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Clinical Trial and Pharmacovigilance process automation

Posted: February 14, 2011 at 2:06 pm

I had posted last month about the Pegasystem pharmacovigilance solution.

Pega Systems the industry leader in Business Process Management (BPM) software solutions, released a Pharmacovigilance case processing software.

Pega has experience in clinical trial space, specifically in Clinical Trial Management. The solution is designed for rapid deployment to quickly leverage existing adverse event processing rules and requirements and can produce specialized documentation to help ensure compliance in a validated environment.

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I have not come across any new updates after that. But apparently Accenture  has acquired Knowledge Rules, Inc., a Philadelphia-based consulting company that focuses exclusively on implementing and integrating business solutions using Pegasystems’ Business Process Management (BPM) software.

Accenture has a very large Pharmacovigilance division serving several large pharmaceutical companies. It would not be very suprising if Accenture roles out the BPM software for their pharmacovigilance services.

I think that is a possibility because Accenture  has announced plans to use the applications for all its Fortune 500 customers.

I would predict that United Health Group could be one of those customers as they are an existing customer of Pega.

Speaking of which Pega sounds like an attractive target Oracle can acquire

Recommendation and review posted by Fredricko

A difference between normal and cancer SC biology in the nervous system

Posted: February 14, 2011 at 2:06 pm

Neural Tumor-Initiating Cells Have Distinct Telomere Maintenance and Can be Safely Targeted for Telomerase Inhibition by Pedro Castelo-Branco and 12 co-authors, including Uri Tabori, Clin Cancer Res 2011(Jan 1); 17(1): 111-121 [Full text]. Translational Relevance:

Pediatric neural tumors (brain tumors and neuroblastoma) are the leading cause of morbidity and mortality in childhood cancer. This is due to their ability to recur after minimal disease is achieved. Telomerase is active in most malignant pediatric neural tumors. Therefore, telomerase inhibition may offer an effective treatment option for such patients. Because normal stem cells may require telomerase for continuous self-renewal, this therapy may have devastating effects on normal nervous system development and maintenance.

This study reveals that telomerase activation exists only in the tumor-initiating cancer subpopulation and is critical to sustain their survival and self-renewal potential. Importantly, normal neural or neural crest stem cells do not require telomerase for their self-renewal. Furthermore, as opposed to conventional chemoradiation therapies, telomerase inhibition results in irreversible loss of self-renewal capacity of tumor initiating cells in vitro and in vivo.

These observations uncover a difference between normal and cancer stem cell biology in the nervous system and suggest that telomerase inhibition may offer a specific and safe therapeutic approach for these devastating tumors.

For a commentary on this article, see: Anita B Hjelmeland and Jeremy N Rich, Clin Cancer Res 2011(Jan 1); 17(1): 3-5 (unlike the article, the commentary is not publicly accessible). Abstract:

Telomerase is an important mechanism by which cancers escape replicative senescence. In neural tumors, cancer stem cells express telomerase, suggesting that this may explain their preferential tumorigenesis. Oligonucleotide telomerase targeting selectively disrupts cancer stem cell growth through the induction of differentiation, adding to the armamentarium of anticancer stem cell therapies.

Recommendation and review posted by Fredricko

Two new initiatives from the CSCC

Posted: February 14, 2011 at 2:06 pm

The Cancer Stem Cell Consortium (CSCC) has announced the launch of two new initiatives for 2011-2012. Information about these initiatives is available via the websites of the CSCC and Genome Canada.

The two initiatives are:

1. C4Resource: The Canada-California Collaborative Cancer Stem Cell Resource and Technology Platform Network or C4Resource, which would coordinate cancer stem cell research resources and platform technologies more efficiently and effectively to advance research and discovery and accelerate clinical translation of new findings; and,

2. Partnership with CIRM: A second funding partnership with the California Institute for Regenerative Medicine (CIRM) through the CIRM's Disease Team Therapy Development Research Awards.

Information about the CIRM Disease Team Therapy Development Research Award RFA is available at: http://www.cirm.ca.gov/RFA_10-05

Recommendation and review posted by Fredricko

International Stem Cell Corporation: A Multitude Of Potential Products From Its Parthenogenesis Technology by Jason Chew

Posted: February 14, 2011 at 2:06 pm

International Stem Cell Corporation (ISCO) is at the forefront in the field of stem cell research. Its key technology is a technique to create an immortal stem cell line by activating a human egg to create stem cells without the need for fertilization by a sperm. This method is called parthenogenesis and is one of only two known ways to create human stem cell lines without genetic manipulation that have the potential to become any cell in the body that might be needed for therapy.

Most commonly, these cell lines are created from unwanted embryos stored at IVF clinics. To distinguish the two methods, stem cell lines created through parthenogenesis are called hpSC; those created from fertilized eggs are called “embryonic” or hESC. Both have the potential to create any cell in the human body, but only hpSC lines do not involve the use or destruction of a fertilized human egg.

ISCO has formed several business units to advance its hpSC technology. The Lifeline Skin Care unit has created a stem cell based anti-aging cream. The Lifeline Cell Technologies division encompasses both the sale of growth media and human cells used in stem cell and other research. UniStemCell® was established to create a stem cell bank. And most recently, a business unit call Cytovis® was formed to further the company’s stem cell derived corneal and retinal tissue programs.

The Company launched its skin care products, consisting of a Day and a Night conditioning crème, in December through a joint marketing venture with noted Internet financial and economic advisor, John Mauldin. The initial launch involved only a limited number of targeted customers and was intended to analyze acceptance rates and refine the company’s customer service and delivery systems. The Company has stated that, although the data base needs to be expanded by an additional offering scheduled in January before meaningful statistics can be generated, early customer responses indicate that users of the crèmes are getting favorable results from the product, which confirms the Company’s own pre-market test results.

The market for skin care products is large; according to Mintel market research, total US sales in 2009 was $4.35 billion. By individual brand, the best selling anti-aging creams in 2008 range in market share from 3% for Olay Regenerist, to 1.3% for L’Oreal RevitaLift. Applied to the 2009 sales total, this translates to roughly $130 million and $57 million, respectively. These are likely upper bounds for sales of any new product.

Without the ability to run a large marketing campaign, ISCO is smart to offer its product first to its shareholders and followers. On the surface, its partnership with entrepreneur and newsletter writer John Mauldin seems a bit odd, it will be interesting to see how his marketing skills will be used to convert his 1.5 million readers into Lifeline Skin Care buyers.

ISCO sells reagents and human cells for research through its Lifeline Cell Technology unit. Stem cell research is a fast-growing field requiring specialized, high quality products. Lifeline Cell Technology has signed distribution agreements with such powerhouses as American Type Culture Collection (ATCC) and Millipore for its products, as well as regional distributorships in Europe, Japan and elsewhere. These products generate revenue for the company while providing a source of quality reagents for in-house research.

Other business units under the ISCO umbrella are still in the early stages of development. The unit that may best leverage the hpSC technology may be the UniStemCell cell bank.

One of the major promises in stem cell research is in the field of regenerative medicine. Embryonic and parthenogenetic stem cells can be turned into any human cell type; in theory, these cells can then be used to treat diseases such as diabetes, degenerative brain diseases, cardiac arrest, spinal cord injury, all by aiding in the re-growth of damaged tissue.

A major problem in the use of hESC in regenerative medicine is the ability to find proper matches for the recipient. As with any transplant, strategies must be used to prevent rejection of the donor tissue. By their nature, hESC cell lines express a highly variable set of antigens involved in graft rejection. These antigens are part of the major histocompatibility complex (MHC).

The high variability causes difficulty in finding matches between hESC lines and recipients. On the other hand, hpSC technology produces cell lines with a much more uniform set of MHC molecules. Through proper selection, a single hpSC cell line can provide fairly good histocompatibility match for a large segment of the US population. Additional cell lines can provide matches for additional subgroups so that, in time, a match may be possible for almost all potential transplant candidates.

Through the cell bank, ISCO is providing material for outside groups to conduct cutting edge research and develop therapies based on hpSC technology. The potential is great, but revenue in the form of royalties is far off and uncertain.

Further along in development is the company’s stem cell derived corneal and retinal tissue therapy program. ISCO has partnered with Absorption Systems in the US, Sankara Nethralaya in India, and Automation Partnership in the UK to develop the technology, now under the Cytovis® brand- CytoCor ®for corneal tissue and CytoRet® for retinal tissue.

The Cytovis® technology is in pre-clinical testing and has many potential therapeutic applications including: age-related macular degeneration, retinitis pigmentosa, and the repair of traumatic eye injuries.

The company is also actively testing its CytoCor® tissue for use as an alternative to live animals and animal eyes in drug and consumer products testing. ISCO estimates this to be a $500 million dollar market. Recent laboratory results have shown the CytoCor® corneal tissue to have optical properties. It was also observed to have drug absorption properties similar to real cornea.

The large number of business units is unusual for a company this size. A lack of focus is always a concern, but at the same time, it speaks to the considerable potential of the company’s stem cell technology.

Recommendation and review posted by Fredricko

International Stem Cell’s Scientists in Collaboration with World Leading Stem Cell Experts Extend Understanding of Human Parthenogenetic Stem Cells…

Posted: February 14, 2011 at 2:06 pm

International Stem Cell's Scientists in Collaboration with World Leading Stem Cell Experts Extend Understanding of Human Parthenogenetic Stem Cells in Peer-Reviewed Publications


International Stem Cell Corporation (OTCBB:ISCO), http://www.internationalstemcell.com, in collaboration with leading stem cell scientists, announces findings that human parthenogenetic stem cells (hpSC) and human embryonic stem cells (hESC) are similar in their undifferentiated state, and are capable of differentiating into neural lineages such as functional retinal pigment epithelial (RPE) cells that have potential to treat retinal diseases such as age-related macular degeneration.

ISCO's CEO Andrey Semechkin, Ph.D., said: "These data are extremely important as they demonstrate that parthenogenetic stem cells have therapeutic potential like conventional embryonic stem cells; however, parthenogenetic stem cells have the additional benefit of superior immune-matching capabilities."

This evidence is presented in a recently published paper entitled: "Equivalence of conventionally-derived and parthenote-derived human embryonic stem cells" published in PLoS ONE (Public Library of Science).

Hans Keirstead, Ph.D., Professor of Anatomy and Neurobiology and Neurological Surgery at the University of California, Irvine and the senior author of the paper, said: "This work is the first wide-ranging comparison between these two important pluripotent stem cell types and demonstrates that human parthenogenetic stem cells are capable of differentiation along retinal lineages."

According to Nikolay Turovets, Ph.D., ISCO's Director of Research and Therapeutic Development and co-author of the paper, "Derivation of RPE from hpSC is the next logical step on the way to developing patient-specific therapies to treat eye degenerative disorders. If studies using RPE derived from hESC demonstrate utility in treating such diseases, it may become necessary to address problems associated with immune rejection. RPE derived from hpSC can be better immune-matched to the patient, thus reducing the chance of immune rejection."

This work forms part of ISCO's ophthalmology program developed in collaboration with the team of scientists at the University of California, Irvine led by Dr. H. Keirstead. One of the principal aims of the program is to create three-dimensional retinal tissue for transplantation that may be used to rescue the vision of individuals with retinitis pigmentosa, a group of inherited disorders characterized by progressive vision loss.

ISCO has established collaborations with other leading stem cell researchers to exploit the unique qualities of hpSCs. In addition to the collaboration with Keirstead, ISCO scientists co-authored a publication with Jeanne Loring, Ph.D., the Director of the Center for Regenerative Medicine at The Scripps Research Institute in La Jolla, entitled "Dynamic changes in the copy number of pluripotency and cell proliferation genes in human ESCs and iPSCs during reprogramming and time in culture" published in Cell Stem Cell in January, 2011. Ruslan Semechkin, Ph.D., Vice President of ISCO and co-author on this paper, said: "We are excited about being involved in Dr. Loring's work, which compares molecular characteristics of hundreds of different human pluripotent cell lines." Dr. Loring added: "hpSCs are intriguing because they are pluripotent like hESCs, but have differences in imprinting, the process in embryonic development in which certain genes are inactivated. This makes hpSCs tremendously valuable for understanding the molecular basis of the imprinting process in humans."

ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB):

International Stem Cell Corporation is a California-based biotechnology company focused on the therapeutic applications of human parthenogenetic stem cells and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells with minimal immune rejection after transplantation into hundreds of millions of individuals of differing sexes, ages and racial groups. This offers the potential to create the first true stem cell bank, UniStemCell™, while avoiding the ethical issue of using fertilized eggs. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology and cell-based skin care products through its subsidiary Lifeline Skin Care. More information is available at ISCO's website, http://www.internationalstemcell.com.

To subscribe to receive ongoing corporate communications please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.

FORWARD-LOOKING STATEMENTS

Statements pertaining to anticipated technological developments and therapeutic applications, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update these forward-looking statements.

Key Words: Stem Cells, Biotechnology, Parthenogenesis

International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com
or
Jeffrey Janus, Senior VP
760-940-6383
jjanus@intlstemcell.com

Recommendation and review posted by Fredricko

International Stem Cell's Scientists in Collaboration with World Leading Stem Cell Experts Extend Understanding of Human Parthenogenetic Stem Cells…

Posted: February 14, 2011 at 2:06 pm

International Stem Cell's Scientists in Collaboration with World Leading Stem Cell Experts Extend Understanding of Human Parthenogenetic Stem Cells in Peer-Reviewed Publications


International Stem Cell Corporation (OTCBB:ISCO), http://www.internationalstemcell.com, in collaboration with leading stem cell scientists, announces findings that human parthenogenetic stem cells (hpSC) and human embryonic stem cells (hESC) are similar in their undifferentiated state, and are capable of differentiating into neural lineages such as functional retinal pigment epithelial (RPE) cells that have potential to treat retinal diseases such as age-related macular degeneration.

ISCO's CEO Andrey Semechkin, Ph.D., said: "These data are extremely important as they demonstrate that parthenogenetic stem cells have therapeutic potential like conventional embryonic stem cells; however, parthenogenetic stem cells have the additional benefit of superior immune-matching capabilities."

This evidence is presented in a recently published paper entitled: "Equivalence of conventionally-derived and parthenote-derived human embryonic stem cells" published in PLoS ONE (Public Library of Science).

Hans Keirstead, Ph.D., Professor of Anatomy and Neurobiology and Neurological Surgery at the University of California, Irvine and the senior author of the paper, said: "This work is the first wide-ranging comparison between these two important pluripotent stem cell types and demonstrates that human parthenogenetic stem cells are capable of differentiation along retinal lineages."

According to Nikolay Turovets, Ph.D., ISCO's Director of Research and Therapeutic Development and co-author of the paper, "Derivation of RPE from hpSC is the next logical step on the way to developing patient-specific therapies to treat eye degenerative disorders. If studies using RPE derived from hESC demonstrate utility in treating such diseases, it may become necessary to address problems associated with immune rejection. RPE derived from hpSC can be better immune-matched to the patient, thus reducing the chance of immune rejection."

This work forms part of ISCO's ophthalmology program developed in collaboration with the team of scientists at the University of California, Irvine led by Dr. H. Keirstead. One of the principal aims of the program is to create three-dimensional retinal tissue for transplantation that may be used to rescue the vision of individuals with retinitis pigmentosa, a group of inherited disorders characterized by progressive vision loss.

ISCO has established collaborations with other leading stem cell researchers to exploit the unique qualities of hpSCs. In addition to the collaboration with Keirstead, ISCO scientists co-authored a publication with Jeanne Loring, Ph.D., the Director of the Center for Regenerative Medicine at The Scripps Research Institute in La Jolla, entitled "Dynamic changes in the copy number of pluripotency and cell proliferation genes in human ESCs and iPSCs during reprogramming and time in culture" published in Cell Stem Cell in January, 2011. Ruslan Semechkin, Ph.D., Vice President of ISCO and co-author on this paper, said: "We are excited about being involved in Dr. Loring's work, which compares molecular characteristics of hundreds of different human pluripotent cell lines." Dr. Loring added: "hpSCs are intriguing because they are pluripotent like hESCs, but have differences in imprinting, the process in embryonic development in which certain genes are inactivated. This makes hpSCs tremendously valuable for understanding the molecular basis of the imprinting process in humans."

ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB):

International Stem Cell Corporation is a California-based biotechnology company focused on the therapeutic applications of human parthenogenetic stem cells and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells with minimal immune rejection after transplantation into hundreds of millions of individuals of differing sexes, ages and racial groups. This offers the potential to create the first true stem cell bank, UniStemCell™, while avoiding the ethical issue of using fertilized eggs. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology and cell-based skin care products through its subsidiary Lifeline Skin Care. More information is available at ISCO's website, http://www.internationalstemcell.com.

To subscribe to receive ongoing corporate communications please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.

FORWARD-LOOKING STATEMENTS

Statements pertaining to anticipated technological developments and therapeutic applications, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update these forward-looking statements.

Key Words: Stem Cells, Biotechnology, Parthenogenesis

International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com
or
Jeffrey Janus, Senior VP
760-940-6383
jjanus@intlstemcell.com

Recommendation and review posted by Fredricko


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