Why You Need to Start Thinking About Meaningful Differentiation Much Earlier

Posted by Emily Mandell on Mon, Jul 01, 2019

Josh Hattem co-wrote this blog post with Emily Mandell.

“That's the problem with the American dream: It makes everyone concerned for the day they're gonna be rich.”

–President Bartlett, The West Wing

Pharma companies may have a winning asset, a winning development plan and an important disease target with unmet needs, but only one product can be first to market, only one can be the most efficacious and only one will become the standard of care. If your asset is entering a disease area with similar efficacy to an established standard of care, or if your asset is one of multiple products in a class entering within one to two years of one another, it’s critical to have a clear understanding of what it will take to meaningfully differentiate, and to do this early enough—in phase I or II—so there's enough time to correct the development plan.


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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 After releasing its draft guidance more than two years ago, and following a lengthy comment period, the FDA issued the long-awaited document on May 10th.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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Want Reliable Advice? Consider Machines

Posted by Arun Shastri on Mon, Jun 17, 2019

An old story about Jeff Bezos that I read years ago resurfaced in my memory when I learned that Amazon just abruptly changed course and decided to shutter its restaurant delivery business. According to the teller of this tale, Bezos once visited Basecamp to give a talk and take questions from employees there. At one point, Bezos described the kind of people who are “right a lot.” The smartest people, he said, are always revising their thinking. They might think one thing today that they’ll readily contradict tomorrow because they have new data to support a new opinion.

Other luminaries have shared this opinion. Science fiction author Vernor Vinge, in his book Fire Upon the Deep, wrote “Intelligence is the handmaiden of flexibility and change.” Salesforce CEO Marc Benioff was quoted as saying, “You must always be able to predict what's next and then have the flexibility to evolve.”

I wholeheartedly agree with this line of reasoning, and I see direct connections to machine learning.


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Now I Know What It Means to Be a Rock Star

Posted by Michael Thomas on Wed, Jun 12, 2019

The lights go down. The crowd erupts in anticipation. An iconic rock band is about to step on stage, and you are about to take part in an immersive, overwhelming experience for the next three hours. I love this moment, and I’ve always wondered what it must be like on that stage, knowing that people are so inspired by what I do. 


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