NAE Grand Challenges

The National Academy of Engineering has announced 14 'grand challenges' for engineering in the 21st century. While they range from making solar and fusion energy possible to advancing personalized learning and making cyberspace secure, four of the fourteen are directly related to biology and health: manage the nitrogen cycle, advance health informatics, engineer better medicines and reverse engineer the brain.

Per the extensive website: "In each of these broad realms of human concern - sustainability, health, vulnerability, and joy of living - specific grand challenges await engineering solutions. The world's cadre of engineers will seek ways to put knowledge into practice to meet these grand challenges. Applying rules of reason, the findings of science, the aesthetics of art, and the spark of creative imagination, engineers will continue the tradition of forging a better future."

Good stuff - makes engineering sound like an exciting future - share it with young people you know who want to make a difference in the world!

From our friends at Research!America, we have an update on the Specter/Harkin amendment, which proposes to add $7B of additional funding for healthcare and education to the president's budget. The amendement passed the Senate 73-27 earlier this month. It is now moving to the House of Representatives, championed by Representative Mike Castle (R) of Delaware. When all the dust settles around the federal government's discussion of health information technology, improving the healthcare delivery system, lowering costs, improving quality - yadda, yadda, yadda - it will be about the resources we are willing to invest as a country to fix things. Here's a chance to affect the allocation of those resources!

Technology for Aging

A while ago I posted on the idea that there were good market opportunities in addressing technologies to support aging. Here's a clip that I saw on BoingBoing today of yet another Japanese robotic effort in this area. Link

And also, an interesting new report from the US Census Bureau titled: "65+ in the United States". Loaded with thought-provoking statistics and data on aging and longevity in the US. For anyone who can extrapolate, it creates a somewhat unsettling picture of what life will be like in 20 years.

After last week's HealthGrid conference, I found myself thinking about new ways to use the grid for healthcare and lifesciences. Reading Boingboing this weekend, I found this interesting idea from Ralph Koster's website - for those who are into online gaming:

"Picture an MMORPG just like the ones today, but everywhere you see combat, replace it with healing. A six-man encounter would be a surgical operation that required teamwork. Soloing would be a brilliant doctor doing drive-by diagnostics. Raids would be massive experimental treatments.

Rather than spawning mobs, spawn ill people. Instead of weapons, have medicines. Instead of managing aggro, manage fever. Instead of armors, we have disinfectants.
Quests would include tasks to find and gather new plants for pharmaceuticals, and bespoke missions to fix the sanitation in a remote village. Puzzles might involve finding the standing water where the mosquitoes are breeding.

You can level up by building up immunity to the most common diseases. Your abilities are new forms of intervention and diagnosis; some classes might use homeopathic medicine, others might be trained in a Western mode. And death? Well, that would be a case of fighting off the infection youself, and failing.

You could go pretty psychedelic and “virtual” on the visuals, if you chose, with plenty of full-screen particle effects to keep the “fight” interesting. You could even, if you wanted to betray the Hippocratic Oath, have Dr vs Dr combat biowarfare."

Wonder when the new 'Mortal Kombat H5N1' will debut?!! Here's the link.

Last two days I've been in the wilds of Frederick, MD attending a meeting on "HealthGrid: Grid Technologies for Biomedicine", sponsored by the US Army Medical Research and Materiel Command's Telemedicine and Advanced Technology Research Center - better know to its friends as USAMRMC-TATRC. I kid you not. And they say IBM has too many undecipherable acronyms!!

In any case, it was a really interesting meeting because it brought together a lot of folks who know a great deal about high performance computing and grids with a lot of folks who know a great deal about biology and medicine. I was struck by a number of thoughts:

First, there are a lot of interesting projects going on out there, which can be prototypes for a world of seamless access to resources, information and expertise. Some interesting projects included: very cool visualization and anatomical data ("The Visible Human Project") discussed by Michael Ackerman from the National Library of Medicine; Parvati Dev from Stanford spoke about bringing people from entertainment and the arts into creating virtual environments that enhanced 'human-human interactions' in medicine; Dr. Jim Wilson from TATRC and Georgetown University talked about grids and networks to develop situational awareness for epidemiological monitoring and tracking for diseases like avian flu as well as biodefense.

Second, there are huge challenges ahead of us. Ken Buetow from the National Cancer Institute and his colleague Peter Covitz spoke on the Cancer Biomedical Informatics Grid (CaBIG). This effort is a monumental task to organize both the data and applications that are useful to cancer researchers in a common, standardized architecture. On top of that, they are attempting to drive more standards so that data that are collected at all the cancer centers can be shared among them as a valuable research resource - something we simply can't do today. Our science culture - both public and private - is one that does not encourage sharing, at least not prior to publication in a peer-reviewed journal. The Genome Project was cited many times as the right way to create a mandate to share prior to publication, and your funding depends on that. Most people agreed that was the way to do it, but the GP had a strong central control and this grid world operates in a much more self-assembling (or not) way. So how do you agree on standards?

Our good friend Lee Hood spoke about his vision of the future of medicine, as the '4P's' - predictive, preventive, personalized and participatory. Lee's views are always bold, and I love how he challenges an audience with ideas that are 'out there' - like how the world will be different when we all can get our full genome sequenced for under $1000. Or how doctors will have a diagnostic test that makes a few thousand proteomic measurements on a patient blood sample a couple times a year that will enable them to detect and treat incipient disease including all types of cancers. The very cool thing is that he and his colleagues at the Institute for Systems Biology are inventing these technologies even as we speak.

Yin and Yang

OK, it is 4am in China and I am pretty jet-lagged. Sleepy at 3 in the afternoon, and wide awake at 3 in the am. What better than to blog?

I had a really interesting side conversation yesterday with Mr. Ren Dequen, who is former head of the Chinese FDA – actually to call it a ‘conversation’ is not exactly right, as he speaks only a little English and I virtually no Chinese. He is a leading expert in traditional Chinese medicine (or TCM), which of course includes numerous and complex herbal remedies. These remedies (and the diagnostics used to prescribe them) are based on thousands of years of tradition, but only recently have western scientific methods been used to attempt to characterize them. This poses a very interesting dichotomy between East and West. On the one hand a school of medicine that treats the patient holistically, uses complex naturopathic remedies that are ill-understood but heuristically validated, and uses diagnostics that seem sometimes more like magic than science to the western mind. This meets a regulatory environment that is linear and reductionist, based on the Scientific Method, and which demands statistically validated experimental results to demonstrate efficacy and can mostly only deal with one molecule at a time. How on earth, I wondered, do you bring Chinese herbal medicines through a system like that?

Most Chinese medicines derived from herbs are complex mixtures of organic compounds and it is generally believed that the efficacy is not in any single ingredient but rather in the right proportions of the right compounds. There is only one drug that has become fairly widely accepted in Western medicine that came from TCM – that is an anti-malarial (actually one of the first new drugs for malaria in a long time) called artemisinin. In this instance, a single compound was isolated from the plant artemesia annua, purified and taken through western-style clinical trials to demonstrate efficacy. Artemisinin was researched and proven efficacious by Chinese scientists, and since has been used to create new drugs by companies like Novartis. Interestingly, it is now being mixed with other single-compound anti-malarials to create potent combination therapies. Its a very exciting example of something very new, very effective that can come from traditional medical knowledge like TCM.

But if it is the case that most TCM medicines are plant-based and depend on the right mixture of compounds, then new techniques are needed to ensure that the mixtures are correct and defining ‘purity’ is a nighmare. Mr. Ren indicated that the Chinese FDA is currently using HPLC fingerprints to attempt to characterize Chinese medicines and then bring them through western-style clinical trials. As long as the mixture is 90% or better similar to the accepted ‘fingerprint’, it is deemed to have sufficient quality to be used as a drug. I believe our FDA is also working on methods to look at safety and efficacy in naturopathic remedies, but I have to believe this is not very high on their list! Here's an interesting proposal for changes to the US regulatory system that might be used to address regulation of traditional medicines, including Chinese, Indian and others. I wonder if we don’t need just such a total re-thinking of the regulatory environment for therapeutic approaches like this, not just a force-fit of thousands of years of experience into the small, constrained box of modern pharmaceutical regulation.

China Lifesciences Partnering Meeting

I am back in China this week, participating in the China Lifesciences Partnering meeting sponsored by Burrill and Company. Today’s meeting was hosted by CapitalBio, a small but very fast-growing biotechnology company in Beijing. They are located in a brand new lifesciences industrial park in Changping District on the northwest outskirts of the city. CapitolBio is a company to watch – they have very interesting technology (microarrays, readers and other lab instrumentation), are branching out into new areas aggressively (including clinical information systems and other software), and they are mastering the art of partnering and building relationships. They’ve gotten a lot of visibility recently in the western press and have attracted a lot of investment attention as well. No wonder – they have grown their revenues about 300% for the last two years, and have a trajectory that takes them to an IPO on the NASDAQ by 2008, according to their CEO, Mr. Cheng Jing (following Chinese convention of family name first).

The conference itself included both speakers from western companies like myself, Bill Haseltine, and Ron Cape as well as panelists from Chinese organizations such as Wei Huacheng (Chairman of the Beijing Pharmaceutical Group) and Ren Dequen (former head of the Chinese FDA). Many large global pharma companies were sponsors and/or attendees, including Eli Lilly, Amgen, Roche and Baxter.

Big global pharma companies seem to be focused on China mostly for developing capability in areas like chemical manufacturing of intermediates, pre-clinical toxicology testing, pilot manufacturing for clinical trials and other pharmaceutical services. There is little focus on the local Chinese market for pharmaceuticals, as this is still very small and China is struggling with healthcare insurance and reimbursement for the majority of its people (more on this later). So right now the primary focus for international partnering is on developing reliable sources that use ‘good laboratory practice’ (GLP) and ‘good manufacturing practice’ (GMP) and can deliver materials and study results that will be compliant with both Chinese and US FDA standards. Companies like WuXi Pharma Tech (more on them later) and Bridge Pharmaceuticals are organized around this value proposition. Clearly these are going to be very important partners for global pharmas (and biotechs). I expect that over time these companies and many others are going to move up the value chain to capture more of the value-add of R&D and bringing their own drugs to market. If China can solve some of her healthcare access and insurance problems, these companies will be well-positioned to be leaders in a Chinese pharmaceutical market that will rapidly expand. (But that’s a big ‘if’!)

Disclaimer: I own no financial interest in any of the above-mentioned companies.

Happy New Year! OK, I've made several resolutions this year, and one of them is to blog more regularly, which I know I haven't been good at. Of course, the other one is the one you all made too, which is to watch my diet and exercise regularly and hopefully lose a little weight! So its a perfect topic for this blog, because although new years resolutions have a way of fading from memory by the second week of January, I think the trend in healthcare toward wellness management is one that's here with us for awhile.

We've all been reading about the rising cost of healthcare and what its doing to the bottom lines of companies like GM and others. But whether its an employer or an individual or the federal government that is picking up the tab for our healthcare, its incredibly costly and payors are going to be aggressively looking for ways to cut costs. How do you do that without rationing care and reducing the access of people who need it most?

Let's agree on this - keeping people healthy and well is generally less expensive than treating them once they are sick. Large employers are starting to pick up on this and incorporating in their benefits plans more focus on diet, exercise and smoking cessation. I'm a major technology fan, as most of you know, but we don't need genomic medicine to tell us that we could cure a lot of cancer right now by getting people to stop smoking.

There are interesting companies out there working on the emerging 'wellness' market. Some, like Matria are coming at this from a more traditional business in disease management. By monitoring patients with chronic diseases - like diabetes and congestive heart failure - Matria can help those individuals manage their disease and stay in control. Keeping them out of the hospital is not only better for the patient, but also saves their employer or insurer big money. Its a little harder to measure the return on investment for a similar approach to wellness, but its got to be enormous, because it starts even earlier - before a patient has chronic disease. Last April, Matria acquired Miavita, a company that Mike Milken helped found, which focuses on web-based solutions to help healthy people stay well.

Pharmaceutical companies are not unmindful of the wellness opportunity. While on the one hand, therapies to treat disease are becoming more and more targeted to narrower sets of patients, drugs that help more broadly promote wellness may be the blockbusters of the future - because we will all take them to keep from getting sick. I suppose you could think about the statins as an example of that category - we take them pre-symptomatically to prevent the development of heart disease, based on a diagnostic test (cholesterol level) result. Its likely that obesity will be the next big market for wellness blockbuster drugs.

The relatively wild west world of 'nutraceuticals' has been promoting wellness for a long time. My friend and advisor Steve Burrill has raised a fund to invest in companies in this space, and has . Steve would point out that the current market for nutraceuticals is $150B, which is almost half that for prescription drugs and is ALL paid out of pocket. Foods like Benecol, a margerine that lowers cholesterol by adding a natural plant sterol called sitostanol to the spread, have made it to the mainstream supermarket shelves.

So happy new year - and think about your own personal wellness this year. I'll take a moment to share some of my personal favorite wellness tips with you:

Great diet book, if you are a data-driven person like me: "The Business Plan for the Body" by Jim Karas. Good common sense and helpful advice to change your habits. And formulas!

Self assessment, web-based tool that tells you how 'old' you are (healthwise) compared to your chronological age. Makes you stop and think, and helps you create a good plan for action on the things you can do something about. http://www.realage.com/

Pilates - ok, you have to do cardio too, but strength training and flexibility are often neglected, especially by Type A personalities like me. I've become religious about my weekly Pilates class, which is a gentle way to strengthen your core muscles, including your back if you have back problems. As always, consult your doctor before embarking on new fitness routines - especially if you have health issues.

OK, time to get moving! Wishing you a healthy new year!


(Disclaimer: I own no stock or financial interest in any of the companies mentioned above. I just think they are interesting!)