| This week's sponsor is Premier Research. | | | 7 Things to Watch When Recruiting for an Opioid Trial
Recruiting for an opioid trial? Consider seven key factors, such as avoiding drug abuse and diversion and minimizing screen failures. Find the details here. Premier Research. It's what we do. Best. |
Today's Rundown Celgene confirms $9BN Juno buyout, sees $3BN sales for JCAR017 FDA hunkers down as government shutdown furloughs 42% of staff Gilead’s Kite to buy ex-Agensys R&D site for $135M: report Eureka nets $60M to take T-cell therapy into the clinic In conversation with: WuXi NextCODE CEO Hannes Smárason Sanofi snaps up Biogen's spun-out Bioverativ in $11.6B deal Featured Story | | | Monday, January 22, 2018 Celgene has agreed to buy CAR-T specialist Juno Therapeutics for around $9 billion in a deal that instantly makes it a big cheese in this emerging therapeutic category. |
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Top Stories Monday, January 22, 2018 The FDA is set to furlough 42% of its staff and significantly cut back its activities in response to the government shutdown. Drugmakers cannot file regulatory submissions that require the payment of a fee until politicians pass a bill to fund the federal government. Monday, January 22, 2018 Gilead is set to buy an R&D facility for its CAR-T unit Kite Pharma. Costar reports the big biotech has bid $135 million for a 160,000-square-foot site in Santa Monica, California, formerly occupied by Astellas’ Agensys. Monday, January 22, 2018 With a $60 million series D round, Eureka Therapeutics will go full speed ahead on a phase 1 trial for its lead candidate, a T-cell treatment for relapsed and refractory CD19+ non-Hodgkin lymphoma. Monday, January 22, 2018 Hannes Smárason has seen a lot of good news since he was put at the helm of WuXi NextCODE in February 2017, including several industry veterans signing on at leadership posts and a $240 million series B. He recently took time to chat with FierceBiotech about the genomics shop's technology, products, investments and the road ahead. Monday, January 22, 2018 Sanofi has finally scored a deal. The French pharma, which has been shopping for a big add-on to bolster revenue as its diabetes business falters, will shell out $11.6 billion for Bioverativ, the hemophilia-focused drugmaker spun off by Biogen just last year. | This week's sponsor is IQVIA. | | | Discover a new path to your success via Human Data Science. IMS Health and Quintiles are now IQVIA™ – created to advance your pursuits of human science by unleashing the power of data science and human ingenuity. Join the journey today. Learn More. |
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: 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 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 ICI Boston Summit 2018 March 19-21, 2018 | Boston, MA Field Service Medical February 26-28, 2018 | Hilton La Jolla, Torrey Pines, CA | 