Newsletter | February 14, 2019

02.14.19 -- Biosimilar Sustainability Requires A Step-Wise Approach

Featured Editorial
2019 CBI Biosimilars Summit: Sustainability Requires A Step-Wise Approach
By Anna Rose Welch, editor, Biosimilar Development

Just as the FDA emphasized that companies should take a “step-wise” approach to biosimilar development, I’d argue this same approach needs to be embraced in our commercialization and education efforts moving forward.

How Healthy Is The Biopharma Pipeline Heading Into 2019?
By Eduardo Schur and Rares Barbu, Navigant

This article analyzes key indicators of pipeline strength over the past three years, including R&D spend, new chemical entity approvals, and Phase 2 and Phase 3 development. 

Industry Insights
How Can Your Biomanufacturing Facility Benefit From Process Automation?
Article | By Pete Genest, GE Healthcare Life Sciences

With today’s complex manufacturing systems and processes, can a manufacturer afford to not have a centralized automation platform?

How Droplet Digital PCR Has Revolutionized Noninvasive Plasma-Based Detection Of Mutations
Application Note | Bio-Rad Laboratories, Inc.

There is an unmet need for assays that monitor and detect the emergence of resistance mutations to targeted therapies, especially for advanced solid tumors where tissue availability is limiting. MolecularMD was interested in developing a plasma-based assay to detect EGFR T790M mutation in circulating tumor DNA as a method for monitoring the emergence of resistance to first-generation EGFR tyrosine kinase inhibitors.

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