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January 22, 2020___

Today's Rundown

Featured Story

With phase 2 in the bag, Akcea to test triglyceride-buster in FCS

One month after Akcea’s partner Novartis opted out of its triglyceride-targeting program, the treatment beat placebo handily at lowering blood triglyceride levels in patients who have, or are at risk of, heart disease. The phase 2 data tee it up for trials in specific cardiovascular ailments, including familial chylomicronemia syndrome (FCS).

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

Top Stories

‘Does intrinsically good and bad technology exist?’ Bayer CEO says no: Davos 2020

Bayer CEO Werner Baumann highlighted “less and less trust in society for advances in technology” as a hurdle for pharma companies working on gene editing during a panel on genetic modification and engineering that took place at the World Economic Forum meeting in Davos, Switzerland.

Targovax plans checkpoint combo trial after posting early data on oncolytic virus

Targovax has shared data from an early-phase trial that administered ONCOS-102 to mesothelioma patients. The response rate was lower in the ONCOS-102 arm than in the control cohort, but Targovax saw positives elsewhere, leading it to outline plans to pair the drug with a checkpoint inhibitor.

Korean VCs pile into PDC*line to bankroll NSCLC vaccine trial

PDC*line Pharma has turned to Korean investors to help raise a €13.9 million ($15.5 million) series B round. The money will fund a phase 1/2 trial of a therapeutic vaccine in patients with non-small cell lung cancer that got underway last year.

Kintai’s obesity drug that works via the gut microbiome moves closer to the clinic

Microbes that live in the gut are believed to play an important role in human metabolism. Kintai Therapeutics, a Flagship Pioneering portfolio company, says its drug candidate that leverages the microbiome showed sustained weight loss, as well as markers of improved glucose control and liver health in rodents.

Notable Labs launches rolling blood cancer trial to test its AI system

Precision oncology firm Notable Labs is launching its first self-sponsored clinical trial, designed from the ground up to help validate its cancer patient matching platform over the long term.

Moderna, federal researchers kick off vaccine work against deadly new coronavirus

As fears about the spread of a new coronavirus grip communities ranging from Washington State in the U.S. to China and beyond, scientists have already started working on vaccine candidates. And Moderna's mRNA technology is in the mix.

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