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SAN DIEGO, CA–(Marketwired – August 31, 2015) – Dr. Charles M. Hulsey, a premier family orthodontist, is using a revolutionary new practice known as epigenetics to influence growth in adults and treat alignment and sleep apnea issues.
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Engineers at the University of California, San Diego, have developed a mouth guard that can monitor health markers, such as lactate, cortisol and uric acid, in saliva and transmit the information wirelessly to a smart phone, laptop or tablet. The technology, which is at a proof-of-concept stage, could be used to monitor patients continuously without invasive procedures, as well as to monitor athletes’ performance or stress levels in soldiers and pilots.
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MabVax Therapeutics HuMab 5B1 Antibody Is Highlighted at Upcoming World Molecular Imaging Congress in Five Separate Presentations
SAN DIEGO, Aug. 31, 2015 /PRNewswire/ — MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX) aclinical stage oncology drug development company announces that the Company’s lead antibody, HuMab 5B1, will be garnering major attention as the subject of five separate presentations during the upcoming World Molecular Imaging Congress (WMIC) being held in Hawaii September 2-5, 2015. Researchers from the Department of Radiology at Memorial Sloan Kettering Cancer Center (MSK) will present results on the use of MabVax’s lead antibody as a PET imaging agent and as a radioimmunotherapy agent targeting pancreatic cancer.
Presenters at the WMIC include Jacob Houghton, Ph.D. of MSK, who will present results from two preclinical in vivo studies using the HuMab 5B1 antibody as an ImmunoPET imaging agent in the context of circulating antigen as well as new pretargeted methods for the immunoPET imaging of CA19.9 in murine models of pancreatic cancer. Dalya Abdel-Atti will present the results of using HuMab5B1 in ImmunoPET imaging with newly developed murine organoid models of pancreatic cancer. A third presenter, Jan-Philip Meyer, Ph.D., will present results of using HuMab 5B1 as a pre-targeting agent followed by administration of the short-lived (18F)-NOTA-labeled tetrazine radioligand for PET imaging and in vivo coupling, examining the efficiency of HuMab5B1 in imaging and the reduction in exposure to the radiolabel. All four presentations illustrate the potential utility of the antibody as a next generation imaging agent for pancreatic cancer. Lastly, Ryan Lanning, M.D. Ph.D., will present the results of using HuMab 5B1 as a radioimmunotherapy agent for treatment of pancreatic cancer.
Because five-year survival rates in pancreatic cancer are only 5% and more than half of all patients initially diagnosed already have metastatic disease, the difficulties in identifying distant metastases that often go undetected as well as developing advanced therapeutics to treat this difficult cancer are significant unmet medical needs. These researchers at MSK are on the cutting edge of this technology and may well help develop a new generation of diagnostic and therapeutic agents using HuMab 5B1. Continuing studies of HuMab 5B1 could further demonstrate the utility of a broad technology platform useful both as a imaging and therapeutic agent.
About HuMab 5B1
The fully human antibody HuMab 5B1 was recovered from patients undergoing cancer vaccine treatment at Memorial Sloan-Kettering Cancer Center. The HuMab 5B1 has demonstrated high specificity, affinity, and lack of cross-reactivity with similar antigens. The antibody has also shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon, and small cell lung cancers. Ongoing toxicology results continue to demonstrate an acceptable profile in acute and repeat dose studies in animals. MabVax plans to initiate two complementary Phase I clinical trials in the first quarter of 2016. One clinical trial is aimed at determining the safety and potential utility of HuMab 5B1 as a therapeutic agent in subjects with metastatic pancreatic cancer. The second clinical trial is aimed at demonstrating the utility of 89Zr-HuMab 5B1, the Company’s radio-labeled HuMab 5B1 antibody, as a next-generation PET imaging agent for the diagnosis, staging, and management of pancreatic cancer.
MabVax Therapeutics Holdings, Inc. is a clinical stage biotechnology company focused on the development of vaccine and antibody based therapies to address unmet medical needs in the treatment of cancer. MabVax has discovered a pipeline of human monoclonal antibody products based on the protective immune responses generated by patients who have been immunized against targeted cancers with the Company’s proprietary vaccines. MabVax has the exclusive license to the therapeutic vaccines from Memorial Sloan Kettering Cancer Center. MabVax has two cancer vaccines targeting recurrent sarcoma and ovarian cancer in proof of concept Phase II multi-center clinical trials, and a vaccine targeting neuroblastoma ready for Phase II clinical development.
Additional information about the Company is available at www.mabvax.com.
Forward Looking Statements
This press release contains “forward-looking statements” regarding matters that are not historical facts, including statements relating to upcoming presentations expected to be made by researchers at MSKCC related to the use of HuMab 5B1. We have no assurance that all of the product development opportunities related to current research studies of HuMab 5B1 will be fully developed by the Company. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipates,” “plans,” “expects,” “intends,” “will,” “potential,” “hope” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon current expectations of the Company and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release relating to the Company may be found in the Company’s periodic filings with the Securities and Exchange Commission, including the factors described in the section entitled “Risk Factors” in its annual report on Form 10-K for the fiscal year ended December 31, 2013 and in the Proxy Statement dated July 25, 2014, as amended and supplemented from time to time and in our quarterly report on Form 10-Q for June 30, 2014. The parties do not undertake any obligation to update forward-looking statements contained in this press release.
Robert B. Prag
The Del Mar Consulting Group, Inc.
Alex Partners, LLC
SOURCE MabVax Therapeutics Holdings, Inc.
Brian Wong, M.D., Ph.D., joins as Chief Executive Officer and William Ho, M.D., Ph.D., joins as Chief Medical OfficerDual mechanism of FLX925 holds promise for the treatment of hematological malignancies, including acute myeloid leukemia associated with mutant FLT3 and CDK4/6
SOUTH SAN FRANCISCO, Calif., Aug. 31, 2015 /PRNewswire/ — FLX Bio, Inc., a biopharmaceutical company focused on the discovery and development of novel cancer immunotherapies, announced today that it has appointed Brian Wong, M.D., Ph.D., as Chief Executive Officer and William Ho, M.D., Ph.D., as Chief Medical Officer. Drs. Wong and Ho join an experienced management team led by veterans of Flexus Biosciences, Inc., FLX’s predecessor company: Jordan Fridman, Ph.D., Chief Scientific Officer; Jay Powers, Ph.D., Vice President, Drug Discovery; and Steve Young, Ph.D., Vice President, Technology.
FLX Bio also announced today the initiation of a Phase 1 study in patients with relapsed or refractory acute myeloid leukemia (AML), under an Investigational New Drug (IND) application for FLX925 (previously known as AMG 925), a dual inhibitor of FLT3 and CDK4/6.
“We are delighted to welcome Drs. Brian Wong and Bill Ho to the management team at FLX Bio as the company advances its growing oncology pipeline into the clinic. The organization will benefit greatly from the experience of these accomplished executives in discovering and developing innovative therapies for cancer,” said David V. Goeddel, Ph.D., of FLX Bio’s Board of Directors.
Brian Wong, M.D., Ph.D. and William Ho, M.D., Ph.D. Bring Immuno-Oncology Expertise and Leadership to Advance FLX Bio’s Programs
Dr. Wong most recently served as Senior Vice President, Research and Head of Immuno-Oncology at Five Prime Therapeutics, which he joined in 2009. There he led the discovery of novel immuno-oncology therapeutics, one of which has progressed to clinical trials in combination with Opdivo™. Prior to Five Prime, Dr. Wong served as Director of Research in the Inflammation Disease Biology Area at Roche Palo Alto from 2005 to 2009. He led the development of Roche’s Rheumatology discovery portfolio, consisting of ~20 biologics and small molecule programs in phases from discovery to mid-stage clinical development. From 2000 to 2005, Dr. Wong held various leadership roles at Rigel Pharmaceuticals, where he identified and developed clinical candidates against multiple novel targets for allergic, autoimmune and respiratory disorders. Dr. Wong received an M.D. from the Weill Cornell Medical College and a Ph.D. in Immunology from The Rockefeller University under Dr. Yongwon Choi, Ph.D., a Howard Hughes Medical Institute Investigator, and in collaboration with Nobel laureate Dr. Ralph Steinman, M.D.
“I’m very excited to join the FLX Bio team,” said Dr. Wong. “With a clinical-stage asset, a rich pipeline of immuno-oncology agents targeting regulatory T cells, an exceptional management team and scientific staff, and strong support from The Column Group, Kleiner Perkins Caufield & Byers and Celgene, FLX Bio is positioned to become a key player in the immuno-oncology space.”
Dr. Ho most recently served as Vice President of Clinical Development at Igenica Biotherapeutics, leading the clinical development of antibody-based therapeutics. Prior to Igenica, he was a Senior Medical Director in the Exploratory Clinical Development (BioOncology) group at Genentech, where he spent seven years leading the clinical development of multiple small molecule, antibody and antibody-drug conjugate programs at stages ranging from IND filing to Phase 3, including clinical development of Gazyva® (obinutuzumab). Dr. Ho received an A.B. in Molecular Biology from Princeton University and holds both an M.D. and a Ph.D. in Microbiology and Immunology from the Stanford University School of Medicine, where he studied cellular immunology in the laboratory of Mark Davis, Ph.D., a Howard Hughes Medical Institute Investigator. He continued his medical training at the University of California, San Francisco and at the University of Washington and Fred Hutchinson Cancer Research Center, where he studied adoptive immunotherapy methods to treat leukemia, including early work contributing to current CAR-T technology.
Initiation of Phase 1 Trial of FLX925, a Selective Inhibitor of FLT3 and CDK4/6 in Acute Myeloid Leukemia
FLX925 is a selective inhibitor of fms-like tyrosine kinase 3 (FLT3) and cyclin-dependent kinases 4 and 6 (CDK4/6) that was licensed from Amgen. The preclinical data for FLX925 are consistent with a potential best-in-class profile in the treatment of certain cancers that are driven by abnormal levels of FLT3 and/or CDK4/6 activity.
“Acute myeloid leukemia remains a disease with great unmet medical need,” said Beth Seidenberg, M.D., of FLX Bio’s Board of Directors and General Partner at Kleiner Perkins Caufield & Byers. “We believe FLX925 has the potential to bring meaningful benefit not only to patients with AML, but also to patients with other malignancies driven by CDK4/6.”
For more information about the clinical trial, including enrolling centers, please visit www.clinicaltrials.gov under trial identification number NCT02335814.
About FLX Bio
Founded in 2015 following the acquisition of its predecessor company, Flexus Biosciences, Inc., by Bristol-Myers Squibb, FLX Bio, Inc. is a privately-held biopharmaceutical company focused on the discovery, development and commercialization of novel cancer immunotherapies. The company is leveraging unexploited insights in immunology to discover novel agents that combat cancer by reversing tumor immunosuppression. This disruptive approach to cancer therapy targets that which is common to all tumors: the host immune system.
Located in South San Francisco, Calif., and funded by leading investors, including Kleiner Perkins Caufield & Byers (KPCB), The Column Group (TCG) and Celgene, FLX Bio has assembled a management and R&D leadership team with a proven track record of success and an advisory group and team of scientists with substantial knowledge and expertise in drug discovery and translational areas essential to execute on this approach. For more information, please visit www.flxbio.com.
Contact: Timothy Lin, email@example.com
SOURCE FLX Bio, Inc.
MicuRX Reports Positive Top-Line Results In Phase 2 Clinical Trial For Novel Antibiotic MRX-I In Complicated Skin And Soft Tissue Infections
– Enrollment Complete in Second Phase 2 Trial with Results Expected in 4Q15 —
HAYWARD, Calif. and SHANGHAI, Aug. 31, 2015 /PRNewswire/ — MicuRx Pharmaceuticals, Inc., a privately-held biopharmaceutical company developing next-generation antibiotics, today announced positive top-line results from the first Phase 2 clinical study for its lead drug candidate MRX-I. MRX-I is an oral oxazolidinone antibiotic designed to treat drug-resistant bacteria such as MRSA and VRE, while offering physicians and patients a safer and better tolerated therapeutic option than currently available oxazolidinone agents.
“These clinical data demonstrate that MRX-I has the potential to be a safe and effective antibiotic for a broad range of infections, including those that are multidrug-resistant,” said Dr. Zhengyu Yuan, president and CEO of MicuRx Pharmaceuticals, lnc.
In the double-blind study conducted at 29 sites in China, patients with complicated skin and soft tissue infections received either 600 mg or 800 mg of MRX-I, or 600 mg of linezolid, twice daily for a period of up to 14 days. Of 199 patients with confirmed or suspected Gram-positive bacterial infection at the time of admission, 178 patients were clinically evaluable at the test-of-cure (TOC) visit. For the clinically evaluable patients, the clinical cure rates at the TOC visit were comparable for the MRX-I 800 mg group (96.5 percent) and the linezolid group (95.5 percent). Both doses of MRX-I demonstrated a favorable safety and tolerability profile. No drug-related serious adverse events were noted in patients receiving either MRX-I or linezolid.
“The oxazolidinone class of antibiotics stands out from others with a remarkably low propensity for bacterial resistance,” commented Dr. Yingyuan Zhang, director of the Institute of Antibiotics at Fudan University and the principle investigator of this study. “However, these antibiotics typically come with the myelosuppression adverse event, which limits its use. Data from the Phase 2 study of MRX-I reported today combined with prior Phase 1 trial results indicate that this promising agent may offer the efficacy of the oxazolidinone class without bone marrow toxicity.”
Dr. Yuan further noted that, “Adding to our body of clinical knowledge, we have completed dosing in a second Phase 2 trial conducted in the United States, and results will be available in the fourth quarter of 2015. The full data set for MRX-I will inform the design of our planned Phase 3 clinical trials.”
This Phase 2 study was funded through MicuRx’s joint venture with Shanghai Zhangjiang Biomedical Industry Venture Capital, founded to advance the development of MRX-I for the Chinese market. Data from two Phase 1 studies in China and Australia have confirmed that MRX-I was safe and well tolerated in healthy volunteers at all dose regimens, including 28-day repeated dosing regimen alongside Zyvox® as comparator, with no evidence of myelosuppression that is typical for this class.
About MicuRx Pharmaceuticals, Inc.
MicuRx (http://www.micurx.com) is discovering and developing novel antibiotics to combat infections due to drug-resistant bacteria. Positioned to capture the benefits of United States research and development expertise together with the high quality, cost-efficient discovery, preclinical and development infrastructure in China, the company has built a pipeline of discovery and development programs targeting Gram-positive and Gram-negative pathogens. The company has research and development facilities outside San Francisco, CA in the United States and in Shanghai, China.
SOURCE MicuRx Pharmaceuticals, Inc.
If you tried to count on one hand the number of New York City biotech startups to get a substantial funding round this year, you’d probably have a few fingers left over. A stealthy startup out of…
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