Newsletter | July 3, 2019

07.03.19 -- How Amgen Is Taking An Adaptive Approach To Clinical Trials

Featured Editorial
How Amgen Is Taking An Adaptive Approach To Clinical Trials
By Elliott Levy, SVP, global development, Amgen

Clinical research is sometimes viewed as a box-checking exercise, where we run fairly cut-and-dried, randomized, placebo-controlled studies based on long-established protocols. But things are actually changing very rapidly in the world of clinical development, which is by far the largest part of pharma R&D spending. We are on the threshold of a transformation that will allow us to dramatically accelerate the acquisition of useful knowledge, get new medicines to patients sooner, and expand their usage to new indications more quickly.

Is RBM Right For You?

In March 2019 I had the opportunity to interview Jennifer Newman, global project leader, regulatory affairs/clinical operations, for Celldex Therapeutics. Newman was once part of the largest implementation of risk-based monitoring (RBM) and was able to share insights from her experience. Specifically, she was able to discuss the benefits and challenges of RBM and what companies should be prepared for when adopting the technology. In this video, Newman discusses whether or not RBM might be a fit for your company and dispels some of the myths about RBM.

Industry Insights
Innovation, Quality, And Expertise: Keys To The Post-Brexit Clinical Landscape
Article | By Tom Harris and Kate Godwin-Smith, Cenduit LLC

Many sponsors might have teams dedicated to a post-Brexit clinical landscape — and might have already formulated a plan — but much is still unknown as we enter into new, unchartered territory. For many sponsors, this scenario will be especially relevant for inventory registered within an interactive response technology (IRT) system manufactured and packaged outside the U.K., with the need to be imported in-country. Let’s look at one of most vitals area of concern: drug depots.

How To Reduce Clinical Supply Expense Using An IRT System
Article | By Korinne D’Orsi, YPrime

Mismanaging clinical supplies can threaten study outcomes, bring studies to a halt, and even jeopardize a clinical research program. This article outlines a solid clinical supply management program, defines interactive response technology (IRT) and its role in clinical supply management, and explains how implementing it can reduce risks and costs.

Regulatory Requirements For Medical Devices In China
White Paper | Syneos Health

Successful regulatory approval requires a deep understanding of the regulations, processes and technical standards, as well as an appropriate regulatory strategy.

Q&A With Nash Imaging Expert, Dr. Mustafa Bashir
Q&A | Medpace

Dr. Mustafa Bashir, associate professor of radiology and medicine in the gastroenterology division at Duke University School of Medicine, discusses his experience with imaging biomarkers for use in clinical trials for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH).

Small Size, Big Plans: Drug And Biologic Development Advice For Small Companies
Webinar | Rho

This webinar will provide advice on how to set your small company up for long-term success through the use of strategic development plans, purposeful outsourcing, patent protection, partnership strategies, and will also provide specific examples of success stories and lessons learned.

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