Newsletter | October 3, 2018

10.03.18 -- CMC Hiring And Practice: 6 Lessons For Outsourcing


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From The Editor
CMC Hiring And Practice: 6 Lessons For Outsourcing
By Louis Garguilo, Chief Editor, Outsourced Pharma

Things have progressed nicely for Ruby Casareno, Vice President, Chemistry, Manufacturing and Controls (CMC), Allakos Inc. For executives wishing the same for your CMC leadership and organization, there are lessons on why that’s the case. Those lessons also recall for Casareno an earlier experience where progression traversed a rockier road. It all adds up to 6 best practices particular to outsourcing drug development and manufacturing.

Featured Editorial
5 Questions To Ask Your CDMO: #2 — Can You Tell Me About A Project Where Things Went Wrong?
By Bernhard J. Paul, Ph.D., principal consultant, Carinth Consulting LLC

Virtually every biotech or pharmaceutical company relies on CDMOs for R&D and manufacturing services or to access specialized technology to bring their drug candidates to the market. Identifying and selecting CDMOs is a lengthy and difficult process, and it is critically important to select the right partner. This is the second article in a five-part series exploring questions that will help you during the selection process and enable you to choose the right partner for your project.

What Is The Link Between Quality Metrics, Data Integrity, And Quality Culture?
By Sue Schniepp, Regulatory Compliance Associates Inc.

Quality metrics, quality culture, and data integrity are among the current and emerging topics of interest to the pharmaceutical industry of particular concern to both the industry and regulatory authorities. To understand how these three topics relate to each other it is important to understand some of the history that led up to today’s environment, where quality metrics, quality culture, and data integrity come together to establish current global regulatory expectations.

Industry Insights
Collaborating To Get Biopharma In The Fast Lane
Q&A | By Stephanie Sutton, GE Healthcare Life Sciences

Scaling up a bioprocess doesn’t need to be a headache — especially when there are firms out there that can lend a helping hand.

Quality By Design (QbD) In Pharmaceutical Development
Article | Piramal Pharma Solutions

The emphasis on quality by design (QbD) began with the recognition that increased testing does not essentially improve product quality; however, quality must be built into the product.

Capitalize On Merger/Acquisition: 4 Tips To Consolidate Your CMO Network
Article | Pfizer CentreOne Contract Manufacturing

Complex CMO networks are expensive and require many resources to manage. Plus, they prevent purchasing and operating at scale. Yet, the process of consolidating CMOs is daunting.

Cost Savings And Speed: The Untapped Value Of A Single-Source Solution
Article | Patheon

Small and emerging companies face significant challenges in today’s market. This calls for an alternative solution to help them achieve success.

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