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Vitamins and Good Sense

November 29th, 2010 6:14 pm

By Bernadine Healy M.D.
Posted 3/4/07

Vitamin studies always seem to stir controversy, but certainly not visions of death. On that score, last week's report on antioxidant vitamins, published in the Journal of the American Medical Association, was a doozy. The researchers concluded that people taking the antioxidants vitamins A, its precursor beta carotene, and vitamin E, for whatever reason, at whatever dose, and for however long, may be putting their lives in jeopardy. But before you toss out your vitamin pills, let's examine this alarmist study a little bit closer.

Researchers from Copenhagen University Hospital set out to determine whether the antioxidant supplements lengthen one's life. That's difficult to answer, since most people taking vitamins are healthy. So the researchers identified antioxidant clinical trials large and small, as long as they reported at least one death. Any death counted, whether from heart disease or cancer, kidney failure or hip fractures, murders or suicides. Out of 747 antioxidant trials reviewed, 68 met the bill. Then, in what is called a meta-analysis, the 68 trials were combined into what is effectively one study. Read more...

Diet detox , detox patch , kidney detox

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Malpractice Fears Can Influence Medical Practice

November 29th, 2010 6:14 pm

(HealthDay News) -- Peer pressure and fear of malpractice lawsuits seem to be behind the decisions by some doctors to order unnecessary cardiac catheterizations, new research suggests.

When asked in a national survey why they might order this potentially hazardous procedure that measures blood flow to the human heart, even when it might not be called for clinically, the top two reasons that cardiologists around the country gave were the fact that other doctors do it routinely and that patients might sue if the test wasn't done.

"We didn't say unnecessary," noted study author Frances Lee Lucas, an epidemiologist with the Maine Medical Center in Portland, whose report was published in the April 13 online edition of Circulation: Cardiovascular Quality and Outcomes. "We said how often for non-clinical reasons. We didn't want to say unnecessary because we knew nobody would ever say they ordered an unnecessary test."

The study of 598 cardiologists didn't attempt to determine the number of catheterizations performed that weren't really needed -- an important issue in an era of rising worry about medical costs. That would be a very difficult study to do, and it would have to include errors in both directions, people who need one and don't get it as well as people who get one and don't need it, Lucas said. Read more...

Detox fast, detox center , detox programs

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Scientific regress: When science goes backward

November 29th, 2010 6:14 pm

To celebrate the ends of years, decades and other milestones, science publications often churn out "Whither science?" predictions. Just last week, The New York Times Science Times section celebrated its, um, 32nd birthday with a special issue on "What's next in science". What I found fascinating was the issue's overall tone of caution rather than the traditional boosterish enthusiasm.

Gina Kolata recalled a job interview 25 years ago with U.S. News and World Report, an editor of which asked her, "What will be important medical news next year?" Kolata replied that "next year gene therapy will be shown to work." Gene therapy, of course, has been a big bust. Kolata goes on to say that the best answer to "Whither science?" is to expect the unexpected. (Fortunately for her, Kolata didn't get the job with what a mean friend of mine liked to call "U.S. Snooze and World Distort," the print version of which just died after years of terminal illness.)

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trends in the life sciences and pharma research and development outsourcing (RDO)

November 29th, 2010 6:14 pm

Vicki Phelan, Managing Director, Pharmaceutical and Life Sciences Practice
with Stan Lepeak, Managing Director, Global Research

Trends in the life sciences and pharma research and development  outsourcing (RDO)

The complete report is available at http://goo.gl/MgVBu

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Oracle Business Intelligence Enteprise Edition (OBIEE) for Clinical Trial Management System (CTMS)

November 29th, 2010 6:14 pm

Oracle Siebel CRM is the base application behind Oracle’s Siebel CTMS.

Prepackaged OBIEE Applications does not have a module for Clinical Analytics and so there is a need to develop a complete custom OBI application in order to accomplish the requirements. This was untill Oracle has introduced Oracle Clinical Development Analytics (CDA) which is based on OBIEE+

Oracle CDA includes prebuilt data models, prebuilt Extract-Transform-Load programs sourcing from Oracle Clinical / Remote Data Capture and Oracle’s Siebel Clinical Trial Management System

Business Intelligence can be deployed in several Core functions

  • Protocol Design and Study Start-Up
  • Patient and Investigator Recruitment
  • Clinical Trial Management
  • Clinical Data Management
  • Data Analysis
  • Clinical Supplies
  • Regulatory and Safety

Nonclinical Use of  Business Intelligence in Clinical Trial
There are a number of ways in which business intelligence as a technology platform can be used to support the pharmaceutical value chain. There is ample evidence to show how business intelligence has been used successfully in a number of areas including:

  • Sales and Marketing
  • Manufacturing
  • Finance
  • Human Resources
  • Information Services
  • Executive and Portfolio Management

Clinical Use  of  Business Intelligence in Clinical Trial
Within clinical research, the strongest use of technology is in pre-clinical research, clinical, statistical programming and supporting other groups such as:

  • Data management (patient profiles)
  • Medical writing
  • Finance
  • Project management
  • Patient registries and post-marketing surveillance

 

Without CDA an OBIEE architect needs to understand CRM data model and also the actual business process flow of a CTMS application.It is observed that usually there is a customization to an extent of 25% on the CRM application.

Original Old Article on OBIEE for CTMS which was the only Business Intelligence solutions for Clinical trial management before Oracle announced CDA is Available at http://www.obieetalk.com

Requirements gathering sessions must be interactive with group of SME’s, Team of members from business, project sponsors to mitigate any risk of
slipping the time lines. It is recommended to plan for regular client reviews and approvals of every build to avoid any gaps in the expectations by the client .

At a high level the reporting requirements may include tracking budget and finance, clinical trials, activities, investigators,Initiations, enrollments, expiration’s, terminations. Cross dimensional hierarchies from Program to Protocol to Site to Subject is commonly desired.

Major dimension tables specific to CTMS includes Program, Protocol,Site,Subject, application, Investigator. Other common dimensions include Accounts, Contacts, Activities, Time, Geography,product, etc.

Here is a screen shot of a sample rpd for CTMS

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Microsoft in Clinical Trials Management System (CTMS) and Electronic Data Capture (EDC)

November 29th, 2010 6:14 pm

one of the very few interesting article by Microsoft Engineers on Clinical Research Industry. Certainly interesting as it is written by none other than      Les Jordan-CTO, Life Sciences Industry Unit at Microsoft . Microsoft and IBM had much longer and deepr association with Lifescience/Healthcare/Bioinformatics industry than Oracle.

But I love to see microsoft grow beyond Sharepoint for Clinical Research and the BioIT alliance. Also love to ask microsoft what is the current status of some of those applications mentioned in the blog by Les, Especially the Microsoft Clinical Trial Initiation solution

Original article from microsoft website

Interesting how weeks become months when you’re writing and updating blogs.  This CTMS project certainly hasn’t gone away, but it did go on a bit of a hiatus while my “day job” intervened.  Enough excuses.  Mea Culpa.  On to the fun!

As we discussed in the previous post, the key to a clinical trials management system is thinking of it in terms of a project – after all, the people who run the clinical trial think of it in terms of a project, and it is measured in project management terms, so why not treat it that way from an architectural point of view?

A second and equally important “requirement” is one that we are increasingly seeing as an industry trend: having EDC (Electronic Data Capture) functionality and CTMS (Clinical Trials Management System) functionality in the same system, or at the very least having EDC and CTMS closely integrate and interoperate.

The clinical trials world of today is fairly fractured.  Think of all the different systems – often standalone systems – that are used by Life Science organizations:

  • EDC – Electronic Data Capture
  • CTMS – Clinical Trials Management Systems
  • CLIP – Clinical Investigator Portals
  • Project – Clinical Trials Project Management
  • Analysis – OK, it’s SAS, but how do you get the data there?  What about real-time analytics?
  • IRB & DSMB – Outside organizations with their own management systems, like a Click Commerce Research Compliance Automation solution?

What if you could have a system that gets close to doing all of that – or at least being able to manage all of it – through one interface?  How much would that save in training costs, integration costs, and implementation costs?

Well – that’s the vision.  Here’s how we pull it off:

  1. Start with Microsoft Office SharePoint Server 2007 and SQL Server 2008 as the foundation to build upon.
  2. As discussed in the last post, we’ll use Microsoft Office Project Server as a way to organize the information and provide us with a trial specific taxonomy, along with roll-up of reporting metrics.
  3. To cover the EDC aspects, we’ll utilize Microsoft Office Forms Server 2007 – which is a web facing InfoPath solution – to handle data entry and front-ending the workflow for data checks, etc.

EDC forms in Forms Server can even handle digital signatures (with compliance and security being the subject of a future post) inside the InfoPath forms.  This has implications for those organizations that are involved with SAFE BioPharma (worth checking out).

The beauty of all of this is that it is all Web Service enabled, which means that you have easier integration mechanisms with existing analysis and EDC systems:

  • SAS – With integration with .NET, SOAP, and Web Services.
  • Medidata – We’ve demonstrated use of their Web Services API module that utilizes CDISC.
  • Perceptive Informatics – At the DIA annual meeting a couple years ago, we did a demonstration using DataLabs (now Perceptive) and InfoPath integration, using Web Services and about 5 lines of code!
  • EHR/EMR Integration – While it is still on the horizon, I think it is getting closer.  Check it out.

Resources to get you started:

Finally – there are other organizations and software vendors that are thinking along these lines.  Check out the following solutions:

Next up in this series:

  • Using MOSS templates for maintaining Part 11 compliance
  • Extranets & Identity Management
  • Architecture Diagrams & Screen shots
  • Validation and compliance

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Clinical Trial and Pharmacovigilance process automation

November 29th, 2010 6:14 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.

pega.JPG

 

 

 

 

 

 

 

 

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

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collaborative clinical trials management software for Central Laboratories

November 29th, 2010 6:13 pm

Laboratory Corporation of America Holdings…announced…a collaboration between Esoterix Clinical Trials Services, a division of LabCorp, and Clearstone Central Laboratories, a global central laboratory specializing in drug development and pharmaceutical services.…The collaboration provides LabCorp with access to Clearstone’s global network of labs, including China, France, Singapore and Canada, in addition to LabCorp’s existing labs in the United States and Belgium. The companies will collaborate on providing standardized central laboratory testing for clinical trials to their respective clients. The transaction also provides LabCorp access to Clearstone’s clinical trials management system APOLLO CLPM clinical trials management software, enhancing the ability of clients to conveniently send, receive and manage data.

APOLLO CLPM is a secured globally accessible web based, 21 CFR part 11 validated clinical trials management software. Designed and developed by subject matter experts of every applied discipline integral to the system. Built on an Oracle database, the APOLLO CLPM system is a truly singular database that replaces multiple legacy systems and sub-systems, helping to drive improvements in efficiency and quality across the central laboratory business Apollo provides for global standardization of requisitions, reports, kits, barcode labels, as well as scientific information, and improves the accuracy and speed of sample reception and processing

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MNC Pharma tries to capture the $1.9 billion Indian OTC market by selling Drugs through India’s 170000 post offices

November 29th, 2010 6:13 pm

The multinational pharma companies are planning to approach the health ministry with a proposal calling for the utilisation of the 1.7 lakh post offices across the country to distribute over the counter drugs.

The move if implemented would increase the reach of OTC drugs by 20%.

The plan initially submiited 2 years ago requires  the approval of and coordination between department of pharma under the ministry of chemicals and fertiliser, department of post under ministry of communications and the health ministry.

The Organization of Pharmaceutical Producers of India (OPPI), an association of multinational pharma companies, is in the process of reviving the proposal as top officials at the health ministry have shown interest in discussing it and considering its implementation

The Indian over-the-counter (OTC) medicines market, the 11th largest globally, is pegged at $1.9 billion. It is the second fastest growing market globally with a growth rate of around 9% per annum.

Ranjit Shahani, country president, Novartis gives the analogy of the how petrol pumps have metamorphosed into multi-utility centres in last two decades. “One simple legislation can change that for over the counter medicines,”

Would you support this, even in US where people are more educated and FD keeps a watch on drug advertisement , people are often misguided.

India is yet to come up with a strong and comprehensive adverse drug event reporting infrastructre.

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Scott Stern Kellogg School of Management speaks about “New Drug Development: From Laboratory to Blockbuster to Generic,”

November 29th, 2010 6:13 pm

Scott Stern, Associate Professor, Kellogg School of Management, speaks on the topic of, “New Drug Development: From Laboratory to Blockbuster to Generic,” at the Judicial Symposium on The Pharmaceutical Industry: Economics, Regulation, and Legal Issues, hosted by the Northwestern Law Judicial Education Program

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Widespread fraud in the Clinical Trial of Drugs is pervasive event in United States

November 29th, 2010 6:13 pm

There have been several cases where Fraud in clinical trial has questioned the  Integrity of Data and ethics , when conducting clinical trial in India, which have been used by crusaders against outsourcing. But the new evidence suggest that the clinical trial fraud is more prevalent even in US. The most recent being MannKind Corporation Accused of Covering Up Adverse Clinical Trial Results

India’s poor history on adhering to patents, strong legal system, and the image of corruption means, any fraud in conducting clinical trial in India will invite serious punishment from FDA and western world. Yes we can cry that we will be singled out , or we can take necessary steps to avoid incidents such as above

MNC pharma MannKind is accused of Data Fraud Coverup  in securing FDA approval for Afrezza the inhaled insulin drug. A senior manager uncovered unlawful clinical trial conduct pertaining to the company’s Afrezza inhalant insulin device.  John Arditi, who was MannKind’s senior director of worldwide regulatory affairs, filed a wrongful termination lawsuit against his former employer, in New Jersey Superior Court, claiming he was unfairly fired by MannKind after internal audits he conducted in November 2009 uncovered “potential fraud and scientific misconduct” involving Afrezza clinical trial data

Arditi discovered discrepancies in data at both a Russian and Bulgarian trial site, according to his lawsuit.  For several months, Adverse event results were either not being recorded properly, or were fabricated to favor the approval of Afrezza.  Arditi’s lawsuit asserts that he informed superiors at MannKind, on November 9, 2009, of his adverse findings and encouraged the company to approach the U.S. Food and Drug Administration (FDA) but MannKind did not contact the agency because negative information would delay approval of the New Drug Application (NDA) for Afrezza.

The new revelation on MannKind Afrezza Clinical Trial that emerged last week , comes just days after the report published by The Council for Clinical Research Subject Safety & Data Integrity (CCRSSDI)  on widespread fraud in the Clinical Trial drugs by pharma and CROs in Unites States.

Two time Emmy winning reporter Kathy McDevitt led an investigative team from The Council for Clinical Research Subject Safety & Data Integrity (CCRSSDI), to record Subjects committing fraud. Her investigation led to on-air confessions by two such subjects on the nature and the extent of the fraud in the industry

Ms. McDevitt and CCRSSDI have jointly released a documentary tilted “Pervasive Fraud in the Clinical Trial World” . It is available on the CCRSSDI website. Copies of the DVD may also be requested by the video.

Among the findings in the documentary:

  • Multiple simultaneous trial enrollments by Subjects
  • Inability of research sites to check for dual clinical trial enrollments
  • No single record of all the studies a subject has taken
  • Inability to verify amount of actual drug usage by a Subject in a Study
  • Potential for flawed results in Studies

Watch the Documentary on YouTube

“I was shocked by how lax the identification process is for potential Study Subjects”, said Kathy McDevitt. “I always had assumed that a thorough identification and verification was required to enroll qualified patients in studies for drugs that you and I take”

Kerri Weingard, the Director of CCRSSDI, further adds “We here at the Council have consistently raised this issue. Many members of this Council run their own Study Sites and we have seen the level of fraud increase year after year. Unfortunately, no steps are being taken by the industry as a whole to combat this problem. If this problem is left unchecked, the whole industry will suffer and public confidence in our Drug Testing process will be fundamentally undermined”

CCRSSDI has led the charge on this issue. Its charter clearly defines that the primary goal of CCRSSDI is to ensure that every study by every site and every sponsor utilizes and identification and verification process to ensure that there is no fraud occurring and that subjects are not dual-enrolled or have been expelled from previous studies.

Download the explosive documentary “Pervasive Fraud in the Clinical Trial World”, at http://www.CouncilForClinicalResearch.com

For further information please contact Kerri Weingard, Director, Council for Clinical Research Subject Safety & Data Integrity at KWeingard(at)CouncilForClinicalResearch(dot)com or 646-225-6624

Council for Clinical Research Subject Safety & Data Integrity is composed of established members of the medical profession. Its goal is to ensure that our testing process for Clinical Research Trials remains error free and that Subject Safety is always assured. meetings are open to all. For further information please email  at info@CouncilForClinicalResearch.com.
ONE of Australia’s most senior cancer specialists has accused pharmaceutical companies of manipulating some clinical trials of medicines for commercial reasons, including deliberately delaying the release of negative findings and being reluctant to fund research into the toxicity of their drugs.  More details

Professor Stephen Clarke, who has conducted clinical trials involving humans for 15 years, agreed to speak publicly for the first time because he said it was essential for governments to fund trials of great public importance rather than leaving critical research solely to drug companies.

A number of researchers who spoke to The Age agreed, saying commercial decisions meant the public did not always get the full picture about a drug’s usefulness and safety.

Other more high profile clinical trial related issues in recent past are PPD Inc responsibility in Ketek Trial for Aventis

The FDA found the fraud 2002 in a trial supervised by PPD, the doctor was indicted 2003, convicted 2004 and Ketek was approved 2004 by the FDA using the faulty data. It wasn’t until early 2006 that liver problems in patients using Ketek came to light and subsequently, the continued reliance on the fraudulent data. Congressional hearings were called for in 2006 which were held 2007 and again 2008 when Fred Eshelman, founder of PPD testified

The FDA and drug maker Aventis were directly faulted. Eshelman washed his hands. . This clip is one of three showing Fred Eshelman’s verbal responses to questions.

Some of the other high profile cases are

News that Schering-Plough, one of the largest drug companies in the world, has been outright bribing physicians to prescribe drugs and operate sham clinical trials http://www.naturalnews.com/001298.html

University of California findings in the October issue of the Annals of Internal Medicine, that 167 placebo-controlled trials published in peer-reviewed medical journals in 2008 and 2009 and found that 92 percent of those trials never even described the ingredients of their placebo pills.

The Utah Attorney General has filed a lawsuit charging GlaxoSmithKline illegally marketed its controversial Avandia diabetes pill as a new “wonder drug” that would reduce cardiovascular risks for diabetes, but instead increased the possibility of heart attacks. Consequently, the AG alleges Glaxo hoodwinked the state Medicaid program out of $7.8 million, which is the amount Utah spent to purchase Avandia between Jan. 1, 2001 and June 30, 2010

The more recent events in India were

Glenmark Pharmaceuticals and Omnicare have closed a clinical trial site in India operated by the contract research organisation (CRO) amid accusations that an investigator acted fraudulently.

Clinical Trial Fraud – How to Identify and Steps to Handle If Found, events like these makes adherence to GCP and training of CRA, and all stake holders in clinical trial more and more important

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SalesForce.com partner introduces CRM for clinical trial management on Force Platform

November 29th, 2010 6:13 pm

Had an interesting chat with the CEO of the US based IT service provider for clinical research industry in June. Apparently the company a SalesForce.com partner introduces new CTMS application in India. Just came to know that they are going commercial this month. The applications is aimed at clinical trial management, Study site management and Patient Recruitment in the clinical research industry . Aimed at CROs, Hospitals, University Research centers and clinical trial Study Sites.

The application is based on Force platform by SalesForce and already have few Indian Organization using it for several months. The product will be offered in SaaS/Hosted/Cloud versions, which will render affordable TCO and higher ROI with less or no Capital investmental.

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Harvard Medical Schools new automated safety surveillance system provides faster early warnings in the postmarket evaluation of medical device safety

November 29th, 2010 6:13 pm

Implementation of a computer-automated safety surveillance system of clinical outcomes registries for cardiovascular devices resulted in the identification of a drug-releasing stent that had significantly higher rates of major adverse cardiac events than similar stents

“Monitoring the safety of approved medical products is of vital public health importance, given that in clinical practice such medical products are often used in numbers far greater and in patient populations more diverse than when studied in premarket evaluations and clinical trials,” the authors write. “Ensuring the safety of medical devices challenges current surveillance approaches, which rely heavily on voluntary reporting of adverse events. Automated surveillance of clinical registries may provide early warnings in the postmarket evaluation of medical device safety.”

“In conclusion, automated safety surveillance of medical devices is feasible using automated monitoring tools applied to detailed clinical registries and can efficiently help identify emerging potential postmarket safety risks. Automated medical product surveillance can complement existing public health strategies, providing an additional mechanism to assess the comparative safety of approved medical products and improve the quality of health care delivered,” the authors write.

 

Original article on

http://www.scientificcomputing.com/news-DA-Computer-automated-System-for-Identifying-Medical-Devices-with-Safety-Risks-111110.aspx

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International Stem Cell Corporation Announces the Commercial Launch of Its Breakthrough Stem Cell-Based Line of Skin Care Products

November 29th, 2010 6:13 pm

International Stem Cell Corporation (OTCBB:ISCO), http://www.internationalstemcell.com, announced today the commercial launch of its innovative line of topical skin care products by the company's wholly-owned subsidiary, Lifeline Skin Care ™ (http://www.lifelineskincare.com). Containing extracts from human "parthenogenetic" stem cells (hpSC), the products were formulated by a team of ISCO's research scientists in collaboration with cosmetic formulation experts to create an advanced scientific approach to skin care. The patent pending serums, which come in separate formulations for day and night time use, have been safety tested by highly regarded, independent laboratories, and have been shown to promote anti-aging of the skin.

The initial launch of the serums is to a pre-existing list of interested parties. We expect that the products will be available to the general public via our online store http://www.lifelineskincare.com in the near future.

A key innovation in creating the Lifeline Skin Care™ serums was the encapsulation of the parthenogenetic stem cell extractsinto nanospheres, which not only protect the proteins, but substantially enhance the effectiveness of the serums. World renowned skin cream formulation experts assisted ISCO's scientists to create the finished products and ensure that the final serums deliver the most up-to-date advances in skin rejuvenation technology that also helps to prevent and repair damage caused by the environment.

According to Gregory S. Keller, MD, FACS (2007 Specialist of the Year in Facial Cosmetic Surgery in Strathmore's "Who's Who"): "These new day and night serums represent a huge step forward in anti-aging skin care products. Combining liposome-encapsulated proteins derived from ISCO's powerful new class human stem cells with a unique blend of anti-oxidants, vitamins and natural extracts, allowed Lifeline Skin Care to create highly effective stem cell-based serums that provide strong anti-aging benefits."

The new skin rejuvenation serums are based on the breakthrough discovery that certain proteins derived from ISCO's proprietary pluripotent human parthenogenetic stem cells are beneficial to the culture of human skin cells in the laboratory. ISCO, the world leader in human parthenogenetic stem cell technology, is studying this new class of stem cells, and has demonstrated their therapeutic potential in many fields of regenerative medicine. Human parthenogenetic stem cells are created from unfertilized human eggs and do not involve any harm to a viable human embryo, thus avoiding serious ethical questions that surround other areas of stem cell research. hpSC possess unique immune-matching attributes making them an excellent platform for the development of cellular therapies for large populations of individuals. As of today, ISCO has successfully derived ten hpSC lines. One of these lines carries the most common immune type found within the US population and can be immune-matched to an estimated 75 million people worldwide.

"The commercial launch of the new skin care products represents an important step in the execution of ISCO's strategy. The revenue generated from sales will help support the development of our therapeutic programs utilizing our unique and powerful class of human pluripotent stem cells," said Dr. Ruslan Semechkin, CEO of Lifeline Skin Care.

ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB)

International Stem Cell Corporation is a California-based biotechnology company focused on therapeutic and research products. ISCO's core technology, parthenogenesis, results in creation of pluripotent human stem cells from unfertilized oocytes (eggs). These proprietary cells avoid ethical issues associated with use or destruction of viable human embryos and, unlike most other major stem cell types, can be immune matched and be a source of therapeutic cells with minimal rejection after transplantation into hundreds of millions of individuals of differing racial groups. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary, Lifeline Cell Technology, and is developing a line of cosmeceutical products via its subsidiary, Lifeline Skin Care. ISCO is advancing novel human stem cell-based therapies where cells have been proven to be efficacious but traditional small molecule and protein therapeutics have not. More information is available on 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 developments, product introduction plans, the potential benefits of planned products, collaborations, affiliations, 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 and the management of collaborations, 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 forward-looking statements.

Key Words: Stem cells, parthenogenesis, biotechnology, skin care, anti-aging

http://cts.businesswire.com/ct/CT?id=bwnews&sty=20101116005754r1&sid=14230&distro=ftp

International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
1-760-940-6383
kaldrich@intlstemcell.com

or
Lifeline Skin Care, Inc.
Ruslan Semechkin, PhD, President & CEO
Vice President, ISCO
ras@intlstemcell.com

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Amino acids are latest in growing list of nutrients shown to extend life span

November 14th, 2010 9:31 am

Researchers are zeroing in on specific nutrients and natural therapies that not only can prevent and heal disease but promote longevity. For example, as NaturalNews previously reported, a research team from Nu Skin Enterprises, Inc., and LifeGen Technologies found that Cordyceps sinensis (Cs-4), a traditional Chinese mushroom, is a powerful anti-aging food that could lengthen lifespan (http://www.dreddyclinic.com/forum/viewtopic.php?f=13&t=24075). And University at Buffalo endocrinologists recently documented for the first time that resveratrol, a phytochemical found in red grapes, grape juice and red wine, has anti-inflammatory and antioxidant properties in humans and may promote human longevity, too (http://www.dreddyclinic.com/forum/viewtopic.php?f=21&t=20422). Read more...

Detoxify , detoxifying, holistic detox

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Exercise in Adolescence May Cut Risk of Deadly Brain Tumor

November 7th, 2010 9:34 am

(HealthDay News) -- Exercising during adolescence may help guard against a deadly form of brain tumor in adulthood, new research suggests.

The study also found that avoiding obesity during the teen years was associated with a lower risk of developing the cancerous brain tumors called gliomas, while being tall increased the chances of such malignancies.

The study appears in the Nov. 1 issue of Cancer Research.

Gliomas are the most common type of brain and central nervous system cancers, accounting for 80 percent of cases, according to background information in the study. Gliomas cause 13,000 deaths in the United States each year.

Though little is known about why people develop the tumors or who is at risk, previous research has hinted that "early life exposures" may increase the risk of developing the cancer in adulthood, said study author Steven C. Moore, a research fellow in the Nutritional Epidemiology Branch of the U.S. National Cancer Institute. Studies have shown that people who are left-handed, for example, are at higher risk of the disease. Read more...

Memory concentration, loss of memory, short term memory loss

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Chinese mushroom found to have powerful anti-aging benefits

November 7th, 2010 9:34 am

The cordyceps mushroom is back in the spotlight again, except this time for its anti-aging properties. Researchers from Nu Skin Enterprises, Inc., and LifeGen Technologies have found that Cordyceps sinensis (Cs-4), a traditional Chinese mushroom, is a powerful anti-aging food with the ability to improve energy metabolism, decrease fatigue, bolster endurance levels and lengthen lifespan.

Back in March, we covered breakthrough research on the power of cordyceps to treat cancer (http://www.dreddyclinic.com/forum/viewtopic.php?f=19&t=22848,http://www.dreddyclinic.com/forum/viewtopic.php?f=13&t=22276), but the new research has found even more beneficial uses for this emerging superfood. By encouraging human genes to express in ways that promote longevity, cordyceps has incredible potential in helping to reverse the negative effects of aging.

"We're making great breakthroughs in gene expression science that have application in the fields of health and longevity," explained Joe Chang, Ph.D., chief scientific officer and executive vice president of development at Nu Skin. "These studies ... help validate the critical role gene expression modulation plays in the aging process. We believe that the future of anti-aging is in developing consumer solutions that support youthful gene expression." Read more...

Youtharia for Anti-Aging & Longevity

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Western medicine teams up..

November 7th, 2010 9:34 am

This LA Times article will let you see where Integrative Medicine may be taken over by major medical centers. There are some important observations made by this Times Staff Writer that can help you differentiate for your clients what you offer them from what these centers are doing.

The concerns voiced about appearing unscientific etc. by a cancer patient here is important to appreciate. Please understand that in my view, no one is fully offering adequate Vitamin C based programs to their patients. The books written can provide your patient with scientific information that will help most begin to deal with their problem of ill health, which virtually always needs to be a multifactorial approach. They can start with Irwin Stone's Vitamin C The Healing Factor, which anyone can obtain free of charge from following the links on Wikipedia after you search on Vitamin C, to newer books like Dr Levy and Dr Hickey have written or the audiotape by Dr Riordan. Read more...

More information's about detox diets

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Experimental Treatment Could Fight Muscular Dystrophy

November 7th, 2010 9:34 am

(HealthDay News) -- Injecting a therapeutic molecule into muscle appears to jump-start the production of a crucial protein that's missing in patients with Duchenne muscular dystrophy, British researchers report.

The treatment so far is only applicable to about 13 percent of people with the debilitating and ultimately fatal disease, but scientists are hopeful that similar molecules might expand the treatment to a wider range of patients.

Duchenne muscular dystrophy affects about one in 3,500 males, and involves a progressive wasting of muscle due to a genetic inability to produce the protein dystrophin, a key component of muscle structure. No treatments are available for the illness, and most of those affected die by age 30.

Recently, molecules called antisense oligonucleotides have shown some promise. These molecules work by "skipping over" portions of the defective gene that would otherwise block dystrophin production. Read more...

Heart health

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Carla wants to know

November 7th, 2010 9:34 am

In response to a question posed by one of my oldest and most perceptive friends, I posted what follows to my Facebook profile.

Her question was posed after watching this video http://vimeo.com/15979195

"Rocky, am I really ignorant and paranoid?

It seems like this technology holds they key to either really, really good stuff for us as a species, or it has the potential for really really bad stuff.

I trust the science and the scientists. I don't trust the Money that controls what's done with the science.

Einstein was a really nice guy. He had no idea his science would be used for war. I don't think any of the Manhattan Project scientists went into it knowing what they were unleashing on the world."

~ Carla Conrad

My answer: A most perspicacious observation, and right on the mark. Occam’s Razor, 21st century style, meaning that you have hit upon the simplest explanation for the potential outcome; like every technological innovation in the past, nanoscale technologies have both the potential for tremendous good and/or tremendous bad. And don’t let my seemingly cavalier use of "tremendous" lull you into a false sense of security; I mean "tremendous" as in "things that have the potential to change everything we think we know about ourselves, while enabling each of us with the power to effect and experience our surroundings in ways heretofore only imagined."

I have been actively and intensely following nanoscale technologies since the early ‘90’s. At the end of the day, my most prescient observation would be that these technologies will have an impact on our global society many times greater than ALL past technological revolutions. Let me put it another way: nanoscale technologies - and the products thereof - will enable far greater change than our discovery, development and use of fire, bronze, iron, steel, electrical power, cars, planes and space travel put together.

Any person, institution or government entity that says "Oh yeah, nanotechnology, we got that handled" is lying their ass off. Equally, any person, institution or government entity that says "Oh yeah, nanotechnology, it’s gonna kill us all in one or more horrible ways" is also lying their ass off. Anyone that fervent usually has a hidden agenda, and one which serves a higher master. You’ll notice I said "usually" – many of my colleagues in the nanospace are humanitarians in the best sense and are talking about and planning for ways in which the good things can be emphasized and the bad minimized or eliminated.

My philosophy is summed up thus:

Nanotechnology will certainly play a pivotal role in our future; now, with the introduction of lighter/stronger materials in the auto, space, and military industries, and later, with the introduction of molecular manufacturing (making items per your specifications, in your own home, for pennies on the dollar of current prices – think "replicator" and you will not be too far off).

Expect to see revolutionary changes in solar, fuel cell and hydrogen storage technologies within the next few years. And expect to see a great deal of interest in and subsequent higher funding of nanotech-enabled sensor technologies for military, homeland security and civilian applications within the next few years. Put another (albeit obvious) way: expect to see cultural tsunamis of a magnitude that rival anything we have thus far experienced.

No informed person doubts that developments at the nanoscale will be significant. We debate the time frame, the magnitude and the possibilities, but not the likelihood for large-scale change. The least-speculative views suggest that we're in for changes of an order that justifies – if not demands – our undivided attention. Will we be ready? (BTW: not kidding, not even the weensiest amount)

OK, off my high horse and back to your previously programmed station…

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