Today's Rundown 5AM Ventures raises nearly half a billion for 2 new VC funds FDA panel backs J&J’s ketamine-like depression drug Parexel nabs high-profile former FDA staffers, beefing up its regulatory offerings [Sponsored] Invert to Convert: Rethinking Patient Recruitment & Enrollment Strategies Charles River swoops on early-stage CRO Citoxlab Sygnature backs Pathios in hunt for GPR65 modulators Featured Story | | | Wednesday, February 13, 2019 5AM Ventures has closed two new biotech-focused capital funds, totaling $497 million in commitments—a significant leap for the firm’s total, which had previously reached about $1 billion since its founding in 2002. |
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| This week's sponsor is Camargo. | | | [Webinar] Maximizing the Value of Your Drug Development Program
Thursday, February 21 | 11am ET / 8am PT
This webinar will benefit executives at Biotech and Pharmaceutical companies interested in learning more about 505(b)(2) drug development and how to save time and money while maximizing the value of their drug development program. Register Now! |
Top Stories Wednesday, February 13, 2019 A FDA advisory committee has voted overwhelmingly in favor of Johnson & Johnson’s depression drug esketamine. The panel’s decision to back the ketamine-like drug despite the shortcomings of its clinical program tees J&J up to win approval for one of the most notable antidepressants in decades. Tuesday, February 12, 2019 The revolving door of FDA staffers into the life science industry continues apace as no less than four former executives at the U.S. regulator have joined the CRO’s ranks. Monday, February 11, 2019 90% of clinical trials will meet their enrollment goals if their original timelines are doubled. WCG breaks down the barriers to ramping up and meeting patient enrollment goals. A new approach addresses root causes and accelerates study timelines by 33%. Wednesday, February 13, 2019 Charles River Labs has added another string to its early-stage R&D bow by acquiring preclinical services specialist Citoxlab for around $510 million in cash. Wednesday, February 13, 2019 Pathios Therapeutics has enlisted CRO Sygnature Discovery to support its hunt for novel modulators of GPR65. The deal sees Sygnature take a stake in Pathios in part payment for its involvement in the Oxford-based biotech’s hit-to-lead program. 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 Presented by: SDC If commonly used statistical phrases like two-sample t-test, difference in proportions, or hazard ratio intimidate you, join this webinar for an introduction to statistical analyses in clinical trials. Sponsored by: Patheon, part of Thermo Fisher Scientific When a biologics company prepares to launch a new product, it must forecast the manufacturing capacity it will need, factoring in its estimate of the size of future sales, the timing of the launch, the dosage of the product, its strategy for building its market and a host of other variables. Sponsored by: Oracle Health Sciences 92% of survey respondents make changes to their RTSM/IRT systems due to study changes. See what else puts a strain on their clinical trials. Download the Research Whitepaper. Sponsored by: Patheon, part of Thermo Fisher Scientific Download this whitepaper to learn more. Sponsored by: The Kinetix Group Explore how the pharma industry can adapt its approach to the changing healthcare marketplace in the era of the Quadruple Aim Sponsored by: Cofactor Genomics Learn how Health Expression Models provide increased sensitivity, specificity, and accuracy for characterizing immune response in solid tumor specimens. Sponsored by: BioAnalytix, Inc. This whitepaper reviews fundamental aspects of HCPs that pertain to biologic drug development and presents current and emerging approaches to HCP analysis. Sponsored by: Veradigm Clinical trials take too long and cost too much—here's what needs to change. Sponsored by: AlphaSense It’s never been more challenging to stay on top of competitive factors impacting your industry. Discover how AI can help competitive teams achieve more proactive market intelligence. Sponsored by: Reprints Desk, Inc. Go from Search to Full-Text Scientific Papers in a Single Click! Sponsored by: Blue Latitude Health This white paper consists of original data and expert interviews. Download it today for exclusive tools, tips and analysis on achieving launch excellence in challenging pharma markets. Sponsored by: Outer Edge Technology With FDA approval imminent, start-up Life Sciences company partners with an industry focused MSP to design and manage its regulated cloud-based infrastructure to speed time to market. Sponsored by: DeciBio Consulting With the liquid biopsy market maturing and >80 companies still competing with liquid biopsy offerings, it is crucial for investors to be able to cut through the noise and identify the winners. Presented by: Veeva Share your thoughts on the life sciences industry's progress in improving study execution. Sponsored by: Biotech Primer The Biopharma industry is moving at lightning speed and it can be a challenge to keep pace. Here at Biotech Primer we spend hours each week researching, writing, and editing original content for the Biotech Primer WEEKLY with one goal in mind: to help everyone better understand the latest science and technology driving today’s healthcare industry. BIO Asia International Conference March 5-6, 2019 | Grand Hyatt Tokyo | Tokyo, Japan PEGS: The Essential Protein Engineering Summit April 8 – 12, 2019 | Boston, MA Middle East Life Sciences Compliance Training April 29, 2019 – May 2, 2019 | Dubai U.A.E. Drug Development Boot Camp® 2019 November 20-21, 2019 | Boston, MA | Register and start preparing Today! | 