Newsletter | October 10, 2019

10.10.19 -- FDA's Woodcock: Biosimilar Development Promotes Better Biologics

Featured Editorial
FDA’s Woodcock: Biosimilar Development Promotes Future Of Better Biologics
By Anna Rose Welch, editor, Biosimilar Development

While some regulators may express skepticism that we’ll see major changes to the clinical component of the biosimilar development pathway, Woodcock’s DIA keynote exemplified what I found to be a strikingly different attitude about the future possibilities for biosimilar development.

What Celgene Corp. v. Peter Means For Biosimilar Developers
By Jonathan Bachand and William O. Adams, Knobbe Martens

A recent decision by the U.S. Court of Appeals for the Federal Circuit has indicated that pharmaceutical makers with patent protection are unlikely to receive any compensation from the government for the loss of their patents during inter partes review (IPR) decisions by the Patent Trial and Appeal Board (PTAB).

FDA’s Top 5 Drug GMP Inspection Citations In FY2018: With FDA Analysis
By Jerry Chapman

In Part 1 of this two-part article, three quality experts presented #10 through #6 of the top drug GMP inspection citations for FY2018 and provided insight into the observations. This part counts down citations #5 through #1.

Industry Insights
Multidimensional Scale-Up Of The mAb Capture Step Contributes To Shortened Time-To-Market
Application Note | GE Healthcare Life Sciences

This application note demonstrates a multidimensional scale-up (change of both column diameter and bed height) of the mAb capture step, using the ÄKTA pilot 600 chromatography system.

Services Marketing: You Can’t Build A Strong Marketing Strategy On A Weak Foundation
Article | By Kevin Olson, Industry Standard Research

Too often, marketers lack vital information to create an effective marketing strategy and your organization and department suffer due to constant disruption of marketing plans. 


C5 presents its Global Legal and Regulatory Summit on Biosimilars where the latest legal and regulatory ramifications for biosimilar stakeholders will be tracked. Be part of interactive discussions that will enable you to develop a holistic strategy for maximizing commercial results for your biosimilar products. Gain insights from key global industry stakeholders including Amgen, Formycon AG, and Glenmark Pharmaceuticals. 10% Off with Code: D10-510-510BX01

NGC Chromatography Systems For Protein Purification
Bio-Rad Laboratories, Inc.
A Networking Event For Small Biotechs: Cambridge ConneXtions

October 22, 2019 | 4:30 pm to 7:30 pm | Cambridge, MA

A unique networking event for biopharma professionals in the heart of Kendall Square. Are you looking to make strategic connections that can help accelerate your company or your bioprocess? Learn from our panelists who will share their stories of success, hardships, and lessons learned along the way. Register here.

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