AstraZeneca Announce Real-World Evidence Data Collaboration

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.

 

How to improve R&D productivity: the pharmaceutical industry’s grand challenge

 

 

personalized medicine might be making drug development more complicated

According to a new report from the Tufts Center for the Study of Drug Development at Tufts University 12 to 50 percent of the drugs companies are developing, depending on the company, involved a personalized medicine approach.

The Tufts report is based on a survey of 25 companies, large and small, to which 16 companies responded, as well as interviews with representatives of 13 companies.

Relatively few drugs are now accompanied by such so-called companion diagnostic tests. They are most common in oncology. The breast cancer drug Herceptin, for instance, is given only to women whose tumors have an abundance of a protein called Her2.

According to the report Other key therapeutic areas in which personalized medicine is making headway include cardiovascular, central nervous system, and immunologic therapies, whereas personalized medicine development is just getting started for metabolic and respiratory therapies, as well as virology.

 

Oracle starts the Oracle Health Sciences Institute (OHSI), in partnership with Sun Labs

The Institute is focused on research that will accelerate IT innovation to advance personalized medicine and the delivery of safe and effective   treatments and health care services to patients around the globe. OHSI will work in tandem with academic research centers, focusing on a targeted set of research areas fundamental to the R&D and health care delivery challenges facing health sciences organizations today. Research priorities currently include: artificial intelligence and semantic technology; genomic, genetic and phenotypic data analysis; data mining to support optimization of clinical trials; and predictive algorithms and other technology to advance patient safety and provide advanced decision support at the point of care.Academic institutions interested in collaborating with OHSI in these focus areas should contact OHSI representatives at Oracle http://linkd.in/bXf98c

Oracle starts Oracle Health Sciences Institute (OHSI), in partnership with Sun Labs. This is exiting news and I hope we get to see the participation of Open Source Drug Development Network (OSDD) and initiative by CSIR India earlier supported by Sun Microsystems

CombiMatrix Molecular Diagnostics Launches Microarray Test for Detection of Autism Spectrum Disorder

CombiMatrix  has completed the clinical validation of the  BAC array CGH based clinical microarray tests. ATScan is designed to detect known genomic copy-number variations  associated with Autism Spectrum Disorder and this test is now available to physicians and consumers.

So Thats how Humans Evolved! – Now we can begin to answer the big question

Which of the thousands of long stretches of repeated DNA in the human genome came first? And which are the duplicates the question have been answered by a team of scientists from University of Washington School of Medicine and University of California, San Diego.The research published by Evan Eichler from the University of Washington School of Medicine provide the first evolutionary history of the duplications in the human genome that are partly responsible for both disease and recent genetic innovations.

Evan Eichler has analyzed segmental duplications in the human genome and have successfully pinpointed the ancestral origin of each and identified the newly named core duplicon.

The study presents a comprehensive global analysis of the evolution of segmental duplications in the human enome. The authors identify the origin of ancestral duplication loci, regions of clustered duplicons, and evidence upporting a punctuated model of evolution.

This work marks a significant step toward a better understanding of what genomic changes paved the way for modern humans, when these duplications occurred and what the associated costs are – in terms of susceptibility to disease-causing genetic mutations.

Apart from the above study  the recently completed (check previous blogs) Genome of the marsupial Monodelphis domestica reveals innovation in non-coding sequences the study helps to explain the evolutionary origins of human DNA and the role played by transposons

Genomes can duplicate long stretches of DNA from one chromosome and insert the duplication in another area of the genome. The resulting segments of DNA are called segmental duplications.  They are important because they hold evolutionary secrets

Finding answers to questions such as, Which set came first? What changes were innovated, when and why? What was sacrificed when an innovation took effect? What is the connection between disease and innovations within segmental duplications?, are important because researchers can then design specific medical treatments and can lead to ket discoveries in  Pharmacogenomics research

Download the Research Article

Gene Logic sells in genomics division

It hardly a week I have wrote about acquisition and mergers , it seems the rain is noit going to stop any time soon, the latest one , to give away the home plate is Genelogic agreeing to sell its genomics division to India HQ Ocimum Biosolutions subject to the authorization of the transaction at a special meeting of shareholders of Gene Logic.

This is a transforming event of significant strategic proportion,” said Charles L. Dimmler, III, President and Chief Executive Officer of Gene Logic.

Genelogic bought its preclinical division from TherImmune, a Gaithersburg company, in April 2003 for $51 million which was sold to Bridge Pharmaceuticals for $15 Million,

Gene Logic Inc said it agreed to sell its Genomics assets to Ocimum Biosolutions Ltd for $10 million in cash. Under the terms of the Ocimum sale agreement, Gene Logic retains full rights in perpetuity to utilize the existing information data bases of its former Genomics business as key elements in building its emerging drug repositioning and development business. Furthermore, the Company will retain specified assets related to molecular diagnostics and will continue to explore strategic alternatives for these assets

The sale is part of the Genelogic new strategy to focus on to build drug repositioning and development business which was decided last year.

Ocium will assume certain liabilities associated with the Genomics assets and business and will pay Gene Logic $7 million at closing and $3 million payable in a promissory note due 18 months from closing.

The purchase includes Gene Logic’s Knowledge Products business including the The BioExpress® System a continually growing genomic database of gene expression data and associated clinical information from over 18,000 human and animal tissues and cell line samples. ToxExpress® a toxicogenomics reference database.

Ocimum will continue to operate the business out of the current state-of-the-art laboratory facility of Gene Logic in Gaithersburg, Maryland.

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.

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. Copyright © 2007, Oracle Corporation and/or its affiliates. All rights reserved.

Transplant Patients Could Live Free of Anti-Rejection Drugs

Scientists from the Lucile Packard Children’s Hospital and the Stanford University School of Medicine have identified a pattern of gene expression shared by a small group of patients who beat the odds and remained healthy for years without medication, after undergoing Organ transplant.

The findings made by Minnie Sarwal, MD, PhD, a pediatric nephrologist at Packard Children’s is a major advantage in organ transplantation treatment. Transplant recipients who share the same pattern of genes but are still on conventional medication may be able to reduce or eliminate their lifelong dependence on immunosuppressive drugs. The study may also help physicians determine how best to induce acceptance, or tolerance, of donor organs in all transplant patients, regardless of their gene expression profiles.

Although the anti-rejection medications, known as immunosuppressants, tamp down the immune system enough to permit lifesaving organ transplants, their benefits come at a price. They also quash the body’s natural response to dangerous invaders, such as bacteria and viruses, and to rogue cancer cells. Transplant physicians prescribing immunosuppressants to their patients walk a fine line between avoiding organ rejection and increasing the risk of infection and cancer

The researchers used microarray, or gene chip, technology to compare gene expression patterns in blood samples from 16 healthy volunteers with those from three groups of adult kidney transplant recipients from the United States, Canada and France

The IBM Clinical Genomics for targeted clinical research

THe Haifa Lab of IBM provides the Technlogy for Clinicalgenomics and leads the research in lifesciences fieds.

The Clinica, Genomics division plans to provide technology to integrate clinial genomics data and HL7 and other complaince protocls followed in clinical research and clinia, trial and integrate them to provide better and focused clinical trials

Clinical genomics for biopharmaceuticals from IBM

the main advatages as per IBM website is that

• Encapsulate raw genomic data into an HL7 Clinical Genomics message, including transformation services of proprietary data formats to standardized formats like MAGE and BSML
• Access patient’s clinical history stored in an enterprise EHR system
• Access all major ontologies that provide genotype-phenotype relationships like OMIM, PharmGKB, etc.
• Parse the encapsulated raw genomic data and bubble-up selected genomic data items based on ontological knowledge as well as the patient clinical data
• Compare two Genotypes (the data model at the heart of the HL7 specs) in order to provide case-based reasoning services to decision support application that will use CGL7 as a specialized clinical genomics middleware
• Find a similar pedigree in case base of pedigrees in order to support risk assessment applications that base their assessment on family history

Pharmacogenomics has started

IT been a long time since my last post, So I thought of catching up with other blogger before going to do anything myslef. So here is what got my attention from Alla Katsnelson blog on the scientist magazine  that  USFDA approved updated labeling for the widely used blood-thinning drug, Coumadin, to explain that people’s genetic makeup may influence how they respond to the drug.

so whats going to be good for common man, the next time (not very soon) you are going to be under treatment of a controversial drug you might get to know how your genetics makeup can affect the treatment, thats going to be a good relief especially cancer patients and those who undergo HRT

while Frost&Sullivan reports in its latest industry update that  genomics platforms that are too inefficient and expensive for ultra-high throughput comprehensive genome-wide analysis are hindering the realization of personal genomics.

Affymetrix expands into personalized medicine The next big thing

Affymetrix expands into personalized medicine! Why because The next big thing in health care? is You the individual

personalized medicine is the place step every one wants to be. Roche recently went after Nimblegen for a small foothold in this developing ssicne field, Now its the turn of Affymetrix the leader in microarray DNA chips.

The company is trying to get ahead of the market curve by partnering with drug companies that are making precisely targeted medicines, tailored for patients who have specific gene variations

the company opened the Affymetrix Clinical Services Laboratory to analyze the genes in blood and saliva samples for pharmaceutical companies, diagnostic laboratory businesses and hospitals

Microarray to detect mutations in largest Human Gene

The average human gene consists of 3000 bases, but sizes vary greatly, with the largest known human gene being dystrophin at 2.4 million bases. Residing at Chromosome 4 it has long been of interest to the medical community because its the gene responsible for huntington’s disease, polycystic kidney disease, a form of muscular dystrophy and a variety of other inherited disorders. Chromosome 2 is noteworthy for being the second largest human chromosome, trailing only chromosome 1 in size. It is also home to the gene with the longest known, protein-coding sequence – a 280,000 base pair gene that codes for a muscle protein, called titin, which is 33,000 amino acids long.

Now reseacrhers at Emory university has developed a microarray based test to chek for mutations in this gene. The current test do not detect all types of mutation that affects 1 in 3500 males according to the university wesbite.

Mutations in the dystrophin such as point mutations in a sequence of DNA can result in mistakes in gene  expression and nonfunctional proteins that causes Duchenne muscular dystrophy (DMD).

A detailed presentation of the advantages of the test is available at the Emory Genetics Testing website. The test offeredon the Nimblegen CGH array platform gains more prominance as the company is now being acquired by Roche who has plans to dominate the clinical microarray market with its products in genetics testing space

The emory university Genetics testing lab offers numerous other genetic tests

Indian genetic database offers R&D advances

Imagine a diabetic patient from NewYork being put on a drug regimen distinct from a patient London. Personalized medicine allows tratement to decided on the genetic make up of the individual. Genetically europeans and asians and others have different ways of responding to same treatment genetically

FortunatelyIf Indian researchers have their way, such customised medication based on genetic differences could be a possibility for a range of illnesses.

A consortium of Indian scientists recently completed a genetic database for India, home to one of the world’s most ethnically diverse populations that will allow researchers to understand the genetic predisposition of ethnic groups to diseases. Icelanders are considered for Human genome project because of very less number such diversity

The genetic map will enable global and Indian pharma companies to enhance research on predictive medicine and targeted drugs. Research firm TCG Life Sciences is about to become the first private player to use the database.

The consortium collected data on the genetic codes of over a 1,000 genes from among 15,000 individuals belonging to Indian sub-populations

Another user of the data is the clinical diabetics’ consortium, which aims to identify if there are specific genetic reasons for a particular ethnic group to be predisposed to the disease. It is already known that some cultures are pre disposed to certain diseases so Indian are more prone to heart attack and diabetes and such

The Indian Genome Variation Consortium, a public-private partnership that networks six Council of Indian Scientific and Industrial Research labs and some private software firms, undertook the genetic variation mapping.

UK is appealing for volunteers to help worlds biggest medical experiment project- to understand impact of Genetics and life style in illness and medical treatment

 UK is appealing for volunteers to help worlds biggest medical experiment project- to understand impact of Genetics and lifestyle in health and medical treatment

The  BBC reports about a medical experiment aiming to be the biggest in the world is appealing for volunteers to help end Scotland’s reputation as the “sick man of Europe”.

The project named as  UK Biobank will be the world’s biggest resource for the study of the role of nature and nurture in health and disease.

Funded and guided under the supervision of leading scientists from the UK and around the world. Funded by the  Wellcome Trust, the UK’s largest independent medical research charity, the  Medical Research Council, the Department of Health, the Scottish Executive and the Northwest Regional Development Agency. and many other major medical research charities, including the British Heart Foundation and Cancer Research UK. The project is also supported by the National Health Service.

claiming to help not just the volunteer, but for the future generation to come the £61m UK Biobank project will track the health of thousands of people for up to 30 years.

Information and DNA gathered from volunteers will be used by researchers to help tackle serious diseases.

Volunteers will be asked to attend an assessment centre where they will fill out a lifestyle questionnaire, have body measurements such as bone density, blood pressure, height and weight recorded, and donate a small sample of blood and urine for long-term storage as a resource for researchers in the future.

Researchers will study the relationship between our genes, our lifestyles and our current health to find out why some people develop certain illnesses and others do not.

It is hoped the project will eventually include 500,000 volunteers from across Britain, making it the biggest study of its type ever undertaken.

The Biobank will run alongside the complementary Generation Scotland project, which focuses on how genes inherited from our parents affect the likelihood of developing diseases.

Data collected by the two projects will be used to help prevent and develop new treatments for cancer, heart disease, diabetes, Parkinson’s, Alzheimer’s, mental health illnesses, osteoporosis and arthritis.

12 DNA tests that Could Change Your Life-selected by Forbes

The complete list is published at forbes website

• Breast Cancer
• Adult-Onset Diabetes
• Obesity
• Drug Metabolism
• Crohn’s Disease
• Prostate Cancer
• Duchenne Muscular Dystrophy
• Rett Syndrome
• Macular Degeneration
• Alzheimer’s Disease
• Heart Attack

Gene Testing:

Related Blogs

eyeondna , gensherpa , OmicsOmics

ASGT unveils new Platform for Regulating Expression of therapeutic Genes

During 10th Annual Meeting of the American Society of Gene Therapy (ASGT) in Seattle a new methid for  Regulating Expression of therapeutic Genes was introduced.

For many applications, gene transfer is being employed to engineer cells for therapeutic applications, chek the following links for article 1 IFR , 2 (Nature), 3 (NIH) , that require precise regulation in order to ensure gene expression in the correct tissue and prevent it in unwanted cell types,

Now, a team of scientists led by Dr. Luigi Naldini at the San Raffaele Telethon Institute for Gene Therapy (HSR-TIGET) in Milan have developed a new design that enable delivered genes to become highly responsive to a cell’s identity with the helps of gene regulation mediated by small RNA molecules, known as microRNA. This is particularly relevant for the emerging field of stem cell gene therapy, in which genes are delivered into a cell that can give rise to many distinct cell types.

MicroRNAs downregulate the expression of specific genes in cells where the gene is not needed, and thereby have an important influence over the identity of the cell.

Addition of microRNA binding sites into their gene delivery vectors results in gene regulation dictated by the cell’s own microRNA. Simply put, they could engineer their gene to be turned off in cells where the microRNA is present.

Dr. Naldini’s group has already begun to successfully exploit microRNA regulation for achieving stable long-term correction of hemophilia in the mouse model and for improving the safety of hematopoietic stem cell gene therapy.

Genes add up risk of autoimmune disease

Geneticists have identified a link between the number of copies of a specific gene an individual has and their susceptibility to autoimmune diseases like lupus.

The research by Professor Tim Aitman of the Medical Research Council Clinical Sciences Centre at Imperial College London, and colleagues, is published in Nature Genetics.

From Medical News 

Microarray based DRUG DISCOVERY and CLINICAL DIAGNOSIS and biosensor designed to identify viruses

 Prof. David Dandy of Colorado State University chemical and biological engineering has proven that called microarray assays can be used for biomedical disease and drug screening assays could rapidly increase drug discovery,

Although not ready for hospital or office use, microarrays represent a novel miniaturized multi-spot diagnostic format that has huge potential for patient diagnosis if found reliable and approved.

Smaller is often better, according to a new scientific study that appears this week in the Proceedings of the National Academy of Sciences by Professor David Dandy, head of the Department of Chemical and Biological Engineering at Colorado State. Dandy co-wrote the paper with David Grainger, a former chemistry professor at Colorado State who now is chair of the Department of Pharmaceutics & Pharmaceutical Chemistry at the University of Utah.

The study was funded by a multi-year, $2.5 million grant from the National Institutes of Health.

“This work is extremely useful from an industrial perspective,” said Michael Lochhead, chief scientist at Accelr8 Technology Corp., a Denver-based developer of innovative materials and instrumentation for advanced applications in medical instrumentation, basic research, drug discovery, and bio-detection.

The critical importance of this work is illustrated by the fact that, to date, a single microarray-based test has been approved by the FDA for clinical use.

According to Roche, the manufacturer of this diagnostic microarray, “This test analyzes a patient’s Cytochrome P450 2D6 and 2C19 genotypes from genomic DNA extracted from a blood sample. Test results will allow physicians to consider unique genetic information from patients in selecting medications and doses of medications for a wide variety of common conditions such as cardiac diseases, pain and cancer.”

 

 

‘Personalized Medicine’ Goal of Human Genetics Initiative

Oregon Health & Science University effort, launched 25-April 2007 during National DNA Day, will meld genetics and clinical care

OHSU today is launching the Human Genetics Initiative (HGI), an effort that brings together the university’s vast array of genetics research resources and brainpower, and applies them in a health care setting. It will allow the university to seek new ways of understanding the role of genetics in common disorders like obesity, hypertension, osteoporosis and diabetes.

The goal of HGI is to accelerate the translation of scientific knowledge to patient care by recruiting new geneticists, building a campuswide bank of advanced technology, developing new educational programs for the next generation of health care providers, and, eventually, establishing a novel delivery model for genetics health care.