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Quintiles Transnational Signs Five Year Agreement for OmniComm Systems’ TrialOne

OmniComm Systems, Inc. (OTCQB: OMCM), a global leading provider of clinical data management solutions for clinical trials, recently announced the signing of a five year agreement with Quintiles Transnational (Quintiles) for OmniComm Systems’ market leading TrialOne technology for Phase I clinic automation. Quintiles is the world’s largest provider of biopharmaceutical development and commercial outsourcing services with a network of more than 28,000 employees conducting business in approximately 100 countries.

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

Quintiles Asks, ‘Why Not Test for Many Biomarkers at Once?’ When Evaluating Therapies for Cancer Patients

Calling the concept “pre-profiling,” Quintiles (Research Triangle Park, NC) is collaborating with US Oncology Research (the research arm of McKesson Specialty Health) to test the value of running multiple biomarker tests at once for cancer patients—in this case those with metastatic colorectal cancer (mCRC). Either for initial therapy, or as a step to selecting candidates for clinical trials, the current practice is to look for genomic data that is relevant to one type of therapy; if the suitable genomic variant is found, the clinician then knows that the patient is a good trial candidate, or that the patient could benefit from a specific therapy. Quintiles is suggesting to look at many variants or makers initially and then make treatment or trial recruitment decisions.

In practice, says Dr. Jeffrey Spaeder, CMO at Quintiles, a biopsy would be retrieved from the patient, DNA and other genomic information sequenced, abnormalities identified, and bioinformatics analysis conducted, then returning the results back to the clinician. “All these steps sound intuitively straightforward, but they involve complex handoffs of information and clinical decisions,” he says. Understanding what the clinician can do with the data needs to be determined; what choices the patient might have for one therapy or another; and in the final analysis, whether better outcomes could be achieved remain to be evaluated. Eventually, the multiple-biomarker process could become a step in the clinical pathways that various organizations have developed for treatment of cancers. “Early indications from this study suggest that we can provide physicians and patients with early visibility on potentially clinically actionable biomarkers within a rapid two-week timeframe. This level and speed of analysis has promise to save valuable time in administering potentially life-saving therapies to patients, and reduce the development times of precision medicines.”

The biomarker field, while demonstrating exciting new potential and spurring the evolution of personalized (or “precision”) medicine, is fraught with operational difficulties. Insurers are selective about what biomarker tests they are willing to pay for; practitioners have varying enthusiasm for the tests, and the clarity around which tests lead to beneficial outcomes are not clear. Even so, this study could be one of a series of medical innovations to make biomarkers a standard element of cancer therapy.

Source: Pharmaceutical Commerce

Quintiles Releases Perspectives on Early Phase Oncology and Hematology Biomarkers

In advance of the American Society of Clinical Oncology (ASCO) Annual Meeting, Quintiles recently announced the release of its perspective on two areas of focus for clinical oncologists – the impact of patient selection in early-phase studies and the use of biomarkers in the treatment of hematologic malignancies.

The first of these reports, Tomorrow’s Path to Improved Early-Phase Oncology Drug Development, explores the importance of key elements to maximize quality and efficiency of go/no-go decisions in early-phase studies. As the understanding of the biology of cancer becomes more sophisticated and generates more opportunities, fundamental challenges caused by the complexities of this group of diseases are becoming more evident. Molecular profiling and leveraging molecular selection of patients has the potential to significantly improve the quality of early decisions in oncology drug development.

“By identifying a well defined group of patients with a particular molecular biological profile, we have the potential to make more efficient decisions on product candidates at the earliest possible stage,” said Philip Breitfeld, M.D., vice president and therapeutic strategy head, Quintiles. “As the cost of oncology drug development rises, the use of targeted therapies represents a path toward more precise treatment approaches that would drive down costs, timelines and failure rates.”

The second report, Biomarkers: Recent Advances in their Application to the Treatment of Hematologic Malignancies, presents a point of view on the value of biomarkers in the early detection and stratification of groups at risk for aggressive disease to improve the overall survival rates associated with late stage diagnosis.

Hematopoietic malignancies, which include a heterogeneous group of diseases such as multiple myeloma, lymphomas and leukemias, are characterized based on the appearance of the cells as well as demonstrating the presence or absence of certain cell surface proteins (Cluster of Differentiation or CD markers), characteristic chromosomal abnormalities, and by the identification of particular genetic mutations.

“While the use of biomarkers is widely supported and the hope of early detection is promising, few biomarkers have been identified or clinically validated for the early detection, progression or risk assessment for such malignancies,” said Harish Dave, M.D., MBA, vice president, global medical strategy head, hematology and oncology, oncology therapeutic area, Quintiles. “Recent advances in understanding of these malignancies and the advent of high-throughput technologies have the potential to facilitate rigorous translational research toward the discovery, development and clinical validation of novel biomarkers.”

Source: Quintiles

Oxford Cancer Biomarkers Announces Biomarker Discovery Deal with AstraZeneca

Oxford Cancer Biomarkers Ltd (OCB), the UK-based company developing tests that allow medicines to be personalised for the benefit of the cancer patient, recently announced an agreement with AstraZeneca for biomarker discovery, with the potential for further collaboration on validation and development of resulting biomarkers.

OCB will work with an undisclosed AstraZeneca cancer drug to discover biomarkers that have the potential to predict responders and non-responders to the drug. Under the agreement, AstraZeneca has been granted an option to license biomarkers from the programme.

Nick McCooke, CEO of Oxford Cancer Biomarkers, commented: “The discovery and development of biomarkers of drug response is becoming an essential component of cancer drug development and commercialisation. With more targeted treatments being made available for more defined patient populations, the need for companion diagnostics is growing. We are a young company but already making a name for ourselves in the cancer biomarkers space, and we are delighted to be working with AstraZeneca on this important program.”

Andrew Hughes, Vice President of Clinical Oncology at AstraZeneca said: “Identifying the right patients is key for the development of AstraZeneca’s targeted oncology drugs. We are excited to be working with Oxford Cancer Biomarkers to explore how their novel approaches can contribute to our biomarker strategy in the early stages of drug development.”

Oxford Cancer Biomarkers uses its proprietary platform CancerNav® to rapidly generate predictive biomarkers for cancer drugs. It has successfully proven its platform through from biomarker discovery to clinical validation.

The company was founded by Nick La Thangue, Ph.D., Chair of Cancer Biology at Oxford University and David Kerr, CBE, D.Sc., M.D. FMedSci, Professor of Cancer Medicine at Oxford University. Its major investor is Quintiles with whom it also has a strategic relationship
in the biomarker space.

Source: AstraZeneca