| | Collecting Quality Data in Psychiatric Trials Understanding interactions among the many factors that give rise to mental illness is a complex task. Learn how to identify and mitigate these elements early on to help ensure trial data accurately captures your compound’s safety and efficacy potential. Premier Research. Built for BiotechSM |
Today's Rundown Vertex guns for virtual trials but hits pause, sees delays for 'some new study starts' FDA moots virtual AdComms but delays GSK, Intercept meetings U.K. government-backed medical research shut down amid COVID-19 Sanofi, Translate Bio jump on mRNA bandwagon to fight COVID-19 Big Pharma companies join forces for fightback against COVID-19 In conversation with: Science 37 and the response to COVID-19 Pear Therapeutics nets digital pre-cert clearance for its insomnia-treating app Safely overcoming resistance to checkpoint inhibition in cancer by blocking a growth factor EuroBiotech Report—COVID-19 vaccine, Ipsen cans trial, AstraZeneca, Boehringer and Roche FiercePharmaAsia—Chloroquine COVID-19 trial, import leniency, export ban; BeiGene’s Abraxane woe Chutes & Ladders—Urovant brings on Astellas alum Robinson as CEO Featured Story | | | Friday, March 27, 2020 Vertex is keeping mum on exact details but, as with the rest of its biopharma peers, is seeing trial disruption due to the COVID-19 pandemic. |
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| | Metabolon reveals a new ally for drug research and development programs. Learn more. |
Top Stories Friday, March 27, 2020 The FDA has expressed an openness to using virtual advisory committee meetings to mitigate the restrictions on face-to-face interactions imposed by COVID-19. However, that openness is yet to translate into action, with the FDA delaying meetings to discuss submissions by GlaxoSmithKline and Intercept Pharmaceuticals rather than having people participate remotely. Friday, March 27, 2020 The U.K.’s major biomedical body, the NIHR Clinical Research Network, is shutting down in the midst of the growing COVID-19 epidemic in the country. Friday, March 27, 2020 Here comes another mRNA vaccine against the novel coronavirus. In its second partnership in the COVID-19 space, Sanofi is expanding its infectious disease pact with Translate Bio to include work on a new vaccine for COVID-19. The duo will to discover and develop “a number of” vaccine candidates against the new coronavirus. Friday, March 27, 2020 A who’s who of leading biopharma companies have joined forces to strengthen the drug industry’s response against the COVID-19 pandemic. Companies including Novartis and Pfizer are contributing to the joint response through actions including the sharing of proprietary compound libraries. Friday, March 27, 2020 In March, the FDA urged biopharmas and CROs to take a virtual approach to clinical trials in reaction to COVID-19 and the attempt to slow its spread. Thursday, March 26, 2020 Expanding the reach of its digital therapeutic programs from substance abuse disorders to insomnia, Pear Therapeutics has received a new FDA clearance for its neurobehavioral app aimed at chronic sleeplessness. Thursday, March 26, 2020 Despite the strong anti-cancer effects of PD-1/L1 inhibitors, many patients still don’t respond to these drugs, which work by lifting the brakes tumors use to evade immune attacks. Scientists at Scholar Rock found that selectively targeting TGF-beta1 growth factor with its investigational drug SRK-181 could overcome resistance to checkpoint inhibitors. Thursday, March 26, 2020 In this week's EuroBiotech Report, U.K. government backs COVID-19 vaccine trial, Ipsen scraps pivotal trial and AstraZeneca inks siRNA deal. Friday, March 27, 2020 COVID-19 hopefuls chloroquine, Kaletra and Arbidol flopped China clinical tests. As FDA lifts import alert on an Indian chloroquine supplier, the Indian government has put an export ban on the malaria drug. BeiGene's Abraxane has been kicked out of China's bulk procurement program. And more. Friday, March 27, 2020 Urovant snags Astellas exec Robinson as CEO; Viracta poaches Nordic Nanovector CMO Rojkjaer; Epizyme brings on Kutok as CSO. 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: Outer Edge Technology To survive in these challenging conditions, companies need to promptly address business continuity issues - especially the remote delivery of data and voice solutions. See how Outer Edge can help. Sponsored by: Patheon, by Thermo Fisher Scientific Poorly soluble molecules hindering your workflow? 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: 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: 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. Bioprocessing Summit Europe – Practical Solutions for Today’s Bioprocess Challenges March 24-26 2020 | Barcelona, Spain 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 BIO International Convention June 8-11, 2020 | San Diego, CA U.S. Healthcare Compliance Certificate Program June 8-10, 2020 | Newark, NJ 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. | 