For July 4: Let’s Thank the Inventors

For this week’s IP News Weekly, I emphasized stories about research breakthroughs and U.S. healthcare reform. In honor of this July 4, I’m taking a moment thank the researchers, business entrepreneurs and investors, and inventors who, as encouraged and protected by the U.S. Constitution, work tirelessly to create solutions to global health and environmental needs.

While I watched “The Fashion Show” on Bravo last night, one of the contestants proclaimed that “a designer is only as good as his last fashion show.” Its easy to forget that the United States’ economy (read = our jobs and homes) is only as strong as our last innovation. Further, everyone (from artists like clothing designers to high-technology workers) understands that it takes a long time to create the next “masterpiece.”

The complexity of creating biotechnology products is especially investment and time-consuming, and both the research process and the final product have a fragile relationship with human health and the environment. The intellectual property framework protects biotechnology innovators when they need it most, during the research and development process and the period of time the patent holder uses to recoop the investors funding. This protection creates a safe environment for investors that increases the possibility of the inventor producing a sustainable, high-quality product.  Americans do not prefer low-quality, high-risk solutions to the biggest problems of our time.

I hope that the current members of Congress will take it upon themselves to appreciate the need for data and patent protection for follow-on biologics, intellectual property rights and enforcement in international trade agreements, and increased funding for the NIH, FDA and PTO. No government can force innovation that comes out of the natural creative capabilities of its citizens, even in times of need.

My hope for America this July 4? I hope, in 100 years, the response time to human and environmental suffering will be immediate. Until that day arrives (thanks to scientific breakthroughs funded  by individual citizens) — let’s thank the scientists, investors, and inventors around us.

Finally, let’s also thank the founding fathers for knowing America’s innovative potential without seeing it for themselves.

For U.S. Healthcare Reform and Global Health Crises, Both Public and Private Efforts Needed

This morning Laura and I attended 2 sessions about the benefits of collaborative public-private partnerships at the International Convention.

The first was the super session “Global Biotechnology Innovation: Connecting the Laboratory, the Field, and the Marketplace” with speakers from the Food & Drug Administration, National Cancer Institute, the Centers for Disease Control and Prevention – moderated by former U.S. Secretary of Health & Human Services, Louis Sullivan. The speakers discussed how discoveries created through collaborative initiatives have accelerated biotechnology innovation to address global health disparities. The second session, “Time for Action: A prescription for Health-Care Reform” was moderated by BIO’s President & CEO and included speakers from the American Cancer Society, Regence BlueCross BlueShield, and the American Medical Association. The speakers presented their association’s perspectives on how U.S. healthcare reform could become a reality under the Obama Administration after decades of Congressional failures to comprehensively address rising costs and limited access to care.

The two panels addressed what are seemingly different topics: one global heath, and the second national healthcare reform. What struck me was the need to sustain new, complex collaborations between all stakeholders in order to encourage finding solutions to “old” problems.

The old view of global health programs states that logistical issues, including a lack of needed resources and capacity, require a top-down strategy with governments leading the efforts. Yesterday’s idea about healthcare reform, taken up by many a Congress the past 20 years, asserts that only the grassroots efforts of individual Americans can encourage permanent, sustainable solutions in communities where the government is unable to keep up (and often times hurts innovation rather than helping).

The truth is, for both global health goals and national healthcare reform, innovation requires both a “grass-top” and a “grass-roots” approach. I stole that phrase from the CEO of the American Cancer Society, John Seffrin. Seffrin is also CEO of the ACS Action Network. Both branches of the ACS facilitate efforts at the individual level (encouraging prevention and wellness efforts, for example) and the national level (analyzing Congressional proposals for reform). Both entities working together help solidify the foundation upon which the war on cancer can be won.

Indeed, the driving factor of encouraging biotechnology innovation to meet health care goals comes from the individual human beings who suffer, manage, and cure their own or another’s illness. Individuals collectively bring their unique experience and knowledge as patients, physicians, researchers, venture capitalists, university administrators, and government policymakers to public discourse, and by working together, benefit each other and accelerate finding a solution to health needs.

Some examples taken from the 2 sessions:

1. Gardasil, the blockbuster cervical cancer vaccine appeared under the guidance of collaborative efforts via the CDC.

2. The hope of collaboration helped the FDA form the basis for what would become the Critical Path Initiative for clinical trials.

2. Collaboration was the key for the American Medical Association’s work to address streamlining patient care by studying inefficiencies inequalities in the healthcare system, as Dr. Patrice Harris described this morning.

3. AMA, BIO, and ACS joined together to create the “Health Economy Now” website, which puts the focus of U.S. healthcare reform efforts on the need to lower costs through health information technology, changes in the reimbursement system, and encouragement of prevention & wellness. Jason Daughn of Regence remarked that “real reform lets innovators innovate, and preserves competition through public-private partnerships.”

4. James Curran, Dean of the Rollins School of Public Health at Emory University described that when the HIV/AIDS epidemic first emerged in 1981, it was thought that we would never find the cause or be fully able to characterize the disease. Since then, we can now screen the blood supply, extend the lives of those infected with HIV with antiretroviral therapy, prevent pregnant women from passing the virus to their unborn children, and measure the viral load of an infected individual’s blood.

 Both public and private entities are needed at the table of public discourse, not one or the other. We can address health needs in both the United States and developing countries at the same time by working together via open, fair, and collaborative partnerships. It saves money, time, effort and – most important of all – lives.

This post was co-written by Margarita Noriega and Laura Sambataro at BIO.

A Stimulated NIH Discovers the Devil in the Grant Details

In February, Congress awarded the National Institutes of Health with stimulus funds to the tune of $10.4 billion through the American Recovery and Reinvestment Act of 2009 (Recovery Act). The funding is directed towards helping the United States improve its “scientific infrastructure”: education initiatives, research, “investment in biomedical research and development, public health and health care delivery” (NIH Press Release), including $400 million for comparative effectiveness studies.

Acting National Institutes of Health Director, Raynard S. Kington, MD, has done an excellent job of diversifying the kinds of projects that funding will support, as well as looking for solutions to some of the more, well, I’ll call them opportunities for growth (read: beaurcratic red tape).

Science Magazine further describes these opportunities in the April 17 edition article “NIH Stimulus Plans Triggers Flood of Applications—and Anxiety.”

Grant applicants question whether the NIH has the capacity to manage the tsunami of applications.  Researchers in the Science article also ask if the NIH baseline funding “will grow at anywhere close to the rate needed to handle the blizzard of new ideas and expanded scientific work force” that the Recovery Act funding will produce once the stimulus funds expire. This would allow the projects to continue, if further research was recommended.

Additionally, an April 24 Burrill Report podcast (http://www.burrillreport.com/article-1311.html) interviews Reg Kelly, Director of the California Institute for Quantitative Biosciences (QB3), about whether the stimulus could slow down discoveries. University researchers, seeing state and alumni funding cuts, will spend all of their time preparing grant applications.  Researchers are forced to ignore current projects during the application process. Even if they do receive funding, they will face a technology transfer system that isn’t quite ready for a grand influx of fresh ideas just “waiting” to get picked up for further research & development. Kelly further asks if the technology transfer community is collectively incentivized (and collectively capable) of prioritizing funding for stated NIH priorities like personalized medicine, vaccines (read today: swine flu), cancer, and HIV/AIDS research.

While the stimulus created an “innovation backlog”, it can only be a good thing. For the next two years, NIH programs like “Grand Opportunities” and “Challenge Grants” will enable today’s bright minds to forge new paths into health and environmental sustainability – at least for the next 2 years, when the grant rivers run dry.  In 2012, the new challenge will be utilizing the innovation boomtown the stimulus will have inevitably created. 

If the stimulus succeeds in providing researchers enough funding to help form ideas to improve the world, it will take just as much effort for the biotechnology industry to turn that research into tangible products for a global audience.

Next question: Are the other United States federal agencies (FDA, USDA, and USPTO among them) ready to usher these innovations into the economy?