| 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 Juno stock jumps as reports suggest Celgene wants a buyout FDA chief Gottlieb backs away from plan to publish CRLs China's Innovent eyeing IPO this year—and could list in U.S. [Sponsored] Contract Execution Timelines: An Important Factor in Site Selection Merck KGaA taps CRUK, ICR for source of cancer candidates Carmot Therapeutics bags $15M for GLP-1R/GIPR agonist GAO to FDA: Release new or revised guidance on complex generics; FDA says it's on it Featured Story | | | Wednesday, January 17, 2018 After a $7 billion biobucks deal for Impact Biomedicines at the J.P. Morgan Healthcare Conference last week, Celgene is lining up another deal for the CAR-T biotech Juno Therapeutics, according to several media reports. |
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Top Stories Wednesday, January 17, 2018 FDA Commissioner Scott Gottlieb, M.D., has backed away from an earlier commitment to publish complete response letters (CRLs). Gottlieb talked up the prospect of releasing redacted versions of the letters in his confirmation hearings but has now watered down his interest in the idea. Wednesday, January 17, 2018 Chinese biotech Innovent Biologics is considering a $200 million IPO later this year that could take place in the U.S., according to media reports. 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 Merck KGaA has teamed up with Cancer Research UK (CRUK) to access cancer candidates. The pact sets Merck up to work with researchers at CRUK’s unit at The Institute of Cancer Research (ICR) on three preclinical oncology projects. Wednesday, January 17, 2018 Carmot Therapeutics' series B will carry its lead Type 2 diabetes drug through clinical proof of concept. Wednesday, January 17, 2018 In a 50-page report released Tuesday, the Government Accountability Office said the FDA should release plans to issue or revise guidance for complex generic drugs. In response, the FDA said they are working on new changes. | 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 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 | 