| This week's sponsor is Premier Research. | |  | Designing a Novel Therapy? 6 Clinical Trial Considerations
Researchers are turning a corner in treating and curing blood disorders. Download our paper for 6 dosing and safety considerations for developing early-phase trials. Premier Research. It's what we do. Best. |
Today's Rundown Featured Story | | | Tuesday, January 16, 2018 After the dust had settled on another J.P. Morgan Healthcare Conference, we caught up with Doug Ingram, the relatively new chief at rare disease biotech Sarepta, and discussed how he aims to remove the term “controversial” that we bio reporters keeping slapping in front of the company’s name. |
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Top Stories Tuesday, January 16, 2018 Eiger BioPharmaceuticals is ready to stop development of ubenimex in pulmonary arterial hypertension (PAH). The biotech indicated ubenimex failed to find a hint of efficacy after a phase 2 trial in the indication. Tuesday, January 16, 2018 AveXis is expanding trials of its gene therapy for children with spinal muscular atrophy (SMA) with a series of new trials as it plays catch-up with Biogen and Ionis, which claimed the first approval for an SMA drug. Monday, January 15, 2018 The impact of protracted contracting timelines can be felt throughout the study start-up process. Coupling predictive enrollment analytics with contract execution timelines of a site decreases time to Last Patient First Visit by up to 25%. Tuesday, January 16, 2018 Pherecydes has raised money to take bacteriophage-based anti-infectives into clinical trials. The €8.7 million ($10.6 million) series B will support studies targeting two bacterial infections and the creation of a drug manufacturing unit. Tuesday, January 16, 2018 Pfizer has struck a broad cancer companion diagnostic deal with Foundation Medicine. The alliance will see Foundation Medicine use pan-cancer test FoundationOne CDx as a companion diagnostic for Pfizer drugs. Tuesday, January 16, 2018 On its way to developing a universal flu vaccine, University of Oxford spinout Vaccitech has raised £20 million in series A financing, backed by Google parent company Alphabet’s venture capital arm GV, Sequoia China and Oxford Sciences Innovation. | This week's sponsor is Eurofins Advinus. | |  | |
Enrollment Showcase | | | Sponsored by: Drexel University Online Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more. |
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Resources Sponsored by: Agilent This Agilent intact protein analysis includes: Sponsored by: Seton Hall Don’t miss this educational program trusted by multi-national companies as part of their employee’s compliance training. Explore legal, regulatory and ethical issues faced by pharmaceutical, biotech and medical device manufacturers operating in the Asia-Pacific region. Visit event page for session topics. Presented by: Patheon Download Patheon’s whitepaper to discover two main areas where a drug developer can face significant obstacles during biologics development and how by evaluating these capabilities, it can answer the critical question of whether its in-house strategy is ready for these uncertainties. Presented by: SDC and Stiris Research What do you do when timelines are missed, data is dirty, and everyone is pointing fingers? Join this webinar to learn how to prevent, identify, and implement a successful clinical trial rescue. Sponsored by: Veeva Systems Expanding into new markets places a spotlight on inefficient processes. Sponsored by: Veeva Systems Regulatory leaders share challenges and best practices from a lack of standardization, manual processes, and fragmented systems. Sponsored by: WCG Selecting the right sites to conduct your clinical trials will determine the success or failure of meeting your enrollment goals. Sponsored by: Veeva Systems Read this guide if you’re a global life sciences company - conducting clinical trials across several countries, or manufacturing and distributing products in multiple regions - to learn five steps to align and improve quality oversight, as well as avoid common mistakes in harmonization initiatives. Presented By: Covance Global clinical trials are the trend and gaining in popularity, but running a global trial is not a straightforward process. This white paper explores some of the challenges associated with global clinical trials and considerations for ensuring that the collected data comply with the trial's overall objectives. Presented By: Charles River Join us as we discuss how Charles River Celsis® helped Labor L+S AG validate a 7-day membrane filtration sterility test using existing protocols. Presented By: Catalent Learn how Catalent Biologics is paving the way for flexible biologics development and manufacturing through advanced technologies and fully integrated multi-product facility. Presented By: Catalent Download the eBook to get articles from various Elsevier journals highlighting developments in ADC technology. Presented By: Catalent Learn how cell development and process scale-up can be optimized for antibodies requiring additional processing. Sponsored By: RTI Health Solutions In this webinar, we will introduce the rapidly-evolving within-subject clinical trial (WSCT) methods for early phase evidence generation that require fewer people, less time, and usually less funding than traditional early phase methods. | 
