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
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
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
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
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
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
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.
CRST suggest that clinical research sites should:
Full results of the survey are available on the CRST website http://www.crstnet.com
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
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.
CRST suggest that clinical research sites should:
Full results of the survey are available on the CRST website http://www.crstnet.com
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
AstraZeneca Pharmaceuticals LP (NYSE: AZN) and HealthCore, Inc., the health outcomes research subsidiary of WellPoint, Inc. (NYSE: WLP), announced a collaborative agreement to conduct real-world studies designed to determine how to most effectively and economically treat disease
Unlike controlled clinical trials, real-world evidence studies use observational data such as electronic medical records, claims information and patient surveys. By examining data associated with the delivery of care, real-world analyses can assess treatment impact on hospital length of stay, readmissions, overall health status, cost of care and other key evidence-based outcomes.
A leader in health outcomes research, HealthCore maintains the largest data environment in the nation. HealthCore’s near real-time, fully-integrated data environment combines medical, pharmacy, laboratory results and other information drawn from 36 million enrollees in local Blue Cross and/or Blue Shield plans with concentrated populations in 16 states.
AstraZeneca Pharmaceuticals LP (NYSE: AZN) and HealthCore, Inc., the health outcomes research subsidiary of WellPoint, Inc. (NYSE: WLP), announced a collaborative agreement to conduct real-world studies designed to determine how to most effectively and economically treat disease
Unlike controlled clinical trials, real-world evidence studies use observational data such as electronic medical records, claims information and patient surveys. By examining data associated with the delivery of care, real-world analyses can assess treatment impact on hospital length of stay, readmissions, overall health status, cost of care and other key evidence-based outcomes.
A leader in health outcomes research, HealthCore maintains the largest data environment in the nation. HealthCore’s near real-time, fully-integrated data environment combines medical, pharmacy, laboratory results and other information drawn from 36 million enrollees in local Blue Cross and/or Blue Shield plans with concentrated populations in 16 states.
Ever heard of people getting obnoxious amount of money to conduct research or get a PhD for pointless research. Thats what came to my mind when I first came across this news from IBM.
Just remind these were some of the winning ideas that funded by Government in US for Research papers and PhDs
1. the National Science Foundation once gave $100K grant to research why American players go to greater lengths to mod the popular MMO than do Chinese WoW players.
2. Pressures Produced When Penguins Pooh — Calculations on Avian Defaecation”, Polar Biology, 2004
3. Suicide rates are linked to the amount of country music played on the radio, , Medicine, 2005
4. Rats can’t always tell the difference between Japanese spoken backwards and Dutch spoken backwards, winner, Linguistics, 2007
As much as I stand to loose a chance to get a job at IBM by this post, its so hard not to think loud, and ask IBM what the heck was wrong with your brains, when you made the decision to patent the patent.
The Original Post Pasted from http://www.tomshardware.com/news/ibm-patents-the-patent,11868.html
Reading through IT patents these days requires patience and tolerance. When you can patent common sense, there is clearly something wrong with the system. But as long as no changes are being made, you are inviting people to exploit what is available and IBM has just demonstrated what may be possible, if one of their most recent patent applications is accepted by the USPTO.
The company felt it would be beneficial to patent the patent strategy process all the way from training inventors, to competitor monitoring and protecting (i.e. suing someone) a patent from infringement. This patent does not describe anything new, but a strategy that is being pursued by anyone who owns a patent and especially patent trolls or people like Paul Allen, who is just taking another shot at suing Google for patent infringement.
The patent application could mean that IBM in fact is working on a software that automates patent management or the company simply felt it was necessary to patent the idea of filing a patent and treating it in the way it could be considered common sense. It is especially revealing how much focus the inventor put on a “defend” module that implies a lawsuit strategy. It would take a genius to figure that out.
Reading through this patent is a good lecture how a patent these days should not look like. IBM is the natural place for this idea as there is no other company that files for as many patents (and receives as many patents) as IBM does. But if the patent idea gets approved
OFFICE OF , INSPECTOR GENERAL of US Department of Health and Human Services, released a report on the national incidence of adverse events for hospitalized Medicare beneficiaries, the preventability of such events, and associated costs to Medicare.
The report released last month month found that one in seven of the patients experienced an adverse event such as excessive bleeding, a hospital-acquired infection or aspiration pneumonia. Those events, both preventable and not preventable, led to about 180,000 deaths a year.
The complete report available at
http://oig.hhs.gov/oei/reports/oei-06-09-00090.pdf
The implementation of this platform enables rapid study set-up, automated CRF generation and better study recruitment and communication tools for general and special populations. Mobile workstations allow for rapid data entry and data is captured directly using bar codes and interfaces to medical equipment, such as blood pressure monitors. The Initiator platform also interfaces with the Company’s LIMS, as well as its diagnostic laboratory software and investigational drug management system.
Detailed PR available at PharmNet website
http://phx.corporate-ir.net/phoenix.zhtml?c=234619&p=irol-newsArticle&ID=1506686&highlight=
Sanofi-Aventis and Oxford University have entered into an agreement with INDOX, an academic oncology network to conduct oncology clinical and translation research in India.
The company said that through this partnership, Sanofi-Aventis will have access to experience and expertise of India’s top oncologists which will help the company in conducting clinical research. “The collaboration between sanofi-aventis, Oxford University and the Indian Cancer Centers fosters a model for academic researchers and industry to work together for the benefit of patients,” said Debasish Roychowdhury, MD, Senior Vice President, Head of Oncology, sanofi-aventis.
Sanofi-Aventis said that the company will provide financial assistance to Oxford University to manage INDOX’s eigh cancer reseach centres in India. The university, on its part, will provide training and support to investigators and reseach coordinators to help in carrying out the research.
INDOX is a partnership between Oxford University and India’s top eight cancer research centres in India.
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
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
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:
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:
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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