Today's Rundown With phase 2 in the bag, Akcea to test triglyceride-buster in FCS ‘Does intrinsically good and bad technology exist?’ Bayer CEO says no: Davos 2020 Targovax plans checkpoint combo trial after posting early data on oncolytic virus Korean VCs pile into PDC*line to bankroll NSCLC vaccine trial Kintai’s obesity drug that works via the gut microbiome moves closer to the clinic Notable Labs launches rolling blood cancer trial to test its AI system Moderna, federal researchers kick off vaccine work against deadly new coronavirus Featured Story | | | Wednesday, January 22, 2020 One month after Akcea’s partner Novartis opted out of its triglyceride-targeting program, the treatment beat placebo handily at lowering blood triglyceride levels in patients who have, or are at risk of, heart disease. The phase 2 data tee it up for trials in specific cardiovascular ailments, including familial chylomicronemia syndrome (FCS). |
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| Thank you to Rho for sponsoring this year's JPM 2020 coverage. |
Top Stories Wednesday, January 22, 2020 Bayer CEO Werner Baumann highlighted “less and less trust in society for advances in technology” as a hurdle for pharma companies working on gene editing during a panel on genetic modification and engineering that took place at the World Economic Forum meeting in Davos, Switzerland. Wednesday, January 22, 2020 Targovax has shared data from an early-phase trial that administered ONCOS-102 to mesothelioma patients. The response rate was lower in the ONCOS-102 arm than in the control cohort, but Targovax saw positives elsewhere, leading it to outline plans to pair the drug with a checkpoint inhibitor. Wednesday, January 22, 2020 PDC*line Pharma has turned to Korean investors to help raise a €13.9 million ($15.5 million) series B round. The money will fund a phase 1/2 trial of a therapeutic vaccine in patients with non-small cell lung cancer that got underway last year. Wednesday, January 22, 2020 Microbes that live in the gut are believed to play an important role in human metabolism. Kintai Therapeutics, a Flagship Pioneering portfolio company, says its drug candidate that leverages the microbiome showed sustained weight loss, as well as markers of improved glucose control and liver health in rodents. Wednesday, January 22, 2020 Precision oncology firm Notable Labs is launching its first self-sponsored clinical trial, designed from the ground up to help validate its cancer patient matching platform over the long term. Tuesday, January 21, 2020 As fears about the spread of a new coronavirus grip communities ranging from Washington State in the U.S. to China and beyond, scientists have already started working on vaccine candidates. And Moderna's mRNA technology is in the mix. 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: Quotient Sciences Tufts Center for the Study of Drug Development (CSDD) white paper sharing study results that indicate Quotient Sciences’ Translational Pharmaceutics® platform reduces development times by more than 12 months and lowers R&D costs by more than $100 million per approved new drug, compared to traditional multi-vendor development paradigms. Sponsored by: DocuSign A digital transformation is taking place in the life sciences industry, from research laboratories to manufacturing facilities. But there has always been a gap in these technologies. Download the whitepaper to learn how this challenge was addressed. Sponsored by: DocuSign This paper discusses some of the challenges that the GDPR will introduce, with a particular focus on its requirements for obtaining verifiable, unambiguous consent. Sponsored by: DocuSign Download this paper to learn how you can fully digitize all paper processes. By doing so, you will see shorter cycle times, reduced development costs, and greater customer satisfaction. Sponsored by: Benchling As emerging modalities transform the needs of life science R&D, how can biotech and pharma companies use modern software approaches to increase productivity and reach breakthroughs faster? Sponsored by: Catalent Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible. Sponsored by: Catalent Regardless of the assigned FDA expedited approval designation and approach, the key action items should be: the assurance of a detail-oriented plan and the adaption of a “forward-thinking” approach that will assist in any future challenges and opportunities for growth of each project. Sponsored by: ICON Clinical Research Ltd The beginning of this digital transformation is well underway and is likely to accelerate. Read our white paper, “Digital Disruption in Biopharma: How Digital Transformation can reverse declining ROI on R&D,” to learn more. Sponsored by: snapIoT, Inc. Download this white paper and read the expert feedback that snapIoT has gathered from industry thought leaders on the evolution, evaluation, and use of telemedicine solutions in clinical trials. Sponsored by: EVERSANA How are your launch strategies can convert “innovation” into value for patients? Sponsored by: Amazon Web Services From IoT to data management to high-performance computing and machine learning, leading life sciences organizations are using Amazon Web Services (AWS) to develop scalable, global, predictable, and secure solutions to modernize clinical trials while mitigating risks Sponsored by: Outer Edge Technology, LLC Why companies leverage the expertize of industry focused cloud service providers to design and build quality systems and facilitate the FDA Validation of Mission Critical Apps in the Cloud. Sponsored by: Colorcon Learn more: Best practices for defending supply chain security and compliance by efficiently managing product authentication. Sponsored by: Metabolon Small or emerging pharmaceutical and biotech companies pursuing novel molecules and targets have two important goals: achieve clinical success and attract new rounds of funding. While there’s never a guarantee of either, certain actions can influence the outcome in your favor. Sponsored by: Catalent Learn how recent innovations in demand-led supply and direct-to-patient distribution are converging to create a next-generation clinical supply chain that is flexible, lean and most importantly patient-centric. Sponsored by: Altran This whitepaper highlights the challenges of implementing the right digital twin strategy while providing key use cases in the manufacturing domain for which a digital twin is extremely useful and several examples of technology trends that will shape the future. Sponsored by: Catalent Pharma Solutions In this Q&A, four Catalent Biologics experts share how scale-up, regulatory expectations, demand forecasting and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey. Asia-Pacific Healthcare Compliance Certificate Program March 9-12, 2020 11th Annual SCOPE Summit: Summit for Clinical Ops Executives February 18-21, 2020 | Orlando, FL BIO International Convention June 8-11, 2020 | San Diego, CA Drug Development Boot Camp® 2020 November 18-19, 2020 | Register now and begin Pre-Boot Camp Preparation. | Take your new medicine development skills to the next level. Middle East Healthcare Compliance Certificate Program March 23-26, 2020 | 