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 Ablynx investor opens door to Novo deal at a higher price BIO urges more VC, R&D in neglected areas, starting with depression Heptares, Sosei shuffle leadership as CSO Marshall departs [Sponsored] Contract Execution Timelines: An Important Factor in Site Selection Broad Institute knocked back by European CRISPR patent ruling Switching off enzymes to block cell division in cancer EuroBiotech Report—Merck-CRUK, U.K. drug discovery, Biofrontera IPO, Inositec CMO and Pherecydes series B FiercePharmaAsia—J&J diabetes sale, Novartis-Biocon biosimilar deal, Keytruda-Lenvima combo Chutes & Ladders—Pandion emerges with Pfizer, Biogen veterans as leaders Featured Story | Friday, January 19, 2018 Ablynx’s largest shareholder is open to supporting a takeover by Novo Nordisk. The fund, Van Herk Investments, thinks Novo’s most recent offer was too low, but it will encourage Ablynx to enter talks if a sufficiently sweetened bid is received. |
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| Top Stories Friday, January 19, 2018 In response to declining venture investment in a range of "highly prevalent, chronic diseases," the Biotechnology Innovation Organization (BIO) is releasing a series of reports calling for more work to be done in these spaces, starting with depression. Friday, January 19, 2018 Fiona Marshall, Ph.D., is set to leave Sosei. Marshall has served as CSO of the company since it bought Heptares but is now departing to take on a senior role at another business. 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%. Friday, January 19, 2018 Determining who owns the intellectual property surrounding the gene-editing CRISPR/Cas9 technology has been a combative affair, and the Broad Institute just came out on the wrong side of the latest skirmish. Thursday, January 18, 2018 Using mass spectrometry, researchers from Sweden and the U.K. have discovered how drugs bind to the enzyme DHODH, which could lay the groundwork for more selective cancer drugs that slow or stop cell division. Thursday, January 18, 2018 In this week's EuroBiotech Report, Merck KGaA pens cancer pact, MDC details U.K. drug discovery goals and more. Friday, January 19, 2018 Several Chinese buyers were reportedly eyeing Johnson & Johnson's diabetes unit, Novartis and Biocon have formed an alliance to co-develop biosimilars, Merck and Eisai has nabbed the FDA’s breakthrough designation for their Keytruda-Lenvima combo in kidney cancer, plus more pharma news from Asia. Friday, January 19, 2018 Pandion Therapeutics emerged with two industry veterans as its CEO and CSO; Hikma tapped ex-Fresenius scientist as R&D chief; Ipsen hired ex-Amgen oncology leader as head of North America; plus more hirings, firings and retirings throughout the industry. 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 |