Biopharma – especially big pharma – gets all sorts of grief for being large, stodgy, and unable to innovate (or evolve);this Corey Goodman interview represents the perspective well.
Before writing off these companies entirely, however (an ignorant reaction in any case), it’s important to consider how much experience they have in doing two very difficult, very important things: (a) documenting the medical value of their products through a rigorous series of clinical studies conducted in a highly regulated environment; and (b) navigating their way through a complex maze of stakeholders in order to successfully market their products.
Much of the difficulties facing the industry these days stem not from their lack of regulatory experience or marketing skill, but rather from the intrinsic value proposition of the products they offer; simply put, making an impactful new drug is extremely hard and quite expensive, as Matt Herper’s recent piece makes clear.
My sense is that the view from the digital health/start-up side is in many ways the mirror-image of this: the space seems to be brimming with promising nascent ideas; yet, as I’ve discussed before, the measurable health impact of these technologies is usually unclear (at best).
Some emerging digital health companies don’t worry about this – they are deliberately seeking to circumvent the regulatory process by aiming directly at consumers, and avoiding explicit health claims. Others seem to be leaning pretty heavily on the concept of being so disruptive that, in effect, the world will change for them.
I’d suggest that there still is a huge opportunity for digital companies that are keen to robustly demonstrate health benefits, at the high level of rigor that is standard in the medical products industry.Continue reading…
Over four years of Congresses, Sage Bionetworks has drawn together leading thinkers and doers throughout the fields of genetic research and drug development. For two days each year, the conference floor is colonized by clumps of eagerly networking PhDs from academic, pharma, government, non-profits, biotech firms, and patient advocacy groups–people who often glide from one domain to another within this tight-knit cohort.
A cohort, certainly, we can characterize this group of attendees, sharing as they do a mysterious language drawn from years of research most of us will never understand. But is it a community? That will be tested over the following year as Sage Bionetworks lets go of the Congress. Founder Stephen Friend says it is up to others to create the next Congress, and its success or failure will be a measurement of the sweat and passion that Friend and Sage have put into attempts to build a community.
Why should a reader look further at this struggle among a tiny elite, rather than clicking on the next article? Well, first, if you’re one of the 48% of Americans who took a prescription drug this month, you should be concerned about where new breakthrough drugs will emerge. If you visit this web site because you want a more responsive health care system that can match patients to treatments more quickly and cheaply, recognize that new methods are important nowhere as much as at the foundation of the system where new treatments are discovered. And if you are just curious about the potential for global cross-institutional teams and loose networks connecting experts with ordinary members of the public to find creative solutions to old problems, this article will provide insights.
Don’t get too close, you don’t know what I have
The premise on which Friend founded Sage is that research and drug development have stagnated and cannot progress without more collaboration and data sharing. Therefore, with all due regard for the presentations at the recent Sage Congress on cancer research projects and other individual experiments, the real theme of the conference is in the keynotes about open source, the use of social media, and crowdsourcing. The challenge of this community–if we find that it has indeed become a community–is to analyze and deal with the particular challenges that genetic research and drug development inject into trends toward open collaboration.
A few months ago, I heard a young design entrepreneur named Aza Raskin talk about his idea for a consumer health company, MassiveHealth, built around the concept of providing rapid feedback. For example, if you had a skin dye that faded a certain amount each time you took a dose of your antibiotic, you would be more likely to complete the full course.
Skip ahead not very far. Recently, MassiveHealth launched its first, free app (dubbed an experiment), called the Eatery. The idea is that you take a picture of your meal and rate its healthiness, which is then shared with other users. You benefit, as I understand it, by thinking more about your food and by getting input on your food from other users. What the company itself gets is not yet clear. They’ve shared some pretty maps of San Francisco and New York City showing where people are eating more vs. less healthy foods, and they’ve drawn some fairly general conclusions about how the supposed healthiness of our food changes during the day (good at breakfast, bad during the day, partial recovery at dinner).
At least as important, I’d imagine, they have an engaged group of users who seem (at least at this early stage) to be interested in interacting with the platform, and thus contributing to the development of the emerging data set; after only a week, more than one million food ratings were reportedly received.
I wrote here the other day about the NIH’s new translational medicine plans. The New York Times article that brought this to wide attention didn’t go over well with director Francis Collins, who ended up trying to disabuse people of the idea that the NIH was going to set up its own drug company.
But there’s been an overwhelming negative response from the academic research community, largely driven (it seems) by worries about funding. Given the state of the budget, flat funding would be seen as a victory by NIH, so this isn’t the best environment to be talking about putting together a great new institute. The money for it will, after all, have to come out of someone else’s pile. Collins spends most of that statement linked above denying this, but it’s hard to see how there won’t be problems.
I think, though, that there’s an even more fundamental problem here. In the latest BioCentury, there’s an interesting sidelight on all this:
In comments submitted to NIH, Joseph Zaia, associate director of the Center for Biomedical Mass Spectrometry at the Boston University School of Medicine, argued against setting timetables for research results. “I do not believe that running medical science on a short sighted business time schedule will produce more cures faster. It will, however, deplete NIH resources very rapidly and possibly tear down an infrastructure of knowledge that took decades to create.” Zaia complained that the NCATS “process seems to be driven by the FasterCures movement sponsored by Michael Milken,” which he said has “been masterful in manipulating the political system for their purposes, and forcing NIH into this reorganization.”
FasterCures’ Margaret Anderson, executive director of the non-profit group that advocates for accelerating medical innovation, submitted a letter strongly endorsing NCATS, which she said “will provide a significant stimulus to moving ideas out of the lab and into the clinic.” Continue reading…
For most of the past decade, Democrats and Republicans in Congress have competed over who could pour more money into the National Institutes of Health, the largest funder of biomedical research in the world.
But the party is over. The budget cuts proposed by a leading House Republican this week included cancellation of the $1 billion that the Obama administration wanted to add to the $31 billion NIH budget.
It was part of a broad assault on science funding that was announced by appropriations chairman Hal Rogers, R-Ky., who also called for large cuts at the National Science Foundation, the White House Office of Science, the National Oceanic and Atmospheric Administration and the National Aeronautics and Space Administration.
The purpose, according to Rogers, is “to rein in spending to help our economy grow and our businesses create jobs.”
If creating jobs is his goal, Rogers might want to take a look at a new study that appeared yesterday in the New England Journal of Medicine, which found that publicly-funded research is a far more important contributor to the creation of new drugs and vaccines than previously thought. The classical view of innovation is that government funds basic science, while industry comes up with the new and innovative products based on that science.Continue reading…
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