Big Changes at Biobank Central

by Kate Blenner, Program Analyst, FasterCures

We at FasterCures are very pleased to announce some big changes to BiobankCentral.org, the Web site we have established to highlight the importance of biobanks to medical research. This site links researchers to resources, encourages the donation of specimens, and educates the public about the benefits of research on banked biospecimens. After interviewing key stakeholders, including patient advocates, biobank operators, and leaders in the field of biospecimen research, we will begin staging some new features and functions that will make Biobankcentral.org even more useful to visitors hoping to learn more about these critical resources.

The first of these new features is the Spotlight on Innovation which will highlight individuals and organizations doing exceptionally innovative work in biobanking. Our first Spotlight focuses on the Susan G. Komen for the Cure® Tissue Bank at the Indiana University Simon Cancer Center, or Komen Tissue Bank (KTB) for short. This bank’s mission is to collect samples of normal, healthy breast tissue and other biospecimens from healthy women for breast cancer research. Yes, you read that correctly—normal tissue. Healthy women.

In its 1998 priorities for cancer research, the National Cancer Institute identified the lack of knowledge about the normal biology and development of the mammary gland as a significant barrier to finding a breast cancer cure. Most research to date has focused on characterizing diseased tissue, but without the frame of reference of how healthy tissue develops and functions opportunities for a cure could be missed. Complicating the issue was a shortage of normal tissue available for study. The NCI’s recommendations to address the ‘tissue issue’ languished for a few years, until some motivated advocates and clinicians at IU Simon Cancer Center decided to form the KTB.

Despite initial skepticism that healthy women would want to go through an invasive collection procedure, KTB put its faith in the motivation of the breast cancer advocacy community—and it paid off. They have collected thousands of samples to date, and communities across the country have asked KTB to set up its collection tent at their local Race for the Cure events. As bank co-founder and patient advocate Connie Rufenbarger told me: “These women have walked, they’ve written checks, they’ve lit candles—they’ve done everything they can to demonstrate they want to help. [The response] really speaks to the fact that there isn’t a whole lot you could ask that women wouldn’t give you to cure this disease.”

I hope you enjoy this first Spotlight of the Komen Tissue Bank as much as I enjoyed speaking with its remarkable founders and staff. If you have a moment, stop by the KTB Web site to find out how you can get involved in their work to find a cure. And, of course, keep an eye on BiobankCentral.org—we have many more exciting new changes to come.

FasterCures Task Force Calls for New Mission and Focus for National Institutes of Health's Intramural Research Program

Everyone in Washington who’s interested in medical research is currently focused on whether the NIH will get some additional money in the forthcoming stimulus package. We at FasterCures care about that too. But we are focused on something else: what will the Obama Administration do with the $3 billion asset it has on the NIH’s Bethesda campus, its Intramural Research Program?

A six-member task force, convened by FasterCures and chaired by Nobel Laureate Dr. David Baltimore, recently issued a set of recommendations regarding how to strengthen the mission and impact of the Intramural Research Program (IRP). Given the likelihood of constrained budgets in the near future, it is especially critical that NIH make the best and most efficient use of the IRP, one of its most valuable resources. FasterCures shared the task force’s recommendations with the Obama transition team.

The IRP consumes nearly ten percent of the NIH’s budget. It has a highly regarded history of discovery but today lacks a clearly defined mission within the overall NIH effort. The task force recommends a framework within which to refresh the IRP, giving it a distinct mission and identity in the service of improving public health. This mission is three-fold:

• to focus on translational research, especially work that utilizes the unique capabilities of the NIH Clinical Center;
• to be prepared to respond expeditiously to new scientific opportunities and challenges; and
• to focus on high-risk, long-term basic research goals that would be difficult to pursue in the extramural research environment.

The task force recommends the following:

• NIH should articulate an overarching mission for the IRP and strategies for meeting goals over the next five years, focused specifically on advancing translational and clinical research in the interest of public health.
• The Clinical Center must be fully utilized and the IRP’s clinical research program should be expanded.
• The IRP should be encouraged to systematically and proactively mobilize resources to rapidly and effectively respond to emerging scientific challenges and opportunities.
• The IRP should be the premier national program for translational and clinical research training.
• The IRP should play a central role in developing and sustaining large-scale, long-term projects.

In the coming years, the American public and policymakers will be focused on reforming our healthcare system, and rightly so. But at the same time, we must nurture our health cure system. Only if we translate promising scientific research into new therapies and acquire a better understanding of how to prevent and treat disease will we have any hope of reducing healthcare costs, productivity losses, and human suffering. To advance human health at a time of constrained federal budgets, we must increase the effectiveness of our investment in medical research and maximize the impact of the significant investment we make every year in the NIH Intramural Research Program.

My Hopeful Wishlist for HIV/AIDS’ Long, Tragic, and Complicated Saga

by Margaret Anderson, COO, FasterCures

An estimated one in 20 adults in Washington, DC is infected with HIV. With the highest rate of new AIDS cases in the country, at 11 times the national average, our nation’s capital is setting records that we’d rather not see. It is against this backdrop that I attended the last Institutional Review Board (IRB) meeting of the Whitman-Walker Clinic recently. This local IRB is being closed for cost-savings purposes, as using a centralized IRB will save resources. Resources are currently in short supply for Whitman-Walker, one of the preeminent HIV/AIDS clinics in the country.

The economic downturn has hit the clinic hard, as has AIDS fatigue, coupled with extremely high demand for HIV services in the District. I first began volunteering at the clinic doing paperwork for the support group programs, then I began leading support groups for men with HIV. After 10 years, I moved over to the IRB which met my need for involvement that was one step removed from direct services and the burnout that I’d faced in that role. In the course of my support group work, we lost so many to HIV, all before the current therapies had come on the market and changed the face of HIV/AIDS.

Despite the medical successes in finding treatments for HIV, there is still so much work that needs attention. The trajectory of the HIV/AIDS story is truly stunning from a research standpoint, and yet anti-HIV therapy is a lifetime commitment. Dr. Jeffrey Laurence of amfAR wrote in a November 2008 piece about how for every person that gets on treatment, two to three new people get infected. “We need a cure for AIDS. We can’t treat our way out of this epidemic,” he wrote.

The advent of a new year calls for lists. Here’s what’s on mine:

• We need adequate levels of basic and translational research in HIV/AIDS so we can eradicate HIV.
• We need to be able to get proven therapies into the hands of those who should be on therapy, help them adhere to the treatment, and get these paid for, so that those who should initiate anti-HIV therapy actually do.
• And finally, research needs to be continued at valuable sites like Whitman-Walker that are on the front lines of the epidemic.

HIV/AIDS in the U.S. has woven a long, tragic, and complicated saga. There has been some hope though. We’ve seen the research and drug development system move swiftly and change when need be. Yet, even when there are medicines on the shelf we need to keep on searching for treatments and cures.

FastTrack Year-End Issue Just Released

Check out the just released year-end issue of FastTrack, FasterCures' quarterly electronic newsletter.

FasterCures’ Ten to Watch in 2009: Bigger Bang for Our Research Bucks

1. Philanthropic capital. In this economic environment, investors are going to be more careful with their for-profit and their philanthropic investments. Nonprofit organizations – and particularly those that fund medical research, which requires significant dollars – need to embrace this moment to demonstrate their value. Is your organization ready to provide transparent and relevant information about your practices and results to help donors evaluate their investments?
2. Big pharma business model. Goldman Sachs is putting money into creating a “research pool” of early-stage products from a number of pharmaceutical companies. The discussion on how to build a business model around the targeted therapies of personalized medicine is getting more focused and serious. Is the veil lifting from big pharma’s eyes?
3. Stem cells. Forget about the politics, it’s time to talk about the science and the process. Now the urgent questions are how prepared are we to review, approve, and use stem cell therapies?
4. Cure entrepreneurship. Social entrepreneurship has attracted copious scholarship, media attention, and financial resources to support innovative approaches to solving social problems over the last decade. Now cure entrepreneurs, those pursuing novel approaches to accelerating the process of treating and curing disease, want to get in on the action. Can we create an ecosystem of human, intellectual, and financial capital to support the work of these innovators?
5. NIH U. The National Institutes of Health spends $3 billion every year supporting the work of about 6000 scientists in its Intramural Research Program (IRP), largely on its campus in Bethesda, MD. The IRP is an underutilized weapon in the arsenal of the U.S. biomedical research effort. NIH should articulate an overarching mission for the IRP and strategies for meeting goals over the next five years, focused specifically on advancing translational and clinical research in the interest of public health.
6. Patient power. The Internet empowered patients with information, and now social networking is taking it to the next level. What’s the power of informed patients gathering online to share their information and experiences? Can it help drive the agenda and speed up the pace of medical research?
7. Effective comparisons. There will be a lot of talk during the coming healthcare reform debate about comparative effectiveness. But we’re more interested in effective comparisons. A more efficient way of managing diabetes is a separate debate from a more effective option to treat cancer. Comparative effectiveness research should be about patient access to optimal care and continued medical innovation as solutions to healthcare challenges. Track developments of the Partnership to Improve Patient Care, a new group focused on addressing this.
8. Global health as foreign policy. We think that the President-elect gets that global health is not simply charity or aid and cannot be relegated to goodwill ambassadors. It is an unwavering commitment to medical research and access to cures that will end death and suffering. Global health done right demonstrates our leadership and diplomacy and is key to how we move forward on issues like national security, climate change, and trade.
9. Health IT: Stop talking, start typing. It’s long since time to face the reality that information technology will permeate healthcare with or without the right policies in place. So we might as well manage it from day one to make sure it’s accessible, integrated, and interoperable. We are after all building an infrastructure for 21st Century healthcare. We are all aching for a nationwide health information system that can improve patient care AND enable medical research.
10. Citizen action. This is the year of civic involvement. Americans are answering President-elect Obama’s call to be involved in a public way. How do we channel this activism to improve health? Can we inspire people to not only walk for cancer but to participate in a clinical trial or contribute in other ways to science?