StemCell Therapy

Source:
http://microarray.wordpress.com/feed/

CAMBRIDGE, Mass.--(BUSINESS WIRE)--

bluebird bio, a world leader in the development of innovative gene therapies for severe genetic disorders, today announced the appointment of David M. Davidson, M.D., to the role of chief medical officer.

“David brings a wealth of gene therapy, rare disease and clinical drug development expertise to bluebird bio during an exciting time in our company’s growth,” said Nick Leschly, chief executive officer of bluebird bio. “Operationally, David’s deep gene therapy and translational medicine experience will help guide bluebird bio’s clinical development efforts and regulatory strategies. With the addition of David to our team, we are well positioned to maximize the high priority opportunities available to us through our broad product platform.”

Prior to joining bluebird bio, Dr. Davidson served as a senior medical director at Genzyme Corporation where he led clinical research for programs in Phases 1 through 4 across a wide range of therapeutic areas for more than a decade. Most recently, Dr. Davidson was the medical leader for Genzyme’s gene therapy and Pompe disease enzyme replacement therapy programs. In addition to Dr. Davidson’s translational medicine experience, he has also worked on a number of commercial products, including Fabrazyme® and Myozyme®/Lumizyme®, and was integral in crafting the new drug application that resulted in the approval of Welchol®. Prior to Genzyme, Dr. Davidson was a medical director at GelTex Pharmaceuticals. Previously, he completed clinical and research fellowships in infectious diseases at the Harvard Longwood Combined Infectious Diseases Program. Dr. Davidson received a B.A. from Columbia University and his M.D. from New York University School of Medicine. In addition, he completed an internal medicine internship, residency training and an endocrinology research fellowship at the University of Chicago Hospitals.

“bluebird bio’s platform has the potential to be truly transformative,” said Dr. Davidson. “It is rare to be presented with an opportunity to develop a novel, clinically validated platform with promising early proof-of-concept data in two indications that can have such a dramatic effect across a broad set of severe genetic diseases. In the next two years, bluebird looks to have its ALD program well into a Phase 2/3 trial and two other programs nearing completion of Phase 1/2 trials for beta-thalassemia and sickle cell disease. I look forward to this exciting challenge and the potential to have a fundamental and meaningful impact on patients and their families.”

About bluebird bio

bluebird bio is developing innovative gene therapies for severe genetic disorders. At the heart of bluebird bio’s product creation efforts is its broadly applicable gene therapy platform for the development of novel treatments for diseases with few or no clinical options. The company’s novel approach uses stem cells harvested from the patient’s bone marrow into which a healthy version of the disease causing gene is inserted. bluebird bio’s approach represents a true paradigm shift in the treatment of severe genetic diseases by eliminating the potential complications associated with donor cell transplantation and presenting a one-time potentially transformative therapy. bluebird bio has two later stage clinical products in development for childhood cerebral adrenoleukodystrophy (CCALD) and beta-thalassemia/sickle cell anemia. Led by a world-class team, bluebird bio is privately held and backed by top-tier life sciences investors, including Third Rock Ventures, TVM Capital, ARCH Venture Partners, Forbion Capital Partners, Easton Capital and Genzyme Ventures. Its operations are located in Cambridge, Mass. and Paris, France. For more information, please visit http://www.bluebirdbio.com.

See the article here:
bluebird bio Appoints David Davidson, M.D., as Chief Medical Officer

Via Scoop.it – inPharmatics

pharmaceuticals Researchers say pharmaceutical and other life sciences companies are ramping up their uses of analytics…
Via smartdatacollective.com

Source:
http://microarray.wordpress.com/feed/

The invention of an internet set top box has nothing to do with healthcare or  clinical trial at first look. But if HP and other companies are capable of delivering the research, then internet on any display device could change the way clinical trial is practiced at-least beginning with EDC. Yes I agree it is bit far fetched wild thought, but why not. It can also perhaps bring some transformation into patient waiting rooms in hospitals. HP’s invention along with Microsoft Kinect for PC is capable of bringing some big changes to healthcare  practice, mostly notably in TeleHealth.

If nothing else it would atleast bring internet to the masses much faster and cheaper than Android, 3G, and LTE, WiMax all put together, for the simple reason that most of the households that are capable of benefiting from the internet has access to TV as well. atleast in India

Take a look at news coverage “ HP India Research Labs brings Internet TV for the masses with the help of a TV set top box that cost less than $150″ news by Times of India

HP Labs has recently came out with what they call as “Internet TV Set Top Box for the masses” the product is called  Vayu Internet Device or VInD. HP Labs India has created the product which was reviewed by Times of India News paper. The solution enables people to receive internet content on even the most basic TV sets and manage all screen operations using basic TV remotes.

More About HP Labs Vayu Experience Platform

The HP product offers the following solutions,

Task Genie: This is a store of  apps, Yes apple has tons of them , but how many of them are useful , and several of those apps are me too products. Before anyone shouts shoot him let me tell you I have an iPhone4 loaded with 319 apps, I don’t think any one can beat that, and yet I don’t use almost 300 of them at-least once in a month, despite the fact that except one or 2 games most  other are serious apps. Yes I agree among the 300 are several apps which are me too copy cat apps which offers same function, like contact management and duplicate remover, SMS apps, chat solutions. The point is more the apps the better is not true, its the quality that matters that’s were Android fails

Web Tuner: This allows the user to create web categories, such as say News or Tech or Nature, and within each he can have the particular websites he is most interested in

Libraries: allows users to store photos, videos, music and documents in the set-top box’s hard disk. Users can tag and share them with others who have similar set-top boxes.

Contacts and Whiteboard: Users can create and store a contacts list. They can share content or have a video-conference with others who have similar set-top boxes.

Pairing with mobile phone: The set-top box can be paired with mobile phones. So, if it is paired with the user’s phone,he  can send messages to his  TV

Sensor: VInD comes with a built-in Zigbee sensor network. VInD detects the motion and sends an alert to the paired phone.

Keyboard and mouse: Vayu, which uses aLinux  operating system, can also be used as a regular PC, with a keyboard and mouse with a browser and with the TV acting as the monitor. It can be a wired or a wireless keyboard and mouse. This is were I think ViND can bring some advantage in clinical research space, every clinical trial monitoring room has  a TV

Tech Specs#: VInD has 1 GB of built-in RAM, 8GB of flash memory and the ability to add an additional 300 GB hard-disk. It comes with built-in Zigbee sensor network, USB ports, Wi-Fi, ethernet and Bluetooth 2.1 and infrared connectivity. It connects to the TV via HDMI and regular AV channel ports. It also supports GPRS, 3G and HSDPA through the use of a USB modem. It has in-built microphone and speakers and a display

Microsoft has released the Kinect for PC. It was reported that Microsoft is keen to see kinect taking an active part in Healthcare industry. Doctors are using Kinect to help stroke patients regain movement full St0ry Here. Then later there was news that Microsoft and Asus have built a laptop with Kinect motion-sensing technology.

Of-course HP is not the first to come out with this kind of  technology,

 most of the existing expensive solutions are not  comprehensive and too focused on living room with limited or no net browsing capability.

iChip Technolgies has announced their solution called @Box which claimed to bring internet to any display device including even the office projector. @Box is smaller than palm and would be sold in standard package with a key board, track ball, power adaptor and a cable to connect to the TV and would cost less than $100

iChip Technologies which was based in India was later acquired by Techfarm Ventures US-based incubator and early stage investor in technology companies. Gordon Campbell, Chief Executive Officer of Techfarm, is also the CEO and Co-founder of Personal Web (PW) Systems, a company incorporated in the US.

Techfarm Ventures had earlier invested in PortalPlayer, which went in for an IPO in 2004, and subsequently got bought out by nVIDIA in January 2007. Techfarm has earlier incubated more than a dozen companies such as the first Ethernet chip and graphics controller

Neuros Technology produces a similar product that works on Ubuntu platform called Neuros LINK, which seems to be more closer to the HP solution

Logitech and Google has released Revue a solution based on Android

Apple is talking about Apple TV for sometime

UK based Telecom operator Vodafone has launched Webbox a product that seems to draw power from Vodafones EDGE/GSM/3G network using Opera Mini Browser

Source:
http://microarray.wordpress.com/feed/

Via Scoop.it – inPharmatics

pharmaceuticals Researchers say pharmaceutical and other life sciences companies are ramping up their uses of analytics…
Via smartdatacollective.com

Source:
http://microarray.wordpress.com/feed/

The invention of an internet set top box has nothing to do with healthcare or  clinical trial at first look. But if HP and other companies are capable of delivering the research, then internet on any display device could change the way clinical trial is practiced at-least beginning with EDC. Yes I agree it is bit far fetched wild thought, but why not. It can also perhaps bring some transformation into patient waiting rooms in hospitals. HP’s invention along with Microsoft Kinect for PC is capable of bringing some big changes to healthcare  practice, mostly notably in TeleHealth.

If nothing else it would atleast bring internet to the masses much faster and cheaper than Android, 3G, and LTE, WiMax all put together, for the simple reason that most of the households that are capable of benefiting from the internet has access to TV as well. atleast in India

Take a look at news coverage “ HP India Research Labs brings Internet TV for the masses with the help of a TV set top box that cost less than $150″ news by Times of India

HP Labs has recently came out with what they call as “Internet TV Set Top Box for the masses” the product is called  Vayu Internet Device or VInD. HP Labs India has created the product which was reviewed by Times of India News paper. The solution enables people to receive internet content on even the most basic TV sets and manage all screen operations using basic TV remotes.

More About HP Labs Vayu Experience Platform

The HP product offers the following solutions,

Task Genie: This is a store of  apps, Yes apple has tons of them , but how many of them are useful , and several of those apps are me too products. Before anyone shouts shoot him let me tell you I have an iPhone4 loaded with 319 apps, I don’t think any one can beat that, and yet I don’t use almost 300 of them at-least once in a month, despite the fact that except one or 2 games most  other are serious apps. Yes I agree among the 300 are several apps which are me too copy cat apps which offers same function, like contact management and duplicate remover, SMS apps, chat solutions. The point is more the apps the better is not true, its the quality that matters that’s were Android fails

Web Tuner: This allows the user to create web categories, such as say News or Tech or Nature, and within each he can have the particular websites he is most interested in

Libraries: allows users to store photos, videos, music and documents in the set-top box’s hard disk. Users can tag and share them with others who have similar set-top boxes.

Contacts and Whiteboard: Users can create and store a contacts list. They can share content or have a video-conference with others who have similar set-top boxes.

Pairing with mobile phone: The set-top box can be paired with mobile phones. So, if it is paired with the user’s phone,he  can send messages to his  TV

Sensor: VInD comes with a built-in Zigbee sensor network. VInD detects the motion and sends an alert to the paired phone.

Keyboard and mouse: Vayu, which uses aLinux  operating system, can also be used as a regular PC, with a keyboard and mouse with a browser and with the TV acting as the monitor. It can be a wired or a wireless keyboard and mouse. This is were I think ViND can bring some advantage in clinical research space, every clinical trial monitoring room has  a TV

Tech Specs#: VInD has 1 GB of built-in RAM, 8GB of flash memory and the ability to add an additional 300 GB hard-disk. It comes with built-in Zigbee sensor network, USB ports, Wi-Fi, ethernet and Bluetooth 2.1 and infrared connectivity. It connects to the TV via HDMI and regular AV channel ports. It also supports GPRS, 3G and HSDPA through the use of a USB modem. It has in-built microphone and speakers and a display

Microsoft has released the Kinect for PC. It was reported that Microsoft is keen to see kinect taking an active part in Healthcare industry. Doctors are using Kinect to help stroke patients regain movement full St0ry Here. Then later there was news that Microsoft and Asus have built a laptop with Kinect motion-sensing technology.

Of-course HP is not the first to come out with this kind of  technology,

 most of the existing expensive solutions are not  comprehensive and too focused on living room with limited or no net browsing capability.

iChip Technolgies has announced their solution called @Box which claimed to bring internet to any display device including even the office projector. @Box is smaller than palm and would be sold in standard package with a key board, track ball, power adaptor and a cable to connect to the TV and would cost less than $100

iChip Technologies which was based in India was later acquired by Techfarm Ventures US-based incubator and early stage investor in technology companies. Gordon Campbell, Chief Executive Officer of Techfarm, is also the CEO and Co-founder of Personal Web (PW) Systems, a company incorporated in the US.

Techfarm Ventures had earlier invested in PortalPlayer, which went in for an IPO in 2004, and subsequently got bought out by nVIDIA in January 2007. Techfarm has earlier incubated more than a dozen companies such as the first Ethernet chip and graphics controller

Neuros Technology produces a similar product that works on Ubuntu platform called Neuros LINK, which seems to be more closer to the HP solution

Logitech and Google has released Revue a solution based on Android

Apple is talking about Apple TV for sometime

UK based Telecom operator Vodafone has launched Webbox a product that seems to draw power from Vodafones EDGE/GSM/3G network using Opera Mini Browser

Source:
http://microarray.wordpress.com/feed/

Via Scoop.it – inPharmatics

In other words, computing in the banking industry is perfected, so why can’t healthcare get its act together? (Irrespective of the sea change of difference between simple financial data and incredibly complex medical data.) …
Via hcrenewal.blogspot.com

Source:
http://microarray.wordpress.com/feed/

Via Scoop.it – inPharmatics

Do you want your boss to realize the full potential of social media? Yesterday on Pixels & Pills we talked about John Mack’s observation that very few senior executives attend digital pharma conferences.
Via http://www.pixelsandpills.com

Source:
http://microarray.wordpress.com/feed/

Via Scoop.it – inPharmatics

Oracle Exadata gets into Personlized Medicine & Bioinformatics space dressed as Oracle® Health Sciences Omics Data Bank.    Oracle Health Sciences today announced availability of Oracle® Health Sciences Omics Data Bank, a molecular data model, which is part of Oracle Health Sciences Translational Research Center.   The new data model provides integration and analysis of cross-platform omics data to support translational research. Oracle Health Sciences Translational Research Center runs on Oracle Exadata Database Machine, delivering the extreme performance required for querying vast data sets.
Via http://www.oracle.com

Source:
http://microarray.wordpress.com/feed/

Via Scoop.it – inPharmatics

Oracle Exadata gets into Personlized Medicine & Bioinformatics space dressed as Oracle® Health Sciences Omics Data Bank.    Oracle Health Sciences today announced availability of Oracle® Health Sciences Omics Data Bank, a molecular data model, which is part of Oracle Health Sciences Translational Research Center.   The new data model provides integration and analysis of cross-platform omics data to support translational research. Oracle Health Sciences Translational Research Center runs on Oracle Exadata Database Machine, delivering the extreme performance required for querying vast data sets.
Via http://www.oracle.com

Source:
http://microarray.wordpress.com/feed/

Via Scoop.it – inPharma

Drug makers are now asking their sales representatives to switch from making forceful, tightly scripted sales pitches to acting more like a resource supporting physicians’ treatment.
Via online.wsj.com

Source:
http://microarray.wordpress.com/feed/

Via Scoop.it – inPharma

Drug makers are now asking their sales representatives to switch from making forceful, tightly scripted sales pitches to acting more like a resource supporting physicians’ treatment.
Via online.wsj.com

Source:
http://microarray.wordpress.com/feed/

Good news for all Foreign CEOs of Global Pharma’s who left India after learning that, in India drug sales are driven by Freebies, and no one would listen to their advice to mend sales practices and unethical marketing practices.

Indian Government issues a strong dose of medicine . The new norms to hold pharma MDs, CEOs responsible for offering freebies to doc.

Under new guidelines drug firms will be barred from offering freebies to doctors — free travel tickets, hotel stay, gifts and hospitality, and the like. If any drug firm is found violating these guidelines, the responsibility would lie squarely with the MD and CEO of the respective company.

Further, the drug firms concerned may be prohibited from using brand names of competitive products in their promotional activities trying to claim superiority for its products.

The new guidelines would also prohibit drug firms to get doctors to endorse their products both online and offline

Source:
http://microarray.wordpress.com/feed/

Good news for all Foreign CEOs of Global Pharma’s who left India after learning that, in India drug sales are driven by Freebies, and no one would listen to their advice to mend sales practices and unethical marketing practices.

Indian Government issues a strong dose of medicine . The new norms to hold pharma MDs, CEOs responsible for offering freebies to doc.

Under new guidelines drug firms will be barred from offering freebies to doctors — free travel tickets, hotel stay, gifts and hospitality, and the like. If any drug firm is found violating these guidelines, the responsibility would lie squarely with the MD and CEO of the respective company.

Further, the drug firms concerned may be prohibited from using brand names of competitive products in their promotional activities trying to claim superiority for its products.

The new guidelines would also prohibit drug firms to get doctors to endorse their products both online and offline

Source:
http://microarray.wordpress.com/feed/

U.S. Supreme Court, ruling allows shareholders to sue Pharma and biotechnology companies for failing to report adverse drug events/ dangerous side effects.

Maker of homeopathic remedies Matrixx Initiatives, was sued by investors once it came to know their marketed nasal spray linked to a string of instances in which people using the treatment lost their sense of smell. The adverse events were reported back to the company by several medical professionals and patients, but never amounted to a statistically significant group. Matrixx argued it wasn’t responsible for reporting scattered and unreliable anecdotal evidence of adverse events. But the supremed court said No

http://www.bloomberg.com/news/2011-03-22/drugmaker-investor-lawsuits-backed-by-u-s-supreme-court-4-.html

Compare that to the Indian Law System

Madras High Court in India allowed a stay on immediate withdrawal of drugs banned  due to Severe Side Effects. The  pediatric doses of pain reliever nimesulide and anti-cold medicine phenylpropanolamine banned in  market due to harmful side effects, Indian Drugs Manufacturers Association & Confederation of Indian Pharmaceutical Industries put revenue loss to industry above safety of patients & managed to get a reversal of the ban.

http://www.business-standard.com/india/news/hc-stayimmediate-withdrawalbanned-drugs/429458/

U.S. Supreme Court, ruling allows shareholders to sue Pharma and biotechnology companies for failing to report adverse drug events/ dangerous side effects.

Maker of homeopathic remedies Matrixx Initiatives, was sued by investors once it came to know their marketed nasal spray linked to a string of instances in which people using the treatment lost their sense of smell. The adverse events were reported back to the company by several medical professionals and patients, but never amounted to a statistically significant group. Matrixx argued it wasn’t responsible for reporting scattered and unreliable anecdotal evidence of adverse events. But the supremed court said No

http://www.bloomberg.com/news/2011-03-22/drugmaker-investor-lawsuits-backed-by-u-s-supreme-court-4-.html

Compare that to the Indian Law System

Madras High Court in India allowed a stay on immediate withdrawal of drugs banned  due to Severe Side Effects. The  pediatric doses of pain reliever nimesulide and anti-cold medicine phenylpropanolamine banned in  market due to harmful side effects, Indian Drugs Manufacturers Association & Confederation of Indian Pharmaceutical Industries put revenue loss to industry above safety of patients & managed to get a reversal of the ban.

http://www.business-standard.com/india/news/hc-stayimmediate-withdrawalbanned-drugs/429458/

A new survey of 500+ clinical research site professionals outlines the  impact of complex, clinical trials in clinical trial sites. The survey focused on 3-year trial trends and found key challenges in subject recruitment/retention and tracking and reporting data. Increased complexity also impacted trial financials– especially negotiating contracts and managing profitability.

The December, 2010 survey was conducted among investigators, study coordinators and other clinical site professionals from large organizations, such as Mayo Clinic and Johns Hopkins, hospitals like Rush Presbyterian and the Hospital for Sick Children, as well as multi-specialty and private practices. Clinical Research Site Training (CRST), conducted the survey.

Analysis of the survey findings shows that

• 66% of large organizations report an increase in trials conducted
• 60% of trial sites report increasing difficulty in managing trial profitability
• 40% report increasing difficulty in recruiting and retaining subjects
• Training remains a major issue, even though over 50% report an increase in training
• 80%+ of nurses want more QA training
• 60%+ of all respondents want more FDA Audits training

The survey also explored sites’ Web use for work information. In spite of increased specialized Web content about the clinical research site “world”, awareness and usage were both relatively low.

• Google (or other search sites) was the primary information tool
• Only the NIH and Clinical Trial Network sites have over 50% awareness among all site professionals
• Usage of major specialized sites averaged less than 40% for nurses and less than 20% for doctors

CRST suggest that clinical research sites should:

• Increase training on financial management, site QA, subject recruitment/retention and FDA inspections;
• Manage the convergence of increased and more complex trials by improving both new staff recruitment and experienced staff retention;
• Reach out on the Web for new/improved ways of working from both formal information sites and clinical research site communities.”

Full results of the survey are available on the CRST website http://www.crstnet.com

Contacts

CRST
Lester Levine, 484-798-7503
President
Fax: 215-477-2522
lester.levine@crstnet.com

Dr. Pauline Chen in the NY Times reports that “When Patients Share Their Stories, Health May Improve”. HC Catalyst uses the same methodology to increase patient adherence to prescription medicines.

hcCatalyst Adherence Driver uses patients to motivate other patients to stay adherent. And, we do this without remunerating, scripting or training. It’s genuine and without the liability issues associated with paid or trained spokespersons.

Details on http://www.hccatalyst.com/solutions.html

A new survey of 500+ clinical research site professionals outlines the  impact of complex, clinical trials in clinical trial sites. The survey focused on 3-year trial trends and found key challenges in subject recruitment/retention and tracking and reporting data. Increased complexity also impacted trial financials– especially negotiating contracts and managing profitability.

The December, 2010 survey was conducted among investigators, study coordinators and other clinical site professionals from large organizations, such as Mayo Clinic and Johns Hopkins, hospitals like Rush Presbyterian and the Hospital for Sick Children, as well as multi-specialty and private practices. Clinical Research Site Training (CRST), conducted the survey.

Analysis of the survey findings shows that

• 66% of large organizations report an increase in trials conducted
• 60% of trial sites report increasing difficulty in managing trial profitability
• 40% report increasing difficulty in recruiting and retaining subjects
• Training remains a major issue, even though over 50% report an increase in training
• 80%+ of nurses want more QA training
• 60%+ of all respondents want more FDA Audits training

The survey also explored sites’ Web use for work information. In spite of increased specialized Web content about the clinical research site “world”, awareness and usage were both relatively low.

• Google (or other search sites) was the primary information tool
• Only the NIH and Clinical Trial Network sites have over 50% awareness among all site professionals
• Usage of major specialized sites averaged less than 40% for nurses and less than 20% for doctors

CRST suggest that clinical research sites should:

• Increase training on financial management, site QA, subject recruitment/retention and FDA inspections;
• Manage the convergence of increased and more complex trials by improving both new staff recruitment and experienced staff retention;
• Reach out on the Web for new/improved ways of working from both formal information sites and clinical research site communities.”

Full results of the survey are available on the CRST website http://www.crstnet.com

Contacts

CRST
Lester Levine, 484-798-7503
President
Fax: 215-477-2522
lester.levine@crstnet.com