Cancer Immunotherapies. Some metrics..

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    Whatever one makes of Dendreon's challenges in bringing Provenge to market and then its ups and downs in the market, the whole affair has brought a much bigger spotlight to cancer immunotherapies and cell-based immunotherapies in particular.

    This is true on all fronts.  Cancer immunotherapy conferences are popping up everywhere.  A growing number of of analysts are now covering a growing number of companies in the space with coverage ranging from bearishly critical to ebullient bullishness. Some venture capital firms are now loosening their purse strings for immunotherapy plays and both pharma venture funds and business development departments are now spending an increasing amount of time actively monitoring and exploring potential plays in the sector.



    One of the best annual industry summaries of what is happening in the sector is sponsored by MD Becker Partners through its annual Cancer Immunotherapy: A Long Awaited Reality conference held each in New York, this year on October 4 and select video replays it hosts on its YouTube channel.

    Some Segment Metrics
    As part of our ongoing industry intelligence and consulting services we actively track the activity and progress of industry-sponsored clinical trials of all cell therapies in addition to the products already on the market.  Here's how our data stacks up regarding the cell-based immunotherapies segment of the sector:
    Commercial:
    • Dendreon's Provenge
      • Autologous immunotherapy for prostate cancer (1 monthly dose for 3 months)
      • Efficacy: prolongs survival
      • Markets: only the United States (approved April 2010)
      • Next markets: submitted the marketing authorisation application to the EMA (European Medicines Agency) in early 2012 and hopes to introduce Provenge in the European market in 2013
      • 2011 Revenue $290,000
      • Projected 2012 Revenue: ~$380,000

    Phase III or II/III:

    Phase II or I/II

    • 50 industry-sponsored clinical trials of cell-based immunotherapies actively recruiting, active no longer recruiting, active not yet recruiting, or anticipated to commence yet in 2012
      • ~10 of these are expected to have readouts yet this year
      • Trial sites in US, Canada, UK, continental Europe, Israel, South Korea, India, Australia
      • Expected enrollment of 3,500+
    Investment:

    The following are notable cash infusions into the sector for 2012 to-date:
    • Bellicum Pharmaceuticals.  $20M series B. 
    • CellMedica. $15M grant from CPRIT in Texas.
    • Argos Therapeutcs. $25M Series D.
    • Northwest Bio.  $5.5M grant from German gov't Saxony Development Bank

    Hope this is useful.

    --

    This post has been brought to you by your friends at CTG.  All cell therapy. All the time. 🙂  

    -- Lee @celltherapy

    p.s.  As always we welcome your feedback, comments, and corrections.  












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    Clinical trial costs

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    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 IV: $17,042
    Average cost per patient for a cardiovascular trial:
    Phase II: $33,700
    Phase IIIa: $21,750
    Phase IIIb: $6,830
    In oncology, the average per patient trial cost:
    Phase II: $73,303
    Phase IIIa: $57,207
    Phase IIIb: $65,900
    For central nervous system disorders:
    Phase II: $28,197
    Phase IIIa: $33,768
    Phase IIIb: $41,824
    For diabetes:
    Phase II: $ 8,854
    Phase IIIa: $12,667
    Phase IIIb: $10,700
    Anyone have any thoughts or data as to how this compares to cell therapy trials?
    --Lee
    *survey conducted by Cutting Edge Information.

    In vivo cell trafficking just took a leap forward

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    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 patients. Cell Sense is a novel perfluorocarbon tracer agent used to safely and efficiently label cells ex vivo without the use of transfection agents. Labeled cells are then transplanted into the patient enabling researchers and clinicians to non-invasively track the administration and migration of therapeutic cells using MRI. Applications include tracking cells in immunotherapy or regenerative medicine as well as the diagnosis of inflammatory sites by tracking selected populations of immune cells.

    Cell Sense has been studied extensively in preclinical testing with many different human cell types including human cells in animals. For instance, in 2009 a paper was published in Informa's Cytotherapy, in which Celsense’s novel perfluorocarbon tracer agent (product “Cell Sense”) was used to label human DCs ex vivo for the purpose of tracking the cells in vivo post-transplant by 19F MRI. The paper provided an assessment of the technology and demonstrated that human DCs were effectively labeled without significant impact on cell viability, phenotype or function. Furthermore, the labeled dendritic cells were clearly detected in vivo by 19F MRI in a model system, with the labeled cells being shown to migrate selectively towards draining lymph node regions within 18 hours after transplant.

    Many investigators looking at various ways to label cells to enable in vivo imaging have expressed concern that the FDA would delay the regulatory progress of their therapeutic candidates if an imaging modality was introduced.

    This concern is based on numerous reports of MRI contrast reagents, such as the commonly investigated USPIO (ultrasmall superparamagnet iron oxide), deleteriously affecting the cells (see recent paper in Cell Transplantation).

    "We believe that the authorization of this IND will alleviate such concerns and lower the barriers for adoption. The agency’s tangible support for bringing new technologies to bear in the translation of cell-based therapeutics is very encouraging,” s Charlie O'Hanlon, President and CEO of Celsense.

    While there have been approved uses of imaging reagents (e.g., Feridex, etc) with cell therapies in other countries (e.g. Isreal), I believe this may be the first FDA-sanctioned use of a particle-based imaging label with a cell-based therapy. Other approaches to cellular imaging include nuclear imaging reagents and genetically modifying cells with reporter genes such as those provided by CellSight Technologies.

    Imaging labels are capable of providing investigators with data demonstrating where the cells go, at what volumes, and for how long they stay at the target location.

    The industry has been keen to see these kinds of technologies clinically employed but different cell-based labels have created their own technical, clinical, and/or regulatory hurdles. I'm hopeful that Celsense and others like them are now ushering us into a new era where we will eventually be able to use various technologies to monitor and collect valuable data concerning cells after they have been administered as a therapy to a patients.

    Additional resources on the topic of imaging for cell therapies:

    CIRM recently hosted a webinar - "CIRM/RMC Webinar: Imaging Technology for Cellular Therapies. One of the speakers, Dr. Shahriar Yaghoubi from CellSight Technologies, provides an overview of cell therapy imaging with emphasis on PET. Click hear for the archived playback.

    A very interesting article posted today on Harvard's StemBook website. "In-vivo Stem Cell Imaging - Regulatory Challenges and Advances". Nice overview intel from J. Bulte and a snapshot into E. Wirth's (of Geron) perspective re: stem cell imaging.

    A new book from CRC Press edited by Dara Kraitchman and Joe Wu will be out soon. It gathers together different methods for comparison. The issue will remain the sensitivity of the methods to track few cells. "Stem Cell Labeling for Delivery and Tracking Using Non-Invasive Imaging".

    MRI contrast agents can change stem cell proliferation

    There s also a very informative discussion thread on the topic in the Cell Therapy Industry group on LinkedIn.

    Careers in cell therapy & regenerative medicine

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    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 that regenerative medicine is one of the fastest growing life science sectors.

    Given the pace of the industry's growth, the amount of public money being "invested" in the sector, and the general enthusiasm that the science generates, it is no surprise that is increasingly an area of interest for those seeking a new career path.

    One commonly held misconception is that career opportunities in the sector are limited largely to those in early-stage research.

    While it is true that the industry is still in the nascent stages of commercial development compared to other more mature segments in the broader biopharmaceutical industry, careers in regenerative medicine span the full research and commercial spectrum from pre-clinical to clinical research in both academic and corporate settings, manufacturing, regulatory, quality, operations, logistics, finance, business development, marketing, sales, communications, and executive management.

    As has been discussed here in the past, most analysts agree that in 2008 the industry passed the $1 billion mark in annual revenue generated from sale of approved therapeutic products falling under the regenerative medicine category (see here for more in-depth analysis).

    Furthermore, most large multinational life science companies are now investing heavily into the sector on the promise that it will revolutionize healthcare in the coming decades.

    I believe the 2008 decision by Pfizer to create a substantial new Regenerative Medicine division will be seen as a seminal turning point in corporate perspectives on the industry. Since that point most life sciences have begun investing in regenerative medicine strategies and the trend has even leaked outside of life science to companies such as Google Ventures which has informally identified regenerative medicine as one of their primary areas of interest when looking at companies in which to invest.

    Most major universities have now created both academic and research programs dedicated to the emerging field of regenerative medicine such that there is a new class of graduates now emerging in both scientific and commercial disciplines with regenerative medicine as a primary focus.

    However, one of the difficulties with finding a career in regenerative medicine is that it is comprised of what has heretofore been fairly discrete disciplines of stem cell biology, pharmaceutical sciences, biotechnology, tissue engineering, stem cell transplantation, device technologies, cell therapies, etc.

    Furthermore, most recruiters and online job sites have very little experience or focus on the industry making recruiting difficult for positions in regenerative medicine companies or departments. The task is further complicated by the fact that the candidate pool is small and diversely spread over a multitude of disciplines, centers, and a multitude of small companies.

    Finally there are only now emerging industry publications, organizations, online communities, and websites that truly represent the broad spectrum of regenerative medicine and that can be used as central resources for recruiting.

    All this is why my partners and I saw the need for an online recruiting tool that really focused on regenerative medicine in a way that would support the industry's maturation. What we wanted to bring was a very simple solution that would create as much value as possible for those looking to recruit the right talent into their regenerative medicine efforts. This was the genesis behind RegenerativeMedicineJobs.com.

    (here comes the shameless part....)

    About RMJ

    At RegenerativeMedicineJobs.com, we believe the growth trajectory of this industry requires a specialized, online recruiting system – one that is more than just a website for posting jobs but also plugged into the large and diverse network of associations, publications, and social media that serves this industry.

    RegenerativeMedicineJobs.com is a specialized online job board focused on recruiting for positions in the rapidly growing field of regenerative medicine. The site is simple to use and focused in scope. But this is more than just another website.

    RMJ has developed a sophisticated system designed to leverage our extensive network in RM to ensure every post gets maximum attention and attracts the best candidates.

    Traffic is pulled to the site and job postings are pushed to a targeted audience by focused social media and marketing campaigns. This is the latest way to recruit for any position in a regenerative medicine department, division, or company. This is regenerative medicine recruiting with a focus.

    RegenerativeMedicineJobs.com (RMJ) is a collaboration between CTG Consulting, Co. and Pencilneck Software, Co. The personnel behind this collaboration created Cell Therapy News, Cell Therapy Blog, the LinkedIn Cell Therapy Industry Group, and have produced over a dozen organizational or event-based websites in the cell therapy, stem cell, and regenerative medicine space.

    The site has been designed to be simple and intuitive with only one goal in mind: to be the best online tool for recruiting personnel into positions in the regenerative medicine industry.

    We don't offer resume posting, career advice, assistance building your CV, hand holding, shoulders to cry on, or job postings outside of regenmed. We believe in the value of specialization.

    The site is a listing of regenerative medicine jobs (period). All types of jobs for all types of organizations but only regenmed job (period).

    We have only one rule: the jobs posted m
    ust be for a position within the regenerative medicine space. We define regenerative medicine as anything involving cell therapy, stem cells as therapies or tools for discovery or toxicity testing, or non-cell based programs/products (e.g., small molecules, biologics, devices, etc) used to replace or regenerate cells, tissues, or organs to restore, repair, or establish normal function.

    The site has a topical niche with no regional focus or bias. This is meant to be a global tool equally useful for a company or university in Poland, Taiwan, Brazil, the United States, etc.

    The site is also meant to be useful for recruiting any positions scientific or commercial, business or technical, executive or laborer.

    *

    We hope you find it useful.

    We hope it contributes to the industry's growth and maturation.

    We hope you will provide us feedback on what we're doing well and what we can do better.



    Stem cells for a Webby!

    Posted on by

    I know I haven't been a very good blogger for quite some time but I wanted to pass on a letter I just received from my friend James Price as a Charter member of the Canadian Stem Cell Foundation. They're going for a Webby award. You don't have to be Canadian to support their cause - you just have to:

    • believe in the power of interactive, online network-based activism,
    • support the potential of stem cells to change people's lives, and
    • wanna have a little fun raising awareness for our otherwise-sometimes-stodgy-science!

    Go vote - it's good for you and the world! (WARNING: you might find out some things about some pretty cool stuff nominated in the other categories while you're there).

    CSCFHeader

    Dear Lee,

    I'd like to thank everyone who has voted and helped spread the word about the Webby Awards nomination. We think a big part of the Foundation's success, and especially this nomination, is due to your enthusiasm, creativity and support.

    That support has taken us a long way. Right now, we're in the lead for Best Activism Website. But our lead is narrow, only 3%, so we need you to pull out all the stops. There are only two days left to vote, so let's make sure it's a win for stem cells!

    Why Activism?

    A large part of what makes our website and social media pages work is the Charter community. All the material we create - the Stem Cell Charter, "Rock Star Scientists" video and all the posts on our social media pages - are designed to give the stem cell movement a voice - your voice. You are the most important part of getting the word out about stem cell science and helping people see the amazing potential of the field.

    Voting and encouraging others to vote is a perfect way to do this. Tweet, post, blog, email and shout your support from the rooftops. Let's show the world how important we think stem cell science is.

    How to vote

    Step 1: Click HERE and fill in your email address and a password.

    Step 2: You will receive an email from the Webby Awards - click the link to activate your account.

    Step 3: Go HERE TO VOTE and choose RENEW THE WORLD.

    Voting closes at midnight on April 29th. We have two days left!

    webby banner

    Thanks for your support,


    James Price
    President & CEO



    Latest Cell Therapy Approval by FDA. Dendreon's Provenge.

    Posted on by

    It has been a long-time coming. It has been hyped and scoffed, bet against and hoped for, but now none of that matters. It's here. Dendreon has brought Provenge to market. Here, in the word's of the FDA...

    FDA NEWS RELEASE

    For Immediate Release: April 29, 2010

    FDA Approves a Cellular Immunotherapy for Men with Advanced Prostate Cancer

    The U.S. Food and Drug Administration today approved Provenge (sipuleucel-T), a new therapy for certain men with advanced prostate cancer that uses their own immune system to fight the disease.

    Provenge is indicated for the treatment of asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatment.

    Prostate cancer is the second most common type of cancer among men in the United States, behind skin cancer, and usually occurs in older men. In 2009, an estimated 192,000 new cases of prostate cancer were diagnosed and about 27,000 men died from the disease, according to the National Cancer Institute.

    “The availability of Provenge provides a new treatment option for men with advanced prostate cancer, who currently have limited effective therapies available,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research.

    Provenge is an autologous cellular immunotherapy, designed to stimulate a patient’s own immune system to respond against the cancer. Each dose of Provenge is manufactured by obtaining a patient’s immune cells from the blood, using a machine in a process known as leukapheresis. To enhance their response against the cancer, the immune cells are then exposed to a protein that is found in most prostate cancers, linked to an immune stimulating substance. After this process, the patient’s own cells are returned to the patient to treat the prostate cancer. Provenge is administered intravenously in a three-dose schedule given at about two-week intervals.

    The effectiveness of Provenge was studied in 512 patients with metastatic hormone treatment refractory prostate cancer in a randomized, double-blind, placebo-controlled, multicenter trial, which showed an increase in overall survival of 4.1 months. The median survival for patients receiving Provenge treatments was 25.8 months, as compared to 21.7 months for those who did not receive the treatment.

    Almost all of the patients who received Provenge had some type of adverse reaction. Common adverse reactions reported included chills, fatigue, fever, back pain, nausea, joint ache and headache. The majority of adverse reactions were mild or moderate in severity. Serious adverse reactions, reported in approximately one quarter of the patients receiving Provenge, included some acute infusion reactions and stroke. Cerebrovascular events, including hemorrhagic and ischemic strokes, were observed in 3.5 percent of patients in the Provenge group compared with 2.6 percent of patients in the control group.

    Provenge is manufactured by Seattle-based Dendreon Corp.