This week's sponsor is Premier Research. | | iRECIST: The Future of Solid Tumor Evaluation? The iRECIST guidance on solid tumor response focuses new attention on standardizing and validating immune response criteria. Will it be the new standard for clinical trials? See what our experts think. Premier Research. It's what we do. Best. | Featured Story | Monday, October 2, 2017 KSQ Therapeutics has raised $76 million and named former Genzyme boss David Meeker as CEO. Meeker is taking charge of a biotech that spent the past 18 months interrogating 20,000 human genes across 600 cancer- and immune-based models, providing it with a wealth of data to power its drug discovery efforts. |
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| This week's sponsor is Deloitte. | | | Top Stories Monday, October 2, 2017 With hepatitis C virus starting to look like a conquered foe, attention is turning to the fight against chronic hepatitis B virus, and Vivek Ramaswamy’s Roivant has just put another sizable block of cash behind a program in development at Canada’s Arbutus Biopharma. Monday, October 2, 2017 A phase 3 trial of Ablynx’s caplacizumab has met its primary endpoint. The trial linked the anti-von Willebrand factor single-domain antibody to a statistically significant drop in time to platelet count response, bolstering Ablynx’s pitch for approvals in the U.S. and Europe. Monday, October 25, 2017 Learn how one company sought support at multiple junctures—from manufacturing to biomarker evaluation to market access—to enable a faster and more effective launch of their new programmed death receptor-1 (PD-1)-blocking antibody. Monday, October 2, 2017 A few months ago, Endocyte was shedding R&D programs and staff, with questions being raised about its future. Now, it says its prospects have been resurrected by licensing a phase 3-ready prostate cancer drug. Monday, October 2, 2017 Seres Therapeutics has posted top-line data from a phase 1b of SER-287 in ulcerative colitis. The microbiome pioneer thinks the data support the rapid advance of SER-287 deeper into the clinic, although question marks about the results remain. Monday, October 2, 2017 As most people who are trying to lose weight can testify, the older you get, the harder it is to burn that ever-growing roll of belly fat. Scientists at Yale believe they’ve found an immune connection to this problem—and a possible solution in an existing class of depression drugs. 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: Veeva Systems The 2017 Unified Clinical Operations Survey finds that 99% of respondents report the need to unify their clinical applications, including CTMS, EDC, eTMF, and study start-up. 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: Ashfield Healthcare Join this webinar to learn how to design, deliver, and measure a successful patient support program. Presented by Nareda Mills, Ashfield's SVP of Patient Services in the US, you’ll discover how to improve adherence and improve patient outcomes using 5 key methods. Presented By: PRA Health Sciences Children participating in pediatric clinical trials are included in the contraceptive requirements applied to women of child-bearing potential, creating significant challenges for sponsors, parents, investigators and study staff. 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. 2nd Strategic Partnerships for Drug Repurposing October 26-27, 2017 | Boston, MA Compliance Certificate and Training for Life Sciences Professionals October 9 -12, 2017 | Newark, NJ CBI’s MedComm 2017 Conference October 26-27, 2017 | San Francisco, CA Drug Development Immersion (New Jersey) Life Sciences Innovation Awards Application Deadline: Friday, October 20th, at 11:59 PM EST Application Deadline: Friday, October 20th, at 11:59 PM EST Drug Development Primer (San Diego) Drug Development Immersion (Boston) BioBasics: Biotech for the Non-Scientist (Boston) FierceBiotech Executive Summit- London October 2, 2017 | London Drug Development Boot Camp® 2017 November 15-16, 2017 | Boston, MA |