Global News

Dixie-Lee Esseltine joins HBS Kraft Precision Medicine Accelerator

Friday, September 29, 2017

Dr. Dixie-Lee Esseltine, formerly the Vice President of Global Clinical Development at Takeda Pharmaceuticals, recently joined the Harvard Business School’s (HBS) Kraft Precision Medicine Accelerator. Esseltine will lead the Accelerator’s Clinical Trials work stream, which is comprised of leading nonprofit organizations (NPOs) and clinical leaders focused on precision medicine. The goal of this work stream is to accelerate the advancement of innovative platform trials across cancers by identifying best practices and sharing knowledge, helping NPOs build their understanding of the design and operation of master protocols, and working with the FDA to improve master protocols.

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PharmaSeek launches clinical research sites payment solution

Friday, September 29, 2017

PharmaSeek, an investigative site network, has launched a new service aimed at eliminating the burden of slow payments for clinical research sites. This service, called PS Pays, is unique to the industry and allows sites to get paid for their work in as little as 72 business hours, instead of waiting for sponsor payments which can take up to 150 days.

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Allianz Teams, Cyence partner on cyber risk modeling and analysis

Wednesday, September 27, 2017

Allianz Global Corporate & Specialty SE (AGCS), Allianz Group’s specialist carrier for corporate insurance business, has teamed up with Silicon Valley-based cyber risk analytics and modeling firm Cyence to boost its global cyber risk analysis capabilities. By combining Cyence’s cyber analytics platform with AGCS’ underwriting processes, the insurer will be able to analyze cyber exposures at company level for large businesses, creating a detailed understanding of their cyber risks and quickly allowing it to tailor coverage to fit specific customer profiles.

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Rubius Therapeutics appoints Chief Medical Officer Chris Carpenter

Wednesday, September 27, 2017

Rubius Therapeutics, a “Fierce 15” company pioneering the creation of a new class of extraordinarily active, ready-to-use and life-changing cellular therapies, announced the appointment of Chris Carpenter, M.D., Ph.D., as chief medical officer. Dr. Carpenter will oversee Rubius’ clinical and regulatory strategy as the company prepares to enter human clinical trials in 2018. In addition, Rubius announced the appointments of Joanne Protano as vice president of finance; Mark Boshar as vice president of legal affairs; and Theo Proukou as vice president of human resources.

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Sound Pharmaceuticals initiates STOP Ototoxicity study in cystic fibrosis

Wednesday, September 27, 2017

Sound Pharmaceuticals (SPI) has initiated enrollment on its first study involving Cystic Fibrosis (CF) patients receiving antibiotics that cause inner ear disease or ototoxicity. The STOP Ototoxicity study is led by Patrick Flume, MD, Professor of Medicine and Pediatrics at MUSC in Charleston. Dr. Flume is an international expert in CF and pulmonary disease and has co-chaired the development of the CF Foundation’s care guidelines on the treatment of pulmonary exacerbations. “We recently explored the incidence of tinnitus and vertigo in the CF population, and will present these initial findings at the next North American CF Conference,” said Dr. Flume.

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W. L. Gore & Associates completes enrollment in GORE CARDIOFORM study

Wednesday, September 27, 2017

W. L. Gore & Associates has completed enrollment for the pivotal phase of the Gore ASSURED Clinical Study. This investigational device exemption (IDE) trial is researching the new GORE®CARDIOFORM ASD Occluder for the interventional closure of Atrial Septal Defects (ASDs), sized 8 to 35 mm. The GORE® CARDIOFORM ASD Occluder is designed with a unique, anatomically adaptable waist to accommodate the natural anatomy of the heart and mitigate the potential for cardiac injury. This new device will complement the existing GORE® CARDIOFORM Septal Occluder to allow the treatment of a broader range of ASDs with a soft, conformable device design.

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