| 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 Esperion’s phase 3 LDL study raises flags with treatment-arm deaths Johnson & Johnson pens $140M deal for preclinical oncolytic virus startup Deshpande leaves Achillion after overseeing R&D pivot, leaving CEO chair free for Truitt [Sponsored] Getting to True Agile IRT: 5 Questions to Ask Your IRT Vendor Iterum files for $92M IPO to bankroll phase 3 trials of ex-Pfizer antibiotic Ironwood to slim down, split into 2 distinct companies Refuge Biotech scores $25M from Chinese backers for 'intelligent' CAR-T [Sponsored] Australia the not-so-secret destination for pharma and biotech clinical trials Charles River expands discovery services in the U.S. and Europe Daphne Koller, A-list backers unite to create machine learning drug R&D startup Featured Story | | | Wednesday, May 2, 2018 Esperion unveiled top-line results from a yearlong phase 3 trial of bempedoic acid, showing it lowered LDL cholesterol by an additional 20% over 12 weeks in high-risk patients taking statins. However, the study also reported 15 fatalities the company said were unrelated to treatment. Shares tumbled by more than 20% premarket. |
|
|
Top Stories Wednesday, May 2, 2018 Johnson & Johnson is paying $140 million upfront to buy oncolytic immunotherapy startup BeneVir Biopharm. The outlay gives J&J control of preclinical drug prospects designed to evade the body’s immune system, enabling them to keep killing cancer cells for longer. Wednesday, May 2, 2018 Achillion has promoted Joseph Truitt to replace outgoing CEO Milind Deshpande, Ph.D. The change puts the person who has overseen Achillion’s business development and commercial strategy for almost a decade in charge of the biotech as it nears midphase complement factor D data. 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 The IPO funds will support phase 3 trials of oral and intravenous sulopenem in complicated and uncomplicated urinary tract infections and complicated intra-abdominal infections. Tuesday, May 1, 2018 Ironwood Pharmaceuticals plans to split into two independent companies, spinning off some of its research and development work into a yet-unnamed business venture in the first half of 2019, focused on orphan diseases and products currently undergoing phase 2 testing. Wednesday, May 2, 2018 Chinese backers led Refuge's recent funding round, which will advance the biotech's platform. The platform controls a cell's gene expression, generating therapeutic cells "that are programmed to make cancer-fighting decisions inside the patient's body." 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. Wednesday, May 2, 2018 Charles River Laboratories is expanding its services into the early discovery setting, offering high-speed pharmacokinetics screening of compounds’ underlying biology to help companies identify small-molecule candidates. Wednesday, May 2, 2018 Daphne Koller has unveiled her next goal: improving drug R&D. The ex-Calico AI expert plans to enlist data and machines to address shortcomings in drug discovery and development—and she has persuaded a stellar investment syndicate to bankroll the work. | 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 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! | 