Previous production master data experience within a medical, pharmaceutical, or biotechnology environment. The Master Data Business Analyst I position is an…
From Becton Dickinson – 24 Feb 2015 14:25:51 GMT
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SAN DIEGO, Feb. 24, 2015 /PRNewswire/ — Agena Bioscience today released the MassARRAY 24-Well System for mass spectrometry-based genetic analysis, adding to its existing MassARRAY portfolio. The new 24-well format is tailored to smaller clinical testing laboratories requiring modest sample throughput, reduced initial hardware costs, and reduced time to result.
Agena began developing the new instrument based on the clinical community’s feedback shortly after acquiring the MassARRAY platform from Sequenom in 2014. To Peter Dansky, Agena’s CEO, it is an early move in the company’s drive to ultimately make precision medicine routine and affordable for smaller, regional testing laboratories that may not have access to extensive IT resources and infrastructure to support complex data analysis.
“Labs repeatedly told us if various platforms afforded greater freedom—in terms of test development, accurate results at low cost, and turnaround times—they could be providing more genetic tests to more patients. We’re answering those sentiments with a flexible platform that drives down costs to a few dollars to tens of dollars per sample and cuts out big bioinformatics,” said Dansky.
“While the research community explores the potential hidden in the human genome, clinicians can utilize validated biomarkers to guide the best outcome for their patients. With our powerful, proven MassARRAY technology, we are working towards enabling clinical laboratories to translate precision medicine into widespread use.”
“With the new 24-well system labs can cut wait times and costs for smaller panels or panels that are run less often, such as a lung cancer panel for ALK and other gene mutations. The 24-well scale is also ideal for clinical research studies, which often involve targeted testing of a small cohort of 5 to 50 patients,” said Dansky.
The MassARRAY system detects genetic variation directly by label-free mass spectrometry, analyzing up to 50 genetic loci per well. Due to the confidence level that mass spectrometry provides, MassARRAY data are often used to validate variants detected from genome sequencing in the research and clinical settings. The MassARRAY platform’s assay design software and services allow clinical laboratories to develop targeted, actionable panels for routine or specialized tests. Genetic testing on a MassARRAY system can cost less than a tenth of the cost of next-generation sequencing tests.
The liquid biopsy field can also exploit the smaller MassARRAY format. Assays specific to an individual can be developed from genome sequencing data within a day and run repeatedly from blood samples at regular intervals, for as little as tens of dollars per test. The latest MassARRAY chemistry, UltraSEEK™, can detect rare variations as low as 0.1% allele frequency, making it one of the most sensitive methods for analyzing cell-free DNA or mutations in circulating tumor cells. UltraSEEK assays can assess up to 10 genetic loci per well, making UltraSEEK the only multiplex methodology for sensitive analysis of liquid biopsies.
Existing 96- or 384-well MassARRAY system users can use the new 24-well format SpectroCHIP® without any hardware modifications for more economical lower-volume testing and method development.
Labs that purchase the MassARRAY 24-Well System can, as testing volumes expand, upgrade the instrument to support 96- or 384-well formats for increased throughput.
The MassARRAY system is research use only. The U.S. Food and Drug Administration issued in 2014 a premarket clearance for Agena’s regulated mass spectrometry-based genotyping instrument, the IMPACT Dx™ System, when used to perform two specific genetic tests as an aid in the diagnosis of patients with suspected thrombophilia.
For more information, visit www.agenabioscience.com/24.
About Agena Bioscience
Agena Bioscience is a San Diego, CA based life sciences and clinical diagnostics company that recently acquired the Bioscience business of Sequenom, Inc. and is now offering the MassARRAY® System. The system is a highly sensitive, quantitative method for nucleic acid detection via MALDI-TOF mass spectrometry for high-throughput genotyping and mutation profiling for cancer and other disease research, companion diagnostics, pharmacogenomics, molecular blood group typing, epigenetics, clinical genetics, ag-bio genetics, and molecular sample identification for bio-banking.
SOURCE Agena Bioscience
GenomeDx’s Decipher Shows Broad Applicability in Advancing Prostate Cancer Care in Data Presented at 2015 ASCO Genitourinary Symposium
Data from Multiple Studies Include Potential Ability for Technology to Further Subtype Patients, Guide Treatment Decisions
SAN DIEGO, Feb. 24, 2015 /PRNewswire/ — GenomeDx Biosciences today announced that data presented at the 2015 ASCO Genitourinary Symposium shows further development of its prostate cancer test, Decipher®. Results from three new studies highlight data on the combination of genomic markers with MRI for improved diagnosis, and the identification of prostate cancer patient subtypes that may influence response to treatment at different stages of the disease. The studies featuring the findings will be presented on February 26 at the 2015 ASCO Genitourinary Symposium from 11:30 a.m. to 1:00 p.m. ET in Orlando, FL.
“GenomeDx has built the largest genomic database for prostate cancer, with data that follows patient tumor cases over 5, 10 or even 20 years,” said Doug Dolginow, MD, CEO of GenomeDx. “With this database, we are showing that we can identify molecular signatures with the potential to answer multiple clinical questions that have meaningful implications for treatment decisions. This will take us well beyond the current clinical applications of Decipher, as we continue to identify the genomic subtypes of patients that may respond uniquely to treatment at different stages of disease.”
In a study presented by Scott A. Tomlins, M.D., Ph.D., of University of Michigan, Decipher was used to profile 1,577 patients and define three major prostate cancer molecular subtypes. The study found that molecular subtypes may arise early in the development of the disease and have potential to be used in guiding use of hormone therapy and chemotherapy. The abstract, titled “Molecular and clinical characterization of 1,577 primary prostate cancer tumors reveals novel clinical and biological insights into its subtypes,” will be presented at board B1 during the poster session.
In a study presented by Kosj Yamoah, M.D., Ph.D., of Thomas Jefferson University, researchers identified a subset of prostate cancer biomarkers that predict race-dependent clinical outcomes. These findings may explain the biological contribution to racial disparity observed in prior studies of comparing outcomes of prostate cancer patients of African and European decent. The abstract, titled “A novel biomarker signature which may predict aggressive disease in African-American men with prostate cancer,” will be presented at board B16 during the poster presentation.
In a study presented by R. Stoyanova, Ph.D., of University of Miami, researchers found a high concordance between genomic information and imaging features across multiple tumors in MRI-directed biopsies. The study is the first to demonstrate that genomics and advanced imaging may be combined to lead to improvements in the diagnosis of clinically significant prostate cancer. The abstract, titled “Using radiomics to characterize MRI-guided prostate cancer biopsy heterogeneity,” will be presented at board B17 during the poster presentation.
The Decipher® Prostate Cancer Classifier is a highly validated and commercially available genomic test for men with intermediate and high risk prostate cancer. Decipher predicts cancer aggressiveness by looking for a unique genomic signature comprised of a validated series of biomarkers associated with metastatic disease. Adding truly unique information to the treatment decision-making process, Decipher generates a risk result that is completely independent and distinct from PSA, Gleason score and other clinical risk factors. Clinical studies from leading cancer centers published in over a dozen medical journals demonstrate that Decipher can accurately predict metastatic disease, which men may benefit from radiation therapy following prostate surgery, and can lead to significant cost-savings for healthcare systems. Decipher was developed in partnership with the Mayo Clinic.
Decipher is covered by Medicare and multiple private insurance plans and is available to eligible US patients through their physicians.
Learn more at: www.DecipherTest.com.
About GenomeDx Biosciences
GenomeDx Biosciences is focused on transforming cancer patient care by putting usable genomic information in the hands of patients and their physicians. GenomeDx is developing and commercializing Decipher®, a highly validated genomic test for predicting metastatic disease in men with prostate cancer. In partnership with leading medical centers, the company has assembled the largest genomic catalogue of prostate cancer tumors in the world, representing billions of data points and more than 20 years of prostate cancer research expertise. Using advanced cloud-based bioinformatics, GenomeDx mines the genomic data to develop proprietary tests that address key clinical questions in cancer patient management. GenomeDx has partnered to share genomic data with leading clinician-scientists worldwide to collaboratively enrich the knowledge and understanding of urologic cancers for the goal of improving global cancer patient care. GenomeDx is based in San Diego, California and Vancouver, British Columbia.
Learn more at: www.genomedx.com.
SOURCE GenomeDx Biosciences
BioNano expands commercial access of the Irys System to Japan
SAN DIEGO, Feb. 24, 2015 /PRNewswire/ — BioNano Genomics announced today that it has mapped and analyzed more than 100 unique species, including human, plant, animal and microbe, on the Irys® System. BioNano’s Irys System creates a high-resolution genome map for the precise assembly of DNA sequences, completion of large genomes and understanding of genomic structural variation.
Achieving this milestone demonstrates the compatibility of the Irys System across a variety of species and highlights the importance of a comprehensive understanding of structural variations for genomic analysis and research.
“BioNano’s Irys System resolves the variant information generated by next generation sequencing platforms, as well as reveals new, previously undetected variants in days not months,” said Han Cao, Ph.D., founder and chief scientific officer of BioNano Genomics. “Scientists are using the Irys System to complete their genomes and perform more comprehensive analysis to enable genomic discovery.”
To date, 32 institutions, located in the United States, Europe and Asia Pacific, already own an Irys System. To further support this growth, BioNano recently expanded its existing Asia-Pacific distribution to Japan, in partnership with AS ONE Corporation.
New features in development for the Irys System and recent research will be presented at the 16th Annual Advances in Genome Biology and Technology (AGBT) meeting, which will be held February 25 to 28 in Marco Island, Florida. BioNano will be hosting presentations during the coffee breaks in Suite #183. To request a private meeting during AGBT 2015, email email@example.com.
Irys makes it possible to routinely and accurately detect genomic structural variation and to finish genome assemblies. The fully automated Irys benchtop instrument uses the IrysChip® to uncoil and confine long DNA molecules in proprietary Nanochannel Arrays™ where they are uniformly linearized in a highly parallel display for high-resolution, single-molecule imaging. Irys does not employ DNA fragmentation or amplification, which are typical with next-generation sequencing. The result is sequence information over extremely long “reads” ranging from hundreds of kilobases to a megabase, where the sample’s valuable structural information is preserved. Irys makes it possible for researchers to directly observe structural variants including replications, deletions, translocations and inversions.
About BioNano Genomics
Headquartered in San Diego, BioNano Genomics is delivering an altogether better way of gaining a fully informed understanding of genomes. The Company’s platform provides researchers and clinicians the most comprehensive, organized and actionable picture of a genome with unprecedented insights into how the individual components of genomes are ordered, arranged, and interact with each other. BioNano Genomics works with institutions in life science, translational research, molecular diagnostics and personalized medicine. The Company is supported by private investors and grant funding from genomics programs at federal agencies, including the NIH and NIST-ATP.
Notes: BioNano Genomics is a trademark of BioNano Genomics, Inc. Any other names of actual companies, organizations, entities, products or services may be the trademarks of their respective owners.
SOURCE BioNano Genomics
SAN FRANCISCO and BERKELEY, Calif., Feb. 24, 2015 /PRNewswire/ — Bayer HealthCare and Aronora, Inc. today announced its strategic alliance to manufacture Aronora’s AB-022 compound for the treatment of cardiovascular diseases. As a tenant of the U.S. CoLaborator, Bayer’s life sciences incubator facility based in San Francisco, Aronora will partner with Bayer HealthCare’s Global Biologics Development group in Berkeley for the pre-clinical manufacturing of AB-022.
“We have established a close, trusted relationship with Bayer HealthCare,” said Andras Gruber, CEO of Aronora. “We are thrilled to extend our relationship with this agreement. The close proximity of Bayer’s research and manufacturing sites to the CoLaborator has made this partnership a natural fit for us. The in-depth drug discovery and manufacturing expertise at Bayer has been valuable for advancing our compound towards the clinic.”
“This partnership with Aronora highlights Bayer’s unique Bay Area footprint spanning from early stage research through development and manufacturing. We are proud to offer our partners access to Bayer’s experts across the entire drug development process,” said Chris Haskell, Head of Bayer’s U.S. Science Hub. “Our partnering strategy is designed to be flexible, to meet the needs of our collaborators—including start-ups like Aronora. We are excited to advance this collaboration to share our manufacturing expertise and capabilities.”
Bayer HealthCare’s Bay Area biotechnology presence includes its U.S. Innovation Center in San Francisco and Bayer’s Berkeley site, which is a global biologics manufacturing center and functions as the headquarters for its biotechnology product supply organization.
About Aronora, Inc.
Aronora, Inc. is a small translational biotechnology company engaged in the early-stage commercial development of proprietary biologics. Aronora is based in Portland, Oregon, with satellite operations in San Francisco, California. Aronora’s products are intended to be used in difficult-to-treat life-threatening diseases, including heart attack, stroke, and severe infection-associated coagulopathy. These conditions often present as true medical emergencies that currently have no or limited causal field treatments. Building on the company’s ground-breaking rational approaches to exceptional drug safety, Aronora’s product candidates have the potential to become first-in-class medical emergency therapeutics. More information is available at www.aronorabio.com.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG, with annual sales of EUR 18.9 billion (2013), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 56,000 employees (Dec 31, 2013) and is represented in more than 100 countries. More information is available at www.healthcare.bayer.com.
About Bayer in the Bay Area
Bayer HealthCare is the third largest biotech employer in the Bay Area and a global leader in the research, development and manufacturing of biotechnology and specialty pharmaceutical therapies that improve human health. Bayer HealthCare’s presence on the U.S. West Coast includes a manufacturing facility in Berkeley and its U.S. research hub, the U.S. Innovation Center in San Francisco.
© 2015 Bayer HealthCare LLC
BAYER and the Bayer Cross are registered trademarks of Bayer.
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
SOURCE Bayer HealthCare
SAN DIEGO, Feb. 24, 2015 /PRNewswire/ — Mast Therapeutics, Inc. (NYSE MKT: MSTX), a clinical-stage biopharmaceutical company, today announced that the Company’s Chief Executive Officer, Brian M. Culley, will present at Cowen and Company’s 35th Annual Healthcare Conference on Monday, March 2, 2015 at 4:50 p.m. Eastern time in Salon H at the Boston Marriott Copley Place hotel in Boston.
Interested parties can access a live audio webcast on the Mast Therapeutics web site at www.masttherapeutics.com. An archived presentation will be available on the web site for 30 days.
About Mast Therapeutics
Mast Therapeutics, Inc. is a publicly traded biopharmaceutical company headquartered in San Diego, California. The Company is leveraging the MAST (Molecular Adhesion and Sealant Technology) platform, derived from over two decades of clinical, nonclinical and manufacturing experience with purified and non-purified poloxamers, to develop vepoloxamer (MST-188), its lead product candidate, for serious or life-threatening diseases and conditions typically characterized by impaired microvascular blood flow and damaged cell membranes.
The Company is enrolling subjects in EPIC, a pivotal Phase 3 study of vepoloxamer in sickle cell disease, and in a Phase 2 study to evaluate whether vepoloxamer improves the effectiveness of recombinant tissue plasminogen activator therapy in patients with acute limb ischemia. The Company also is planning to initiate a Phase 2 study of vepoloxamer in patients with heart failure this year. More information can be found on the Company’s web site at www.masttherapeutics.com. (Twitter: @MastThera)
Mast Therapeutics™ and the corporate logo are trademarks of Mast Therapeutics, Inc.
Forward Looking Statements
Mast Therapeutics cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to anticipated timing of development milestones for the company’s product candidates, including commencement of a Phase 2 study of vepoloxamer in heart failure. Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: the uncertainty of outcomes in ongoing and future studies of the Company’s product candidates and the risk that its product candidates, including vepoloxamer, may not demonstrate adequate safety, efficacy or tolerability in one or more such studies; delays in the commencement or completion of clinical studies, including as a result of difficulties in obtaining regulatory agency agreement on clinical development plans or clinical study design, opening trial sites, enrolling study subjects, manufacturing sufficient quantities of clinical trial material, being subject to a “clinical hold,” and/or suspension or termination of a clinical study, including due to patient safety concerns or lack of funding; the potential for additional nonclinical or clinical studies to be required prior to initiation of a planned clinical study; the risk that, even if clinical studies are successful, the FDA or other regulatory agencies may determine they are not sufficient to support a new drug application; the potential that, even if clinical studies of a product candidate in one indication are successful, clinical studies in another indication may not be successful; the Company’s reliance on contract research organizations (CROs), contract manufacturing organizations (CMOs), and other third parties to assist in the conduct of important aspects of development of its product candidates, including clinical studies, manufacturing, and regulatory activities for its product candidates, and that such third parties may fail to perform as expected; the Company’s ability to obtain additional funding on a timely basis or on acceptable terms, or at all; the potential for the Company to delay, reduce or discontinue current and/or planned development activities, including clinical studies, partner its product candidates at inopportune times or pursue less expensive but higher-risk and/or lower return development paths if it is unable to raise sufficient additional capital as needed; the risk that, even if the Company successfully develops a product candidate in one or more indications, it may not realize commercial success and may never achieve profitability; the risk that the Company is not able to adequately protect its intellectual property rights and prevent competitors from duplicating or developing equivalent versions of its product candidates; and other risks and uncertainties more fully described in the Company’s press releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.
You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. Mast Therapeutics does not intend to revise or update any forward-looking statement set forth in this press release to reflect events or circumstances arising after the date hereof, except as may be required by law.
SOURCE Mast Therapeutics, Inc.
With the largest installed base and support network for automated sample management systems, Brooks has more than 180 systems worldwide, including installations…
From Brooks Automation, Inc. – 24 Feb 2015 07:01:27 GMT
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Compile and maintain “gold” standard data sets for regression testing. Reporting to the LIMS Test Manager, the Software Test Engineer will have full…
From Sequenom – 24 Feb 2015 05:59:12 GMT
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Details: JOB TITLE Sr. Manager, Statistical Programming LOCATION San Diego, CA JOB DESCRIPTION The Statistical Programmer provides statistical programming technical leadership and support to team members including programming outputs (datasets, tables, listings, figures, compliance and oversight documentation) for protocols, product defense, and commercial support. The Statistical Programmer also provides expertise in clinical programming, partnering with internal and external groups to ensure quality and compliance in clinical programming deliverables. RESPONSIBILITIES Effectively designs and codes SAS programs for assigned project(s), consistently meeting objectives of the project. Codes complex SAS programs for applications designed to analyze and report complex clinical trial data and for electronic submissions of data with minimal instruction or input from supervisor. Provides guidance on the resolution of highly complex clinical trial reporting problems within budget and time line constraints, while assuring high quality standards. Performs quality control checks of advanced SAS code. Responsible for maintaining excellent working knowledge of medical data, the design and phases of clinical trials, statistics, relevant regulatory requirements, and the pharmaceutical industry. Makes certain that documents and specification are consistent and comply with company standards by providing input into study protocol, CRF and data structures tables, listings and figures for phase I-IV clinical trials and submission activities. Maintains records for all assigned projects and archiving of trial/project analysis and associated documentation. Participates in the selection of CROs and supervises the trial activities of the CROs. Provides input on process improvement initiatives and participates in non-clinical project activities. Manages project timelines and schedules of specific phases of projects and contracts with internal personnel and outside customer representatives. Other projects and activities as assigned. SKILLS & ABILITIES Proven record of effective and successful project management tasks and skills. Good understanding of global clinical trials practices, procedures, methodologies. Demonstrates advanced experience with all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH. Demonstrates advanced knowledge of electronic submissions and CDlSC. Displays highly advanced knowledge regarding software validation and system development life cycle concepts. Communicates effectively in verbal presentations and written technical reports to both internal and external customers. Equipment: PC, scanners, facsimile machine, voice mail and email systems, and other common machines. Must have the ability to be trained on new equipment. Software Knowledge: SAS, Windows, MS Office (Outlook, Word, Excel, PowerPoint), and Adobe. ENVIRONMENTAL CONDITIONS While performing the duties of this job, the employee is frequently required to sit at desk for a long period of time; intermittently answer the telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The employee may need to use their hands to finger, handle, or feel objects, tools, or controls, and reach with their arms. The noise level in the work environment is usually low to moderate. The vision abilities required by this job include close vision and the ability to adjust focus. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION & EXPERIENCE B.S. in a math or science related field Minimum of five (5) years of relevant experience w/SAS in the pharmaceutical industry. Oncology experience preferred.
Work experience in Biotech or Life Science environment a plus. Indows / Linux Systems Administrator – Scientific Applications Support….
From Diverse Lynx – 24 Feb 2015 04:34:26 GMT
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