Quantcast

Industry news that matters to you.  Learn more

Quintiles’ Study Offers View of How Pre-screening for Personalized Cancer Treatments Would Work

How do you match up the appropriate patient with the right drug and implement treatment rapidly? That is a question at the heart of personalized medicine and the focus of a study by Quintiles to develop best practice.

In a study of patients with colorectal cancer, it’s investigating how pre-profiling and genomic sequencing data, including the number of genetic changes that occur, could support physician treatment decisions, including the identification of appropriate clinical trials for patients. The Feasibility study of Biomarker Analysis for Patients with Metastatic Colorectal Cancer is expected to go on for 10 weeks. US Oncology Research is participating in the study and it’s supported by McKesson Specialty Health and the US Oncology Network.

The tumor analysis and assessing the bioanalytic requirements is done in Quintiles labs in Durham, North Carolina. Those observations and assessments are being packaged into a report for physicians.

In a phone interview with Quintiles Chief Medical and Science Officer Jeffrey Spaeder, he said: “Instead of looking at just one biomarker and method of action and determining if the patient is appropriate for inclusion in a study, we are looking at a much larger number of genomic variants and allowing the healthcare provider and patient to make more informed decisions about [which treatment to go forward with.”

It’s about matching FDA-approved therapies, as well as therapies in development that have a specific benefit-risk profile for specific patient populations. Instead of bench to bedside, it’s more like bedside to bench and back again.

Spaeder said: “We have the capabilities to do this appropriately and think it is a new way of providing information to the treatment of patients and clinical research.”

Many groups see the benefit of personalized medicine since, based on our genetic makeup, two people with the same condition are likely to respond better to one treatment than another. But one of the challenges has been how to implement that approach. The Quintiles study represents an important piece of that puzzle.

Source: MedCity News

DHMRI and Metabolon Announce Strategic Partnership to Provide Expanded Metabolomics Capabilities

The David H. Murdock Research Institute (DHMRI) at the North Carolina Research Campus and Metabolon, Inc., recently announced that they have entered into a strategic agreement to align metabolomics research services. Metabolon is a pioneering leader in discovery metabolomics and specializes in rapidly assessing metabolism in biological samples to quickly identify prospective biomarkers and to understand metabolic effects of treatments, interventions, nutritionals, etc. The agreement complements DHMRI’s mass spectrometry and NMR‐based metabolomics services through access to Metabolon’s industry‐leading high‐throughput biomarker discovery and profiling platform which provides an extensive, untargeted, broad metabolite survey of more than 4000 biochemicals.

“This agreement leverages the strengths of our organizations to best serve DHMRI collaborators to understand metabolism and ultimately answer key research questions and deliver healthy food products for consumers. We have worked extensively in food science and nutrition and recognize that our combined resources are indeed complementary. DHMRI is a center of excellence in nutrition research and we are delighted to do our part to meet their growing needs,” says Chris Bernard, senior Vice President of Sales & Marketing for Metabolon.

DHMRI is an established not‐for‐profit research institute that provides flexible, client‐focused research services to academia, government and industry collaborators. This agreement,
consistent with the DHMRI’s collaborative approach to scientific inquiry, provides partners with additional resources for metabolomics. Metabolon’s global metabolomic approach can
pinpoint active pathways which can be further interrogated by targeted and or customized approaches offered by the DHMRI Metabolomics team.

“We are excited to broaden the breadth of services offered by the DHMRI to our collaborators. The benefits stemming from the collective knowledge of our organizations will be readily
realized by researchers, companies and consumers,” said Steve Lommel Ph.D., Interim President, David H. Murdock Research Institute.

Source: David H. Murdock Research Institute

Baby Knows Best: Fetuses Emit Hormone Crucial to Preventing Preeclampsia

In a study using mice, researchers from the University of North Carolina School of Medicine found that a hormone, adrenomedullin, plays a crucial role in preventing the pregnancy complication preeclampsia. Surprisingly, this hormone protects women from preeclampsia when emitted by the fetus, not the mother, during the most critical times in pregnancy.

“We’ve identified the fact that the baby is important in protecting the mom from preeclampsia,” said the study’s senior author, Kathleen M. Caron, PhD, assistant dean for research at the UNC School of Medicine and an associate professor in the Department of Cell Biology and Physiology. “If the baby’s cells are not secreting this hormone, the mother’s blood vessels don’t undergo the dilation that they should.”

Preeclampsia affects roughly one in fifteen pregnancies. An important characteristic of the condition is that blood vessels in the placenta fail to enlarge, or dilate, to accommodate increased blood flow to the fetus. Untreated, it can threaten the life of both mother and baby.

“We really don’t know that a pregnant woman is going to get preeclampsia until she has it,” said Caron. Because the condition has numerous risk factors and causes, it’s difficult for doctors to know which patients are at highest risk. “Identifying molecules that could predict preeclampsia would be really important.”

The researchers studied mice that were genetically programmed to produce either reduced or increased levels of adrenomedullin. The study revealed that in a normal pregnancy, the fetus secretes adrenomedullin into the placenta during the second trimester, signaling special cells called “natural killer cells” to help dilate the mother’s blood vessels and allow more blood to flow to the growing fetus.

The study is one of the first to identify an important chemical message sent from fetus to mother in the womb. Scientists understand more about the mom’s side of the ‘chemical conversation’ that goes on between mother and baby, but much of the hormonal signaling in the placenta remains a mystery.

By identifying the key role of adrenomedullin, the research could pave the way to new methods for detecting and preventing preeclampsia. For example, adrenomedullin levels could potentially be used as a biomarker, or early indicator, to identify which patients might be predisposed to the condition. “Having a biomarker would be wonderful—it could allow the physician to manage a woman differently in the early part of her pregnancy,” said Caron.

As a next step, the researchers plan to build upon their mouse studies to examine patterns of adrenomedullin levels and preeclampsia in pregnant women.

This paper was published online ahead of print on May 1, 2013 in the Journal of Clinical Investigation (JCI). The paper will appear in the June 2013 print edition.

The study’s co-authors include Manyu Li, Nicole M.J. Schwerbrock, Patricia M. Lenhart, Kimberly L. Fritz-Six, Mahita Kadmiel, Kathleen S. Christine, Scott T. Espenschied, Helen H. Willcockson and Christopher P. Mack of UNC and Daniel M. Kraus of Duke University Medical Center.

Study: Fetal-derived adrenomedullin mediates the innate immune milieu of the placenta

Source: University of North Carolina at Chapel Hill (UNC) Heath Care and University of North Carolina at Chapel Hill (UNC) School of Medicine

Gentris Corporation Partners with the Shanghai Institutes of Preventative Medicine

Gentris Corporation, 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.

NCBiotech Weighs Personalized Medicine Sector

The North Carolina Biotechnology Center has approved a $100,000 grant to explore the state’s readiness for a Center of Innovation (COI) to help capitalize on the growing field of personalized medicine.