Newsletter | October 24, 2019

10.24.19 -- Inside The Great Canadian Biosimilar Transition

Featured Editorial
Canadian Patients Speak Out In Favor Of British Columbia Biosimilar Transition
By Anna Rose Welch, editor, Biosimilar Development

I reached out to learn the inflammatory arthritis patient community’s thoughts on British Columbia’s (BC's) large-scale transition to biosimilars. I also wanted to know which best practices the government employed behind the scenes to ensure the policy would be a success.

Pharma 4.0: Building Quality Into Pharma Manufacturing
By Bikash Chatterjee, Pharmatech Associates

A race is being run to create the pharmaceutical manufacturing of the future, and with Pharma 4.0, powerful market trends are shaping the running field. While the focus of Pharma 4.0 is the manufacturing supply chain, the principles are being applied in a much broader fashion across the entire drug development life cycle.

New Bill Aims To Drive Insulin Price Reductions
By James Shehan, Lowenstein Sandler

The Insulin Price Reduction Act (IPRA) proposes to drive price reductions by providing drug companies with incentives to roll back the list price of insulin products to 2006 levels. Specifically, IPRA would make it illegal for pharmacy benefit managers (PBMs) and insurers to recover rebates from manufacturers that reduce the prices they charge wholesalers for insulin to those 2006 levels.

An Intro To Prefilled Syringe Selection: Needle-Free And Dual-Chamber Devices
By Michael Song, Ph.D., AstraZeneca

This two-part article will provide an introduction to the three general prefilled syringe (PFS) types and will share important factors to take into consideration for your drug product. In this first part we will discuss the needle-free PFS and the dual-chamber system.

Industry Insights
Converting From ELISA To Biacore SPR Assays
Application Note | GE Healthcare Life Sciences

Biacore SPR assays provide an automated and reproducible real-time determination of active concentrations that can be considered an alternative to traditional ELISA approach. This article provides general guidance on how to convert an existing ELISA assay to a Biacore SPR-assay, and by doing so, shows how you can get results in less than half the time compared with ELISA.

Don’t Let Insufficient Data Undermine Your CMO And CRO Selection Processes
Article | By Kevin Olson, ISR Reports

Selecting a partner is challenging, but with the right information you can simplify your efforts and increase your likelihood of making the best decision. 

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