It may be that TEDMED founder Richard Saul Wurman is the Brett Favre of emcees, or perhaps he’s like Al Pacino in Godfather III, who proclaims in exasperation, “Just when I thought I was out—they pull me back in!”

But after a five-year hiatus, TEDMED has returned this week (opening last night at San Diego’s Hotel del Coronado), and Wurman, who is both the TEDMED chairman emeritus and lead master of ceremonies, stepped back onstage for what must be a familiar role. He is the folksy glue that brings the sometimes-esoteric show back to Earth as leading thinkers in medicine, health care, and life sciences deliver 15- to 20-minute talks about their work and big ideas.

So, for example, after J. Craig Venter, a leader in genomic sequencing and synthetic biology, ended his presentation last night, Wurman took the stage and reassured the crowd by saying, “I’ve heard Craig speak a number of times. And I don’t understand it all…”

The four-day TEDMED symposium, which costs $4,000 per person to attend (and is sold out), follows a format similar to the first conference in Technology, Entertainment, and Design (TED) that Wurman established in 1984. Chris Anderson acquired rights to that TED business in 2001 and Boston entrepreneur (and Xconomist) Marc Hodosh got rights earlier this year to TEDMED and its focus on health care. Wurman told us he had agreed to help Hodosh out this year, and between sessions he often helped the audience by identifying themes they would likely see emerging in presentations to come.

“Maps are also patterns, and patterns are the threads that run through this conference,” Wurman said. “They are the constructive tissue that holds ideas together.” Those emerging ideas include:

—J. Craig Venter, the co-founder and CEO of San Diego-based Synthetic Genomics, said about 21 million genes have been discovered since the first genome was sequenced in 1995—“and over 20 million have been taken from the deck of my sailboat.” (Venter’s sailboat, the Sorcerer II, embarked from San Diego in March on an expedition to collect and sequence marine organisms.) Venter also outlined synthetic biology research that aims to transplant a chromosome from one cell into another cell—and turn it into a different species. Venter says, “I think it’s possible we’ll have the first species powered by a synthetic chromosome by the end of this year, although that’s something I’ve been saying now for two years.”

—Anthony Atala, a urologist and director of the Wake Forest Institute for Regenerative Medicine, showed how researchers are using “smart biomaterials” to patch damaged organs and grow new heart valves, blood vessels, liver, muscle, skin, ears, and even fingers. Still, Atala said, “90 percent of patients on transplantation waiting lists are waiting for kidneys.” He also noted that the organs with lots of blood vessels—the heart, liver, and kidney—are the hardest to grow.

—Bill Davenhall, who leads the health and human services marketing team at ESRI, the Redlands, CA, company that specializes in geographic information systems, argued for the creation of new programs and training in “geo-medicine”—and for ensuring that GIS data can be included in electronic health records. He demonstrated his point with a map that shows geographical areas in mid-Atlantic and Midwestern states where heart attacks occur far more frequently than other parts of the country. Davenhall, who said he suffered a heart attack in 2001, associates environmental factors in the places where he has lived with the higher incidence rate. He grew up with high levels of sulfur dioxide in Scranton, PA, before moving to Louisville, KY, with high levels of chloropene and benzene. He now lives east of Los Angeles in Redlands, CA, which has high levels of airborne particulates, carbon dioxide, and ozone. He told the audience, “Doctors never ask me about my place history. But if I wanted to have a heart attack, I’ve lived in the right places.”

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The role of information technology in healthcare reform is such a huge, sprawling topic that it’s hard to make any real progress in just an hour or two of discussions. Yet that’s just what transpired at a stellar event last night called “Healthcare-IT—Innovations That Will Transform Healthcare Now and in the Future.” It all took place at the Herban Feast in Sodo Park, South Seattle, and it was organized by the Washington Technology Industry Association.

Over some fancy appetizers, a distinguished panel of technologists, executives, and entrepreneurs debated everything from the technical and cultural issues of privacy and security in electronic medical records to who’s going to get a piece of the $19 billion in federal stimulus funding for digital healthcare; everything from whether consumers really want e-health enough to drive regulatory changes to—and this was particularly interesting to Xconomy—what the real opportunities are for startups in the space. The panel showcased some of the first-rate expertise we have here in the Seattle and Portland regions.

Moderator Joel French, the founder and managing director of Nephalios Group, a management consultancy, kicked things off by saying the whole healthcare debate boils down to four things: a cost problem, quality variability, access and coverage, and wellness. In each of these issues, IT plays an important role. “You can’t really share information if it’s not digital,” French said.

With that, it was open season on the panelists:

—Henry Albrecht, CEO of Bellevue, WA-based Limeade, an online health and productivity startup making software-as-a-service for employers (we reported Limeade raised money in July).

—Carla Corkern, CEO and chairman of Bellevue, WA-based Talyst, a company that makes software and systems to help pharmacies manage medications in hospitals and long-term care facilities (we reported on Talyst’s broader strategy and funding in June).

—Luis Machuca, CEO of Hillsboro, OR-based Kryptiq, a maker of collaborative software that lets healthcare providers share information with patients, labs, and physicians (we’ve reported on some of Kryptiq’s deals and customers, including NASA).

—Mohan Nair, executive vice president and chief marketing executive of Oregon-based Regence, the largest health insurer in the Northwest (he has a background in tech entrepreneurship).

—Michael Raymer, global market strategist and general manager for Microsoft’s Health Solutions Group (we’re reported on HealthVault, the company’s Web platform for medical records).

For the next hour, some tough questions flew out from the audience, and among the panelists. Here are my takeaways from the discussion:

1. “The magic pill is data liquidity.” That was from Luis Machuca, who argued that patients need to be able to own and access their own digital health information and use it to get better healthcare. “Universal health will fail, everything will fail, if we don’t have data liquidity and digitization,” Machuca said.

2. An open market, human behavior, and connectivity are important too. Nair argued that the present closed marketplace for healthcare services encourages entitlement instead of earned rewards. Albrecht noted that we should pay more attention to behavior, and less to technology. Raymer added, “Data liquidity needs to be coupled with tools to empower people to make changes, and connect people together.”

3. If you want better healthcare, go to jail. “We see the best compliance for …Next Page »

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When Cambridge, MA-based Genzyme (NASDAQ: GENZ) shut down its Allston, MA, bioreactor plant in June after discovering viral contamination, it was clear that there would be worldwide shortages of its best-selling enzyme replacement therapies, agalsidase beta (Fabrazyme) and imiglucerase (Cerezyme), and that there would be a hit to the company’s bottom line. The company got more specific about those matters today, saying in a press release that it’s taking longer than expected to restore full production of agalsidase beta, and that sales of both drugs this year will be below previously anticipated levels.

Revenue from agalsidase beta, a treatment for Fabry disease, is expected to be roughly $450 million in 2009, about $60 to $70 million less than the company had predicted in previous guidance. Revenue from the Gaucher disease treatment imiglucerase is expected to reach $800 million, which is at the low end of the previously predicted range of $750 million to $1 billion. Genzyme’s stock price was roughly flat this morning.

After sanitizing the Allston plant, Genzyme resumed production of both drugs in July, and it said today that it expects to begin shipping newly produced batches of the Gaucher drug in November, as planned.

But the news for Fabry disease patients is not as encouraging. New shipments of agalsidase beta won’t go out until mid-December, the company says, and there will be less of it to go around than previously thought. The problems: Genzyme took some extra time to do preventive maintenance before restarting the bioreactors that make agalsidase beta; the vessels are now producing the drug in lower quantities than in the past, for reasons the company isn’t disclosing; and the company has been making the drug in smaller batches, which is faster but less efficient.

As a result, “additional product conservation measures are now needed to help ensure that the limited remaining Fabrazyme inventory can be made available to as many patients as possible until new material is available,” the company said in today’s announcement. Specifically, the company said that from October 1 through the end of the year, it will only ship enough agalsidase beta to meet 30 percent of global demand; up to now, the company said it had enough of the drug on hand to cover about 80 percent of demand.

Genzyme says it’s working with doctors to set up clinical guidelines for conserving doses of the drug. The company expects to work its way back to full production—covering 100 percent of demand—sometime in the first quarter of 2010.

“We will continue to work with all stakeholders to prepare for the release of this material so that it can reach patients as quickly as possible,” Genzyme chairman and CEO Henri Termeer said in today’s announcement. “I want to express my deep appreciation to the Gaucher and Fabry communities for their support of the existing product conservation guidelines and for their anticipated collaboration in helping to manage the remaining limited product supply through the end of this year.”

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If you’re the kind of person who needs a little help remembering to take your prescription meds, Cambridge, MA-based Vitality might have just the technology you need. It’s a wireless, Internet-connected medicine bottle cap that blinks and plays a tune when it’s time to down your pills.

The company’s “GlowCaps” system, which goes on sale today for $99, is designed to appeal to baby boomers looking for ways to keep their aging, forgetful parents out of expensive nursing homes or assisted care, says Vitality founder and CEO David Rose. But eventually, users might not have to pay for GlowCaps at all, because Vitality thinks the technology will also appeal to health insurers—and to pharmaceutical companies that want to recover the billions they lose in revenues when prescriptions aren’t used as directed or refilled on time.

The GlowCaps system is available exclusively through Amazon. It’s intended for people with hypertension, diabetes, and other chronic problems that can only be controlled through regular daily medications. In one beta test involving 50 Boston-area residents, Rose says, the system prompted patients to take their medicines on schedule 86 percent of the time, compared to the average adherence rate of about 50 percent.

And that’s bound to interest a couple of big constituencies. “There are really two primary customers for our company,” says Rose. “One is pharmaceutical companies that want to sell 25 pills a month rather than 15. If you’re a company like Novartis and you have a $2.5 billion drug like Diovan [a blood pressure medication] and it costs $4 a pill, that’s a lot of revenue you should be getting.” There’s also plenty of literature, Rose says, showing that high adherence rates lower the overall cost of care. “The other path to market, then, is the companies who pay for healthcare—both insurance companies and large self-insured employers.”

For now, though, Vitality is trying to build a market beachhead by selling the GlowCaps system directly to consumers. Inside the box are three components—a GlowCap, a reminder nightlight, and a small Wi-Fi router.

The GlowCap is the key component. It fits on top of a standard plastic pill bottle, and contains an LED light, a tiny sound chip, a wireless chipset, a watch battery, and a sensor that can detect when the bottle is opened. Most of the time, the LED emits a cool blue light, but when it’s time to take a pill, it switches to a pulsing orange light and plays a little electronic ditty. If the bottle isn’t opened, the ditties get longer and more insistent.

After two hours, the cap sends a wireless message to the patient’s home Wi-Fi router, which relays it to Vitality’s servers via the Internet. (For the system to work, the user’s household needs a broadband Internet connection with an available Ethernet port—and obviously, the cap needs to be within range of the router.) Vitality’s system can then initiate an automated phone call to remind the patient to take their medicine.

Vitality keeps records of each time the GlowCap is opened, and uses this information to produce a weekly “adherence report” that can be e-mailed to the patient or an appointed caregiver or loved one. The data can also be shared with doctors via online personal health record systems like Google Health, Microsoft HealthVault, and Dossia.

Then there’s the nightlight, which plugs into a kitchen or bathroom outlet and connects wirelessly to the router. It shines orange or blue in synchrony with the GlowCap, providing an extra reminder.

The whole system is about creating “persuasive feedback loops” that start with unobtrusive lights and electronic sounds, and escalate to …Next Page »

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Dendreon, the Seattle-based cancer drug developer, may open a new manufacturing plant in Georgia, according to a report in the Atlanta Business Chronicle. Dendreon’s product, a new drug to treat prostate cancer, is being reviewed for approval by the FDA. Xconomy has written about Dendreon’s limited manufacturing before. The possible plant could cost $80 million and create more than 300 jobs in Atlanta. Currently, Dendreon has a commercial manufacturing plant in Morris Plains, NJ.

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Next week, the U.S. Senate is expected to take up debate on health care reform. Regardless of what happens in Washington DC, the impact will be felt on virtually every business and individual in Washington State.

Without question, a simple solution to our health care crisis is elusive, and in the coming days and weeks many complicated and important issues will be debated, but from where I stand today, there is one key health care issue with no room for debate.

The issue is the development of a pathway for regulatory approval of biosimilars by the Food and Drug Administration (FDA). Biosimilars, as the name implies, are drugs that are similar to, but not the same as, innovator biologics. Biologics are molecular structures that can be hundreds of times more complex. That’s why copycat versions of biologics aren’t called “generics.” Biotechnology-based therapies that fight diseases such as cancer, diabetes, and Alzheimer’s are made from living cells—a process far more complex than the one used to manufacture chemical-based drugs such as aspirin.

The illustration below helps to put into perspective the differences between small molecule drugs and biologics:

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To give a sense of size, same-scale computer models of three drugs—aspirin (a small molecule), somatropin (human growth hormone), and Herceptin (an antibody)—are presented as an example of the relative complexity: The molecules are to scale and the objects are not, but the objects (bike, car, private jet) indicate relative size and complexity of these molecules. Used with Permission. Source: Genentech
http://www.gene.com/gene/about/views/followon-biologics.html

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Here in Washington State, we are fortunate to have great leadership on this issue from Representative Jay Inslee (D, WA-1). Rep. Inslee is one of the lead sponsors of the Pathway for Biosimilars Act (H.R. 1548), bipartisan legislation that protects patient safety and strikes the appropriate balance between increasing competition and maintaining our nation’s status as the world’s leader in science and innovation.

Rep. Inslee wants to make sure that biosimilar manufacturers are required to provide the FDA with clinical data on the safety and efficacy of their medicines. And his legislation preserves incentives for …Next Page »

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Framingham, MA-based Interlace Medical, which develops medical devices for gynecologists, announced today it has raised $20.5 million in Series C funding. The round was led by Baird Venture Partners and HLM Venture Partners and included new investors Hambrecht & Quist Capital Management and Aperture Venture Partners. Previous backers New Leaf Venture Partners and Spray Venture Partners returned for this round as well. Interlace says the Series C funds will be used to initiate the commercialization of its MyoSure system, which is intended as a less invasive method of removing fibroids and polyps from the uterus.

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In a private placement of stock, Marlborough, MA-based Exact Science (NASDAQ: EXAS) has raised $8.2 in new funding, according to an announcement today. The company, which has developed a molecular screening test for colorectal cancer, also said it has licensed technology developed by cancer researcher David Ahlquist at the Mayo Clinic covering aspects of sample processing and data analysis related to DNA screening for the disease.

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It has been almost five years since a team of aerospace entrepreneurs funded by a software billionaire claimed the Ansari X Prize, the $10 million prize competition to develop the first reusable private spacecraft.

Since then, the frustrated space enthusiast who established the X Prize as a way to re-ignite astronautical innovation, Peter Diamandis, has won some prizes of his own. He was the inaugural winner of the 2006 Heinlein Prize for his efforts to deliver humanity to space; a Lindbergh Award in recognition of his pioneering work in creating incentive prizes; and an Arthur C. Clarke Award for innovation.

As the chairman and CEO of the X Prize Foundation, based near Los Angeles in Playa Vista, CA, the 48-year-old Diamandis says his goal now is to make the X Prize “the gold standard of incentive prizes that are well-promoted, well-executed, and hit the mark” in terms of targeting technology breakthroughs in such fields as energy, astronautics, transportation, medicine, genomics, and exploration.

In anticipation of his talk at San Diego’s MIT Enterprise Forum, I recently asked Diamandis how the X Prize Foundation has changed since it wrote a $10 million check in 2004 to spacecraft designer Burt Rutan and his investor, Microsoft co-founder Paul Allen.

For one thing, Diamandis says, the foundation has grown almost tenfold—from five people to a staff of 45. The foundation also is working more rigorously now on what he calls “prize methodology,” developing the principles, procedures, and rules for prizes that will drive key breakthroughs in such fields as life sciences, exploration, energy, global development, education, and the environment. Among other things, he says the group has been working with scientists at UCSD’s Scripps Institution of Oceanography to develop prize methodologies for a possible “Ocean X Prize” in three possible areas:

—Ocean exploration. Since the U.S. deep submergence vehicle Alvin was launched 45 years ago and Russia’s MIR submersibles are over 20 years old, Diamandis says the foundation is considering a prize to create new technologies needed to explore the “Challenger Deep” of the Mariana Trench, 7 miles beneath the surface of the Pacific Ocean.

—Ocean floor mapping. Diamandis says we know more about the surface of Mars than about the bottom of the ocean. So a prize for mapping the ocean floor could encourage the development of new underwater mapping technologies.

—Ocean conservation. The Great Pacific Garbage Patch is a region of the Pacific Ocean where plastic trash accumulates into vast masses of unsinkable drifting litter. The X Prize Foundation is considering a prize that would spur the development of innovative ways to “heal” such garbage patches.

To Diamandis, it is only a matter of time before incentive prizes become as important to innovation as venture capital. Diamandis says he’s heard Rick Burnes say that venture capital also seemed like a “very strange idea” in 1970, when Burnes co-founded Charles River Ventures in Waltham, MA. “Now venture capital is everywhere,” Diamandis says. “I think the same thing will happen with incentive prizes.”

With the success of the Ansari X Prize, similar …Next Page »

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Cancer is the one of the most intense fields of R&D in the pharmaceutical business, and if you need convincing, take a look at the enormous heaps of data that started appearing online last night.

The annual cancer drug data frenzy known as the American Society of Clinical Oncology (ASCO) got its official kickoff of sorts as it released thousands of brief summaries, known as abstracts, that serve as a preview of coming attractions at the group’s annual conference May 29 to June 2. This year’s meeting, to be held in sunny Orlando, FL, because it’s one of the few places with a big enough convention center, is expected to draw the usual crowd of 30,000 physicians, drug company executives, Wall Street analysts, and journalists who are seeking insights into what’s new and hot for the treatment of tumors.

There’s a reason for all this interest: there’s a lot of money to be made. The global market for cancer drugs, worth $66 billion in 2008, will grow to $84 billion by 2012, according to a report by Cowen & Company. Some 861 new cancer medicines and vaccines are now being tested in clinical trials by biotech and pharmaceutical companies, a record number, according to the Pharmaceutical Research and Manufacturer’s Association.

Many of these products come from the Boston biotech cluster, and here’s a rundown from some of the drugs to watch from Bay State labs.

—ImmunoGen (NASDAQ: IMGN), the Waltham,MA-based company with technology to make a “souped-up” version of Herceptin for breast cancer, will have one of the highly anticipated presentations. This drug, called trastuzumab DM1, or TDM1, has been developed in collaboration with Genentech, now owned by Swiss drug giant Roche. It takes the hit antibody drug for breast cancer, marketed as Herceptin, and aims to make it more potent by attaching a potent toxin to it.

Preliminary results presented in December from 107 patients in a mid-stage clinical trial showed that about 40 percent had partial or complete tumor shrinkage after taking the drug. This happened …Next Page »

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Marlborough, MA-based Sepracor (NASDAQ: SEPR), known mainly for its sleep aid Lunesta, said today that it has applied to the U.S. Food and Drug Administration for approval of a compound called eslicarbazepine acetate as an adjunct to other therapies in adult epilepsy patients. Sepracor says the sodium-channel blocker—developed by Portuguese pharmaceutical company BIAL-Portela and licensed by Sepracor in 2007—has been tested in a multi-country Phase III study involving more than 1,000 patients. The company, which proposes to market the compound under the trade name Stedesa, estimates the U.S. market for epilepsy drugs at $3.5 billion.

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For months and months, we heard the mantra of “Obama: the change we need; change we can believe in.” The election is finally over. The people have spoken. Now that Senator Barack Obama is president-elect, it is my hope that certain “changes” supported by the president-elect will help jump-start two areas of focus in the Boston life sciences community: embryonic stem cell research and “personalized medicine.”

Since 1996, a law has banned federal spending on research that harms human embryos. In August 2001, President George W. Bush issued an executive order that loosed this restriction slightly by allowing federal funding for embryonic stem cell research that used one of the few then-existing stem cell lines. Now, seven years later, President-elect Obama is reviewing President Bush’s order and may reverse or amend the decision made in 2001. Expectations are high for a change. In a 2007 news release supporting legislation to loosen restrictions on stem cell research, Mr. Obama said:

I am frustrated … that we are preventing the advancement of important science that could potentially impact millions of suffering Americans … My hope, and the hope of so many in this country, is to provide our researchers with the means to explore the uses of embryonic stem cells so that we can begin to turn the tide on the devastating diseases affecting our nation and our world.

Some have asked why, given the advances in stem cell research with the federal prohibitions in place, particularly the dramatic results seen in the last few years with making stem cell-like cells from skin cells (also known as reprogrammed or induced pluripointent stem cells (iPS)), any change is needed. But there are a number of reasons why removing limitations on embryonic stem cell research is “change we need.”

Research in reprogrammed cells, while dramatic, is still in its infancy. In fact, the first reprogrammed cells were reported just a few short years ago. As a result, many issues need to be worked out. iPS cells are currently produced, at least in part, through the introduction of genes associated with cancer, using a virus that could lead to cancer-causing mutations. Needless to say, more research is needed before this methodology reaches the clinic.

Another important issue is the equivalence of iPS and other types of stem cells. Are the cells the same? Do certain types of stem cells have properties that might provide clinical advantages? Some scientists believe that iPS cells will never be suitable for cell therapy. Time and research will tell. Relaxing the ban would allow scientists in the field to use equipment and facilities funded with federal research dollars, potentially accelerating research while, at the same time, reducing research costs.

Relaxing the ban could provide another important dividend. For ethical and political reasons, many pharmaceutical and biotechnology companies have stayed away from stem cell research. It is hoped that federal support of stem cell research will encourage commercial investment, resulting in what we all hope for: clinical treatments.

Will the Obama administration change the federal position on embryonic stem cell research? …Next Page »

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It seems that Sermo, the exclusive online community for physicians, is finding new ways to monetize its population of members almost as quickly as that population is growing.

Last year, the password-protected site, where some 90,000 practicing physicians consult with one another on medical cases and other issues via a system of comments and polls, rolled out a service called AlphaMD that gives investors read-only access to Sermo’s user forums, plus the ability to query members directly through surveys. The company markets AlphaMD as a source of early, “actionable” intelligence about healthcare industry trends.

And today, at the Health 2.0 conference in San Francisco, Sermo CEO Daniel Palestrant introduced a new service called the Health Exchange that amounts to a vast expansion of AlphaMD. All 280,000 analysts and investors who use the Bloomberg Professional information service will soon have access to Sermo as part of their regular subscriptions, Palestrant announced. For an extra fee, Bloomberg users will also be able to survey Sermo users on breaking healthcare news and other questions and connect directly with consenting physicians.

Sermo touts the Healthcare Exchange as an exclusive source of information that could help Bloomberg subscribers outmaneuver other investors, by providing them with new “transparency” in an industry where gatekeepers such as journal editors and paid pharmaceutical-industry consultants have traditionally had an outsized influence on investor opinion. “The Healthcare Exchange tears down the barriers between those who need information and those who have it,” Palestrant said in a speech at the Health 2.0 meeting.

Of course, it’s a rarefied form of transparency that Sermo is promoting. The group of investors who could make good use of the insights exchanged on the Sermo network is arguably much larger than the group that can afford to pay $1,500 to $1,800 per month for access to Bloomberg terminals.

But there are certainly plenty of voices on Sermo vying to be heard. When Rebecca first reported on Sermo in July 2007, the Cambridge, MA-based startup had only about 20,000 members. That number had grown to 26,000 by the time of her followup story in September 2007, nearly 50,000 by January 2008, and 77,000 by late August. It’s now 90,000, and growing at 7,000 per month, according to Palestrant.

For Bloomberg, supplying subscribers with access to these medical experts could give service a big leg up over its main rival, the newly-merged Thomson Reuters. Sermo, which has been staffing up rapidly since its $26.7 million Series C financing round last fall, obviously stands to benefit as well. The terms of the agreement with Bloomberg weren’t disclosed, but on top of any direct fee it’s collecting from the news service, it will likely have a long line of Bloomberg subscribers queuing up to quiz physicians directly—say, about the prospects that a particular company’s drugs will fare well in clinical trials.

And investors aren’t the only ones feasting on the physician discussions at Sermo. As Ryan reported in August, Palestrant says he has lined up deals giving site access to M.D.’s at nine of the world’s 12 largest drug companies, including New York-based Pfizer.

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No sooner did Rebecca note the recent dearth of life sciences venture financings than we got word of a sizable one: Lexington, MA-based Predictive Biosciences, which has a small office in San Diego and is out to help build a new era of personalized medicine, announced today that is has secured $21.75 million in Series B financing. The round was led by new investor New Enterprise Associates and joined by Kaiser Permanente Ventures (also new) and previous investors Highland Capital Partners and Flybridge Capital Partners.

Predictive, founded in 2006, had previously raised $10 million and was formed around work done over a number of years at Children’s Hospital Boston. We profiled the startup almost a year ago to the day, in a piece that looked at its strategy of trying to develop tests designed to facilitate better, more individualized treatment of cancer. The company’s first goal: developing tools to allow doctors to detect cancer from urine samples, thereby sparing patients expensive and often grueling practices such as invasive exams and biopsies.

One of the company’s co-founders, Marsha Moses, currently leads the Urinary Proteomics Initiative at Children’s Hospital, where she helped to build what she described as “the largest urine bank in the world.” As our correspondent Malorye Allison wrote, “Having all that pee on hand and all those years of research under their belts has helped the Predictive team identify a new set of biomarkers, or telltale molecules, that are shed into the urine by a range of cancers, including biggies like breast and colon tumors.”

In today’s announcement, Predictive said the new funds will help support ongoing clinical development of its urine-based assays, which are focused initially on detecting bladder cancer recurrence. (Bladder cancer patients typically must endure a cystoscopy—an extremely uncomfortable procedure where a tube is inserted into the bladder—every three months for the first two years after their cancer is removed, and more than a dozen times in total over a five-year period.) “Over the coming months, we will continue to execute our clinical development and commercialization plans, and complete preparations to launch a multi-center clinical trial in bladder cancer recurrence patients,” said Predictive CEO Peter Klemm in a statement.

The company also has high hopes for another program for ruling out bladder cancer in patients with hematuria, or blood in the urine, says Eugene Chiu, another Predictive co-founder who is now VP of business development. Only a small percentage of patients with hematuria actually have bladder cancer, but many have to undergo cystoscopy to rule out the disease, Chiu says. For a patient who doesn’t actually have cancer, Predictive’s tests could determine that with such a high accuracy the patient and his doctor could decide to skip the cystoscopy, he says.

Ultimately, the company aims to develop tests for breast, ovarian, prostate, and colorectal cancers, among other cancers—thereby helping usher in a new era of more personalized treatment. “What this really does is in a way it individualizes and personalizes the diagnostic interventions which are done,” says Chiu.

Although Predictive is based in Massachusetts, both CEO Klemm and CFO Vikram Lamba work out of San Diego. (Klemm and Lamba were CEO and CFO, respectively, of San Diego’s GeneOhm Sciences, which was sold for $230 million to Becton Dickinson in 2006.) “We’re looking at building a global organization, and the fact that our management team is actually on both coasts in a way is an advantage for us,” says Chiu.

And he predicts that Predictive’s success will be good for both regions. “We’re going to make some waves,” Chiu says.

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Newton, MA-based InnovationRx, a medication reminder service that we profiled on June 24, has officially opened its doors to patients. The service, organized with Northeastern University’s School of Pharmacy, lets patients upload lists of their medications, then helps them create a customized plan for taking and refilling their prescription drugs on time—in part via e-mail, text message or automated phone reminders.

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For the better part of a decade, advocates of computing in healthcare have fixated on the dream of paperless medicine—a new era in which every patient’s medical records would be stored digitally and every hospital, physician’s practice, pharmacy, and insurer would have access to these records, reducing paperwork costs and medical errors. But for all of the time stakeholders have spent squabbling over standards for electronic medical records, and all of the money providers have spent rolling out costly and controversial proprietary medical-database systems, these dreams haven’t gotten very far. More than 80 percent of medical practices still keep paper records, according to a study published last week in the New England Journal of Medicine.

Meanhile, the Internet has given birth to a totally new way of doing business and interacting with consumers: Web 2.0. And in a rush of Web-based health initiatives that has picked up significant steam just in the last few weeks, entrepreneurs and programmers are leapfrogging over the problem of electronic medical records to tackle much broader (and ultimately more important) issues such as how to use the Internet to track people’s health, how to use the power of social networking to improve standards of treatment, and how to deliver medical advice over the Web.

And it’s not surprising—given the Boston area’s dense concentration of high-tech hospitals, leading universities and medical schools, computing hardware and software companies, and Web startups—that much of this “Health 2.0″ revolution is happening right here in the Bay State. Last week’s launch of Boston-based American Well is only the most recent local example, and it’s sure to be followed by more.

The area’s Health 2.0 cluster may not be quite as big as the New England clean energy cluster, but it’s larger and more varied than some other clusters we’ve covered, such as the music and technology cluster and the Internet video cluster. It’s also growing fast, with new companies being launched every month. And it has all the hallmarks of success, including buy-in from big outside players like Microsoft (which is partnering with American Well to roll out its HealthVault service) and Google (which recently signed up Boston’s Beth Israel Deaconess Medical Center and Blue Cross Blue Shield of Massachusetts as its first partners for its Google Health project in the hospital and insurance industries, respectively).

What qualifies a company as a Health 2.0 venture? In this list, we’re including any New England-based company that uses the Web or other digital media to deliver software or services intended to help people manage their own health or to help providers manage healthcare delivery. That means we’ve left out a number of local firms, such as Health Dialog, D2Hawkeye, MedAptus, MedVentive, and mTuitive, that could be classified as “e-health” companies, since they are in the business of collecting or analyzing data that’s used to improve patient health or healthcare administration. But if a company doesn’t tap into Web 2.0 technologies and/or use digital media to communicate with consumers, we didn’t include them here.

As always, we invite you to send comments and additions to editors@xconomy.com.

American Well
Boston, MA

A 24/7 online network that matches consumers seeking medical care with doctors for live consultations via Webcam, instant message, or telephone (profiled in Xconomy last week).

Athenahealth
Watertown, MA

Subscription, Web-based software aimed at helping individual clinics and provider networks manage billing and electronic medical records. (Athena shelved plans for a secondary public offering in February 2008.)

Body1
Cambridge, MA

Creates online, interactive multimedia training courses for healthcare executives and clinicians as well as consumer-oriented, advertising-supported health information portals such as Heart1.com.

…Next Page »

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When I wrote my post yesterday about the launch of American Well, the Boston-based startup that plans to let patients visit with doctors via a multimedia Web interface, I couldn’t tell you the whole story. That post was tied to the company’s formal debut at the AHIP Institute 2008 meeting in San Francisco Wednesday morning–which, truth be told, was a bit of a non-event, considering that executives have been talking with the press for months and that many details of the company’s plans have been up on its website for just as long. Two much more interesting pieces of news about American Well had to wait until today, due to embargoes requested by the partner companies involved in the announcements. Here’s the scoop:

1) American Well has signed up its first major customer. The Hawaii Medical Service Association (HMSA)—the Hawaii franchise of the Blue Cross Blue Shield network and the state’s largest health plan, covering some 710,000 citizens of the island state—says it will make American Well’s online services available to its entire membership starting with the plan’s next open enrollment period in January 2009. The 600,000 Hawaiians who don’t belong to HMSA will also be able to use the American Well system, on a pay-to-play basis.

2) American Well will work with Microsoft to integrate the software giant’s HealthVault health information management service into the American Well interface, and will promote HealthVault as an option to American Well users, starting with members of HMSA. The HealthVault system allows users to collect their personal health information online and share it with authorized users; integrating HealthVault with American Well’s system means, among other things, that caregivers will be able to view information stored in HealthVault accounts during their live sessions with patients.

Together, the two announcements lend substance to American Well’s story. The two-year-old startup boasts well-spoken executives, colorful mockups of its patient-doctor interface, slick Web videos explaining the service, expert public-relations handlers, and lavish 26th-floor offices overlooking the Custom House Tower in Boston’s financial district. But until now, it’s been unclear whether the company’s ambitious plan for an online healthcare marketplace is actually practical.

American Well promises that its service will set up video, instant-messaging, and telephone links between patients who need medical advice urgently and physicians who have time to moonlight on the Web, while handling all of the tedious details of the healthcare process, such as computerized record keeping, claims processing, and malpractice coverage, behind the scenes. On the surface, it sounds like a great idea: virtual house calls from credentialed caregivers with virtually no wait, at far less cost than a traditional office visit. (A 10-minute online session with a physician will cost roughly $45, billed either to the patient’s credit card or directly to their health plan, according to American Well.)

But making such a system work poses several Herculean challenges. The communications technology is the least of it: in the era of Internet dating, features such as webcams, text chat interfaces, and automated telephone systems are old hat. “If we had just wanted to build a system that allows Web chats between consumers and providers, we could have done it in a week,” says Roy Schoenberg, CEO of American Well Systems, the operational side of the venture. (Roy’s brother and co-founder Ido Schoenberg is CEO of American Well Incorporated, the company’s business side. Both brothers are Israeli-born MDs, and privately funded American Well is their third healthcare-industry venture together.) Much more problematic is …Next Page »

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Boston startup American Well lifted the veil on its ambitious and long-awaited online health care marketplace today. With its 24/7 online network—where people with medical concerns can log on and be matched within minutes with a physician who will provide a live medical consultation—the company hopes to disrupt business-as-usual in the healthcare industry, and potentially lower costs for both consumers and health insurers.

American Well co-founder and co-CEO Roy Schoenberg, who started the company with his brother Ido Schoenberg, jokingly calls the marketplace “almost like a Web 2.0 dating service for consumers and health-care providers.” Indeed, interactive, Web 2.0-style technologies have been seeping gradually into the healthcare industry over the last couple of years. Companies such as Atlanta-based RelayHealth and San Francisco-based Medem, for instance, have introduced “e-visit” services that allow consumers to exchange secure text-based messages about non-urgent health problems with doctors.

But American Well says its system will go far beyond this text-based model, supporting sessions where doctors and patients can connect in real time via webcam, instant message, or telephone. Physicians will have patients’ medical records at their fingertips during the consultation, and will be able to recommend treatments and write prescriptions online if appropriate. American Well will handle all billing and insurance matters related to each consultation behind the scenes.

The company thinks consumers will like the model because it offers immediate access to medical care, at any time of the day or night, without the hassle of scheduling an appointment and going to a doctor’s office. And it thinks doctors will be interested, too, since it will allow them to log into the system, offer their services, and earn reimbursements whenever they have time.

American Well designed the marketplace mainly to be offered to consumers by health plans as an add-on to their existing care options. But it will also be available on an a la carte basis to uninsured patients, according to Schoenberg. The system isn’t intended to keep patients from seeing doctors in person when they need to—but it could cut down on overall health costs by helping patients solve simple health problems without an expensive hospital or clinic visit. “What we are doing is drastically expanding the scope of care that can be rendered to patients in the least expensive possible setting, which is their homes,” says Schoenberg.

“We’re not claiming that this is going to replace traditional healthcare,” he adds. “There are numerous areas of care that require an in-person experience, where a physical examination is important. And certain diagnoses cannot be done over the Web. But the fact that you have a complementary tier of access that is much more immediate to you wherever you are will have a significant impact on your ability to utilize medical services.”

American Well timed the launch of its online marketplace to coincide with the AHIP Institute 2008, the annual meeting of America’s Health Insurance Plans, the leading trade association and lobbying group for the health insurance industry. American Well is a sponsor and exhibitor at the meeting, which is being held in San Francisco, and produced a free recorded webinar on Web 2.0 technologies in the healthcare industry that’s accessible via the meeting website.

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Vertex Pharmaceuticals (NASDAQ:VRTX) of Cambridge, MA, saw its stock soar today after preliminary data from a small ongoing trial of its oral hepatitis C drug Telaprevir were released in a conference abstract.

The abstract indicated that patients for whom standard hepatitis treatments had previously failed responded well to Telaprevir. The data are scheduled to be presented at a late April meeting of the European Association for the Study of the Liver in Milan.

Vertex shares reached as high as $24.20 before closing at $23.89, up $5.23 (28 percent) from yesterday’s close.

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In 2006, the Nobel Prize in medicine went to two American biologists, Stanford’s Andrew Fire and UMass Medical School’s Craig Mello, who had discovered a way to shut off individual genes by blocking key RNA molecules in the cell. But while the technique, called RNA interference or RNAi, immediately became a powerful research tool, it was unclear how quickly it could be translated into drugs to treat the myriad health conditions that crop up when gene activity is out of whack. At a meeting in Singapore today, however, researchers from Alnylam Pharmaceuticals (NASDAQ: ALNY) of Cambridge, MA, are reporting what they call the first evidence of the effectiveness of an RNAi-based treatment in humans.

In a Phase II trial, researchers deliberately exposed 88 healthy adults to respiratory syncytial virus, or RSV, which mainly affects the breathing passages and can be life-threatening for infants and elderly people. Some of the volunteers, who were all men living in London, England, received a placebo treatment, while others received a five-day, nasally administered course of Alnylam’s ALN-RSV01, which is believed to shut down a gene that’s hijacked in infected lung cells to let RSV replicate. Compared to the placebo recipients, volunteers receiving the RNAi drug had a 38 percent lower rate of developing an RSV infection, Alnylam said in a press release. The effect was statistically significant, and the drug had no untoward side effects in the study, the results of which are being presented at the International Symposium on Respiratory Viral Infections in Singapore but have not yet been published in a peer-reviewed journal.

According to the Wall Street Journal, a Miami company called OPKO Health is contesting Alnylam’s claim that its study is the first to demonstrate a health benefit of an RNAi treatment in humans. OPKO says it conducted a trial in 2006 showing that its own RNAi-based drug was effective against macular degeneration, a leading cause of blindness, but the effect fell just short of statistical significance.

Alnylam–which is named after Alnilam, the center star in Orion’s belt—was founded in 2002 by MIT biologists Philip Sharp (an Xconomist) and Dave Bartel and three other researchers. The company’s initial venture backing came from Polaris Venture Partners and Cardinal Partners, and ARCH Venture Partners and Atlas Venture joined later financing rounds. The company went public in 2004. As of 1:30 EST, Alnylam’s stock was trading at around $29.50, down approximately 1.5 percent from Thursday’s close.

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