Today's Rundown Trump tries to lure CureVac to make a 'U.S. vaccine,' but German government steps in With weeks to go to COVID-19 vaccine trial, BioNTech lands $135M deal and advances Pfizer talks Apellis CEO Cedric Francois shares COVID-19 diagnosis [Sponsored] Biogazelle launches novel high-throughput RNA sequencing and data analysis services Allogene chair, former Kite Pharma CEO Belldegrun reveals COVID-19 diagnosis Blueprint hits goal in midphase rare disease trial, teeing up pivotal study FDA quickly OKs its 2nd commercial COVID-19 test, from Thermo Fisher Melatonin? Stem cells? Researchers step up with unconventional approaches to COVID-19 Featured Story | | | Monday, March 16, 2020 It’s a pretty extraordinary story that started off with a CEO exiting a biotech and has now become about the U.S. president allegedly wanting to lure that biotech over to the U.S. to build a vaccine for the coronavirus—but just for Americans. |
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Top Stories Monday, March 16, 2020 BioNTech is in advanced talks with Pfizer over ex-China development of a coronavirus vaccine that is due to enter the clinic late next month. News of the progress of the vaccine and deal-making inside and outside of China sent shares in BioNTech up more than 50%. Monday, March 16, 2020 Another biotech executive has tested positive for COVID-19. Apellis CEO Cedric Francois revealed his diagnosis in a LinkedIn post this weekend. He was tested a day after he started feeling ill, with “[no] fever, no cough or shortness of breath, but general malaise.” Monday, March 16, 2020 Biogazelle NV, a CRO specializing in genomics and transcriptomics, announced the launch of HTPathwaySeq and HTTargetSeq, two cost-effective high-throughput RNA sequencing and data analysis services. Monday, March 16, 2020 A “minimal dry cough and transient low-grade fever” led to biotech veteran Arie Belldegrun being diagnosed with COVID-19 as the U.S. and the world issue tighter crackdowns to keep this new coronavirus under control. Monday, March 16, 2020 A phase 2 trial has linked Blueprint Medicines’ avapritinib to statistically significant improvements in the symptoms of patients with indolent systemic mastocytosis (SM). The results tee Blueprint up to move the kinase inhibitor into the pivotal efficacy part of the midphase rare disease clinical trial. Monday, March 16, 2020 Shortly after the FDA granted an Emergency Use Authorization to its first commercially developed coronavirus test—developed by Roche for use on its high-throughput cobas system—the agency did the same for Thermo Fisher Scientific’s diagnostic. Monday, March 16, 2020 At a time of unprecedented panic over the rapidly spreading COVID-19 coronavirus, several research groups are asking whether existing therapies could be repurposed in fighting the disease. Suggestions over the past week include combinations of drugs and supplements as well as a stem cell product that has proven effective in reducing inflammatory biomarkers. Enrollment Showcase | | | Presented by: Global EMBA for Healthcare & the Life Sciences, University of Toronto Prepare to step up in your career, build the expertise you need to reshape your organization, and explore opportunities worldwide. |
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Resources Sponsored by: eClinical Solutions Key findings from the 2019 Life Sciences Data & Analytics Survey conducted by the Tufts Center for the Study of Drug Development will be unveiled during this live webinar led by industry expert and study lead, Ken Getz, Director of Sponsored Programs and Associate Professor. Sponsored by: Catalent Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study. Sponsored by: Catalent Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study. Sponsored by: Catalent Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study. Sponsored by: Outer Edge Technology See why innovative BioPharma’s are partnering with Cloud Service Provider’s to design, manage and implement cloud strategies to smooth the path to FDA approval and enhance their competitive prowess. Sponsored by: Metabolon Metabolomics can help you streamline your drug development process by providing the framework to make a stronger, more confident, and more valuable case for a molecule in a shorter timeframe. Sponsored by: Epsilon Download this e-book to learn 9 ways to enhance the customer experience within healthcare marketing. Sponsored by: Reprints Desk/Research Solutions 3 ways you may be overspending on scientific literature access, and how to fix them. Sponsored by: Baxter When different drug products are produced in shared facilities, potential for cross-contamination needs to be addressed. Outsourcing to a CMO with experience in multiproduct facilities can be an option. Sponsored by: WCG Metrics Champion Consortium Ineffective measurement could mean wasting both time and money. This whitepaper showcases a custom-built Metric Maturity Model that helps illustrate and define the process for measuring the right things the right way. Sponsored by: Eagle Productivity Solutions Mediocre adoption rates aren’t due to poorly designed software or lazy users. They’re the result of how skills are trained. Achieve high adoption rates by implementing the right methodology with a focus on behavior change. Sponsored by: The Kinetix Group Read about the innovative ways payers are making smart moves in the healthcare game. Sponsored by: Catalent This whitepaper discusses the benefits of end-to-end solutions and share case studies on how flexible manufacturing strategies can accommodate the changing landscape of pharmaceutical products and help bring a drug to market. Sponsored by: Blue Matter Consulting White paper describing how a biopharma company can successfully differentiate an oncology product when the clinical profile alone is not enough to get the job done. 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: 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. Bioprocessing Summit Europe – Practical Solutions for Today’s Bioprocess Challenges March 24-26 2020 | Barcelona, Spain BioBasics 101: The Biology of Biotech March 26-27, 2020 | Boston, MA Clinical Trial Innovation Summit – Technology, Data, Operations, Oversight April 6-8, 2020 | Cambridge, MA Medical Affairs Strategic Summit (MASS) East April 14-16, 2020 | New Brunswick, NJ BioBasics 101: The Biology of Biotech April 16-17, 2020 | Philadelphia, PA Drug Development Immersion April 23-24, 2020 | Boston, MA European Healthcare Compliance Certificate Program June 2-5, 2020 | Paris, France U.S. Healthcare Compliance Certificate Program June 8-10, 2020 | Newark, NJ 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. | 