Thursday, October 17, 2013

Give me your innovators yearning to breathe free

by Bernard Munos, FasterCures Senior Fellow

Ingenuity defines America. From sea to shining sea, the country bristles with innovation. GoogleeBayIntelTeslaYahooSpaceXLinkedInFlickrFacebook, exemplify the indomitable American genius… or perhaps the indomitable genius of its immigrants, as all these companies were (co-) founded by foreign-born entrepreneurs.
This is no artifact. Economic geography shows that innovation thrives where cultures blend. It is true of countries built by immigrants, such as the United States, Australia, or Israel. It is also clear from the capitals of former European empires – Berlin, Vienna/Budapest, Paris, London – where the mingling of ethnicities created the ferment that transformed them into cosmopolitan beacons of artistic and technological power. Further back in history, Florence, Venice, Rome, Athens, Constantinople, and Alexandria have all at some point leveraged their positions on trading routes, or their dominion over faraway provinces, to create the cultures that gave us the Renaissance, Hellenism, and the Islamic golden age – when roving scholars from Cordoba to Bukhara made major contributions to medicine, mathematics, and astronomy. 
Today, innovation continues to thrive where cultures overlap: Silicon Valley, Boston, Quebec, Singapore, the Baltic Rim, Switzerland, Flanders, and many other regions.  In the United States, the foreign-born represent 12% of the population, but they account for 25% of its Nobel prizes, 25% of the founders of venture-backed companies,30% of its patents, and 47% of its scientists and engineers with doctorate degrees. Immigrants are over-represented among members of the National Academy of Sciences and the National Academy of Engineering, and among the authors of highly-cited science and engineering journal articles.
It is as if innovation somehow comes more naturally to people who internalize various cultures. Research and casual observation actually support that idea. Polyglots know, for instance, that one does not think alike in various languages. A Frenchman does not think like a German. One is holistic, the other is methodical. These differences carry over to how we solve problems. Some cultures are analytic and reductionist, others are intuitive and associative. No single approach is better, but, depending upon the problem, some may be more appropriate. People steeped in multiple cultures can access a broader set of problem-solving pathways and pick one that best fits the situation at hand.
There are other reasons that put immigrants at an advantage when it comes to innovation. They are apt at challenging norms and authority, and prone to act when unhappy with their lot. With their accents and customs, they never quite fit in, and are used to being different and operating from the margin. They are also at ease with disruption, which is part and parcel of being an immigrant. Like entrepreneurs, they have a tolerance for risk, and a bias for action.  And they top that with a relentless drive to succeed because they can never be completely mainstream.
Research also shows that immigrants have an uncanny ability to function in multiple worlds at the same time. They often grow up speaking one language at home and a different one at school, and they sometimes must learn several languages as their parents change countries to flee war or persecution. Those who become scientists retain the agility to move back and forth between multiple domains. They are boundary crossers, with interest and expertise in multiple disciplines, but operating preferably at their interface. They are not biologists or chemists or physicists, they straddle the boundaries between these sciences, and can see connections that might elude less versatile scientists. This makes them especially effective problem-solvers. They think differently, can approach problems from various angles, and harness multiple problem-solving tools.
With such attributes, one would think that countries blessed with immigrants would see them as assets to be leveraged, not a ball and chain on the economy. Indeed, those that value them, such as Israel, are among the world’s most innovative societies.  But most nations see immigrants unfavorably, like welfare collectors, and relegate them to camps and ghettos. It does not help that many have a precarious immigration status – like temporary visas that get overstayed or no visa at all. But then, people who flee war and misery seldom have their papers in order. This makes much of the current US debate on immigrants – and whether they arrived legally – a bit disingenuous. We should do what best serves the interests of America, and not lose ourselves in legalistic arguments.  Immigration is like free-trade. It benefits a country, even if the other party does not play fair. Just as a nation gains from engaging in free-trade, even if its partners do not reciprocate, it also gains from welcoming immigrants, however they arrived. This is not a plea to lift all restrictions, but one to manage them wisely.
Immigrants build great nations, but as societies mature, they tend to lose their vitality. They become risk-averse while entrenched interests and bureaucracy combine to enshrine the status quo into complex regulations that deter change and innovation. America has aged better than most, due in no small part to the fact that it remains by far the top destination for the migrants of the world, taking in roughly 20% of its “huddled masses yearning to breathe free”. This has been America’s enduring success formula: a multicultural society constantly refreshed by a flux of immigrants that accomplish here what they could have never done elsewhere. Immigration has given us many of our leading scholars and entrepreneurs, and the technological advances that have shaped our society and the world. Let’s make it easier for immigrants to continue to help us remain in the vanguard of innovation. No one else will.

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Look Who's Talking at Partnering for Cures 2013

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Partnering for Cures 2013: November 3-5
Partnering for Cures is a meeting focused on innovation, science, and collaboration. It is a platform for big ideas, transformative programs, and tangible results brought forth by some of the most disruptive innovators of our time.

A shared sense of urgency binds together meeting participants, because we all know that when it comes to the search for cures, "soon" is just not good enough.


Look who's talking at #P4C2013
Partnering for Cures speakers
quote  Partnering for Cures emphasized the urgency that time is lives... We have to be willing to approach [challenges] in a different way to get solutions." 
– Academic scientist
quote  It's a place to challenge conventional thinking."  
– Start-up company executive
quote  [Partnering for Cures] is the biggest gathering of patient advocacy groups, biotech companies, pharma companies, and regulators."  
– Xconomy
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Thursday, July 18, 2013

Evaluating “Value”: How Do We Foster Innovation in Today’s Cost-Conscious Healthcare Environment?

Two out of three participants in a recent FasterCures workshop believe that patients’ needs and priorities are not driving decisions made by payers, innovators, and providers. To have a stronger grasp on the role the patient can and must play in reimbursement decisions, FasterCures and the Cystic Fibrosis Foundation convened a one-day multi-stakeholder workshop earlier this month titled, “Value and Innovation: What Will the New Day Look Like for Patients?”
Fifty-three leaders participated from across the four Ps – venture philanthropy patientorganizations from TRAIN (the Research Acceleration and Innovation Network), biotechnology and pharmaceutical company executives, payers (public and private), and provider organizations.
Anchoring the day-long conversation, the first of five sessions focused on the stakes for patients in a cost-constrained environment, and how patients and their advocates can help shape the dialogue and decisions about who will pay for development of new treatments and rising healthcare costs. An overview of the Affordable Care Act followed, providing important context to the conversation about curbing health care costs. Next, the group focused on resources and infrastructure for research being created by innovative patient foundations – and how these groups are doing more and more to transform both the path toward cure and care for their disease. The fourth session looked into the types and sources of evidence payers use and are looking for to make informed reimbursement decisions. Finally, participants dug into the meaning of the term “value” and how new payment and delivery models are driving the definition of value and affecting innovation.
Five themes surfaced during the dynamic discussion:
  1. Patient-relevant outcomes will ultimately drive the definition of value: Patient engagement in all stages of drug and device research and development, care delivery and payment decisions is vital. Determining and measuring outcomes that are important to patients is an emerging area of research and practice that will require experimentation and refinement.
  2. Innovators and patients need to understand the evidentiary needs of payers: Defining what evidence is needed and collecting it at the earliest possible point can help drive toward a shared understanding of value across all stakeholder groups. High quality evidence is needed to make regulatory and payment decisions and will ultimately be generated through both traditional and novel study designs and analytical methods.
  3. Better data is needed to make better decisions: A lot of data and information is being collected and stored from multiple sources across multiple platforms. Agreeing on standards and facilitating stronger interoperability would enable sample sizes to grow and better evidence to be harvested for the benefit of all stakeholders.
  4. All stakeholders agree that it’s imperative to remove waste from the healthcare system: Up to 50 percent of healthcare delivered is of uncertain value and this uncertainty impacts all stakeholders. Cost pressures can force payers into the uncomfortable role of being “watchdogs” for quality and the evidence available to make decisions is uneven and may be applied inconsistently by different payers in the system.
  5. The concept of value is derived from the total cost of a patient’s care, not the cost of an individual product: There is a strong need to unite sources of information about costs of care delivered in different settings by different providers, including family caregivers, and to identify means to calculate savings achieved through prevention and avoidance of harms. Costs of individual products are important but not sufficient to inform decisions about effective care to achieve better health outcomes for the individual and the broader population.
The call to cut waste out of the health care system and streamline the process of finding, delivering, and paying for the best possible therapy was a resounding theme.  Patient groups may also find themselves in the unfamiliar position of having to advocate for reducing inefficient treatments and care for their own patients out of the system.
Participants concurred that innovation and value aren’t mutually exclusive concepts and in fact need to be mutually reinforcing. Balancing the real-world competitive market factors for innovators and payers while striving to meet patient needs will require transparency, flexibility, communication, and – above all – trust within and between stakeholder groups.
These are issues of growing concern to many organizations with diverse constituencies and you’ll be hearing more about them. FasterCures will issue a detailed report on the workshop and its outcomes and an upcoming blog post will focus on recommendations generated at the workshop.

Friday, June 28, 2013

Science, Cures and All the Stuff In Between

by Margaret Anderson

Reblogged from the Huffington Post

The outlook for science has never been brighter -- we know more today than ever before about the molecular basis for thousands of diseases that impact millions of patients -- but the outlook for funding has also never been bleaker. With the National Institutes of Health losing a billion and a half dollars to the sequester, traditional investors retreating from early-stage life sciences, industry pipelines shrinking, and philanthropy unable to fill the gap, we are poised to leave a huge scientific opportunity on the table, namely our ability to get important new medicines out of the lab and to patients more quickly. And with millions of lives hanging in the balance, it's just not something Americans can afford to do.
FasterCures hosted over 100 congressional staffers, patient advocates, academics and drug developers at a Capitol Hill briefing about the importance of federal support for translational research, the phase of medical R&D between the birth of a basic scientific discovery made in the lab and when a pharmaceutical company tests out a potential new therapy with patients -- or, more plainly put, "the stuff in between" microscope and marketplace.

"If there is anything I believe can bring this nation together for a cause, it is finding cures for disease," said House Majority Leader Eric Cantor in his opening remarks. "We ought to be about research regardless of political leaning, because it is an investment that yields tangible returns for our country." In an environment where Congress is laser-focused on coming up with ways to spend dollars more wisely, his advice to advocates was to emphasize the following message to policymakers:
  1. It is good to be about cures. Disease touches us all, and as compassionate humans we should all care about improving and saving lives.
  2. It is good for the economy to invest in research. This leads to job creation and global competitiveness.
  3. It is a good way to bend the cost curve of health care. We have mounting deficits and debts, and we should prioritize the allocation of funds to areas like this that have the greatest impact.
"This is really an engineering problem," said NIH Director Francis Collins. "It's about taking a pipeline that is too long and too leaky and fixing it." With each new therapy that comes to market taking up to 15 years to develop and costing over $1 billion, it's more challenging than one might think to successfully navigate the translational stage. There is great momentum in science, and we are poised to start solving several of these problems, particularly with the existence of the new National Center for Advancing Translational Science (NCATS) at NIH, but if we don't continue to invest, we risk losing not only time and lives but a significant driver of economic health.

"NCATS is a unique new entity, purpose-built to solve this central paradox: that we know more than ever before about how the body works and what goes wrong in disease but lack the equivalent ability to fix it," said NCATS director Chris Austin. "We're designed to be perpendicular to how the rest of NIH works, and to focus not on what's different about disease but what is common." He went on to describe the institute as a biomedical equivalent to the Internet, focusing not on creating companies or products but on allowing people with ideas to share them in a more productive way, and de-risking investment by other sectors in this translational space.
Both Collins and Austin said that there is no better time to pursue translational research. Today, we know the molecular causes behind 4,500 diseases, yet there are drugs available to treat just 250 of them.
"We are operating on hope, not hype," said Sharon Terry of the Genetic Alliance. "The network solutions that have overtaken other industries and streamlined them are finally starting to hit the biomedical research space, and we can't afford to lose momentum." She specifically referenced networked programs such as the Clinical and Translational Science Awards at NIH that are significantly advancing systems improvement in the translational phase and are primed, with the proper support, to foster more integrated research across communities. A new report released this week by the Institute of Medicine goes into more detail.
"Industry can't do it alone. ... Companies depend on basic science coming from the NIH," Simeon Taylor of Bristol-Myers Squibb said. He described how Big Pharma relies on the basic science discoveries made early on in the lab to develop drugs for patients who need them so desperately. Just last week, BMS, along with eight other companies, provided 58 compounds for an NCATS pilot program called Discovering New Therapeutic Uses for Existing Molecules, designed to develop partnerships between pharmaceutical companies and the biomedical research community to advance the development of therapeutics.
I had the privilege of moderating this discussion. The message that rose the top was clear: Getting a therapy from discovery to patients requires partnership and collaboration across all sectors in the medical research ecosystem: scientists, regulators, industry, investors, and, most importantly, the patients themselves. An effective R&D system is an efficient one, but reengineering the system in the way we know is possible requires support, and with funding at critically low levels, the ripple effects could be devastating. If we are to improve our odds for success for our patients and for our economy, there is no time to waste.

Thursday, May 30, 2013

Medical research investment: an opportunity for bipartisanship?

By Cecilia Arradaza, Director, Communications and Policy, FasterCures
May 29, 2013
Photo courtesy of the NIH
A few weeks ago, House Majority Leader Eric Cantor led a bipartisan group of members to the National Institutes of Health campus to learn more about their work, but also to discuss the future.  Reps. Earl Blumenauer (D-OR), Michael Burgess (R-TX), Renee Ellmers (R-NC), Eliot Engel (D-NY), Chaka Fattah (D-PA), Andy Harris (R-MD), Tim Murphy (R-PA), and Ted Yoho (R-FL) joined the Majority Leader.  Cheryl Jaeger, Megan Whittemore, and Matthew Zackon of Leader Cantor’s office and Karen Summar of Rep. Cathy McMorris Rodgers’s office also participated.
Photo courtesy of the NIH
Seeing is believing – walking through the NIH Clinical Center, the crown jewel of our nation’s research framework, provides you not only with hope for the future but a real sense of optimism that science matters and that it can make a difference in our lifetime. So to see our Members of Congress carve out time to visit the NIH provides the medical research advocacy community with great hope we can reaffirm our commitment to the biosciences.
At the Milken Institute Global Conference, on a panel with Senate Majority Leader Harry Reid and FasterCures founder Michael Milken, Leader Cantor said that “[we] believe that science should be a priority.” He added that he “hopes when [the Congress] gets to the point where there are issues that seem insurmountable, let’s go ahead and try and practice doing things together so that we can get some things done.”
He then cited the creation of the National Center for Advancing Translational Sciences (NCATS), as one of the demonstrable results of him working closely with Leader Reid. “Harry, when you and I did NCATS, it was a great example I think of the ways that we can work together without a lot of fanfare and just practicing and putting points on the board, and maybe we can work our way towards larger goals after that.”
Cantor then alluded to the May 9th bipartisan trip to the NIH that he was organizing. “Not only will we spend a couple hours together one afternoon in Washington, but also perhaps learn something together we can practice trying to solve problems together,” he said.
During the panel discussion, Leader Reid concurred with Cantor’s statement on the critical importance of supporting science and noted that “if we’re going to make progress in some of the dreaded diseases we have, we have to step up as a federal government to do that. It’s going to take us working together to fund these programs so that our great scientists can continue doing what they know needs to be done. And we can’t do it on the cheap.”
Investing in our nation’s medical research infrastructure is an investment in our future.
From a dollars-and-cents vantage point, consider the economic payoff of the Human Genome Project: the U.S. government’s $4 billion investment in the Human Genome Project spurred an estimated $796 billion in economic growth from 2000-2010—a 141-fold return on investment, after adjusting for inflation.
And, we are living longer, more productive lives, due in large part to research advances that started at the NIH. For example, U.S. death rates from heart disease and stroke have fallen more than 60% in the last half-century.
The case for investing in science and medical research is clear. To punctuate this point, let’s turn to the cost of inaction. Well –
  • talk to the brilliant PhD with bleak prospects for a career in science…
  • talk to the employer who has lost his or her most productive and talented staffer because that person had to instead become a full-time caregiver…
  • talk to the patient who just walked out of the doctor’s office after having been diagnosed with a debilitating disease for which there are no cures or meaningful treatment options…
Point punctuated.
Now to further underscore, consider the global environment we’re in. At a time when other countries are doubling down on their biomedical research spending, the U.S. is cutting our investment (figure 1) in the industry that promises more jobs, greater productivity, and lives saved.
With all these compelling arguments to back us up, let’s remind our elected officials of what’s at stake, and get them to act on making medical research a national priority.
Figure 1
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