Health Advances

Oklahoma City, MA, United States

Health Advances

Oklahoma City, MA, United States
SEARCH FILTERS
Time filter
Source Type

News Article | December 15, 2016
Site: www.businesswire.com

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Synlogic, a privately-held biopharmaceutical company developing novel medicines based on its proprietary synthetic biology and microbiome platform, today announced the appointment of biotech industry veteran Samantha Truex as Chief Operating Officer (COO) and Head of Corporate Development. “We expect 2017 to be a pivotal year for Synlogic as we further demonstrate the breadth and power of our platform. Sam’s drug development background at both large and small biotechnology organizations will serve as a valuable asset to our team as we prepare to take our lead programs into the clinic,” said Jose Carlos Gutierrez-Ramos, Ph.D., CEO of Synlogic. “In addition, her deep experience leading corporate development efforts will serve us well as we seek to execute strategic partnerships that will fuel Synlogic’s growth into a fully-integrated biotechnology company focused on bringing a new class of drugs -- synthetic biotics -- to patients.” As COO and head of corporate development, Sam will be broadly responsible for developing and executing on a strategic plan that integrates internal programs and business development activities, including the development of financing strategies. In addition to strategic planning, corporate development and legal activities, Sam will also provide leadership for Synlogic’s corporate communications and alliance management activities. Sam comes to Synlogic with more than 20 years of industry experience, most recently from Padlock Therapeutics where she was integral to Padlock's operations and led the business development process culminating in its acquisition by Bristol-Myers Squibb earlier this year. Prior to Padlock, Sam spent several years each at Biogen and Genzyme. At Biogen, Sam served as vice president of corporate development, leading the negotiations for multiple licensing, collaboration and acquisition transactions and serving as program executive of FAMPYRA® during its launch phase and of ELOCTATE™ and ALPROLIX™ during the preclinical and early clinical phases. At Genzyme, Sam handled licensing and M&A transactions across multiple business units, including for Genzyme Molecular Oncology and Genzyme Genetics. Earlier in her career, Sam worked for Chiron Diagnostics and Health Advances. Sam earned a B.A. in biology from Dartmouth College, a B.E. in biomedical engineering from the Thayer School at Dartmouth and a MBA from the Tuck School at Dartmouth. Synlogic is a privately-held biopharmaceutical company based in Cambridge, Massachusetts, pioneering the development of a novel class of therapeutics, called synthetic biotics, based on its proprietary synthetic biology and microbiome platform. Synlogic’s two lead therapeutic programs are being developed for the potential treatment of rare inborn errors of metabolism of Urea Cycle Disorder (UCD) and Phenylketonuria (PKU). In addition to the company’s proprietary pipeline focused on rare diseases, the company is leveraging the broad potential of its synthetic biotics platform for novel drug development in major disease areas through partnerships with pharmaceutical and biotechnology companies. Synlogic is collaborating with AbbVie to develop synthetic biotics-based treatment for inflammatory bowel disease (IBD). Synlogic is backed by leading life sciences investors, including Atlas Venture, New Enterprise Associates (NEA), Orbimed, Deerfield and the Bill & Melinda Gates Foundation. For more information, please visit http://synlogictx.com/.


News Article | December 5, 2016
Site: www.eurekalert.org

NEW YORK NY (December 2, 2016)--The inability to hear subtle changes in pitch, a common and debilitating problem for people with schizophrenia, is due to dysfunctional N-methyl-D-aspartate (NMDA) brain receptors, according to a study by Columbia University Medical Center (CUMC) researchers. The study also shows that this hearing issue can be improved by combining auditory training exercises with a drug that targets NMDA receptors. The findings were published online today in the journal Brain. "Slight variations in our tone of voice are an important way of communicating emotions, such as happiness or sadness," said lead author Joshua T. Kantrowitz, MD, assistant professor of clinical psychiatry at CUMC. "This inability to detect subtle changes in pitch can also make it difficult to "sound out" words while reading, with over 70 percent of patients meeting criteria for dyslexia and further exacerbating communication problems in social and work situations. But while psychiatrists have recommended medications for symptom control, these treatments have not addressed the underlying auditory deficits." Dr. Kantrowitz and his colleagues compared auditory plasticity (the ability to learn from hearing tasks) in 40 stabilized schizophrenia patients and 42 healthy controls. Each subject listened to a series of tone pairs and was asked to indicate which tone was higher. Based on a subject's performance, the difficulty of the task was changed for the next pair of tones. When subjects correctly identified the higher tone, the pitch difference in subsequent tone pairs decreased; when subjects failed to identify the higher tone, the tones were moved further apart. "People with normal auditory plasticity usually get better at discriminating between the two tones as the test progresses, reflecting the ability to learn," said Dr. Kantrowitz. "And that was the case with the healthy controls in our study." At the start, there was a 50 percent difference in the pitch of the tones (e.g., 1,000 Hz and 1,500 Hz). On average, the healthy controls were able to discern between tones with a difference in pitch of as little as 3 percent. In contrast, the patients did not improve as much, detecting an average 16 percent difference in pitch. EEG recordings, made while the subjects performed auditory brain exercises, revealed that the schizophrenia patients had lower brainwave activity than the controls. Lower brainwave activity is associated with impaired auditory sensory cortex functioning and a reduced response to the training exercises. Dr. Kantrowitz and his colleagues suspected that schizophrenia patients' inability to improve their pitch discrimination is caused by dysfunction in their NMDA receptors, which are critical for learning and memory. If true, improving NMDA activity would improve their ability to discriminate between pitches. To test this hypothesis, some schizophrenia patients in the study were given D-serine, an amino acid that activates NMDA receptors, once a week for up to three weeks, while others were given a placebo. The patients significantly improved their pitch detection with auditory training, but only when D-serine was taken for two consecutive weeks. No improvement was seen in patients who took D-serine only once or in those who took a placebo. "It remains to be seen whether D-serine or another NMDA-activating drug is best suited for this purpose," said Dr. Kantrowitz. "What's important is that we now know that people with schizophrenia can improve their pitch detection with a combination of auditory training exercises and repeated doses of a learning-enhancing drug that effects the NMDA receptor." The study's senior investigator was Daniel C. Javitt, MD, professor of psychiatry at CUMC and director of schizophrenia research at the Nathan Kline Institute for Psychiatric Research, a facility of the New York State Office of Mental Health. The paper is titled, "Neurophysiological Mechanisms of cortical plasticity impairments in schizophrenia and modulation by the NMDA receptor agonist D-serine." The other contributors are: Michael L. Epstein, Odeta Beggel, Stephanie Rohrig, Jonathan M. Lehrfeld, Nadine Revheim, Nayla P. Lehrfeld, Jacob Reep, Emily Parker, Gail Silipo, and Merav Ahissar. The study was supported by grants from the National Institutes of Health (UL1 RR024156, P50 MH086385, and R01 MH049334), and the Dr. Joseph E. and Lillian Pisetsky Young Investigator Award for Clinical Research in Serious Mental Illness. Dr. Kantrowitz received consulting payments in the last two years from Vindico medical Education, Annenberg Center for Health Sciences at Eisenhower Health Advances, LLC, Strategic Edge Communications, Transperfect, Slingshot Insights, Kinetrix Croup, Havas Life and Cowen and Company. He has conducted clinical research supported by the National Institute of Mental Health, the Stanley Foundation, Roche-Genentech, Alkermes, Merck, Lundbeck, Forum, Sunovion, Novartis, Pfizer, and Lilly. He owns a small number of shares of common stock in GlaxoSmithLine. Dr. Javitt received consulting payments in the last two years from Sunovion, Forum, and Takeda. He has received research support from Roche. He holds intellectual property rights fro use of NMDA modulators in treatment of neuropsychiatric disorders. He holds equity in Glytech, AASI, and NeuroRx, and serves on the advisory boards of Promentis and NeuroRx. The others authors declare no conflicts of interest. Columbia University Medical Center provides international leadership in basic, preclinical, and clinical research; medical and health sciences education; and patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, public health professionals, dentists, and nurses at the College of Physicians and Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Columbia University Medical Center is home to the largest medical research enterprise in New York City and State and one of the largest faculty medical practices in the Northeast. The campus that Columbia University Medical Center shares with its hospital partner, NewYork-Presbyterian, is now called the Columbia University Irving Medical Center. For more information, visit cumc.columbia.edu or columbiadoctors.org.


News Article | February 2, 2017
Site: www.realwire.com

Acquisition will strengthen and add scale to current commercialisation and medical affairs services LONDON, February 2, 2017 – PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, today announced that the Company has entered into a definitive agreement to acquire The Medical Affairs Company, LLC (“TMAC”), a leading provider of outsourced medical affairs services to the pharmaceutical, biotechnology, and medical device industries. The acquisition is expected to close in February. Terms of the transaction were not disclosed. Founded in 2007, TMAC is a full-service contract medical organisation. TMAC offers strategic and tactical medical science liaison (MSLs) and clinical nurse educator support services in addition to medical affairs consulting, medical communications support, and direct placement services. TMAC is based in Kennesaw, Georgia, and has approximately 200 U.S.-based employees. Outsourcing medical affairs services presents a compelling option for biopharmaceutical companies as a way to reduce fixed costs. The increasingly complex nature of new products, and the need to demonstrate the therapeutic and reimbursement value of a product, is creating demand for credentialed healthcare professionals, such as MSLs, to lead clinically robust dialogues with key medical stakeholders on a peer-to-peer level. “The commercialisation-outsourcing market continues to grow as biopharmaceutical clients increasingly require medical affairs solutions to optimise awareness and understanding of their products in development or already on the market,” said Josef von Rickenbach, Chairman and CEO, PAREXEL. “As a company, we are focused on opportunities within commercialisation, market access, regulatory, pharmacovigilance, and medical outsourcing. With TMAC, PAREXEL will gain new and distinct medical affairs outsourcing capabilities that will strengthen and expand our commercialisation and market access offerings.” “We are excited to become a part of PAREXEL and offer our clients a comprehensive range of services delivered by a single company. Working together, PAREXEL and TMAC will deliver greater value to clients and meet evolving client needs, throughout the lifecycle of their products,” added Evan Demestihas, MD, RPh, Chief Executive Officer, TMAC. After the close of the acquisition, the TMAC management team will remain in place and continue to manage its employees and the services it currently provides to clients. About PAREXEL International PAREXEL International Corporation is a leading global biopharmaceutical services company, providing a broad range of expertise-based clinical research, consulting, medical communications, and technology solutions and services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialisation continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, and reimbursement. PAREXEL Informatics provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL has offices in 85 locations in 51 countries around the world, and had approximately 19,625 employees in the first quarter. For more information about PAREXEL International visit www.PAREXEL.com. PAREXEL and PAREXEL Informatics are trademarks or registered trademarks of PAREXEL International Corporation or its affiliates. All other trademarks are the property of their respective owners. This release contains “forward-looking” statements regarding future results and events, including, without limitation, statements regarding expected financial results, future growth and customer demand. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words “believes,” “anticipates,” “plans,” “expects,” “intends,” “appears,” “estimates,” “projects,” “will,” “would,” “could,” “should,” “targets,” and similar expressions are also intended to identify forward-looking statements. The forward-looking statements in this release involve a number of risks and uncertainties. The Company’s actual future results may differ materially from the results discussed in the forward-looking statements contained in this release. Important factors that might cause such a difference include, but are not limited to, risks associated with: actual operating performance; actual expense savings and other operating improvements resulting from restructurings, the loss, modification, or delay of contracts which would, among other things, adversely impact the Company’s recognition of revenue included in backlog; the Company’s dependence on certain industries and clients; the Company’s ability to win new business, manage growth and costs, and attract and retain employees; the Company’s ability to complete the acquisition of The Medical Affairs Company, LLC and additional acquisitions, and to integrate newly acquired businesses including the acquisitions of The Medical Affairs Company, LLC, ExecuPharm, Inc. and Health Advances, LLC, or enter into new lines of business; the impact on the Company’s business of government regulation of the drug, medical device and biotechnology industry; consolidation within the pharmaceutical industry and competition within the biopharmaceutical services industry; the potential for significant liability to clients and third parties; the potential adverse impact of health care reform; and the effects of foreign currency exchange rate fluctuations and other international economic, political, and other risks. Such factors and others are discussed more fully in the section entitled “Risk Factors” of the Company’s Annual Report on Form 10-K and subsequent quarterly reports on Form 10-Q, as filed with the Securities and Exchange Commission, which “Risk Factors” discussion is incorporated by reference in this press release. The Company specifically disclaims any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing the Company’s estimates or views as of any date subsequent to the date of this press release.


Miller I.,bioMerieux | Pothier K.,Health Advances | Dunn M.,Health Advances
Personalized Medicine | Year: 2010

Multiple stakeholders play a role in the adoption of personalized medicine, including payers, patients, policy makers, diagnostic manufacturers and providers, and clinicians. These stakeholders span multiple positions, institutions and points of view, and are interested in making sure that each diagnostic launch covers a particular, sometimes contradictory, market need. A growing number of advocacy groups have emerged to unify these stakeholders in this increasingly complex marketplace. This perspective will identify examples of these advocacy efforts in personalized medicine today. It will discuss how far these groups have been able to go, what they are currently pursuing and how they and others can continue to work to move personalized medicine from concept to reality. © 2010 Future Medicine Ltd.


News Article | September 26, 2016
Site: www.realwire.com

Acquisition will strengthen and add scale to current functional services offering to meet growing demand London, UK: September 26, 2016 – PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, today announced that the Company has entered into a definitive agreement to acquire ExecuPharm, Inc. (“ExecuPharm”), a leading, global functional service provider (FSP) serving the biopharmaceutical industry. The acquisition is expected to close in the next three weeks. Terms of the transaction were not disclosed. Established in 1995, ExecuPharm provides clients with qualified professionals across functional areas, such as clinical monitoring or study management, along with associated operational activities including onboarding, training, line management, performance management and policy administration. The company is headquartered in King of Prussia, PA, and it works with many of the top 20 and mid-sized and small biopharmaceutical companies. ExecuPharm’s strong client relationships have led to 85 percent growth in the company in the past three years. “Functional services represent an established and growing model within the biopharmaceutical industry. Clients are increasingly using a combination of programmatic and functional outsourcing models,” said Josef von Rickenbach, Chairman and CEO, PAREXEL. “With ExecuPharm, PAREXEL will expand and strengthen our existing functional services offering and capabilities to meet the growing market demand while allowing our clients to fulfill all of their clinical development outsourcing needs through a single company.” Functional service providers offer biopharmaceutical clients stand-alone outsourced services, such as clinical monitoring, data management, biostatistics, site monitoring, study management, medical writing, pharmacovigilance and other related functions. Customers may outsource functions tactically, on a particular trial, or strategically to constitute or supplement an entire department. “We are excited to become a part of PAREXEL and offer our clients an expanded global presence, increased therapeutic expertise, broad product development knowledge, and high quality service. By providing clients the ability to outsource only certain functions, we provide clients flexibility in their drug development programs,” added Maria Larson, Founder and Chief Executive Officer, ExecuPharm. About PAREXEL International PAREXEL International Corporation is a leading global biopharmaceutical services company, providing a broad range of expertise-based clinical research, consulting, medical communications, and technology solutions and services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialisation continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, and reimbursement. PAREXEL Informatics provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL has offices in 84 locations in 51 countries around the world, and had approximately 18,600 employees in the fourth quarter. For more information about PAREXEL International visit www.PAREXEL.com. PAREXEL and PAREXEL Informatics are trademarks or registered trademarks of PAREXEL International Corporation or its affiliates. This release contains “forward-looking” statements regarding future results and events, including, without limitation, statements regarding expected financial results, future growth and customer demand. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words “believes,” “anticipates,” “plans,” “expects,” “intends,” “appears,” “estimates,” “projects,” “will,” “would,” “could,” “should,” “targets,” and similar expressions are also intended to identify forward-looking statements. The forward-looking statements in this release involve a number of risks and uncertainties. The Company’s actual future results may differ materially from the results discussed in the forward-looking statements contained in this release. Important factors that might cause such a difference include, but are not limited to, risks associated with: actual operating performance; actual expense savings and other operating improvements resulting from restructurings, the loss, modification, or delay of contracts which would, among other things, adversely impact the Company’s recognition of revenue included in backlog; the Company’s dependence on certain industries and clients; the Company’s ability to win new business, manage growth and costs, and attract and retain employees; the Company’s ability to complete the acquisition of ExecuPharm, Inc. and additional acquisitions, and to integrate newly acquired businesses including the acquisitions of ExecuPharm, Inc. and Health Advances, LLC, or enter into new lines of business; the impact on the Company’s business of government regulation of the drug, medical device and biotechnology industry; consolidation within the pharmaceutical industry and competition within the biopharmaceutical services industry; the potential for significant liability to clients and third parties; the potential adverse impact of health care reform; and the effects of foreign currency exchange rate fluctuations and other international economic, political, and other risks. Such factors and others are discussed more fully in the section entitled “Risk Factors” of the Company’s Annual Report on Form 10-K and subsequent quarterly reports on Form 10-Q, as filed with the Securities and Exchange Commission, which “Risk Factors” discussion is incorporated by reference in this press release. The Company specifically disclaims any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing the Company’s estimates or views as of any date subsequent to the date of this press release.


Hayes D.F.,University of Michigan | Allen J.,Friends of Cancer Research | Compton C.,Critical Path Institute | Gustavsen G.,Health Advances | And 9 more authors.
Science Translational Medicine | Year: 2013

Despite prodigious advances in tumor biology research, few tumor-biomarker tests have been adopted as standard clinical practice. This lack of reliable tests stems from a vicious cycle of undervaluation, resulting from inconsistent regulatory standards and reimbursement, as well as insuf cient investment in research and development, scrutiny of biomarker publications by journals, and evidence of analytical validity and clinical utility. We of er recommendations designed to serve as a roadmap to break this vicious cycle and call for a national dialogue, as changes in regulation, reimbursement, investment, peer review, and guidelines development require the participation of all stakeholders. Copyright © 2013, American Association for the Advancement of Science.


Pothier K.,Health Advances | Gustavsen G.,Health Advances
Personalized Medicine | Year: 2013

We are entering an era of unprecedented complexity in personalized medicine. Therapeutic targets, biomarker detection technologies, regulatory and reimbursement pathways, and commercialization strategies have all reached new levels of intricacy. These complexities are occurring in the context of the current economic environment, in which outsourcing offers a way for innovators to decrease large internal investment. These factors combine to create a perfect setting for a partnership explosion. Now, and as we move into the future, it will be critical for innovators to access outside expertise with a diverse set of partners in order to bring novel personalized medicine products to the market successfully and economically. Only companies that truly embrace this trend and adopt a collaborative approach will emerge successful. © 2013 Future Medicine Ltd.

Loading Health Advances collaborators
Loading Health Advances collaborators