Today's Rundown Nektar pulls NDA for pain drug after unanimous AdComm rejection Galapagos bags option on 4 more Fibrocor programs JPM: 'An embarrassment of riches'—Lyndra CEO Hurter on the promise of ultralong-acting pills Emendo raises $61M to build on Takeda-partnered gene editing platform JPM Tuesday roundup: Pfizer CEO talks up pipeline, bolt-on deals the name of the game in 2020? JPM: Mayo Clinic, nference launch ambitious data platform initiative Featured Story | | | Wednesday, January 15, 2020 Nektar Therapeutics has withdrawn the new drug application for its opioid oxycodegol after an advisory committee unanimously recommended against approval. The 27-0 vote against approval followed questioning of Nektar’s decision to run one pivotal trial and the extent to which it assessed the risk of abuse. |
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| Thank you to Rho for sponsoring this year's JPM 2020 coverage. |
Top Stories Wednesday, January 15, 2020 Galapagos has struck another deal to expand its fibrosis pipeline, picking up an option to license four Fibrocor programs. The deal comes one year after Galapagos landed global rights to an early-stage idiopathic pulmonary fibrosis treatment in development at Fibrocor. Wednesday, January 15, 2020 SAN FRANCISCO—After working on cystic fibrosis medicines during her 15 years at Vertex Pharmaceuticals, Patricia Hurter was ready for retirement. She hoped to line up more flexible work she could do while traveling, but when she met with Lyndra CEO Amy Schulman about a potential board position, Schulman offered Hurter her own job instead. Wednesday, January 15, 2020 Emendo Biotherapeutics has raised a $61 million series B to take forward programs based on its gene editing platform. The New York-based biotech has worked to expand the list of diseases amenable to treatment with gene editing, resulting in a pipeline of hematology and ophthalmology programs. Wednesday, January 15, 2020 SAN FRANCISCO—The second day of the annual J.P. Morgan Healthcare Conference again saw no major M&A deals but did see some of the bigger pharma companies present and talk a little more about their pipelines and R&D. Tuesday, January 14, 2020 SAN FRANCISCO—Just a week after backing its $60 million series B round, the Mayo Clinic has tapped healthcare data analytics firm nference to build out an artificial intelligence-powered engine that will collate its years of clinical research and pathology work into something more searchable. 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 | 