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Posts from the ‘Pharma’ Category

10 Disruptive Technologies That Will Transform Pharma

My article about those 10 trends that I think can disrupt the whole pharmaceutical industry was just published on Pharmaphorum.com. An excerpt of the article:

When I speak to pharma companies I tell them they need to act now or they will lose business, or even be left with no business at all. I try to underscore this radical statement by highlighting the following trends and examples:

To give you an idea, here is my list:

  1. Empowered patients
  2. Health gamification
  3. Augmented reality and virtual reality
  4. Genomics and truly personalized medicine
  5. Body sensors
  6. ‘Do it yourself’ biotechnology
  7. The 3D printing revolution
  8. The end of human experimentation
  9. Medical decision making with artificial intelligence
  10. Nanorobots
  11. Here is a recent video I recorded about the technologies I’m the most excited about.

The Future of Clinical Trials: Video

An excerpt from The Guide to the Future of Medicine:

Today, new pharmaceuticals are approved by a process that culminates in human clinical trials. The clinical trial is a rigorous process from development of the active molecule to animal trials before the human ones, costing billions of dollars and requiring many years. Patients participating in the trial are exposed to side effects, not all of which will have been predicted by animal testing. If the drug is successful in trial, it may receive approval, but the time and expense are present regardless of the trial outcome.

But what if there were another, safer, faster, and less expensive route to approval? Instead of requiring years of “ex vivo” and animal studies before human testing, what if it were possible to test thousands of new molecules on billions of virtual patients in just a few minutes? What would be required to demonstrate such a capability? At the very least, the virtual patients must mimic the physiology of the target patients, with all of the variation that actual patients show. The model should encompass circulatory, neural, endocrine, and metabolic systems, and each of these must demonstrate valid mechanism–based responses to physiological and pharmacological stimuli. The model must also be cost efficient, simulating weeks in a span of seconds.

Such simulations are called computational cognitive architectures, although the current ones actually lack a comprehensive representation of human physiology. A truly comprehensive system would make it possible to model conditions, symptoms, and even drug effects. To order reach this brave goal, every tiny detail of the human body needs to be included in the simulation from the way our body reacts to temperature changes to the circadian rhythms of hormone action.

HumMod is a simulation system that provides a top–down model of human physiology from organs to hormones. It now contains over 1,500 linear and non–linear equations and over 6,500 state variables such as body fluids, circulation, electrolytes, hormones, metabolism, and skin temperature. HumMod was based on original work by Drs. Arthur Guyton and Thomas Coleman in the early 1970’s.

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HumMod is not the only effort in this area. The Avicenna project, partially funded by the European Commission, aims to construct a roadmap for future “in silico” clinical trials, which would make it possible to conduct them without actually experimenting on people. Other projects use real models instead of computational ones. A liver human organ construct, a physical object that responds to toxic chemical exposure the way a real liver does, was designed at the Gordon A. Cain University. The goal of the five–year, $19 million multi­institutional project is to develop interconnected human organ constructs that are based on a miniaturized platform nicknamed ATHENA (Advanced Tissue–engineered Human Ectypal Network Analyzer) that looks like a CPR mannequin.

It would then be possible to test molecules without risking the toxic effects on humans, and to monitor fluctuations in the thousands of different molecules that living cells produce and consume. The beauty of this project is its plan to connect their working liver device to a heart device developed by Harvard University. If successful, they hope to add a lung construct in 2015 that is being developed at Los Alamos, and a kidney designed by the UCSF/Vanderbilt collaboration by 2016, thus building the first physiological model of a human being piece by piece.

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Iodine: Better information about medications

I met Thomas Goetz at Google years ago and he provided me with excellent advice about my future. Then I read his book, followed his path and was glad to see him as entrepreneur-in-residence at the Robert Wood Johnson Foundation. Now he came up with Iodine, a site with huge potentials. A few things they offer:

  • Drug reviews
  • Side effect database
  • What to expect from a specific drug
  • Compare drugs to each other
  • Popular medications
  • Medical Translator extension for Chrome
  • How people feel about certain medications

Check it out!

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How Pharma Tries to Engage With Customers Through Social Media: Nature News Report

I’ve been working with major pharmaceutical companies for years creating digital strategies for them as well as designing ways to let them engage with their customers through social media. For long, it was a struggle as there was no clear guidance from FDA so we crowdsourced one.

Now Virginia Hughes asked my views on this for her Nature News report. Don’t miss this amazing summary of the whole social media and pharma story.

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Open Access Social Media Guide for Pharma: Let’s Crowdsource the New Version!

In 2011, we published a crowdsourced open access guide for pharmaceutical companies containing practical pieces of advice about how to use and how not to use social media. As there was no guide from the FDA that time, we thought we would assist the FDA and the EMA in creating one that would make it simpler for companies to interact with patients and physicians online. Later, the FDA issued its own guidance but the EMA confirmed to me they did not plan to.

We still think that a less legally complicated, but more practical short guide is still needed therefore Paul Lane, the Director of Social Media and Web-based Information at the Envision Pharma Group (Medical Communications Agency) and I decided to release an updated version for which we are looking for contributors. Last time, over 50 people worked on the document.

Please let us know here if you are interested in participating!

Until then, here is the latest version:

Talking Drug Box Against Accidental Prescription Overdose

Last year, the healthcare innovation world cup was won by AdhereTech that developed a drug box that changes its color when the next medication should be taken. Now here is Kaleo’s talking drug box that can provide spoken instructions to patients about how to administer an injection.

According to the Center for Disease Control and Prevention, more people die each year from drug overdoses than car accidents — and 70 percent of those deaths are caused by legally prescribed medication. Kaleo, a pharmaceutical firm, hopes it can change that. It’s creating a device called Evzio, a small, easy to use drug delivery system that can safely administer a life-saving dose of naloxone.

Many patients are afraid of needles, and the process of properly filling and using a syringe isn’t exactly user friendly. That’s why Kaleo equipped its device with not only clearly written instructions, but a voice: Evzio verbally tells users how to use it properly.

The company’s study concluded that 90% of patients could perform the task even though they have never done it before.

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Social Media Guidelines Proposed by the FDA: Finally!

After years, finally the United States Food & Drug Administration came up with a proposal in the form of a guide about how pharma companies should deal with social media.

One of the so-called draft guidances offers instructions on how companies should attempt to correct product information on websites that are run by others, such as chat rooms. The other addresses how products – including risk and benefit information – can be discussed in venues such as Twitter, as well as paid search links on Google and Yahoo, all of which have limited space. This will involve using links to product web sites, for instances, that can be clicked.

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