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Orexigen Therapeutics Expands Commercial Capabilities with Appointment of Beth Eastland, Vice President of Sales, and Eight Additional New Employees
SAN DIEGO, April 25, 2016 /PRNewswire/ — Orexigen Therapeutics, Inc. (Nasdaq: OREX) today announced the appointment of Beth Eastland as Vice President of Sales and eight other additional new employees. In March 2016, Orexigen acquired full United States rights to Contrave® (naltrexone HCI and bupropion HCI), and the company is preparing to assume United States commercialization of the product later this year. Orexigen is launching an efficient U.S. commercial organization to execute a targeted, data-driven sales and marketing plan to drive the next phase of growth for Contrave.
Eastland is a key member of Orexigen’s commercial team and brings many successful years of sales and marketing experience from her tenure at Merck & Co., Inc., where from 1989 through 2015, she held roles of increasing responsibility in the United States Human Health Division. At Merck, she led sales teams for primary care, specialty and hospital products and multiple product launches. Eastland’s staff positions at Merck included Chief of Staff to the President of Global Human Health from 2012-2014 and, in 2007-2008, strategic planning and marketing for the New Commercial Model project redesigning the company’s U.S. commercial operations.
“We are very excited to have Beth join Orexigen as we build out our commercial capabilities,” said Dr. Thomas Cannell, Executive Vice President and Chief Commercial Officer at Orexigen. “Beth brings extensive sales and marketing experience and is well known by colleagues as a strong cross-functional leader with a consistent track record building and leading exemplary sales teams and as a top performer.”
Orexigen today also announced that on April 19, 2016 the Compensation Committee of the Company’s Board of Directors approved the grant of inducement stock options to purchase a total of 482,500 shares of common stock to Eastland and eight other new employees.
The granted options have a strike price of $0.45 per share, the fair market value on the grant date. Each stock option vests over the course of four years, with 25% vesting on the one-year anniversary of the grant date and 1/48 of the shares vesting monthly thereafter so that all of the shares subject to the stock option shall be vested on the fourth anniversary of the grant date, subject to the new employee’s continued service relationship with the Company on each such date. Each stock option has a ten-year term and is subject to the terms and conditions of the Company’s 2007 Equity Incentive Award Plan and the stock option agreement pursuant to which the option is granted.
The stock options were granted as an inducement material to Eastland’s and the other new employees’ entering into employment with Orexigen Therapeutics in accordance with NASDAQ Listing Rule 5635(c)(4).
CONTRAVE, approved by the United States Food and Drug Administration in September 2014, is indicated for use as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus or dyslipidemia).
The exact neurochemical effects of CONTRAVE leading to weight loss are not fully understood. CONTRAVE has two components: naltrexone, an opioid antagonist, and bupropion, a relatively weak inhibitor of the neuronal reuptake of dopamine and norepinephrine. Nonclinical studies suggest that naltrexone and bupropion have effects on two separate areas of the brain involved in the regulation of food intake: the hypothalamus (appetite regulatory center) and the mesolimbic dopamine circuit (reward system).
Four 56-week multicenter, double-blind, placebo-controlled Phase 3 clinical trials were conducted to evaluate the effect of CONTRAVE in conjunction with lifestyle modification in 4,536 subjects randomized to CONTRAVE or placebo. In these studies, the most common adverse reactions (>5 percent) seen in patients taking CONTRAVE included nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea.
Important Safety Information
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS; AND NEUROPSYCHIATRIC REACTIONS
Suicidality and Antidepressant Drugs
CONTRAVE is not approved for use in the treatment of major depressive disorder or other psychiatric disorders. CONTRAVE contains bupropion, the same active ingredient as some other antidepressant medications (including, but not limited to, WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, and APLENZIN). Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects over age 24; there was a reduction in risk with antidepressant use in subjects aged 65 and older. In patients of all ages who are started on CONTRAVE, monitor closely for worsening, and for the emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. CONTRAVE is not approved for use in pediatric patients.
Neuropsychiatric Reactions in Patients Taking Bupropion for Smoking Cessation
Serious neuropsychiatric reactions have occurred in patients taking bupropion for smoking cessation. The majority of these reactions occurred during bupropion treatment, but some occurred in the context of discontinuing treatment. In many cases, a causal relationship to bupropion treatment is not certain, because depressed mood may be a symptom of nicotine withdrawal. However, some of the cases occurred in patients taking bupropion who continued to smoke. Although CONTRAVE is not approved for smoking cessation, observe all patients for neuropsychiatric reactions. Instruct the patient to contact a healthcare provider if such reactions occur.
CONTRAVE is contraindicated in: uncontrolled hypertension; seizure disorder or a history of seizures; use of other bupropion-containing products; bulimia or anorexia nervosa, which increase the risk for seizure; chronic opioid or opiate agonist (e.g., methadone) or partial agonists (e.g., buprenorphine) use, or acute opiate withdrawal; patients undergoing an abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs; use during/within 14 days following treatment with monoamine oxidase inhibitors (MAOIs)—there is an increased risk of hypertensive reactions when CONTRAVE is used concomitantly with MAOIs and use with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated; known allergy to any component of CONTRAVE anaphylactoid/anaphylactic reactions and Stevens-Johnson syndrome have been reported; pregnancy.
WARNINGS AND PRECAUTIONS
Suicidal Behavior and Ideation
All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. This warning applies to CONTRAVE because one of its components, bupropion, is a member of an antidepressant class.
Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.
Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of anxiety, agitation, irritability, unusual changes in behavior, and other symptoms, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for CONTRAVE should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.
Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment
CONTRAVE is not approved for smoking cessation treatment, but serious neuropsychiatric symptoms have been reported in patients taking bupropion for smoking cessation. These have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, hostility, agitation, aggression, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Observe patients for the occurrence of neuropsychiatric reactions. Instruct patients to contact a healthcare professional if such reactions occur.
CONTRAVE can cause seizures. The risk of seizure is dose-related. Discontinue treatment and do not restart CONTRAVE in patients who experience a seizure. Caution should be used when prescribing CONTRAVE to patients with predisposing factors that may increase the risk of seizure, including: history of head trauma or prior seizure, severe stroke, arteriovenous malformation, central nervous system tumor or infection, or metabolic disorders (e.g., hypoglycemia, hyponatremia, severe hepatic impairment, and hypoxia); excessive use of alcohol or sedatives, addiction to cocaine or stimulants, or withdrawal from sedatives; patients with diabetes treated with insulin and/or oral diabetic medications (sulfonylureas and meglitinides) that may cause hypoglycemia; concomitant administration of medications that may lower the seizure threshold, including other bupropion products, antipsychotics, tricyclic antidepressants, theophylline, systemic steroids.
Clinical experience with bupropion suggests that the risk of seizure may be minimized by adhering to the recommended dosing recommendations, in particular: the total daily dose of CONTRAVE does not exceed 360 mg of the bupropion component (i.e., four tablets per day); the daily dose is administered in divided doses (twice daily); the dose is escalated gradually; no more than two tablets are taken at one time; coadministration of CONTRAVE with high-fat meals is avoided; if a dose is missed, a patient should wait until the next scheduled dose to resume the regular dosing schedule.
Patients Receiving Opioid Analgesics
Vulnerability to Opioid Overdose: CONTRAVE should not be administered to patients receiving chronic opioids, due to the naltrexone component, which is an opioid receptor antagonist. If chronic opiate therapy is required, CONTRAVE treatment should be stopped. In patients requiring intermittent opiate treatment, CONTRAVE therapy should be temporarily discontinued and lower doses of opioids may be needed. Patients should be alerted that they may be more sensitive to opioids, even at lower doses, after CONTRAVE treatment is discontinued. An attempt by a patient to overcome any naltrexone opioid blockade by administering large amounts of exogenous opioids is especially dangerous and may lead to a fatal overdose or life-threatening opioid intoxication (e.g., respiratory arrest, circulatory collapse). Patients should be told of the serious consequences of trying to overcome the opioid blockade.
Precipitated Opioid Withdrawal: An opioid-free interval of a minimum of 7 to 10 days is recommended for patients previously dependent on short-acting opioids, and those patients transitioning from buprenorphine or methadone may need as long as two weeks. Patients should be made aware of the risks associated with precipitated withdrawal and encouraged to give an accurate account of last opioid use.
Increase in Blood Pressure (BP) and Heart Rate (HR)
CONTRAVE can cause an increase in systolic BP, diastolic BP, and/or resting HR. These events were observed in both patients with and without evidence of preexisting hypertension. In clinical practice with other bupropion-containing products, hypertension, in some cases severe and requiring acute treatment, has been reported. Blood pressure and pulse should be measured prior to starting therapy with CONTRAVE and should be monitored at regular intervals consistent with usual clinical practice, particularly among patients with cardiac or cerebrovascular disease and/or with controlled hypertension prior to treatment.
Anaphylactoid/anaphylactic reactions and symptoms suggestive of delayed hypersensitivity have been reported with bupropion, as well as rare spontaneous reports of erythema multiforme, Stevens-Johnson syndrome, and anaphylactic shock. Instruct patients to discontinue CONTRAVE and consult a healthcare provider if they develop an allergic or anaphylactoid/anaphylactic reaction (e.g., skin rash, pruritus, hives, chest pain, edema, or shortness of breath) during this treatment.
Cases of hepatitis, clinically significant liver dysfunction, and transient asymptomatic hepatic transaminase elevations have been observed with naltrexone exposure. Patients should be warned of the risk of hepatic injury and advised to seek medical attention if they experience symptoms of acute hepatitis. CONTRAVE should be discontinued in the event of symptoms/signs of acute hepatitis.
Activation of Mania
Bupropion, a component of CONTRAVE, is a drug used for the treatment of depression. Antidepressant treatment can precipitate a manic, mixed, or hypomanic episode. The risk appears to be increased in patients with bipolar disorder or who have risk factors for bipolar disorder. Prior to initiating CONTRAVE, screen patients for history of bipolar disorder and the presence of risk factors for bipolar disorder (e.g., family history of bipolar disorder, suicide, or depression). CONTRAVE is not approved for use in treating bipolar depression.
The pupillary dilation that occurs following use of many antidepressant drugs, including bupropion, may trigger an angle-closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.
Hypoglycemia with Use of Antidiabetic Medications
Weight loss may increase the risk of hypoglycemia in patients with type 2 diabetes mellitus treated with insulin and/or insulin secretagogues (e.g., sulfonylureas). Measurement of blood glucose levels prior to starting CONTRAVE and during CONTRAVE treatment is recommended in patients with type 2 diabetes. Decreases in medication doses for antidiabetic medications which are non-glucose-dependent should be considered to mitigate the risk of hypoglycemia.
Most common adverse reactions (≥5%) include: nausea (32.5%), constipation (19.2%), headache (17.6%), vomiting (10.7%), dizziness (9.9%), insomnia (9.2%), dry mouth (8.1%), and diarrhea (7.1%).
Increased risk of hypertensive reactions can occur when CONTRAVE is used concomitantly with MAOIs. Use caution and consider dose reduction of drugs metabolized by CYP2D6 when using with CONTRAVE. Avoid concomitant use with CYP2B6 inducers. Reduce CONTRAVE dose when taken with CYP2B6 inhibitors. Dose CONTRAVE with caution when used with drugs that lower seizure threshold. Use caution and monitor for CNS toxicity when using CONTRAVE concomitantly with dopaminergic drugs (levodopa and amantadine). CONTRAVE can cause false positive urine test results for amphetamines.
CONTRAVE is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:
* 30 kg/m2 or greater (obese) or
* 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia)
Limitations of Use
The effect of CONTRAVE on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of CONTRAVE in combination with other products intended for weight loss, including prescription drugs and over-the-counter drugs, and herbal preparations, have not been established.
Please see accompanying full Prescribing Information and Medication Guide for CONTRAVE.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
CONTRAVE® is a trademark of Orexigen Therapeutics, Inc. registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc. All other trademarks are the property of their respective owners.
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. Orexigen’s first product, Contrave® (naltrexone HCl and bupropion HCl extended release), was approved in the United States in September 2014 and became the most prescribed branded obesity medication in the United States in June 2015. In Europe, the drug has been approved under the brand name Mysimba® (naltrexone HCl/ bupropion HCl prolonged release). Orexigen is undertaking a range of development and commercialization activities, both on its own and with strategic partners, to bring Contrave / Mysimba to patients around the world. Further information about Orexigen can be found at www.orexigen.com
Orexigen cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “should,” “intends,” “potential,” “suggests,” “assuming,” “designed” and similar expressions are intended to identify forward-looking statements. These statements are based on our current beliefs and expectations. These forward-looking statements include statements regarding: Orexigen’s assumption of the commercialization of Contrave in the United States later this year, the launch of an efficient U.S. commercial organization, the execution of a targeted data-driven sales and marketing plan to drive the next phase of growth for Contrave, the potential commercialization of Contrave later this year and the potential build out of Orexigen’s commercial capabilities. The inclusion of forward looking statements should not be regarded as a representation by Orexigen that any of its plans will be achieved. Actual results may differ materially from those expressed or implied in this release due to the risk and uncertainties inherent in the Orexigen business, including, without limitation: : the potential that the marketing and commercialization of Contrave will not be successful; additional analysis of the interim results or the final data from the terminated Light Study, including safety-related data, and the additional CVOT may produce negative or inconclusive results, or may be inconsistent with the conclusion that the interim analysis was successful; Orexigen’s ability to obtain and maintain global intellectual property protection for Contrave; legal or regulatory proceedings against Orexigen, as well as potential reputational harm, as a result of misleading public claims about Orexigen; the therapeutic and commercial value of Contrave; Orexigen’s ability to maintain sufficient capital to fund its operations for the foreseeable future; estimates of the capacity of manufacturing and other facilities to support Contrave; the potential for a Delaware court to determine that one or more of the patents are not valid or that Actavis’ proposed generic product is not infringing each of the patents at issue; and other risks described in Orexigen’s filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward looking statements, which speak only as of the date hereof, and Orexigen undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading “Risk Factors” in Orexigen’s Annual Report on Form 10-K filed with the Securities and Exchange Commission February 26, 2016, and its other reports, which are available from the SEC’s website (www.sec.gov) and on Orexigen’s website (www.orexigen.com) under the heading “Investors.” All forward looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Julie Norm art
VP, Corporate Communications and Business Development
SOURCE Orexigen Therapeutics, Inc.
SAN DIEGO, April 25, 2016 /PRNewswire/ — Trovagene, Inc. (NASDAQ: TROV), a developer of cell-free molecular diagnostics, today announced the appointment of William (Bill) Welch as Chief Executive Officer, effective immediately. In addition, the Company announced that Matthew Posard, the Company’s Chief Commercial Officer, has left the Company.
Chairman of the Board and Interim CEO Thomas Adams said, “We are very excited about having Bill join the Trovagene team. As the Company transitions from a development company to a commercial company, Bill’s experience and leadership in commercializing diagnostic products, particularly in the personalized medicine space, will add materially to our ability to accomplish our strategic plan and goals.”
Mr. Welch was President and Chief Executive Officer of Sequenom, Inc. from June 2014 to September 2015. Mr. Welch began his career at Sequenom as Senior Vice President, Diagnostics in January 2011 and became President and Chief Operating Officer in June 2014. Prior to joining Sequenom, Mr. Welch was a consultant to molecular diagnostic companies in the personalized medicine sector. From August 2005 to September 2009, Mr. Welch was senior vice president and chief commercial officer at Monogram Biosciences, a bioscience laboratory services company. Prior to his time at Monogram, Mr. Welch was vice president of sales and marketing at La Jolla Pharmaceuticals and vice president of global marketing with Dade Behring MicroScan. Mr. Welch entered the healthcare field with Abbott Laboratories where he held progressive management positions, including General Manager. Mr. Welch earned a B.S. with honors in chemical engineering from the University of California at Berkeley and received his M.B.A. from Harvard University.
Adams also stated, “It is with deep regret that Matt Posard has informed the Board that he cannot continue as Chief Commercial Officer of Trovagene. We thank Matt for all he has done for the Company and respect his decision and wish him well in his future endeavors.”
About Trovagene, Inc.
Headquartered in San Diego, California, Trovagene is leveraging its proprietary technology for the detection and monitoring of cell-free DNA in urine. The Company’s precision medicine diagnostic assays detect and quantitate oncogene mutations in cancer patients for improved disease management. Trovagene’s Precision Cancer Monitoring® platform is designed to provide important clinical information beyond the current standard of care, and is protected by significant intellectual property, including multiple issued patents and pending patent applications globally.
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend,” or other similar terms or expressions that concern Trovagene’s expectations, strategy, plans or intentions. These forward-looking statements are based on Trovagene’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our need for additional financing; uncertainties of patent protection and litigation; clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or fourth party payer reimbursement; limited sales and marketing efforts and dependence upon fourth parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any medical diagnostic tests under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that our Precision Cancer Monitoring® platform will be utilized by oncologists or prove to be commercially successful. Trovagene does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Trovagene’s Form 10-K for the year ended December 31, 2015 and its other periodic reports filed with the Securities and Exchange Commission.
Corporate Practice Counsel
Inventiv Health Public Relations
SOURCE Trovagene, Inc.
SAN DIEGO, April 25, 2016 /PRNewswire/ — Pfenex Inc. (NYSE MKT: PFNX), a clinical-stage biotechnology company engaged in the development of biosimilar therapeutics, today announced that it will be presenting at the 2016 Bank of America Merrill Lynch Healthcare Conference in Las Vegas, NV at the Encore Hotel. Dr. Bertrand Liang, chief executive officer of Pfenex, will provide an overview of the company’s development programs and business strategy on Wednesday, May 11th at 3:40 pm PT (6:40 pm ET). A live audio webcast and archive of the presentation will be available in the Investor Relations section of the Pfenex website at www.pfenex.com.
Pfenex investors and others should note that we announce material information to the public about the Company through a variety of means, including our website (http://www.pfenex.com/), our investor relations website (http://pfenex.investorroom.com/), press releases, SEC filings, public conference calls, corporate Twitter account (https://twitter.com/pfenex), Facebook page (https://www.facebook.com/Pfenex-Inc-105908276167776/timeline/), and LinkedIn page (https://www.linkedin.com/company/pfenex-inc) in order to achieve broad, non-exclusionary distribution of information to the public and to comply with our disclosure obligations under Regulation FD. We encourage our investors and others to monitor and review the information we make public in these locations as such information could be deemed to be material information. Please note that this list may be updated from time to time.
About Pfenex Inc.
Pfenex Inc. is a clinical-stage biotechnology company engaged in the development of biosimilar therapeutics and high-value and difficult to manufacture proteins. The company’s lead product candidate is PF582, a biosimilar candidate to Lucentis (ranibizumab), for the potential treatment of patients with retinal diseases. Pfenex has leveraged its Pfēnex Expression Technology® platform to build a pipeline of product candidates and preclinical products under development including other biosimilars, as well as vaccines, therapeutic equivalents to branded products, and next generation biologics.
SOURCE Pfenex Inc.
Celebration Held on National DNA Day in San Diego, the “Genomics Capital of the World”
SAN DIEGO, April 25, 2016 /PRNewswire/ — Stephen Kingsmore, M.D., D.Sc., president and CEO of Rady Children’s Institute for Genomic Medicine at Rady Children’s Hospital – San Diego, is the official title holder of the Guinness World Records® designation for fastest genetic diagnosis, which he accomplished by successfully diagnosing critically ill newborns in just 26 hours, as published in the journal Genome Medicine.
The feat was made possible by several time-shrinking technologies, including Edico Genome’s genomic data-crunching computer chip, DRAGEN, and one of Illumina‘s high-throughput sequencing instruments. In addition, other parameters of the sequencing process were optimized.
Dr. Kingsmore achieved this Guinness World Records title while serving as executive director of Medical Panomics at Children’s Mercy Kansas City; he will implement the enabling technologies at the new Rady Children’s Institute for Genomic Medicine. Today’s celebration in San Diego, often called “the genomics capital of the world,” is being held on National DNA Day, which commemorates the completion of the Human Genome Project and the discovery of DNA’s double helix.
“Diagnosing acutely ill babies is a race against the clock, which is why it’s so essential for physicians to have access to technology that will provide answers faster and help set the course of treatment,” Dr. Kingsmore said. “My work at Children’s Mercy Kansas City that led to this recognition would not have been possible without our key technology partners Edico Genome and Illumina, who share a vision for unraveling mysteries of disease and giving hope to families with ill newborns. I look forward to collaborating with both parties to implement this approach at Rady Children’s Institute for Genomic Medicine and ultimately neonatal and pediatric intensive care units across the country.”
Up to one-third of babies admitted to a neonatal intensive care unit in the United States have a genetic disease, and more than 20 percent of infant deaths are caused by genetic illnesses. Treatments are currently available for more than 500 genetic diseases; for about 70 of these, initiation of therapy in newborns can help prevent disabilities and life-threatening illnesses. The cost of whole-genome sequencing has fallen to the point of feasibility for clinical testing of these and other conditions, and a new bioinformatics chip for genomic data is reducing time needed for analysis, facilitating the use of genomic medicine in acute medical care.
“San Diego is home to world’s brightest minds that are leading the world in creating innovative technologies and generating life-saving research,” said Mayor Kevin L. Faulconer. “Dr. Kingsmore’s work in genomics represents some of the best of what San Diego has to offer. On behalf of the City of San Diego, congratulations to Dr. Kingsmore, Rady Children’s Hospital and all of those involved for accomplishing something that has never been done before. This work reaffirms San Diego’s position as the Genomics Capital of the World.”
“Illumina has achieved many firsts in its history as the global leader of DNA sequencing technology, but this historic initiative is one we’re particularly honored to be part of,” said Kevin Hall, D. Phil, senior director of sequencing systems for Illumina. “We congratulate Dr. Kingsmore, the team at Edico Genome and others who are working to advance the practice of medicine.”
“A growing hurdle for genomic medicine is the time required to analyze big data generated by sequencing instruments, a need that is clearly illustrated by the plight of critically ill newborns,” said Pieter van Rooyen, Ph.D., chief executive officer of Edico Genome. “We applaud Dr. Kingsmore’s tireless work to find rapid answers for newborns and families desperately searching for diagnoses. We are proud that our DRAGEN bio-IT processor could play a role in this milestone for genomic medicine.”
About Rady Children’s Institute for Genomic Medicine
Rady Children’s Institute for Genomic Medicine was founded by Rady Children’s Hospital – San Diego to bring together world-class scientists and clinicians into shared research infrastructure for accelerated translation of research discoveries into prevention, diagnosis, treatment and ultimately cures for childhood diseases. This integrated approach to precision medicine includes epigenomics, metabolomics and proteomics. This research provides a comprehensive view of a child’s health status and risk factors for disease.
About Rady Children’s Hospital-San Diego
Rady Children’s Hospital-San Diego is a 520-bed pediatric care facility providing the largest source of comprehensive pediatric medical services in San Diego, Southern Riverside and Imperial counties. Rady Children’s is the only hospital in the San Diego area dedicated exclusively to pediatric healthcare and is the region’s only designated pediatric trauma center. In June 2015, U.S. News & World Report ranked Rady Children’s among the best children’s hospitals in the nation in all ten pediatric specialties the magazine surveyed. Rady Children’s is a nonprofit organization that relies on donations to support its mission. For more information, visit www.rchsd.org and find us on Facebook, Twitter and Vimeo.
About Edico Genome
Edico Genome has created the world’s first bioinformatics processor designed to analyze next-generation sequencing data, DRAGEN™. The use of next-generation sequencing is growing at an unprecedented pace, creating a need for a technology that can process this big data rapidly and accurately. Edico Genome’s computing platform has been shown to speed whole genome data analysis from hours to minutes, while maintaining high accuracy and reducing costs, enabling clinicians and researchers to reveal answers more quickly. For more information, visit www.EdicoGenome.com or follow @EdicoGenome.
Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture and other emerging segments. To learn more, visit www.illumina.com and follow @illumina.
About Children’s Mercy Kansas City
Children’s Mercy, located in Kansas City, Mo., is one of the nation’s top pediatric medical centers. The 354-bed, not-for-profit hospital provides care for children from birth through the age of 21, and is ranked by U.S. News & World Report as one of “America’s Best Children’s Hospitals.” For the third time in a row, Children’s Mercy has achieved Magnet nursing designation, awarded to fewer than seven percent of all hospitals nationally, for excellence in quality care. Its faculty of more than 700 pediatric subspecialists and researchers across more than 40 subspecialties are actively involved in clinical care, pediatric research, and educating the next generation of pediatric subspecialists. For more than a century, Children’s Mercy has provided the highest level of medical care to every child who passes through its doors, made possible through generous community support.
SOURCE Edico Genome
The candidate should have a B.S. or M.S. degree in biology, immunology or related life sciences. The candidate will join an immunoassay development team of SD Medical Systems Inc., a company located in Science Park, North Torrey Pines, San Diego, to […
Ascentage Pharma and UNITY Biotechnology Announce Collaboration for the Development of Senolytic Healthspan Therapies
SAN FRANCISCO, April 24, 2016 /PRNewswire/ — Ascentage Pharma, a clinical-stage biopharmaceutical company focused on apoptosis-targeted oncology drug discovery and development, and UNITY Biotechnology, a San Francisco-based biopharmaceutical company focused on the development of medicines to improve healthspan, announced a worldwide collaboration to develop senolytic treatments for age-related disease.
The Ascentage team has been working for over a decade to create small-molecule drugs targeting programmed cell death and has established a best-in-class compound library and clinical-stage lead compounds for oncology therapeutics.
UNITY Biotechnology, backed by ARCH Venture Partners, Venrock and Wuxi Healthcare Ventures, has been working for four years to elucidate the link between senescence and aging and has demonstrated in animal models that clearing senescent cells reverses or prevents many age-related pathologies, including osteoarthritis, atherosclerosis, glaucoma, and kidney disease.
“At UNITY, we have demonstrated that senescence is a key mechanism in aging and age-related disease,” said Dr. Nathaniel David, founder and CEO of UNITY Biotechnology. “We have evaluated a wide panel of drug candidates that clear senescent cells, and Ascentage’s compounds are some of the best we’ve seen. Access to their compound library through this collaboration will significantly accelerate our efforts to develop drugs to improve healthspan by halting or reversing several age-related diseases.”
The Ascentage R&D team has a proven track record in structure-based drug design and lead optimization of small-molecule drug candidates targeting protein-protein interactions. “We chose Ascentage as our partner in this exciting anti-aging field not only because of its cutting-edge technology, but also because this partnership will allow us to reach a global market,” David said. As part of the deal, the companies will also form a joint venture for the development and commercialization of senolytic drugs in China.
Though specific terms are undisclosed, Ascentage will acquire an equity interest in UNITY, and UNITY will make an investment in Ascentage. Robert Nelsen, the co-founder and managing director of ARCH Venture Partners and a UNITY board member, will join the Ascentage board as an observer.
“We have been tracking the science at Ascentage for some time and are incredibly pleased to enter this collaboration with them,” Nelsen said. “We are confident that they will complement what we are doing at UNITY to drive major improvements in the treatment of diseases of aging to impact healthspan.”
Mr. Eric Zhao, partner of Oriza Seed Capital and Board member of Ascentage, said, “It is great to see two true innovative companies work together. I am sure they will bring extra value to everyone.”
Ascentage Chairman and CEO Dr. Dajun Yang added, “We are one of the leading biopharmaceutical companies with clinical stage compounds targeting key proteins that control programmed cell death pathways. We will continue our efforts to advance clinical stage compounds for targeted anti-cancer therapy and are very pleased to work with UNITY for several unmet medical indications outside of the oncology space, with each aging-related disease potentially representing a multi-billion-dollar market.”
About Ascentage Pharma
Ascentage Pharma is a China-based, global-oriented, clinical-stage biopharmaceutical company, dedicated to discovery and development of “first-in-class” and “best-in-class” targeted small-molecule cancer therapeutics. A rich portfolio of innovative small-molecule agents has been discovered and developed through the company’s unique, robust, and world-class innovative drug development pipeline. Currently, Ascentage Pharma has four molecules in phase I-II trials in US, Australia and China, and another four molecules at IND reviewing or IND-enabling stages in US, Australia and China.
Ascentage Pharma focuses on clinically validated cancer targets. Its established R&D pipelines include: inhibitors to a number of key proteins, including IAP, Bcl-2/Bcl-xL and MDM2-p53, that restore a tumor cell’s apoptotic program; 2nd and/or 3rd generation of kinase inhibitors that overcome mutant resistance in cancer therapy; and inhibitors to epigenetic targets with enormous potential in oncology therapy. For more information, please visit www.ascentagepharma.com.
About UNITY Biotechnology
UNITY Biotechnology is developing therapeutics that increase healthspan by preventing, halting or reversing diseases of aging. UNITY’s initial focus is on creating senolytic medicines, which clear senescent cells that drive age-related afflictions such as osteoarthritis, atherosclerosis, eye diseases and kidney diseases. Backed by ARCH Venture Partners and Venrock, UNITY’s world-class management team has experience building companies and developing medicines together and has collectively moved 91 therapeutic candidates into human clinical trials and developed 13 FDA-approved medicines. UNITY’s mission is to build a future in which it doesn’t hurt to be old — a future in which people stay healthy and mobile long into old age. More information is available at www.unitybiotechnology.com.
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SOURCE UNITY Biotechnology
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