| This week's sponsor is Premier Research. | | | Opportunity Knocks: Seizing the Promise of Orphan Drugs
Orphan drug developers enjoy more favorable regulatory conditions today than ever. Read our white paper for tips on maximizing this opportunity. Premier Research. It's what we do. Best. |
Today's Rundown Novartis lures John Tsai from Amgen to fill CMO seat Novartis’ Jay Bradner bemoans 'redundant investment in the biotech sector' for some cancer R&D Top Sangamo executive loses control of email account, exposing company secrets [Sponsored] It Might Be a Bumpy Ride: Why Life Sciences Companies Should Consider Embracing the New Wave of Change Argos abandons kidney cancer vaccine after phase 3 fail CNS Pharma turns to crowdfunding to advance glioblastoma drug Tmunity dials series A round up to $135M to fuel progress of T-cell immunotherapy pipeline Bluebird's gene therapy eliminates blood transfusions for some beta-thalassemia patients Icon to implement Intel’s AI-enabled remote monitoring platform for clinical trials 'Cell-free' CRISPR could improve cancer diagnostics, unravel how gene editing works Allergan reportedly swoops in as Takeda's third Shire bid falls short at $61B Featured Story | | | Thursday, April 19, 2018 Vas Narasimhan, M.D., has persuaded John Tsai, M.D., to fill the vacant CMO role at Novartis. Tsai took up the same position at Amgen just 11 months ago but had his head turned by the digitally enabled pipeline Narasimhan is building at Novartis. |
|
|
| This week's sponsor is Trianni. | | | |
Top Stories Thursday, April 19, 2018 Jay Bradner, president of Novartis’ Institutes for BioMedical Research, questions whether billions in cancer research funding is going in the right direction as he points out a “flood of fast followers, narrow differentiators and distracting hype” around some new therapies and research. Wednesday, April 18, 2018 Earlier this year, someone accessed a Sangamo Therapeutics executive's company email and, for the next 11 weeks, was able to access sensitive and secret information on the company and, potentially, its partners, according to a Tuesday securities filing. Monday, April 16, 2018 Changes in technology and geopolitics, coupled with U.S. tax reform and new financial accounting standards, are creating disruption in accounting and financial reporting for life sciences companies. Thursday, April 19, 2018 Argos Therapeutics is ending its phase 3 kidney cancer trial and considering options, including a merger or sale, to stay alive. The move comes more than a year after an independent monitoring committee told it to ditch the program due to futility. Thursday, April 19, 2018 CNS Pharma says berubicin is the first anthracycline drug to cross the blood-brain barrier and could transform treatment of the highly invasive brain tumor if phase 2 trials are positive. Thursday, April 19, 2018 Tmunity has added $35 million to its series A round, bringing its total haul up to $135 million. The cash sets ex-Novartis executive Usman “Oz” Azam up to build out the infrastructure Tmunity needs to hustle its pipeline of T-cell-based immunotherapies through clinical development. Thursday, April 19, 2018 Fifteen of the 22 patients in a gene therapy trial no longer needed blood transfusions, while the remaining seven needed fewer transfusions. Six of them had a more severe form of beta-thalassemia. Thursday, April 19, 2018 Icon has reached a preliminary agreement with Intel to use the Intel Pharma Analytics Platform, which can continuously monitor and collect clinical data from study participants using wearables and can use artificial intelligence methods to analyze the data. Thursday, April 19, 2018 Christiana Care scientists edited DNA outside the cell for what they say is the first time, laying the groundwork for a diagnostic test that can replicate DNA mutations in a patient's tumor and help physicians identify the more appropriate treatment. Thursday, April 19, 2018 Three of Takeda’s anticipated Shire buyout bids have already been rejected—and now, the Japanese drugmaker might just lose out to a competing bidder. Allergan, for instance, is reportedly already in talks for a buy. | This week's sponsor is Thermo Fisher. | | | |
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. |
|
|
Resources Sponsored by: Veeva Systems Learn how leading companies, from the world’s top pharma to emerging biotechs, are empowering their medical affairs teams. Sponsored by: Veeva Systems To deliver value to key opinion leaders, medical affairs needs to tailor their engagement with deeper analytics and insights. Sponsored by: Veeva Systems Explore a new model for events management, and learn how to deliver more value. Sponsored by: WCG Small biopharma companies are conducting almost 50% of the clinical trials in the US today, yet they face unique challenges that large pharma do not. In this paper, we explore some of those challenges, and solutions that can reduce the pressure on small biopharma teams and timelines. Sponsored by: Halo Pharma Why does confidence matter when outsourcing Fixed-Dose Combination products? Download Halo Pharma’s white paper on the importance of product design, technology, and analyticals tools for FDC. Sponsored by: USDM Life Sciences What are the biggest trends in life sciences this year? Presented by: Patheon, part of Thermo Fisher Scientific Patheon's Stephen Lam reviews the formidable challenges and decisions facing biopharma manufacturing executives. Watch as he shares unique insights and perspectives and demonstrates how there is really no one-size-fits-all solution in biomanufacturing, regardless of company size. Presented by: Charles River How do you get your oncology therapy to the clinic? The path isn’t always clear. In vitro, ex vivo, xenograft, syngeneic, PDX, humanized models, immunology considerations, safety regulations – which do you need to plan for and when? Sponsored by: DocuSign Life science companies are experiencing a significant transformation in how they bring new products to market. Sponsored by: Reprints Desk The competitive landscape in medical device R&D is tough. And simply investing in R&D is no guarantee for profitability. So how do you accelerate time-to-market? Sponsored by: WCG Selecting the right sites to conduct your clinical trials will determine the success or failure of meeting your enrollment goals. 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 Drug Development Immersion April 25-26, 2018 | New York City Biotech for the Non-Scientist May 2-3, 2018 | San Diego, CA MIXiii-Biomed 2018 May 15-17, 2018 | Tel-Aviv, Israel Drug Development Immersion May 17-18, 2018 | Boston, MA BIO International Convention June 4-7, 2018 | Boston, MA
FierceBiotech Executive Breakfast at BIO 2018 – CAR-T 2.0: Innovation Never Stands Still June 6, 2018 | Boston, MA BioBasics: Biotech for the Non-Scientist June 13 - 14, 2018 | Toronto, Canada BioBasics: Biotech for the Non-Scientist June 13 - 14, 2018 | West Windsor, NJ Sensors Expo & Conference Conference & Expo: June 26-28, 2018 | Pre-Conference Symposia: June 25, 2018 | San Jose, CA 18th International Biotechnology Symposium and Exhibition August 12-17, 2018 | Montreal, Canada Drug Development Boot Camp® 2018 November 14-15, 2018 | Boston, MA | Register and start preparing Today! | 