It’s not Goodbye, It’s See You Later.

by Greg Simon, President, FasterCures

Effective June 1, I will resign as President of FasterCures and join Pfizer Inc as Senior Vice President for Worldwide Policy. It is hard to imagine it has been six years since I joined Mike Milken to start FasterCures.

In that time we have gone from future tense to present tense as our hopes and ambitions became real, thanks to the efforts of our Board, hundreds of allies, our supporters and simply the best staff I have ever had the pleasure to work with. Because we are not a research organization ourselves, our best moments are not “Eureka” moments. Our best moments are when patients, nonprofit organizations, companies, and even the government say to us, “Thank you for helping us – by creating networks that otherwise would never exist, for providing a different perspective on how to pursue medical research, for creating a marketplace of information to help the world understand what nonprofit research groups are doing to cure diseases.”

In the last year I have come to realize that the cure community has created its own brand of capital – what I call Passion Capital. Passion Capital is what you have when dedicated people spend their time and financial capital to do whatever it takes to make progress in the fight against deadly and debilitating diseases. The return they seek is not wealth or fame, not a building or an endowment. They seek a cure. That is their passion and what drives everything they do. That is why they have created novel collaborations for drug development, why they line up to join clinical trials, why they invest in biobanks and genomics.

Passion Capital is contagious. I have “caught it” and hope never to lose it. “Catching it” by spending time with patients and their families, and the scientists, doctors and corporate/nonprofit leaders trying to help them has changed my life. I never expected to be so moved when I began this effort. I thank all of you who have been so generous with your time, ideas, resources, and passion.

It was a bittersweet moment when I chose to take this new opportunity at Pfizer, sweet for the opportunities I will have to make a difference in the future of health here and around the world but bitter because of my deep affection for everyone at FasterCures.
From working with the team at FasterCures, with Mike Milken, Mike Klowden, and all of you who shared your passions with us, I realized that, presented with the opportunity to stop talking and start walking, I had to walk. And unfortunately the first step takes me out the door at FasterCures. But I am not leaving, I’m taking all of you and all the memorable moments with me to a new position in the leading company in the sector that is so important to everything we have been trying to do to bring better cures to people faster. I am convinced I can make a difference in this new position and I am not afraid to fail trying.

“Not afraid to fail trying” – I learned that from all of you and I will honor it everyday.

I leave knowing that Margaret Anderson – my partner at FasterCures for the last five years -- will take the organization to new heights with the dedication and passion that are her trademark. And the FasterCures staff will continue to help and support all of you who work everyday to save lives.

As a Board member and an advisor, I will stay involved. But most of all, I will remain a steadfast friend and supporter of FasterCures because the Passion Capital I have acquired won’t let me have it any other way.

FasterCures Announces Leadership Change as Organization Grows from an Innovative Idea to an Effective Reality

(Washington, DC) May 12, 2009 – FasterCures / The Center for Accelerating Medical Solutions today announced that Margaret Anderson, currently Chief Operating Officer, will take on additional interim responsibilities in managing the organization, effective June 1, 2009. Greg Simon, President of FasterCures since its inception in 2003, will be leaving his post to join Pfizer Inc as Senior Vice President, Worldwide Policy.

For the past six years, FasterCures has analyzed the barriers to medical progress and developed innovative programs to address them, such as: the Philanthropy Advisory Service, an online information marketplace designed to make philanthropic investment in medical research more effective and productive; “TRAIN” (The Research Acceleration and Innovation Network), established to create opportunities for medical research innovators to discuss and tackle the challenges that cut across diseases; and PHD (Patients Helping Doctors), an effort aimed to empower patients to contribute to medical research.

“By accelerating the process of medical research, the work of FasterCures is bringing improved treatment outcomes for people everywhere. That effort will produce more lifesaving cures,” said Michael Milken, chairman of FasterCures.

FasterCures, a center of the Milken Institute, is an “action” tank committed to saving lives by saving time in the research, discovery, and development of new treatments for deadly and debilitating diseases. It is nonpartisan, nonprofit and independent of interest groups.

“I look forward to continuing to work with the outstanding FasterCures team to implement strategies key to developing new medical solutions,” said Anderson. “As we continue to energize the biomedical research community, we’re pleased that Greg will serve on the FasterCures advisory board.”

Anderson has extensive experience in managing biomedical and public health initiatives and facilitating multi-sector collaborations. Since she joined FasterCures in 2004, she has managed the organization’s day-to-day operations. She came to FasterCures from the Academy for Educational Development (AED) where she was the deputy director and a team leader in the Center on AIDS & Community Health. Prior to AED, she led programs and studies at the Society for Women's Health Research, American Public Health Association, and the Congressional Office of Technology Assessment. Margaret holds a bachelor’s degree from the University of Maryland, and a master’s degree in science, technology, and public policy from George Washington University’s Elliott School of International Affairs.

About FasterCures
FasterCures/The Center for Accelerating Medical Solutions is committed to saving lives by saving time in the research, discovery and development of new treatments for deadly and debilitating diseases. FasterCures, as a center of the Milken Institute, is nonpartisan, nonprofit and independent of interest groups. For more information, visit www.fastercures.org.

A Bridge Too Far Away

by Susan Semeleer, Associate Director of Communications, FasterCures

FasterCures recently held a briefing in collaboration with the Parkinson’s Action Network (PAN) discussing the translation gap between basic and clinical research, known colloquially as the “valley of death” – where promising ideas for treatments for deadly disease are often slowed and sometimes dropped before they can be fully explored. After reviewing the drug-development pipeline – from the most basic research to large-scale Phase III clinical trials conducted by major pharmaceutical companies – PAN concluded that a critical step toward bridging the valley of death is a rethinking of NIH 's approach to supporting translational research. PAN CEO Amy Comstock Rick told forum attendees that under the current system, too many promising ideas become mired in institutional inertia or lost in information silos. They don’t move or, if they do move, researchers lack the skills and infrastructure to follow through.

“More money is not necessarily the solution,” said Rick. Instead, what is needed is a fundamental soup-to-nuts change in the way NIH conducts its business. It is change that Rick insists must be implemented from within; Congress must mandate change, then leave it to NIH to comply. “If Congress tries to fix NIH,” said Rick, “it’s not going to be done right.” But it must be done; the chasm between concept and cure is growing ever wider.

In a paper "Entrepreneurs For Cures: The Critical Need for Innovative Approaches to Disease Research" released last Fall, FasterCures noted that "for all the money flowing through the [health] system, there is remarkably little emphasis on specific goals or milestones to cure disease or achieve specific clinical results. As a result, emphasis on speed or direct responsiveness to health needs is spotty, and the time from initial discovery to dissemination and commercialization can sometimes be measured in decades—an outcome that is simply unacceptable to the citizens who fund this research and expect to benefit from it."
Rick said that there is no treatment for Parkinson’s -- and nothing in the pipeline -- that slows progression of the disease. Instead, the best that can be done for Parkinson’s patients are treatments that manage or temporarily mask symptoms. It’s a common story that so many patients hear, every day, and it is no less unbearable in its repeated telling: This is all we can do for you.

That’s not good enough for a desperate patient whose shoulder has been clamped by the cruel hand of illness. What PAN is seeking to do is make it not good enough for our medical research community, either.

PAN’s proposal calls for patient advocacy groups, in collaboration with the drug development and research communities, to promote legislative change that would encourage NIH to fully support translational research. PAN Deputy CEO Mary McGuire Richards echoed Rick’s contention that it should fall to Congress to establish goals for reforming NIH, and mandate its reform, but that the implementation of those reforms must originate within the halls of NIH.

Panel moderator and FasterCures COO Margaret Anderson raised the question of possible obstacles on the road to NIH reform. Rick noted a resistance to change within the research community, particularly among basic researchers.

While Rick was careful to emphasize the importance of basic research, she pointed out that a vast difference exists between basic research and drug development. The two must be managed differently and, under the current NIH business model, no culture exists for managing translational research. She used as an example the difference between an elementary school and high school principal: their jobs are equally important, equally challenging, but require wholly different skill sets. The same, Rick said, holds true for basic and translational research. When your central organizing principle is studying biology, as is the aim with basic research, the institutional mechanisms that govern the process are completely different than with research that is organized around the principle of curing disease. Both are vital pieces of the cure puzzle, but translational research is a square peg that can’t be pounded into a round hole; what PAN is calling for is a long-overdue creation of a square -shaped niche within the research community.

As FasterCures noted in its report "Entrepreneurs For Cures: The Critical Need for Innovative Approaches to Disease Research", "the true measure of success should be in lives saved and suffering diminished – not the number of grants awarded, publications presented, or laboratory space acquired."

Healthcare Reform: Once More Into the Breach

The third day of the Milken Institute Global Conference featured a panel that discussed healthcare reform, an issue that continues to gain steam as the new Administration juggles priorities and attempts to present workable solutions to a health system that many contend to be broken.

Each panelist represented distinct sectors within the healthcare industry – insurance, pharmaceutical, advocacy, and patient groups – each sector with its own agenda and unique perspective on the best solution. And yet, as FasterCures COO Margaret Anderson, panel moderator, dug deeper beneath the surface with provocative questions, a common thread quickly emerged: all agreed on the need for universal coverage for the currently 46 million uninsured Americans, and for delivering better, more cost-effective care.
A simple Google search on “healthcare reform” netted hundreds of millions of results, with headlines that range from those that promise solutions, predict gloom, or examine the issue from a variety of angles, like the article titled: Healthcare Reform: The Good, The Bad and The Ugly.
With so many competing priorities and special interests surrounding the issue, Anderson asked the panel what’s different this time around to ensure our nation’s healthcare system sees sustainable reform.

• Samuel Nussbaum, chief medical officer of WellPoint Inc., one of the largest insurance companies at more than 35 million members, said it’s about sustainable cost and quality, not just coverage. Until recently, most private insurers were against universal coverage. Nussbaum said that it is time to align incentives with health-related outcomes. Commenting on high readmission rates of Medicare patients and the inefficiencies of the health-care system, he said “(Currently) someone’s inefficiencies are someone else's revenues."
• Chris Singer, executive vice president of the Pharmaceutical Research and Manufacturers of America, another unusual advocate for universal coverage said he sees the reform process to unfold like a two-act play. The first act to focus on how we get people covered in an affordable way. The second act, to look into how we deal with unfunded Medicare liabilities. To make this happen, the process to reform needs to be open and transparent, with each sector willing to work with unlikely allies. Anderson pointed to PhRMA’s partnership with the labor union SEIU as an example.
• Kenneth Thorpe, Robert W. Woodruff professor and chair of the Department of Health Policy & Management at Rollins School of Public Health, Emory University and executive director of the Partnership to Fight Chronic Disease said that although coverage is front and center of the reform discussion, “85 percent of the population has health insurance. [They] like what they got, it just costs too much.” He said the average cost of coverage for a family is approximately $12,000.
• Marian Mulkey, senior program officer at the California Healthcare Foundation, an organization focused on expanding coverage and access in the state. Mulkey noted that states have limited opportunity to manage costs and to navigate some of the regulatory baggage that is in place at the federal level.
  

Healthcare reform in contextThe panel discussed healthcare reform as part of a much broader set of social issues. Effective reform goes beyond the healthcare system and is shaped by what goes on in communities, schools, and the workplace. Panelists agree that for healthcare reform to be sustainable, prevention efforts, including initiatives to address chronic diseases; need to be factored as a solution as these are critical to curbing escalating healthcare costs that are directly impacting the nation’s bottom-line.

So, when will reform happen?
In an attempt to forecast change, Anderson asked the panel to opine on where they think we’ll be by year’s end. All four panelists believe a healthcare reform measure will pass – but that it will be far from perfect. They cautioned that reform will be incremental rather than sweeping, with various stakeholders making short-term concessions.

Thorpe said, “Stakes are very high. If it doesn’t work this time around, it will take another 15 years [to revisit reform].”

Indeed, with stakes this high, we don’t think anyone has the patience to wait another 15 years.

View the panel online.
Read the session summary.

Stem Cell Research: Hope or Hype

Stem cells have enormous potential to shape the future of medicine but may not live up to the hype, according to a panel convened at the Milken Institute Global Conference featuring Brock Reeve, executive director of the Harvard Stem Cell Institute; Alan Tronsoun, president of the California Institute for Regenerative Medicine; John McNeish, executive director of regenerative medicine at Pfizer; and R. Alta Charo, Warren P. Knowles Professor of Law and Bioethics at the University of Wisconsin.

The expert panel, moderated by FasterCures COO Margaret Anderson, illuminated a number of scientific possibilities that stem cells bring – from growth of replacement connective tissue to more predictive cellular models for drug development to conversion of pancreatic cells to insulin-producing beta cells for curing diabetes. They also discussed how lifting federal funding restrictions will renew the pace and productivity of stem research by not only allowing more federal support, but also by eliminating the need for duplicative research infrastructure. By opening federal funding to new stem cell lines this increases the genetic diversity and quality of stem cells leading to higher quality research. It is expected that overall morale of stem cell researchers and collaborations between them will increase. All of these promises support the argument for hope.

But it wouldn’t be fair to discount the hype also associated with stem cell research and the obstacles yet to be tackled. For example, Charo highlighted the moral dispute over whether we as a society should derive benefit from an act that we deplore, like taking organ donations from a murder victim or buying a good made in a sweatshop or using a discarded embryo for stem cell research. She also eloquently dissected the “conspiracy of hype” in which multiple stakeholders (i.e., patient advocates, Congress, scientists, etc) have contributed to the escalating promise of stem cells that might never be realized.

The journey to achieving the scientific potential of stem cells will not be a straight and clearly marked path. The FDA needs to be prepared to incorporate stem cell methods into their preclinical calculus, intellectual property complexities will need to be worked through, and a critical mass of dedicated researchers will need to be assembled to advance the field.

Bottom line, we wouldn’t have hope without hype and hype without hope. It’s not one or the other but a healthy tension between the two that drives scientific exploration in a purposeful and thoughtful way. FasterCures is supportive of the lifting of the funding restrictions and excited to bear witness to the scientific journey about to be embarked upon.

Happening Now:
You have an opportunity to shape the future of stem cell research. The National Instiutes of Health recently issued draft guidelines creating a framework for federal funding of embyonic stem cell research pursuant to the President's Executive Order. The public has until May 26th to comment on these guidelines. NIH will be analyzing both the content and volume of comments they receive during this period as they consider changes to the draft. Go to http://stemcells.nih.gov/policy/guidelines.asp for more information.

FasterCures is part of the Coalition for the Advancement of Medical Research, a coalition dedicated to advancing stem cell research.