| 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 Kite executives are back with a CAR-T startup, $300M and Pfizer drugs Dermavant hires CSO from GlaxoSmithKline, buys excessive sweating drug Rigel slips as fostamatinib trial misses the mark in IgA nephropathy [Sponsored] Personalized Medicine Requires Personalized Measurement AstraZeneca leukemia drug bags priority review status, setting up third-quarter approval Medical device CRO Genae buys health data management company Special Report—The top 15 patent expirations of 2018 Featured Story | | | Tuesday, April 3, 2018 After selling Kite Pharma off to Gilead for $11.9 billion, former executives Arie Belldegrun and David Chang are working on allogeneic, or off-the-shelf, CAR-T treatments. |
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| This week's sponsor is STEMCELL Technologies. | | | |
Top Stories Tuesday, April 3, 2018 Dermavant Sciences has lured David Rubenstein, M.D., Ph.D., away from GlaxoSmithKline to serve as its CSO. The Roivant company unveiled the hire alongside other executive appointments and news of the in-licensing of a drug to treat excessive sweating. Tuesday, April 3, 2018 Rigel Pharma—just days away from hearing from the FDA on its first marketing application for lead drug fostamatinib—has reported disappointing phase 2 data in a follow-up indication. Monday, April 2, 2018 How we measure outcomes will evolve from applying one solution to finding an empirical basis for a highly customized application of all of them. Personalized medicine needs a more personalized approach to measurement. Read more. Tuesday, April 3, 2018 The FDA has granted priority review status to AstraZeneca’s treatment for hairy cell leukemia. Snagging the accelerated review sets AstraZeneca up to win approval of the antibody-drug conjugate in the third quarter. Tuesday, April 3, 2018 Belgium-headquartered medical device CRO Genae has bought Hilbert Paradox to strengthen its recently launched data management platform called Staicy. Tuesday, April 3, 2018 Each year, dozens of branded pharmaceutical products lose their legal lock on the market, paving the way for cheap generic competitors and the sales hit they bring—and for patients, pricing relief in costly drug categories. This year is no different, featuring some serious sales heft and household names at the top of the list. | This week's sponsor is Sensors Expo. | | | |
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: USDM Life Sciences What are the biggest trends in life sciences this year? 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: 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. 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 Sensors Expo & Conference Conference & Expo: June 26-28, 2018 | Pre-Conference Symposia: June 25, 2018 | San Jose, CA IRT Europe – Interactive Response Technologies in Clinical Trials April 10th-11th, 2018 | Brussels, Belgium Field Service USA 2018 April 17-April 20, 2018 | JW Marriott Palm Desert Resort & Spa, CA
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
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 Drug Development Boot Camp® 2018 November 14-15, 2018 | Boston, MA | Register and start preparing Today! | 