To view this email as a web page, click here

   Home

Subscribe

Advertise

 

 

 

 

April 30, 2020___

Today's Rundown

Featured Story

Gilead's remdesivir speeds COVID-19 recovery in first controlled trial readout, but it's no 'silver bullet'

After dribs and drabs surfacing about Gilead’s COVID-19 hopeful, remdesivir, the first data from a placebo-controlled study are here—at least, an early look at them. Remdesivir cut recovery time for hospitalized COVID-19 patients by four days, or 31%, in an NIH-sponsored study pitting the drug against placebo in more than 1,000 patients.

Top Stories

Fauci says White House remdesivir reveal preempted potential leaks: Reuters

The first look at a much-anticipated study of Gilead’s remdesivir came not in a news release or a scientific journal, but in a White House briefing. The unorthodox data reveal was an effort to get ahead of leaks of fragmented information that could cause confusion, Anthony Fauci, M.D., director of the NIH body that sponsored the study, told Reuters.

GSK sees 'modest' impact on trials, getting head down for 'busy few months' on COVID-19 work

GlaxoSmithKline is following suit with fellow British Big Pharma AstraZeneca in downplaying the overall risk to its trials during the pandemic.

[Sponsored] Connecting biotech, pharma and life sciences ecosystem to ramp up COVID-19 capabilities

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.

Adicet inks resTORbio reverse merger, plots financing to fuel CAR-T pipeline

Adicet Bio has struck a deal to merge with resTORbio, bagging itself a Nasdaq listing to support its pipeline of allogeneic gamma delta CAR-T cell therapies. The combined company will take Adicet’s name and focus on its pipeline but will be led by resTORbio CEO Chen Schor.

Targovax nabs Roche veteran as CSO

European cancer vaccine biotech Targovax has hired a former Roche and Molecular Partners exec as its new chief scientific officer.

Mojo Vision sees $51M round for its smart, vision-improving contact lens

Mojo Vision has raised an additional $51 million for its smart contact lens project—including the development of a tiny augmented reality display that would sit just above the pupil which could help people with impaired vision better navigate their surroundings.

Harvard-designed 'backpacks' turn immune cells into better cancer killers

Harvard scientists packed interferon gamma into little "backpacks" that can latch onto immune cells called macrophages and coax them into an anti-tumor state.

'Operation Warp Speed' aims to deliver a COVID-19 vaccine by year-end: Bloomberg

Biopharma players worldwide have committed big money and talent to the hunt for a COVID-19 vaccine, and experts predict a shot might be available in 12 to 18 months. Behind the scenes, the Trump administration is working up a Manhattan Project-type initiative to further accelerate the work, Bloomberg reports.  

Resources

[Whitepaper] New Lonza Whitepaper on Modulating lgG Effector Function

This whitepaper summarises approaches for modulating antibody effector functions and pharmacokinetics, and provides examples of antibodies in clinical studies.

[Magazine] Perspective: the patient edition

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.

[GUIDE] Managing Clinical Trial Patient & Site Engagement During COVID-19

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.

[Whitepaper] Navigating the Changing Clinical Trial Landscape

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.

[Whitepaper] Successful BYOD in Any Phase

This white paper includes a Phase III case study and discusses BYOD advantages and misconceptions, regulatory, copyright, and equivalency considerations.

[Whitepaper] A Fast Way to Curb Your R&D Spend: Make Failure a Strategy

Turn your drug failures into competitive advantage.

[Whitepaper] Payers’ Perspectives on Digital Therapeutics In-Depth Interviews Reveal What Manufacturers Can Expect

How will US payers evaluate and manage digital therapeutics? Get insights and recommendations on successful market access considerations.

[Whitepaper] Data Integration and the R&D Organization

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?

[Webinar] Model-Based Approach to Design Bispecific Modalities in Early Discovery

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

[Whitepaper] Digital Twins: Creating Digital Operations Today to Deliver Business Value Tomorrow

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.

[Guide] Pandemic Survival Guide --- IT Solutions for Business Continuity

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.

[Whitepaper] Ensuring the Greatest Return From Your Poorly Soluble Molecule

Poorly soluble molecules hindering your workflow?

[On Demand] Tufts-eClinical Solutions Data & Analytics Survey Results

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.

[eBook] Expecting the Unexpected: Strategies for Efficient Clinical Supply Management and Forecasting

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.

[Fact Sheet] Forecasting to Optimize Clinical Trial Supply Management

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.

[Case Study] Establishing Parameters for Success

Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study.

[Executive Summary] Strategies for Flexible Manufacturing

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.

[Presentation] Flexible Manufacturing Strategies

Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible.

[Executive Summary] Overcoming Manufacturing Challenges for Accelerated Drug Development

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.

[Case Study] Precision Analytics for Product Launch and Growth

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. 

Events