SAN FRANCISCO, Dec. 1, 2015 /PRNewswire/ — Twist Bioscience, a company focused on synthetic DNA, today announced that its CEO, Emily Leproust, Ph.D., has been selected as one of Foreign Policy’s 100 Leading Global Thinkers of 2015 for fast-tracking the building blocks of life. Each year, Foreign Policy selects the leading Global Thinkers whose contributions and work have changed lives and are shaping the world.
“It is an honor to be recognized among these incredible global leaders,” said Leproust. “At Twist Bioscience, we continue to accelerate applications that benefit from DNA writing, from health and medical breakthroughs to environmental sustainability, to improve the lives of people around the world. We look forward to continued innovation through all areas of research that benefit from the decreasing cost and increasing scale of DNA synthesis.”
Emily Leproust, Ph.D. serves as CEO, co-founder and director of Twist Bioscience. As an early pioneer in the high throughput synthesis and sequencing of DNA, Dr. Leproust is disrupting the current process of gene synthesis to enable the exponential growth of synthetic biology applications in multiple fields including medicine, agricultural biology and industrial chemicals. Prior to Twist Bioscience, she held escalating positions at Agilent Technologies where she architected the successful SureSelect product line that lowered the cost of sequencing and elucidated dozens of Mendelian diseases. She also developed the Oligo Library Synthesis technology, where she initiated and led product and business development activities for the team. Dr. Leproust designed and developed multiple commercial synthesis platforms to streamline microarray manufacturing and fabrication. Prior to Agilent, she worked with Dr. X. Gao at the University of Houston developing DNA and RNA parallel synthesis processes on solid support, a project developed commercially by Xeotron Corporation. She was named one of the Most Creative People in Business by Fast Company. Dr. Leproust has published more than 34 peer-reviewed papers—many on applications of synthetic DNA, and is the author of numerous patents. She earned her Ph.D. in organic chemistry from the University of Houston and her M.Sc. in industrial chemistry from the Lyon School of Industrial Chemistry in France.
About Twist Bioscience
At Twist Bioscience, our expertise is synthetic DNA. We have developed a proprietary semiconductor-based synthetic DNA manufacturing process featuring a 10,000-well silicon platform capable of producing synthetic biology tools, such as oligonucleotides, genes, pathways, chassis and genomes. By synthesizing DNA on silicon instead of on traditional 96-well plastic plates, our platform overcomes the current inefficiencies of synthetic DNA production, and enables cost-effective, rapid, high-quality and high throughput synthetic gene production. The Twist Bioscience platform has the potential to greatly accelerate the development of personalized medicine, sustainable chemical production, improved agriculture production as well as new applications such as in vivo diagnostics, biodetection and data storage. For more information, please visit www.twistbioscience.com. Twist Bioscience is on Twitter. Sign up to follow our Twitter feed @TwistBioscience at https://twitter.com/TwistBioscience.
SOURCE Twist Bioscience
CardioCell Plans Phase IIb Clinical Trial Using Its Stem Cells for Patients With Chronic Heart Failure
Heart Failure Advisory Board of Leading Cardiologists and CardioCell Scientific Advisory Board Members Recommend Phase IIb Studies Based on Promising Safety and Efficacy Data From Phase IIa Study
SAN DIEGO, Dec. 1, 2015 /PRNewswire/ — CardioCell LLC, a Stemedica Cell Technologies Inc. subsidiary that uses allogeneic stem cells for cardiovascular indications, intends to proceed with finalizing a Phase IIb clinical trial protocol based on recommendations from a Heart Failure Advisory Board comprising cardiology key opinion leaders and its Scientific Advisory Board members. In a recent meeting members of both boards analyzed preliminary Phase IIa safety and efficacy data from CardioCell’s on-going chronic heart failure (HF) study, “Single-blind, Placebo-controlled, Crossover, Multi-center, Randomized Study to Assess the Safety, Tolerability and Preliminary Efficacy of a Single Intravenous Dose of Ischemia-tolerant Allogeneic Mesenchymal Bone Marrow Cells to Subjects With Heart Failure of Non-ischemic Etiology” (NCT02123706). Data from three months following a single infusion show signs of potential efficacy in the treated group in contrast to the control group. As a result, the group unanimously recommended that CardioCell expand the study into Phase IIb and designed new protocols to more definitely assess the effects of this novel intervention on cardiac function and the outcomes in patients with heart failure.
“Given the negative results of many trials conducted in patients with heart failure, innovation is required in this field. As a result of encouraging animal and clinical data, we are developing a robust Phase IIb program using CardioCell’s therapy,” says Heart Failure Advisory Board Co-chair Dr. Mihai Gheorghiade, Professor of Medicine and Surgery and Director of Experimental Therapeutics at the Center for Cardiovascular Innovation at Northwestern University Feinberg School of Medicine.
The proposed Phase IIb study will include approximately 600 patients with heart failure and reduced ejection fraction due to coronary artery disease and/or primary cardiomyopathy. Once the protocol is finalized and the FDA’s IND approval is received, the Phase IIa study centers – Northwestern University, Emory University, the University of Pennsylvania and Stony Brook University – will be asked to participate. In addition to those sites, CardioCell is in a process of identifying more sites in the United States to conduct this relatively large Phase IIb program.
In order to assure patient safety and create the most effective Phase IIb protocol design, CardioCell assembled the following top experts for its Heart Failure Advisory Board:
- Dr. Javed Butler, the Chief of the Cardiology Division at Stony Brook Heart Institute, Co-chair of CardioCell’s Heart Failure Advisory Board and CardioCell Scientific Advisory Board Member
- Dr. Mihai Gheorghiade, Professor of Medicine and Surgery and Director of Experimental Therapeutics at the Center for Cardiovascular Innovation at Northwestern University Feinberg School of Medicine, Co-chair of CardioCell’s Heart Failure Advisory Board Co-chair and CardioCell Scientific Advisory Board Member
- Dr. Stephen Epstein, Director, Translational and Vascular Biology Research at MedStar Heart Institute, Clinical Professor of Medicine at Georgetown University and CardioCell Scientific Advisory Board Chair
- Dr. Gregg Fonarow, Eliot Corday Professor of Cardiovascular Medicine and Science at the University of California Los Angeles (UCLA) and Director of Cardiomyopathy Center at UCLA School of Medicine
- Dr. Barry Greenberg, Director of Advanced Heart Failure Treatment Program at the University of California San Diego (UCSD) Medical Center and UCSD Professor of Medicine
- Dr. Marco Metra, Professor of Medicine and the University of Brescia, Italy, and Editor of “European Journal of Heart Failure”
- Dr. Scott Solomon, Professor of Medicine at Harvard Medical School, Director of Non-invasive Cardiology and Director of Cardiac Imaging and Clinical Trials Endpoints Center at Brigham and Women’s Hospital and Associate Editor of “Circulation”
- Dr. James Udelson, Professor of Medicine at Tufts Medical Center, Chief of Division of Cardiology at Tufts University and Editor of “Circulation: Heart Failure”
Only CardioCell’s chronic HF therapies feature itMSCs, which are exclusively licensed from CardioCell’s parent company Stemedica. Unlike all other MSCs – which are grown under normoxic conditions – Stemedica’s bone-marrow-derived, adult, allogeneic itMSCs are unique because they are grown under hypoxic conditions. In vitro experiments demonstrate cells that are exposed to hypoxic conditions show greater homing and engraftment than cells grown under normoxic conditions. Compared to other MSCs, itMSCs secrete higher levels of growth factors and other important proteins associated with neoangiogenesis and healing.
About CardioCell LLC
Founded in San Diego, California, in 2013, CardioCell LLC is a global biotechnology company that explores therapeutic applications of unique, patented, ischemia-tolerant mesenchymal stem cells manufactured under cGMP conditions. CardioCell is a subsidiary of Stemedica Cell Technologies Inc., a global biotechnology company that manufactures adult allogeneic stem cells. The company’s technology is based on more than 30 years of research and clinical experience conducted by scientists and physicians in the United States, Europe and the former Soviet Union. CardioCell therapies offer a unique, proprietary technology based on the expansion of cells in constant hypoxia, which provides critical benefits in terms of safety, efficacy and scalability. The company has an exclusive, worldwide license from Stemedica to explore therapeutic indications for unmet cardiovascular needs, such as acute myocardial infarction (AMI), chronic heart failure (CHF) and peripheral artery disease (PAD). For more information, visit www.stemcardiocell.com.
About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. is a global biopharmaceutical company that manufactures multiple lines of allogeneic adult stem cells and stem cell factors. The company is licensed by the State of California’s Department of Public Health, Food and Drug Branch to manufacture cGMP, clinical-grade stem cells currently used in U.S.-based clinical trials for chronic heart failure, cutaneous photoaging, ischemic stroke and Alzheimer’s disease. Stemedica’s products are also used on a worldwide basis by research institutions and hospitals for pre-clinical and clinical (human) trials. Stemedica is currently developing additional clinical trials for other medical indications using adult, allogeneic stems cell under the auspices of the FDA and other international regulatory institutions. The company is headquartered in San Diego, California and can be found online at www.stemedica.com.
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The Townsend Team
SOURCE CardioCell LLC
Candidates must have 2+ years in selling software solutions to Phama and or Biotech customers and ideally have experience in Genomics or related Biotechnology…
From Indeed – 01 Dec 2015 14:12:52 GMT
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Candidates must have 2+ years in selling software solutions to Phama and or Biotech customers and ideally have experience in Genomics or related Biotechnology…
From Indeed – 01 Dec 2015 14:12:52 GMT
– View all San Diego jobs
SAN FRANCISCO, Dec. 1, 2015 /PRNewswire/ — InCarda Therapeutics, Inc. (InCarda), a privately-held biopharmaceutical company focused on the development and commercialization of therapies for cardiovascular conditions via the inhalation route, today announced that it has established a subsidiary business in Australia. InCarda is planning to undertake its first human clinical trial in Australia in the first half of 2016. The company is collaborating with leading investigators and medical centers in Adelaide and Melbourne. In addition, InCarda has contracted with Australian clinical research organizations (CROs) and is conducting formulation manufacturing and testing in Australia—both in preparation for the upcoming trial. Government incentives are available for conducting such R&D activities in Australia, and thus, InCarda’s clinical trial will be substantially subsidized.
“Australia has become an important region for medical research given its resident world-class clinicians, many of whom are involved in conducting clinical trials, as well as its strong collaborators for pharmaceutical development,” stated Grace E. Colon, Ph.D., chief executive officer and president of InCarda. “Establishing a subsidiary in Australia makes excellent sense for InCarda given the subsidies we will benefit from as well as the vast infrastructure available to us as we prepare to enter the clinic with our first product targeting paroxysmal atrial fibrillation.”
“InCarda is a welcome addition to our emerging pharmaceutical region that is growing here in Australia,” stated Brendan Case of Case Governance. “Our compliance team has been delighted to help InCarda get established as they’ve begun to capitalize on all that Australia has to offer biotechnology and pharmaceutical companies. We are also fortunate to be working with MPR Group for strategic tax advice in Australia.”
InCarda’s Lead Product for PAF
Paroxysmal atrial fibrillation, the most common type of cardiac arrhythmia (abnormal heart rhythm) is an episode patients experience when the heart flutters instead of beating normally. Flecainide is commonly prescribed for arrhythmias, and InCarda is evaluating an inhaled formulation of the drug for patients experiencing PAF.
About InCarda (www.incardatherapeutics.com)
InCarda Therapeutics, located in the San Francisco Bay Area with operations in Australia, is focused on transforming cardiovascular disease treatment through pulmonary delivery of established drugs. The company is product-focused with significant capabilities and led by a team with extensive experience in drug development. The lead product under development is an inhaled therapy intended to treat paroxysmal atrial fibrillation (PAF). InCarda is also working on additional research concepts that leverage the same platform technology to target the heart for acute cardiac conditions. The company’s approach is designed to reduce the risk normally associated with drug development. InCarda’s model is based on the following three tenets: known diseases, known drugs, new delivery.
Cook Williams Communications, Inc.
SOURCE InCarda Therapeutics
MabVax Therapeutics Files IND for Phase I Clinical Trial with HuMab 5B1 as a Therapeutic for Pancreatic Cancer
Enrollment Expected to Begin in Early 2016
SAN DIEGO, Dec. 1, 2015 /PRNewswire/ — MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage oncology drug development company, announces it has filed an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) for the Company’s lead fully human antibody product HuMab 5B1 as a therapeutic agent. Subject to FDA acceptance, MabVax plans to initiate the Phase I clinical trial early in 2016.
The planned Phase I trial will evaluate the safety, tolerability and pharmacokinetics of HuMab 5B1 as a single agent or in combination with the current standard of care chemotherapy regimen in subjects with metastatic pancreatic cancer. The first cohort of patients to be enrolled in the planned clinical trial will be enrolled in a traditional dose escalation regimen to assess safety and determine the optimal dose of the antibody. A second patient cohort will establish the safety and optimized dose of the antibody when administered with standard of care chemotherapy and a third patient cohort will be administered the optimized dose of antibody as a single agent for the treatment of patients with advanced cancer.
David Hansen, MabVax’s President and Chief Executive Officer, said, “The filing of the first of two planned INDs for our novel HuMab 5B1 antibody is a significant achievement for MabVax. Pending FDA acceptance of the IND, we will begin the dose escalation portion of this Phase I trial as early in 2016 as possible and anticipate reporting on the early safety assessment and determination of a maximum tolerated dose in mid-year 2016. Achievement of this important interim milestone will enable us to move into the combination therapy and monotherapy portions of the trial where we could learn much more about the pharmacological effects of this new therapy. The milestone could also have a positive impact on our future commercial and corporate development activities. We currently anticipate having full enrollment of all three patient cohorts sometime before the end of 2016.”
MabVax plans to file a second IND application this month for its HuMab 5B1-based PET imaging agent and, subject to FDA acceptance, will begin this Phase I trial as early as possible in 2016. When the antibody is combined with a radio-label as a novel PET imaging agent, the 89Zr-HuMab 5B1 product has demonstrated high image resolution of tumors in established xenograft animal models, making it attractive as a potential companion diagnostic for the HuMab 5B1 therapeutic product.
“We believe the data generated in the early portions of these two Phase I trials will help demonstrate the initial safety, targeting specificity, and utility of the HuMab 5B1 antibody in this devastating disease,” added Mr. Hansen. “We are excited about the potential applicability of our dual-product development approach in other cancers with HuMab 5B1, as well as with follow-on antibodies under development at MabVax.”
About HuMab 5B1:
MabVax’s HuMab 5B1 antibody is fully human and was discovered from the immune response of cancer patients vaccinated with an antigen-specific vaccine during a Phase I trial at Memorial Sloan Kettering Cancer Center. In preclinical research, the 5B1 antibody has demonstrated high specificity and affinity, and has shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon and small cell lung cancers. The antigen the antibody targets is expressed on more than 90% of pancreatic cancers making the antibody potentially broadly applicable to most patients suffering from this type of cancer.
MabVax Therapeutics Holdings, Inc. is a clinical-stage biotechnology company focused on the development of vaccine and antibody-based products and vaccines 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 also 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 multicenter clinical trials, and a vaccine targeting neuroblastoma that will be ready for a Phase II clinical trial in 2016. Additional information 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 the Company’s filing on an IND and product development pipeline. We have no assurance that all of the product development pipeline 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, 2014, as amended and supplemented from time to time and the Company’s Quarter Reports on Form 10-Q and other filings submitted by the Company to the SEC, copies of which may be obtained from the SEC’s website at www.sec.gov. The parties do not undertake any obligation to update forward-looking statements contained in this press release.
Senior Vice President
Robert B. Prag
The Del Mar Consulting Group, Inc.
Alex Partners, LLC
SOURCE MabVax Therapeutics Holdings, Inc.
Symic Secures $25 Million in Series A-2 Financing to Advance Clinical-Stage Biotherapeutics Platform
- Company Is Currently Investigating Its Lead Candidate, SB-030, in the Phase 1/2 SHIELD Clinical Trial –
SAN FRANCISCO, Dec. 1, 2015 /PRNewswire/ — Symic, a clinical-stage biotherapeutics company developing multiple compounds that target and affect the extracellular matrix (ECM), today announced that it has secured $25 million in a Series A-2 financing to advance the company’s pipeline, including its lead candidates SB-030 and SB-061. The financing was led by Lilly Ventures and includes the participation by all existing major investors, as well as several new investors. This new funding brings the total capital raised by Symic to over $43 million since being founded in 2012.
The company recently initiated the Phase 1/2 SHIELD clinical trial to evaluate the safety and efficacy of SB-030, a locally applied, single-use treatment for the reduction of acute inflammation resulting from the vascular injury following percutaneous transluminal angioplasty in patients with peripheral artery disease. The company is also advancing its proprietary treatment SB-061 in osteoarthritis.
“This $25 million round of financing puts Symic on strong footing to execute on our promising pipeline of compounds targeting and affecting the extracellular matrix,” said Ken Horne, Chief Executive Officer of Symic. “We are now well capitalized to move our vascular and osteoarthritis programs through Phase 1/2 studies in the clinic and to continue the exciting research on what our next clinical program will be.”
Dr. Armen Shanafelt, general partner at Lilly Ventures, said, “The combination of Symic’s high quality management team and its novel approach targeting the extracellular matrix make Symic a very exciting company. The Symic team has made significant progress with its two lead programs, moving the first of these into human clinical trials less than a year after closing the Series A. We look forward to data from these studies in 2017.”
Symic is a clinical-stage biotherapeutics company developing multiple compounds that target and affect the extracellular matrix (ECM), the non-cellular component of tissues that is critical for healthy tissue function. Components of the ECM, particularly proteoglycans, which are important structural and functional macromolecules native to the ECM, play a critical role in healing following injury and in chronic diseases. Symic’s proprietary compounds function like proteoglycans, and have been designed to promote healing and repair in a variety of disease states. SB-030 is Symic’s lead compound under evaluation in the Phase 1/2 SHIELD clinical trial for vascular endothelial injury.
Symic is based in San Francisco. For additional information, please visit the company’s website at http://www.symic.bio or follow us on Twitter at www.twitter.com/symicbio and LinkedIn at www.linkedin.com/company/symic-bio/.
SAN DIEGO, Dec. 1, 2015 /PRNewswire/ — Profil Institute for Clinical Research, a clinical research organization (CRO) focused on diabetes, obesity and NAFLD/NASH, announced today the addition of Christian Weyer, M.D., M.A.S. to its executive management team as President and Chief Development Officer. Dr. Weyer was most recently President and CEO of Fate Therapeutics. Prior to that he held a number of senior leadership positions at Amylin Pharmaceuticals where he contributed to the development and approval of several first-in-class medicines for diabetes and lipodystrophy, while also leading the company’s programs and global strategic partnership in obesity. Dr. Marcus Hompesch will continue to lead Profil Institute as the company’s CEO and Chairman of the Board.
Dr. Weyer’s career in metabolic drug development spans more than 20 years, involving clinical studies and regulatory submissions at all stages of product development and across the continuum of diabetes, obesity and NAFLD/NASH. In the newly created role of Chief Development Officer, Dr. Weyer will oversee the company’s clinical development services and forge new strategic partnerships with biopharmaceutical companies and other stakeholder groups pursuing clinical development programs or licensing opportunities for metabolic drug or device candidates.
“Building upon its long-standing scientific reputation, therapeutic focus, track record of clinical trial execution, and growing network of metabolic research partners, Profil Institute is uniquely positioned to further expand its global leadership as the partner of choice for metabolic R&D,” said Dr. Weyer. “I’m excited to join the Company during this next stage of strategic expansion, as we work to offer clients worldwide an unrivaled and comprehensive suite of clinical research and development services to enable efficient and expeditious paths to value creation.”
“We are excited to welcome Chris to our leadership team during this time of dynamic growth,” said Dr. Hompesch. “Chris’ career leading drug development programs and global pharmaceutical partnerships, in addition to his deep scientific expertise in metabolic research, makes him an ideal addition to the leadership team at Profil Institute. Chris will be instrumental as we expand our clinical development consulting services for clients seeking a science-driven, therapeutically focused CRO with a proven track record of facilitating clinical, regulatory and licensing strategies.”
Dr. Weyer is globally recognized as an accomplished business leader with scientific expertise in diabetes and obesity through his work in academia, government research, and the biopharmaceutical settings. Following training at the Department of Metabolic Disorders, World Health Organization Collaborating Center for Diabetes Treatment and Prevention, at the University of Düsseldorf, Germany, Dr. Weyer worked at the National Institutes of Health, NIDDK, conducting clinical research on the pathogenesis of obesity and type 2 diabetes. During his subsequent 12-year tenure with Amylin Pharmaceuticals, he held a number of senior leadership positions in R&D and corporate development, serving most recently as Senior Vice President of R&D. Following Amylin’s acquisition by Bristol-Myers Squibb in August 2012, he joined Fate Therapeutics as President and CEO, where he steered the company’s transition into a publicly-traded cellular therapeutics company, advancing new programs and partnerships in immuno-oncology, inherited metabolic disorders and type 1 diabetes.
About Profil Institute for Clinical Research, Inc.
Profil Institute is an early engagement clinical research organization (CRO) exclusively focused on metabolic diseases, including diabetes, obesity and NAFLD/NASH. The company is recognized globally for its scientific expertise, expanded scope of research methodologies, and experience with every clinically relevant drug class in diabetes. Profil Institute provides a full scope of CRO services from consulting for strategic clinical development and regulatory planning through design and completion of complex clinical trials, including the reporting and publication of final study results.
Profil Institute has completed more than 230 clinical trials focused on metabolism, including diabetes, obesity and NAFLD/NASH. Profil Institute is leveraging that deep expertise in metabolic disease to become the leading CRO pursuing solutions for the unmet medical needs of NAFLD/NASH patients.
Profil Institute’s expertise and experience encompasses small and large molecule therapies, biologics and biosimilars through all routes of administration, as well as devices. The company’s clients range from large pharma and drug discovery companies to small virtual companies throughout the Americas, Europe and Asia.
Profil Institute is also widely recognized as an innovator of methodologies, including its Automated Glucose Clamp technology, and for driving new, higher standards in metabolic clinical research through collaborative science with key academic and industry partners. For more information, please visit www.profilinstitute.com.
SOURCE Profil Institute for Clinical Research, Inc.
This position offers significant opportunity to develop scientific and managerial skills in a biotechnology environment….
From DeviceSpace.com – 01 Dec 2015 08:26:44 GMT
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Minimum of 2 years of experience in administrative support required preferably within a pharmaceutical, biotechnology or CRO setting….
From DeviceSpace.com – 01 Dec 2015 08:25:45 GMT
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