The Research Advocate, our award-winning membership newsletter, provides the latest news and information on medical, health and scientific research advocacy, as well as reports from Research!America and member organizations. Regular features include policy articles, profiles of Research!America members, media coverage of research advocacy issues, a column by Research!America President and CEO Mary Woolley, and important updates to help our members in their own efforts to make research to improve health a higher national priority. For questions or comments contact Jennifer Santisi,

From Research!America

Panelists Discuss the Future of Medical Innovation

Demonstrating the value of medical research is critical to increasing support among policymakers and the public for the research ecosystem. Leaders representing various sectors of the research community discussed efforts to advance policies in support of medical innovation at Research!America’s 2015 National Health Forum Thursday, September 10 at the Newseum in Washington, DC. “If we want America to remain the epicenter of medical innovation, we need to learn from past lessons and engage in passionate advocacy…to create a groundswell around medical research,” said Jeffrey Bloss, M.D., senior vice president of scientific and medical affairs, Astellas Pharmaceuticals U.S., lead sponsor of the event.

Sudip S. Parikh, Ph.D., vice president and general manager of health & analytics, Battelle, described the need for “breaking down the silos” to enable researchers to work together toward a common goal. Ron Mobed, chief executive officer, Elsevier said government officials worldwide are demanding more accountability for public investments in research. “If you can't convince taxpayers of the value, then you don't get the funding to follow your nose,” he added.

Stephen M. Ostroff, M.D., acting commissioner, Food and Drug Administration (FDA), noted the importance of the FDA keeping pace with innovation and ensuring “that we have the skill-sets that we need to be able to properly evaluate what comes before the agency. That is not an easy task.” The use of real-world data in FDA decision-making was applauded by Amy Comstock Rick, J.D., president and chief executive officer, Food and Drug Law Institute, who also stressed the need to review “how drugs are actually used by people and how they are prescribed by clinicians.”

Other panelists discussed the prevalence of chronic conditions, telemedicine, vaccines and challenges with educating the public about health services research. Richard Kronick, Ph.D., director, Agency for Healthcare Research and Quality, acknowledged his agency must do a better job communicating the value of AHRQ’s work to improve quality of care. There are “50,000 fewer death in hospitals and 1.3 million fewer bad things happening” as a result of AHRQ’s efforts. “I and my colleagues need to tell the story better and that story needs to be amplified more effectively,” Kronick said. Anne Schuchat, M.D., principal deputy director, Centers for Disease Control, described the interconnectedness of global health. “For the CDC to keep Americans safe and healthy requires strong health protection in every country. Because the weakest link in the global chain can mean problems at home, as well as devastating problems abroad,” she emphasized.

Other panelists included Barbara Newhouse, president and CEO, The ALS Association; Reed V. Tuckson, M.D., FACP, managing director, Tuckson Health Connections, LLC; and Lucinda L. Maine, Ph.D., RPH, executive vice president and CEO, American Association of Colleges of Pharmacy; Gary H. Gibbons, M.D., director, National Heart, Lung, and Blood Institute, National Institutes of Health (NIH); William Hait, M.D., Ph.D., global head, Janssen Research & Development; Anil Jina, M.D., senior vice president and head of global medical affairs at Shire; and Vincent A. Forlenza, chairman, chief executive officer and president, BD;  Larry J. Shapiro, M.D., executive vice chancellor for medical affairs, Washington University in St. Louis; and Marc Boutin, J.D., chief executive officer, National Health Council.

The moderators were Richard Harris, science correspondent, NPR; Seema Yasmin, M.D., medical correspondent, CNN and staff writer, The Dallas Morning News; and Frank Sesno, director of the George Washington University School of Media and Public Affairs.

For more information on the event, photos and videos, visit

Campaign for Cures Voter Education Initiative

With election season well underway, Research!America has launched a new national voter education initiative, Campaign for Cures: Vote for Medical Progress! The campaign intends to make medical progress and policies that support scientific innovations part of the conversation on the campaign trail. By arming Americans with information on the importance of medical research, we can ensure their voices are heard by candidates running for national office.

Increasing public awareness about the research ecosystem and the role of the public and private sector in the discovery, development and delivery of lifesaving treatments to patients is critical to boosting federal support for medical and health research. A plurality of Americans (40%) agree that elected officials are not doing enough to combatting the diseases and disabilities that afflict Americans, according to a national public opinion poll commissioned by Research!America.

The campaign website includes online resources for voters to use as they meet and engage with candidates running for President and Congress. An online toolkit provides voters background information on the issues, and sample materials to participate in conversations on social media, write op-eds, letters to the editor, and letters to candidates running for office. Participants can take an online pledge to engage candidates about medical research during the election season, and share personal stories, photos and videos on how research improved their quality of life. 

More than two decades of Research!America’s polling shows that Americans place a high value on U.S. leadership and investment in medical and health research. Research advocates must ensure that medical progress is a priority in the upcoming elections, and we hope you will join us and add your voice to the national conversation. For more information, visit  

If you are interested in becoming a partner in the campaign, please contact Carol Kennedy,

Federal Policy Update

On September 30, Congress passed a stopgap spending bill that keeps the government running until mid-December. This short-term continuing resolution (CR) gives Congress more time to reach an appropriations agreement for FY16 and beyond. Based on the FY16 appropriations bills pending in the House and Senate, NIH stands to benefit from a budget deal that prioritizes funding rather than maintaining the status quo. The Senate “Labor-H” Appropriations measure would increase NIH funding by $2 billion and the House bill by $1.1 billion. House and Senate leadership have reportedly begun longer-term budget negotiations with President Obama, with rumors of a possible two-year budget deal that “pauses” the sequestration budget caps and staves off the risk of a government shutdown until 2017. 

Work continues on the Senate companion to the House 21st Century Cures Act.  Health, Education, Labor, and Pensions (HELP) Committee Chairman Senator Lamar Alexander (R-TN) recently reaffirmed his commitment to addressing the onerous regulatory burden on NIH-funded researchers as part of this effort.   While, as of this writing no date has been named for release of draft legislation, the Chairman may reportedly do so during the second or third week of October. 

In mid-September, President Obama signed the Executive Order “Using Behavioral Sciences to Better Serve the American People.” The order encourages federal agencies to incorporate insights from behavioral psychology and economics research into policy decisions. It also establishes the Social and Behavioral Sciences Team (SBST) under the National Science and Technology Council, chaired by John Holdren, Ph.D., to facilitate this process.

Also in September, President Obama nominated Robert Califf, M.D., former Duke University research and professor and current Deputy Commissioner of the Food and Drug Administration (FDA) Office of Medical Products and Tobacco, to be the agency’s next commissioner. Dr. Califf’s nomination is pending Senate confirmation. In other FDA news, the agency announced this month the launch of the first-ever Patient Engagement Advisory Committee, which will integrate patient perspectives into the regulatory process. 

A report by the National Academies this month says researchers in the U.S. are spending too much time applying for federal grants, impacting science progress. “Increasing federal regulations have hindered the output of the remarkable research enterprise that rose from government-academic partnership,” said Larry Faulkner, Ph.D., who chaired the committee responsible for the report. Research!America continues to push for policies that meaningfully address this growing administrative burden. 

The Precision Medicine Initiative is progressing, with this month’s rollout of a framework for constructing a national research participant group by the NIH Advisory Committee. The goal is to start enrolling participants in the cohort in 2016 and enroll over 1 million people by 2020. Read more on the initiative in this issue of the newsletter. 

Iowa Voters Map Out Federal Budget

Investment in science, including medical research and innovation, as well as investing in education and infrastructure --among other public goods -- is being sorely squeezed. Failure by policymakers to address key drivers of our federal deficit – entitlement programs, healthcare spending and the tax system, is wreaking havoc. A group of about 100 Iowa voters discussed federal spending and structural reforms to the federal budget at an interactive budget exercise on September 22 at Drake University in Des Moines conducted by The Concord Coalition. Research!America was a partner in the event, which helped voters understand the complexity of the federal budget and determine what they consider to be priorities for federal spending.  

Research!America president and CEO Mary Woolley participated in the program and described the impact of sequestration, automatic spending cuts, and policies that hinder private sector innovation, on achieving medical progress. “What we need now is concrete action by policymakers in reaching a budget deal and passing legislation to modernize our research ecosystem to accelerate the pace of bringing new lifesaving treatments to patients,” Woolley said. “Research is leading us to more efficient and effective ways to treat deadly and costly diseases; and, it’s the way we can head off the tsunami of escalating health care costs.”

In The Hill’s Congress blog, Concord Coalition Executive Director Robert Bixby says presidential candidates should be pressed on how they would balance the budget in upcoming debates. They need to provide details on their various proposals for Social Security and tax reform, he says. ”How does it all add up over time?” 

For more information on the Concord Coalition’s budget exercise, visit

Action Alert

Please Fight for Medical Progress

Please take a minute to thank members of Congress for passing a short-term budget measure that prevents a government shutdown and to urge them to work together to craft a longer term spending bill that ends sequestration. 

If fiscal year 2016 spending is subject to sequestration spending limits, it will not be feasible to meaningfully boost funding for medical research. Ask members of Congress to come together on a budget deal that puts American priorities, including faster medical progress, first.

Take action now at

Regular Features

President's Letter

This is awards season for the science community. Awards at the highest level are a mark of personal achievement, as well as national pride and - importantly - contributions to society that are life-changing.  Societal progress at this level is often made possible by public investment, followed by private sector innovation and development. Last month, the Lasker awards were presented, and now, within a few days’ time, we will know the identity of the next Nobel Laureates. I hope you will take the opportunity to congratulate the Nobel winners publicly: through a letter to the editor of your local media outlet, and/or via social media. But don't stop with congratulations! As appropriate, connect the dots between a given winner and longtime taxpayer support of basic science, philanthropic support and/or industry partnership and support. And look for ways to send a message to those running for the Presidency that recognition at the Nobel level is something that nations aspire to, but don't earn without long-term, sustained public investment. It wasn't so very long ago that few, if any, Americans earned the Nobel Prize, and it is by no means guaranteed that Americans will win this year, or in the future.

I had the opportunity last month to participate in a ‘budget exercise’ in Iowa, sponsored by the Concord Coalition.  It was very interesting to sit in with the participants as they worked to achieve consensus on whether to reduce components of the federal budget, add to it, or leave it untouched. I was struck by how committed people were to listening to arguments pro and con, and then to reaching agreement.  It was a model of what Congress should be doing more of! Some of the issues that were the most difficult for the group concerned healthcare-related topics. There was a general realization that research could help drive down costs, and further, that research is not fueling the deficit by any stretch of the imagination! Read more about the budget exercise in this newsletter. 

Member Spotlight: American Society of Gene and Cell Therapy

Founded: 1996

Location: Milwaukee, WI

Mission: Advance knowledge, awareness, and education leading to the discovery and clinical application of genetic and cellular therapies to alleviate human disease.

The American Society of Gene and Cell Therapy (ASGCT) is a non-profit medical and professional organization that represents researchers and scientists devoted to the discovery of new genetic and cellular therapies. ASGCT was established in 1996 by Dr. George Stamatoyannopoulos, Professor of Medicine at the University of Washington’s School of Medicine, and a group of the country’s leading researchers in gene therapy. With over 1,800 members in the United States and worldwide, ASGCT is the largest association of individuals involved in genetic and cellular therapeutics.

“The field of gene and cell therapy is experiencing dramatic advances reflected in breakthrough clinical results obtained in a variety of pathologies, from eye diseases to blood disorders to cancer,” said Michel Sadelain, M.D., Ph.D., president of the American Society of Gene and Cell Therapy (ASGCT). ASGCT has supported cell and gene therapies from conception to clinical translation and is poised for growth.  With 1,900 attendees, the 18th Annual Meeting held in May 2014 saw the highest attendance since 2006.

Despite emerging clinical success, cell and gene therapy researchers continue to face challenges to fund their research in a global context of stagnating or diminishing federal support for health research. As a 501(c)3 organization, ASGCT’s abilities to advocate and lobby for research funding are limited. Nonetheless, ASGCT strives to assist its members in obtaining funding by strategically working with patient advocacy foundations and other health research advocacy groups to communicate the importance of supporting cellular and genetic health research with Congress, the Food and Drug Administration (FDA) and the National Institutes of Health (NIH).

ASGCT has developed initiatives over the last several years to reach these governmental entities directly, including the organization of visits with the NIH directors, scientific programs to educate NIH leadership and FDA. ASGCT also supports programs aiming to advance standardization and harmonization of regulatory issues, clinical trial development and commercialization. For example, at its most recent Annual Meeting, ASGCT hosted the FDA and regulatory agencies from over ten different countries in a session aimed at discussing international regulatory issues surrounding biodistribution studies.

Reaching governmental personnel through education is one way ASGCT has established a relationship with Congress, the FDA and the NIH. ASGCT seeks to identify champions of the gene and cell therapy field with the anticipation that key opinion leaders and influential administrators will serve as advocates for health research funding related to gene and cell therapy.

Building a network of supporters and advocates of the gene and cell therapy field within government entities is one of many goals outlined in ASGCT’s recent strategic plan. Other strategic objectives are geared towards promoting the awareness, acceptance and appreciation of gene therapy and ASGCT. These include establishing an informative web presence for the community, supporting activities of other gene therapy societies, creating new educational programs for clinicians and basic researchers on the progress and development in the field, strengthening relationship with foundations and engaging the media. Through these objectives ASGCT aims to increase overall awareness and excitement surrounding the progress of the field, which will incentivize funding entities to provide more support to gene and cell therapy research.

As a new member of Research!America, ASGCT sees potential for Research!America to serve as ASGCT’s voice in helping to boost federal funding for health research. “Many individual members of ASGCT conduct research, either full or part-time, which largely depends on securing funding from NIH, NCI, DOD and other federal research programs. Cell and gene therapy holds great promise to alleviate human disease and warrants better support for basic and translational research,” said Sadelain.

To learn more, visit

From Washington

Advocates Gather in DC to Rally for Research

It’s time to make funding for the National Institutes of Health (NIH) sustainable and predictable.  More than 300 research advocates from across the country implored Congress to do just that during the Rally for Medical Research Hill Day on September 17. Research!America was a lead supporter for the event which focused on making investments in biomedical research a higher national priority.

Founded by the American Association for Cancer Research (AACR), a Research!America member, the two-day program featured remarks from NIH Director Francis Collins, M.D., Ph.D., and members of Congress including Chairman Tom Cole (R-OK), Senator Jerry Moran (R-KS), Senator Dick Durbin (D-IL), Senator Patty Murray (D-WA), Senator Amy Klobuchar (D-MN) and Congressman Brian Higgins (D-NY). Research!America President and CEO Mary Woolley and board member Mary Hendrix, Ph.D., president and CEO of the Stanley Manne Children’s Research Institute, spoke at the Rally reception. 

“We are having a quite remarkable ‘moment’ for medical research and the NIH this year – at long last -- with all the focus we’ve seen on it this year, in the appropriations process and in specific bills that finally raise the priority of finding cures and preventions and answers,” said Woolley. 

“The human genome project revolutionized medicine and wouldn't have been possible without federal investment in research,” said Senator Durbin. He stressed the need to lift the budget caps to ensure “America remains a world leader in medical research.”

In a floor speech to Congress, Higgins cited a National Cancer Institute report “that identifies research that won’t be conducted unless Congress restores its purchasing power with sustained annual funding increases over the next decade. We must not let that happen.”

For more information, visit

19th Annual NFID Influenza/Pneumococcal News Conference

Each year, 5 - 20 percent of the U.S. population gets the flu, according to the National Foundation for Infectious Diseases (NFID).  With flu season underway, health officials are emphasizing the importance of individuals six months of age and older to get vaccinated.  This year’s vaccine has been modified to better match a strain which caused illness to millions last flu season, especially among senior citizens. 

During a September news conference at the National Press Club, Centers for Disease Control and Prevention Director Thomas R. Frieden, M.D., MPH, said “The vaccine has been updated to better match the H3N2 strain. Normally, as I say, the flu vaccine is about 50-60 percent effective. This year, we want to see a steady increase in the momentum on increasing flu vaccine, and there is more flu vaccine than ever being produced by manufacturers – at least 171 million doses of flu vaccine. At least 40 million of those doses have already been distributed.” 

Research!America President and CEO, Mary Woolley joined Dr. Frieden and others in receiving the flu vaccine at the news conference.  In addition to vaccination, CDC urges preventive measures such as frequent handwashing user soap or alcohol-based rubs, covering sneezes and coughs and avoiding close contact with sick people.

Incorporating Patient Perspectives in R&D and Forging New Partnerships

Research!America member FasterCures recently published key takeaways from a workshop held in June, “Partnering with Patients on Value, Coverage, and Reimbursement,” that highlights participants’ feedback on demystifying the payer landscape, the process by which coverage and reimbursement decisions are made, and integrating patient input into formulary recommendations.

The workshop brought together over 100 patients, payers, biopharmaceutical companies and providers to facilitate greater understanding of challenges, needs and perspectives, and to foster more effective partnerships. Topics included the challenge of regulatory approval, utilizing patient data, integrating patient input, and the need for transparency among stakeholders.

The report outlines five key takeaways for breaking down barriers between stakeholders: 1) Early engagement with payers can improve alignment between regulatory and post-market evidentiary needs; 2) Both patient organizations and payers need to broaden their views and understanding of each other’s role; 3) Build a common framework for soliciting and using patient output; 4) Patient data can contribute to the “tapestry of evidence” that is useful for payer decisions; 5) And the patient community must maintain as united a front as possible, and not break down into disease silos.

Participants also discussed the need to find new ways to define and conceptualize value at all levels, and the challenge of identifying what is ‘valuable’ to patients. Multiple panelists shared how important it is for patients, providers and caregivers to have honest conversations about the value of a particular treatment or procedure and incorporate the patient’s perspectives, goals and needs into the regulatory process.

For the full report visit:

Supporting Breast Cancer Research and Raising Awareness

Patient advocates across the country are organizing fundraisers and highlighting investments in research during the month of October for breast cancer awareness month. Susan G. Komen, a Research!America member, also announced new grants to 124 researchers in 25 states and eight countries internationally, with about half of the grants targeted to early-career researchers.

“We committed two years ago to do all that we can to ensure that talented early-career investigators remain in the breast cancer research field, while continuing our support for established researchers,” said Komen President and CEO Judith A. Salerno, M.D., M.S., in a press release. “We cannot afford to lose talented scientists to other fields for lack of funding.”

The grants span the entire cancer continuum, from prevention to treatments for aggressive and metastatic disease, including funding to improve understanding of metastatic breast cancer, investigate how tumors develop drug resistance and develop new and novel therapies, among many other programs.

In addition to funding breast cancer research, Komen has invested more than $1.95 billion into community health outreach and global programs that serve hundreds of thousands of women and men annually through breast cancer health and support programs that screen, educate and provide financial, medical and psychosocial assistance. Learn more about Susan G. Komen at

NIH Precision Medicine Initiative Plans to Recruit One Million People

The National Institutes of Health (NIH) expects to begin recruiting at least one million people for the Precision Medicine Initiative Cohort Program (PMI-CP) as early as next year, potentially making it the largest study on how genes influence disease risk. Details of the program are outlined in the working group’s report, “The Precision Medicine Initiative Cohort Program- Building a Research Foundation for 21st Century Medicine.”

The report includes recommendations in six areas important to the development, implementation, and oversight of the program: cohort assembly, participant engagement, data, biobanking, policy, and governance. The initiative aims to develop better estimates on individuals' risk for developing disease by looking not only at genetic factors but also at the role of environmental exposures and their impact on genetic predispositions.

“Many factors have converged to make now the right time to begin this ambitious project,” said NIH Director Francis Collins, M.D., Ph.D. “Americans are engaging in improving their health and participating in health research more than ever before, electronic health records have been widely adopted, genomic analysis costs have dropped significantly, data science has become increasingly sophisticated and health technologies have become mobile. We have to seize this moment to invest in these promising scientific opportunities to help Americans live healthier lives.”

A major challenge of the program is to assemble a cohort that accurately represents the diversity of the U.S. population. “We will need to figure out ... how to make sure that we’re not filling up all of the available slots with a certain demographic,” said NIH Deputy Director for Science, Outreach, and Policy Kathy Husdon, quoted in an article in the journal Science published by the American Association for the Advancement of Science, a Research!America member.

The working group proposes an innovative strategy allowing any person living in the U.S. to voluntarily enroll in the study directly or through participating healthcare provider organizations.

To view the full report, visit

In the News

Media Matters

National Health Research Forum

Research!America’s National Health Research Forum - Straight Talk: Advocacy for a New Era in Science featured leaders in government, industry, patient advocacy, and academia discussing policies and other variables impacting medical innovation and public health. Inside Health Policy, Medpage Today, Politico Pro, Bloomberg BNA and Scrip were among those who published articles about the Forum. WebMD live streamed the event and many followed the conversation on social media.

Research!America in Iowa

Research!America partnered with The Concord Coalition for an “interactive budget exercise” with voters at Drake University in Iowa in September. Research!America president and CEO Mary Woolley spoke about federally-funded research and urged Iowans to engage candidates in an article in The Business Record. An interview with Woolley about the budget exercise was aired on Des Moines, Iowa area radio stations KWQW-FM, KJJY-FM and KGGO-FM.

FY16 Budget Proposals and Deadline

In an article in Kaiser Health News about proposals to increase funding for some agencies at the expense of others such as The Agency for Healthcare Research & Quality, Woolley said “We're no fans of that kind of rob Peter to pay Paul. Best case scenario, we find a way around sequestration.”  The article was also featured in GenomeWeb, Medscape, NPR, and Newsweek.

Chemical and Engineering News included comments from Woolley in an article about the FY16 federal budget deadline. “While the conversation has switched to putting out fires, decision-makers are taking their eyes off the ball of what people really care about,” she said.

Addressing Medical Diagnostic Errors

The National Academy of Medicine (NAM) released a report recommending greater communication between doctors, patients and their caregivers in order to reduce medical diagnostic errors in the U.S.  Reuters included comments from Research!America board member and NAM President Victor Dzau, M.D. "Diagnostic errors are a significant contributor to patient harm that has received far too little attention until now," he said.

Rally for Medical Research

In an article about the Rally for Medical Research in The Cancer Letter, Mary Woolley spoke about the dedication of research advocates. “At the Rally for Medical Research reception, the energy in the room was palpable, fueled by a sense of determination by Senators Durbin, Murray, Klobuchar and Moran to increase and sustain our national commitment to research,” she said.

Science Survey

CEO of the American Association for the Advancement of Science and Research!America board member Rush Holt, Ph.D. spoke to the Associated Press about the results of a Pew Research Center online science quiz of U.S. adults. Holt lamented that the survey does not provide the full picture of the general public’s understanding of science and was concerned about the gender and racial knowledge gaps.

The Lasker Awards

Research!America member, The Albert and Mary Lasker Foundation 2015 Lasker Award winners were featured in several media outlets across the country, including The Los Angeles Times, The New York Times, and The Wall Street Journal

Media Contacts

Suzanne Ffolkes
VP Communications

Anna Briseño
Communications Manager

If concerted, long-term investments in research are not made, America will lose an entire generation of young scientists.
Brenda Canine, PhD; McLaughlin Research Institute, Montana