Newsletter | June 27, 2022

06.27.22 -- Why Karen Correa Built Takeda's Study Optimization Team

New Podcast Episode
Featured Articles
Takeda’s Mission To Improve Communication With Patients, Sites, And CROs

Being a better partner for your patients, sites, and CROs begins with effective communication. When Karen Correa joined Takeda as VP, head of global clinical operations, she made improved communications her top priority.

Diversity In Clinical Research Execution And Participation

In this article we compare the 2020 and 2021 result of the WCG Avoca Industry Survey, which explores industry respondents’ views on patient diversity in clinical research participation.

CRO Leadership Award Winners

See the winners of this year's CRO Leadership Awards.

Web-Exclusive Content
ARW’s C&G (+RNA!) Manufacturing Must-Reads (Dracula Edition!)

Day-in and day-out, I write, read, listen to, and watch as much content as I can about C&G therapy manufacturing, in particular, and/or other C&G industry-related topics that you should at least be aware of in the manufacturing facility. Every two weeks, I compile the articles and industry updates I think are most worthy of your time into an unconventional newsletter format (below) and send them out via email. But inboxes can be shifty places. (Cue George Carlin on “Losing Things.”)

Industry Insights
Balancing Cost Efficiencies In The Drug Development Process

Cost efficiencies and expertise again go hand in hand, with companies often outsourcing or partnering primarily to gain access to manufacturing know-how.

Parenteral Packaging And Delivery Systems: Container Closure Integrity

This article discusses the chapters in USP <1207> Package Integrity Evaluation – Sterile Products, which covers CCI and different methods of selection and validation.

The Raw Material Hurdle: Plasmids For Viral Vector-Based Gene Therapies

The success of using viral vectors to deliver a molecular payload into a cell or replace defective genes with functional ones is an inflection point in the future of modern medicine.

Build Vs. Buy: When To Outsource Protein Biologics Development And Manufacturing

Learn the elements and market factors impacting the make/build vs. buy decision, considerations to examine when evaluating options, and best practices for navigating this decision.

Avoiding 20% In Investment Waste During Launch

It’s a long-standing perception that pharma overspends during launch, but we can now understand and validate this notion with data. Reasons and cost types were two major sets of drivers for why overspending consistently happened.

Digital Edition
June 2022 Digital Edition

Inside you will find more on:

  • Arcellx's Big Plans
  • Industry Research
  • Leadership Lessons
  • Supply Chain

View the digital edition.

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