Find Drugs that Work for Cancer

by Cecilia O. Arradaza, Communications Director, FasterCures
To win the war on cancer, our nation’s decision-makers need to enact policies that support cutting-edge developments in cancer research and facilitate patient-centered approaches throughout the research continuum. This message permeated through discussions at Friday’s Clinical Research Conference convened to address pressing scientific and regulatory challenges and opportunities for progress in innovations in cancer therapy. The conference was organized by Brookings Institute, Friends of Cancer Research, American Society of Clinical Oncology, and American Association of Cancer Research.

More than a hundred leaders in cancer research and advocacy representing academia, government, industry, and the nonprofit sectors convened for a full day discussion of scientific and policy issues impacting clinical cancer research. The diversity of viewpoints and the depth of commitment to furthering cancer research spurred an engaged discussion among participants anxious to address our nation’s cancer challenges.

NCI Director John Niederhuber said in his opening remarks, that the 21st century paradigm will be anchored on translational science and based on multiple, highly-targeted agents matched to molecularly selected patients. Important issues were raised by panels that followed and some key recommendations rose to the top. Highlights include:

• The first panel looked into data standards and evidence requirements and noted that “it’s easy to get data…the challenge is to ensure the data we have is any good.” To make sure new drugs are safe and effective with the optimal amount of information, the panel recommended the development of qualitative and quantitative standards for data collection to streamline the path to more efficient clinical trials.
• Measuring treatment efficacy is a complex and subjective process and the oncology community has long sought endpoints other than overall survival. Looking for a better way of measuring the effectiveness of new drugs and accelerating safe and effective cancer drug development, the second panel proposed three different scenarios that look into progression-free survival as an indicator of clinical benefit.
• The promise of personalized cancer therapy remains largely unfulfilled and there have been few successful efforts to develop therapies and their targets simultaneously. The third panel recommended the following:
  - External stakeholders should be engaged in the design of a pathway for the development of diagnostics for tumor markers.
  - Tumor-marker clearance and approval should be based on demonstrated clinical benefit.
  - An advisory committee similar to the FDA’s Oncologic Drugs Advisory Committee should be developed for tumor marker clearance and approval in order to improve consistency and coordination with other oncology programs in the agency.
• The final panel painted a vision for the FDA’s future. FOCR’s Ellen Sigal noted that complex science is at the base of all the discussions and that the process for defining a clear path forward is always evolving, making it critical to garner the input of diverse stakeholders every step of the way.

At day’s end, having mined the combined braintrust of panelists and participants, former FDA Commissioner David Kessler articulated a key action step and perhaps a challenge for the next person to lead the FDA. Kessler said we “need an FDA Commissioner who will say: find drugs that work for cancer.” Someone who is willing to take risks, make mistakes but who has a clear idea of what they want and be able to articulate this amidst competing priorities. On this note, be on the lookout for FasterCures’ upcoming recommendations for the new administration regarding the FDA.
READ AND COMMENT

Magical Thinking

Margaret Anderson, COO, FasterCures
I appreciated the message of Carol Diamond and Clay Shirky’s recent piece in the August 2008 Health Affairs titled “Health Information Technology: A Few Years of Magical Thinking?” In it they say that “proponents of health IT must resist “magical thinking,” such as the notion that isolated work on technology will transform our broken system.” It’s interesting to think about systems change at the front end, and how easy it is to get stars in our eyes about how things like health IT or personalized medicine will transform the world as we know it, and how all of our problems will then magically go away.

I was speaking recently to a colleague here Kristin Schneeman about her life working in Vice President Gore’s office in the early days of the Clinton Administration and how new and novel email was at that time. I recall getting my first work email account and not having anyone to really email anything to, except my colleagues on the same floor. Greg Simon, President of FasterCures has talked about how he had a cell phone in the early days and was embarrassed to be talking on the street with it so he’d take it into a pay phone booth to look more “normal.”

Cell phones, email, and the Internet have certainly transformed things in ways we couldn’t have imagined, but they’ve introduced problems we couldn’t have imagined. Technologies such as FAX machines have been leapfrogged over. Problems such as the overabundance of information, and the speed of information flow are here to stay it seems. In the case of health IT, FasterCures sees it as a vital bridge to the future of more rapid information collection, characterization, and analysis which could speed our time to cures.

We are working on a white paper for the U.S. Department of Health and Human Services about educating and building awareness among consumers about personalized healthcare. This is another area where we must resist “magical thinking” and get down to brass tacks. Too often, the discussion about personalized medicine has been at a 30,000 foot level. For this paper, we’ve talked to many patient advocacy and disease research groups and everyone holds their breath about the potential power that these technologies may hold for their disease areas. They all want more targeted therapies with fewer side effects, which is ultimately the promise of personalized medicine. But they also recognize its complexities. It needs to take into account the world of co-morbidities we all live in; even if baby boomers are out running marathons and eating their greens and blueberries, the reality is that many of us are living with many conditions and diseases, not just one. It will probably raise costs before it can lower them. It's unlikely many diseases will yield to the relatively easy HER2-Herceptin gene-to-drug relationship. Patients are likely to get much more information about their genetic makeup than they can act on in the near-term. So, with all these complexities, is it magical thinking to ponder how scientific advancements in genomics and proteomics may change things for the better? Is it magical thinking to imagine a health IT system that can propel these advancements forward even faster? Or can we make it real? You tell me.

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.

InnoCentive and FasterCures Align to Seek Help in Finding Innovative Treatments and Cures for Major Diseases

The first Challenge posted on InnoCentive will seek ideas for encouraging more investment and collaboration on biomarker research within the biopharmaceutical industry to accelerate medical solutions

Waltham, Mass. and Washington, DC — InnoCentive, Inc., the Global Innovation Marketplace, and FasterCures / The Center for Accelerating Medical Solutions, today announced that they have partnered to seek solutions from the public that advance medical research, encourage faster development of new diagnostics, and enable personalized medical treatments. The just-released Challenge seeks innovative ideas for spurring biopharmaceutical industry investment and collaboration in biomarker research.

News Highlights

• The first Challenge will seek ideas that encourage companies to invest and collaborate more in biomarker research and qualification.
• According to the Institute of Medicine, a biomarker is “any characteristic that can be objectively measured and evaluated as an indicator of normal biological or pathogenic processes, or of pharmacological response to a therapeutic intervention.”
• Biomarkers are used by medical professionals to determine proper diagnosis, prognosis and the optimal course of treatment for a patient. Furthermore, biomarkers are widely viewed as a critical technology to personalizing treatment choices and maximizing the impact of medical treatments.
• Biomarkers are also a pivotal part of biomedical research process and can shave years and millions of dollars from the research and development process.
  FasterCures is a nonprofit organization whose mission is to identify and implement global solutions to accelerate the process of discovery and clinical development of new therapies for the treatment of deadly and debilitating diseases.
• This Challenge will be posted in InnoCentive’s Global Health Pavilion, a section of the website that focuses on Challenges that contribute to solving some of the world’s biggest Health challenges.
• In support of its mission to change the world and influence the lives of people everywhere, InnoCentive is providing shared funding for this Challenge as its initial philanthropic initiative in open innovation.
• The partnership will allow FasterCures to reach InnoCentive’s network of more than 160,000 Solvers based in 175 countries worldwide.
• This is one of many partnerships InnoCentive has had with nonprofit organizations to encourage solutions to world problems. Other partners include: GlobalGiving, Prize4Life, the Rockefeller Foundation, the ASSET India Foundation, and the Rural Innovations Network.

Executive Quotes
Gregory C. Simon, President, FasterCures

“Accurate and reliable biomarkers can shave years and millions of dollars from the biomedical research process. But the healthcare industry has little incentive to invest in biomarker research and development and keep the results of their investment in the public domain, where it can do the most good. Reducing the ‘first-mover disadvantage’ in biomarker research and validation can significantly accelerate the search for cures and improved treatments for deadly and debilitating diseases.”

Tom Venable, Executive Vice President, InnoCentive, Inc.

“We are excited to announce this partnership as our first philanthropic challenge where InnoCentive is providing award funding as part of our mission to invest in causes that our employees and shareholders are passionate about. We believe FasterCures is a great organization to partner with as any ideas generated will be shared with research organizations across the disease spectrum. Over the years we’ve found that some of the best solutions have come from the most unexpected sources and by using our solver community, FasterCures will increase its likelihood of finding great ideas to change the economics and speed of biomarker development.”

For more information contact:
Cecilia Arradaza, Communications Director, FasterCurescarradaza@fastercures.org or
202-336-8912

FasterCures in Esquire’s 75th Anniversary Issue

by Greg Simon, President, FasterCures

Esquire’s 75th Anniversary Issue Features FasterCures Public Service Announcement, FasterCures Chairman Mike Milken as 75 Most Influential People of the 21st Century, and FasterCures Esquire House Event

Esquire's 75th anniversary issue released Sunday debuts the FasterCures public service announcement, Fifteen Years: That’s how long it takes to develop new medical treatments. The ad highlights FasterCures’ core principle of saving lives by saving time. Also in this issue, Esquire names Mike Milken, Chairman of the Milken Institute and Chairman of FasterCures, as one of the 75 Most Influential People of the 21st Century citing his decades-long commitment to improving the medical research infrastructure to accelerate the development of cures.

"FasterCures is honored to be featured in this special Esquire edition and grateful for Esquire’s steadfast support of our mission," said Gregory C. Simon, FasterCures president. "FasterCures is committed to reducing suffering and death from disease in the 21st Century and the 21st Century begins now."

Since 2003, Esquire has hosted a series of Esquire House events on behalf of nonprofit organizations. On November 12, Esquire House Hollywood Hills will host FasterCures, one of six organizations to hold events at this remarkable venue this year.