| This week's sponsor is Patheon. | | | In-House Versus Outsource: A Decision-Making Guide
Here’s a step-by-step guide for biopharmaceutical executives to use when considering if outsourcing fits into their strategy, as well as how to select the best CDMO partner for their business. |
Today's Rundown Regeneron halts high doses of phase 3 osteoarthritis drug fasinumab amid risk-benefit concerns Foresite Capital closes oversubscribed $668M venture fund Achaogen slides after ‘yes and no’ adcomm verdict on plazomicin [Sponsored] Getting to True Agile IRT: 5 Questions to Ask Your IRT Vendor Casma launches with $58.5M for treatments targeting the cell's garbage disposal C4 Therapeutics promotes chief science officer to CEO Bristol-Myers Squibb and Flatiron to collaborate on real-world data standards for regulatory decisions [Sponsored] Australia the not-so-secret destination for pharma and biotech clinical trials Horizon Discovery rejects Abcam’s ‘highly opportunistic’ £270M buyout bid Christoph Westphal back on the horse with new immunotherapy startup Featured Story | | | Thursday, May 3, 2018 Regeneron has halted the higher-dose arms of its phase 3 fasinumab trials on the recommendation of a data monitoring committee. The committee made the call after assessing the risk-benefit profile of the osteoarthritis regimens based on data generated to date. |
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Top Stories Thursday, May 3, 2018 Foresite Capital closed $668 million in capital commitments and will focus on backing companies that apply data science and machine learning in the life sciences and healthcare space. Thursday, May 3, 2018 Achaogen got a mixed outcome from the FDA advisory committee meeting on its antibiotic plazomicin yesterday, with a vote in favor of approval for complicated urinary tract infections but against its use in bloodstream infections. Monday, April 30, 2018 Download the article and better understand the five questions that will help you separate myth from reality when it comes to Agile IRT. Thursday, May 3, 2018 Armed with $58.5 million in series A cash from Third Rock, Casma Therapeutics is working on harnessing a cellular process called autophagy to treat various diseases. Thursday, May 3, 2018 Andrew Phillips was named CEO of C4 Therapeutics, a 2016 Fierce 15 winner focused on small-molecule treatments that target the body’s naturally occurring protein degradation pathways. Wednesday, May 2, 2018 Bristol-Myers Squibb and Flatiron Health expanded their relationship with a new three-year agreement and plan to form a joint scientific advisory board focused on using real-world evidence in regulatory submissions. Monday, April 30, 2018 Supported by generous tax breaks and backed up by strong clinical research and healthcare organizations, Australia has become the not-so-secret destination for both small and large pharmaceutical and biotech companies looking to conduct early stage clinical trials. Thursday, May 3, 2018 Horizon Discovery has rejected a £270 million ($367 million) takeover bid from Abcam. The gene-editing specialist issued a strongly worded rebuttal of the offer after Abcam went public with its plan, calling the bid “highly opportunistic” and repudiating the strategic rationale for the merger. Thursday, May 3, 2018 Details on Westphal's new venture are sketchy, with an April 23 corporate filing saying the company is "developing immunotherapy treatments for cancer." | This week's sponsor is ExL Events. | | | |
Resources Sponsored by: Veeva Systems Learn how cloud-enabled solutions provide real-time insights and actionable analytics to improve clinical trial safety and performance in this short presentation. Presented by: Patheon There are many parenteral dosage forms from which the pharmaceutical scientist can choose to develop their drug product. In this article, the author discusses the choices available and strategies which can be employed at the different stages of development. Sponsored by: Veeva Systems Find out how to eliminate regulatory’s tracking spreadsheets for good. Sponsored by: Veeva Systems UCB took a more holistic approach to managing regulatory processes. Read how their efforts are paying off. Sponsored by: Veeva Systems Learn how to reduce change management burden, keep systems current, and maintain compliance by applying a risk-based approach to change management of GxP systems. Sponsored by: Seton Hall Law 4-day interactive educational program trusted by multi-national companies as part of their compliance training for employees. Explore legal, regulatory and ethical issues faced by pharmaceutical, biotech and medical device manufacturers operating globally. Visit event homepage for session topics. 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. 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 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. Drug Approval, Manufacturing Quality & Regulation 2018 | Online Translational Biomarkers: Advancing Neuroscience Drug Discovery and Development May 14, 2018 | South San Francisco, 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! | 