| This week's sponsor is Premier Research. | | | 6 Considerations When Designing Hematology Clinical Trials
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 1-year data set Spark on track with hemophilia B gene therapy Sage wows with phase 2 depression data, sending stock to new highs FDA opens door to multiarm, multicompany clinical trials Metabolic biotech Metacrine gains $22M for NASH tests Juno strikes 3 deals to advance multiple myeloma combo treatment Activating the hedgehog pathway protects mice from obesity Augmented reality startup Apprentice bags $2.5M cash to build on uptick in biopharma interest Featured Story | | | Thursday, December 7, 2017 Patients with hemophilia B have seen their symptoms controlled for up to a year with a single dose of a gene therapy developed by Spark Therapeutics, almost entirely eliminating the need for treatment with clotting factors. |
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| This week's sponsor is Precision Oncology. | | | Precision Oncology Tips: 4 keys to take your molecule to market sooner
Ready for accelerated therapeutic approval? Novel vaccine therapies? Genome editing technology? We explore the pre-ASH buzz. Download our POV and visit Precision Oncology at ASH Booth 2540. |
Top Stories Thursday, December 7, 2017 Sage Therapeutics has scored another big win in the clinic. SAGE-217 triggered near-immediate, fairly durable improvements in patients with major depressive disorder, sending its stock on a tear for the second time in the past month. Thursday, December 7, 2017 The FDA has outlined how developers of drugs targeting rare pediatric diseases can streamline their clinical development programs by collaborating. Officials want drug developers to consider teaming up to test multiple candidates in single trials, thereby cutting the number of patients who need to receive placebos. Thursday, December 7, 2017 We’ve spoken a lot about NASH this week—this year in fact. Yet Metacrine is seeing us talk about it again after completing a series B as it aims to combat the fatty liver disorder. Thursday, December 7, 2017 Juno Therapeutics, which dumped its lead CAR-T program in March, has inked license agreements with Eli Lilly, OncoTracker and Fred Hutch. Wednesday, December 6, 2017 Boosting a protein signaling pathway in the body known as "hedgehog" prevented weight gain in mice, a team from Washington University in St. Louis found. The method, which stops fat cells from growing larger, targets a common cause of obesity in adults. Thursday, December 7, 2017 Apprentice has raised money to build out its biopharma-focused augmented reality business. The startup provides smart glasses applications that enable hands-free data capture, remote problem solving and other tasks at drug research and manufacturing facilities. Resources 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: Deloitte Sourcing research externally seems to be the preferred path for biopharma companies to strengthen their R&D pipeline. 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. Sponsored by: Veeva Systems Read Deloitte Consulting's whitepaper on the value of a holistic RIM capability, covering the potential cost savings and revenue gains from doing RIM right. 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. Sponsored by: Veeva Systems See the results from one of the largest, most in-depth surveys of clinical data management professionals on data management practices, performance, and challenges. Sponsored by: Veeva Systems Gain a complete, real-time view of quality and streamline operations. Incorporate partners into processes for critical oversight and 30% greater efficiency, and transform cross-functional processes like change control. Presented by: DSM Biomedical Discover DSM's Dyneema Purity® membrane, an effective and efficient material to construct stent grafts used in minimally invasive surgeries to treat both cardiovascular and peripheral arterial diseases. Sponsored by: ePharmaSolutions As clinical trials become more complex, safety document distribution to investigative sites has reached the point that demands a solution. Sponsored by: Ashfield Healthcare December 5, 2017 | 2pm EST / 11am PST Join this webinar to learn methods that maintain and build sales momentum despite turnover. 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. FierceBiotech Executive Breakfast: Get Good Science and the Money will Follow January 9, 2018 | San Francisco, CA BIO CEO & Investor Conference February 12-13, 2018 | New York, New York | 