| 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 Message to Trump: Alnylam CEO proud to be a ‘shitholer’ Biofrontera files for IPO to run skin cancer clinical trials Hikma names ex-Fresenius scientist as global R&D chief [Sponsored] Contract Execution Timelines: An Important Factor in Site Selection Charles River buys immunology player KWS BioTest for $20M Merck's Keytruda nabs new data to rival Bristol-Myers' Opdivo at fending off melanoma's return Featured Story | | | Monday, January 15, 2018 Describing a country as a ‘shithole’ isn’t going to endear you to anyone, but President Trump’s latest alleged outburst has struck a nerve with one particular biotech leader. |
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Top Stories Monday, January 15, 2018 Biofrontera has filed for a Nasdaq IPO. The German company is seeking $22 million (€18 million) to support a clutch of clinical trials designed to expand use of Ameluz in types of skin cancer and other dermatological conditions. Monday, January 15, 2018 Hikma Pharmaceuticals has named Surendera Tyagi, Ph.D., as its CSO and global head of R&D. Tyagi joins Hikma with a brief to stimulate noninjectable R&D activity at a time when the company's generic drug unit is suffering. 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%. Monday, January 15, 2018 Charles River Laboratories has snapped up British CRO KWS BioTest for about $20 million, a deal that will enhance its offerings in immuno-oncology and inflammatory and infectious diseases. Monday, January 15, 2018 Merck & Co. and Bristol-Myers Squibb have been head-to-head competitors in melanoma ever since their two immuno-oncology treatments, Keytruda and Opdivo, both won their first FDA approvals. Now, with its latest data, Keytruda can play catch-up with its rival for another new use. | 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. Drug Development Boot Camp® 2018 November 14-15, 2018 | Boston, MA Drug Approval, Manufacturing Quality & Regulation 2018 | Online TMF Operations: a Quality and Regulatory Approach March 19 - 21, 2018 | Berlin, Germany
Drug Development Boot Camp® 2018 November 14-15, 2018 | Boston, MA Field Service Medical February 26-28, 2018 | Hilton La Jolla, Torrey Pines, CA | 