Wednesday, December 23, 2009

'Tis the season

'Tis the season for digging out from under and clearing off the piles and the clutter. 'Tis the season for looking back at the year that flew and planning ahead for a year that's new.

At FasterCures, we will launch our new strategic plan in the coming months, an effort to help us "stay in our lane" and focus on much needed outcomes towards accelerating medical solutions. As FasterCures board member Larry Flax has said, "That which gets measured gets done."

As we further define our strategic priorities and implement outcomes-driven programs, here’s a preview of what’s on our agenda for 2010:
  • Fostering innovation and accountability in medical research.
  • Creating a more informed, transparent, and results-oriented marketplace for medical philanthropy.
  • Empowering patients to play an active role in clinical research.
  • Exploring and expanding opportunities at the Food and Drug Administration for acceleration of cures.
  • Strengthening medical research tools (e.g., electronic health records, biobanks) to better support a more effective and efficient health cures system.
We look forward to hearing from you in the new year, and working with you to advance our mission of saving lives by saving time. Wishing everyone health and a multitude of outcomes that advance cures in the new year.

Wednesday, December 16, 2009

Putting Cures on the Health Reform Agenda

by Margaret Anderson, Executive Director, FasterCures

For months, we've all heard arguments from all sides about how best to improve our health care system. Many of the solutions that have surfaced have focused on curbing costs and improving quality of care - unarguably critical issues that need to be addressed. As the marathon search for solutions is approaching sprint speed, we at FasterCures wanted to share that the search for cures has made it on the agenda. Senator Arlen Specter (D-PA) introduced the Cures Acceleration Network (CAN) Act of 2009 as an amendment (SA 2866) to the health reform bill in the Senate.

The Specter amendment seeks to expedite the time it takes to turn a scientific discovery into an accessible, life-saving therapy by establishing CAN within the Office of the Director of the National Institutes of Health. Among the functions of the CAN are to:
  • conduct and support revolutionary advances in basic research, translating scientific discoveries from bench to bedside;
  • award grants and contracts to eligible entities to accelerate the development of high need cures;
  • provide the resources necessary for government agencies, independent investigators, research organizations, biotechnology companies, academic research institutions, and other entities to develop high need cures;
  • reduce the barriers between laboratory discoveries and clinical trials for new therapies; and
  • facilitate review in the Food and Drug Administration for the high need cures funded by the CAN.
We need to do a better job of translating promising scientific research into new means of preventing and treating disease. Otherwise, we will not be able to contain health care costs, improve productivity and prevent human suffering. Unless we invest in an effective medical research enterprise as part of an effort to improve our health system, we are limiting ourselves to stop-gap measures that will be unsustainable in the long-term.

For all the human and financial capital flowing through our healthcare system, there remains a formidable list of diseases for which there are no cures or even meaningful treatment options. And yet, it can take nearly two decades to turn a research discovery into a medical solution. Our need for cures has never been greater.

Tuesday, December 15, 2009

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.

Thursday, December 10, 2009

Monday, December 7, 2009

Partnering for Cures Coverage Highlights

Maria Bartiromo, anchor of CNBC's Closing Bell, speaks with Dr. Joshua Sharfstein, FDA deputy commissioner; Dr. Gail Cassell, Eli Lilly & Co. vice president for scientific affairs and Michael Milken, FasterCures chairman about preventing chronic disease, investing in innovation, putting a cost on cures, ensuring access, and forecasting the promise of healthcare reform. View interview.
From the blogosphere:

Medical Research Leaders Explore Novel Strategies to Expedite the Search for Cures

NEW YORK (December 2, 2009) – Nearly 600 medical research executives, scientists, policy makers, and funders today convened to explore novel development approaches and innovative funding strategies at the inaugural Partnering for Cures meeting.

FasterCures, the Washington-based center of the Milken Institute, convened Partnering for Cures to facilitate multi-sector collaborations needed to turn a scientific discovery into an accessible therapy. This effort unites the power of philanthropy, passion of nonprofit disease organizations, and the expertise of biotechnology and pharmaceutical companies.

“With all the financial and human capital flowing through America’s medical system, there are still too many diseases for which there are no cures or effective treatments. We want to help change that,” said Margaret Anderson, Executive Director of FasterCures. “One of our goals for this effort is to catalyze a more effective and efficient medical research enterprise through more strategic and timely allocation of critical resources.”

Partnering for Cures highlighted best practices in the conduct and management of medical research and outcomes-oriented approaches that could streamline the process. It provided participants with a unique opportunity to learn first-hand from cure entrepreneurs, nonprofit leaders who are producing dramatic results for patients, from cystic fibrosis and multiple myeloma to malaria and HIV.

“We believe the incentives of all the stakeholders in medical research can be better aligned to produce the result all are working towards – value and benefit for patients. This effort helps facilitate this alignment.” added Anderson.

The meeting featured more than 80 of the most forward-thinking leaders spotlighting solutions to decades-long challenges facing the medical research system, 42 medical research foundations presented their research portfolio and development strategies, and a partnering system that facilitated one-on-one connections between participants.

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, a center of the Milken Institute, is nonpartisan, nonprofit and independent of interest groups. For more information, visit www.fastercures.org.

Video highlights and session summaries available at www.partneringforcures.org.

Tuesday, November 24, 2009

Act now and help catalyze a more effective & efficient medical research enterprise

Curing disease has the greatest potential to reduce suffering and grief. It's also the best way to improve the bottom line of spending on health. Real economic growth depends on our ability to develop medical solutions that eliminate untimely death and disability.

No one can do this work alone. Expediting cures requires collaboration.

In a week, hundreds of medical research leaders and decision-makers from different sectors will come together at the inaugural Partnering for Cures meeting to do just that. Join us.

This first-of-its-kind meeting will be held December 1-3 in New York City.

Program: More than 80 confirmed speakers including:
  • Pfizer's Jeffrey Kindler
  • FDA's Joshua Sharfstein
  • Dana-Farber Cancer Institute’s Edward Benz
  • Dr. Susan Love Research Foundation’s Susan Love
  • Biotechnology Industry Organization’s James Greenwood
  • Harvard Medical School's Levi Garraway
  • Johnson & Johnson’s Garry Neil
  • Blueprint Research & Design’s Lucy Bernholz
  • NIH Chemical Genomics Center’s Christopher Austin
  • Eli Lilly & Company's Gail Cassell
  • Juvenile Diabetes Research Foundation's Alan Lewis
  • International AIDS Vaccine Initiative's Seth Berkley
Presentations: 42 nonprofit foundations to highlight their capabilities and research and development strategies to potential funders and partners

Partnering: customized partnering system facilitates one-on-one connections among potential collaborators; therapeutic affinity roundtables jumpstarts networking across sectors; networking opportunities that will link you to key organizations whose mission and strategies match your priorities

Participants: More than 400 attendees from more 350 organizations are registered. They represent a broad range of sectors: philanthropy, foundations, industry, academia, government, media and venture capital.

Don’t miss this opportunity to help accelerate the time it takes to develop new medical treatments. Register now.Link

Thursday, November 12, 2009

The FDA's To-Do List

by Margaret Anderson, COO, FasterCures

The U.S. Food and Drug Administration’s priority to-do list is long. Dr. Joshus Sharfstein, FDA's Principal Deputy Commisioner spent some time recently addressing the list with members of the Alliance for a Stronger FDA. At the top of the list was transparency, a critical priority and one that the agency is addressing through a Task Force dedicated to delve deeper into this area. Also on the list were credibility, standards, global supply chain, guidance, integrity, enforcement. FDA’s credibility is of paramount importance, without it the medical research enterprise and health care delivery system will come to a grinding halt. "If we can successfully build something with all these strands together it will be more than the sum of its parts."

I asked about how the agency can work more closely with companies so there is more predictability. We’ve all heard stories of promising compounds languishing because the regulatory hurdles were high and in the end, the patients pay the ultimate price if that promise sits idle.

The expansion of the agency’s commitment to advance regulatory science spans work in the Critical Path shop, the Reagan-Udall Foundation (of which FasterCures is a recent supporter), and a list of key science areas that could make a big difference in the markers of whether something works. In order for the baton to be passed from NIH-funded work to translation at companies into products, the FDA needs to be ahead of the innovation curve. Sounds like the topic is clearly on the to-do list.

The Alliance for a Stronger FDA has made a huge difference in the FDA’s funding levels. Its only goal is to get the agency more appropriated dollars and I 'm proud to be a Board member. If your organization is not a member, I urge you to get engaged. The agency’s funding situation has improved, but we have a long way to go to ensure FDA gets to where it wants to be vis-à-vis innovation in all areas, but particularly in medical research.

Which makes FasterCures' Partnering for Cures meeting all the more timely and relevant. To be held December 1-3 in New York, we're bringing together medical research leaders, investors, and decision-makers, including Dr. Sharfstein, to explore innovative approaches to pursuing high-risk, long-term investments that could lead to therapeutic breakthroughs. Joining Dr. Sharfstein on the speaker roster are some of the most forward-thinking leaders in medical research: Pfizer CEO Jeffrey Kindler, Cystic Fibrosis Foundation's Bob Beall, NIAID's Anthony S. Fauci, Harvard Stem Cell Institute's Doug Melton. The list goes on...but what I think is most interesting is the coming together of sectors to explore partnerships needed to turn a scientific discovery into a viable therapeutic option. Learn more and be a part of this first-of-its-kind effort: http://www.partneringforcures.org.

Friday, November 6, 2009

Jeff Kindler, Anthony Fauci, Kathy Giusti, Michael Milken among featured speakers at Partnering for Cures

Philanthropists, Medical Research Foundations, and Industry Leaders Gather in New York for Inaugural Partnering for Cures Meeting
First-of-its-kind meeting designed to forge collaborations needed to accelerate the pace of therapeutic development


(November 5, 2009) WASHINGTON, DC – Hundreds of medical research leaders, investors, and decision-makers are coming together at the inaugural Partnering for Cures meeting to explore innovative approaches to pursuing high-risk, long-term investments that could lead to therapeutic breakthroughs.

This first-of-its-kind meeting, to be held December 1-3 at the Millennium Broadway Hotel in New York City, brings together innovators from philanthropy, medical research foundations, and the biotechnology and pharmaceutical industries with the goal of forging collaborations necessary to develop new medical solutions.

The meeting is designed to facilitate informed investments and cultivate relationships by featuring panels that spotlight solutions to decades-long challenges facing medical research, adapting the outcomes-oriented approach of investor conferences, and building on the networking opportunities at industry "partnering" meetings. Speakers include:

Decision-makers from the biotechnology and pharmaceutical industries:
  • Jeffrey Kindler, Chief Executive Officer and Chairman of the Board, Pfizer
  • The Hon. Billy Tauzin, President and Chief Executive Officer, Pharmaceutical Research and Manufacturers of America (PhRMA)
  • The Hon. James Greenwood, President and CEO, Biotechnology Industry Organization
  • Garry Neil, M.D., Corporate Vice President, Corporate Office of Science and Technology, Johnson & Johnson
Venture philanthropy leaders:
  • Robert J. Beall, Ph.D., President and Chief Executive Officer, Cystic Fibrosis Foundation
  • Debi Brooks, Co-Founder, Michael J. Fox Foundation
  • Kathy Giusti, Founder and Chief Executive Officer, Multiple Myeloma Research Foundation
  • Hala Moddelmog, President and Chief Executive Officer, Susan G. Komen for the Cure
Philanthropists who are transforming the medical research enterprise
  • Michael Milken, Chairman, FasterCures/The Center for Accelerating Medical Solutions; Chairman, The Milken Institute
  • Debra Black, Founder and Chair, Melanoma Research Alliance
And, some of the most forward-thinking leaders in medical research:
  • Anthony S. Fauci, M.D., Director, National Institute of Allergy and Infectious Diseases
  • Douglas A. Melton, Ph.D., Co-Director, Harvard Stem Cell Institute
  • Seth Berkley, M.D., President and Chief Executive Officer, International AIDS Vaccine Initiative
  • Anne Wojcicki, Co-Founder and President, 23andMe
Philanthropic investment in medical research, though it accounts for only three percent of overall research spending – relatively small compared to government and industry funding –plays an essential role in catalyzing high-risk research, far beyond its proportion of funding. But, it requires a significant investment in effort, resources, and time to find the right research partner. Partnering for Cures streamlines this process by connecting similar-minded organizations and sharing best practices, further amplifying the transformative impact of medical research philanthropy.

Partnering for Cures is convened by FasterCures, the Washington, D.C.-based center of the Milken Institute, that's committed to breaking down the barriers that exist across the research continuum – from basic research to drug development – to clear the path to faster medical progress.

NOTE TO MEDIA:
Complete information about Partnering for Cures, including a full program and an up-to-date list of all speakers, is available at www.partneringforcures.org. Credentialed press wishing to cover Partnering for Cures, please email Cecilia Arradaza, FasterCures Communications Director, at carradaza@fastercures.org.



Monday, October 26, 2009

Five Reasons to Register Today for Partnering for Cures

Every day, thousands of people are diagnosed with deadly and debilitating diseases for which there are no cures. And yet, it takes 15 years to develop new medical solutions. As you know, no one can do this work alone. Expediting cures requires collaboration.

Partnering for Cures, a first-of-its-kind meeting to be held December 1-3, 2009 in New York City, facilitates these collaborations by bringing together philanthropy, medical research foundations, and the biotechnology and pharmaceutical industries.

Here are the top five reasons to register today and be a part of this inaugural effort:
  • Learn from "cure entrepreneurs," leaders who have championed some of the most innovative approaches to disease research that are paving the way to a more effective and efficient research system.
  • Find the right research partner who can support your program, move a discovery down the development path, and/or augment your therapeutic pipeline.
  • Identify organizations whose mission and programs match your charitable priorities or complement your business development pipeline.
  • Better understand the processes, policies, and players involved in therapeutic discovery and development in order to make targeted strategic investments and partnership decisions.
  • Hear from some of medical research's most forward-thinking leaders in panels that spotlight solutions to decades-long problems facing the medical research enterprise, including:

Partnering for Cures is convened by FasterCures, the Washington, D.C.-based center of the Milken Institute, that's committed to breaking down the barriers that exist across the research continuum - from basic research to drug development - to clear the path to faster medical progress.

Thursday, October 22, 2009

FasterCures' Margaret Anderson Writes about R&D Challenges in the Winter 2009 Milken Institute Review

With the Obama administration and Congress now negotiating reform, the American health care system as we know it may be about to undergo the most significant makeover since the introduction of Medicare. Meanwhile, the unprecedented public engagement on the fundamental issues faced by policymakers offers a window into systemic transformation in action. But as Americans focus on how best to deliver and pay for health care, we believe it is equally important not to lose sight of what I would call our "health cure" system. For unless we do a better job of translating promising scientific research into new means of preventing and treating disease, we will lack the wherewithal to contain health care costs -- or, for that matter, productivity losses and human suffering. Read the online print version of the Milken Institute Review.

Wednesday, October 21, 2009

Call for Presentations: Apply for One of 48 Slots Dedicated to Innovative Approaches to Medical Research

Apply for One of 48 Presentation Slots Dedicated to Innovative Approaches to Medical Research Submit your application today. Space is limited; decisions are made on a rolling basis.
By now we hope you're aware of Partnering for Cures, a first-of-its-kind conference being hosted by FasterCures December 1-3 in New York. Partnering for Cures will bring together a unique audience of philanthropists, medical research foundations, and biopharmaceutical companies interested in building cross-sector collaborations to accelerate the search for cures.

Partnering for Cures is inviting nonprofit foundations that fund medical research to apply to present their cutting-edge work and innovative strategies to potential investors and partners. This is one of the unique features of the event, which distinguishes it from other conferences on medical research or philanthropy, and is based on the proven model of industry partnering meetings. We are planning to feature 48 medical research foundations, each with the opportunity to provide a 25-minute overview of its strategy, operations, assets, capabilities, and funding needs to an audience of potential investors and partners.

There is an open application process for these slots, and we want to encourage your organization to apply for one. An external advisory committee will help review applications and provide input to the selection process. Your completed application will be reviewed by our committee and organizations will be notified of the decision, the first round in late-October and on a rolling basis after that. Space is limited, however, so organizations are encouraged to apply early. FasterCures will provide successful applicants with a template for their presentations and Web-based training to help foundations maximize this opportunity.

You must register for the conference in order to apply for a slot. Click here for information on the registration and application process.

We very much hope you avail of this unique opportunity!

Monday, October 19, 2009

Be an informed and engaged partner in medical research

Register today for Partnering for Cures, December 1-3 at the Millennium Broadway Hotel in New York City. This first-of-its-kind meeting will bring together philanthropy, medical research foundations, and the biopharmaceutical industry in an effort to forge strategic collaborations key to the timely development of new medical solutions.

Partnering for Cures combines the outcomes-oriented approach of investor conferences, the networking opportunities at biopharmaceutical industry partnering meetings, and the knowledge sharing that drives patient advocacy events.Some of the world's most forward-thinking leaders engaged in the top issues that impact biomedical research will be speaking at Partnering for Cures, including:

Partnering for Cures is convened by FasterCures, the Washington, D.C.-based center of the Milken Institute, that's committed to breaking down the barriers that exist across the research continuum - from basic research to drug development - to clear the path to faster medical progress.

Thursday, October 1, 2009

Building the Platform for the 'Health Internet'

Kristin Schneeman, Program Director, FasterCures

For two days this week, I joined a group of leading thinkers and entrepreneurs from a variety of sectors gathered to discuss an idea that originated with Harvard’s Isaac Kohane and Ken Mandl – the development of an “iPhone-like platform” for health information technology (HIT). Their basic premise, expressed in a paper published in The New England Journal of Medicine last March, is that “a vibrant and evolving health system requires a healthcare information technology infrastructure based less on monolithic, pre-defined products and more on a general-purpose platform that would support a collection of simple applications each doing a single task consistently and reliably.”

Internet pioneer Mitch Kapor started the meeting with this proposal: that the federal government expand its efforts to enable a Nationwide Health Information Network (NHIN) by engaging consumer health information platform providers and consumer health organizations as participants in the effort; instead of the status quo that focuses on standards for health information exchange among providers and government agencies. Kapor said the agenda for such an initiative would be to identify changes and extensions to NHIN specifications needed to support consumer requirements; to implement these changes in the government’s open-source CONNECT software gateway and elsewhere; with the goal of getting live patient data flowing by the second quarter of 2010.

Harvard Business School professor Clay Christensen, author of The Innovator’s Prescription on disruptive innovation in healthcare opened up day two with his analysis of what it will take to drive down costs in the healthcare system. In his view, the general hospital – which seeks to solve every problem for everybody – is no longer a sustainable business model. Care must become increasingly decentralized, and technology must be driven outward: to outpatient clinics, doctors’ offices, and even patients’ homes. In this environment, the locus of care coordination is a patient’s electronic health record. The patient/consumer must be at the center.

Lo and behold, by the end of day two, the federal government – in the form of President Obama’s Chief Technology Officer, Aneesh Chopra, and the Department of Health and Human Services’ CTO Todd Park – arrived and committed to doing exactly what Kapor had proposed. They even proposed renaming the NHIN the “Health Internet” (bless you, gentlemen). Many details remain to be worked out, of course, but the energy and enthusiasm of the dynamic duo of Chopra and Park was infectious, and many in the room committed their energy and resources to the project. The commitment of the new Administration to realizing the benefits of health IT is evident and welcome.

FasterCures’ interest in health IT is in research uses of electronic health information. We know the hosts of this meeting share the view that the value of HIT is as much in its potential to accelerate the development of new and better treatment options as it is in its ability to improve the quality of care and reduce costs. We are also interested in how patients can become drivers of disruption in the search for cures; those who suffer from disease are highly motivated to share their health information through vehicles like patient registries and social networking sites, and they are beginning to understand how they might leverage their data resources to influence the research agenda.

We hope the organizers of this new federal effort will make research uses of the network a priority, and that patient groups will be among the new stakeholders invited to the table. Then the Health Internet can revolutionize cures as well as care.

Wednesday, September 23, 2009

Join Medical Research Innovators at the Inaugural Partnering for Cures Meeting








"When it comes to medical research, never has it been more important to
think about the end game: getting therapies to people. To realize this, industry
and medical research foundations must work together early in the research and
development process, with philanthropy helping to pave the way."
- David Panzirer, Trustee, The Leona M. and Harry B. Helmsley Charitable Trust
FasterCures is committed to accelerating the process of turning exciting new medical discoveries into therapies that can treat patients. But, as you know, no one can do this work alone. Expediting cures requires collaboration. Join medical research innovators at the inaugural Partnering for Cures meeting. Uniting the passion of medical research foundations, the power of philanthropy, and the focus of biopharmaceutical companies, this meeting will catalyze a more effective and efficient medical research enterprise.
This first-of-its-kind meeting is designed to forge strategic cross-sector collaborations that will:
  • empower philanthropists to measure the impact and return on their philanthropy;
  • enable medical research foundations to find the right partners and investors needed to discover and commercialize new therapies; and
  • facilitate biopharmaceutical industry partnerships that could yield cutting-edge medical solutions.
Register today and take part in this timely and crucial effort. Make one-on-one connections, share information, and meet potential collaborators through a customized partnering system designed to build relationships that could accelerate the pace of life-saving research and development. http://www.partneringforcures.org/
Space is limited, please register early. Significant discounts apply for early registration, special rates available for nonprofit medical research and patient advocacy groups.

Tuesday, September 8, 2009

Improving the Science of Drug Safety

By Margaret Anderson, COO, FasterCures and board member, Alliance for a Stronger FDA
How is FDA doing vis-à-vis the Science of Drug Safety? That was the topic of an Institute of Medicine (IOM) Drug Forum session held Wednesday to provide a review of activity since IOM, and the FDA Science Board released their reports, and the 2007 FDA Amendment Act. There is new leadership and energy at the agency around the drug safety question under Dr. Peggy Hamburg and her Deputy Dr. Josh Sharfstein and an evolving safety landscape.
For several hours, officials from the FDA, industry, and policy opinion leaders provided progress reports that showcased the work that’s underway at the FDA. Each had a resounding sentiment: much has been done, but more needs to be accomplished, and it won’t happen without substantial infusion of human and financial capital.
Indeed, much is on the FDA’s plate. Speakers echoed the importance of a life-cycle approach to evaluating drugs and medical devices – a way to monitor a product from its pre-approval through its post-marketing phases to ensure safety and efficacy. Such a holistic approach would require, among other thing,
  • standardizing the collection and analysis of observational data,
  • updating epidemiological approaches to go with evolving public health needs,
  • ensuring interoperability and integration across federal agencies (i.e., efforts that relate to comparative effectiveness research and health information technology), and
  • implementing communications channels to collect data from consumers in real-time (especially as it relates to adverse events), as well as relay back transparent, accurate, and reliable information

Several aspects of the risk management/drug safety question threaded through presentations. Such as: how much risk are we willing to accept in the area of drug safety? How does the advent of health IT and new batches of health data gathered per the Health Information Technology for Economic and Clinical Health (HITECH) Act impact what FDA needs to do to ensure drug safety? How can we tell if things are improving in terms of FDA’s ability to monitor drug safety?
The final message was from Dr. Gail Cassell, Co-chair of the Forum and Vice President, Scientific Affairs and Distinguished Lilly Research Scholar for Infectious Diseases, who ended with a reminder that FDA’s appropriated dollars are still not enough to tackle the drug safety to-do list. As an Alliance for a Stronger FDA board member I couldn’t agree more. We are conveying that message as loudly as we can, but need more voices.
This is an enormous undertaking. How do you eat an elephant? One bite at a time.

Thursday, August 27, 2009

It's Time to Turn to Research's Most Valuable, Yet Underutilized Resource: Patients

By Margaret Anderson, COO, FasterCures
A piece in yesterday's New York Times, Research Trove: Patients' Online Data, recounts the story of a young woman stricken by a rare pulmonary disease, and her attempts to raise money and connect a network of scientists to research her ailment. In collaboration with a Harvard cancer researcher, she launched a Web site for others facing her same diagnosis, on which patients could share symptoms and report health information.

This kind of observational research, that focuses on empirical and experiential input, could prove invaluable in the quest to gain better understanding of disease and how it corrupts the functions of the human body. But there is more. Just as importantly, this story reinforces the contribution patients can make to their own medical care. In the search for cures, there is no substitute for patient engagement. For biomedical research to be effective and successful, it is imperative that it be patient driven. Empowering patients to play an active role in medical research requires transparent communication from trusted sources (i.e., frontline healthcare providers), a mechanism to ensure the patient's voice is heard loud and clear by decision and policy makers, the means for effective two-way communication between researchers and patients in real time, and informing the public about the value of clinical research to increase awareness and spur involvement.

FasterCures remains committed to supporting healthcare access but also in the creation of a “health cure” system that puts patients first.

Wednesday, August 26, 2009

FasterCures Statement on the Passing of Senator Kennedy

FasterCures joins the nation, and the world, in mourning the passing of Senator Ted Kennedy. He lived his life in service of the American people, fearlessly protecting and improving the way we live. His leadership in health, education, and labor has shaped our nation and his legacy will live on.

His relentless commitment to improving the well-being and health care for all Americans will continue to guide and inspire our work and that of the health advocacy community for generations to come. The roar of the Senate's lion will endure, his dream shall never die.

Our deepest condolonces go to his family, friends, and the nation.

Tuesday, August 18, 2009

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.

Wednesday, August 12, 2009

FasterCures Joins Council for American Medical Innovation

Council for American Medical Innovation Welcomes Newest Partners, The AIDS Institute and FasterCures
WASHINGTON, D.C. – The Council for American Medical Innovation is pleased to announce its new partnership with The AIDS Institute, one of the country's foremost champions for HIV/AIDS research and education, and FasterCures, a non-profit organization that accelerates the development of scientific research into new medical cures and treatments. Margaret Anderson, Chief Operating Officer of FasterCures has also joined the Council's advisory board.

"The AIDS Institute and FasterCures have tirelessly championed medical innovation by building public and political support for the research and funding necessary to develop new medical treatments and technologies," said Debra Lappin, president of the Council for American Medical Innovation. "Their efforts underscore the Council's mission to call on Congress to adopt public policies that spur medical innovation and put cures within patients' reach."

Beginning as a grassroots advocacy effort in the late 1980s, The AIDS Institute has expanded to become a leading national public policy research, advocacy and education agency. The AIDS Institute has offices in Washington, DC and Tampa, FL at the Division of Infectious Diseases and International Medicine at the University of South Florida, College of Medicine. The AIDS Institute is focused on HIV/AIDS work and incorporates work on related health care issues such as Hepatitis, as well as other infectious and chronic diseases.
FasterCures is a non-profit "action tank" formed under the auspices of the Milken Institute with a mission 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.

The new partners join seventeen other organizations in the Council for American Medical Innovation, including: AdvaMed, ALS Association, American Society for Radiation Oncology, American Academy for Child and Adolescent Psychiatry, American Academy of Nursing, Association of American Universities, Association of Clinical Research Organizations, Cleveland Clinic, College of Physicians of Philadelphia, Leukemia & Lymphoma Society, National Health Council, National Organization for Rare Disorders, National Venture Capital Association, Parkinson's Action Network, Pharmaceutical Research & Manufacturers of America (PhRMA), RetireSafe, and Whitman-Walker Clinic.

About the Council for American Medical Innovation
The United States faces serious challenges to maintaining its leadership position in innovation. The Council for American Medical Innovation is bringing together leaders in research, medicine, public health, academia, education, labor, and business, who are working in partnership toward a national policy agenda aimed at preserving U.S. leadership in medical innovation. American medical innovators create millions of high-paying jobs, and their discoveries are integral in the fight to cure cancer and other illnesses. The Council for American Medical Innovation views leadership in medical innovation as a key part of America's economic recovery, future prosperity and health.

Tuesday, August 11, 2009

Register Now: Partnering for Cures, Dec 1-3, New York


Every day, thousands of people are diagnosed with deadly and debilitating diseases for which there are no cures...And yet, it takes 15 years to develop new medical solutions.

Join those on the front lines in the fight against disease in a first-of-its-kind meeting - Partnering for Cures - convened by FasterCures, the Washington, DC-based center of the Milken Institute. The meeting will bring together three separate and distinct pieces of the cure puzzle: research organizations with innovative medical approaches, biopharmaceutical companies that develop cures, and philanthropists who fund the search.

FasterCures is organizing Partnering for Cures with the goal of forging strategic cross-sector collaborations that will:
  • empower philanthropists to make informed investment decisions and measure the impact and return on their philanthropy;
  • enable medical research foundations to find the right partners and investors needed to discover and commercialize new therapies; and
  • facilitate biopharmaceutical industry partnerships that could yield cutting-edge medical solutions.
Register now to participate in this timely and crucial effort. Make one-on-one connections, share information, and meet potential collaborators through a customized partnering system designed to accelerate the pace of life-saving drug research and development.
Space is limited, please register early. Significant discounts apply for early registration, special rates available for nonprofit medical research and patient advocacy groups. For more information: www.partneringforcures.org

Friday, August 7, 2009

FasterCures in today's NY Times: Why Patients Turn Down Clinical Trials



Why Patients Turn Down Clinical Trials
To the Editor:

Re “Lack of Study Volunteers Is Said to Hobble Fight Against Cancer” (“Forty Years’ War” series, front page, Aug. 3):

I read with interest your article about the chilling effect that low recruitment for clinical trials has had on the search for meaningful treatments.

Patients can play a critical role in the search for cures, but it is time we rethink the entire paradigm surrounding clinical trial design and recruitment.

Clinical trials offer patients some say in their own destinies, and to leave a legacy that may save others, even if it’s too late to save themselves.

Unfortunately, the current system governing clinical trials gives patients concrete reasons to balk at participating. Often, clinical trials are aptly named: they are trials — difficult and exhausting, at a time when a patient’s physical and emotional capacities are already stretched thin.

Within each of us is a Rosetta Stone that could unlock the potential to cure disease, but it requires that we reconsider how we approach treating a seriously ill patient — and how we approach being one.

Margaret Anderson
Washington, Aug. 4, 2009
The writer is chief operating officer of FasterCures, which aims to accelerate the pace of medical research and development.

http://www.nytimes.com/2009/08/07/opinion/l07cancer.html?_r=1&ref=opinion

Thursday, July 9, 2009

FasterCures Applauds Choice of Dr. Francis Collins to Helm NIH

Swift confirmation urged for renowned geneticist and research pioneer.

FasterCures enthusiastically greets today's announcement of Dr. Francis
Collins as director of the National Institutes of Health. We urge Congress to move with deliberate speed through the confirmation process,
 and look forward to working with Dr. Collins and his staff to help chart 
a new course for NIH.



FasterCures is confident that Collins is an excellent choice to lead a
revitalized, modern NIH capable of making a huge contribution to improving the health of the world, and finding cures and treatments for the diseases that rob us of our loved ones. We call on Dr. Collins to begin the process of retraining the focus of NIH, toward outcomes-centered research and clinical research, in order to most efficiently work toward that goal.





With a budget of almost $30 billion, NIH is responsible for nearly
one-third of the biomedical research funding in the United States. It is a massive entity with boundless potential for breakthroughs; the Collins
nod is a positive step toward realizing that potential. During his 
tenure as head of the National Human Genome Research Institute, Dr.
Collins led the effort to crack the human DNA sequence. Now, as NIH
director, he has the opportunity, the resources, and the authority to push the Institutes in an equally groundbreaking direction.

"We have a great need to cure the diseases and illnesses that afflict so many of our national and global neighbors," said FasterCures COO Margaret Anderson. "With new leadership comes new opportunity. Under Dr. Collins's leadership, NIH is positioned to be a global leader in the search for cures. We need to ask more of our research enterprise - take greater risks, abandon the ethos of caution that guides government
entities and challenge the accepted limits. Dr. Collins's groundbreaking work on the genome project signals his willingness to make scientific leaps of faith. Our capacity for scientific discovery is limited only by our own timidity. This appointment could mark a new day in biomedical research."

Wednesday, July 8, 2009

FasterCures Supports Grassroots Approach to Medical Research

July 7, 2009 - FasterCures today announced its support of Research Revolution, 23andMe's just launched effort that aims to change the way we learn about how genes and environment affect the causes and treatments of disease.

"In fighting disease, patience is not a virtue. Patients are. FasterCures supports efforts like 23andMe's Research Revolution that engage patients, the most valuable resource in medical research," said Margaret Anderson, COO, FasterCures.

23andMe hopes to do research on dozens of diseases, starting with these 10:
  • ALS
  • Celiac Disease
  • Epilepsy
  • Lymphoma and Leukemia
  • Migraines
  • Multiple Sclerosis
  • Psoriasis
  • Rheumatoid Arthritis
  • Severe Food Allergies
  • Testicular Cancer
Learn more about the Research Revolution.

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, a center of the Milken Institute, is nonpartisan, nonprofit and independent of interest groups. For more information, visit http://www.fastercures.org/

About 23andMe23andMe, Inc. is a privately-held company dedicated to helping individuals understand their own genetic information using recent advances in DNA analysis technologies and web-based interactive tools. 23andMe enables individuals to gain deeper insights into personal ancestry, genealogy and inherited traits. 23andMe was founded in April 2006 by Linda Avey and Anne Wojcicki. More information is available at http://www.23andme.com/.

Tuesday, July 7, 2009

Taking Comparative Effectiveness Research from "Buzz-Phrase" to Practice

by Susan Semeleer, Associate Director, FasterCures
The Institute of Medicine (IOM) recently released a report outlining its recommendations for 100 health topics that should get priority focus and funding from a $1.1 billion effort to improve the quality and efficiency of our nation’s healthcare system. At the behest of Congress, IOM conducted a study on comparative effectiveness research to provide independent guidance on how to spend $400 million to compare best practices in healthcare delivery.

Comparative effectiveness research (CER) means exactly what its name implies: it analyzes and quantifies the benefits and harms of medical treatments. It is a crucial part of the research landscape, for doctors, for patients and their caregivers, helping to build the evidence base with which to make better informed point of care decisions.

Our primary mission at FasterCures is to identify ways to accelerate the discovery and development of new therapies for the treatment of deadly and debilitating diseases. But the mission does not – cannot – stop there. The fact is, medicine is not a one-size-fits-all proposition. What works for me may make someone else violently ill; what cures you could cripple me. This is where comparative effectiveness research becomes paramount.

As we had noted in comments to the Federal Coordinating Council for CER, we hope and expect that the vision driving federal spending and prioritization on CER will continue to be enhancing and customizing care for patients. So much of medicine is driven by guess work, and a system of educated trial and error – with patients ultimately paying the price for errors. What CER aims to do is provide clinicians – and patients – with empirical evidence of what treatments, procedures and diagnostics work best.

The priority areas laid out by the IOM sets the course for a comprehensive approach to CER that calls for coordination of public and private strategies. It's one of the first few steps among many, many steps we'll need to take to ensure the health system is as effective and efficient as it could be. Now we need to focus on real examples of comparative effectiveness being done to start to dissect how this is really going to work.

Tuesday, June 30, 2009

Clinical Research should be Part of EHR "Meaningful Use"

On June 26, 2009, FasterCures submitted comments on the proposed definition of "meaningful use" of electronic health records, urging the Office of the National Coordinator for Health Information Technology to ensure that meaningful use requirements for EHRs address support for clinical research at the earliest possible time. FasterCures' comments include:
  • FasterCures has long advocated that one of the highest and best uses of a nationwide health information infrastructure – and one of its most underappreciated – is in accelerating the search for new and better treatments for disease. As the healthcare system addresses the challenges of widespread adoption of EHR systems, research capacity must be part of the architecture. Given the simultaneous priority the federal government has placed on comparative effectiveness research, we feel that this imperative cannot be overlooked or delayed.

  • A truly effective nationwide health information network will require that a single set of standards be developed and adopted for the collection and exchange of data across all health communities, including the clinical research community. If a common set of standards for key information is not required from the beginning (in this case 2011), it will be much more difficult to require these downstream.

  • One of the widely agreed-upon objectives of meaningful use is clearly to provide clinical decision support at the point of care. Clinical decision support is informed by research, and it is therefore important to include an opportunity to support clinical research through EHRs in 2011 (with standards that will be available before 2010). Similarly, if one of the stated objectives of meaningful use is “aggregating clinical summaries from multiple sources available to authorized users,” standards and controlled terminology are essential for such aggregation if it is to be useful. These should be required in 2011 so that this 2015 goal can be realized.
For more information, download a copy of the FasterCures publication, "Think Research: Using Electronic Health Records to Bridge Patient Care and Research"

Monday, June 22, 2009

Just in time for July 4th, FasterCures signs the Declaration of Health Data Rights

by Kristin Schneeman, Program Director, FasterCures

What is the most important ingredient in the recipe to cure cancer, or Alzheimer’s, or Lou Gehrig’s disease? Battalions of highly-educated doctors and Ph.D.’s? Buckets of cash? An armament of high-tech lab equipment? The answer is none of the above – it’s you. All of us. Patients.

Each of us contains the information necessary to unlock the relationship of genetics, proteomics, behavior, nutrition, and environment to the emergence and, ultimately, the management of diseases. That information is contained in the data in our medical records; biological material such as tissue, blood, and DNA; and our biology as observed in clinical trials. By enrolling in clinical trials to test potential new therapies, providing tissue and blood samples, and allowing researchers access to our medical histories with appropriate safeguards, patients provide the critical information and resources without which the search for cures would grind to a halt.

Patients are also an increasingly important driving force in setting the medical research agenda and providing the capital needed to turn promising ideas into new treatments. What started as fundraising telethons and walks is rapidly expanding to patient-oriented groups using social media to conduct virtual clinical trials of experimental treatments; foundations participating in the design of trials that meet patients’ needs; and patient groups providing seed funding to companies to incent them to develop drugs for their particular disease.

In the words of a recent Forbes magazine article, “Patients are the new power brokers.”

A strong democracy needs informed, thoughtful, and active citizens. A strong healthcare and “health cure” system requires informed, thoughtful, and active patients – especially now, as the health system undergoes major reform, and as the use of information technology and electronic health records is being ramped up to improve the system.

FasterCures is pleased to join with other organizations signing on to the Declaration of Health Data Rights, which state that individuals have the right to their own health data, to know where data in their record has come from, to take possession of it in paper or electronic form, and to share it with others as they see fit. We hope this is an important part of a movement to empower all of us to become more engaged with our health, our care, and our cures. It can’t happen without us.

Wednesday, June 17, 2009

Lives and Livelihoods are on the Line

by Margaret Anderson, COO, FasterCures
For the past three weeks, the nation's policymakers have turned their attention to healthcare. It seems like each day featured a seminal study, a pivotal finding, a fresh perspective. National statistics and budget forecasts are strengthened by stories from the frontlines. Patient-centered care. Comparative effectiveness. Cost. Private vs. public plans. Government option. Access. Quality. Affordability. Incentives. Health reform's steady drumbeat is at its crescendo.

We at FasterCures stand at the ready to support efforts that hold the potential to fixing what we all know is a broken, unsustainable healthcare system. Our medical research enterprise and the life sciences industry - the forces behind medical innovation and progress - are at stake. Today, we join other health advocates in an effort to ensure that the health reform conversation continues to focus on improved health and an opportunity to gain access to care for individuals, families, and communities. Forty-five million Americans without health insurance is not just a factoid, it's the reality that face Americans whose lives and livelihoods are on the line.

Fixing America’s broken healthcare system is a crucial step toward fixing America's broken healthcure system. Only if we translate promising scientific research into new treatments will we have any hope of reducing healthcare costs, productivity losses, and human suffering.

Tuesday, June 16, 2009

A Cure for What Ails FDA

by Margaret Anderson, COO, FasterCures

No agency is asked to do more, with less, than the Food and Drug Administration. It regulates 80 percent of U.S. food supply, every drug, vaccine, and medical device, consumer cosmetics, and could potentially now have a hand at regulating tobacco products. One entity is charged with ensuring the safety of everything from spinach to statins, produce to pacemakers, totaling over $1 trillion in consumer products; 25 cents of every dollar consumers spend in the U.S. every year. No government entity is more important than FDA to the daily lives – and safety – of Americans.

Unfortunately, the importance of the FDA is often lost in the din of political arguments over health reform. But no one is well-served by omitting FDA reform from the health reform debate; indeed, it could be argued that both the health and welfare of every American is guarded within FDA’s walls. The healthcare debate should begin with FDA. Yet, we rarely hear about FDA unless there’s a recall, or a salmonella outbreak, a political skirmish over a “controversial” drug, or when its already stretched scope is further expanded. We hope that the newly formed Transparency Task Force, in its effort to make more information available and foster better understanding of decision-making within the FDA, will also shed light on the breadth and depth of the agency's scope.

Every day, far too many patients receive diagnoses that are tantamount to death sentences, and every day, researchers uncover promising new treatments. But before any treatment can reach a patient’s local pharmacy, it must first go through the approval process. If you have a system based on rigorous standards that doesn’t have enough resources to meet those standards, either science or safety suffers.

Last February, former FDA chief counsel Peter Barton Hutt warned a Congressional panel of an agency that was “barely hanging on by its fingertips.” His comments were followed by testimony of several other experts, all of whom agreed that the agency has neither the financial nor human resources to do its job. Indeed, the FDA’s own science board arrived at the same conclusion.

We hope that the Senate’s swift voice vote approval of Dr. Margaret Hamburg as Commissioner indicates a renewed commitment to strengthening the FDA. It’s a start, and not an insignificant one. But for the FDA to maximize its effectiveness, further steps must be taken.

Once regarded as the regulatory gold standard of the world, the FDA has a way to go to come back. A New England Journal of Medicine piece co-authored by Hamburg and Deputy Dr. Joshua Sharfstein outlines the call to action. We agree with their assertions, and add these as our own:

FDA needs consistent, strong leadership. We have every confidence that Drs. Hamburg and Sharfstein will meet that overarching need. Just as important, FDA needs political and financial support from both the White House and Capitol Hill. FDA also needs to redefine its mission, streamline its institutional portfolio, and bring its IT systems into the 21st century. An updated mission, and the infrastructure to achieve it.

For too long, medical research has not been a political priority, and the tide of progress has been stemmed because of it. The FDA, charged with protecting 300 million people, has a budget that mirrors that of the school budget in Montgomery County, Maryland. Good news for Montgomery County; less so for the rest of us. FDA needs increased appropriations from Congress, especially for initiatives such as the Reagan-Udall Foundation and the Critical Path Initiative.


  • The Reagan-Udall Foundation was established to address weaknesses within the FDA’s scientific infrastructure. Though Reagan-Udall was aimed at establishing a public-private partnership to modernize medical product development, accelerate innovation and enhance product safety, Congress failed to appropriate seed funding.

  • In an effort to explain the reasons for declining productivity in the field of medical research, FDA launched the Critical Path initiative. More and more money is being spent on medical research, with fewer and fewer results. Critical Path was created to find out why. Critical Path can go a long way toward answering the question that has stymied researchers and activists: why aren’t we getting more bang for our research buck, and what can be done to fix it?

Our mission here at FasterCures is exactly what our name implies. We work to help foster a climate conducive to smart, productive medical research that doesn’t waste time or money. FDA is a critical element in the fight to save lives by saving time. We hope that Congress and the White House will work with Dr. Hamburg to provide her with the resources she needs to govern the FDA, and depoliticize the drug research process. Millions of lives are at stake, and patients shouldn’t be held hostage by politics. When elephants fight, it’s the grass that suffers.

FasterCures joins healthcare advocates in convening "flash mob" meeting

The impetus to pass comprehensive health reform legislation continues to grow as an energetic Congress and new leadership in our federal health agencies provide unprecedented support for expanding access to quality healthcare. The road ahead is both exciting and full of the unknown. Congress is promising passage of healthcare reform this summer. Now is the time for us to come together in urgency and openness to articulate our shared principles that focus reform on what truly matters: improved health for individuals, families, and communities. Fixing America’s broken healthcare system is a crucial step toward fixing America's broken healthcure system. Only if we translate promising scientific research into new treatments will we have any hope of reducing healthcare costs, productivity losses, and human suffering.

What: The Future of Advocacy and Improved Health During Healthcare Reform
When: Wednesday, June 17, noon to 4 p.m. EDT
Where: Biotechnology Industry Organization 1201 Maryland Ave SW, Suite 900, Washington, D.C. 20024

This meeting is convened by the Biotechnology Industry Organization, Coalition for 21st Century Medicine, Coalition for Affordable Health Coverage, FasterCures, Inspire, Research!America and Genetic Alliance. We welcome other umbrella/networks to co-convene this meeting with us.

Please RSVP to Julie Baumberger at BIO, outbind://25-000000006B968182C502C54C9BA36E0AE48FFDEB070058DAEF7DB9ED77439F719E1ECD4423210000027B8F21000058DAEF7DB9ED77439F719E1ECD442321000003A766740000/jbaumberger@bio.org, by June 15. Questions? Please contact Andria Cornell, Genetic Alliance's Advocacy and Health Policy Coordinator, at acornell@geneticalliance.org, (202) 966-5557 x207.

Thursday, June 11, 2009

FasterCures Comments on the Federal Coordinating Council for Comparative Effectiveness Research Draft Prioritization Criteria and Strategic Framework

FasterCures submitted the below comments on the prioritization criteria and strategic framework developed by the Federal Coordinating Council for Comparative Effectiveness Research.
________________________________
June 10, 2009

To: Federal Coordinating Council for Comparative Effectiveness Research

From: Margaret Anderson, Chief Operating Officer, FasterCures

Re: Draft Prioritization Criteria and Strategic Framework

Submitted Electronically: http://www.hhs.gov/recovery/programs/cer/draftdefinition.html

Thank you for the opportunity to comment on the Council's Draft Prioritization Criteria and Strategic Framework. They are both very concise and thoughtful documents with which we substantially concur. We did, however, want to highlight some issues which we don't feel are directly addressed that may inform your thinking going forward.
  • In addition to informing better point-of-care decisions by patients and providers, building the evidence base through comparative effectiveness research can elucidate critical clinical research questions deserving investigation, which will accelerate the development of new and improved diagnostics and therapeutics. If that can be reflected in the prioritization criteria in some way (perhaps under #5, "potential for multiplicative effect"), we believe that would be of great value.
  • We are pleased that the Strategic Framework addresses not only the research studies themselves, but also the human and scientific capital necessary to execute the research -- including, very importantly, developing methodologies needed to conduct the research efficiently and effectively. We urge you to give this issue the attention it requires. The scientific underpinnings of comparative effectiveness research are still being developed, and it will be important to monitor the progress of the field as early studies funded through ARRA yield results.
  • Also addressed in the Strategic Framework is the data infrastructure supporting CER, another area we hope will be given careful attention. In particular, we hope the Council will make an effort to ensure that investments in health information technology being advanced separately with ARRA funds are supportive of the requirements for conducting CER to the greatest extent possible.
  • We are also pleased to see recognition of the fact that translation, dissemination, and adoption of the results of CER are as important as the studies themselves and hope that funding will be devoted to pursuing this critical goal.
  • We hope and expect that the vision driving federal spending on CER will continue to be enhancing and customizing care for patients, and that it will not be used to limit access to or availability of effective treatments on an individualized basis.
FasterCures' mission is to identify ways to accelerate the discovery and development of new therapies for the treatment of deadly and debilitating diseases both in the United States and around the globe. The organization was founded in 2003 under the auspices of the Milken Institute to aggressively catalyze systemic change in cure research and to make the complex machinery that drives breakthroughs in medicine work for all of us faster and more efficiently. FasterCures is independent and non-partisan. We do not accept funding from companies that develop pharmaceuticals, biotechnology drugs, or therapeutic medical devices. Our primary mission is to improve the lives of patients by improving the research environment, research resources, and research organizations.

Thursday, June 4, 2009

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.

Wednesday, June 3, 2009

Hope, Healing, and Heroism Through Science

by Susan Semeleer, Associate Director of Communications, FasterCures
There is some exceptionally innovative work in biobanking. BioBank Central, a web portal that provides information and resources to the biobanking community recently launched its "Spotlight on Innovation series" to highlight the individuals and organizations involved in some of biobanking's best practices. We recently trained our spotlight on Autism Speaks and two of their research programs, the Autism Tissue Program (ATP), a post-mortem brain tissue bank for autism research, and the Autism Genetic Resource Exchange (AGRE).

This month's Spotlight is the first in a two-part series on the Autism Speaks banks and focuses on the ATP. Through a dedicated and innovative public education campaign, patient advocacy groups like Autism Speaks have made tremendous strides toward dispelling the stigma and misinformation that surrounds autism. With the ATP, they are taking that education campaign one critical step forward: providing researchers with precious tissue that could hold the key to unlocking the mysteries of the autistic brain.

To learn about the ATP from both a clinical and personal perspective, we interviewed Autism Speaks' Vice President of Clinical Programs, Dr. Clara Lajonchere; the ATP Director Dr. Daniel Lightfoot; and the family of Reid Thompson, an 11-year old tissue donor. Dr. Lajonchere and Dr. Lightfoot told us that tissue samples – particularly pediatric tissue samples – are absolutely critical for gaining better understanding of autism and are necessary for the kinds of molecular, genetic, and biochemical research needed to keep the pace of discovery moving.

The ATP wouldn’t be possible without the generosity of families like Reid Thompson's. The day after Reid passed away unexpectedly in his sleep, his parents and step-parents learned about the ATP tissue donation program. At a time when many among us would be immobilized by loss, Reid's family didn't hesitate; Reid's tissue was collected for the ATP bank and is now being used in studies that will help doctors learn more about the brain's development in autism. Reid's family told us that he was a teacher during his life, and that they take great comfort in knowing the ATP enables him to continue teaching.

What Dr. Lightfoot and his colleagues are doing, and what Reid Thompson and donors like him have done, is nothing short of heroic. What we found most impressive about them is that they didn’t seem to see the heroism in their actions. But we here at Biobank Central do, and we’ve no doubt you will as well. Please stop by ATP Spotlight, and visit the Autism Speaks and Autism Tissue Program Web sites to learn more about their innovative programs.

Stay tuned--BioBank Central's Spotlight will focus on the Autism Genetic Resource Exchange.

Waiting for a Tipping Point in Science

by Margaret Anderson, COO, FasterCures

Where are we on the path to treatments and cures for brain and nervous system illnesses? Had a chance to learn more about new models of collaboration, funding, and partnerships at the recent Collaborating for Cures summit hosted by the Neurotech Industry Organization. Too often we focus on the overflowing bins of problems and forget to focus on where change has taken hold and started to move the needle. John Wilbanks of Science Commons gave participants food for thought when he asked how many nonprofit funders put dollars into collaboration, and cited the need to put our knowledge into a network instead of relying on tin cans connected by a string.

If, as Wilbanks said, resistance to collaboration in science is enormous, what are some ways to change behavior? What is possible when you take John’s advice and “resist the resistors?” What are some ways to get to collaboration, in a purposeful way instead of hoping it will happen? Some tried and true tools such as AlzForum, a 13-year-old online destination for the scientific community to learn and share information and research developments about Alzheimer's disease, is adding new features. AlzForum's June Kinoshita cited upcoming features of the SWAN (Semantic Web Application in Neuromedicine) database, a community-driven knowledge base of Alzheimer disease that relies on a moderated community process to capture the collective insights of the AD field. Michael T. Rogan from the Michael J. Fox Foundation cited the need to “move away from huddled hallway chats” in science to better our chances to find treatments and cures. Rogan leads the development of “PD Online Research” which is a collaborative scientific community which will conduct ongoing critical analysis of PD research and help connect high-priority research with the necessary financial resources.
I moderated a panel on “New Models of Funding” featuring:
With the imperative for them to have “more shots on goal” for their disease areas, these organizations are forging ahead into the future using new models via prizes, venture funds, open science tools, and managing the science. The conference ultimately posed the question: if we have seen massive efficiency for things that might be deemed frivolous (internet shopping, learning about celebrities every move via Twitter), when can we expect a tipping point in science? Many of the models discussed there will create a path for others to follow, and hopefully end up with faster cures.