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Category Archives: Regenerative Medicine

Good Data? $100. Good Product Development? $100. Good Commercialization Strategy? Priceless.

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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 (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.
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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 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

    Posted in Regenerative Medicine | Comments Off on Cell Therapy's Got Talent Technology Showcase – A Call for Cell Therapy Manufacturing Technology Presentations

    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 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

      Posted in Regenerative Medicine | Comments Off on Cell Therapy’s Got Talent Technology Showcase – A Call for Cell Therapy Manufacturing Technology Presentations

      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 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.

      Posted in Regenerative Medicine | Comments Off on In vivo cell trafficking just took a leap forward

      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 cell therapy.


      Certainly it is the Cell Therapy Group's view, that this is both timely and much-needed as more cell therapies reach later-stage. Issues related to larger scale production and lowering the costs associated with it will be critical to successful commercialization of these products. It is encouraging to see both content-providers and and companies involved in potentially bringing solutions to these issues now bringing their focused energies to this sector.

      This focus has come from a number of different sources including conferences focused solely on the topic, companies engaging stakeholders in identifying potential bottlenecks they might be positioned to solve, more conference sessions dedicated to these issues, and now a commitment by one of the leading publications in bioprocessing to engage both the cell therapy industry and the traditional bioprocessing community in stepping up the level of two-way education, dialog, and problem-solving that will be critical to commercializing these products.

      In March/April 2011, watch for a special issue of BioProcess International entitled "Cell Therapies: Commercializing a New Class of Biopharmaceuticals".

      BioProcess International is a publishing leader of cutting edge technologies, improved processes and breakthrough sciences. With this cell therapy focused issue, in partnership with ISCT and others, BPI is launching what we hope will be a regular supplement and increased focus on the unique bioproduction issues related to cell-based therapies.

      BioProcess International aims to accomplish three main objectives with this supplement:
      • Educate the bioprocess and cell therapy market (suppliers and end-users) on the similarities and differences between the two processes;
      • Educate and encourage the investor community to keep increasing their interest and investment;
      • Expedite the commercialization process.

      Distribution will include:

      • BPI's 30,010 qualified readers;
      • Delegates attending ISCT's 2011 Annual Meeting (included in all delegate bags)
      • Delegates attending ESACT 2011 (Chair drop at the Cell Therapy Plenary Session)
      • INTERPHEX 2011 Cell Therapy Roundtable (VIP Invitations, 200 attendees, produced by BPI)
      • BIO 2011 International Convention (BioProcess Theatre - Cell Therapy track)

      If you are interested in advertising, click here for more info.

      While the content for this issue is now being finalized, it you are interested in contributing something to BPI, we are looking for more cell therapy related content. As the cell therapy representative on BPI's advisory board I would be happy to champion it through submission.

      Cheers.

      --Lee

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