Today's Rundown New Gilead remdesivir data likely enough for speedy FDA approval: Jefferies AstraZeneca downplays risk of COVID-19 to late-stage timelines Pfizer, BioNTech finish dosing in COVID-19 vax test; emergency use could start in the fall [Sponsored] Connecting biotech, pharma and life sciences ecosystem to ramp up COVID-19 capabilities Radius CEO Høiland hands reins to ex-Elan boss Martin One IPO attempt pulled, a drug on partial hold and a pandemic, but ADC tries again Taysha Gene Therapies hits the ground running with $30M, 15 programs Merck taps Almac in neurodegenerative disease drug discovery deal AACR: Thrive's early blood test doubles real-world cancer screening rates IQVIA: 80% of our trial sites are 'inaccessible' due to pandemic, eyes Q4 for turnaround Featured Story | | | Wednesday, April 29, 2020 As investors and much of the world await any glimmer of hope for treating the ongoing pandemic, it shouldn’t be much of a surprise that Gilead Sciences' shares rocketed up on word that one key trial was positive and details were out in another for severe patients. |
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Top Stories Wednesday, April 29, 2020 AstraZeneca has downplayed the risk COVID-19 poses to its clinical trial timelines, telling investors it “does not expect material delays to anticipated dates of late-stage and lifecycle-management news flow in 2020 and 2021.” Wednesday, April 29, 2020 Pfizer and partner BioNTech are keeping pace with the speed of the sweeping pandemic as they finish dosing in the first cohort of their COVID-19 inoculation test. Monday, April 27, 2020 The life sciences industry is moving in record time to beat COVID-19, but it must connect with partners across the entire ecosystem to ramp up capabilities and deliver the billions of vaccines doses and treatments needed. Wednesday, April 29, 2020 Radius Health CEO Jesper Høiland is stepping down after nearly three years in the post. Taking his place will be Kelly Martin, the banker-turned-biopharma-chief who led Elan Pharmaceuticals for more than 12 years. Høiland will return to his native Denmark after 25 years abroad, as Radius chief and in various roles at Novo Nordisk. Wednesday, April 29, 2020 One of the more surprising elements of the pandemic is how well biotech IPOs have managed, and now Swiss startup ADC Therapeutics is hoping for a second-time lucky attempt despite COVID-19. Wednesday, April 29, 2020 The team that developed Zolgensma is back for round two. A group of former AveXis executives and investors unveiled a new gene therapy company, and they’re wasting no time. With 15 programs, $30 million in seed funding and an “unrivaled” partnership with UT Southwestern Medical Center, Taysha Gene Therapies plans to be in the clinic by the end of the year. Wednesday, April 29, 2020 Merck has weathered some neuroscience setbacks in recent years, but it’s picked up new programs through licensing and M&A. Its latest deal? An R&D pact with Almac Discovery centered on deubiquitinases, a family of enzymes that play many roles in cellular regulatory processes. Tuesday, April 28, 2020 Thrive found its blood test more than doubled the number of cases detected by traditional diagnostics, from 25% to 52% when added to a routine workup—and also revealed several cancers that have no standard screening methods, like mammograms or colonoscopies. Tuesday, April 28, 2020 As IQVIA released its first-quarter financials Tuesday morning, the CRO-analytics firm outlined just how hard its R&D business had been hit by the COVID-19 pandemic. Resources Sponsored by: Lonza This whitepaper summarises approaches for modulating antibody effector functions and pharmacokinetics, and provides examples of antibodies in clinical studies. Sponsored by: Blue Latitude Health Report: Think you’re patient-centric? Think again. Find out how patients really feel about patient-centricity. Learn what they would like to experience along with tools and tips for maximising patient engagement across the product life cycle¬ – from clinical trials to service design and creative campaigns. Sponsored by: BBK Worldwide Leverage strategic solutions to respond to immediate challenges to patient and site engagement from COVID-19, and learn to maximize the FDA guidance on the conduct of clinical trials during a pandemic. Sponsored by: Oracle Health Sciences The research conducted here is to help understand and solve the top challenges in clinical operations, to remove barriers that are slowing down our ability to bring new drugs to market as quickly as possible to patients waiting in need. Sponsored by: Clinical Ink This white paper includes a Phase III case study and discusses BYOD advantages and misconceptions, regulatory, copyright, and equivalency considerations. Sponsored by: Research Solutions Turn your drug failures into competitive advantage. Sponsored by: ICON How will US payers evaluate and manage digital therapeutics? Get insights and recommendations on successful market access considerations. Sponsored by: Copyright Clearance Center Despite advances in content aggregation and search, silos still limit the free flow of data and analytics. So, what can be done, and how can you get more value from the data you already have? Sponsored by: Applied BioMath Learn how we used a tiered model-based approach of a bispecific antibody to appropriately cover multiple antigen pairs to help teams with informed antibody design, prioritization of experiments, and triaging of challenging antigen pairs 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: 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: 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. Sponsored by: Clarify Health Pharma launch teams spend significant resources on data and analytics with limited ROI. Read this case study to learn how a Life Sciences company identified two times more patients best suited for therapy, using Clarify’s deep and longitudinal patient and HCP insights. Medical Affairs Strategic Summit (MASS) East April 14-16, 2020 | New Brunswick, NJ PEGS Boston – The Essential Protein Engineering & Cell Therapy Summit May 4-8, 2020 | Boston, MA 8-week Online Courses in Life Sciences Law and Compliance Virtual Course | May 31st, 2020 European Healthcare Compliance Certificate Program June 2-5, 2020 | Paris, France BIO 2020 Now Fully Virtual: Announcing BIO Digital June 8-11, 2020 | Virtual Event 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. | 