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January 21, 2020___

Today's Rundown

Featured Story

GSK nabs speedy review for one of its top prospects

With a new research team, outlook and more than a little help from the tech world, GSK has been quietly going about shoring up its pipeline.

Thank you to Rho for sponsoring this year's JPM 2020 coverage.

Top Stories

Revolution files for $100M IPO to advance KRAS candidates

Revolution Medicines has filed to raise $100 million in an IPO. The anticipated fundraising haul will bankroll development of a pipeline of RAS programs up to the completion of IND-enabling studies.

Chi-Med stops pivotal pancreatic cancer trial upon early success

Hutchison China MediTech has stopped a phase 3 trial of surufatinib in pancreatic neuroendocrine tumors early for positive efficacy. An independent data monitoring committee found the trial had hit its primary endpoint by the time of an interim analysis, enabling Chi-Med to stop the study and start work on a filing for approval.

WHO berates 'lack of innovation' when it comes to antibiotic pipeline

The World Health Organization has called out Big Pharma for its dearth of antibiotic innovation amid a growing threat of antimicrobial resistance.

GSK bets on tech to help boost lagging R&D as it looks to start 23andMe trial

As the dust settles on another busy and ruinously expensive four days at the J.P. Morgan Healthcare Conference in San Francisco, GlaxoSmithKline’s CEO Emma Walmsley took some time out on the sidelines to talk R&D.

LabCorp's CRO unit Covance doubles down on cell, gene therapy offerings

LabCorp has unveiled a new suite of cell and gene therapy development offerings from Covance as it looks to get in on this burgeoning new trend.

Cyclerion drug's 4-pronged cracking of neurodegenerative diseases passes early test

Scientists have been testing various ways to tackle neurodegenerative diseases. Now, Ironwood Pharma spinout Cyclerion Therapeutics says its drug candidate, an sGC stimulator, has the potential to address four important hallmarks of neurodegenerative diseases, and it showed early promise in a phase 1 trial.

Fitbit for the flu: Researchers show the fitness wearables can help track outbreaks

A new study showed that by employing secondary signals from heart rates, physical activity and sleep quality, common Fitbit trackers may be able to predict the spread of the flu in real time and better than current infectious disease surveillance methods.

How the 8 biggest U.S. pharmas enriched their shareholders in 2019

With tens of billions of dollars in revenue each year, the largest publicly traded U.S. pharmaceutical companies answer drug-pricing critics by pointing to their hefty investments in research and development. But they answer to some of the most powerful institutional investors, too—and those shareholders reaped rich rewards in 2019.

Enrollment Showcase

Online Graduate Programs Designed for Your Career

Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career.  Learn more.

Resources

[Whitepaper] Assessing the Financial Impact of Translational Pharmaceutics®

Tufts Center for the Study of Drug Development (CSDD) white paper sharing study results that indicate Quotient Sciences’ Translational Pharmaceutics® platform reduces development times by more than 12 months and lowers R&D costs by more than $100 million per approved new drug, compared to traditional multi-vendor development paradigms.

[Whitepaper] Simplify 21 CFR Compliance Documentation

A digital transformation is taking place in the life sciences industry, from research laboratories to manufacturing facilities. But there has always been a gap in these technologies. Download the whitepaper to learn how this challenge was addressed.

[Whitepaper] Consent and the GDPR: An Essential Guide

This paper discusses some of the challenges that the GDPR will introduce, with a particular focus on its requirements for obtaining verifiable, unambiguous consent.

[Whitepaper] Solutions Overview: 10 Digital Prescriptions for Life Sciences

Download this paper to learn how you can fully digitize all paper processes. By doing so, you will see shorter cycle times, reduced development costs, and greater customer satisfaction.

[Whitepaper] What to Look for in an Informatics Platform for Large Molecule R&D

As emerging modalities transform the needs of life science R&D, how can biotech and pharma companies use modern software approaches to increase productivity and reach breakthroughs faster?

[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 Disruption in Biopharma: How Digital Transformation can reverse declining ROI on R&D

The beginning of this digital transformation is well underway and is likely to accelerate. Read our white paper, “Digital Disruption in Biopharma: How Digital Transformation can reverse declining ROI on R&D,” to learn more.

[Whitepaper] Telemedicine: Facilitating Clinical Trial Participation

Download this white paper and read the expert feedback that snapIoT has gathered from industry thought leaders on the evolution, evaluation, and use of telemedicine solutions in clinical trials.

[Whitepaper] Are We Transforming in the Right Way? Why Launches Can’t Be Distracted By Empty Promises.

How are your launch strategies can convert “innovation” into value for patients?

[Whitepaper] Modernizing clinical trials with Amazon Web Services (AWS)

From IoT to data management to high-performance computing and machine learning, leading life sciences organizations are using Amazon Web Services (AWS) to develop scalable, global, predictable, and secure solutions to modernize clinical trials while mitigating risks

[Whitepaper] Why Partner with CSP’s to Validate Mission Critical Apps in the Cloud?

Why companies leverage the expertize of industry focused cloud service providers to design and build quality systems and facilitate the FDA Validation of Mission Critical Apps in the Cloud.

[Whitepaper] How to Protect your Supply Chain from Security and Compliance Threats Utilizing On-Dose Authentication Technologies

Learn more: Best practices for defending supply chain security and compliance by efficiently managing product authentication.

[Whitepaper] The Unexpected Key to Building Value in Drug Discovery and Development

Small or emerging pharmaceutical and biotech companies pursuing novel molecules and targets have two important goals: achieve clinical success and attract new rounds of funding. While there’s never a guarantee of either, certain actions can influence the outcome in your favor.

[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