| 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 After FDA rebuff, Celgene on track to refile ozanimod—in 2019 Moderna grabs $125M in expanded Merck cancer vaccine collaboration FDA delays decision on inotersen, handing lead to Alnylam [Sponsored] Getting to True Agile IRT: 5 Questions to Ask Your IRT Vendor Adverum loses CEO, CMO in quick-fire departures [Sponsored] Australia the not-so-secret destination for pharma and biotech clinical trials Sarepta adds muscular dystrophy gene therapies via Myonexus pact EuroBiotech Report—Crescendo’s $70M round, Horizon rebuffs Abcam, FDA slows Compugen and Iterum IPO FiercePharmaAsia—China’s historic drug nod, Biogen’s stepped-up biosim bet; WuXi’s expansions Chutes and Ladders—Achillion appoints Joseph Truitt CEO Featured Story | | | Friday, May 4, 2018 An FDA refuse-to-file notice delayed Celgene's ozanimod by about a year, but it could be worse—it is still “better than worst fears of 2020 refiling and long delay," Jefferies analysts wrote. |
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Top Stories Friday, May 4, 2018 On the heels of a $500 million round, Moderna picked up another $125 million as it expands its cancer vaccine partnership with Merck. Friday, May 4, 2018 The FDA has delayed the PDUFA date for Akcea’s hereditary TTR amyloidosis drug inotersen, handing first-mover advantage to Alnylam. Akcea suffered the setback after the FDA asked for more time to review its response to requests for information on the rare disease antisense drug. 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. Friday, May 4, 2018 The CEO and CMO of Adverum Biotechnologies have left the gene therapy startup. Adverum said Amber Salzman, Ph.D., stepped down as CEO and president by “mutual determination,” while CMO Athena Countouriotis, M.D., resigned after less than one year in the job. 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. Friday, May 4, 2018 Sarepta is determined to stay at the forefront of genetic medicines for muscular dystrophies. To that end, it has signed another R&D deal—this time with Myonexus Therapeutics—and taken an option on buying the company. Thursday, May 3, 2018 In this week's EuroBiotech Report, Crescendo raises $70 million, Horizon rebuffs Abcam, FDA delays Compugen trial start and more. Friday, May 4, 2018 China hands a speedy nod to Merck's Gardasil 9 based on foreign data, a new approach for the CFDA; Biogen aims to raise its stake in Samsung Bioepis by almost half, jacking up its bet on biosimilars; WuXi AppTec's branches are building gigantic new facilities; and more. Friday, May 4, 2018 Achillion appoints Joseph Truitt to replace CEO Milind Deshpande, Lilly hires Leena Gandhi to lead a new I-O team, C4 promotes Andrew Phillips to CEO, plus more hirings, firings and retirings throughout the industry. | 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: 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 FierceBiotech 3rd Drug Development Forum October 1–3, 2018 | Hilton Boston Logan Airport Hotel | Boston, MA Drug Development Boot Camp® 2018 November 14-15, 2018 | Boston, MA | Register and start preparing Today! | 