Today's Rundown GlaxoSmithKline offloads rare disease gene therapies to Orchard Therapeutics Roivant, Arbutus set up RNA JV, put ex-Ariad, Roche executives in leadership posts Abpro files $69M IPO to take bispecific antibodies into the clinic Bellicum shares jump as FDA lifts clinical hold Versant, Novartis power cystic fibrosis startup Enterprise Therapeutics to series B round FDA relaxes clinical hold on Translate Bio’s cystic fibrosis drug Gene-targeted animal model CRO Biocytogen nets $65M series C, eyes global expansion This week's sponsor is TD2. | | 6 Signs You Need a New CRO for Your Preclinical Research Are your preclinical studies where they deserve to be? If progress has stalled, maybe it's your CRO that's the problem...not you. Learn these six telltale signs it's time to switch. Fast-Track Your Research with TD2. | Featured Story | Thursday, April 12, 2018 Orchard is picking up a pair of late-phase candidates, as well as the EMA-approved "bubble-boy" med Strimvelis. The move comes nine months after GlaxoSmithKline announced it was considering selling off its rare disease portfolio. |
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| This week's sponsor is Deloitte. | | | Top Stories Thursday, April 12, 2018 Roivant and Arbutus have pooled their resources to create an RNA-focused biotech, Genevant. The startup begins life with RNA delivery technology from Arbutus, $37.5 million in seed funding from Roivant and plans to take 5 to 10 programs into the clinic by 2020. Thursday, April 12, 2018 Preclinical-stage biotech Abpro Therapeutics has filed a $69 million IPO that it hopes will fund clinical trials of its lead antibody drugs for cancer and vascular eye disease due to start next year. Wednesday, April 11, 2018 The FDA lifted a clinical hold it placed on Bellicum's lead cell therapy, BPX-501, in January, after learning of three cases of brain damage. Thursday, April 12, 2018 Versant Ventures and Novartis Venture Fund have co-led a £29 million ($41 million) series B round in cystic fibrosis disease startup Enterprise Therapeutics. The financing tees up Enterprise to take three projects into the clinic and push one of them through a midphase proof-of-concept trial. Thursday, April 12, 2018 The first trial of Translate Bio's nebulized messenger RNA therapy is now due to start in mid-2018, with results due a year later. Thursday, April 12, 2018 Biocytogen, a Chinese CRO specialized in gene-targeted animal models and related services, has just closed a $65 million series C round. It plans to expand its footprint in both China and the U.S., including a new R&D operation in Boston. 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: 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 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
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 | West Windsor, NJ BioBasics: Biotech for the Non-Scientist June 13 - 14, 2018 | Toronto, Canada 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! |