all the information, none of the junk | biotech • healthcare • life sciences

Got Cancer? Sorry, There’s No App for That

Xconomy Seattle — 

That’s right. I hate to be the bearer of bad news, but there are no apps for treating Parkinson’s either. Or ALS. Or Alzheimer’s, or one of a large number of other diseases I could name and you don’t want to have. Numerous pharma and biotech companies have created more than a hundred different apps, but none of them are going to cure you. They simply provide patients or healthcare providers with product information or tools for tracking disease status or drug compliance. And unless current trends reverse themselves, there may be fewer new investments to find treatments for any of the diseases mentioned above in the foreseeable future.

Why? Because developing new drugs takes a long time and costs a lot of money, an outlay that is said to be doubling every six years. As a result, the pendulum appears to be swinging away from investing in the riskiest, early stage sector of this industry. The situation is even worse for so called “neglected diseases.” Investors who are looking for yields beyond those available in the equity and bond markets often look at start-ups, hoping to get in on the ground floor of the next Apple or Amgen. Despite this, a recent report on venture capital investments in biotech startups revealed a precipitous decline in early stage investments in these companies.

Why are VCs turning away from putting money into early stage biopharmaceuticals? The most likely explanation: they’ve had a difficult time making money in this sector over the past decade. There’s a limited pool of investment money, and many VCs can put these funds to work in one of the more highly favored industries these days, such as software development. Opportunities include mobile phone apps, social media sites, and cloud computing and backup solutions.

I can see the attraction of investing in these areas. A couple of caffeine-fueled programmers toiling away in a cut-rate workspace can crank out the code for a software project in a few months. If it works out, terrific. And if it doesn’t, the expense wasn’t great, they’ve “failed fast,” and it’s time to move on to the next investment opportunity. Let’s keep in mind, however, that funds poured into developing the latest smartphone app is money that’s not going towards developing treatments for cancer or other serious diseases.

There’s nothing inherently wrong with creating software products. The work is a decent way to make a living, pays a very good salary, and provides value to customers. A venture capitalist’s primary focus is making money, and if I were one of them, I’d probably be putting money into this sector as well. However, as Christian Chabot, CEO of Seattle-based Tableau Software, recently observed “One of the great tragedies of the modern technology industry is that a majority of the world’s most brilliant and talented people, many of them computer scientists, have spent the last 15 years working on projects that are primarily about getting people to click on more ads, or put more stuff in their shopping cart.”

Many people believe they can’t live without the latest app or gizmo, but their views on what matters most are likely to change rapidly when they get bad news in the doctor’s office. The total amount spent in the U.S. each year on biomedical research (which includes drug development) appears to be dwarfed by what is expended on developing software. In 2004, U.S. businesses spent around $250 billion on software development, far greater than the approximately $100 billion spent on all biomedical research (not just drug development) by government and industry groups combined in 2007. And with all due respect to the programming gurus, creating new drugs is a significantly more difficult (and expensive) undertaking.

While both software and genetic engineers need top of the line computer gear, lab researchers also need a significant amount of expensive equipment and consumable supplies. Biology is one of the most complex fields imaginable and there are no shortcuts. Genes and the proteins they encode must be examined in great detail, preferably on both a case-by-case basis as well as a systems biology approach. While it is relatively easy to fix mistakes in computer code, there is, as yet, no reliable way to repair errors in the genetic code (i.e. DNA) that are frequently found within the cells of patients.

I’m not saying that programming isn’t valuable to the general public. In fact, achieving success in cutting-edge genomics research these days is going to depend on having excellent software to analyze the Big Data that is rapidly accumulating in our server farms. It really comes down to the choices we make as a society and what we value most. Do we really need more variations on FarmVille and Facebook? Wouldn’t we be better off investing more money trying to create the medical miracles we’ll wish for when our personal forecast reads mostly cloudy with a chance of death? Fighting disease isn’t just a good investment in our health; it’s also an excellent investment in our economy. Cancer, for example, has a major impact on the American financial system. A recent study showed that some 3.3 million workers are diagnosed with cancer each year, which results in some $7.5 billion in lost productivity.

So how do we incentivize the marketplace to invest more in drug development? As with many aspects of our national fabric, your answer may reflect your political inclinations. Conservatives will look to private industry for answers, while liberals may turn to a government-sponsored solution. Independents might seek salvation in both camps, and libertarians would argue that there’s no need to incentivize anything in a free market. Let’s compare and contrast some different approaches that might serve to increase the number of valuable medicines to see where we stand.

Let’s start with the conservative angle. In our free enterprise system, people with significant financial resources seek out opportunities ordained by the Holy Trinity of capital investment: High yields, rapid returns, and low risk. Investing in early stage biopharmaceuticals is clearly a very risky business. Although it can produce substantial monetary returns (because drug patents lead to monopoly pricing), it is exceedingly difficult to come up with novel drugs that are both demonstrably safe and effective. Only about 8 percent of drugs that enter clinical trials actually wind up being approved by the FDA and marketed. Getting a “rapid return” on invested funds in this sector generally requires an acquisition or IPO event, and IPOs have been tough to come by in recent years. Maybe traditional venture capital funding, as it currently stands, is not the best vehicle for assuring the development of a steady stream of new medicines.

Other private sector options abound. Big Pharma has been investing in a variety of approaches focused on resuscitating their waning fortunes. These include funding their own investment arms as well as establishing a large number of alliances with academic research institutions. They’ve also joined forces recently to form TransCelerate Biopharma, a non-profit organization whose mission is to develop innovative solutions to clinical trial problems faced by all of their members companies. New approaches to tackling dreaded diseases are not just the realm of drug manufacturers. The University of Texas’s MD Anderson Cancer Center estimates that its Moon Shots program to reduce cancer deaths may cost upwards of $3 billion in the first 10 years. Those funds will come from “institutional earnings, philanthropy, competitive research grants and commercialization of new discoveries.” Non-profit charities and disease organizations also remain a force in the voluntary sector, including the Michael J. Fox Foundation for Parkinson’s Research and the Cystic Fibrosis Foundation (who helped pave the way for the new breakthrough CF drug ivacaftor [Kalydeco] in partnership with Vertex Pharmaceuticals).

Let’s turn to the government side of the equation. Federal funding comes from agencies such as the National Institutes of Health, the Defense Advanced Research Projects Agency, and Small Business Innovation Research grants. Most of the money that the federal government spends in this area has traditionally been focused on basic, not applied research, but an increased emphasis is now being placed on translational research programs. Make no mistake: this has been money well spent, for the data generated by the thousands of research grants funded year after year forms the solid foundation upon which most of the applied work that follows has been built. State agencies, such as the California Institute for Regenerative Medicine and the Cancer Prevention and Research Institute of Texas (currently mired in serious charges of political cronyism) have committed billions of dollars to both basic research as well as translational medicine. Traditionally, however, the government has not been the key player in drug development, which resides in the skilled hands of pharma and biotech companies.

John W. Gardner once wrote “The society which scorns excellence in plumbing as a humble activity and tolerates shoddiness in philosophy because it is an exalted activity will have neither good plumbing nor good philosophy: neither its pipes nor its theories will hold water.”

Let me recast this in the light of my current theme:

The society which scorns investing in drug development (because it is both costly and risky) at the expense of investments in mobile phone and social media applications will produce few novel and helpful medicines: its citizens, however, may be too distracted by their electronics to care.”

So how do we go about incentivizing investments in drug discovery? I’ve suggested a few possibilities in the past, including legislation that provides special tax breaks for long-term biopharma investments as well as government funded cash prizes for cures. Others have suggested selling Biomedical Research Bonds to the public as a way of raising funds. Both the public and private sectors need to be involved in this process. With healthcare taking up an increasingly large portion of the nation’s GDP and contributing to our ever-increasing deficit, the government cannot afford to bear this burden alone. I believe a healthy dialogue between all of the interested parties, especially patient advocacy groups, is likely to come up with a wide spectrum of interesting and actionable proposals. Feel free to share an idea in the comments section below.

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  • David Doherty

    Hi Stewart,

    Thanks for sharing this interesting point of view.

    “in 2004, U.S. businesses spent around $250 billion on software development, far greater than the approximately $100 billion spent on all biomedical research”

    Could you imagine if you could somehow leverage the opportunity we now have because of the billions being spent (or in your view wasted!) on software development for the benefit of citizens?

    I see this already happening all over the world and think it’s only going to increase. Here are a few good examples:

    The 1 million + Kaiser Permanente patients that can now communicate with their carers, access their lab results, etc, via a secure mobile website.

    The low cost mobile connected smoke alarm or the care monitor in my neighbours home (she is blind and wishes to continue living alone/independently)

    The pedometer app that runs natively on the Raku Raku mobiles of millions of senior citizens in Japan (it works like a fitbit and motivates you to exercise!).

  • http://twitter.com/brianreid Brian Reid

    Stewart —

    While you’re absolutely right that the industry needs to keep the VC spigot going if we want tomorrow’s great biopharma technologies to actually arrive, I feel compelled to defend the over-caffeinated coders, because they’re going to play a major role in changing health care for the better. Some of the most interesting stuff I saw this week at J.P. Morgan was coming from computer programmers, and it went a good deal further than Farmville or compliance apps.

    One company I talked to is working on a game that will allow patients to improve — and neuroscientists to monitor — cognitive function, which has the potential for better patient outcomes in an increasingly abandoned therapeutic category. Another seeks to reshape the economics of rehabilitation by using Kinect-style video capture to provide real-time, remote physical therapy that has the promise to get more people more healthy — more quickly and more cost-effectively — after hospitalization.

    No, it’s not a cure for cancer, but it’s progress toward better, smarter and cheaper health care. And that’s something worth throwing dollars at.

    — Brian

  • Stewart Lyman

    Brian and David, Thanks for you for taking the time to comment. Let me reiterate that I have nothing against coders or software development; they do good work and make very valuable contributions to society. The examples you brought up are good ones to illustrate the point I was trying to make. In terms of enhanced communication via apps, I now can access my “medical records” via the Internet. Unfortunately, the system that was set up (1) doesn’t allow access to my actual test results, only what my doctor had to say about them e.g. “looks good” and (2) there is also no way to contact my doctor: no email replies allowed. This system is nearly useless to me as the end user. It provides very limited information and only one-way communication. An old-fashioned phone call from my doctor would work much better for me. I’m
    sure others have better products for staying in touch with their doctors, but
    the one I have is pretty bad. However, it will allow my insurance provider to
    advertise that you can access your medical records 24/7.

    I have seen a presentation several times from one of the
    companies (I think there are several) working on developing a Kinect-enhanced approach to physical therapy. I had serious concerns about both the basic business model as well as the lack of IP, but most of all, was dismayed to see no data to support the idea that PT patients who use this device get well faster than patients with similar problems who didn’t use it (maybe they have that data now?). It is a cool idea, and it may be more fun for the user, but at the end of the day, people needing PT can get better without this product and have been doing so for years. Let’s contrast this to folks who show up in their doctor’s office with a diagnosis of ovarian cancer or amyotrophic lateral sclerosis (ALS). They are in serious need of a new drug and without it they are going to die. They will not get better without one. To put this in business terms, I see a new drug for a cancer patient as “mission critical”, whereas the software products mentioned above are more in the “nice to have” category. This is why I am suggesting that maybe we need different mechanisms (for reasons stated in the article) to fund research and product development for drugs vs. software products.

  • Art Lamstein

    One reason venture investment in biotech is declining is that the typical biotech business model does not support a wide enough market to make a profit at scale. Just as in Covey’s first dictum, “Begin with the end in mind,” the ability to scale to a profitable bottom line must be considered first and incentives (which never last) should not even be in the equation. If the product sales price is too high, the market for the product becomes smaller and less likely to be an allowable treatment covered by medical insurance. Far better is to have a low-cost product that can be utilized by a broad swath of customers.

    One of the main factors keeping biotech product prices high is the high cost of nanomaterials, like quantum dots, with a low end of $2000/Gm at the Kg size purchase (Nanoco). Factors contributing to their high cost of manufacture include using a batch synthesis, toxic chemicals, time and manpower. Despite their expense, university and government research in quantum dot applications is rapidly growing, and the National Nanotechnology Initiative has identified “advanced nanomaterials” and “the development of technologies that will enable commercial scale manufacturing” as Nanotechnology Signature Initiatives.

    For those of you who know the power of quantum dots for the future of biotech, in assays, diagnostics, theranostics, drug delivery and point-of-care devices, just to name a few, what if there was a new “green” quantum dot synthesis approach using continuous flow chemistry mass production that could dramatically lower the cost of energy transfer conjugates while delivering better features and more accurate results and outcomes? This Holy Grail does exist. These quantum dots are Tetrapod shape, uniform, low cost and mass producible.

    FRET and BRET assays using tetrapod quantum dots instead of chromophores or fluorophores have advantages of brightness, stability and reaction time. Quantum dots coupled to biomarkers for BRET assay diagnosis of disease could eventually become point-of-care (POC) devices in doctor’s offices making instant readouts. Bio-compatible tetrapod QD used as a multiplexing drug delivery platform is just beginning to be explored for killing cancers. For many biotech applications the ultimate “enabling technology” will be easily synthesized and scaled high quantum yield and uniform quantum dots. To read more on this, may I suggest the online article, “Review of Quantum Dot Technologies for Cancer Detection and Treatment”. (http://www.azonano.com/article.aspx?ArticleID=1726)

    Quantum Materials Corporation is developing specialized quantum dots for a private biotech company, NanoAxis LLC to functionalize with their proprietary biomedical nanomaterials for a multiplexing drug delivery platform for drug/gene therapy and diagnostic medical devices technologies. Quantum Materials’ CEO Stephen Squires will report on this joint alliance and our progress developing new quantum dots at the CHI Emerging Diagnostics Partnership Forum in San Francisco on February 11th.

    If the goal is ubiquitous low cost, rapid diagnosis and treatment of presently incurable disease and conditions, we believe that our bespoke yet mass produced tetrapods constitute a new approach and an extremely viable partner to that goal. If you have been told your QD biotech application is too high priced to bring to market, let’s talk and run the numbers and see if together we can enhance its financial viability to the investment community.

  • sam

    It’s arguable whether pouring more money into biomedical research is the right way to approach tackling issues in cancer, etc., given the # of marginally more effective and copycat drugs out there. In fact, without slashing the $1 billion+ development cost per drug, you’re just pouring money down the sink.

    A two-pronged approach, one for incurable diseases like ALS and cancer, and another relying on health IT and behavior changes for obesity and lifestyle diseases makes sense. But both seem necessary.