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Archive for the ‘Regenerative Medicine’ Category

Inactive and recently failed or terminated phase III or II/III cell therapy trials

Sunday, December 18th, 2011

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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 III cell therapy trials which appear to be inactive and those which failed or were terminated.


INACTIVE INDUSTRY PHASE III    

  •     Aastrom              BRCs
  •     Aldagen              ALD-101
  •     Arblast               AMT-301
  •     Avax                  Mvax
  •     HepaLife Tech      HepaMate
  •     KeraCure             KeraPac
  •     t2cure                BMCs
  •     TVAX                 TV-Brain
  •     TVAX                 TV-Kidney-1

   
RECENTLY FAILED /TERMINATED INDUSTRY PHASE III   

  •     ABH (now Shire)        Dermgraft
  •     Cellerix                    Cx401

I don't imagine this is an exhaustive list but as I have encouraged in previous posts, I welcome feedback as to errors, corrections, or omissions.   I'm using the 2009-11 time-frame here.  I'll update the post accordingly.

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

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Recently approved cell therapy products

Sunday, December 18th, 2011

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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 2009 representing the first EMA approval of an ATMP:

  • TiGenix                              ChondroCelect                   EU

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Inactive and recently failed or terminated phase III or II/III cell therapy trials

Sunday, December 18th, 2011

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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 III cell therapy trials which appear to be inactive and those which failed or were terminated.


INACTIVE INDUSTRY PHASE III    

  •     Aastrom              BRCs
  •     Aldagen              ALD-101
  •     Arblast               AMT-301
  •     Avax                  Mvax
  •     HepaLife Tech      HepaMate
  •     KeraCure             KeraPac
  •     t2cure                BMCs
  •     TVAX                 TV-Brain
  •     TVAX                 TV-Kidney-1

   
RECENTLY FAILED /TERMINATED INDUSTRY PHASE III   

  •     ABH (now Shire)        Dermgraft
  •     Cellerix                    Cx401

I don't imagine this is an exhaustive list but as I have encouraged in previous posts, I welcome feedback as to errors, corrections, or omissions.   I'm using the 2009-11 time-frame here.  I'll update the post accordingly.

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

Source:
http://feeds.feedburner.com/CellTherapyBlog

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2011 Summit: Harnessing Regenerative Medicine for US Service-members, Major General James K. Gilman – Video

Saturday, December 17th, 2011

Major General James Gilman, Commanding General of the US Army Medical Research and Material Command, outlined the US army's extensive research efforts in stem cell technologies and their mission to discover, develop and translate regenerative medicine. He spoke about the military's desire to partner with academia and industry to generate effective treatments for volume, bone, muscle and tissue injuries and about spinal cord regeneration as the military's biggest challenge and hope.

See the article here:
2011 Summit: Harnessing Regenerative Medicine for US Service-members, Major General James K. Gilman - Video

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Active phase III or II/III cell therapy trials

Sunday, December 11th, 2011
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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 there and hope you will feel obligated to assist me in ensuring its accuracy rather than critical of the effort.
What follows is what I currently believe to an current and relatively comprehensive list of phase III or II/III cell therapy trials around the world.  I am more confident of the industry list than the academic one.  More confident of its completeness and accuracy for North American and Europe than of Asia (particularly China). 
There is a spreadsheet behind this that includes more data fields like therapeutic category, cell/tissue source, cell type, expansion, indication, expected completion date, clinical trial site locations, etc.  If you want a copy of it, just email me (I'm not hard to find) or comment below.

INDUSTRY PHASE III or II/III (active or expected to be active in 1H 2012)  

       
    Aastrom                         Ixmyelocel-T
    Baxter                            ACT34-CMI
    Bioheart                         Myocell
    Cardio3 Biosciences         C-CURE
    Cardio3 Biosciences         C-CURE
    Cell Medica                     adoptive cellular therapy
    Cook Myosite                  AMDC
    Cytori                            ADRCs
    GamidaCell - Teva           StemEx
    Genzyme                        MACI
    Harvest Technologies       SmartPReP 2 BMAC
    Innovaell                        IES13 (Urocell?)
    Kiaidis Pharma                ATIR
    Miltenyi                         CliniMACS CD34 Selection System
    Medipost                       Cartistem
    MolMed                         TK
    Newlink Genetics            HyperAcute Pancreas
    NovaRx                         Lucanix
    Osiris                           Prochymal
    Osiris                           Prochymal
    Pervasis                        Vasugel
The 21 active or imminently active cell therapy industry-sponsored trials listed above break down as follows:
    • 52% (12) are autologous
    • 33% (7) are allogeneic
    • Two are gene-modified allogeneic
    • One involves autologous and allogeneic cells
    • 24% (5) are for cardiac-related indications
    • 33% (7) are for oncology or related indications
    • Two are for cartilage repair

 
* ACADEMIC PHASE III or II/III
  • Assistance Publique - Hôpitaux de Paris (France)
  • Association of Dutch Burn Centres (Netherlands)
  • Barts and The London NHS Trust (UK)
  • Erasmus Medical Center (Netherlands)
  • European Group for Blood and Marrow Transplantation (Europe)
  • Leiden University Medical Center (Netherlands)
  • Meshalkin Research Institute of Pathology of Circulation (Russia)
  • Meshalkin Research Institute of Pathology of Circulation (Russia)
  • Ministry of Health (Malaysia)
  • Royan Institute (Iran)
  • Rush University Medical Center, University of Sao Paulo, Uppsala University (US, Brazil, Sweden)
  • Third Military Medical University (Chia)
  • University of Minnesota, Masonic Cancer Center (US)
  • University of Minnesota, Masonic Cancer Center (US)
  • University Hospital of North Norway (Norway)
  • University of Utah (US)
* Active trials only - excludes trials which appear inactive, abandoned, and/or are stem cell transplant in oncology.  Primary source is CinicalTrials.gov.
___________________________________
I will try to keep this list updated at least once-per-quarter and indicate the date of the last update at the top of the post.
I eagerly encourage all readers to comment below or email direct with any errors and/or omissions.
http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

Source:
http://feeds.feedburner.com/CellTherapyBlog

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Active phase III or II/III cell therapy trials

Sunday, December 11th, 2011
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 there and hope you will feel obligated to assist me in ensuring its accuracy rather than critical of the effort.
What follows is what I currently believe to an current and relatively comprehensive list of phase III or II/III cell therapy trials around the world.  I am more confident of the industry list than the academic one.  More confident of its completeness and accuracy for North American and Europe than of Asia (particularly China). 
There is a spreadsheet behind this that includes more data fields like therapeutic category, cell/tissue source, cell type, expansion, indication, expected completion date, clinical trial site locations, etc.  If you want a copy of it, just email me (I'm not hard to find) or comment below.

INDUSTRY PHASE III or II/III (active or expected to be active in 1H 2012)  

       
    Aastrom                         Ixmyelocel-T
    Baxter                            ACT34-CMI
    Bioheart                         Myocell
    Cardio3 Biosciences         C-CURE
    Cardio3 Biosciences         C-CURE
    Cell Medica                     adoptive cellular therapy
    Cook Myosite                  AMDC
    Cytori                            ADRCs
    GamidaCell - Teva           StemEx
    Genzyme                        MACI
    Harvest Technologies       SmartPReP 2 BMAC
    Innovaell                        IES13 (Urocell?)
    Kiaidis Pharma                ATIR
    Miltenyi                         CliniMACS CD34 Selection System
    Medipost                       Cartistem
    MolMed                         TK
    Newlink Genetics            HyperAcute Pancreas
    NovaRx                         Lucanix
    Osiris                           Prochymal
    Osiris                           Prochymal
    Pervasis                        Vasugel
The 21 active or imminently active cell therapy industry-sponsored trials listed above break down as follows:
    • 52% (12) are autologous
    • 33% (7) are allogeneic
    • Two are gene-modified allogeneic
    • One involves autologous and allogeneic cells
    • 24% (5) are for cardiac-related indications
    • 33% (7) are for oncology or related indications
    • Two are for cartilage repair

 
* ACADEMIC PHASE III or II/III
  • Assistance Publique - Hôpitaux de Paris (France)
  • Association of Dutch Burn Centres (Netherlands)
  • Barts and The London NHS Trust (UK)
  • Erasmus Medical Center (Netherlands)
  • European Group for Blood and Marrow Transplantation (Europe)
  • Leiden University Medical Center (Netherlands)
  • Meshalkin Research Institute of Pathology of Circulation (Russia)
  • Meshalkin Research Institute of Pathology of Circulation (Russia)
  • Ministry of Health (Malaysia)
  • Royan Institute (Iran)
  • Rush University Medical Center, University of Sao Paulo, Uppsala University (US, Brazil, Sweden)
  • Third Military Medical University (Chia)
  • University of Minnesota, Masonic Cancer Center (US)
  • University of Minnesota, Masonic Cancer Center (US)
  • University Hospital of North Norway (Norway)
  • University of Utah (US)
* Active trials only - excludes trials which appear inactive, abandoned, and/or are stem cell transplant in oncology.  Primary source is CinicalTrials.gov.
___________________________________
I will try to keep this list updated at least once-per-quarter and indicate the date of the last update at the top of the post.
I eagerly encourage all readers to comment below or email direct with any errors and/or omissions.
http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

Source:
http://feeds.feedburner.com/CellTherapyBlog

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StemCellTV Talks to Morrie Ruffin of Alliance for Regenerative Medicine at Meeting on the Mesa – Video

Saturday, December 10th, 2011

William Bruyea, host of StemCellTV talks to Morrie Ruffin, co-founder and managing director of Alliance for Regenerative Medicine at the Meeting on the Mesa partnering forum at Sanford Consortium in La Jolla, CA. Morrie discusses regenerative medicine, stem cells and development.

Go here to read the rest:
StemCellTV Talks to Morrie Ruffin of Alliance for Regenerative Medicine at Meeting on the Mesa - Video

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StemCellTV Talks to Michael Werner of Alliance for Regenerative Medicine at Meeting on the Mesa – Video

Saturday, December 10th, 2011

William Bruyea, host of StemCellTV talks to Michael Werner, co-founder and executive director of Alliance for Regenerative Medicine at the Meeting on the Mesa partnering forum at Sanford Consortium in La Jolla, CA. Michael discusses regenerative medicine, stem cells and development, and stem cell regulation.

See more here:
StemCellTV Talks to Michael Werner of Alliance for Regenerative Medicine at Meeting on the Mesa - Video

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StemCellTV Talks to Elona Baum of the California Institute of Regenerative Medicine – Video

Friday, December 9th, 2011

William Bruyea, host of StemCellTV talks to Elona Baum of the California Institute for Regenerative Medicine (CIRM) about the Meeting on the Mesa Partnering Event at Sanford Consortium and co-sponsoring with Alliance for Regenerative Medicine (ARM).

Originally posted here:
StemCellTV Talks to Elona Baum of the California Institute of Regenerative Medicine - Video

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Sabrina Cohen Foundation Thanks Stem Cell Researchers

Sunday, November 27th, 2011

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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!



The Sabrina Cohen Foundation
The Sabrina Cohen Foundation for Stem Cell Research (SCF) is an internationally recognized nonprofit organization dedicated to building a global network of top scientists and clinicians in the field of Regenerative Medicine, while simultaneously funding cutting edge research and innovative therapies that will reverse spinal cord injury and effectively treat other impairments of the Central Nervous System.


The ‘CELLebrity’ Doctors Calendar
The 2012 CELLebrity Doctors calendar is now available for purchase from http://www.CELLebrityDocsCalendar.com.  All proceeds from calendar sales benefit the Sabrina Cohen Foundation for Stem Cell Research, a 501c3 non-profit organization directly funding stem cell clinical research.   



--Lee


_________________________________________________________________



On the night of November 12, David Porosoff’s Artrageous Gallery hotspot was converted into something likely never imagined -- a hotbed of stem cell research.  Sabrina Cohen fused the vividly artistic backdrop and venue with gambling, cuban music, great food, and beautiful people all to further her mission of raising money and awareness for stem cell research.

Dr. Sally Temple with Sabrina Cohen

Dubbed the Havana Casino Night, the event had several highlights including the granting of the 2011 Sabrina Cohen Foundation award to stem cell researcher Dr. Sally Temple.  


Representing the 3rd recipient of the annual SCF award, Dr. Sally Temple is studying how neural progenitor cells may be employed to create cell-based therapies for neurodegenerative disorders.  Dr. Temple is the co-Founder and Scientific Director of the Neural Stem Cell Institute located in Rensselaer, NY.  NSCI is the first independent, non-profit stem cell research institute in the USA.


The night, sponsored in part by DMR, Evensky & Katz and Harke Clasby & Bushman, raised $10,000 which will be dedicated toward next year’s SCF Award for Stem Cell Research.  


The event also marked the lauch of the the Foundation’s 2012 CELLebrity Doctors Calendar, this year featuring women in the field of stem cell research.  The calendar features academics, industry executives, physicians, and advocates primarily from the United States but also representing Sweden, Australia and Canadian covergirl, Dr. Fiona Costello.


“In science you don't have to accept anything anyone tells you, you can come up with a hypothesis and test it yourself. And you can be the first one to do it,” says Dr. Costello, whose research focus is on multiple sclerolsis and other impairments of the central nervous system. 


“Stem cell science is often accused of being ‘hyped,” says Cohen, “but that doesn’t necessarily translate into monetary support for or society recognition of the enormous contributions made by stem cell resarchers.  They often toil in anonymity making significant discoveries at great personal sacrifice.  I consider it my job to find a way to financially support their work and bring profile to them as people.”  


The ‘CELLebrity’ Doctors Calendar
The 2012 CELLebrity Doctors calendar is now available for purchase from http://www.CELLebrityDocsCalendar.com.  All proceeds from calendar sales benefit the Sabrina Cohen Foundation for Stem Cell Research, a 501c3 non-profit organization directly funding stem cell clinical research.   


The Sabrina Cohen Foundation
The Sabrina Cohen Foundation for Stem Cell Research (SCF) is an internationally recognized nonprofit organization dedicated to building a global network of top scientists and clinicians in the field of Regenerative Medicine, while simultaneously funding cutting edge research and innovative therapies that will reverse spinal cord injury and effectively treat other impairments of the Central Nervous System.


Sabrina Cohen is the Executive Director and President of the foundation. She graduated from the University of Miami with a degree in Communications, double majoring in Advertising and Psychology, and holds a post-graduate degree in Copywriting from the Miami Ad School.  She is a C5 Quadriplegic, as the result of a spinal cord injury from a car accident in 1992. In 2006, she established SCF to raise funds for research because she believes the field of Regenerative Medicine will lead to the greatest advances of our time. Sabrina is a Motivational Speaker & Spokesperson continuously speaking in schools, universities and community centers. She has spoken at scientific conferences around the country, including the "World Stem Cell Summit" at the University of Wisconsin, Harvard University, Stanford University, Baylor College of Medicine at the University of Texas, and at the United Nations. Sabrina believes her wheelchair is a vehicle to promote change.  


Sabrina Cohen was recognized by WebMD Magazine as a 2009 "American Health Hero”.  Sabrina is currently available for interviews highlighting the 2012 “CELLebrity” Doctors Calendar.



http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

Source:
http://feeds.feedburner.com/CellTherapyBlog

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Sabrina Cohen Foundation Thanks Stem Cell Researchers

Sunday, November 27th, 2011

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!



The Sabrina Cohen Foundation
The Sabrina Cohen Foundation for Stem Cell Research (SCF) is an internationally recognized nonprofit organization dedicated to building a global network of top scientists and clinicians in the field of Regenerative Medicine, while simultaneously funding cutting edge research and innovative therapies that will reverse spinal cord injury and effectively treat other impairments of the Central Nervous System.


The ‘CELLebrity’ Doctors Calendar
The 2012 CELLebrity Doctors calendar is now available for purchase from http://www.CELLebrityDocsCalendar.com.  All proceeds from calendar sales benefit the Sabrina Cohen Foundation for Stem Cell Research, a 501c3 non-profit organization directly funding stem cell clinical research.   



--Lee


_________________________________________________________________



On the night of November 12, David Porosoff’s Artrageous Gallery hotspot was converted into something likely never imagined -- a hotbed of stem cell research.  Sabrina Cohen fused the vividly artistic backdrop and venue with gambling, cuban music, great food, and beautiful people all to further her mission of raising money and awareness for stem cell research.

Dr. Sally Temple with Sabrina Cohen

Dubbed the Havana Casino Night, the event had several highlights including the granting of the 2011 Sabrina Cohen Foundation award to stem cell researcher Dr. Sally Temple.  


Representing the 3rd recipient of the annual SCF award, Dr. Sally Temple is studying how neural progenitor cells may be employed to create cell-based therapies for neurodegenerative disorders.  Dr. Temple is the co-Founder and Scientific Director of the Neural Stem Cell Institute located in Rensselaer, NY.  NSCI is the first independent, non-profit stem cell research institute in the USA.


The night, sponsored in part by DMR, Evensky & Katz and Harke Clasby & Bushman, raised $10,000 which will be dedicated toward next year’s SCF Award for Stem Cell Research.  


The event also marked the lauch of the the Foundation’s 2012 CELLebrity Doctors Calendar, this year featuring women in the field of stem cell research.  The calendar features academics, industry executives, physicians, and advocates primarily from the United States but also representing Sweden, Australia and Canadian covergirl, Dr. Fiona Costello.


“In science you don't have to accept anything anyone tells you, you can come up with a hypothesis and test it yourself. And you can be the first one to do it,” says Dr. Costello, whose research focus is on multiple sclerolsis and other impairments of the central nervous system. 


“Stem cell science is often accused of being ‘hyped,” says Cohen, “but that doesn’t necessarily translate into monetary support for or society recognition of the enormous contributions made by stem cell resarchers.  They often toil in anonymity making significant discoveries at great personal sacrifice.  I consider it my job to find a way to financially support their work and bring profile to them as people.”  


The ‘CELLebrity’ Doctors Calendar
The 2012 CELLebrity Doctors calendar is now available for purchase from http://www.CELLebrityDocsCalendar.com.  All proceeds from calendar sales benefit the Sabrina Cohen Foundation for Stem Cell Research, a 501c3 non-profit organization directly funding stem cell clinical research.   


The Sabrina Cohen Foundation
The Sabrina Cohen Foundation for Stem Cell Research (SCF) is an internationally recognized nonprofit organization dedicated to building a global network of top scientists and clinicians in the field of Regenerative Medicine, while simultaneously funding cutting edge research and innovative therapies that will reverse spinal cord injury and effectively treat other impairments of the Central Nervous System.


Sabrina Cohen is the Executive Director and President of the foundation. She graduated from the University of Miami with a degree in Communications, double majoring in Advertising and Psychology, and holds a post-graduate degree in Copywriting from the Miami Ad School.  She is a C5 Quadriplegic, as the result of a spinal cord injury from a car accident in 1992. In 2006, she established SCF to raise funds for research because she believes the field of Regenerative Medicine will lead to the greatest advances of our time. Sabrina is a Motivational Speaker & Spokesperson continuously speaking in schools, universities and community centers. She has spoken at scientific conferences around the country, including the "World Stem Cell Summit" at the University of Wisconsin, Harvard University, Stanford University, Baylor College of Medicine at the University of Texas, and at the United Nations. Sabrina believes her wheelchair is a vehicle to promote change.  


Sabrina Cohen was recognized by WebMD Magazine as a 2009 "American Health Hero”.  Sabrina is currently available for interviews highlighting the 2012 “CELLebrity” Doctors Calendar.



http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

Source:
http://feeds.feedburner.com/CellTherapyBlog

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Dr. Craig Saunders Discusses Stem Cells and Regenerative Medicine at the Evolution of Fat Workshop – Video

Thursday, November 24th, 2011

William Bruyea, host of StemCellTV talks to Dr. Craig Saunders of Harmony Cosmetic Surgery in Keller, Texas about stem cells and regenerative medicine at the Evolution of Fat Workshop in Dallas, TX sponsored by Medical Alliance Services, distributor of Tickle Lipo.

Original post:
Dr. Craig Saunders Discusses Stem Cells and Regenerative Medicine at the Evolution of Fat Workshop - Video

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Coast To Coast AM: Regenerative Medicine / Dulce Base 11-15-2011 Download Link – Video

Thursday, November 24th, 2011

DOWNLOAD LINK: adf.ly (CLICK ON "REGULAR DOWNLOAD" BUTTON FOR FREE DOWNLOAD) FOLLOW ON TWITTER: twitter.com SUBSCRIBE TO MY YOUTUBE CHANNEL: http://www.youtube.com REGISTER FOR HOTFILE ACCOUNT: hotfile.com REGISTER FOR FILESERVE ACCOUNT: http://www.fileserve.com http://www.coasttocoastam.com Date: 11-15-11 Host: George Noory Guests: Anthony F. Sanchez, Christian Wilde In the first half, researcher Christian Wilde talked about the emerging field of regenerative medicine, and how scientists are actually building replacement body parts with stem cells

Original post:
Coast To Coast AM: Regenerative Medicine / Dulce Base 11-15-2011 Download Link - Video

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Stem Cell Based Therapies for Blindness: David Hinton – CIRM Science Writer’s Seminar – Video

Friday, November 18th, 2011

(Part 6 of 9) David Hinton, Ph.D., spoke at the Scientific Writer's Seminar, a workshop presented on September 17, 2008 at CIRM headquarters in San Francisco. Hinton has a CIRM grant to study the therapeutic potential of retinal pigment epithelial cell lines derived from human embryonic stem cells for retinal degeneration. Hinton is a professor of pathology, neurosurgery, and ophthalmology at the Keck School of Medicine at the University of Southern California.

See the article here:
Stem Cell Based Therapies for Blindness: David Hinton - CIRM Science Writer's Seminar - Video

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Coast To Coast AM – 15.11.2011 – 1/4 – Regenerative Medicine/Dulce Base – Video

Thursday, November 17th, 2011

MP3 http://www.4shared.com Guests: Anthony F. Sanchez, Christian Wilde Regenerative Medicine: In the first half of Tuesday's show, researcher Christian Wilde talked about the emerging field of regenerative medicine, and how scientists are actually building replacement body parts with stem cells. He announced that Dr.

More:
Coast To Coast AM - 15.11.2011 - 1/4 - Regenerative Medicine/Dulce Base - Video

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Coast To Coast AM – 15.11.2011 – 4/4 – Regenerative Medicine/Dulce Base – Video

Thursday, November 17th, 2011

Guests: Anthony F. Sanchez, Christian Wilde Regenerative Medicine: In the first half of Tuesday's show, researcher Christian Wilde talked about the emerging field of regenerative medicine, and how scientists are actually building replacement body parts with stem cells. He announced that Dr

Continued here:
Coast To Coast AM - 15.11.2011 - 4/4 - Regenerative Medicine/Dulce Base - Video

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Commercializing Cell-based Regenerative Medicines

Sunday, November 13th, 2011

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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 of issues to keep in mind relative to commercial manufacturing scale?up of cell therapies.

Listen to the podcast here (registration required) or read the transcript below:

Pharma IQ:  Can you give some advice on the best way for a company to develop standards for
commercialization to improve safety?

William Fodor:  Well, with any biological product, you have to do all the appropriate testing and there’s really no standards necessarily to be developed by the company because the regulatory process is pretty well outlined by the FDA and the CBER Division and cell therapy products are regulated by the office of Cell Tissue and Gene Therapy Division.  So, it’s not that you need to develop standards for  commercialization to improve safety.  You need to follow the regulations involved by demonstrating to the FDA that your product is safe, and maintains the identity, in other words, your product doesn’t change during your regular manufacturing process.  Purity and then potency are all assays that need to be developed within the manufacturing process for your particular cellular product.


Pharma IQ:  And what are some approval processes and pitfalls to be aware of within the
scale?up process?

William Fodor:  So as you are scaling up, you absolutely need to maintain current good
manufacturing practices ? it’s known as cGMPs.  Typically, during a phase one, you can get
away with certain reagents that may not be fully GMPs.  Or in other words, if you use a growth
factor or a certain media that doesn’t have or isn’t manufactured under full GMPs,  as long as you test that particular reagent or media that you are using to ensure safety and sterility, you can typically get away with that in the phase one clinical trial process.  But when you move to a phase two, you need to make sure that all your reagents and medias and any compounds that come in contact with your product are all manufactured under good cGMP.

Pharma IQ:  What are some technology transfer and patent protection concerns to be
cognizant of?

William Fodor:  Well, with any cellular?based product, if there’s a technology that is out there
that a company wishes to pursue, to improve yield, or the manufacturing process, you need to
demonstrate that that technology fits within your manufacturing process.  So typically, what is
done is you’ll do validation runs to ensure that that new technology satisfies the regulatory
process for your manufactured product. With respect to patent protection, again, that company needs to maintain their IP portfolio and needs to make sure that they’re not infringing other intellectual property and that’s just standard for the industry.

Pharma IQ:  And do you have any tips for ensuring quality and consistency no matter how little
or how much one is producing?

William Fodor:  Yes, when you manufacture a cell?based product, it’s not that much different than any other biologic product.  And so, whenever you do manufacture, whatever scale it is, you have to ensure safety, and that’s sterility, tests for microplasma, or other adventitious agents; things like bioburden and endotoxins, so all those tests need to be performed. You need to have an identity test to make sure that your cell product ,whatever scale your manufacturing is, that at the end of that manufacturing run, the product hasn’t changed.   Again, no matter what scale you’re at, you need to make sure the identity of the product is
consistent from batch to batch.

For identity, you can do a number of things, and again, for a cell?based product, if you want to look at cell surface antigens to ensure that the cell surface proteins on your cellular product don’t change over time or through your manufacturing process.  And typically, what you like to do is keep it relatively simple.  You don’t want to test for a hundred things because you’re just asking for the potential for something within those hundred things to change.  So typically, what you do is maybe three to four cell surface antigens to ensure your product identity is consistent and you can also do PCR to determine that an intracellular protein of interest doesn’t change during your manufacturing process.

You also need to ensure for purity, so you want to quantitate your active cell or your tissue type.  And then potency; you need to demonstrate the product has a consistent potency and the biological activity of that final product doesn’t change during the manufacturing process.   And then typically, what you do is you archive.  You archive samples from during your manufacturing process. You cryopreserve those so you can always go back to ensure that that a particular batch was consistent with other batches that were manufactured.
...

Join Dr. Fodor and other industry leaders in Philadelphia, December 12th and 13th 2011 for the IQPC Commercialization of Regenerative Medicine Summit.  For more information or to register, visit
http://www.regenerativemedicinesummit.com.

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

Source:
http://feeds.feedburner.com/CellTherapyBlog

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Commercializing Cell-based Regenerative Medicines

Sunday, November 13th, 2011

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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 of issues to keep in mind relative to commercial manufacturing scale?up of cell therapies.

Listen to the podcast here (registration required) or read the transcript below:

Pharma IQ:  Can you give some advice on the best way for a company to develop standards for
commercialization to improve safety?

William Fodor:  Well, with any biological product, you have to do all the appropriate testing and there’s really no standards necessarily to be developed by the company because the regulatory process is pretty well outlined by the FDA and the CBER Division and cell therapy products are regulated by the office of Cell Tissue and Gene Therapy Division.  So, it’s not that you need to develop standards for  commercialization to improve safety.  You need to follow the regulations involved by demonstrating to the FDA that your product is safe, and maintains the identity, in other words, your product doesn’t change during your regular manufacturing process.  Purity and then potency are all assays that need to be developed within the manufacturing process for your particular cellular product.


Pharma IQ:  And what are some approval processes and pitfalls to be aware of within the
scale?up process?

William Fodor:  So as you are scaling up, you absolutely need to maintain current good
manufacturing practices ? it’s known as cGMPs.  Typically, during a phase one, you can get
away with certain reagents that may not be fully GMPs.  Or in other words, if you use a growth
factor or a certain media that doesn’t have or isn’t manufactured under full GMPs,  as long as you test that particular reagent or media that you are using to ensure safety and sterility, you can typically get away with that in the phase one clinical trial process.  But when you move to a phase two, you need to make sure that all your reagents and medias and any compounds that come in contact with your product are all manufactured under good cGMP.

Pharma IQ:  What are some technology transfer and patent protection concerns to be
cognizant of?

William Fodor:  Well, with any cellular?based product, if there’s a technology that is out there
that a company wishes to pursue, to improve yield, or the manufacturing process, you need to
demonstrate that that technology fits within your manufacturing process.  So typically, what is
done is you’ll do validation runs to ensure that that new technology satisfies the regulatory
process for your manufactured product. With respect to patent protection, again, that company needs to maintain their IP portfolio and needs to make sure that they’re not infringing other intellectual property and that’s just standard for the industry.

Pharma IQ:  And do you have any tips for ensuring quality and consistency no matter how little
or how much one is producing?

William Fodor:  Yes, when you manufacture a cell?based product, it’s not that much different than any other biologic product.  And so, whenever you do manufacture, whatever scale it is, you have to ensure safety, and that’s sterility, tests for microplasma, or other adventitious agents; things like bioburden and endotoxins, so all those tests need to be performed. You need to have an identity test to make sure that your cell product ,whatever scale your manufacturing is, that at the end of that manufacturing run, the product hasn’t changed.   Again, no matter what scale you’re at, you need to make sure the identity of the product is
consistent from batch to batch.

For identity, you can do a number of things, and again, for a cell?based product, if you want to look at cell surface antigens to ensure that the cell surface proteins on your cellular product don’t change over time or through your manufacturing process.  And typically, what you like to do is keep it relatively simple.  You don’t want to test for a hundred things because you’re just asking for the potential for something within those hundred things to change.  So typically, what you do is maybe three to four cell surface antigens to ensure your product identity is consistent and you can also do PCR to determine that an intracellular protein of interest doesn’t change during your manufacturing process.

You also need to ensure for purity, so you want to quantitate your active cell or your tissue type.  And then potency; you need to demonstrate the product has a consistent potency and the biological activity of that final product doesn’t change during the manufacturing process.   And then typically, what you do is you archive.  You archive samples from during your manufacturing process. You cryopreserve those so you can always go back to ensure that that a particular batch was consistent with other batches that were manufactured.
...

Join Dr. Fodor and other industry leaders in Philadelphia, December 12th and 13th 2011 for the IQPC Commercialization of Regenerative Medicine Summit.  For more information or to register, visit
http://www.regenerativemedicinesummit.com.

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

Source:
http://feeds.feedburner.com/CellTherapyBlog

Read More...

Opening Remarks, Screening Stem Cells 2009: From Reprogramming to Regenerative Medicine – Video

Sunday, October 23rd, 2011

Program Chair: Kelvin Lam, PhD, Harvard University, USA From the SBS Symposium Screening Stem Cells 2009: From Reprogramming to Regenerative Medicine. Held in Boston, MA, USA - September 2-3, 2009.

Read more from the original source:
Opening Remarks, Screening Stem Cells 2009: From Reprogramming to Regenerative Medicine - Video

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Regenerative Medicine: Pathways to Cure – Version 2.0 – Video

Friday, October 21st, 2011

The Alliance for Medical Research is pleased to present a new video explaining the benefits of Stem Cell Research.

Excerpt from:
Regenerative Medicine: Pathways to Cure - Version 2.0 - Video

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