Posts Tagged ‘Margaret Hamburg’

A Weekly Advocacy Message from Mary Woolley: Hearings on Capitol Hill; Is the Nation Listening?

Thursday, March 8th, 2012

Dear Research Advocate,

The appropriations season has begun in earnest, with hearings on the departments and agencies. Dr. Subra Suresh, director of the National Science Foundation, testified before the House Committee on Science, Space and Technology. You can view his testimony here. Secretary Kathleen Sebelius, Department of Health and Human Services, testified before the House Appropriations Committee on Tuesday and the Senate Appropriations Committee on Wednesday. In her testimony, she recognized the integral role that the NIH plays in improving health while spurring economic growth. The new National Center for Advancing Translational Sciences (NCATS) was also highlighted as a model for partnering with the private sector to foster the development of new treatments and drugs.

Commissioner Margaret Hamburg testified before the House Subcommittee on Agriculture/FDA appropriations last week, thanking the subcommittee for the recent increases in FDA funding. In her remarks, she highlighted the integral role that FDA plays in approving innovative drugs that can help reduce the cost of health care. You can view Commissioner Hamburg’s full testimony here.

More hearings are coming up. Reps. Ed Markey (D-MA) and Brian Bilbray (R-CA) have stepped up to co-author a Dear Colleague letter to the House Appropriations Committee for at least $1.3 billion in increased NIH funding. This bipartisan effort is exactly what is needed to demonstrate that research is not a Republican or a Democrat issue – it is an American issue that has a dramatic impact on our health, our economy and our global competitiveness. Send a letter to your representatives right away and urge them to sign on to the Markey-Bilbray letter to support NIH funding:

Friends of the Agency for Healthcare Research and Quality (AHRQ) is circulating a letter for community sign-on. The letter requests $400 million for AHRQ’s base budget in FY 2013, which is $66 million more than the $334 million level included in the President’s budget. The president supplements AHRQ’s base funding with several budget transfers that, unfortunately, are unlikely to pass Congress. Contact Lindsey Horan at if your organization would like to sign the letter.

The election frenzy continues with exciting results from Super Tuesday, but there are still more than 20 presidential primaries remaining! Kansas, Wyoming, Alabama, Mississippi and Hawaii are right around the corner and there is still plenty of time to craft an op-ed or letter to the editor. Super Tuesday also marks the start of the congressional primaries, which provide another opportunity to engage candidates on medical research issues. Given the current fiscal debates in Washington, we need to keep research for health top of mind for candidates and elected officials alike and encourage them to stand up for research.

I spoke on Super Tuesday to hundreds of volunteers from every state in the nation who had come to Washington to lobby their representatives (over 300 were visited) for increased medical research funding. I talked about assuring that the next Super Tuesday – November 6 – is indeed “super” for research. You can view my slide deck here.

As you know, our annual events are right around the corner! The Mercury News in San Jose, CA, calls attention to our upcoming Advocacy Awards Dinner at which we will honor Mr. Scott Johnson of the Myelin Repair Foundation. Mr. Johnson will be receiving the Gordon and Llura Gund Leadership Award during our event on March 14. I do hope you can join us in recognizing the Foundation and the other honorees, including the inestimable Sen. Barbara Mikulski.


Mary Woolley

So, Why Should YOU Care About Global Health Research and Development?

Tuesday, November 15th, 2011

Over the past several weeks, we’ve written a considerable amount about global health R&D and the methods and partnerships that help bring better health to millions around the world.

Perhaps, while reading one of those posts, you’ve thought that the situation sounded too irrelevant, the location too remote for it to be of consequence to the average American. Quite the contrary: Global health R&D does matter to Americans. In state polling conducted by Research!America, 72% of Georgia residents think Americans should be concerned about diseases that mostly affect poorer countries; in Illinois, 75% thought so; and in New Jersey, 79% thought so.

If numbers don’t sway you, a recent blog post from the Global Health Technologies Coalition might. GHTC interviewed four people with familiar names and titles; each underscores the importance of global health to America.

Amie Batson, deputy assistant administrator and deputy to the administrator for the Global Health Initiative at USAID: “I think the world of global health and America’s ability to have an impact on it really epitomizes the best of what America is – the ‘we can make a difference’ view that Americans bring.”

Margaret Hamburg, MD, commissioner of the Food and Drug Administration: “Eighty percent of the active pharmaceutical ingredients in drugs that we take – the thing that really makes a difference in the drug – come from other countries. The complex global supply chains, the complex global scientific research functions and the fact that products come from all over the world and are used here in the United States means that we want to make sure that health standards and capabilities in those other countries are at the level that we would like to, frankly, see here.”

Rep. Ed Markey (D-MA): “Millions of people cross international borders every day. They’re carrying diseases with them. The United States is not insulated from diseases and the rest of the world. We have to care about the rest of the world because if we don’t, those diseases will eventually wind up in our own country.”

Whoopi Goldberg, comedian and talk show host: “AIDS doesn’t care. It doesn’t care what your affiliation is – doesn’t care if you’re Republican, doesn’t care if you’re gay or straight or a little bitty baby. If it gets you, it gets you.”

Goldberg’s point served as an excellent segue; the interviews were posted the day before Secretary of State Hillary Clinton spoke at the National Institutes of Health in Bethesda, MD. Her topic? Creating an AIDS-free generation.

“But let’s remind ourselves no institution in the world has done more than the United States Government,” she said. “We have produced a track record of excellence in science. Researchers right here at the NIH conducted pivotal research that identified HIV and proved that it did cause AIDS. The first drug to treat AIDS was supported by the United States. Today we are making major investments in the search for a vaccine; for tools like microbicides, which give women the power to protect themselves; and other lifesaving innovations.”

We pay for it, and we benefit from it, despite its far-flung sounding name. Global health research benefits us all.

C-PATH to Host “Creating Consensus Science”

Tuesday, October 25th, 2011

The Critical Path Institute (C-PATH), in conjunction with the Food and Drug Administration and the Clinical Data Interchange Standards Consortium (CDISC), will hold a two-day event focusing on the innovative tools that push drug development toward greater efficacy and lesser risk.

“Creating Consensus Science: New Tools and Tactics for Next-Gen Drug Development” will be held November 30 and December 1 at the Crowne Plaza Silver Spring in Silver Spring, MD.

FDA Commissioner Margaret Hamburg, MD, and Kathy Hudson, PhD, deputy director for science, outreach and policy at the National Institutes of Health, are the keynote speakers.

Other session chairs and panelists include former Sen. Bob Bennett (R-UT); John Castellani of PhRMA; Brian Corrigan, PhD, of Pfizer; Tim Cote, MD, MPH, of the National Organization for Rare Diseases; Jan Gheuens, MD, PhD, of the Bill & Melinda Gates Foundation; Clarice “Risa” Hayes, PhD, of Eli Lilly and Co.; Garry Neil, MD, Gary Romano, MD, PhD, and Mahesh Samtani, PhD, of Johnson & Johnson; Ronald Perrone, MD, of Tufts University; Frank Sistare, PhD, of Merck; Myrl Weinberg of the National Health Council; Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research; and Raymond Woosley, MD, PhD, of C-PATH.

Read more about the event or click here to register.

The FDA’s Biomedical Innovation Blueprint

Thursday, October 13th, 2011

Last week, the Food and Drug Administration released a series of initiatives intended to both spur biomedical innovation and improve the health of Americans. The initiatives, according to the agency, will help FDA keep up with the changing science landscape.

“America is at an important crossroads, where the science before us presents unprecedented opportunities to create new and better medical products and to promote better health for the public,” FDA Commissioner Margaret Hamburg, MD, said in a statement. “Our innovation blueprint highlights some of the initiatives FDA will be implementing to ensure that these opportunities are translated into safe and effective treatments that can help keep both American patients and American industry healthy and strong.”

According to the agency, the new initiatives include:

  • rebuilding FDA’s small business outreach services
  • building the infrastructure to drive and support personalized medicine
  • creating a rapid drug development pathway for important targeted therapies
  • harnessing the potential of data mining and information sharing while protecting patient privacy
  • improving consistency and clarity in the medical device review process
  • training the next generation of innovators
  • streamlining and reforming FDA regulations

FDA has a full report on the new blueprint, available here; the report goes into detail on each of the initiatives and how they’ll help bring better products to patients more quickly.

FasterCures Partnering for Cures

Thursday, July 28th, 2011

FasterCures’ 2011 Partnering for Cures meeting will take place November 6-8 at the Grand Hyatt in New York City, convening leaders from all sectors of medical research to help foster partnerships and collaboration within the field.

Speakers at this year’s meeting will include National Institutes of Health Director Francis Collins, MD, PhD; Food and Drug Administration Commissioner Margaret Hamburg, MD; University of California, San Francisco Chancellor Susan Desmond-Hellmann, MD; Novartis Institutes for BioMedical Research President Mark Fishman, MD, and many more.

Applications are now being accepted for Innovator Presentations from organizations engaged in collaborations focused on reducing the time it takes for medical breakthroughs to reach patients. These collaborations should involved two or more of the following sectors: nonprofit foundations, pharmaceutical and/or biotechnology companies, research institutes, universities, government agencies, investors and private philanthropists.

The application deadline is August 19. For application and evaluation criteria or to apply, click here.

FasterCures and UCSF are Research!America members.

John Castellani Blogs About Research!America 2011 National Health Research Forum

Tuesday, March 29th, 2011

John Castellani, president and CEO of PhRMA, recently wrote a blog post in The Hill’s Congress Blog reflecting on the panel discussion in which he participated at Research!America’s 2011 National Health Research Forum. Castellani wrote:

Much of the strength of America’s private healthcare sector is based on the collaborative research ecosystem that exists among government agencies, academia and biopharmaceutical research companies. That collaboration should be promoted and expanded through a national policy agenda that supports medical innovation and America’s continued global leadership in the healthcare economy.

The time for a national policy of support is now. The future of U.S. biomedical innovation is at a crossroads. Budgets are stretched thin, it’s increasingly difficult to maintain infrastructures that match the pace and complexity of science, and competition for talent and jobs in a global economy is tight. Now more than ever, the decisions we make, the policies we pursue, the funds we allocate – all must keep the preservation and growth of innovation front and center.

In order to sustain American progress and global leadership in medical innovation, we must continue to nurture it. And it will take a joint commitment by all stakeholders – including the esteemed panelists with whom I spoke during the Research!America forum.

Castellani sat on a panel moderated by Clive Crook of The Atlantic. His co-panelists were Margaret Hamburg, MD, commissioner of the FDA; David Page, MD, director of the Whitehead Institute for Biomedical Research; Francis Collins, MD, PhD, director of the National Institutes of Health; former Congressman Mike Castle; and Ellen Sigal, PhD, chair and founder of Friends of Cancer Research.

As reflected in Castellani’s blog post, the panel conversation largely focused on public-private partnerships. This kind of collaboration can facilitate the translation of basic medical and scientific discoveries into products for patients.

PhRMA, Friends of Cancer Research, and the Whitehead Institute are Research!America members.

FDA Report Details Agency’s Vision for Advancing Regulatory Science

Friday, October 8th, 2010

The Food and Drug Administration released a report this week that charts the course ahead for its new Regulatory Science Initiative.

“[T]he Food and Drug Administration (FDA) must play an increasingly integral role as an agency not just dedicated to ensuring safe and effective products, but also to promote public health and participate more actively in the scientific research enterprise directed towards new treatments and interventions,” the report states. “We must also modernize our evaluation and approval processes to ensure that innovative products reach the patients who need them, when they need them. These new scientific tools, technologies, and approaches form the bridge to critical 21st century advances in public health.”

In the report, the FDA proposes that a four-part framework is necessary:

    • Leadership, coordination, strategic planning and transparency to support science and innovation
    • Support for mission-critical applied research, both at FDA and collaboratively
    • Support for scientific excellence, professional development and a learning organization
    • Recruitment and retention of outstanding scientists

The agency believes that each of these tasks will improve the FDA’s “scientific capacity” and improve collaboration among government, industry and academia. FDA says it will rely on several advisory boards and other programs to push toward completion of these tasks.

“Support for these four approaches will develop and advance the field of regulatory science to help provide the tools and the knowledge required to realize the promise of innovation,” the report states. “These efforts will help us bridge the gap from basic science discoveries to safe, effective products that help patients, protect health and security, enhance the safety of our medicines and foods, and support innovative, effective medicine and public health.”

After the report’s release, FDA Commissioner Margaret Hamburg, MD, talked about the initiative at the National Press Club in Washington, DC. A replay of her comments, courtesy of C-SPAN, is available on the Press Club’s website.

Friday’s Media Links of Interest

Friday, June 18th, 2010

A few interesting links to check out on a Friday:

First, Food and Drug Administration Commissioner Margaret Hamburg, MD, and National Institutes of Health Director Francis Collins, MD, PhD, (PDF) co-authored a Perspectives column for the New England Journal of Medicine entitled, “The Path to Personalized Medicine.”

They write:

Moving from concept to clinical use requires basic, translational, and regulatory science. On the basic-science front, studies are identifying many genetic variations underlying the risks of both rare and common diseases. These newly discovered genes, proteins, and pathways can represent powerful new drug targets, but currently there is insufficient evidence of a downstream market to entice the private sector to explore most of them. To fill that void, the NIH and the FDA will develop a more integrated pathway that connects all the steps between the identification of a potential therapeutic target by academic researchers and the approval of a therapy for clinical use. This pathway will include NIH-supported centers where researchers can screen thousands of chemicals to find potential drug candidates, as well as public–private partnerships to help move candidate compounds into commercial development.

The NIH will implement this strategy through such efforts as the Therapeutics for Rare and Neglected Diseases (TRND) program. With an open environment, permitting the involvement of all the world’s top experts on a given disease, the TRND program will enable certain promising compounds to be taken through the preclinical development phase — a time-consuming, high-risk phase that pharmaceutical firms call “the valley of death.” Besides accelerating the development of drugs to treat rare and neglected diseases, the TRND program may also help to identify molecularly distinct subtypes of some common diseases, which may lead to new therapeutic possibilities, either through the development of targeted drugs or the salvaging of abandoned or failed drugs by identifying subgroups of patients likely to benefit from them.

Hamburg and Collins also mention the collaboration between the FDA and the NIH that works on translational science. That collaboration is already paying off, they write, with a recent discovery that identifies “new investigational agents to which certain tumors, identified by their genetic signatures, are responsive.”

The Boston Globe reports that Pfizer Inc., a Research!America member, will open a rare disease research and development center in Cambridge, Mass.

Pfizer, in an alliance with Israel-based Protalix BioTherapeutics Inc., will study hemophilia as well as treatments for muscular dystrophy and serious diseases caused by genetic mutations, the paper reported. Further partnerships with Boston-area universities and biotech firms may also be possible.

Also, this Sunday’s issue of Parade magazine will focus on cancer. There are several stories already online at Parade’s website. One of the stories was written by Collins, another by Jessie Gruman, PhD; her organization, the Center for Advancing Health, won a Research!America Advocacy Award in 2006.

To see if your local newspaper distributes Parade, go to the magazine’s homepage and scroll down for a list of partner newspapers.