Archive for the ‘Personalized Medicine’ Category

IRVINE, Calif. and AMSTERDAM, Aug. 9, 2012 /PRNewswire/ -- Agendia, an innovative molecular cancer diagnostics company and leader in personalized medicine, today announced that Stefan Gluck, MD, PhD, will lead the company's Medical Advisory Board. As Chairman, Dr. Gluck is assembling a panel of leading medical oncologists, surgeons, scientists and pathologists to play a key role in advising Agendia on the clinical application of its extensive product pipeline, including its Symphony suite of FFPE based tests for breast cancer and its ColoPrint test for colon cancer.

"Agendia is at the forefront of the personalized medicine revolution, and as a medical oncologist, I am very excited and honored to collaborate with the company at such a critical time," said Dr. Gluck. "With a robust pipeline of new cancer profiles in development, I look forward to applying my knowledge and expertise to facilitate diagnosis, prognosis and cancer diagnostic development."

Dr. Gluck is a Sylvester Professor at the Miller School of Medicine at the University of Miami in Florida. From 20032008, he was the Clinical Director of the Braman Family Breast Cancer Institute. Before his move to Miami, Dr. Gluck was Director, Southern Alberta Breast Cancer Program at the Tom Baker Cancer Center, and a Professor in the departments of oncology, medicine, pharmacology and therapeutics at the University of Calgary in Alberta, Canada, and Deputy Head, Department of Oncology at the University of Calgary.

"Dr. Gluck brings over 20 years of clinical experience in the medical profession to Agendia's Medical Advisory Board," said David Macdonald, CEO of Agendia. "Agendia is committed to advancing the future of personalized medicine through the development of new diagnostic tests. Dr. Gluck's extensive knowledge and vast experience will provide our Medical Advisory Board with strong leadership as we continue to bring Agendia's rich product pipeline to market."

Dr. Gluck was presented the America's Top Oncologists award from Consumers' Research Council of America. He was also recognized as one of the Best Doctors in America from 2006 through 2012. He has authored or co-authored more than 200 articles. In addition, Dr Gluck has written or co-written a number of book chapters and numerous journal abstracts, and he has presented more than 350 papers at national and international meetings.

Dr Gluck completed his medical studies at the Free University of West Berlin, Germany. The internship in Berlin was followed by residency in internal medicine and fellowship in hematology at the Heinrich Heine Universitat in Dusseldorf, Germany, and a medical oncology and bone marrow transplant fellowship at the Princess Margaret Hospital, University of Toronto in Canada.

About Agendia:

Agendia is a leading molecular diagnostic company that develops and markets genomic-based diagnostic products, which help support physicians with their complex treatment decisions. Agendia's breast cancer Symphony suite was developed using unbiased gene selection, analyzing the complete human genome, ensuring 100% definitive results for cancer patients. Symphony includes MammaPrint, the first and only FDA-cleared IVDMIA breast cancer recurrence assay, as well as BluePrint, a molecular subtyping assay, TargetPrint, an ER/PR/HER2 expression assay, and TheraPrint, an alternative therapy selection assay. Together, these tests help physicians determine a patient's individual risk for metastasis, which patients will benefit from chemo, hormonal, or combination therapy, and which patients do not require these treatments and can instead be treated with other less arduous and less costly methods.

In addition to the Symphony suite of tests, Agendia has a rich pipeline of genomic products in development. The company collaborates with pharmaceutical companies, leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology and is a critical partner in the ISPY-2 and MINDACT trials.

For more information, please visit http://www.agendia.com.

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Agendia Appoints Dr. Stefan Gluck to Chair Medical Advisory Board

BETHLEHEM, Pa., Aug. 6, 2012 /PRNewswire/ -- Saladax Biomedical, Inc., a privately held company developing and commercializing novel diagnostic assays to achieve the promise of personalized medicine for new and existing therapeutics, announced today the company has expanded its existing relationship with Bristol-Myers Squibb Company (BMY) by entering into a Master Early Development Collaboration Agreement, which may include multiple feasibility studies and companion diagnostic development projects. With the signing of this agreement, the companies have already initiated a new companion diagnostic project in an undisclosed field. Terms of the agreement were not disclosed.

"Saladax is delighted to continue working with Bristol-Myers Squibb to deliver on the promise of personalized medicine," said Kevin M. Harter, president and CEO of Saladax. "Building on our previous work together, which resulted in clinically valuable Alzheimer's disease assays, we're eager to continue marrying the scientific and clinical knowledge of Bristol-Myers Squibb and Saladax to improve the lives of patients in other clinical areas."

Saladax and Bristol-Myers Squibb originally entered into a collaboration in 2010 for the development of clinical diagnostic tests for Alzheimer's disease to be used in conjunction with the development of certain therapeutic compounds in the Bristol-Myers Squibb pipeline. In 2011, that partnership was expanded to include a commercial partner, Johnson & Johnson's Ortho Clinical Division.

About Saladax Biomedical, Inc.

Saladax Biomedical develops novel diagnostic assays for the practical delivery of personalized medicine. Our proprietary line of MyCare assays improves the efficacy of existing drugs by optimizing the dose administered for each individual patient. Saladax's initial focus is oncology, with a portfolio of 13 chemotherapy drug assays in various stages of development. Three MyCare assays, My5- FU, MyPaclitaxel and MyDocetaxel, are currently offered to the oncology community in some markets.

The company's MyCare technology platform is broad and flexible, enabling wide application in many therapeutic categories. This technology capability also enables Saladax to serve as a valuable partner to pharmaceutical and biotechnology companies in the development of companion diagnostics (CDx), addressing multiple risks and challenges encountered in drug development.

The company was founded in 2004 and is headquartered in Bethlehem, Pennsylvania. Saladax is ISO 13485:2003 certified.

Saladax Biomedical, Inc.

Kevin M. Harter

President and Chief Executive Officer

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Saladax Biomedical Enters into Master Collaboration Agreement with Bristol-Myers Squibb

Public release date: 26-Jul-2012 [ | E-mail | Share ]

Contact: Michael Bernstein m_bernstein@acs.org 202-872-6042 American Chemical Society

A new genre of medical tests which determine whether a medicine is right for a patient's genes are paving the way for increased use of personalized medicine, according to the cover story in the current edition of Chemical & Engineering News. C&EN is the weekly newsmagazine of the American Chemical Society, the world's largest scientific society.

Celia Henry Arnaud, C&EN senior editor, points out that the U.S. Food and Drug Administration has approved several precedent-setting cancer drugs that provide a glimpse of the "personalized" medical care that awaits patients with cancer and other diseases in the future. Personalized medicine involves selecting treatments that work best with the set of genes present in each individual person. Such treatments work only for patients with conditions related to mutations, or alterations, in certain genes.

The article describes new "companion diagnostics," or diagnostic tests that already have gone into use, with more on the horizon, to identify patients most likely to benefit from a medication. Doctors must perform these tests before starting treatment. Arnaud describes how pharmaceutical companies are embracing an approach that involves co-development of drugs and companion diagnostics that can be used in clinical trials and later when a medication goes into general use.

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A new genre of diagnostic tests for the era of personalized medicine

An ongoing legal battle over gene patents has led many scientists to ask whether such claims help or hinder research. That question will be debated once more on 20 July when Myriad Genetics, a diagnostic company in Salt Lake City, Utah, returns to the US courts to argue that its patents on theBRCA1 and BRCA2 gene variants linked to inherited breast and ovarian cancer are valid. Currently, the patents give Myriad exclusive rights to conduct diagnostic tests on the genes. The judges are expected to issue an opinion by late summer. The case is important because thousands of genes have been patented in the United States, and no one is sure what will happen if the judges rule Myriad's patents invalid. Natureexamines what the Myriad case means to biotechnology and genetic medicine.

An argument over whether isolated DNA is patentable is at the centre of a US court case on existing gene patents.

Alfred Pasieka/Getty Images

In the United States, 'laws of nature' are not able to be patented, along with abstract ideas. The argument against Myriad's patents centres on whether isolated DNA is the same as native DNA, which is defined as a law of nature. If the court decides that the patents are invalid, that ruling would reverse more than 20 years of precedent, during which companies and academic researchers have patented thousands of genes. Some of these genes form the basis of diagnostic tests that determine when someone might respond well to a given therapy, or whether theyre at risk of a disease or a drug side effect, for example.

Although the courtsupheld Myriads patents in July 2011, the Supreme Court ordered the Appellate Court to reconsider the case in light of a ruling in March 2012 against the diagnostics company Prometheus Laboratories in San Diego, California (see 'US Supreme Court upends diagnostics patents'). Prometheus held patents on a method of determining drug dosage for a patient on the basis of the amount of certain components in their blood. According to the judge, this test merely reiterated a law of nature the relationship between the concentration of blood components and the likelihood that a drug dosage will be harmful or ineffective. Legal briefs recently filed by the US Department of Justice urge the judges to consider whether Myriad's patents 'tie up' the future use of laws of nature, as decided in the case against Prometheus.

Yes, according to the American Civil Liberties Union (ACLU) in New York, a legal group that represents the plaintiffs in the case, who include researchers, scientific societies and women with cancer. By claiming a law of nature, they can stop every other lab from performing tests, even with different testing methods, says ACLU attorney Sandra Park. Although there are some 8,000 publications on BRCA genes, which testify to the fact that research on the genes is ongoing, Myriad prevented at least five researchers who are some of the plaintiffs in this case from testing women in-house as part of their academic studies. Its within [Myriads] power to give licences to scientists, Park says, but the way theyve exercised their rights shows that they are intent on maintaining a monopoly. Legal briefs filed by DNA co-discoverer James Watson urge the judges to consider whether the patent leaves the public free to study the genes encoding BRCA1 and BRCA2.

Venture capitalists would be reluctant to invest in a small biotechnology firm if there was no secure patent protection, says Hans Sauer, an intellectual-property lawyer at the Biotechnology Industry Organization in Washington DC, a trade association for biotech companies that has filed a brief in favour of Myriad. Its already quite hard to get good patent protection in the area of personalized medicine, and theMyriadcase adds another layer of complexity, he notes. Companies will still be able to patent genes if Myriad loses its case, but the patents might need to be more narrowly defined and so might not protect companies as effectively, he predicts. For example, a patent might protect a kit that detects specific mutations within a gene associated with causing colon cancer, the result of which helps physicians to tailor their patients treatment. The issue with narrower patents, however, is that other companies can design tests that detect different mutations, or they could develop kits that detect the same mutations using different reagents.

Scientists tend to ignore patent claims on genes or genetic diagnostic methods because the patent-holding companies generally reserve litigation for individuals who seek to profit from their product, Sauer says. Researchers have occaisonally been issued cease and desist letters to stop them working on patented genes but these cases rarely, if ever, result in lawsuits. One way to increase researchers security might be to explicitly allow experimental use exceptions, as occurs in European patent law. It works well in other countries, says Sauer, so I dont see why it wouldnt work here.

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The great gene-patent debate

By Tony Daltorio - July 20, 2012 | Tickers: A, BMY, LLY, QGEN, RHHBY.PK | 0 Comments

Tony is a member of The Motley Fool Blog Network -- entries represent the personal opinions of our bloggers and are not formally edited.

Nearly every investor has heard about the patent cliff facing the major pharmaceutical companies. But there is another, quiet revolution occurring in the pharmaceutical sector right nowwhich very well may change its current business model drastically. That revolution is 'personalized medicine.'

Personalized medicine is the result of advances in genetics and molecular biology. While still in its early stages, it promises improvements in patients' treatment while at the same time reducing healthcare expenditures. It does so through molecular biology and the use of diagnostic tools, which is pivotal to determine whether an individual patient will benefit from a particular drug used to treat a specific disease such as cancer.

A recent advance in personalized medicine happened when the U.S. Food and Drug Administration approved a test called Therascreen from Qiagen NV (NASDAQ: QGEN) that will be used in conjunction with the drug Erbitux (used for colorectal cancer) that ismarketed by Eli Lilly (NYSE: LLY) and Bristol-Myers Squibb (NYSE: BMY). The test will allow the two companies to identify the 60 percent of patients who do not have a mutation in the KRAS gene and will benefit from the drug, thus avoiding giving the drug to patients who do have the mutation and will not benefit.

Based on history, this should be a big boost for sales of Erbitux. AstraZeneca's lung cancer drug Iressa, launched in 2002, had little success because of its high failure rate. But after a diagnostic test was developed in 2009, sales began to grow as the 10 percent of patients (with an EGFR mutation) helped by the drug were identified.

Theokayfor Therascreen is a milestone since the FDA has only approved a handful of drugs with companion tests over the past decade. Perhaps best known is Herceptin from Roche ADR (NASDAQOTH: RHHBY.PK), which is given to the quarter of women with breast cancer that have a so-called over-expression of the Her2 gene. The diagnostic test is a joint venture of Genentech, now owned by Roche, and the Danish diagnostics company Dako which is now owned by Agilent Technologies (NYSE: A). Agilent bought Dako in June for $2.2 billion in cash from the Swedish private equity firm EQT.

The recent FDA approval underscores the growing importance of 'companion diagnostics' used to analyze a patient's genetics to determine whether that patient will benefit from a specific drug. This may change pharmaceutical companies' entire business models to include companion diagnostics with all of their major drugs on the market. For example, Roche says that 60 percent of the drugs in its current pipeline are linked to a companion diagnostic.

Think about it...in the future, such diagnostic testing will nearly eliminate failure of drugs to work in certain patients and those costly side effects will be avoided because drugs will only be given to patients where the genetics have been determined to be compatible with the drug.

Even though some drug companies are keeping the companion diagnostics in house, the advancement of personalized medicine is potentially great news for companies in the diagnostics business such as Agilent Technologies, which is expanding its life sciences business into a fourth division at the firm, and Qiagen, which already manufactures 30 companion diagnostic tests.

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Personalized Medicine Plus Diagnostics Equals Profits for Investors

Newswise Personalized medicine has promised to radically change the way we look at health and disease. Talk of tailored drug therapies and early detection of cancer has captured the attention of scientists and lay people alike. So when will patients start to reap the benefits of this medical revolution?

The transition to personalized medicine wont be seamless or swift, says Lee Gutkind, who co-authored "An Immense New Power to Heal: The Promise of Personalized Medicine" (In Fact Books, May 2012) with novelist and science writer Pagan Kennedy. The authors explain the complex world of personalized medicine in an engaging, approachable story-telling style.

Gutkind is the distinguished writer in residence at ASUs Consortium for Science, Policy & Outcomes (CSPO) and a professor in the Hugh Downs School of Human Communication in the College of Liberal Arts and Sciences. He is also the founder and editor of the journal Creative Nonfiction.

In researching the book, Gutkind learned the tremendous potential for personalized medicine, and the obstacles keeping doctors from putting it into practice.

Giving up turf One aspect of personalized medicine involves the use of genetics to get a detailed and accurate picture of human DNA and how it responds to disease. When the first complete human genome was sequenced in 2007, scientists gained insight into how genetic variations can predict certain diseases and disorders. The idea is that having access to genetic information will allow health care providers to take a more preventative approach to caring for patients.

However, physicians are traditionally reluctant to adopt new technologies. Most primary care doctors have little training in genetics, and many have never even heard the term personalized medicine.

When I started this book between 2007 and 2008, I could go to physicians in major medical centers across the United States and say the phrase personalized medicine, and at least half of those people wouldnt even know what it was, Gutkind says. Again and again, I had to define personalized medicine for the people who ought to have known 10 years ago what it meant.

Of the physicians who were aware of personalized medicine, few seemed eager to share their knowledge with colleagues and patients. Even most medical schools have yet to amend the curriculum to include genetics and personalized medicine. Gutkind attributes this to a lack of understanding of the importance and potential of personalized medicine. It also speaks to the physicians unwillingness to give up turf to the field of genetics, an area they may know little about.

We want a revolution in health care, but we are not making the transition, Gutkind says.

The meaning of genes Its understandable that doctors with no training in genetics would be wary of personalized medicine. But Gutkind was surprised to learn that even for a geneticist, garnering useful health information from genetic data is no easy task.

Read more from the original source:
Book Explores the Promise, Pitfalls of Personalized Medicine

IRVINE, Calif. and AMSTERDAM, July 10, 2012 /PRNewswire/ -- Agendia, an innovative molecular cancer diagnostics company and leader in personalized medicine, today announced that Dr. Mark Gittleman, Medical Director of Breast Care Specialists and Advanced Breast Care Imaging, has joined the company's Medical Advisory Board. The board will play a key role in advising Agendia on the clinical application of its extensive product pipeline, including its Symphony suite of tests for breast cancer and its ColoPrint test for colon cancer.

(Photo: http://photos.prnewswire.com/prnh/20120710/NY37010 )

"I have been impressed by the science and methodologies behind Agendia's product development, the conversion of their tests to an FFPE format and the numerous validation studies that have been published to date," said Dr. Gittleman. "These tests have been extremely useful in appropriately directing targeted systemic therapy for my breast cancer patients. For these reasons, I am pleased to have been asked to join Agendia's Medical Advisory Board, and I look forward to contributing and sharing new ideas to reach our common goals."

As a breast cancer specialist, Dr. Gittleman has a vested interest in new technologies that enable medical professionals to better understand the biology of breast cancer, thereby helping patients attain better outcomes through the application of validated, clinically useful technologies such as Agendia's MammaPrint, BluePrint, TargetPrint and TheraPrint gene profiling tests. He is a past president of the American Society of Breast Surgeons. Dr. Gittleman currently serves on the ASBS Coding and Reimbursement and Breast Imaging Technology committees and is a reviewer for Ultrasound and Stereotactic certification applicants.

"With his vast knowledge and experience in breast imaging and minimally invasive biopsy techniques, Dr. Gittleman brings a unique perspective to our growing Medical Advisory Board," said David Macdonald, CEO of Agendia. "As Agendia invests significantly in clinical research studies to support the use of new diagnostic tests, our Medical Advisory Board will be an integral part of our clinical trial development. We look forward to working with Dr. Gittleman in our efforts to advance the future of healthcare and bring personalized medicine to breast and colon cancer patients."

About Agendia:

Agendia is a leading molecular diagnostic company that develops and markets genomic-based diagnostic products, which help support physicians with their complex treatment decisions. Agendia's breast cancer Symphony suite was developed using unbiased gene selection, analyzing the complete human genome, ensuring 100% definitive results for cancer patients. Symphony includes MammaPrint, the first and only FDA-cleared IVDMIA breast cancer recurrence assay, as well as BluePrint, a molecular subtyping assay, TargetPrint, an ER/PR/HER2 expression assay, and TheraPrint, an alternative therapy selection assay. Together, these tests help physicians determine a patient's individual risk for metastasis, which patients will benefit from chemo, hormonal, or combination therapy, and which patients do not require these treatments and can instead be treated with other less arduous and less costly methods.

In addition to the Symphony suite of tests, Agendia has a rich pipeline of genomic products in development. The company collaborates with pharmaceutical companies, leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology and is a critical partner in the ISPY-2 and MINDACT trials.

For more information, please visit http://www.agendia.com.

For further information, please contact: Post+Beam Melissa Hurley Tel: +1 646 442 2773 E-mail: hurley@postandbeam.is

See original here:
Agendia Welcomes Dr. Mark Gittleman to Expanding Medical Advisory Board

SAN DIEGOand ANN ARBOR, Mich., July 10, 2012 /PRNewswire/ --Everist Genomics (EGI), a privately held personalized medicine company developing innovative diagnostics for oncology and cardiovascular disease, announced today that it will open a new lab at Johnson and Johnson's Janssen Labs, a new life science innovation center, based in San Diego. Out of the more than 300 companies that have applied for space at the state-of-the-art facility, only 15 companies, including EGI, have been selected to date by Janssen Labs.

Janssen Labs, which opened in January 2012, provides its resident life science companies access to world-class infrastructure, equipment and resources to help advance research and development aimed at advancing medical care. Resident companies are chosen by a selection committee consisting of senior Johnson and Johnson management based on a comprehensive review that includes the prospective companies' business plans and financial projections. The companies are evaluated across a number of criteria, including:

"In the biotechnology sector, San Diego is seen as one of the world's biggest hotbeds of innovation, and Johnson and Johnson stands in a class of its own with regards to innovation in research and development," said Alex Charlton, Executive Vice Chairman of EGI Charlton. "The expansion of EGI into Janssen Labs represents an exciting opportunity for us to showcase the unique capabilities of our diagnostics, prognostics and therapeutic selection technologies, which are underpinned by the company's strong IP position. Ultimately, we expect this initiative to support our entire business strategy, from new product development to marketing and sales, catalyzing both short-term and long-term growth opportunities."

EGI plans to open its Janssen Labs satellite laboratory in Q3 2012, enabling the company to achieve greater cost efficiencies across its business by sharing resources such as equipment and administrative support services with other companies at the facility. By locating the company's new laboratory in one of the world's top global biotechnology hubs, the company can evaluate opportunities for partnerships with other life science companies. EGI also sees tremendous added value by having close proximity to Silicon Valley.

Charlton added that while the terms of the Janssen Labs program does not require resident companies to contract with Johnson and Johnson on any research and development or commercialization plans, it ensures that EGI is on the radar screen of the multinational life sciences leader. "There is no obligation for companies operating at Janssen Labs to work or partner with Johnson and Johnson," Charlton said. "But as a natural result of our proximity to Johnson and Johnson, there is a potential to develop such relationships with the company in the future."

EGI has already begun marketing a number of products in areas such as colorectal cancer and cardiovascular disease through its ongoing R&D programs and industry partnerships. The company launched its first companion diagnostic test, OncoDefender-CRC, in June 2011 and has already distributed more than 6,000 OncoDefender-CRC test kits to hospitals around the country. In March 2012, the company expanded its companion diagnostics portfolio and began marketing three new testsOncoSelector, OncoDefender-MMR and OncoDefender-Lynch Syndrome. Through several strategic product acquisitions, the company has also entered the cardiovascular space, launching two new mobile health diagnostics, CardioDefender and AngioDefender. These devices integrate novel sensor technology with mobile digital services, smartphones and other mobile devices to provide flexible monitoring and diagnosis of cardiovascular conditions that traditionally have been limited to observation through legacy hospital diagnostic systems.

At the company's new laboratory at Janssen Labs, EGI will focus on continuing to build out its colorectal cancer and cardiovascular disease portfolios, leveraging its proprietary machine learning algorithm, Evolver, to identify and assess new biomarkers that are relevant to disease prognosis and treatment. EGI is also exploring new technologies and platforms designed to advance treatment planning in other indications, such as metabolic disease

(Photo: http://photos.prnewswire.com/prnh/20120710/NY36911) CardioDefender The world's first hospital quality ECG on a smartphone

About Everist Genomics

Everist Genomics, Inc. (EGI) is a personalized medicine company, which develops and commercializes medically unique diagnostics, prognostics and therapeutic selection technologies. EGI is focused on rapidly growing disease areas with major unmet needs, including cancer, cardiovascular disease and metabolic disease (e.g. diabetes). EGI's innovative products successfully integrate with mobile digital services, smartphones and tablet computers resulting in advanced medical technology, which until now has been confined to the hospital setting. For online information about Everist Genomics, please visit http://www.everistgenomics.com.

Original post:
Everist Genomics Awarded Admission to Johnson and Johnson's Life Science Innovation Center

IRVINE, Calif. and AMSTERDAM, July 9, 2012 /PRNewswire/ -- Agendia, an innovative molecular cancer diagnostics company and leader in personalized medicine, today announced a key addition to their executive team with the appointment of Glen Fredenberg as CFO and Vice President of Finance.

"It is a very exciting time with the recent launch of Agendia's Symphony suite of tests in an FFPE format as well as the ColoPrint recurrence test for stage II colon cancer prognosis and prediction," said Fredenberg. "As a cohesive executive team, we are poised to bring Agendia to the next level."

Fredenberg has more than twenty years of experience with financial management and corporate governance, primarily in the clinical laboratory industry. Previously, Fredenberg was the CFO at US Labs in Irvine, California, which grew from $1 million in revenue to more than $80 million in revenue and was then successfully sold to LabCorp in 2005. Most recently, he has been the CFO at Clarient in Aliso Viejo, California, which has grown to $140 million in revenue and was successfully sold to GE Healthcare in late 2010. Fredenberg holds a Bachelor of Science in Business Administration from California State University, Fullerton, and is a licensed Certified Public Accountant.

"The addition of Glen Fredenberg to our executive team will have a tremendous impact on Agendia and will accelerate our progress in the molecular diagnostics industry," said David Macdonald, CEO of Agendia. "Our team is focused on the commercialization of our current breast and colon cancer Symphony suite of tests as well as the development of our personalized medicine pipeline."

About Agendia:

Agendia is a leading molecular diagnostic company that develops and markets genomic-based diagnostic products, which help support physicians with their complex treatment decisions. Agendia's breast cancer Symphony suite was developed using unbiased gene selection, analyzing the complete human genome, ensuring 100% definitive results for cancer patients. Symphony includes MammaPrint, the first and only FDA-cleared IVDMIA breast cancer recurrence assay, as well as BluePrint, a molecular subtyping assay, TargetPrint, an ER/PR/HER2 expression assay, and TheraPrint, an alternative therapy selection assay. Together, these tests help physicians determine a patient's individual risk for metastasis, which patients will benefit from chemo, hormonal, or combination therapy, and which patients do not require these treatments and can instead be treated with other less arduous and less costly methods.

In addition to the Symphony suite of tests, Agendia has a rich pipeline of genomic products in development. The company collaborates with pharmaceutical companies, leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology and is a critical partner in the ISPY-2 and MINDACT trials.

For more information, please visit http://www.agendia.com.

For further information, please contact: Post+Beam Melissa Hurley Tel: +1 646 442 2773 E-mail: hurley@postandbeam.is

Read more:
Agendia Names Industry Veteran Glen Fredenberg CFO and Vice President of Finance

BETHLEHEM, Pa., July 9, 2012 /PRNewswire/ -- Saladax Biomedical, Inc., a privately held company developing and commercializing novel diagnostic assays to achieve the promise of personalized medicine for new and existing therapeutics, announced today the company has achieved CE mark registration for its MyPaclitaxel and MyDocetaxel therapeutic dose management (TDM) MyCare assays, enabling commercialization in the European Union (EU).

Saladax's MyCare technology platform offers automated, rapid, robust and cost-effective in vitro diagnostic tests for patient-specific chemotherapy dose optimization. These new tests enable a physician to determine the optimal treatment effectiveness/toxicity balance for each unique patient.

"We are gratified to expand our offering of MyCare tests to cancer patients in the EU," said Kevin M. Harter, president and CEO of Saladax. "There is a significant need to provide patients personalized drug dosing to achieve optimal therapeutic benefits while at the same time maintaining a high quality of life. Our MyCare tests, which measure the concentration of paclitaxel or docetaxel in patients' blood, give oncologists the objective information they need to adjust their patients' dose to their individual needs. Adding MyPaclitaxel and MyDocetaxel to the already available My5-FU assay will allow us to help an even broader segment of patients."

Approximately 225,000 cancer patients in the EU are treated with the taxane drugs annually. Paclitaxel is predominantly used to treat ovarian, breast, non-small cell lung (NSCLC) and uterine cancers. Similarly, docetaxel is used to treat breast cancer and NSCLC, but is also an important component of prostate and head and neck cancer treatment regimens. Both of these drugs cause serious toxic side effects, with upwards of 80% to 90% of patients suffering fromlow white blood cell counts that leave patients susceptible to serious and even life-threatening infections.

Both paclitaxel and docetaxel are typically dosed based on a body surface area (BSA) calculation, which does not account for how individuals absorb and clear medications from their bloodstream. Research has demonstrated that patients' reactions to receiving similar BSA-based doses of paclitaxel and docetaxel can vary dramatically. For example, patients receiving the same initial amount of these chemotherapy drugs have been found to metabolize them at very different rates resulting in different levels in the bloodstream. When a patient metabolizes the drug too quickly, there is not enough drug in the bloodstream to kill the cancer cells. Conversely, when a patient metabolizes the drug too slowly, the drug blood level can be very high and cause toxicity. This can compromise treatment benefits to patients and cause premature termination of treatment. Saladax developed the MyPaclitaxel and MyDocetaxel assays to enable oncologists to measure their patients' blood drug levels and adjust the dose for those who are at high risk of serious side effects.

Saladax Biomedical develops novel diagnostic assays for the practical delivery of personalized medicine. Our proprietary line of MyCare assays improves the efficacy of existing drugs by optimizing the dose administered for each individual patient. Saladax's initial focus is oncology, with a portfolio of 13 chemotherapy drug assays in various stages of development. Three MyCare assays, My5-FU, MyPaclitaxel and MyDocetaxel, are currently offered to the oncology community in some markets.

The company's MyCre technology platform is broad and flexible, enabling wide application in many therapeutic categories. This technology capability also enables Saladax to serve as a valuable partner to pharmaceutical and biotechnology companies in the development of companion diagnostics (CDx), addressing multiple risks and challenges encountered in drug development.

The company was founded in 2004 and is headquartered in Bethlehem, Pennsylvania. Saladax is ISO 13485:2003 certified.

Saladax Biomedical, Inc. Adrienne Choma, Esq. Sr. VP & Chief Marketing Officer achoma@saladax.com

Media Contact: Tiberend Strategic Advisors, Inc. 212-827-0020 Andrew Mielach amielach@tiberend.com or Claire Sojda csojda@tiberend.com

Continued here:
Saladax Biomedical, Inc. Extends Availability of its MyCare™ Portfolio in Europe

BOSTON--(BUSINESS WIRE)--

Inform Genomics, Inc., a private company focused on developing novel platforms of genomic based personalized medicine products for cancer supportive care and inflammatory diseases, today announced preliminary results from its initial study for its lead product, OnPART, which is designed to determine an individuals risk of side-effects associated with chemotherapy regimens based on his or her individual genomic profile. The study utilized advanced Bayesian network technology to identify (single-nucleotide polymorphism) SNP networks associated with common side-effects of chemotherapy regimens. In the plenary session Molecular Predictors in Supportive Care, Dr. Stephen T. Sonis, D.M.D., D.M.Sc. who is a co-founder of Inform Genomics and also a Clinical Professor of Oral Medicine at the Harvard School of Dental Medicine, reported that for patients receiving dose-dense doxorubicin, cyclophosphamide, plus paclitaxel (AC+T) a preliminary SNP network correctly identified patients at risk for chemotherapy-induced diarrhea with an accuracy of 96.7% and an area under the receiver operating characteristic (ROC) curve of 0.994.

We are very encouraged by these early results and they are in line with what we previously demonstrated with a high-degree of precision using our Bayesian network technology to predict oral mucositis with our transplant product, said Ed Rubenstein, President & CEO of Inform Genomics. We are excited to see further data demonstrating OnPARTs ability to predict serious toxicities from chemotherapy regimens based on his or her individual genomic profile which may lead to actions to reduce the burden of potentially curable interventions for patients with cancer.

About OnPART

OnPART, Oncology Preferences And Risk of Toxicity, is Inform Genomics lead platform personalized medicine product for treatment decisions in patients who will receive chemotherapy for colorectal, breast, lung, or ovarian cancer. Based upon response rates and survival, more than one chemotherapy regimen may be considered appropriate care for patients with these common solid tumors, yet the regimens vary widely in their side-effect profiles. OnPART is being developed to assess genomic risk for common and often debilitating therapy-related side-effects, including fatigue, nausea and vomiting, diarrhea, oral mucositis, cognitive dysfunction and peripheral neuropathy. The product includes a differentiating factor in personalized medicine, quantifying patient concerns for side-effects, using a copyrighted patient questionnaire (Preference Assessment Inventory). OnPART is expected to provide valuable information for patients and medical oncologists to help clarify critical clinical choices and be commercially available in 2014.

About Cancer Supportive Care

Most patients with cancer receive supportive care as part of their multimodal anti-cancer therapy, regardless of cancer diagnosis, stage of disease, or treatment modality. Common symptoms associated with cancer or its treatments include fatigue, nausea and vomiting, diarrhea, oral mucositis, cognitive dysfunction, and peripheral neuropathy. Some of these conditions are manageable with commercially available medications, while others are the focus of drug development programs. The development of these side-effects may interfere with ongoing anti-cancer treatment, impair patient functioning, negatively impact the patients quality of life, and may increase the risk of mortality. Treatment of these side-effects also results in significant costs for payers and providers.

About Inform Genomics

Inform Genomics, Inc. is a private company focused on developing novel platforms of genomic based personalized medicine products for cancer supportive care and inflammatory diseases, including its lead platform product, OnPART, designed to determine an individuals risk of side-effects associated with chemotherapy regimens based on his or her individual genomic profile. The companys business model leverages existing technology in conjunction with proprietary analytic methods for conducting genome-wide association studies. Product development programs will lead to commercial, single source laboratory tests consisting of single-nucleotide polymorphism (SNP) networks that determine the likelihood of individual patient clinical outcomes to drug therapies. The U.S. market opportunity for these differentiated products exceeds $2 billion annually. Inform Genomics is headquartered in Boston, Massachusetts. For more information, please visit http://www.informgenomics.com.

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Inform Genomics Announces Preliminary Results of OnPART™ Personalized Medicine Product: SNP Network Identifies ...

Douglas Kell has been reappointed as chief executive and deputy chair of the UK Biotechnology and Biological Sciences Research Council, the Minister for Universities and Science David Willetts said this week.

Kell has held the top post at BBSRC since 2008, and before that he was director of the Manchester Centre for Integrative Systems Biology. He also has served as director of research at the Institute of Biological Sciences at the University of Aberystwyth, and he was a founding director of Aber Instruments. His research has included a range of topics including systems biology, analytical chemistry, and biochemical and data modeling.

The Institute for Systems Biology has appointed Robert Lipshutz to be chief business officer and senior VP for strategic partnerships. Lipshutz spent nearly two decades at Affymetrix in various roles focusing on business development, licensing, diagnostics, and emerging markets, and most recently as senior VP for corporate development.

Verinata Health CEO Caren Mason has resigned but will continue to provide the company with consultative services. Mason joined Verinata in November 2010. She was previously the president and CEO of Quidel, president and CEO of MiraMedica, CEO of eMed Technologies, and general manager of GE Healthcare. The firm plans to recruit a new CEO.

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Personalized Medicine Leaders Launch Non-Profit to Educate Dx Industry Stakeholders

DUBLIN--(BUSINESS WIRE)--

Research and Markets (http://www.researchandmarkets.com/research/h3n97n/companion_diagnost) has announced the addition of the "Companion Diagnostics in Personalized Medicine and Cancer Therapy" report to their offering.

Companion diagnostics (CDx) refers to a particular clinical diagnostic test that is under evaluation and is specifically linked to a known drug therapy. This linkage could be important in the therapeutic application and clinical outcome of a drug, such as with personalized medicine for oncology patients. The molecular diagnostics field plays a vital part in personalized medicine and has greatly expanded over the past twenty years, expanding by more than 20% annually compared to most other laboratory procedures. Research will continue to produce an increased understanding of disease processes, and diagnostics manufacturers will continue to expand and refine the technology and automation needed for clinical testing. Companion diagnostics, although smaller at present, is one of the fastest growing segments in the in vitro diagnostic (IVD) market. And while the concept of a drug-diagnostic combination is not new, it has only recently started to generate interest with the move of healthcare towards pharmacogenomics.

This TriMark Publications report examines the use of companion diagnostics in personalized medicine and cancer therapy. The study provides a qualitative and quantitative review of the industry, including cancer biomarker tests, pharmacogenomics tests, recurrence prediction tests, blood-based technologies, proteomics and regulatory trends. Moreover, this analysis profiles the leading companies that are developing and manufacturing companion diagnostics solutions. Each company is discussed in extensive depth with a section on its history, product line, business and marketing analysis, and a subjective commentary of the company's market position. Detailed tables and charts with sales forecasts and market share data are also included.

Key Topics Covered:

1. Overview

2. Companion Diagnostics and Personalized Medicine

3. Companion Diagnostics: Qualitative and Quantitative Market Analysis

4. Trends and Overview

5. Biomarker Tests Co-developed with Cancer Therapeutics as Companion Diagnostics

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Research and Markets: Companion Diagnostics in Personalized Medicine and Cancer Therapy

IRVING, Texas, June 26, 2012 /PRNewswire/--Caris Life Sciences, a leading biosciences company focused on enabling precise and personalized healthcare through molecular profiling and blood-based diagnostic services, today announced the launch of Caris Target Now Select, an advanced, evidence-based molecular profiling service for patients with non-small cell lung cancer (NSCLC), melanoma, and cancers of the breast, colon and ovary. In addition, the company has enhanced the original Caris Target Now comprehensive molecular profiling service offering for all solid tumors.

"This latest effort by Caris is another significant step in what I call health improvement, while at the same time fulfilling on the promise of personalized medicine," said David D. Halbert, Chairman and CEO, Caris Life Sciences. "With these enhancements, we believe we can prolong the lives of patients and improve outcomes, while also lowering costs to the healthcare system."

Caris Target Now Select incorporates updated, evidence-based technology platforms to determine the genomic information unique to a patient's tumor based on the presence of relevant biomarkers. In addition to providing focused biomarker profiles designed for earlier-stage cancer patients, it offers the advantages of known "on-Compendium-only" drug associations, faster turnaround time, the capability to derive meaningful results from smaller tissue samples, up to 30 reported biomarkers per patient (depending on tumor type), and for the first time Clinical Trials Connector, a service that enables biomarker-specific clinical trial matching.

"Caris Target Now Select is an important new tool to assist physicians in choosing among standard drug choices earlier in the course of treatment, where molecular profiling can have the largest benefit to patient care," said Tom Spalding, Oncology Senior Vice President and Group Head, Caris Life Sciences. "In addition, the new Clinical Trials Connector uncovers even more possibilities by linking patients to open and enrolling clinical trials based upon their individual biomarker status."

Using the strongest clinical evidence, Caris Target Now Select highlights known therapeutic associations with appropriate, tumor-specific treatments for the five target tumor types, as identified in the National Comprehensive Cancer Network Drug & Biologics Compendium[1]. In addition, the newly enhanced version of Caris' original molecular profiling service (now renamed Caris Target Now Comprehensive) provides both on- and off-Compendium therapeutic associations for all solid tumors, across a wide range of evidence.

"Caris Target Now Select is an evidence-based molecular profiling service that can help both earlier-stage and later-stage cancer patients, as it employs the most relevant biomarkers and technologies to help decode a patient's tumor," said Sandeep Reddy, MD, Clinical Professor of Medicine at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA) and Senior Medical Director at Caris. "This service allows physicians to augment their years of experience with advanced theranostic resources, further personalizing cancer care based on the expression status of specific biomarkers."

Through analysis with multiple, highly integrated technology platforms such as immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), and DNA sequencing, both the Caris Target Now Select and Comprehensive services provide vital information that may be useful to oncologists in individualizing therapeutic regimens for cancer patients. By utilizing the most relevant, evidence-based molecular profiling technologies to determine the biomarkers unique to a patient's tumor, and performing an extensive review of clinical literature correlating biomarkers to drug response, Caris Target Now Select can help illuminate the benefit (or lack thereof) of specific agents, and may reveal appropriate treatments not previously considered.

Both services can be requested for cancer patients by physicians seeking to utilize biomarker analysis to inform therapeutic decision-making. For more information, visit http://www.caristargetnow.com.

About Caris Life Sciences

Caris Life Sciences is a leading biosciences company focused on developing and delivering innovative molecular diagnostic, prognostic, and theranostic services. The company's evidence-based molecular profiling service, Caris Target Now, matches molecular data generated from a patient's tumor with biomarker/drug associations derived from the world's leading clinical cancer literature. Caris Target Now uses the most advanced and clinically relevant technologies to provide physicians with information to aid in the selection of personalized cancer treatments more likely to work for each patient. Caris is also developing a series of blood tests based on the company's patented Carisome platform a proprietary, blood-based testing technology for diagnosis, prognosis, and theranosis of cancer and other complex diseases. Through the precise and personalized information provided by technologies like Caris Target Now and Carisome, the company believes that the quality of healthcare can be dramatically improved, while also significantly reducing costs. Headquartered in the Dallas metroplex, Caris Life Sciences offers services throughout the United States, Europe, and other international markets. To learn more, please visit http://www.carislifesciences.com or http://www.caristargetnow.com.

The rest is here:
Caris Life Sciences Launches Caris Target Now™ Select for NSCLC, Melanoma, and Cancers of the Breast, Colon, and Ovary

The Institute for Systems Biology has appointed Robert Lipshutz to be chief business officer and senior VP for strategic partnerships. Lipshutz spent nearly two decades at Affymetrix in various roles focusing on business development, licensing, diagnostics, and emerging markets, and most recently as senior VP for corporate development.

Verinata Health CEO Caren Mason has resigned but will continue to provide the company with consultative services. Mason joined Verinata in November 2010. She was previously the president and CEO of Quidel, president and CEO of MiraMedica, CEO of eMed Technologies, and general manager of GE Healthcare. The firm plans to recruit a new CEO.

Bruker has named Charles Wagner to be its new executive VP and chief financial officer, beginning at the end of June, Bruker said this week. Current CFO William Knight will continue to serve on the company's management team and will work with Wagner to ensure a smooth transition. Wagner also has stepped down from his positions on Bruker's board of directors and its audit committee, where he has served since 2010.

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Gentris, Shanghai Organization Partner to Push Along Personalized Medicine Initiatives

MORRISVILLE, N.C., June 21, 2012 /PRNewswire/ -- Gentris Corporation (www.gentris.com), a global leader in the application of genomic biomarkers to clinical studies, announced today that it has signed a Memorandum of Understanding with the Shanghai Institutes of Preventative Medicine to advance global personalized medicine. The goal of this USA-China collaboration is to create translational research and epidemiological projects, as well as training and education programs, focused on pharmacogenomics and clinical sample banking, which will drive innovation in drug development and improvements in patient care.

Through this collaboration, Gentris and the Shanghai Institutes of Preventative Medicine will work together to launch cutting-edge research projects to discover, develop, and validate new genomic biomarkers. Gentris will take the lead to identify sponsors in the United States, e.g., pharmaceutical companies, for these personalized medicine projects while the Shanghai Institutes of Preventative Medicine will seek support from Chinese organizations.

The tuberculosis drug-induced liver injury pilot (TB DILI Study), conducted between Gentris, the Shanghai Institutes of Preventative Medicine, and a non-profit research institute in Research Triangle Park (RTP) serves as a model for USA-China collaborations. In this study, investigators designed a common protocol and pooled their resources to investigate DILI among tuberculosis patients in three Shanghai hospitals. By utilizing metabolomics and pharmacogenomics, they are evaluating biomarkers for early detection. Dr. Tong Zhou, Senior Director of China Initiatives for Gentris, is Co-Principal Investigator for the TB DILI Study and has significant experience in developing and managing collaborations between the United States and China. Dr. Zhou has also drawn upon his extensive network in China to begin establishing a satellite laboratory for Gentris in Shanghai that complies with U.S. regulatory standards.

Dr. Wu Fan, Director General of the Shanghai Institutes of Preventative Medicine and the Shanghai Municipal Center for Disease Control and Prevention (Shanghai CDC), and Dr. Howard McLeod from the University of North Carolina will provide strategic scientific oversight for personalized medicine collaborations. Director Wu is recognized internationally as a leader in public health initiatives. Dr. McLeod, Chief Scientific Advisor for Gentris, has been involved in numerous global initiatives including the Pharmacogenetics for Every Nation Initiative (PGENI), which he founded. It is anticipated that combining the resources and expertise of a research institute, academic institution, and industryin both the United States and Chinawill lead to more rapid improvements in drug development and public health.

For this personalized medicine program, research studies and epidemiological projects will be designed for implementation in Shanghai based on sponsor needs. Key targeted therapeutic areas include oncology, infectious disease, and chronic disease. Training and education initiatives will also be created to bring U.S. quality standards to China including GLP, GCP, CLIA, and CAP. Gentris, the Shanghai Institutes of Preventative Medicine, and their collaborators will work with leading experts to develop workshops, courses, and a fellowship program to educate academic and industry scientists in China regarding best practices in the application of pharmacogenomics for drug development.

The Memorandum of Understanding leverages the relationships that Gentris CEO Rick Williams and Dr. Zhou have built during the past few years between North Carolina and China. While assisting a non-profit research institute in RTP, they helped to create the North Carolina-China Global Bioscience Gateway, a public-private partnership that addresses how to enhance global research innovation. Mr. Williams and Dr. Zhou are also members of the N.C. China Advisory Council, which works with the N.C. Office of the Governor and N.C. Department of Commerce to facilitate economic development between the state and China.

One of the major goals for this new agreement between Gentris and the Shanghai Institutes of Preventative Medicine is to create an expanded network of collaborators among leading universities, pharmaceutical companies, and public health organizations that leads to new pharmacogenomics discoveries, which accelerate drug development and improve patient care globally.

Related Links: http://www.gentris.com, http://www.scdc.sh.cn

Quotes:

"I have worked with the Shanghai CDC and Shanghai Institutes of Preventative Medicine for nearly four years to develop a translational research bridge between our two countries. I'm honored that Gentris now has an opportunity to work even more closely with the Shanghai Institutes of Preventative Medicine," said Rick Williams, Gentris CEO. "Gentris will take the lead to identify U.S. sponsors in the pharmaceutical industry that would like to jointly develop new research, epidemiological, and training programs in Shanghai."

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Gentris Corporation Partners with the Shanghai Institutes of Preventative Medicine

The Institute for Systems Biology has appointed Robert Lipshutz to be chief business officer and senior VP for strategic partnerships. Lipshutz spent nearly two decades at Affymetrix in various roles focusing on business development, licensing, diagnostics, and emerging markets, and most recently as senior VP for corporate development.

Verinata Health CEO Caren Mason has resigned but will continue to provide the company with consultative services. Mason joined Verinata in November 2010. She was previously the president and CEO of Quidel, president and CEO of MiraMedica, CEO of eMed Technologies, and general manager of GE Healthcare. The firm plans to recruit a new CEO.

Bruker has named Charles Wagner to be its new executive VP and chief financial officer, beginning at the end of June, Bruker said this week. Current CFO William Knight will continue to serve on the company's management team and will work with Wagner to ensure a smooth transition. Wagner also has stepped down from his positions on Bruker's board of directors and its audit committee, where he has served since 2010.

Originally posted here:
Ottawa Hospital Looks to Incorporate NGS as Part of Personalized Medicine Initiative

LONDON--(Marketwire - Jun 19, 2012) - Labceutics (www.labceutics.com), the leading personalized medicine laboratory network in the EU, has launched the Labceutics Connect platform. Labceutics Connect provides its network members with a secure portal to share information, promote training and best practices, and discuss personalized medicine partnering opportunities. The platform will also provide members with the ability to introduce new and innovative personalized medicine tests and technologies within the network.

Labceutics has partnered with more than 120 leading EU laboratories to provide pharmaceutical and diagnostic companies with a one-stop personalized medicine laboratory partner. The network's focus is on the development and implementation of companion laboratory testing and related services that enable a high return on investment for personalized therapies.

"Being part of a personalized medicine network and having the ability to use a tool like Labceutics Connect enables our biocluster to be on the cutting edge of personalized medicine and to interact more effectively with our peers across the EU," said Jesus Mara Izco PhD, of CIBER-BBN (Spain). "We are seeing new tests and technology coming to the market every day and we want to ensure the services we provide our community are of the highest quality."

Given the innovation and evolution of personalized medicine on a global level, Labceutics is also partnering with the key stakeholders in the industry including pharmaceutical companies, diagnostic companies, personalized medicine-focused associations, biobanks, biotechnology companies and other healthcare organizations.

Labceutics will have a booth at the ESMO Congress (www.esmo.org), which takes place in Vienna (Austria) between 28 September and 2 October 2012. There will be on-site Labceutics Connect demos, information about the benefits of joining and leveraging the Labceutics network, and details on the launch of the Labceutics network in Asia.

To obtain more information about the connectivity platform or to meet us at the congress, please contact Jose Luis Ferreiro at: joseluis.ferreiro@labceutics.com.

About Labceutics Labceutics (www.labceutics.com), a division of Diaceutics, supports the integration of pharmaceutical and diagnostic companies through its personalized medicine laboratory network that offers early testing access, quality standards, education and real-time communication across stakeholders to help physicians diagnose, prescribe and monitor care effectively.

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Labceutics Launches "Labceutics Connect" Platform

PARIS--(BUSINESS WIRE)--

The scientific program of the 4th WIN Symposium, on Cancer personalized medicine and efficacy of biomarkers, a major event where hundreds of representatives from 20 countries will gather on next June 28 and 29, 2012 in Paris (France), has been endorsed by the American Society of Clinical Oncology (ASCO), the worlds leading professional organization representing physicians who care for people with cancer.

John Mendelsohn, Chairman of WIN Consortium and Director of the Institute for personalized therapy, UT M. D. Anderson Cancer Center, says: we have been proud to receive the endorsement of ASCO for the quality of educational content of the WIN Symposium Program 2012. This is a great achievement and recognition of the scientific value of the WIN Program Symposium and the major impact this symposium may bring.

The WIN Consortium meeting reflects the vision and goals of ASCOs blueprint for transforming cancer research (www.ASCO.org/Blueprint) and the potential that molecularly-driven therapies have to transform clinical research, said Sandra Swain, MD, President of ASCO. ASCO is pleased to endorse this meeting because of the opportunities it provides for international collaboration.

Organized by the WIN Consortium, this congress gathers the main opinion leaders in cancer care and drug development for two days of debates and exchanges and offers an excellent opportunity to advance research in Cancer and biomarkers at international level, facilitating the translation of scientific results into clinical practice. Advanced and innovative concepts to increase efficacy of personalized cancer therapeutics and molecular diagnostics will be disclosed during WIN Symposium: launch of WINTHER, the most advanced study in personalized medicine selected by the European Community EU FP7.

About WIN Consortium: The WIN Consortium is an initiative of the Cancer Institute Gustave Roussy, Villejuif, IGR (France) and University of Texas MD Anderson Cancer Center (USA), which brings together 22 international cancer centers, three technology partners (Agilent Technologies, GE Healthcare and LifeTechnologies) and associations such as Sage Bionetworks and the National Breast Cancer Foundation as part of a legal entity operating non-profit. Countries participating in the symposium: U.S., France, Hungary, Romania, Singapore, Brazil, Spain, Italy, India, China, Israel, Jordan, UK, Canada... The american Foundation Medicine is an official member of the WIN Consortium. The quality of the WIN 2012 Symposium program has been also recognized by several major international organizations: ESMO, INCa and UICC.

ASCO is a registered trademark of the American Society of Clinical Oncology. Used with permission. This is not an ASCO sponsored event.

Original post:
The WIN 4th SYMPOSIUM, on June 28-29 in Paris, Scientific Program Recognized by Leading Oncology Society

MONTREAL, QUEBEC--(Marketwire -06/18/12)- Mr. Michel Saucier, Chairman of the Board of Directors of CepMed, the Center of Excellence in Personalized Medicine, is pleased to announce the appointment of Ms. Manon Decelles, CPA, CGA as Chief Executive Officer. Coincident with Ms. Decelles' arrival, Dr. Clarissa Desjardins, outgoing CEO, is leaving to manage a start-up biotechnology company.

Ms. Decelles has 20 years of experience in the pharmaceutical industry and a proven track record in key areas of business including finance, marketing and business development. Together with this experience Ms. Decelles brings an extensive business network that will enable CepMed in bringing together medical, scientific and business communities to promote innovation and commercialization in personalized medicine. Prior to joining CepMed, Ms. Decelles was Director of Business Development and Acquisitions at Sanofi, a global and diversified healthcare leader, where she was responsible for the Canadian affiliate's business development activities, including in and out licensing, divestitures as well as company acquisitions. In this capacity, Ms. Decelles developed and implemented a Strategic Business Development Plan and review process that guided Sanofi's Canadian strategy. Previously, Ms. Decelles held roles of increasing responsibility in finance, marketing and business development at Marion Merrell Dow, Hoechst Marion Roussel and Aventis. Ms. Decelles is an active member of the Board of Directors of the Canadian Healthcare Licensing Association.

Ms. Decelles first studied in science - microbiology at the University of Sherbrooke. She later obtained a Bachelor of Business Administration from the University of Montreal, HEC and is also a Chartered Professional Accountant (CPA).

"As Cepmed approaches its fifth year of operations, we believe that Manon's background and experience is perfectly suited to take Cepmed to the next level. Going forward, we expect to increasingly attract foreign investment in our centre for translational studies, commercialize the results of our studies and implement personalized medicine tests and strategies into our healthcare system. We welcome Manon to her new position and are confident that she can take on this challenge." - Mr. Michael Saucier, Chairman of the Board, CepMed

The Board extends its best wishes to Clarissa in her new endeavors and its deep gratitude for her contributions to CepMed and the advancement of personalized medicine in Canada. "Her leadership of our public-private partnerships and innovative knowledge translation activities including a Personalized Medicine Portal and the creation of physician's expert panels in cardiology, oncology and family medicine have created an awareness of personalized medicine and its benefits across the country." - Dr. Jean Claude Tardif, Director Montreal Heart Institute Research Centre

About CepMed

Founded by the Montreal Heart Institute and Genome Quebec in 2008, CepMed is a non-profit organization dedicated to promoting the science and practice of personalized medicine. It is a Centre of Excellence for Commercialization and Research (CECR) funded by the Canadian Government, Genome Quebec and industry partners including Pfizer, AstraZeneca, Novartis and Merck. Cepmed's initiatives are designed to promote and enable personalized medical treatment, based on the use of molecular information in clinical decision making, in particular to improve the efficacy and safety of drug therapy. Cepmed participates in several multi-million dollar public-private partnerships (PPP) in translational medicine that incorporate pharmacogenomics into Phase III clinical trials or studies of marketed drugs with partners including Roche and Servier. These partnerships leverage the expertise and capacities of The Beaulieu Saucier Pharmacogenics (PGx) Centre, The Montreal Heart Institute Coordinating Centre (MHICC) and The Montreal Heart Institute Biobank. Generating several millions of dollars in investment these partnerships have established a unique and world class centre for translational clinical research. In addition CepMed is collaborating and partnering with Canadian stakeholders in personalized medicine including physicians, patients, governments, industry and investors to enable the clinical development and implementation of personalized medicine while creating commercial opportunities for Canadian companies.

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CepMed Appoints New CEO

BETHLEHEM, Pa., June 15, 2012 /PRNewswire/ --Saladax Biomedical, Inc., a privately held company developing and commercializing novel diagnostic assays to achieve the promise of personalized medicine for new and existing therapeutics, announced today that Kevin M. Harter has been appointed as the company's president and chief executive officer effective June 18, 2012.

Mr. Harter, who is a co-founder and senior vice president of the Life Science Greenhouse (LSG), a public-private life sciences investment partnership, has been serving as interim CEO of Saladax since January 2012.

Gregory Critchfield, M.D., chairman of the board at Saladax, commented, "After a careful search of highly qualified candidates over the last four months, we are delighted to have Kevin lead Saladax through its growth at this time. Kevin's expertise and connections to the pharmaceutical and investment communities will be invaluable in achieving the company's objectives. We look forward to Saladax's continued progress in financing its operations, commercializing its products and building strategic partnerships, as we achieve the company's mission to personalize the approach to patients."

Most recently, Mr. Harter has been serving as interim CEO of Saladax Biomedical. From 2007 to 2011, Mr. Harter served as executive chairman of Saladax, a LSG-portfolio company, where he led multiple, successful funding rounds and strategic deals for the company. Mr. Harter previously co-founded Keystone Medical Systems in 1990 and managed the company through significant growth until its acquisition by publicly-held Continental Medical Systems. Prior to Keystone, Mr. Harter held several positions within the Pennsylvania Blue Shield organization, including vice president, technology, and has contributed significantly to the development of the field of electronic claims, electronic medical records and physician practice management. He has held more than two dozen board seats in healthcare, technology and financial companies. Recognition for his professional and volunteer achievements include the Entrepreneur of the Year award and the Alumni Fellow and Philip Philip Mitchell Service Awards from the Pennsylvania State University. He holds a B.S. and MBA from Pennsylvania State University.

"I'm honored to be part of a team that is delivering on the promise of personalized medicine," said Mr. Harter. "Given the impressive caliber of the management team and compelling science behind Saladax's technology, I'm eager to work with this group that is having a real impact on patients. Healthcare is increasingly being enabled by information and Saladax's assays provide patients, providers and pharmaceutical companies with answers to important questions about their care and their drugs."

About Saladax Biomedical, Inc.

Saladax Biomedical develops novel diagnostic assays for the practical delivery of personalized medicine. Our proprietary line of MyCare assays improves the efficacy of existing drugs by optimizing the dose administered for each individual patient. Saladax's initial focus is oncology, with a portfolio of 13 chemotherapy drug assays in various stages of development. Three MyCare assays are currently offered to the oncology community: My5-FU, MyPaclitaxel and MyDocetaxel.

The company's MyCare technology platform is broad and flexible, enabling wide application in many therapeutic categories. This technology capability also enables Saladax to serve as a valuable partner to pharmaceutical and biotechnology companies in the development of companion diagnostics (CDx), addressing multiple risks and challenges encountered in drug development.

The company was founded in 2004 and is headquartered in Bethlehem, Pennsylvania. Saladax is ISO 13485:2003 certified.

Saladax Biomedical, Inc. Adrienne Choma, Esq. Sr. VP & Chief Marketing Officer achoma@saladax.com

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Saladax Biomedical, Inc. Appoints Kevin M. Harter as President and Chief Executive Officer

A company specializing in diagnostic assays for personalized chemotherapy drug dosages has made its interim CEO permanent as it prepares for a national expansion. It is also developing an assay for early detection of Alzheimers disease.

Kevin Harter, the co-founder of the Life Sciences Greenhouse, stepped in as interim CEO at Saladax Biomedical in Bethlehem, Pennsylvania earlier this year following the resignation of Edward Erickson, who stepped down for personal reasons. Life Sciences Greenhouse is an incubator and investor in the biotechnology startup. Harter had served as executive chairman of Saladax from 2007 to 2011.

Harter has developed a broad background in healthcare and life sciences having co-founded Keystone Medical Systems in 1990, which was later acquired by Continental Medical Systems. He also worked in several roles at Pennsylvania Blue Shield, which later became part of Blue Cross Blue Shield, and helped develop electronic claims, electronic medical records and physician practice management.

Acknowledging his healthcare technology and investing background in life sciences, Harter told MedCity News in a phone interview, he comes to the company with a different skill set.

Additionally, the company has forged a number of partnerships with pharmaceutical companies using its personalized dosage assays to improve the effectiveness of their drugs as part of their clinical trials.

What we are finding with pharmaceutical companies is they prefer not to have their drugs go to market using expensive molecular diagnostic tests because it can create an additional barrier. We offer a solid, tried and true technology that can get answers for a magnitude less cost than a molecular diagnostic test, so we are getting good interest from pharmaceutical companies because we can make valuable diagnostic tests available at reasonable costs for patients and at a reasonable cost for pharmaceutical companies.

Harter noted that he has seen a shift in attitudes from pharmaceutical companies in working with companies like Saladax to use assays for inclusion criteria to develop more effective clinical trials.

Weve had more conversations with pharmaceutical companies in the past two months than in the entire history of the company, Harter said. We are going to really be building out a full commercial team. Thats really one of my main goals this year. We will continue to grow in Pennsylvania but we would also add quite a bit around the country.

Saladax has been developing an Alzheimers disease assay to detect the onset of the degenerative neurological disease in collaboration with Bristol Myers Squibb and more recently Ortho-Clinical Diagnostics.

The biotechnology company also has another 13 chemotherapy drug assays in various phases of development.

Link:
New CEO leads expansion of personalized medicine dosing assay company

From staff reports

DURHAM -- The N.C. Biotechnology Center approved a $100,000 grant to explore the states readiness for a Center of Innovation to capitalize on the growing field of personalized medicine, according to an announcement from the center.

The center awarded the grant to a statewide consortium of business and academic institutions represented by Dr. Geoffrey Ginsburg, a Duke University professor of medicine, the executive director of the health systems Center for Personalized Medicine and director of genomic medicine in the Institute for Genome Sciences & Policy.

The grant will help the group develop a business plan for an independent Center of Innovation to accelerate the states efforts to commercialize personalized medicine, the announcement states.

If that plan is subsequently approved, it will trigger a four-year, $2.5 million Phase II grant to launch the future Center of Innovation.

Personalized medicine is a health-care model that uses information about an individuals genes, environment, lifestyle and personal preferences to tailor treatments, according to the announcement.

Its creating a new set of businesses providing a wide range of products and services including data collection and processing, diagnostics and therapeutics.

North Carolinas knowledge-based economy is well-positioned to take advantage of the coming growth in personalized medicine, said Mary Beth Thomas, vice president for the Center of Innovation Program at the center.

The center is a private, non-profit corporation supported by the N.C. General Assembly. Its mission is to provide long-term economic and societal benefits to the state by supporting biotechnology research, business, education and strategic policy

Continued here:
Grant to aid planning of personalized medicine innovation center

Verinata Health CEO Caren Mason has resigned but will continue to provide the company with consultative services. Mason joined Verinata in November 2010. She was previously the president and CEO of Quidel, president and CEO of MiraMedica, CEO of eMed Technologies, and general manager of GE Healthcare. The firm plans to recruit a new CEO.

Bruker has named Charles Wagner to be its new executive VP and chief financial officer, beginning at the end of June, Bruker said this week. Current CFO William Knight will continue to serve on the company's management team and will work with Wagner to ensure a smooth transition. Wagner also has stepped down from his positions on Bruker's board of directors and its audit committee, where he has served since 2010.

CLC Bio said this week that it has appointed Richard Lussier as director of business for the Americas region. He has worked in life sciences sales and commercial operations, most recently as VP of worldwide sales at RainDance Technologies. He formerly held leadership positions in sales, service, and support at Solexa, Fluidigm, Applied Biosystems, and Celera Genomics.

Original post:
NCBiotech Eyes Center to Capitalize on State's Personalized Medicine Culture

PLANEGG, Germany--(BUSINESS WIRE)--

Within the last year Biomax Informatics has established the knowledge integration platform in a research project to develop a new generation of healthcare tools for predictive, personalized medicine. The Synergy-COPD project, funded by the European "Framework Programme 7", will generate a simulation environment and clinical decision support system enabling systems medicine. Though generally applicable, the tools created will be validated using data from patients with chronic obstructive pulmonary disease (COPD). The project's goal is to improve patient care and healthcare outcomes, reduce errors and increase efficiency.

Leveraging Biomax's BioXM technology, a comprehensive COPD knowledge base with a graphical frontend for visualizations is being established. The system integrates five well-established simulations of human physiology with biomedical data drawn from experimental studies, epidemiological data, clinical trials, physician interviews, a multi-center longitudinal study on COPD phenotyping, and public datasets. Integrating with a Simulation environment, researchers will be able to perform simulations linking symptoms and pathologies in organs and tissues with other features, such as metabolic pathways. Building on this foundation, a decision support system will allow doctors to anticipate disease progression and optimize therapy.

COPD was chosen to validate the projects systems biology approach because it is a complex, heterogeneous, multi-component disease. COPD is also a major public health problem: it is ranked as the fourth leading cause of death in Europe and one of Europe's leading causes of healthcare costs. "COPD is the ideal target for this project, which aims to realize patient-centered, integrated medicine in general healthcare," says Dr. Dieter Maier, Biomax Project Manager. "Our aim is to equip healthcare providers with innovative tools that lead to the best treatments for patients."

About the Synergy-COPD project

The Synergy-COPD project is funded by the European Union's Seventh Framework Programme for Research and Technological Development (FP7) to develop a simulation environment and a decision-support system enabling systems medicine. The project's research partners are leading experts in the field of COPD and relevant technologies and methods for advancing COPD research. More information about the consortium is available at http://www.synergy-copd.eu.

About Biomax

Biomax Informatics AG (Planegg, Germany), founded in 1997, is a leader in the development of computational solutions for the life sciences. Biomax developed the BioXM Knowledge Management Environment and markets the Viscovery technology for better decision-making and knowledge management in biomedical sciences. More information about Biomax is available atwww.biomax.com.

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Biomax Informatics AG Reaches First Milestone in European Systems and Personalized Medicine Project