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March 27, 2020___

Today's Rundown

Featured Story

Vertex guns for virtual trials but hits pause, sees delays for 'some new study starts'

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.

Top Stories

FDA moots virtual AdComms but delays GSK, Intercept meetings

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. 

U.K. government-backed medical research shut down amid COVID-19

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.

Sanofi, Translate Bio jump on mRNA bandwagon to fight COVID-19

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.

Big Pharma companies join forces for fightback against COVID-19

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.

In conversation with: Science 37 and the response to COVID-19

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.

Pear Therapeutics nets digital pre-cert clearance for its insomnia-treating app

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.

Safely overcoming resistance to checkpoint inhibition in cancer by blocking a growth factor

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.

EuroBiotech Report—COVID-19 vaccine, Ipsen cans trial, AstraZeneca, Boehringer and Roche

In this week's EuroBiotech Report, U.K. government backs COVID-19 vaccine trial, Ipsen scraps pivotal trial and AstraZeneca inks siRNA deal.

FiercePharmaAsia—Chloroquine COVID-19 trial, import leniency, export ban; BeiGene’s Abraxane woe

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.

Chutes & Ladders—Urovant brings on Astellas alum Robinson as CEO

Urovant snags Astellas exec Robinson as CEO; Viracta poaches Nordic Nanovector CMO Rojkjaer; Epizyme brings on Kutok as CSO.

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] Why BioPharma Co’s Leverage the Cloud to Gain Competitive Advantage

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. 

[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.

Events