Thinking Impact, Philanthropically

By Elizabeth West, Program Manager, FasterCures

Impact investing (also known in some circles as mission investing) is a blanket term used to describe a variety of investment practices similar in their intent to generate measurable social and environmental impact alongside a financial return. In 2012 the practice of impact investing blew up, and it seems like this trend is only going to get bigger. As FasterCures’ Philanthropy Advisory Service is committed to helping those investing in the life sciences make the most informed decisions possible, we could not pass up the opportunity to learn about this new trend (permanent fixture?) in philanthropy at two recent conferences.

  

Imagination, Innovation and Impact in Philanthropy

The first was the University of Southern California’s Annual Leadership Forum – Philanthropy: Imagination, Innovation, and Impact. The event brought together philanthropists, foundations, academics, and innovators to focus on understanding the passion and values of philanthropy and its possibilities and strategic practices that create greater impact. The highlight of the event was a candid discussion with Tom Steyer and his wife Kat Taylor - who have signed the Giving Pledge - alongside panels that covered an array of relevant topics from the power of collaboration, networks, evaluation, and learning to innovations like games for social change*. On impact investing, speakers highlighted different models (both familiar and unfamiliar), including the Omidyar Network, social impact bonds, community development financial institutions, and the Nonprofit Finance Fund.

Some key takeaways include:

• The impact investing field is still in a proof of concept stage.
• It is import to conduct financial and impact due diligence on the front-end as well as to evaluate investment on the back-end.
• Impact investing is not philanthropy – it tries to accomplish something that philanthropy and government do not know how to do.

Not surprisingly everyone agreed that evaluation is HARD. According to Steve Goldberg of Caffeinated Capital, of the ten largest federally funded programs, only one has demonstrated success. That may be a clear indicator that – at least according to the professionals at USC – impact investing is still in the “proof of concept” stage.

The second conference we attended was the Council on Foundation’s Annual Family Philanthropy Conference, which offered a three session impact investing track led by professionals from Mission Investors Exchange, RSF Social Finance, and Confluence Philanthropy, among others. These panels focused on some of the granular details of MRIs, PRIs, and broader “impact investing”, as well as valuable insights from the audience members from foundations engaged in this area.

The biggest message: 

• The primary challenge is convincing others of the opportunity and value of impact investing. (According to participants, CFOs, accountants, and trustees are the most difficult to convert.)

A particularly engaging presenter was Charles Kleissner, the co-founder of the KL Felicitas Foundation – a foundation that has led the way in putting both annual disbursements and assets into impact-first and financial-first investment vehicles. Kleissner spoke of how he arrived at impact investing – seeing it both as an alignment of his values and intentions, as well as a more efficient use of his capital. He considers himself a “100% folk” (i.e. someone who has 100% of his wealth in impact investing) and says now there are at least fix or six people in the world who are “100% folks” in all asset classes.

Impact Investing in Medical Research

So what are some potential examples of impact investing in medical research? Well it depends on what kind of entity is involved. Individual accredited investors can invest in companies that are developing new therapies for unmet medical needs. A foundation could use a program-related investment (PRI) to make a loan to a nonprofit research institution to finance a potentially high-impact research project. Philanthropic funds could also be invested at market or below market rates in commercial entities that meet a foundation’s mission, such as advancing the development of new medicines. (The Bill and Melinda Gates Foundation did this in the case of Liquidia in 2011).

Obviously, there is a lot of potential for growth and sophistication in impact investing. This is likely just the beginning of what you will hear from PAS on impact investing this year, especially how it relates to medical research. So stay tuned!

*Relevant Links

--- www.playspent.org

--- www.gamesforhealth.org

---  www.gameslearningsociety.org

A Great Opportunity for Medical Research Philanthropy: Fund Team Science

by LaTese Briggs, Philanthropy Advisory Service Program Analyst, FasterCures

As seen in Philanthropy News Digest:

Today we are plagued by a variety of vexing and complex diseases. Many of us are affected, directly or indirectly, by cancer, HIV/AIDS, diabetes, and heart disease. While there is indeed an army of researchers working persistently to find cures and lifesaving treatments to these and other diseases, the rate at which they are making discoveries is impeded by limited resources and a reward system that discourages collaboration.

While there is a common misconception that most biomedical discoveries that lead to new treatments originate in the laboratories of major pharmaceutical companies, many groundbreaking discoveries are actually made in the labs of academic researchers. These labs are usually severely underfunded, and the intrinsic reward system and career growth opportunities for researchers almost exclusively hinges on the amount of grant funding they are able to secure. In a constrained and highly competitive funding environment, this often indirectly discourages collaboration among researchers, thus slowing progress on finding answers to complex questions in medical research.

Unfortunately, the development of new technologies such as genome sequencing has led the academic research community to realize that many diseases are more complex than originally thought. To tackle the biological complexity of these diseases, researchers across different disciplines need to work together. But to enable this type of "team science," we need to reconsider how the structure of philanthropic research funding affects the research itself and acknowledge that in order to improve the current research paradigm, we need to change the way academic research is funded.

Recognizing this, a new model for medical research philanthropy with an emphasis on scientific collaboration is being brought to fruition at institutions such as the Howard Hughes Medical Institute, the Scripps Research Institute, and the Broad Institute of Harvard and MIT. Each of these institutes initially was funded by seed money from private donors, and each has gone on to become a dramatically successful nonprofit research organization at the forefront of biomedical science. And because they unite multiple academic institutions and bring together experts from various disciplines to work on high-risk, high-impact projects in the absence of traditional funding barriers, they promote collaboration by their very design. The results speak for themselves. Some of their contributions to biomedicine to date include identifying new genetic risk factors for diseases such as schizophrenia, bipolar disorder, and autism; the classification of human cancers by their genomic alterations rather than by their location in the body; and the identification of key genes that regulate stem-cell development. These initial successes have attracted more traditional capital (including public-sector investments) to the field and promoted additional giving by other philanthropic organizations, further expanding the pool of capital available for high-impact research.

But you don't need tens of millions to found a new institute to make an impact in the team science arena. Donors and foundations can choose instead to fund interdisciplinary teams or multi-center collaborations focused on biomedical discoveries with the potential to lead to new treatment options and cures. Philanthropic gifts can also be directed to organizations like the Melanoma Research Alliance, the Michael J. Fox Foundation, and the Burroughs Wellcome Fund that already fund team science.

Philanthropic opportunities in medical research — funding team science among them — will be a hot topic at our annual Partnering for Cures meeting, November 28-30, in New York City. At this year's meeting, more than seven hundred venture capitalists, philanthropists, policy makers, biotechnology and pharmaceutical company executives, patient advocates, and medical researchers will gather for a series of engaging panels and one-on-one meetings, with the ultimate goal of advancing the field of biomedical research and finding cures to a range of diseases. Partnering for Cures is uniquely positioned to introduce new and emerging foundations and philanthropists to the fundamentals of medical philanthropy and to provide more seasoned givers with a range of due-diligence opportunities. We hope you'll join us in further exploring how we can all work together to facilitate the flow of philanthropic capital into medical research in the most impactful ways possible.

About FasterCures and the Philanthropy Advisory Service

The FasterCures Philanthropy Advisory Service (PAS) was specifically created to help philanthropists make informed investment decisions on giving to biomedical research. Since its inception, PAS has successfully channeled funding to a number of high-impact collaborative biomedical research projects and has created a pair of giving guides: Getting Started: The Medical Research and Development Primer and Giving Smarter: Building a High-Impact Medical Philanthropy Portfolio.

About LaTese Briggs

LaTese Briggs is the Philanthropy Advisory Service (PAS) program analyst at FasterCures. Briggs previously served as a pharmaceutical market analyst for Decision Resources, a Boston-based research and consulting firm serving the biopharmaceutical industry. In that capacity, she provided expert analytics on the state of research and clinical development, including research challenges, market drivers, and unmet patient needs in the infectious disease space. She is trained as a biochemist and completed her doctoral studies at the University of Maryland Baltimore County and her postdoctoral training at Harvard University/Broad Institute, where she focused on chemical biology and early drug discovery. In addition, she has received a number of honors, including being named a Gates Millennium Scholar, and has authored several scientific articles.

Transforming Philanthropy by Connecting the Dots

Five accomplished philanthropists who “see things others don’t and connect the dots” gathered for an informative Milken Institute Global Conference discussion moderated by Richard Ditizio, executive director of program development at the Milken Institute.

The panelists’ experiences ranged widely across the globe and across issues. Laura Arnold, co-chair of the Laura and John Arnold Foundation, described the very deliberative process she and her husband went through to arrive at the policy objectives for their U.S.-focused foundation, including government accountability (specifically pension reform), criminal justice, and education.

Phyllis Washington, chairwoman of the Dennis & Phyllis Washington Foundation, reflected on her 25 years of philanthropy primarily in Montana, and highlighted the importance of involving the employees of the company in a meaningful way, a theme which recurred several times.

Denis O’Brien, chairman of Digicel, the biggest cellular provider in the Caribbean, became involved in Haiti after the 2010 earthquake, particularly building schools. He emphasized the importance of good project management and working with people with local knowledge and professional standards. “If you break all Haiti’s problems down, they’re all solvable, but you need capital and capable people,” both inside Haiti and at the nongovernmental organizations you work with.

Seth Merrin, founder and CEO of Liquidnet, told the powerful story of how he and his firm got engaged with building a Youth Village for orphans in Rwanda. He is also engaging his employees in a significant way in this work, and in fact sees it as a meaningful tool for attracting and retaining great people to the company. “Our generation wants hands-on,” he said.

Julie Sunderland, senior program investment officer with the Bill & Melinda Gates Foundation, is responsible for applying investment instruments to the work that the foundation does, a trend which she views as powerful because of “the ability it creates for partnering between philanthropy and the private sector, to tap into innovation within and outside the philanthropic sector. It brings into the foundation the tools and outlook of the investor.”

Several panelists echoed the theme of injecting more private-sector culture and accountability into nonprofits. Merrin noted that of the more than 1 million nonprofit organizations in the U.S., the vast majority are extremely small and probably having very little impact. “There’s no real measure of the efficacy of many of these smaller nonprofits; they’re incredibly duplicative, and have done very little research.” Liquidnet is engaged in a project with the Gates Foundation called Markets for Good, which aims to create standards and metrics for nonprofit performance.

Sunderland agreed that “capital allocation within philanthropy is not particularly effective,” but noted that while metrics are important, making sure the incentives of partners are aligned is also essential. She closed the session by saying, “The opportunity to bring the private sector and philanthropy together and break down the barriers is exciting. Creative conflict between world views allows us to solve these problems.”

View FasterCures’ philanthropy toolkit that helps philanthropists make better decisions and make an impact.

Innovations in Financing Early-Stage Medical Research

Novel models that manage risk and encourage innovation are needed for funding early-stage medical research, according to an expert panel at the 2012 Milken Institute GlobalConference. The discussion focused on a variety of different financing approaches, including innovative partnerships with biopharmaceutical companies and research securitization.

Moderator Melissa Stevens of FasterCures framed the discussion by describing the gap in translational research funding and asking the panelists why they think there is a lack of capital for early-stage research.

Bernard Munos, founder, InnoThink Center for Research in Biomedical Innovation, described the culture change that began in the biopharmaceutical industry 15 years ago that led to increased risk aversion across many of the major companies. He spoke optimistically of the need for these companies to re-harness their innovation infrastructure: “Innovation is in our DNA… Unfortunately, the DNA does not always express itself the way it should.”

Other panelists mentioned organizational structure as well as increased regulatory hurdles as impediments to innovation and changed risk profiles in the industry.

Chris Varma, president and CEO, Blueprint Medicines, described a recent deal around Warp Drive Bio that resulted in a risk reduction for each partner. Novel approaches like this, he said, are indicative of pharmaceutical companies knowing they need to change and having the flexibility to structure creative deals that meet their needs.

Aya Jakobvits, president and CEO, Kite Pharma, and venture partner, Orbimed Partners, also discussed a new model, the Israeli Life Sciences Fund, which features the Israeli government as the silent partner in a recently closed venture fund that focuses on life sciences investment. She described how the government sees the fund as “a pillar in the ability of Israel to gain more value” and offers additional benefits to partners, including downside protection and upside amplification. The panelists discussed the potential of exporting this model to other countries.

In addition to government-backed ventures, philanthropy-backed ventures are increasingly playing an important role in early-stage drug development, both through providing funding and sending a signaling effect to the market. Kathryn Smith, managing director, Fast Forward LLC, described the importance of Fast Forward, founded by the National MS Society, as “opening doors to potential partners, not necessarily because of the money but because of the society and the network of MS experts.” Varma also highlighted the increasingly important role of philanthropic foundations, saying “I think organizations and companies that don’t talk to foundations are at a competitive disadvantage.”

The final model discussed was the research securitization model, which was motivated from observations made during the financial crisis. Andrew Lo, Harris & Harris Group Professor, MIT Sloan School of Management, explained that by creating vehicles of debt financing we can tap into pools of larger capital that can be used to transform the medical research industry. Such a model would create long-term financing for a large pool of research assets with financial products based on different risk/reward portfolios, allowing for patient capital to be funneled toward a variety of projects that are in need of financing at variable time scales. The other panelists were generally supportive of the concept, but raised questions about how to prevent the degradation of science in the portfolio and ensuring that investors can understand how much risk they are undertaking.

Finally, Stevens drew a contrast between models designed to bring more capital to new ventures with models that are designed to decrease overall capital costs, such as open source research and development, product development partnerships, and data sharing.

All of the panelists agreed that a variety of new financing mechanisms are important for early-stage drug development to meet the unmet needs of patients.

Think Medical Research, But Think Smart

by Margaret Anderson, Executive Director, FasterCures/The Center for Accelerating Medical Solutions

As published in the Philanthropy News Digest: 

We all know that philanthropic capital is uniquely positioned to play a powerful role in medical research. But fewer of us are aware of the importance of appropriately leveraged capital in creating impact and advancing promising research.

In 2010, philanthropies in the United States invested over $1.1 billion dollars in medical research. While an impressive number, it represents just 2.3 percent of the $140 billion invested by government, industry, and other groups in health and medical research that year. While funding for medical research has been growing incrementally on a year-to-year basis, public and private budgets are under increasing pressure, leaving a lot of promising research underfunded. In these tough times, therefore, it's more important than ever that we focus on doing more with our philanthropic dollars by investingsmarter.

Leading the flow of "passion capital" into medical research are a relatively new type of philanthropic entity known as "venture philanthropies" — organizations of a philanthropic nature that operate in a venture-capital mode. In addition to bringing a sense of urgency to the medical research community, venture philanthropies and the medical research organizations they partner with are beginning to change the financial infrastructure of medical research by providing risk capital for innovative research at critical (and traditionally underfunded) stages of drug development. These investments are also succeeding at drawing in more traditional capital, including public investment, which further leverages the original funds by expanding the pool of available capital at critical stages. Venture philanthropies also play another important role, as their close relationships with patient communities enhance their understanding of and expertise in specific diseases, resulting in forward-thinking research programs focused on reducing the overall impact of disease and solving problems most commonly faced by patients.

The fact that venture philanthropies are proving to be major players in the medical research arena does not mean that all foundations and philanthropic entities need to adopt the venture funding model in order to make meaningful investments that advance the medical research field. Indeed, at FasterCures we believe it is better to focus one's philanthropic resources on building a medical research investment portfolio that is strategic, intelligent, and...smart. And we want to help. To that end, we've created a pair of giving guides: Getting Started: The Medical Research and Development Primer and Giving Smarter: Building a High-Impact Medical Philanthropy Portfolio. Both are designed to help foundations and individual philanthropists better understand the medical research process, identify critical funding gaps, and explain the unique role of medical philanthropy in accelerating cures. They will also assist you in defining your organization's philanthropic priorities, evaluating the potential impact of your investments based on established criteria, and articulating the key questions you need to ask any research team, company, or nonprofit institution you are thinking about supporting or investing in.

In addition to our publications, we are continuing to facilitate the flow of philanthropic capital into medical research by convening major stakeholders at our annual meeting, Partnering for Cures, which this year will be held November 6-8, in New York City. At this year's meeting, more than eight hundred venture capitalists, philanthropists, policy makers, biotechnology and pharmaceutical company executives, patient advocates, and medical researchers will gather for a series of engaging panels and one-on-one meetings, with the ultimate goal of advancing the field of biomedical research and finding cures to a range of diseases. Partnering for Cures is uniquely positioned to introduce new and emerging foundations and philanthropists to the fundamentals of medical philanthropy and to provide more seasoned givers with complete due diligence opportunities.

We hope you can be a part of Partnering for Cures — it is a unique effort that promises to jumpstart your due diligence process. We also encourage you to download the toolkit, which we have designed with your needs in mind. And we look forward to your working with us to develop the financial infrastructure and create the outcomes-focused approaches needed if we are to speed up the process of getting to much needed therapies more quickly.

Margaret Anderson is executive director of FasterCures/The Center for Accelerating Medical Solutions, an "action tank" working to improve the medical research system and speed up the time it takes to get important new medicines from discovery to patients. Prior to her appointment as executive director, Anderson was FasterCures' COO for five years, served as deputy director of the Academy for Educational Development, and led programs and studies at the Society for Women's Health Research, the American Public Health Association and the Congressional Office of Technology Assessment.

What Metrics Matter Most in Nonprofit Medical Research?

We want your input! From operational processes to research effectiveness, tell us what measures you think matter most in evaluating nonprofit disease research foundations and their impact on the discovery and development of new cures. Whether you’re a foundation, scientist, researcher, advisor, or investor, we want to hear from you.

A year ago, FasterCures launched the Philanthropy Advisory Service (PAS) to establish clear and transparent evaluation of nonprofit activities in medical research—helping philanthropists better understand and evaluate the R&D landscape, and strategically guide their investment dollars in high-impact areas. In its initial phase, PAS features the latest medical research developments and objective analysis of key nonprofit disease research organizations in Alzheimer’s disease, malaria, multiple sclerosis, and tuberculosis.

In developing this resource, FasterCures created an evaluation tool to help measure the performance of such organizations, looking at everything from accountability to collaboration to overall contributions to the field. With a year into this effort, we’re taking another look at the framework to learn how we can make it an even more effective tool—not just for use by philanthropists looking to evaluate investment opportunities, but also for organizations seeking ways enhance their effectiveness.

PAS was developed by FasterCures and supported by grants from the Pioneer Portfolio of the Robert Wood Johnson Foundation and the Bill & Melinda Gates Foundation.

Click here to review our metrics and tell us how we can make them better and stronger. We appreciate your input and believe that, together, we can inform and increase the flow of philanthropic dollars to this critical field of research.

Related resources:

• “From Social Entrepreneurship to ‘Cure Entrepreneurship’” (April 2009) PDF of Full Report
• "Entrepreneurs For Cures: The Critical Need for Innovative Approaches to Disease Research"(May 2008) White Paper (PDF)

Medical Philanthropy: Investing in the Cure Enterprise

by Gillian Parrish, Manager of Alliance Development and Communications, FasterCures

Though philanthropic investment in medical research accounts for only three percent of overall spending, a pittance compared to government and industry funding, it plays a vital role in catalyzing progress. Unburdened by the demands of shareholders, and the legacy mandates of institutional funders like the NIH, nonprofit disease foundations have the flexibility to fund high risk, high reward research that disproportionately accelerates the pace of innovation.

The “Investing in the Cure Enterprise” panel Monday afternoon at the Milken Institute Global Conference explored what’s working in medical philanthropy and how to encourage more philanthropists to invest effectively in the development of new and better treatments for disease.

Melissa Stevens of FasterCures moderated the discussion, noting the important role that medical philanthropy plays in stimulating research in under-resourced disease areas, and bridging the so-called “valley of death” in funding, between basic discovery and later-stage, clinical research.

Panelists from across the philanthropy spectrum agreed that a mix of accountability and measurement in research, together with investments in process infrastructure, would speed the discovery and development of new treatments.

Though perhaps not as “sexy” as disease-specific investments, funding for the development of medical philanthropy process infrastructure—including the sharing of data and best practices across sectors and diseases—is critical to replicating success and learning from failure, noted Matthew Bishop of The Economist. Melanie Schnoll Begun, Managing Director, Morgan Stanley Smith Barney Philanthropic Services, echoed the importance of understanding failures, saying that often in medical R&D, “failures” are actually successes, in that they eliminate ineffective research options and point the way to better cures.

Jane Wales of the Global Philanthropy Forum talked about the growing convergence between the social sector and private sector. “Philanthropists are bringing the rigor of the private sector to the work they do in medical research,” she said, “and the most important thing they can do moving forward is to pass their values along to the generations that follow to drive sustainability towards long-term goals.”

Susan Axelrod of 23andMe, Inc., said: “Philanthropists like us have a high tolerance for risk. We’d rather push the envelope in dramatic ways, even if we might fail, than play it safe.”

FasterCures Names Margaret Anderson Executive Director

WASHINGTON (December 15, 2009) – FasterCures, an organization committed to saving lives by saving time in the research, discovery and development of new medical solutions, today announced the appointment of Margaret Anderson as its Executive Director. Anderson will lead the organization, defining its strategic priorities and positions on key issues, developing its programmatic portfolio, and managing its operations.

Prior to her appointment as Executive Director, Anderson was FasterCures’ COO for five years. Since its inception in 2003, FasterCures, the Washington-based center of the Milken Institute, has worked independently and with partners to break down the barriers that exist across the research continuum—from basic research to drug development—to clear the path to faster medical progress. These include the following programs: the Philanthropy Advisory Service, an online information marketplace designed to make philanthropic investment in medical research more effective and productive; “TRAIN” (The Redstone 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.

“Margaret has been a steady and inspirational leadership force at FasterCures for years," said Michael Klowden, President and CEO of the Milken Institute. "She's been instrumental in developing and implementing strategies that set the organization apart. And she has the unique combination of knowledge, leadership abilities and enthusiasm it takes to energize the biomedical research community.

"The FasterCures mission is to facilitate a medical research culture that encourages innovation and collaboration, operates efficiently and transparently, and - most importantly - gets results. Margaret has proven herself to be the right person to get this done in her new leadership position," added Klowden.

Most recently, FasterCures convened the inaugural Partnering for Cures meeting in New York City, the first‐of‐its‐kind effort that brought together philanthropy, medical research foundations, and the biotechnology and pharmaceutical industries in an effort to forge strategic collaborations needed to expedite the search for cures.

PAS Offers Philanthropists Impartial Analysis of Select Medical Nonprofits

by Margaret Anderson, COO, FasterCures

The FasterCures Philanthropy Advisory Service (PAS) last week unveiled information on select Alzheimer’s disease and multiple sclerosis organizations, the first in a series of completed reports focused on efficacy and efficiency of research organizations. In its pilot phase, PAS features the latest medical research developments and objective analysis of key nonprofit disease research organizations in Alzheimer’s disease, malaria, multiple sclerosis, and tuberculosis.

PAS begins with the premise that when you invest your money, you look for the best return on investment. FasterCures created PAS to help philanthropists make informed investment decisions and have in place a mechanism to assess the return on their philanthropy.

Philanthropic investment in medical research, though small in size, plays a unique, critical role in finding medical solutions. I think of it as a small, but mighty piece of the pie. Philanthropic money fills funding gaps in research that is high-risk but also with potential of high-return. For some diseases, nonprofit funding models are virtually the only source of capital for innovative, risk-taking research. And yet, there is lack of independent, reliable data about disease research.

Launched as part of an effort to fill the information vacuum, PAS is a transparent and impartial resource for the medical research philanthropy community. PAS data and analysis are based on a focused set of criteria: how well – and how effectively – a nonprofit research organization is being run and how it is contributing to the advancement of research. Criteria include:

• Milestones
• Advisory boards
• Knowledge production
• Industry partnerships
• Tools and resources

The PAS pilot phase is available to all registered Premier Users. Those directly involved in medical research philanthropy are invited to become Premier Users and have free access for a full year to PAS resources.

Now available: An archive of the 8/13 web briefing featuring the following speakers and a live PAS demo:

• Lucy Bernholz, Founder & President, Blueprint Research and Design, Inc.; Member, PAS Organizational Review Board
  

  "Philanthropy Advisory Service is bringing about the careful, meticulous,
  well-informed research about diseases, disease research, disease research
  organizations, and bringing that to light in a way that can inform a wide
  variety and ultimately a large number of philanthropic assets so that the goal
  of advancing disease research can be achieved."

• John Q. Trojanowski, M.D., Ph.D., University of Pennsylvania, Co-Director, Center for Neurodegenerative Disease Research; Director, Institute on Aging; and Director, Alzheimer's Disease Core Center; Member, PAS Alzheimer’s Disease Scientific Advisory Board
  

  "I know of no other organization that brings this kind of expertise to bear on
  advising donors about how their investments in research are being used... The advisory service for Alzheimer’s, which is what I’ve specifically been involved with, has been detailed, accurate, substantive, clear, concise. I clearly see this as an important service that foundations can avail to determine whether they are hitting their target in their mission."

• Rusty Bromley, COO, Myelin Repair Foundation
  

  "We saw PAS as an opportunity [for nonprofit research organizaitons] to provide more transparency and help differentiate organizations within the same space based on their mission. Having an outside organization applying uniform criteria to measure operational effectiveness has tremendous value and something we can look at to determine how we're performing against our own internal standards."

• Tim Armour, President and CEO, Cure Alzheimer's Fund
  

  "PAS helps philanthropists and others to understand the niche that an
  organization serves, and then adds additional value of helping to evaluate how well the organization serves that niche... I think PAS does two things [for CAF]. One, we can learn about good practices from other organizations, in virtually real time - which is very valuable, particularly to a young organization like ours. Two, we can identify other organizations with whom we can partner with on specific issues. We can do that with a lot of other homework, person-to-person, but this gives us a very good first-cut."

Visit http://www.philanthropyadvisoryservice.org/ for more information.

How many business plans did Mother Theresa have? Probably none, but just imagine what she could have done if she had one!

by Melissa L. Stevens, Director of Special Projects, FasterCures

Almost 200 participants from over 20 countries convened a couple of weeks ago in London to talk about individual efforts to evaluate nonprofits and a possible mechanism to unify these efforts under a professional association. New Philanthropy Capital, a London-based charity research organization, and Bertelsmann Foundation, one of the largest German Foundations, hosted this conference Valuing Impact: Building an Association of Nonprofit Analysts. Inspiring discussions were interspersed with challenging questions about the community’ preparedness for such an organization.

Matthew Bishop, Chief Business Writer/US Business Editor of The Economist spoke about creating an impact in his keynote address. He said that in this time of economic crisis it is important for "philanthrocapitalism" to emerge, and that a critical role of “virtuous intermediaries” is to rigorously analyze what does and does not work. He underscored that this evaluation work needs to be funded and be democratized for all philanthropists, not just the super-rich.

Other highlights from the meeting include learning about other evaluation frameworks and ways for improving FasterCures' Philanthropy Advisory Service metrics and hearing first-hand accounts of how best to build models and establish evaluation organizations.

Appropriately, participants checked their rose-colored glasses at the door. There was challenging commentary and acknowledgement of significant obstacles in building the field of nonprofit analysts. One of which being the lack of data produced by nonprofits. Ken Berger, CEO of Charity Navigator, noted that in his pilot effort to measure outcomes (in addition to information gleaned from 990 financial data) he found that 85 percent of 4-Star charities could not produce the necessary data for an expanded evaluation. Scary. We also heard there are at least 150 different frameworks in existence, so already, there is significant divergence. Yikes. Finally, there were the weighty pauses after the rhetorical questions like “Who should pay for transparency?”, “Who is the audience – donors or organizations?”, and “Won’t this be done at the expense of programming costs?” Oh my.

But at the end of the day the delegates regrouped and voted on their interest in establishing an association and at least 75 percent indicated they would be. Perhaps it will be a soft launch with at least a bulletin board, listserv, and sector-specific working groups to think through common frameworks. I would be very pleased to join an effort that can quickly connect me to others who have pioneered evaluation frameworks, business models, and donor education efforts. PAS would greatly benefit from the collective thoughts of such a network of relative experts in the field. We look forward to seeing where the journey takes us from here and applaud New Philanthropy Capital and Bertelsmann Foundation for getting us out of the starting blocks.

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.

Helping Philanthropists Make Informed Investment Decisions

“When you invest your money, you look for the best return on investment. When you donate it, shouldn’t you look for the best return on your philanthropy?” - Greg Simon, President, FasterCures

FasterCures just launched the Philanthropy Advisory Service, an online information marketplace that will provide reliable, independent data on the efficiency and productivity of nonprofit disease research organizations. PAS was created to help philanthropists make informed investment decisions and have in place a mechanism to assess the return on their philanthropy.

After two years of medical literature review, organization interviews, expert consultations, and intense data analysis, we are proud to release information on Alzheimer’s disease and multiple sclerosis and the organizations involved in researching cures for these diseases. We are just getting started, this is the first of a planned series of reports. Expect more reports on malaria and tuberculosis in the summer.

PAS allows philanthropists to do just that. They can direct their philanthropy to organizations whose medical research goals match their own and identify where their money can make a critical difference in finding new cures. It’s available to registered Premier Users, free of charge, for a year. Learn more.

Related links:

• Philanthropy 2173: http://philanthropy.blogspot.com/2009/04/fastercures-philanthropy-advisory.html

If You Leave Me Now, You’ll Take Away the Biggest Part of Me…

Susan Semeleer, Associate Director of Communications, FasterCures

The unsettled economy is forcing nonprofits – and the donors who sustain them – to make hard decisions about disbursement of funds. The economic downturn has created more need – and diminished the giving capacity of those best able to meet that need.

An Associated Press story last month chronicled the broadside that nonprofits are expected to take as grim economic statistics mount. Couple a weak economy with shifting fiscal priorities, and the potential consequences for nonprofits are huge. Even a small minority of donors scaling back could add up to billions in lost contributions – enough to topple teetering nonprofits. Real dollars. Real consequences.

So how do charities keep their institutional heads above water when everyone is cutting back on expenses? Conversely, how can donors be assured that their contributions are being put to the best possible use? On this space a few weeks ago, my colleague Melissa Stevens drafted a post on the FasterCures Philanthropy Advisory Service. The PAS was created to fill the information vacuum caused by the lack of reliable, independent data on the efficiency and productivity of charities and nonprofits. The PAS truly is a tool for its time: a convenient, easily navigated one-stop clearinghouse of information, gleaned by using a singularly focused set of criteria: how well – and how effectively – an organization is being run and is contributing to the research community, allowing philanthropists and their advisors to make informed decisions about giving.

Americans are a generous people, even in lean times, and charitable giving in the U.S. has been largely impervious to economic downturns. This morning, NPR's Marketplace reported that "donations to charities in the millions have fallen by one-third, and the need for assistance keeps climbing. But some philanthropists use this as a call to give more in times of greatest need." Indeed, giving increased during the Great Depression. And although there have been 11 recessions since the end of World War II, only in one year has total giving actually fallen in the U.S. – 1987, the year of the Black Monday stock market crash. But, as one philanthropy expert told the AP, “This is a Darwinian moment for the nonprofit sector.” When charity becomes a question of survival of the fittest, it can be expected that many charities won’t survive. Enterprises like PAS ensure that the charities and nonprofits that do survive are very likely to be the ones that will do the most good, for the most people.

FasterCures is Stopping TB

By Loren Becker, Global Health Program Analyst, FasterCures

Today, as health workers and communities globally observe World TB Day, 25,000 new people will be diagnosed with tuberculosis and nearly 5,000 will die from the disease. Most TB sufferers are adults in their working years, costing the world about $12 billion in economic productivity each year. Many more also are infected with HIV/AIDS, compounding an already massive humanitarian crisis, particularly in sub-Saharan Africa. The slogan for World TB Day is “I am stopping TB.” Unfortunately, TB control efforts are unable to keep up with the epidemic: a new report released by the World Health Organization this week tells us that the number of new cases and deaths continues to grow with each passing year.

Many factors contribute to the severity of the global TB problem, not least of which is that the tools we have to fight the disease are antiquated and inadequate. In a world where we can splice genes and grow new tissue out of stem cells, very little attention is paid to improving the options for patients infected with this disease that has long since ceased to be a concern for most of us in the developed world. As a result, health workers in the poorest countries are stuck with a vaccine that is over 80 years old and only protects children, drugs that are over 40 years old and difficult to stomach, and diagnostics that frequently fail to give clear, actionable results. Harsh treatment regimens frequently lead to noncompliance, which, in turn, lead to drug resistance. Increasingly, health workers are confronting strains of TB bacteria that are able to resist some or even most of the available drugs.

Despite the dire statistics, TB experts see room for optimism. As awareness of the global epidemic has grown, so has funding and attention from governments, foundations, and other sources. In the last decade, several new initiatives have joined the fight to control TB and to develop better tools to aid future efforts. Researchers within some of these groups are making key contributions in terms of expanding our basic scientific knowledge about TB, as well as translating that knowledge into improved vaccines, drugs, and diagnostics. The entrance of these new players has led to exciting advances and expanded the opportunities for those concerned to get involved in stopping TB.

Many of the new research groups, as well as their more established counterparts, are nonprofit organizations that receive most or all of their funding from governments and foundations. Private philanthropists also can, and do, play an important role in funding research to develop and deliver new tools in the fight against TB. In order to help these donors understand the field of TB research, the major nonprofit players, and targeted areas of philanthropic R&D investment, the FasterCures Philanthropy Advisory Service is including TB as one of four diseases covered during the project’s pilot phase. The TB module of our Philanthropy Advisory Service is expected launch this June. Through this effort, FasterCures is stopping TB.

You Get What You Pay For?

By Melissa Stevens, Director of Special Projects, FasterCures
You wouldn’t choose a restaurant based on how little it pays its chef, or a surgeon based on how cheaply the hospital retains his services. So why would you choose a charity based on how low its overhead is?

Dan Pallotta is the author of the newly released Uncharitable: How Restraints on Nonprofits Undermine Their Potential. Pallotta spoke at a Milken Institute Forum on February 11 about his new work, which is described as “a manifesto that puts a new cause on the map - equal economic rights for charity.” He addressed the compensation disparities between for-profits and nonprofits, and challenged long-held conventional wisdom that overhead is a reliable measure of effectiveness.
Pallotta argues that charities are pressured into playing by different rules than for-profits, and that these pressures can stifle the organization’s productivity.
Consider:

• Compensation – Salaries for nonprofit executives are frequently criticized as too high. When nonprofits are compelled by external forces to tamp down executive compensation, recruitment quality is the first casualty.
• Advertising – Mass marketing is considered wasteful and frivolous in the nonprofit world – a costly and shortsighted judgment in the era of the multimedia-driven, 24-hour news cycle. The refusal to play in the mass marketing arena stifles charities’ ability to capture market- and mind-share, and cedes the stage to campaigns about the latest soft drink or i-product rather than malaria eradication or ending hunger.
• Vision –Nonprofits are incentivized to spend funds in the near-term to make an immediate impact, leaving them unable to invest in long-term, strategic initiatives, and sacrificing long-term gains for short-term returns.
• Learning – Nonprofits are given very little room for error in the court of public opinion. The climate of hard judgment creates disincentive for creativity and risk-taking. A risk-averse entity will never reach its full potential.
• Capital – Nonprofits are locked out of the financial markets because they do not pay financial returns. This leaves them continually dependent on what FasterCures’ calls “passion capital,” which only promises social returns.

Pallotta also articulated his frustration with the habitually asked “What percentage of my donation goes to the cause and how much goes to overhead?” Pallotta asserts that overhead actually is part of the cause. Investment in management and infrastructure are critical aspects for ultimate success, and should not be treated as incidentals. Further, he noted that measuring overhead does not give donors sound information about outcomes and the impact made by the organization.

Pallotta calls for developing a metric for assessing charitable giving. FasterCures agrees with this approach, and is leading the charge in the biomedical research space with the Philanthropy Advisory Service (PAS), an information resource that aims to create a transparent marketplace about nonprofit disease research organizations that fund and facilitate disease research. The PAS organizes and analyzes information about strategy, research portfolio, management, and financials. Even more importantly, the PAS creates an assessment framework to evaluate an organization’s internal and external contributions to the field. These assessments are made based on the organization’s own mission statements, as well the unique nuances of the disease research system.

The PAS framework organizes our assessment around the following metric categories:

• Accountability: The degree to which an organization engages in planning, demonstrates transparency, and upholds responsibility to stakeholders.
• Collaboration: The degree to which an organization can engage and nurture relationships that accelerate the overall funding and research cycle.
• Research Effectiveness: The degree to which the organization’s research portfolio yields sufficient data and deliverable returns to achieve its stated mission.
• Resource Building: The degree to which the organization contributes critical resources and infrastructure to scientific advancement.

FasterCures has engaged scientific and organizational experts to provide input to the organizational assessments, ensuring an informed, credible, and objective review. The PAS is currently being piloted across four disease areas – Alzheimer’s disease, multiple sclerosis, malaria, and tuberculosis – and is targeted to launch later this spring. FasterCures is excited about the PAS and its contribution to a new paradigm of nonprofit evaluation – the overhaul on overhead is long overdue.

Not enough Alzheimer’s patients?!

by Jeongyeon Shim, Program Analyst, FasterCures

As part of the FasterCures’ Philanthropy Advisory Service program, we invited four eminent scientists in Alzheimer’s disease research to learn more about their perspectives on key opportunities and challenges that the field is facing. We discussed many of the exciting development occurring in the field. In addition to progress in basic research, many potential treatments are showing promise in animal studies and various stages of clinical trials. Many of the efforts targeting what scientists believe to be the causes of the disease are moving along the pipeline, and novel mechanisms of interventions are also discovered.

The meeting also addressed challenges in AD research. Among others, low enrollment in clinical trials was highlighted as a key challenge in transforming exciting scientific discoveries into treatments that benefit the patients. Alzheimer’s is not exactly an orphan disease—it impacts 4.5 million patients in the US today, with a drastic increase of disease burden expected. How is it possible that there are not enough clinical trial participants?

Many clinical trials in Alzheimer’s target the patients in early stage of the disease, since that is when the debilitating effects of dementia, caused by the death of neurons, can be averted. However, a diagnosis is less straightforward at early stage, given that clear biomarkers of the disease are yet to be established. Even in cases where diagnosis is made early, additional challenges to clinical trial participation exist. For example, under the current system of care where primary care physicians are in charge of most Alzheimer’s patients, it is difficult to have patients enroll in clinical trials, which are conducted in more specialized healthcare centers. Trial participation may also increase the burden to the caregiver due to the need for additional visits, especially when the trial site is at a distant location.

While scientists and trial administrators focus on finding solutions to this challenge by developing biomarkers for early diagnosis, reaching out to primary care physicians, educating participants on the importance of trials and developing technological solution to reduce the need for physical visits, the most important lever would be that patients and caregivers learn more about trial options, and when possible, enroll in trials. Participating in trials requires substantial effort from the patients and caregivers as well as courage to commit to a therapeutic regimen that is yet to be proved. No other research tool can substitute for clinical trials in developing novel therapeutics. Trial participants make an invaluable contribution to medicine by making themselves available—we cannot overemphasize the fact that none of the medical breakthroughs we have today would have been realized without their contribution.

To highlight one trial, the Alzheimer’s Disease Cooperative Study, a clinical trial network funded by the NIH, is currently recruiting participants for a trial aiming to curb the toxic effects of beta-amyloid .* This is not the only trial targeting Alzheimer’s disease—ClinicalTrials.gov lists 121 trials in the US and 216 when counted across the globe, actively recruiting participants, as of September 24, 2008. FasterCures has been highlighting clinical trial participation as a key element to accelerate medical research. I look forward to a day when an informed conversation about clinical trial participation becomes part of routine medical care.

*FasterCures does not endorse any specific clinical trial. Decisions on clinical trial participation should be made based on consultation with healthcare professionals.

Is Philanthropy Going to the Dogs? Perhaps it’s Still the Cat’s Meow…

by Melissa Stevens, Program Director, FasterCures
The Bradley Center for Philanthropy and Civic Renewal and the Chronicle of Philanthropy hosted a discussion, “Is Philanthropy Going to the Dogs?,” to debate the issues of donor intent, social justices, and public interest within the context of Leona Helmsley’s $8 billion bequest made in August 2007. The session, moderated by The Chronicle’s Stacy Palmer, brought together Professor Ray Madoff, Professor Leslie Lenkowsky, Pablo Eisenberg, and Judge Robert Burk from the Hudson Institute.

Among the discussion’s highlights:

• Professor Ray Madoff from Boston College argued this bequest is actually subsidized by the taxpayers because it is stipulated to be held in perpetuity and thus avoids the payment of $3.6 billion in estate taxes to the government. So, essentially this averting of taxes is equal to the government making a matching charitable gift to causes supported by the Leona M. and Harry B. Helmsley Charitable Trust.
• Professor Leslie Lenkowsky from Indiana University countered that the philanthropists like Ms, Helmsley leverage their charitable gifts to express their values and their beliefs in what is important for the public good.
• Pablo Eisenberg from Georgetown University projected that with the mass transfer of wealth ($41 trillion dollars between 2002 and 2052) we will see the rise of mega-foundations with assets of $50-$60 billion that will operate under the direction of only a few family members. He argued that limited input into the guidance of vast volumes of resources is contrary to democracy and perhaps the installation of antitrust laws similar to those enacted in the early 1900’s to protect consumers from big business would help to protect our society from philanthropic monopolies. This concentration of resource oversight would most likely also create a funding stream for the organizations (specifically higher education, healthcare, and cultural) that are of interest to the leadership. Many of these recipient organizations are selected because they have large names and thus are presumed to be “accountable” whereas lesser-known start-up nonprofits are assumed to be less fiscally responsible. Therefore, the aggregation of philanthropic dollars under a few mega-foundations would allow the “rich to get richer and the poor to get poorer.”
  

Such a provocative discussion begs you to ask whether philanthropy is indeed going to the dogs.

Amidst all the talk, what struck me most is the apparent need for increased transparency in the philanthropy marketplace to better inform giving and more effectively channel funds to where they are most needed and can make most impact. The FasterCures Philanthropy Advisory Service intends to do this for biomedical research nonprofits such that large organizations like Alzheimer’s Association and smaller organizations like Cure Alzheimer’s Fund are evaluated equally on their approach and execution in accelerating research in the Alzheimer’s disease area.

Eisenberg closed the session noting that despite the potential threats to philanthropy, we should remember that foundations should remain in a “special place” in our economy because they fund innovation, new ideas, and high-risk opportunities that others are unwilling to do. FasterCures has echoed this unique ability and responsibility of nonprofit disease research to tackle the high-risk yet high-reward translational research that the government and industry are not inclined to fund. Although philanthropic dollars only account for about 2% of the R&D investment in the life sciences, it is an invaluable piece of the funding pie. We hope our efforts to inform charitable investment, build collaborations, and promote knowledge-sharing across sectors keep philanthropy from going to the dogs for its true value is the cat’s meow.

FasterCures' Ten to Watch Mid-Year Review

by Greg Simon, President, FasterCures

FasterCures started the year with its Ten to Watch in 2008. Before summer's end, we wanted to share some of our insights on the ten things we've been watching (other than the Olympics) and how they are faring.

1. Return on philanthropy. This fall, FasterCures will preview its Philanthropy Advisory Service, which will help philanthropists decide where their contributions will have the greatest Return on Philanthropy – the greatest impact in finding new cures. The Gates and Robert Wood Johnson Foundations are supporting this effort to create an information marketplace to improve the efficiency and productivity of both the philanthropic investor and the nonprofit disease research organizations that depend on such support. Watch this space for updates.

2. The FDA. It hasn’t been a great year for FDA. In the first half of 2008 alone, the agency had to deal with contaminated heparin from China, salmonella-tainted jalapenos from Mexico, and a Supreme Court decision that has made it a shield protecting medical device manufacturers from lawsuits by patients. The silver lining is that all this bad news is focusing attention on the agency’s critical importance and woeful lack of resources. FDA chief Andy von Eschenbach even broke ranks with the Administration and confessed that the agency needs a larger budget than requested to do its job. But it needs more than that, starting with Congressional leadership that supports it constructively rather than attacking and denigrating it. A key step would be to fund the Reagan-Udall Foundation, and realize FDA’s Critical Path initiative.

3. Research: Lost in translation. The call for more translational research is now coming from a wider range of stakeholders, including interesting messengers such as Katie Couric. In a recent interview about the September 5, 2008 Stand Up To Cancer fundraising effort on “Larry King Live,” Couric said that its focus will be supporting research that has practical applications and patient-relevant outcomes. She noted that the funding will be"...focusing on cutting edge cancer research, which will hopefully inform people about how close we are to new therapies and new approaches and how…scientists need additional funding so these can go from the lab to the clinic and hopefully, eventually, save a lot of lives.”

4. Science 2.0. On June 3rd, members of FasterCures’ TRAIN network of disease research foundations spent some time with two innovators in the use of online platforms for scientific collaboration. June Kinoshita, Executive Editor of Alzheimer Research Forum, a pioneering e-community for Alzheimer’s researchers, is currently working on an ambitious project called Semantic Web Applications in Neuromedicine (SWAN), which will create a common semantic framework to allow researchers to more quickly and seamlessly integrate and combine data from diverse sources rather than just exchange documents. Jeff Shrager, Chief Technology Officer of CollabRx, demonstrated its product – a “virtual biotech,” a Web-based collaborative research platform that would enable funding organizations and research teams to manage, track, and prioritize their operations as well as to share data, knowledge, resources, and services. CollabRx is also working with Science Commons on its Health Commons initiative, which envisions a virtual marketplace or ecosystem where participants share data, knowledge, materials and services to accelerate research.

5. Crowd-sourcing innovation. FasterCures is seeking to benefit from the “wisdom of the crowd” by posting an “ideation challenge” on InnoCentive’s Web site this fall, as one of the company’s first “Public Policy and Citizens in Action” challenges seeking solutions to important issues facing society. The New York Times reported in July how this approach is “catching on…as would-be innovators can sign up online to compete for prizes for feats as diverse as landing on the Moon and inventing artificial meat....” Keep an eye out for more details – maybe you’ll have some ideas to offer and potentially win the prize!

6. Prize philanthropy. Top-down prizes are getting a lot of attention this year, not only by the press but by politicians. A panel appointed by the National Research Council recommended that the National Science Foundation offer prizes of $200,000 to $2 million in various areas of science to encourage innovation. Two weeks ago, The Wall Street Journal challenged political and business leaders to outline how they’d spend $10 billion in four years to address global problems. Newt Gingrich proposed the development and diffusion of new technologies by using large, tax-free prizes, arguing that prizes would be a useful experiment in large-scale breakthroughs.

7. Biomarkers Consortium. The Biomarkers Consortium public-private partnership has taken the interesting step of identifying “High Impact Biomarkers Opportunities.” Rather than be, essentially, investigator-driven and wait for participants (industry, academia, foundations) to walk in the door with good ideas, the Foundation for the NIH has chosen to develop this more strategic and prescriptive path, laying out projects that it believes “will have the greatest and most proximal impact on future diagnosis and treatment of patients and drug development.” We will continue to watch with interest to see if this effort proves to be an effective way of addressing the “first-mover disadvantage” in biomarker research and validation – i.e., the first mover spends all money and its competitors get the advantage of the biomarker.

8. Comparative effectiveness. The healthcare reform drumbeat is getting louder -- and much of the call for change is focused on the need for more cost effective and efficient approaches to our nation’s healthcare woes. Despite the buzz around comparative effectiveness, it’s important to note that both presidential nominees recognize that this issue is more complex than it may appear. In response to a question on the issue posed by the “Your Candidates - Your Health” program (of which FasterCures is a sponsor), Sen. McCain said we need “to ensure that [this] does not stifle the spirit of innovation,” and Sen. Obama cautions that the “decision on which treatment to use should be made by patients and doctors, not government or insurance companies.”

9. Electronic health records (EHRs). As the federal government muddles through its continuing effort to figure out what its role in the development of the “healthcare information superhighway” should be, there are at least small signs that it might be waking up to the importance of factoring research uses of EHRs into their plans. FasterCures recently joined a panel of research leaders that called on the group charged with creating the successor to the American Health Information Community to expand its scope and mesh data standards for medical research with its work on standards for e-health records. The group said it would consider how best to do that. Meanwhile, the FDA has launched its Sentinel initiative to better monitor medical product safety, a massive effort that will involve using existing electronic health records for post-marketing surveillance of approved drugs.

10. Clinical trials: Something’s gotta give. The discovery enterprise is calling for revolutionary change in how we conduct clinical trials. The NIH is studying how to accelerate and improve the conduct of clinical trials at its own Clinical Center, which could provide useful information and models to other trial sponsors. The Pioneer Portfolio of the Robert Wood Johnson Foundation (which supports FasterCures’ Philanthropy Advisory Service project) has made its largest grant to build ARCHeS, a Web-based interface and delivery system that will allow far more health and policy decision-makers to use the Archimedes simulation model – a sophisticated database that some believe could be used to radically streamline the design and simulation of clinical trials. This is definitely an area worthy of focused attention by the next President.