challenge 4 Indian Clinical Research outsourcing,CROs and Pharma R&D because Indians are genetically not single large population

challenge 4 Indian Clinical Research outsourcing, R&D plans because of a new discovery that Indians are genetically not single large population

“Drug companies engaged in clinical trails could be worried as our research shows that many groups in modern India descend from a small number of founding individuals. A common drug may not be the answer, considering the genetic variation in the Indian population. For instance, medicines tested on the Western population may not be effective on the Indian population,” said Lalji Singh, former director of the Centre for Cellular and Molecular and Biology (CCMB) who has co-authored the research findings on Reconstructing the Indian Population History, said on Thursday.

The work, published in the latest issue of Nature, has medical implications for people of Indian descent. More than three-fourths of India’s over one billion people are burdened with genetic disorders. The study shows that Indians have been genetically different from other groups and this could be a major cause of recessive diseases. The incidence of genetic diseases among Indians is, therefore, different from the rest of the world.

That could spell bad news for Clinical Research Outsorucing to India and Indian CRO companies, FDA can request for Pharmacogenomics supplementary data to prove that, Results of clinical trial are applicable to American populations.

“Drug trials should take into account diseases that are specific to the population,” said Lalji. A senior official of a top Indian drug-maker who did not wish to be identified said that pharma companies, the world over, are alive to the issue as the success of clinical trails and the efficacy of a drug hinges on the gene pool.

Ofcourse they knew about it all the time, Indian Ayruvedic medicine was aware that all humans canot be treated for the sames diseases with same treatment, more than 1000 years ago.

The article is available at Nature Magazine

http://www.nature.com/news/2009/090923/full/news.2009.935.html

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Deadline for Personal Genomics Companies

State of New York has issues warning against Personal genomics companies , after they have received many complaints. Now the State of California Department of Helath (CDPH) is trying to keep consumer genetic testing companies from offering their services to the state’s residents and last week sent letters to 13 firms saying they are violating state law. The companies have time till today June 24 to respond to the notice. While New York State warned several companies that genome tests could not be performed on samples from New York residents without formal state approval.

CDPH requirements mandate that

  1. Any business offering genetic tests to California residents must be licensed as a clinical laboratory in California
  2. The laboratory must have must have a CLIA certificate for laboratory testing
  3. All genetic tests must be ordered by a licensed physician

The 3rd part of the requirements mean the end of DIY genetic testing and more headches for companies in coming weeks.

Google-backed 23andMe and Navigenics are also included in the list of companies that received the notice The major companies, including 23andMe, Navigenics, and Decode Genetics have issued statements confirming that theya re using CLIA registered laboraotries for the testing DNA genotyping. 23andMe partners with Illumina, while Navigenics collaborates with Affymetrix.

Steven Murphy compared these companies to napster check out his blog post1 post2 on this subjetcs. He is certainly not likely to be excited to learn that 23andMe has launched a wiki page called 23andWe to recruit its customers to participate in studies trying to shed additional light on genetic predispositions for certain diseases and adverse drug reactions.

23andMe has maintained that it is not selling a medical service but rather giving people access to their genetic information. They company prefers to call its 23andWe study participants “customers” and not “patients,” . Smart move but lets see if CDPH is going to buy that argument.

But today 23andMe shot back to CDPH that they’ll be doing neither cease nor desist. We believe we are in compliance with California law and are continuing to operate in California at this time,” the company said in a statement released to Wired.com

The company has has argued that the testing they provide isn’t a prevention aid, but merely offers “individuals contextual information about their genetic makeup, including ancestry and applicable scientific research.”

Genetics Influence Blood Preassure medication

The study published in Jan. 23 issue of the Journal of the American Medical Association  is a thumps up for those interested towards personalized medicine, a small but important step.

A person’s genetic make-up seems to influence how he or she reacts to certain hypertension medications. The new study focused on the NPPA (atrial natriuretic precursor A) gene, which is involved in forming atrial natriuretic polypeptide, which acts as a diuretic.

n all, 38,462 people with hypertension underwent genotyping [genetic testing] and were randomly assigned to receive a diuretic (chlorthalidone) or one of the following three drugs: a calcium channel blocker (amlodipine); an angiotensin converting enzyme inhibitor (lisinopril); or an alpha-blocker (doxazosin).

people with hypertension and two different NPPA genotypes (known as NPPA G664A and NPPA T2238C) responded differently to different medications.

UK Government-backed sociology study using Genetics raises privacy concerns

The Uk government backed UK Household Longitudinal Study to use genetics analysis of British citizens (previous post on UK BioBank) to assess impact of Genetics and lifestyle in health and medical treatment and how it affects people’s social and economic status over time, is turning into controversy. The expansion of the program to cover “nature versus nurture” questions through genetic and medical testing has raised fears among civil liberties campaigners.

More than 100,000 people, including children as young as 10, will be asked to provide saliva tests and DNA samples in a new annual survey of the lives, behaviour and beliefs of people in the United Kingdom.

I thought of how we are going to look at privacy concerns at such government backed studies, Take a look at the blog by Deepak Singh Your personal health: The internet and privacy

Even though participation is voluntary The plan has been denounced by civil rights campaigners. ‘I would not let my DNA details be taken in this way,’ said Richard Clayton, the barrister representing the rights group Liberty in its fight to prevent police from keeping DNA samples of suspects later cleared of wrongdoing as quoted on The Observer

Details of the study is available at the University Essex website of UK Household Longitudinal Study

Searching Through DNA – Impact of new genetics technologies in American Life

One of the reader had posted a question about my earlier post on genetics of Transplant Organ Rejection so this post is a part answer to her comment, I choose the title american way of life as my first post in 2008 is not mine but an interesting article from Newyork Times

A good article about what can we expect from genomics in clinical decision making and therapeutics

microarray-based Clinical diagnostic tests

 Pathwork Diagnostics, and the Virginia Commonwealth University School of Medicine has initiated an investigational study Genomics-Based diagnostic Test to determine a tumor’s origin so that tissue-specific management can begin.

The test uses microarrays from Affymetrix

More news on Pathworks website 

Oracle Openworld 2007- Personalized Genomics session

Its the time -Personalized Genomics

Advances in genetic information and laboratory technologies mean new ways to diagnose disease and determine patient risk. The wealth of genetic information makes it harder to provide meaningful information. During Oracle OpenWorld 2007 Oracle is presenting how laboratory information systems principles and Oracle customer relationship management and enterprise resource planning applications weave together, using Oracle Fusion Middleware to create a unique platform for translational medicine.


Click here to register now.

Oracle OpenWorld

Experience Innovation. November 11-15, 2007, San Francisco, Moscone Center.

As the Life Sciences industry continues to grow and change, Oracle is there to help you learn, adapt, and succeed.

Please join us this fall in San Francisco as we address some of the biggest challenges facing the Life Sciences industry and how Oracle is prepared to meet those challenges.

Session highlights include:

  • Product Lifecycle Management—At this session, learn how Oracle’s Agile product lifecycle management solutions for Life Sciences improve new product introduction cycle times, reduce direct material and operating costs, and enable cost-effective compliance.
  • A Cure for Clinical Trials: From Data Capture to Submission—Approximately 80,000 clinical trials are being conducted in the United States at any given time. More than half of them are behind schedule by one to six months. Clinical trial sponsors hope to reduce this and other costly delays through the use of IT. Hear how the latest enhancements in Oracle’s industry-leading Life Sciences applications are streamlining the process of data capture, management, analysis, and reporting.
  • Enabling Personalized Medicine in Research and Development—The sequencing of the human genome is yielding exciting new tools to help physicians tailor treatments to individuals and their diseases. This powerful new capability, called personalized medicine, holds great potential to improve patient health. Learn how Oracle’s technology is enabling personalized medicine and improving efficiencies and outcomes in clinical development.

Click here for a full list of Life Sciences sessions.

Registration is now open for the most exciting technology and business conference of the year.
Registration fees go up soon So don’t wait—act now to save $900.

Click here to register now. To receive your special discount, select a registration category and enter keyword: ORF at the bottom of step 2 of the registration process.

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