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March 18, 2020___

Today's Rundown

Featured Story

Swiss bio Addex halts Parkinson's test as trial delays tick up on COVID-19 disruption

Addex Therapeutics has seen its shares down 15% on the news that it has had to delay a registrational study of its Parkinson’s disease candidate.

Top Stories

Iveric bio the latest to be hit by COVID-19 as it delays a key trial

Iveric Bio has been forced to hit the pause button for a pivotal test on its leading drug Zimura as COVID-19 continues to back up clinical trials.

J&J sets sights on November for COVID-19 vaccine trial

Johnson & Johnson expects to land on a COVID-19 vaccine candidate by the end of the month, en route to clinical trials in early November, Paul Stoffels, the company’s chief scientific officer, told CNBC on Tuesday. Along the way, J&J will set up processes for widespread production of the vaccine.

[Sponsored] Biogazelle launches novel high-throughput RNA sequencing and data analysis services

Biogazelle NV, a CRO specializing in genomics and transcriptomics, announced the launch of HTPathwaySeq and HTTargetSeq, two cost-effective high-throughput RNA sequencing and data analysis services.

Ex-Shire cancer leader raises cash for solid tumor research

The former head of oncology research at Shire has raised money to go after a solid tumor target once pursued by his former employer. Randolf Kerschbaumer, CEO of OncoOne, is working with other ex-Shire employees to target oxidized macrophage migration inhibitory factor using several different modalities. 

Sage to run 3 new studies to save once-failed depression drug 

Sage Therapeutics has plotted out how it plans to bounce back from the phase 3 failure of SAGE-217 in major depressive disorder. The strategy centers on three short-term studies Sage thinks may enable it to bring the GABA receptor positive allosteric modulator to market in multiple indications. 

Verily's COVID-19 testing website quickly reaches capacity: NYT

A new pilot project designed to guide people toward local coronavirus testing developed by Google’s health-focused sister company, Verily, hit its capacity for test appointments within a few hours of its unveiling, according to a report from The New York Times.

Fast-moving Regeneron eyes summer clinical trial for COVID-19 antibody cocktail therapy

During the 2018 outbreak of Ebola, Regeneron quickly developed a promising monoclonal antibody triplet therapy that’s now under review by the FDA. Now, amid the ongoing coronavirus pandemic, the biotech is at it again, planning to advance a antibody cocktail into the clinic by early summer.

Get ready to vote: FiercePharma's #FierceMadness drug name tournament is back

College basketball March Madness may be cancelled, but the #FierceMadness drug name tournament is back with lots of borderline absurd, work-from-home distracting fun, now is its 5th year.

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

[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] Strategies for Improving Software Deployments and Business Processes Adoption Rates

Mediocre adoption rates aren’t due to poorly designed software or lazy users. They’re the result of how skills are trained. Achieve high adoption rates by implementing the right methodology with a focus on behavior change.

[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.

[Whitepaper] Achieving Differentiation in the Complex Oncology Market

White paper describing how a biopharma company can successfully differentiate an oncology product when the clinical profile alone is not enough to get the job done.

[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.

[Executive Summary] Clinical Supplies - Made to Order

Learn how recent innovations in demand-led supply and direct-to-patient distribution are converging to create a next-generation clinical supply chain that is flexible, lean and most importantly patient-centric.

[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.

[Q&A] Embarking Upon the Commercial Manufacturing Journey for a Biologic

In this Q&A, four Catalent Biologics experts share how scale-up, regulatory expectations, demand forecasting and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey.

Events