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March 30, 2020___

Today's Rundown

Featured Story

J&J, BARDA commit $1B to COVID-19 vaccine R&D

Johnson & Johnson has joined with a U.S. government agency to commit $1 billion to development of a COVID-19 vaccine. J&J plans to have a vaccine in the clinic by September, win emergency use authorization early next year and add capacity to make more than 1 billion doses. 

Top Stories

COVID-19 causes Moderna to pause a clutch of clinical trials

Moderna has become the latest company to hit pause on clinical trials in response to the COVID-19 pandemic. The biotech, which is leading efforts to develop a COVID-19 vaccine, is pausing enrollment in some infectious and rare disease trials while continuing to try to add patients to its cancer studies.

Abbott to ship portable, 5-minute coronavirus tests nationwide

Abbott is launching a rapid coronavirus test able to deliver positive results in as little as five minutes from a tabletop box the size of a small toaster oven.

GigaGen jumps into COVID-19 arena with polyclonal antibodies

Mining the blood of recovered patients for treatments during a pandemic isn’t a new idea. Takeda and Grifols are already doing it, working on antibody-rich drugs made from the plasma of patients who have fought off COVID-19 infection. GigaGen thinks its approach could be even better.

Aveo gives up on ficlatuzumab in acute myeloid leukemia, citing COVID-19

Back in 2012, Aveo announced that its second most advanced asset, ficlatuzumab, had flopped in a midstage cancer test; for years, we heard nothing about this drug.

ACC: MyoKardia's mavacamten reduces heart stress signs in targeted biomarker study

The former Fierce 15 winner delivered new cardiac biomarker data showing its late-phase mavacamten compound can help improve signs of heart stress and injury in hypertrophic cardiomyopathy.

ACC: Bayer and Merck's vericiguat leads off virtual meeting with positive phase 3 heart failure data

After teasing positive top-line results last November, a deeper dive into Merck & Co. and Bayer’s heart failure drug vericiguat helped kick off this year’s scientific meeting of the American College of Cardiology, presented virtually as a late-breaking trial.

ACC: New owner Novartis presents pooled inclisiran data cutting LDL cholesterol by half

A new, late-phase analysis of cholesterol-lowering inclisiran—a PCSK9 drug picked up by Novartis through its $9.7 billion acquisition of The Medicines Company—showed it was able to cut LDL levels by 51% after nearly a year and a half of treatment.

Enrollment Showcase

What's the value of an MBA to healthcare and the life sciences?

Prepare to step up in your career, build the expertise you need to reshape your organization, and explore opportunities worldwide.

Resources

[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.

[Whitepaper] Create A More Compelling Program Development Dossier With Metabolomics

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.

[eBook] 9 Ways to Enhance Healthcare Customer Experiences

Download this e-book to learn 9 ways to enhance the customer experience within healthcare marketing.

[Whitepaper] The ROI of Document Delivery

3 ways you may be overspending on scientific literature access, and how to fix them.

[Whitepaper] Manufacturing Cytotoxic and Non-Cytotoxic

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.

[Whitepaper] Measure the Right Things at the Right Time: Using A Metric Maturity Model to Optimize Performance Measurement

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.

[Whitepaper] Navigating Today’s Healthcare Transformation: The Evolution of Payers

Read about the innovative ways payers are making smart moves in the healthcare game.

[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.

[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.

Events