CLEVELAND - With many of the nearly 1,000 attendees at the 7th annual Cleveland Clinic Medical Innovation Summit walking around the InterContinental Hotel and Conference Center in October toting black bags with the words: "Cancer Cures Through Innovation" boldly printed in white, it wasn't difficult to pick up on this year's clinical theme.

But what some of those attendees may have been wondering as the conference kicked off was - why cancer?

"Cancer treatment has come a long distance since the days when a lumpectomy was controversial," said Delos Cosgrove, MD, president/CEO of the Cleveland Clinic.

Touching on a hot-button topic nationwide, Cosgrove said that, "healthcare reform is really about payment reform," adding that a broader discussion of healthcare reform is needed.

"Some people see new drugs and devices as part of the problem - we know they're part of the solution," Cosgrove said. He noted that in the long term, new technology is what brings healthcare costs down.

"Innovation is the long-term solution to high quality, affordable healthcare - that should be the essence of healthcare reform," Cosgrove said.

Further attempting to explain why cancer is the focus of this year's summit was Derek Raghavan, MD, PhD, chair and director of the Taussig Cancer Institute at the Cleveland Clinic, who provided a summit overview.

"Surgery is going to be improving its ability to move forward without toxicity," Raghavan said.

He talked about several themes attendees can expect to hear about throughout the three-day summit, including molecular prediction, novel therapeutics, radiation technology, surgical technology and "defining the cancer agenda."

"Our interest is to set a spring-board for the future," Raghavan told attendees.

He also noted several issues important to improving cancer treatment, including recognition of key items; clever prioritization; a strengthened delivery model; and improved data acquisition.

The summit will also provide an opportunity to discuss certain key topics in cancer such as why there are so many discrepancies across the board from one racial group to another, Raghavan said. "We need to drill down and ... get a dialog going," on some of these issues, he noted.

Clearly another issue of interest is the fact that, "we don't enter patients into our clinical trials," Raghavan said, calling the low percentage of patients diagnosed with cancer who are enrolled in clinical trials a "national scandal."

Out in the exhibit halls representatives from many different drug and device companies were eager to talk about how their technology will impact cancer care going forward.

Among them, a company called superDimension (Minneapolis) that has developed the inReach System, which uses electromagnetic navigation bronchoscopy (ENB) to provide minimally invasive access to lesions deep in the lungs as well as mediastinal lymph nodes. According to the company, by extending the reach of conventional bronchoscopes, the inReach system enables physicians to diagnose benign and malignant lung lesions, enhancing treatment decisions and avoiding the need for higher-risk procedures.

Dan Sullivan, president/CEO of superDimension, told BB&T that with the inReach system, the physician inserts a catheter through the patient's throat, which is guided by GPS-like technology to diagnose, minimally invasively, whether or not the spot on a patient's lung is cancerous. "You eliminate two surgeries with one catheter procedure," Sullivan said.

With healthcare costs being at the center of the reform debate, Sullivan was sure to note that his company's technology has the potential to reduce costs associated with lung cancer. He said the cost to Medicare for a wedge procedure is $17,000 if there are no complications - and $25,000 or more if there are complications. In contrast, the cost of an ENB procedure is estimated at $2,600. "It fits everyone's agenda," Sullivan said.

IBM CEO: U.S. needs 'true healthcare system'

In a time of continuous heated debates about reforming America's healthcare system, the CEO of IBM, Sam Palmisano, spoke to attendees at the meting about why the nation's healthcare system isn't a "system" at all.

"The single question that is most critical to the future of healthcare in this country - and the world - is the need for a true healthcare system," Palmisano said. "Underscore 'system.' And I believe we have a better chance now than ever before to build it."

To explain why, Palmisano discussed some of the emerging shifts in technology and business that he believes are helping to make the world smarter.

He mentioned several events that have occurred in the first decade of the 21st century. "In the last few years, our eyes have been opened to global climate change," Palmisano said. "And to the environmental and geopolitical issues surrounding energy." He also noted that, "we have been made aware of the vulnerabilities of global supply chains for food and medicine." Also, he said, "we entered the new century with the shock to our sense of security delivered by the attacks on 9/11." And now of course, "we are in the midst of a global financial crisis."

While these events may seem unrelated, Palmisano has a different view. He believes these are a pattern of events that is a result of the fact that the world is now globally connected. "These wake-up calls have reminded us that we are all now connected - economically, technically and societally."

"The world is becoming smarter and this isn't just a metaphor," Palmisano said. "Intelligence is being infused into the way the world literally works - the systems and processes that enable services to be delivered."

The world is becoming instrumented, Palmisano said. He noted that there are nearly a billion transistors for every person on the Earth, each one costing one ten-millionth of a cent. There are 4 billion mobile phone subscribers, he said, and 30 billion radio frequency identification tags produced globally.

The world is also becoming interconnected, according to Palmisano. Soon, he said, there will be 2 billion people on the Internet. But that's just the beginning, he noted. "Systems and objects can now 'speak' to one another. "Think about the prospect of a trillion connected and instrumented things - cars, appliances, cameras, roadways, pipelines, even pharmaceuticals and livestock. And then think about the amount of information produced by the interaction of all those things. It will be unprecedented."

All of these sensors and data is creating the potential to add intelligence, Palmisano said, reiterating his point that, "the world is getting smarter."

Palmisano quoted Denis Cortese, MD, president/CEO of the Mayo Clinic (Rochester, Minnesota) saying that Cortese surprised audience members at an IBM forum on "smarter cities" in New York last week when he said that the American healthcare system isn't broken because that would imply that there actually is a system to be fixed.

"At IBM this is something we know quite a bit about; we know about systems," Palmisano said. He outlined four essential qualities any system must have to be well-functioning: first, there must be clarity on the system's purpose or goal; second, its elements must be connected - interfaces matter; third, we must be able to know, continually and with confidence, the status of the system and its critical components; and last, the system must be able to adapt as conditions change.

How does this apply to healthcare?

"In theory, everyone agrees on the system's purpose ... that American healthcare must become patient-centric," Palmisano said, adding that the system also must be value-focused, evidence-based, accountable, and sustainable.

"There is wide recognition that the components of American medicine and healthcare - testing capability, hospitals, medical schools, emergency response, pharmaceuticals and the like ... they are not the problem," Palmisano said. He noted the amazing breakthroughs occurring in innovation, thanks in large part to many of the summit's attendees - and said that, "what you guys do is not the problem. The problem is that nothing is actually connected."

"This is something so basic that we simply take it for granted in other areas of life," Palmisano said.

For example, he said, in the banking system we assume we can transfer funds and make payments between institutions. Another example he used is the airline system. "We take for granted that reservations are connected to ticketing, payments and loyalty programs," Palmisano said.

Why do these other systems work?

"All of these systems have standards and interfaces that permit information and data to flow," Palmisano said. "I'm talking about the processes and protocols that comprise the work of any system. Healthcare in America fails this key test of a well-functioning system."

Palmisano said that because the components and subsystems of healthcare are not instrumented it is impossible to know with confidence what their current status is. "Indeed, most of the participants in the system - most notably, patients - must record their status anew every time they interact with it."

For example, he said that more than 20% of lab tests are repeated unnecessarily because patient records are not available at the point of care.

To put it in terminology that the clinical audience at the summit might better understand, Palmisano said that, "if the healthcare system was a patient, and we were its doctors, we would be unable to read its vital signs."

Palmisano did however acknowledge the efforts of the Cleveland Clinic to pioneer the use of electronic patient records, reducing errors, lowering costs and becoming more patient-centric.

His remarks seemed to stick with several attendees and other speakers Tuesday even as they turned their attention to an afternoon session on corporate venturing. Ven Manda, VP of Medtronic Ventures and New Therapies and a panel member on that afternoon session, said that Palmisano's comments about the problem not being at the component levels struck a chord with him. "Are there standards? Are there processes and protocols? That was a key take-away for me and I'm not sure we have the answer to that," Manda said.

Can America's healthcare system adapt to change?

The fourth characteristic of a well-functioning system, according to Palmisano, is adaptability. "Ask yourself, is our healthcare system in America today - spanning providers, hospitals, insurers, pharmaceuticals, employers, communities and government - is that ecosystem ready for what's coming?" He noted that demand is only going to grow, especially as the Baby Boom population enters its senior years.

"If we agree on the need for, and lack of, a healthcare system," Palmisano said, "then the questions become 'how do we get there,' what do we do first and why,' and 'who's going to do it?"

Palmisano asked the audience to think about the retail system. "We take it for granted that store shelves are being stocked, inventories are being managed, global supply chains are operating smoothly and efficiency is being continually improved," he said. "... it began with the invention of having a universal product code - the UPC."

Palmisano said the UPC was originally developed to help supermarkets improve checkout speed. It was first used in a supermarket in Troy, Ohio in 1974 when the cashier scanned a package of Wrigley's gum. We now know, he said, that the invention of the UPC "did much more than improve checkout speed." He said it also "streamlined global supply chains."

What could change healthcare the way the UPC changed retail?

Palmisano says one strong candidate for changing healthcare the way the UPC changed the retail industry is the electronic health record. "Of course, that would just be a start. Connectivity is going to be necessary. But as we've learned painfully over the past decade, it isn't sufficient."

Also needed, Palmisano said, is "the ability to inject intelligence and analytics into the network and the myriad things, processes and management systems it connects." Then again, he noted, "As we've seen in other industries, world-sized trees can spring from seemingly small acorns."

Just like retailers in 1974 didn't know the extent of how the UPC invention would change that industry, Palmisano said that, "we can't know today all the dimensions of such a system."

Corporate venturing explored by panel

At a time when money is difficult to come by all around, the organizers of this year's summit recognized that attendees might find it interesting to learn how large corporations are increasing their activity as it relates to venture investing.

Thus, a panel session focusing on "corporate venturing in a time of innovation and capital shortfalls," moderated by CNBC's Maria Bartiromo, included a panel of corporate and venture leaders who discussed what they look for in new ventures, some of the current challenges facing entrepreneurs and venture capital investors today, and how those challenges might affect the development of new technology down the road.

Darren Carroll, VP of the new ventures division at Eli Lilly (Indianapolis), probably summed it up best when he said at the beginning of the session that, "2008 was a really tough year for everyone."

Adding to that sentiment, Harry Rein, general partner of Foundation Medical Partners (Rowayton, Connecticut), said he has heard it said that "good is the new perfect." Rein says that for him, as an independent venture capitalist, it is a multi-faceted issue. "We have to stay in a lot longer," he said. In other words, exits are not as easy to come by. Also, he added, "selecting becomes much more crucial."

Ven Manda, VP of Medtronic Ventures and New Therapies, making him the strategic leader for Medtronic (Minneapolis) venture funds, said the firm just funded roughly 25 new ventures. Of those, he said nearly 80% are drug-device combinations. He said the company is really interested in finding out "what role can we play in delivering a therapy more efficiently?"

Manda also mentioned external instruments, "enabling technologies" and minimally invasive technologies as being areas of interest for Medtronic. He said the company sees such technologies as being "part of the next wave of innovation in multiple disciplines."

One audience member took advantage of the conversation occurring on the panel stage. "I hate to sound like the only entrepreneur in the room," he asked about midway through the session, "but how does one present a device concept to one of you gentleman?"

While the questions was met with some chuckles from others in the audience the panel members simply replied, "Well, what have you got?" and "Talk to us after the session." While those may not have been the specific answer the entrepreneur was looking for, Mark Vachon, president/CEO of GE Healthcare's (Waukesha, Wisconsin) $9 billion Americas region, said that hopefully he, as well as other entrepreneur attendees in the audience, learned what types of things venture capital investors are looking for in new ventures.

Vachon noted that healthcare companies today are spending so much money on administrative costs, and said that GE is looking for technologies that can help improve workflow and "get that waste out of the system."

On the pharmaceutical side, Caroll responded to a question about why large pharmaceutical companies might hesitate to get involved with a new venture. "In large pharmaceutical companies we love control," Caroll said. "We want to know that any pharmaceutical we send out into the world [is a quality product]. None of us will negotiate or compromise on that."

Caroll also said that currently it's not uncommon for big pharma companies to spend 8 to 10 years in an asset before getting out of it, which he considers a long time. "We think that needs to be closer to three years," he said.

In contrast, Rein, whose firm invests in early-stage medical device companies, said that, "as an early stage investor - if I could get out in three years I'd view that as miraculous."

"Without innovation we will not get from here to there," Rein said. "If you think about a person who gets diagnosed and then they get treated ... sometimes the time between diagnosis and treatment is fairly extensive," he said. He believes information technology is a way to "shrink that time" lag.

As the Baby Boomers make their way through the healthcare system, Rein noted that areas such as orthopedics - particularly spine and joints - as well as the neurology sector are of interest right now. Those, he said, are expected to be "huge growth markets going forward."

Roy Davis, president of Johnson & Johnson Development Corp. (J&J; New Brunswick, New Jersey) said that J&J looks for technologies that could enable a much earlier diagnosis for diseases like cancer. Ultimately, he said, such earlier diagnosis will not only lead to better patient outcomes but also lower healthcare costs.

Clearly cost is a concern, but Manda says that it is difficult to worry about that when dealing with early-stage medical device companies. In the early stages, he said, it is more important to find out if a new device even works, before worrying about whether or not it will lower costs. That's not to say though, that cost effectiveness isn't important.

"My only concern is that it's very difficult to pick a winner, particularly in the very early stages of the development process," Manda said. He said he worries about "inadvertently stomping a therapy early on" that could have been beneficial down the road, simply because it didn't pass some type of preconceived criteria in the beginning stages.

"We need to make these things cost effective, it's just that determining those things early on ... is very difficult," Manda said.

One issue that is clearly a concern for the panel members is the proposed dissolution of the 510(k) process. The FDA late last month said it has commissioned the Institute of Medicine (IOM; Washington) to study the 510(k) process, known to be less stringent than the premarket approval (PMA) process.

Rein said he is concerned about what it will mean for entrepreneurs if the agency does in fact do away with that process. "For an entrepreneur, time is money," he said. "It's an interesting dilemma."

Vachon agreed, saying that the PMA process is "very costly and very long in terms of cycle time."

He encouraged venture capitalists to get involved in the healthcare policies being proposed, or at least to be aware of what is being discussed and the potential impact they could have on innovation. "Comparative effectiveness," he said as an example, "all for it - but be very careful as to how that is managed."

Tansparency key to restoring confidence in FDA

FDA Commissioner Margaret Hamburg, MD, was afraid David Ewing Duncan would ask her to grade the agency, which she was appointed head of less than five months ago. Duncan, an author and science journalist, moderated two sessions at the meeting. Prior to interviewing Hamburg, Duncan interviewed Richard Clark, CEO of Merck (Whitehouse Station, New Jersey), and had asked him to grade his company.

Sure enough, Duncan's first question for Hamburg was "how would you grade the FDA?" Hamburg declined to put a letter grade on the agency, but did offer her general perspective on it.

"The FDA is an incredible institute ... it has been the gold standard for a consumer safety agency," Hamburg said, noting that the agency is responsible for the safety of the food, drug, and device industry - which combined add up to $2 trillion worth of goods. "Overall FDA does a very excellent job."

Agreeing to take on the role of FDA commissioner was not an easy decision for Hamburg to make last May, she confessed. After all, she reads the newspapers - she has seen the level of media scrutiny the agency had been under in the past. "Coming into this agency ... it was viewed by many as a beleaguered agency. It was under-funded, under-resourced and criticized in the media," Hamburg said. But she accepted the job anyway, with the belief that her background as a public health executive would help her return the FDA to its core mission, which is public health.

"Setting priorities is essential," Hamburg said. "Restoring trust and confidence in FDA as a science-based, science-driven agency - that is key." To accomplish that goal, the commissioner said the agency will need to open itself up and explain to the public how it does things and being a vocal advocate for the agency.

"It is stunning how under-funded we are given the importance of what we do and given the uniqueness of what we do," Hamburg said. "If we are not well-funded ... there isn't anybody who is going to come in and back stop for us."

Duncan followed up those comments by asking Hamburg, "how do you restore that trust?"

The commissioner acknowledged, "There will always be problems and there will always be a crisis for us to respond to." She said the FDA would need to improve how it responds and become more transparent. "Really speaking to the concerns of the public and policy makers when there is a crisis and really step out and explain what we know and what we don't know."

Luckily for Hamburg, there hasn't been a major crisis the FDA has had to deal with since she was appointed commissioner in May - and she knocked on the wood desk in front of her as she said so during the interview. That has given her time, she says, to learn about the agency and listen to stakeholders to really understand what issues they are most concerned about with regards to the FDA.

"It's in everyone's interest to have a strong, well-functioning FDA," Hamburg said.

When asked by an audience member what she sees as challenges to regulating devices, Hamburg said it has been "a real eye-opener" for her to see just how differently devices are regulated from drugs.

"It's one of the areas where the world has changed dramatically since our rules were put in place ... devices are much more invasive, they are much more complex," Hamburg said, adding that often devices are not simply a medical device but a combination of a drug and device together. "To really be able to assure the public that the full range of devices that are available to them ... have [undergone appropriate] safety and effectiveness review" there will have to be some changes made to that process, she said.

Such changes might be uncomfortable for people in the device industry, Hamburg admitted, but promised to be "as open as we can" about it.

One such change that could be on the horizon is a possible dissolution of the 510(k) process. The FDA said in September that it had commissioned the Institute of Medicine (Washington) to study the 510(k) processes, known to be less stringent than the premarket approval process.

Top 10 medical innovations for 2010 unveiled

As has become a tradition at the meeting, a panel of Cleveland Clinic practitioners unveiled the clinic's fourth annual much-anticipated Top 10 list of medical innovations expected to have a big impact on healthcare in 2010.

According to the Cleveland Clinic, the team responsible for selecting the list of breakthrough devices and therapies used a rigorous process to gather the opinions of leading Cleveland Clinic physicians and researchers, create a field of nominated innovative technologies for consideration, and develop a consensus perspective of what will be the Top 10 medical innovations for 2010. The team interviewed nearly 60 Cleveland Clinic experts to elicit their nominations. These interviews yielded nearly 100 nominations of emerging technologies.

Technologies that were nominated had to fit four major criteria:

• Had to have significant clinical impact.

• Have a high probability of commercial success.

• Be in or exiting clinical trials to be available on the market sometime in 2010.

• Have significant human interest in its application or benefits, and must have the ability to visualize human impact.

The Top 10 medical innovations for 2010 are in order from last to first:

10. Whole slide imaging for management of digital data in pathology. This technology converts glass slides into digital slides with "excellent" imaging quality that can be viewed, managed, stored, streamed over the Internet, and analyzed on a computer.

Presenter Kandice Kottke-Marchant, MD, PhD, chair of Pathology and Laboratory Medicine Institute at the Cleveland Clinic, said this new technology allows the pathologist to scan and digitize an entire slide, or group of slides, and send the images over the Internet to any consulting pathologist. She noted that the capability would be especially beneficial to smaller pathology groups because they will be able to share images for consultation.

9. Devices for occluding left atrial appendage to reduce stroke risk. The Cleveland Clinic said that in the past, new drugs have been sought to replace long-term warfarin therapy, but none have succeeded. In April, however, an FDA advisory panel voted in favor of approving a new device alternative to long-term use that can prevent clots from developing in patients with atrial fibrillation. A second device is being tested, with FDA approval expected in early 2010, the clinic noted.

During a 90-minute minimally-invasive procedure with one device, a tiny polyester-covered umbrella-shaped mesh device is snaked up via a catheter through a blood vessel in the groin into the right atrium of the heart and implanted permanently just behind or at the opening of the left atrial appendage. The body soon begins to form tissue over the implant, permanently closing off the appendage and eliminating the risk of forming blood clots there. The second device is a clip that is placed over the left atrial appendage, either during surgery or a minimally-invasive procedure, the clinic said.

Presenter Samir Kapadia, MD, an interventional cardiologist at Cleveland Clinic, said the devices offer "an incredible advancement in the field." Of course it requires some fine-tuning, he added, noting that the procedure itself was risky.

8. Oral Thrombopoeitin (TPO) receptor agonist that stimulates platelet production. According to the Cleveland Clinic, roughly 50,000 to 100,000 people in the U.S. are diagnosed with chronic immune thrombocytopenic purpura (ITP). The clinic said that the medical and ITP community welcomed the promising results of an international Phase III trial that were the basis of the recent approval of the first TPO receptor agonist to treat adults with ITP. The new drug works by stimulating the production of cells in bone marrow from platelet cells in the blood.

7. Outpatient diagnosis of sleep-related breathing disorders. According to the Cleveland Clinic, at-home testing devices for sleep apnea allow patients to be diagnosed in the comfort of their own bed, rather than in a sleep center.

6. Forced exercise to improve motor function in patients with Parkinson's disease. According to the Cleveland Clinic, tandem bike riding may be a new way of improving motor function in patients with Parkinson's. After pedaling at more than 90 revolutions per minute (RPM) for more than 50 miles in front while a friend with Parkinson's served as the stoker while pedaling in the back seat of the tandem bike, a scientist noticed that his friend's hand tremors had suddenly disappeared. A small eight-week study was launched to gauge the effects of forced exercise (tandem riding in which patients are forced to pedal 80-90 RPM) on Parkinson's symptoms. The results: 35% improvement in motor functioning for those patients who did the forced exercise compared to those exercisers who pedaled a stationary bike at their own pace.

5. Fertility preservation through oocyte (egg) cryopreservation. According to the Cleveland Clinic, oocyte cryopreservation, or egg freezing, can be used to put a healthy woman's biological clock on hold until years later when she is eventually ready to conceive. This procedure also gives women at risk of losing their fertility due to medical circumstances the chance to circumvent sterility brought on by cancer treatment or other medical maladies that damage childbearing potential, the clinic noted.

New cryopreservation techniques have been able to sidestep previous problems with egg freezing and protect the egg from "freezer burn" that previously compromised the integrity of the egg during freezing and thawing, the clinic said.

4. Non-Vitamin K antagonist oral anticoagulants. According to the Cleveland Clinic, two new non-vitamin K antagonist oral anticoagulants may end up being an alternative to warfarin. The new pill prevents venus thromboembolism (VTE) in patients undergoing hip or knee replacement.

VTEs are treated with anticoagulant therapy, however, problems with the drug's unpredictable effects, the need for close monitoring, long onset of action, and food and drug interactions have made warfarin therapy difficult to manage, the clinic said.

3. Continuous-flow ventricular assist devices. The newest versions of continuous-flow ventricular assist devices are "revolutionizing the transplant process," according to the Cleveland Clinic. Presenter James Young, MD, chair of the Endocrinology and Metabolism Institute at the Cleveland Clinic, provided some history about the ventricular assist devices, noting that the first device was implanted in 1966. Now, it appears that the devices may soon be more than just a bridge-to-transplant therapy, but rather a destination therapy. FDA approval for this indication is expected in 2010, the Cleveland Clinic noted.

"These devices have been a long time coming," Young said. "This year the explosion in implants of these devices has been due to a shift" from the large, bulky earlier versions to the smaller, easier to install continuous-flow devices.

2. Low-volume, low-pressure tracheal tube cuff to reduce ventilator-associated pneumonia (VAP). For patients who must be intubated, there is now an effective way to reduce serious pulmonary problems and save lives in the ICU, according to the Cleveland Clinic. A new low-volume, low-pressure endotracheal tube cuff with a special suction setup that provides effective airway seals at low pressure and allows all secretions to drain from the subglottic space just above the tube cuff, has recently been approved for use in the UK. FDA approval is expected later this year, the clinic said.

The new device "dramatically reduces the risk of VAP by providing continuous effective airway seals at low mucosal pressures," according to the clinic.

1. Bone conduction of sound for single-sided deafness (SSD). A new non-surgical, removable hearing and communication device that is designed to imperceptibly transmit sound via the tooth to help people with SSD regain their hearing when someone speaks toward the deaf ear is expected to get FDA approval next year.

According to the Cleveland Clinic, as a nearly-invisible digital audio device, the system consists of a small microphone unit worn behind the ear on the deaf side and a removable dental retainer-like device that contains electronics, a sealed, flat, rechargeable battery, wireless capability that picks up sound transmissions from the microphone unit, and a small actuator that converts those signals into vibratory energy.

Innovation not discussed in healthcare debate

As a panel at the meeting discussed ways healthcare reform will change life for medical innovators, an interesting theme emerged: Innovation is not at the healthcare reform table.

It was a point made by David Brooks, a New York Times columnist who has recently emerged as a voice in the healthcare reform debate. Panel moderator Debra Lappin, president of the Council for American Medical Innovation (Washington), used Brooks' statement to kick off the discussion about healthcare reform and its potential impact on innovation.

David Nexon, senior executive VP at the Advanced Medical Technology Association (Washington), said that a "huge issue" in the healthcare reform debate is that innovation is not something people in Washington are paying much attention to. Innovation is a "huge blind spot" in the debate, Nexon said.

"I think what our audience doesn't realize is that great innovation is built through incremental steps," said Richard Smith, senior VP of Pharmaceutical Research and Manufacturers of America (Washington). "[We need to] make sure that as we go forward we are putting the systems in place that recognize that."

When the discussion turned to comparative effectiveness another panel member, Beth Seidenberg, MD, a partner with Kleiner Perkins Caufield & Byers, made a startling statement - one that she later admitted she hopes won't come true. She said that venture capital investors won't invest in things for five to 10 years, until there is clarity on how things are going to play out, which in turn would stall innovation. "And I think that would be a crime," Seidenberg added.

Later, in response to a question from an audience member, she said that she is "hoping my comment will not come to fruition." She encouraged the summit attendees to "have a voice" in the healthcare reform debate. "It is important that physicians and scientists speak up and are active in the debate," Seidenberg said. "We all, as leaders in the industry, need to have a voice at the table."

Edward Buckley, director of economic policy at the Biotechnology Industry Organization (Washington), said that comparative effectiveness could be an "incredibly powerful tool to help drive forward scientific knowledge." He added that if done properly, comparative effectiveness could be an "incredible gift" to society. However, he said, if not done properly, it could be a "detriment of innovation."

Seidenberg said the idea of comparative effectiveness is "truly a double-edged sword." To use a specific example, she talked about the National Institute for Health and Clinical Excellence (NICE; London) in the UK. According to its web site, NICE is "an independent organization responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health." As Seidenberg described it, however, it is a gatekeeper organization that has the power to say which products the public should or should not have access to - even after the product has received regulatory approval.

While Seidenberg raised some concerns about the issue of comparative effectiveness and what might happen if the U.S. healthcare system included an organization similar to NICE, Smith said he does not think that is likely to happen. "I'm optimistic about where this issue is going to end up," he said. "I think there is a consensus that we don't want to end up ... with something like NICE." In fact, he added, there is a proposal already on the table that is superior in terms of continued access to innovative products for patients.

At the start of the panel session, Lappin put up a rather complicated flow chart titled "the road to passage of healthcare reform legislation" and then asked the panel members to predict where the healthcare reform legislation will be by the end of the year.

"Change is coming, despite the complexity of that chart," Nexon said. The question is, he said, is "will the bill pass before Thanksgiving or before Christmas?"

Smith agreed with Nexon that a healthcare reform bill would probably pass by the end of the year. He said at this stage the legislation is probably "at the end of the beginning," although he added that he believes "there is a great deal that will get moved around" before we see passage of a bill.

Buckley agreed that, "something will happen," but again said the question remains "what and when." He added that he believes the passage of a healthcare reform bill will "certainly increase access for today's patients for today's innovation." However, he said, "What it does for future patients ... right now is in a state of flux."

Seidenberg simply responded that there are three things she is never willing to make projections on: the weather, the FDA, and "whether we'll have healthcare reform."

As time ran out Lappin concluded the discussion by encouraging the audience - which was comprised primarily of innovators - to get involved with the healthcare reform debate. "Get innovation into this dialog," she said, "it's never been more needed."