| 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 Bristol-Myers Squibb drops phase 3 trials of $800M IDO drug First its offices, then its websites—what will Sinobioway seize next in the Sinovac saga? Incyte wipes out late-phase epacadostat program after pivotal failure of Keytruda combination [Sponsored] Getting to True Agile IRT: 5 Questions to Ask Your IRT Vendor Pfizer culls 5 experimental cancer trials and an acne drug in Q1 clear out Allergan R&D head still sees value in RORγt program after $533M write-off Feng Zhang quietly starting new CRISPR-based company: report Karyopharm slumps, then leaps on selinexor multiple myeloma data [Sponsored] Australia the not-so-secret destination for pharma and biotech clinical trials David Thompson leaves Azure to join bone disorder startup Inozyme Gilead, Verily ally to analyze immune cells from inflammatory disease patients Featured Story | | | Tuesday, May 1, 2018 Bristol-Myers Squibb has pulled two phase 3 clinical trials of the IDO1 inhibitor it acquired through an $800 million takeover of Flexus. The studies are the latest dominoes to fall following the failure of Incyte’s rival IDO drug to move the needle in a pivotal trial. |
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Top Stories Tuesday, May 1, 2018 Sinovac Biotech announced Monday that it had taken its websites offline after Aihua Pan, the chairman of its Sinovac Beijing subsidiary, "inappropriately and without authorization seized control" of them. Tuesday, May 1, 2018 Incyte has taken an ax to its suite of late-phase epacadostat trials after digesting the implications of last month’s pivotal study blowup. The cull sees Incyte downgrade two pivotal epacadostat-Keytruda trials to phase 2 studies and back away from six other late-stage tests of its IDO inhibitor. 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. Tuesday, May 1, 2018 Pfizer has cleared out five early stage oncology drug tests from its pipeline, including three tests for utomilumab, as well as an acne drug. Tuesday, May 1, 2018 Allergan has been forced to write off the second of two drug candidates acquired when it took over Vitae Pharma for $639 million less than two years ago. Monday, April 30, 2018 Beam Therapeutics, a new Cambridge, Massachusetts-based startup co-founded by gene editing innovator Feng Zhang, has raised nearly $100 million in series A funding and early commitments, according to reporting from the Boston Business Journal. Monday, April 30, 2018 Karyopharm took a 15% dip as investors waited for an update on a phase 2b trial of selinexor in patients with refractory multiple myeloma. It then jumped 26% after hours on positive topline data from the trial. 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. Tuesday, May 1, 2018 David Thompson has left Azure Biotech, the company he helped launch, to join Inozyme Pharma as senior vice president and chief scientific officer as the company transitions from the discovery stage to the clinical stage. Tuesday, May 1, 2018 Gilead has teamed up with Verily to analyze the effect its drugs have on the immune cells of patients with inflammatory diseases. The alliance taps into Verily’s work to stratify and analyze white blood cells—and the data-crunching abilities that come from being part of the same company as Google. | This week's sponsor is ExL Events. | | | |
Resources 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. 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 Biotech for the Non-Scientist May 2-3, 2018 | San Diego, CA 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! | 