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PerkinElmer Introduces New Chemical Intelligence Capabilities for Accelerating the Lead Discovery Process

PerkinElmer, Inc., a global leader focused on improving the health and safety of people and the environment, is introducing the newest version of Lead Discovery for the TIBCO Spotfire® software platform at the Company’s Revolutionaries for Global Health Summit. The new functionality of Lead Discovery 5.1 combined with the TIBCO Spotfire® software’s advanced data visualization and analysis capabilities bring a new level of chemical intelligence to the informatics platform for advanced scientific discovery.

PerkinElmer’s Lead Discovery™ 5.1 enhances the TIBCO Spotfire® software data analysis capabilities with new functionality built specifically with chemists in mind. Based on PerkinElmer’s industry-leading ChemDraw® drawing tool, the chemical intelligence in Lead Discovery provides scientists using TIBCO Spotfire® software with extensive chemical structure searching and visualization. Now scientists are able to dynamically filter their experimental data sets by chemical structure and pinpoint promising structural features and scaffolds in the output from their medicinal and combinatorial chemistry programs. The new technology enables users to mine their chemical databases to identify more compounds that have similar chemical structures, broadening their potential pool of candidates based on known properties and shortening their time to discovery of a viable candidate or lead.

“Through our relationship with TIBCO we are able to expand the range and depth of the TIBCO Spotfire® platform to serve the rapidly evolving needs of the scientific research community,” said Michael Stapleton, general manager, PerkinElmer Informatics. “With Lead Discovery 5.1, chemists will be able to explore their data sets in the context of visual chemical structures and as a result quickly filter to find the chemical compounds that are most promising to them. This capability will help them gain the critical insights they need to accelerate decisions on which compounds to pursue, while significantly reducing many of the typical technical bottlenecks to understanding data.”

In addition to dynamic, structure-based filtering, another key functionality of Lead Discovery 5.1 is that it automatically analyzes and displays R-groups (group side chains in chemical structure diagrams) or substituent variations on similar chemical scaffolds. These chemical variations have significant impact on dose response and side effects as they affect how the molecule interacts with a target. Using the new informatics tool, scientists can quickly isolate the variables to identify and optimize promising compound candidates.

“I foresee Lead Discovery becoming a heavily utilized aspect of our discovery scientists’ use of the TIBCO Spotfire® software,” said Dr. Daniel C. Weaver, manager of scientific computing at Array BioPharma Inc. “The capability to perform structure filtering and R-group analysis in real time will help drive compound series prioritization and structure activity relationship (SAR) analysis. This is critical to narrowing down the range of compounds that we are evaluating and helps to accelerate our ability to find the most promising candidates for our research.”

The Revolutionaries for Global Health Summit is PerkinElmer’s annual forum for leading researchers and physicians to network and share best practices in both science and business and participate in cutting-edge discussions to help lead to better prevention, detection and treatment of disease. At the Summit, several important presentations will be made by renowned users of the TIBCO Spotfire® software, and a hands-on workshop will allow attendees to learn how the software can impact their own research.

PerkinElmer leverages its deep scientific knowledge and expertise in the development of the most comprehensive suite of scientific informatics and software solutions – from instrument generated data, to enterprise solutions to mobile applications. Built by scientists for scientists, PerkinElmer’s integrated business-wide information management system provides companies and academic institutions with the necessary tools to aggregate, search, mine, analyze and visualize critical data so that they can turn data into actionable insights in an automated, predictive and scalable way. For more information, visit www.perkinelmer.com/informatics

Source: PerkinElmer

ASU Scholars Advocate Innovation in Regulatory, Payment Pathways for Personalized Medicine

Two innovative programs designed to improve the availability of emerging medical technologies that can help patients receive more effective, efficient and personalized health care are advanced in a commentary written by a team of scientists and policy experts, including seven from Arizona State University, and published today in Science Translational Medicine.

The March 13 article, “Regulatory and Reimbursement Innovation,” explores the benefits of coverage with evidence development (CED) and parallel review for the regulation and reimbursement of molecular diagnostics. Molecular diagnostics include tests that aid in better prediction, diagnosis, prognosis and treatment of disease through the use of DNA, RNA and proteins.

The U.S. Food and Drug Administration (FDA) requires certain diagnostic tests to provide reasonable assurances of safety and effectiveness before they can be marketed. The Centers for Medicare and Medicaid Services (CMS) determines whether such products are “reasonable and necessary” before they can be covered by Medicare. The FDA and CMS currently are reviewing CED and parallel review for more widespread use, according to the article.

One of the co-authors, ASU Regents’ Professor Gary Marchant, Faculty Director of the Center for Law, Science & Innovation (LSI) at ASU’s Sandra Day O’Connor College of Law, said these tests are expected to improve health outcomes by giving providers optimal treatment choices for their patients.

“It’s a new paradigm of health care,” said Marchant, who founded LSI’s Program on Personalized Medicine, Law & Policy, the nation’s first law-school program that fosters the discipline’s study through collaborative, multidisciplinary evaluation of critical issues. “And it’s a critical time for both of these innovative programs, because agencies of the federal government are actively considering expanding them.

“These tests produce complex algorithms that can help your physician direct your health care, where you should go for treatment and what medications can – and cannot – help you,” he said. “People are dying unnecessarily, and we need to get these diagnostics out more quickly and with better data.”

Regulatory and reimbursement roadblocks hinder the tests’ development and slow their integration into routine care decisions, according to lead author, LSI Research Director Rachel Lindor. A graduate of the law school’s J.D. program who is now completing her M.D. degree at Mayo Medical School, Lindor began researching these issues during an externship in 2011 at the U.S. Department of Health and Human Services.

An LSI-hosted workshop in April 2012, “Potential Solutions to Regulatory and Reimbursement Barrier for Molecular Diagnostics: Parallel Review and Coverage with Evidence Development,” followed. It drew notable experts from government, industry and academia to brainstorm solutions to these barriers; their input led to the now-published article.

“Overall, the group seemed to agree that both of these policies were good in theory, but there were pieces of each that made people skeptical they would actually work,” Lindor said. “We came up with a few changes at the workshop that we thought would make them more attractive for developers who may have products coming up through the pipeline.”

Parallel review enables developers to meet with both CMS and FDA early in a product’s review process, in order to clarify the agencies’ evidentiary expectations and reduce inefficiencies. CED allows CMS to temporarily cover new products not yet supported by sufficient evidence to meet its “reasonable and necessary” coverage threshold while additional data are evaluated.

“Our recommendations on CED focused on trying to streamline the process so developers wouldn’t see it as a hurdle to getting paid for their products – things like smoothing out the way that FDA and CMS work together when they review the same product and shortening the time it takes for CMS to actually start a CED,” Lindor explained. “The group was also concerned about CMS’ hints that CED may be used by local Medicare contractors, so one of our recommendations was that CMS provide some more logistics on how exactly that would work.”

Lindor said tweaks to the parallel review program could make it more amenable to diagnostic test developers and speed the tests’ access to insurers, care providers and patients.

“Our group recommended that CMS give developers some assurance that there will be some benefits to participating, which could be done by shortening the time it takes to go through the process, or by providing more flexibility about what type of payment decisions would come from the review,” Lindor said. “We also recommended that the policy be made available to a broader range of products than it’s open to now.”

Dr. Denis Cortese, Director of ASU’s Health Care Delivery and Policy Program, and a co-author of the article, said “The primary goals of these two programmatic recommendations are to more quickly and accurately determine the appropriate role for new medical technologies in medical practice and patient care.”

Another co-author, Dr. George Poste, Chief Scientist of ASU’s Complex Adaptive Systems Initiative, said molecular diagnostics have enormous potential to increase diagnostic accuracy and increase the efficacy and safety of drugs in multiple diseases.

“Current ambiguities in regulation and reimbursement policies for these new tests are a major barrier to corporate investment and R&D innovation,” Poste said.

Study: Regulatory and Reimbursement Innovation

Source: EurekAlert!

Lupus Experts Gather at the FDA to Explore Potential for Biomarkers to Accelerate Clinical Trials

Biomarkers, potential indicators to monitor disease progress and treatment success, are among the most challenging and critical areas of lupus research according representatives of industry, academia, government and advocacy attending a U.S. Food and Drug Administration workshop this week. The meeting was convened to focus on the development of biomarkers to predict acute worsening of disease, called a flare, and their potential for accelerating lupus clinical trials and new drug approvals.

NINDS to Fund Biomarker Clinical Study for Spinal Muscular Atrophy

SMA is associated with a mutation in chromosome 5 — loss of the survival of motor neuron 1 gene (SMN1) — and is considered the second most common autosomal recessive disease in the US, affecting 1 in 6000 live births. SMA Type 1 is one of the most common genetic causes of infantile death. Although the disease can be readily diagnosed, there are no approved treatments for SMA.

COPDF Announces Launch of COPD Biomarkers Qualification Consortium

The COPD Foundation announces the launch of an unprecedented collaborative effort to pool information on Chronic Obstructive Pulmonary Disease (COPD): the COPD Biomarkers Qualification Consortium (CBQC). The CBQC brings together government agencies, academic institutions and pharmaceutical companies that will share research data on COPD biomarkers — indicators of disease progression/severity. The goal is to assemble data under the auspices of the Consortium that will permit official recognition of biomarkers that can improve disease monitoring and expedite new therapies for the world’s fourth leading cause of death.