COVID-19 Clinical Development: What's in the Pipeline to Address the SARS-CoV-2 Pandemic?

Posted by Kristyn Feldman on Tue, Mar 24, 2020

Parul Rewari, Cody Powers and Judith Kulich co-wrote this blog post with Kristyn Feldman.

As nations around the globe are hit hard by the novel coronavirus pandemic, many are asking the same question: What treatments or preventions are in the pipeline that may address COVID-19? Researchers the world over have launched numerous research, preclinical and clinical-stage programs in an effort to identify vaccines and treatments that can tackle the virus or to find treatments that mediate the downstream effects of the virus.


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Clinical Development Risks and Issues in a COVID-19 World

Posted by Jonathan Rowe on Fri, Mar 20, 2020

Global clinical guidelines have shifted the industry toward risk-based approaches for the planning and execution of clinical trials. The ICH’s guidelines for Good Clinical Practice state that sponsors should evaluate identified risks against existing risk controls by considering “the likelihood of errors occurring, the extent to which such errors would be detectable, and the impact of such errors on human subject protection and reliability of trial results” (ICH E6 R2).


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What Pharma Companies Are Getting Wrong About Executing Brand Strategy

Posted by Dan Ogletree on Tue, Aug 06, 2019

Oftentimes in pharma, developing and then executing on a strategic brand goal is like playing a game of telephone: The message gets interpreted—or misinterpreted—by several different teams or vendors all acting independently of each other. The result? An effort that’s disjointed and inefficient, and oftentimes misaligned with the initial strategic objective—in effect, a botched message.


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The Evolving Data Landscape Will Transform Healthcare. Here Are Four Trends to Watch.

Posted by Paul Darling on Fri, Jun 28, 2019

Oladele Ojo co-wrote this blog post with Paul Darling. 

The healthcare system generates approximately a zettabyte (a trillion gigabytes) of data each year, which includes both classic data from sources such as EHRs, diagnostics and genetics, as well as newer data sources such as gut biome sensors, wearable devices and environmental monitors, and social media. Consequently, it’s now possible to quantify a person across three dimensions of human existence: biological, environmental and digital/social.


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Biosimilar Interchangeability: Clarity and Ambiguity in the FDA's Final Guidance

Posted by Scott Kniaz on Wed, Jun 19, 2019

Christina Corridon co-wrote this blog post with Scott Kniaz.

Back in April, we wrote a blog post covering almost everything you needed to know about the hot topic of biosimilar interchangeabilitya special designation that allows pharmacies to substitute a biosimilar for a novel biologic product without the input of the prescribing provider. We also told you why it would continue to be in the news for the remainder of 2019—one reason being because the FDA promised to issue finalized guidance on interchangeability by the end of May. Well, that day has come. After releasing its draft guidance more than two years ago, and following a lengthy comment period, the FDA issued the long-awaited document on May 10th. We’ve had a chance to read it and wanted to save you some time by highlighting the most salient issues.


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