Newsletter

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 editor@researchamerica.org. 

In This Issue of The Research Advocate: MAY 2020

From Research!America

Research!America's Response to COVID-19

In January 2020, the first case of COVID-19 was reported in Washington state. The days since then have been unprecedented in global history. The medical and research community, including so many of our alliance members, have taken on the incredible challenge of beating back the novel coronavirus, not just on the front lines in hospitals, but in laboratories across the world working to understand the virus to protect public health. Scientific societies and other alliance member organizations are advising policymakers from the White House Task Force to governors to large city mayors. Patient advocacy groups are working to ensure the needs of people with chronic illnesses are forefront and our industry members are launching ambitious efforts to develop and manufacture diagnostics, treatments, and vaccines in record times.

Research!America is responding to the pandemic in a number of ways. Our policy team is laser-focused on advocating for federal funding and policy actions to support our nation’s medical and scientific research enterprise now and in the long run. Working with alliance members, we are urging leaders to ensure federal funding and policy decisions provide the flexibility and resources to assure the research enterprise emerges from the COVID-19 crisis stronger than ever, ready to address future threats.

We have increased the pace of our alliance member calls from monthly to weekly – sometimes twice weekly – so members can directly hear from and ask questions of key decision-makers and experts.  Guest speakers have featured CDC Director Dr. Robert Redfield, Dr. Francis Collins, APHA Executive Director Dr. Georges Benjamin, Global Liver Institute’s Donna Cryer, AAMC President Dr. David Skorton, Rear Admiral Erica Schwartz, and many others.  We held an insight-packed, partner-sponsored webinar to better understand the COVID-19 vaccine and treatment R&D landscape. More of these are in the works.  For a full list of past and upcoming alliance member calls and webinars, visit our website.)

We also launched a webpage of timely, reliable resources and have featured blogs posts on issues such as health disparities related to COVID-19, and the inner workings of diagnostic tests.

This is an opportune time to make sure you are staying connected by subscribing to Mary Woolley’s Weekly Letter, always with policy updates, calls to action, the latest developments, and insights unlike from anywhere else. As always, let us know how we can support you!

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Webinar Explores COVID-19 Vaccines and Treatment

As the COVID-19 pandemic surpasses one million cases in the United States, Research!America brought together experts to discuss the R&D landscape for vaccines and treatments. The webinar was moderated by Research!America board member, former FDA Commissioner Dr. Mark McClellan, Director of the Duke-Margolis Health Policy Center and featured Dr. Stefano Bertuzzi, CEO of the American Society for Microbiology, and former CDC Director Dr. Julie Gerberding, Executive Vice President and Chief Patient Officer, Strategic Communications, Global Public Policy and Population Health at Merck.

Dr. McClellan noted that FDA staff are taking on new challenges as collaboratively and with as much communication as possible right now in executing their important role in the development of safe and effective new therapeutics and diagnostics. Kicking off the discussion, Dr. Gerberding explained why it takes time to demonstrate vaccines are effective and safe and that large scale manufacturing is challenging. She emphasized, “there are no shortcuts to vaccine development.” She is hopeful antiviral therapies will prove effective for COVID-19, enabling patients to avoid entering intensive care or dying of the disease. 

Dr. McClellan then turned to Dr. Bertuzzi who explained clinical trial work on COVID-19 has moved so far, so quickly because of the powerful body of science we are standing on. Basic research is essential and now more than ever we need to continue science funding. Dr. Bertuzzi said, Dr. McClellan then turned to Dr. Bertuzzi who explained clinical trial work on COVID-19 has moved so far, so quickly because of the powerful body of science we are standing on. Basic research is essential and now more than ever we need to continue science funding. Dr. Bertuzzi said, “the fact that we were able to develop, so fast, therapeutics repurposed to develop vaccines and all that is because we're building on all that body of research that has happened over time.”

Dr. Gerberding thanked Research!America and all of the alliance members who have continuously pushed for robust science funding. McClellan also noted the importance of research advocacy in this critical time, saying, “If anybody had any doubts about the value of research, basic research, translational research, clinical research to take these products through more efficient testing, where they really work in people, and then applied research, including in manufacturing and even in related issues like real-world evidence and ways to improve the distribution of medical products, If anybody had doubts about the value of those investments, it's really clear here.” 

Dr. Bertuzzi then spoke about the current therapies being tested, such as Emory Institute for Drug Development compound 2801 (EIDD-2801), which he explained is a promising orally administered drug candidate. He shared that ASM.org has generated a valuable registry on its website to ensure rapid acceleration and synergy of ideas. Dr. Bertuzzi also emphasized the value of serology testing and stressed the importance that these tests be FDA approved and/or generated in a CLIA laboratory. 

As the panel closed, both speakers expressed that we are far from returning to our normal lives. Gerberding stated that, at this time, “[she does not] see that a positive antibody test right now tells anyone that they're safe.” She further explained that scaling up viral and serology testing is crucial but also a great challenge. Both panelists were hopeful that breakthroughs in therapeutics and widespread testing will allow us to safely begin to reopen the United States. Bertuzzi ended the meeting on a positive note by saying there are, “several new things that are being tested out, like stem cells for example … I think there is a very composite landscape that gives us a lot of hope.”

 

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Leaders from the American Association of Colleges of Nursing, Pfizer, Wayne State University Elected to Research!America’s Board of Directors

In March, Research!America alliance members elected three new individuals to serve on Board of Directors: Mikael Dolsten, MD, PhD, Chief Scientific Officer & President, Worldwide Research, Development and Medical of Pfizer; Deborah Trautman, PhD, RN, FAAN, President & CEO of the American Association of Colleges of Nursing; and M. Roy Wilson, MD, MS, President of Wayne State University.

“Drs. Dolsten, Trautman, and Wilson have dedicated their careers to improving the lives of patients and supporting efforts to accelerate medical progress,” said Mary Woolley, president & CEO of Research!America. “They bring a wealth of experience – representing academia, private industry, and professional societies –  to our board. The Research!America alliance and the research advocacy community will benefit greatly from their commitment to research for medicine and science.” 

The board thanks outgoing board members for their terrific service: Susan Fitzpatrick, PhD, President of the James S, McDonnell Foundation; Larry Hausner, MBA, President of ConStrat; and Gregory Sorenson, MD, Executive Chairman of IMRIS. 

Mikael Dolsten, MD, PhD is Chief Scientific Officer and President, Worldwide Research, Development and Medical of Pfizer Inc. He focuses on advancing Pfizer’s scientific leadership in small-molecule medicines, biotherapeutics and vaccines. He is a member of the Executive Leadership Team and the company’s Portfolio Strategy and Investment Committee, which governs major pipeline investments and strategic end-to-end R&D priorities. Mikael leads the Worldwide Research, Development and Medical (WRDM) organization at Pfizer, which is responsible for the development of all compounds through proof of concept, and provides pharmaceutical sciences, safety and medical support to the entire R&D pipeline and all marketed products. The WRDM group contains all Pfizer research units, including Oncology, Internal Medicine, Inflammation & Immunology, Vaccines and Rare Disease, as well as the Centers for Therapeutic Innovation (CTI). Mikael also has worldwide responsibility for Pfizer’s groups in medical, safety and external R&D innovation, in addition to science-based teams in pharmaceutical sciences, drug safety R&D, and large and small molecule discovery and development. He is a governor of the New York Academy of Sciences and a fellow of the New York Academy of Medicine, and serves on the Science and Regulatory Executive Committee of The Pharmaceutical Research and Manufacturers of America (PhRMA) as well as the PhRMA Foundation Board of Directors. He is a member of the Board of Karyopharm Pharmaceuticals. Additionally, Mikael is a member of the Board of Overseers – Scripps Research Institute as well as a Foreign Member of The Royal Swedish Academy of Engineering Sciences. Since 2014, Mikael has co-chaired the Accelerating Medicine Partnership (AMP) with National Institutes of Health (NIH) Director Francis S. Collins. Mikael advised the Obama Administration on regulatory and drug development issues as well as Vice President Biden’s Cancer Moonshot Initiative to accelerate cancer research. Through 2019, Dr. Dolsten was a council member of the Government-University-Industry Research Roundtable (GUIRR). Mikael is a named inventor on several patents and has published approximately 150 articles in international journals, with contributions in molecular cell biology, immunology and oncology.

Deborah Trautman, PhD, RN, FAAN, assumed the role of President and Chief Executive Officer of the American Association of Colleges of Nursing (AACN) in June 2014. Formerly the Executive Director of the Center for Health Policy and Healthcare Transformation at Johns Hopkins Hospital, Dr. Trautman has held clinical and administrative leadership positions at the University of Pittsburgh Medical Center and the Johns Hopkins Medical Institutions. She also served as the Vice President of Patient Care Services for Howard County General Hospital and as Director of Nursing for Emergency Medicine at the Johns Hopkins Hospital. She has held a joint appointment at the Johns Hopkins University School of Nursing. Dr. Trautman received a BSN from West Virginia Wesleyan College, an MSN from the University of Pittsburgh, and a PhD in health policy from the University of Maryland, Baltimore County. She has authored publications on health policy, intimate partner violence, pain management, clinical competency, change management, cardiopulmonary bypass, the use of music in the emergency department, and consolidating emergency services. Since her appointment at AACN, Deb has been asked to join a number of high-profile boards and advisory groups. The Secretary of U.S. Department of Veterans Affairs' Special Medical Advisory Group (SMAG), which advises the VA Secretary on matters related to healthcare delivery, research, education, training of healthcare staff and planning on shared care issues facing VA and the Department of Defense. In addition, the Robert Wood Johnson Foundation (RWJF) named her program director of the New Careers in Nursing project, and her colleagues with the Interprofessional Education Collaborative (IPEC) elected her to serve as Chair as of 2019. She also serves on the Joint Commission’s Chief Nurse Executive Council. Dr. Trautman has served as an advisory board member and past chair for Academy Health's Interdisciplinary Research Interest Group on Nursing Issues. Dr. Trautman is a 2007/2008 Robert Wood Johnson Health Policy Fellow who worked for the Honorable Nancy Pelosi, then Speaker of the U.S. House of Representatives.

M. Roy Wilson, MD, MS is a scholar, surgeon, and leader driving innovation in higher education, medicine, and research. Since his appointment as the 12th president of Wayne State University on August 1, 2013. Since assuming leadership, President Wilson has pursued his vision to transform the university into the preeminent, public, urban research university known for academic and research excellence. During his tenure, President Wilson has focused on dramatically improving student success, resulting in the nation’s most improved graduation rate; realigning the university’s research portfolio to emphasize team science; launching programs to improve the pipeline of underrepresented students in the health sciences; overseeing major initiatives to improve the campus experience, including the launch of a new business school, a comprehensive campus housing plan, and an office of multicultural student engagement; and implementing a project to overhaul and improve the university’s performing arts facilities. Prior to joining Wayne State, President Wilson served as deputy director for strategic scientific planning and program coordination at the National Institute on Minority Health and Health Disparities of the National Institutes of Health. Previously, he was dean of the School of Medicine and vice president for health sciences at Creighton University, president of the Texas Tech University Health Sciences Center, and concurrently, chancellor of the University of Colorado Denver/Anschutz Medical Campus and chair of the Board of Directors of University of Colorado Hospital. President Wilson also chaired the Board of Directors of the Charles R. Drew University of Medicine and Science and was acting president during part of that time.

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Survey Results Provide Valuable Tool for Science Advocacy

On March 11, 2020, Research!America released the 20th edition of America Speaks: Poll Data Summary, our annual publication that provides highlights of a year’s worth of public opinion survey results. This year’s report provides a useful tool for research advocates, particularly at this critical time when science is in the spotlight.

“We continue to keep our finger on the pulse of public opinion, identifying widespread support across the political spectrum for prioritizing faster medical progress,” says Research!America president and CEO Mary Woolley in the introduction. “Americans know research is a problem-solver. Equipped with this information, our role as advocates is to work with our members and partners to ensure that in this challenging election year, science is championed like never before.”

The report highlights data indicating the importance of investing in research: 6 in 10 say current spending on medical and health research is not enough. Additionally, 76% support doubling federal spending on medical research over the next five years -- and this question was fielded in January, before the effects of the COVID-19 pandemic were widely felt. A total of 86% agree that basic research is necessary and should be supported by the federal government. 

Recognition of science was up over previous years: while only 25% could name a living scientist, that number represents an increase of five percentage points over 2019. The number of Americans who could name a place where medical and health research is conducted increased by 18 percentage points, from 35% to 53%. And, of great significance in today’s context, 85% of Americans agree that it is important for scientists to inform elected officials about their research and its impact on society. 

The report also contains results from recent surveys on public opinion around genetics research and organ donation for research. Americans agree (77%) that genetics research is important to improving their family’s health and in the importance (74%) of federal funding for genetics research. A strong majority (92%) also agree that donated organs and tissues help scientists make medical breakthroughs.

The survey report is available on the Research!America website. Stay tuned for additional blog posts providing a deeper dive into the survey results and underlying trends.

 
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ALLIANCE MEMBER CALLS PROVIDE ENGAGEMENT WITH EXPERTS

The emergence of COVID-19 as a global pandemic is a clear reminder of the importance of investing in research and strengthening our public health capacity to better understand how to prevent and treat disease. Though the month of March marked a significant shift in the way Research!America operated day-to-day, we wanted to ensure advocacy with and engagement between our alliance member organizations didn’t skip a beat.

Research!America increased the frequency of our alliance member calls from monthly to weekly to share the most timely and relevant information on COVID-19 and other issues impacting the medical and public health research ecosystem. Although information opportunities were growing daily the calls attracted consistently high attendance. Below are the highlights with links to recordings. 

March 16, 2020 - As COVID-19 news was changing the national landscape daily, Research!America hosted a call with Dr. Larry Tabak, NIH’s Principal Deputy Director, and Dr. Michael Lauer, Deputy Director for Extramural Research to offer guidance for NIH grantees. They emphasized NIH would offer as much flexibility as possible during these challenging times.  A recording of the call is here (registration required).

“We want to do what is best to enable the research to go forward and, in a flexible way, deal with the many disruptions that you are going to face.”
-Dr. Michael Lauer, Deputy Director for Extramural Research at NIH

March 19, 2020 - Dr. Jacqueline Corrigan-Curay, Director of the Office of Medical Policy at the FDA’s Center for Drug Evaluation and Research (CDER) spoke about the FDA’s ongoing work on real-world evidence and real-world data, explaining how this powerful tool may be harnessed by researchers to improve clinical trials and drug development. Dana Acton, Legislative Director for House Appropriations Chairwoman Nita Lowey (D-NY-17) discussed the status of FY21 appropriations and the impact of COVID-19 on the process. She encouraged all listeners to continue to advocate for their appropriations “asks” even, and especially, in light of COVID-19. You can see Dr. Corrigan-Curay’s presentation here.

“We understand that these are extraordinary times as [scientists] try to navigate what to do with their clinical trials.”
-Dr. Jacqueline Corrigan-Curay, Director of the Office of Medical Policy at CDER

March 24, 2020 - Dr. David Skorton, President of the Association of American Medical Colleges (AAMC) discussed strategies for medical colleges during the COVID-19 pandemic. Dr. Skorton and his colleagues emphasized the irreplaceable value of fundamental research. You can find a link to this conversation, including alliance member Q&A, here (registration required.)

“We cannot respond and we will not be able to respond better next time if we don’t have more answers. We’re only going to get those answers through funded research.”
-Dr. David Skorton, President of AAMC
 

March 30, 2020 - Deputy Surgeon General Rear Admiral (RADM) Dr. Erica Schwartz, Deputy Surgeon General of HHS spoke about frontline COVID-19 testing and protecting our first responders. RADM Schwartz also urged scientists to provide information to their local leaders and the federal government to ensure evidence-based policymaking and decisions. Emily Holubowich, Vice President of Federal Advocacy, American Heart Association, joined the second half of the call and provided an FY21 appropriations update, focusing specifically on the first three COVID-19 stimulus packages released on March 6, 18 (Families First), and 27 (CARES Act).
 

April 7, 2020 - Research!America board member and APHA Executive Director, Dr. Georges Benjamin discussed the COVID-19 landscape and APHA’s efforts. Dr. Benjamin addressed the “infodemic” and “epidemic of fear” associated with poor communication and misinformation. Dr. Benjamin encouraged everyone to fight misinformation by promoting facts, providing frequent communication, and building trust. Looking forward, Dr. Benjamin discussed societal changes he expects in the future; he called for everyone to consider public health as our second job from now on. Access Dr. Benjamin’s talk here. 

“I’m hoping every person in this country, if they are not primarily in a public health job, that public health will be their second job. I’m hoping that we will be willing to invest in a robust, sustainable public health system.”
-Dr. Georges Benjamin, Executive Director APHA

April 9, 2020 - Adrienne Hallett, Director, NIH Office for Legislative Policy and Analysis shared updates on NIH COVID-19 response efforts. She emphasized that NIH fully recognizes and is committed to doing all it can to mitigate the negative impact of COVID-19 on patients and on current and future scientific discovery. Here is a link to an FAQ resource she recommended during the call. 

April 13, 2020 - Dr. Robert Redfield, Director of the CDC opened with an overview of the COVID-19 pandemic and the CDC’s response to date. He stressed COVID-19 is the greatest public health challenge the United States has faced in more than a century.  Dr. Redfield highlighted CDC’s critical distribution of funding to its partners in state, local, and tribal public health departments who are fighting COVID-19 on the ground. He also emphasized the United States should use this time to expand existing public health infrastructure in order to be better prepared for future public health challenges.

“We do face the gravity of this pandemic and its capacity to disrupt our lives. I do believe that our resolve and dedication all working together, united as a nation, we will get the best data and apply science and we're going to get through this. I look forward to the innovation that we're going to see for many of your members to improve the tools we have for diagnosis, treatment, and prevention.”
-Dr. Robert Redfield, Director, CDC

April 15, 2020 - Scott Whitaker, President and CEO, AdvaMed opened the discussion by sharing the work AdvaMed companies and others have done to produce diagnostics, ventilators, and personal protective equipment (PPE) at an accelerated rate during the COVID-19 outbreak. He stressed cooperation between the private sector and the federal government has been crucial to the response. Next, Dr. Richard Bright, Deputy Assistant Secretary for Preparedness and Response and Director of BARDA, shared an overview of BARDA’s response to the COVID-19 pandemic, emphasizing the importance of public-private partnerships. He encouraged Research!America members to submit ideas for medical countermeasures (MCMs) to medicalcountermeasures.gov, and explained BARDA’s methods for prioritizing the development of certain MCMs.

"It’s interesting now because as we’re fighting as a nation, and around the world, the pandemic of COVID-19, our companies have been on the frontline of dealing with this. We have the diagnostic tools that are being used to diagnose the disease, many of the medical equipment and supplies in the hospitals that treat the patients that suffer from the disease, and most our companies produce PPE that is protecting the heroes on the front line." 
- Scott Whitaker

April 20, 2020 - Dr. Harvey Fineberg, President of the Gordon and Betty Moore Foundation and chair of the National Academies Standing Committee on Emerging Infectious Diseases, joined an alliance member call to discuss the steps needed to contain and someday end the COVID-19 pandemic.

"Looking ahead, the COVID-19 experience is going to leave us with a way of interacting and living that is never going to be exactly like it was in the past."
- Dr. Harvey Fineberg

April 28, 2020 - Donna Cryer, President and CEO of the Global Liver Institute and Leslie Ritter, Associate Vice President, Federal Government Relations at National MS Society, joined an alliance member call. Donna shared updates on GLI's comprehensive COVID-19 response program, including a popular Facebook Live series for the patient, caregiver, and research community. Leslie discussed the disruptive impact of COVID-19 on research supported by voluntary health associations, philanthropies, and scientific societies. 

"How [did] we get to a global covid 19 response program that is reaching 30,000 people a week? Going back six weeks, I had think through, how to respond, first as a patient, when I could see that plans for care for high-risk patients like me were not there yet. I had to think through, as a caregiver, what their needs were going to be. I needed to think about our office, making sure everyone was equipped to do their job remotely. Thinking about sustainable delivery of service from a human-centered place came first."
-Donna Cryer

April 30, 2020 - Dr. Francis Collins, Director, National Institutes of Health and Dr. Keith Yamamoto, Professor Emeritus; Vice Chancellor for Science Policy and Strategy; Director, UCSF Precision Medicine, University of California, San Francisco and Research!America board member joined a call with alliance members. Dr. Collins provided an overview of NIH’s unprecedented Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), a partnership between industry and governmental leaders working to speed COVID-19 vaccines and treatments. Dr. Collins also discussed the Rapid Acceleration of Diagnostics (RADx) Initiative, unveiled just yesterday. RADx will infuse funding into early innovative technologies to speed the development of rapid and widely accessible COVID-19 testing. Dr. Yamamoto discussed COVID-19 related disruptions to the work of postdocs, early-stage investigators, and graduate students, and the broader challenge to medical progress itself. 

"I often like to point out while our initials are NIH….in circumstances like this we’re the National Institutes of Hope. While fear, anxiety, and stress are all around us, hope can be contagious.”
- Dr. Francis Collins 

“We have to keep in mind that the whole spectrum that is so essential to being able to understand the mechanism of diseases, the way to prevent, treat, cure it, has stopped. I’m hopeful as well that we can convey that message clearly enough to get the resources so we can reverse the damage.”
- Dr. Keith Yamamoto

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Regular Features

President's Letter

My grandfather was a general practitioner and surgeon in a small town in North Dakota, long before anything like ‘telemedicine’ existed. It was a sad fact that lives were lost for lack of ability to put physician and patient together in time. But, more positive outcomes were possible thanks to quarantines. My grandfather instructed my brothers, my cousins, and me about the importance of keeping those who were ill with highly contagious diseases like TB and measles strictly apart from others. Stories about houses with red “Quarantine” signs nailed to their front doors by the health department -- or by my grandfather himself since he oversaw that small department -- came back to me over the last few weeks. Achieving what we have against the coronavirus pandemic is due to effective public health measures, as well as 21st-century basic science and innovation, working more rapidly and in stronger partnership than ever before. All of this gives me great hope, reminding me of the words of previous Research!America Board Chair the Hon. Paul G. Rogers: “Without research, there is no hope.” We are working remotely, doing our part to assure the control and ultimate defeat and prevention of COVID-19. We know that you, our members and partners, are pledged to the same outcome, and we thank you for your hard work, your partnership in advocacy, and for your support.

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Member Spotlight: Global Health Technologies Coalition (GHTC)

The Global Health Technologies Coalition’s (GHTC) mission is to advance policies to accelerate the creation of new vaccines, drugs, diagnostics, and other tools to bring healthy lives within reach for all people. Our focus is on health challenges that disproportionately impact the world’s poorest, including both those long-standing — like tuberculosis (TB), malaria, and neglected tropical diseases — and those newly emerging. As the phrase “neglected diseases and conditions” indicates, these areas have historically been overlooked by industry because they offer little profit incentive. That means public sector funding from the U.S. government is even more essential to advance research.

As a result, GHTC’s U.S. advocacy spans across many agencies. This includes those well-known for health research, like the National Institutes of Health, Biomedical Advanced Research and Development Authority, and Centers for Disease Control and Prevention, as well as those sometimes lesser-considered in the realm of health like the Defense Department, which has a long history in malaria and neglected disease research to protect troop health, and the U.S. Agency for International Development, which advances health technologies designed specifically for resource-poor settings.

As we’ve made the case to U.S. policymakers on why global health research is a smart investment, GHTC has often emphasized the interconnectedness between global and American health. It’s a lesson now unfolding in real-time as the world faces a global pandemic unprecedented in modern times. An outbreak that started in one corner of the world has quickly become a global crisis with no country immune from its devastating toll.

Whether motivated by compassion or self-interest, as we confront the global pandemic of COVID-19, we must do so with a global perspective in mind. The fight against this disease won’t be won anywhere until it is won everywhere. That means as a scientific community, we have a responsibility to ensure that the fruits of science now rapidly advancing on COVID-19 are affordable and widely-accessible to all and that special attention is given to advancing products suitable for health systems in the world’s poorest places.

To the adage, “Diseases don’t respect borders,” it’s time to add another: “Science doesn’t respect disease siloes.” We’re seeing that dynamic at play as we deploy our full scientific might against the coronavirus. Drugs originally developed for threats like malaria, Ebola, and HIV/AIDS are now being explored as potential treatments for COVID-19. And, vaccine researchers are studying if a century-old TB vaccine could boost immune response and how platforms originally developed for HIV vaccines can be adapted to this new threat. This pandemic is dismantling the distinction between global and domestic health and breaking down disease siloes in new ways, demonstrating how scientific progress in one area benefits all. It’s a lesson we hope the research community and policymakers will take to heart.

As new Research!America members, we look forward to standing as one with this alliance to confront the pandemic at hand, longstanding health challenges causing suffering beyond the headlines, and health threats still to come. As is so often repeated during these trying times: Even apart, we are stronger together.

 
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Federal Policy Update

 

Earlier this week the Senate announced it will reconvene in Washington, D.C. on Monday, May 4, 2020. The House may not return until May 11 at the earliest. It is unclear what legislation the Senate may take up when it returns. Last week, Congress passed a fourth legislative package responding to the COVID-19 pandemic. The bill, now law, included almost $500 billion for small businesses and hospitals, as well as funding to ramp up testing. There is a chart below detailing how much emergency supplemental funding CDC, NIH, FDA, NSF, and AHRQ have received thus far to combat the pandemic.

Congressional leadership is assessing priorities for a fifth funding package. We sent a letter to leadership making the case for two funding priorities: 1) funding to ensure academic research can resume after the massive disruptions COVID-19 has engendered, and 2) equipping the Agency for Healthcare Research and Quality (AHRQ) to assure our health care system emerges from the COVID-19 pandemic stronger, more resilient, and better equipped for the next major health threat.

The FY2021 appropriations process is also ongoing, but remains fluid. We have heard that some appropriators want to move FY21 bills through the standard mark-up and floor debate process, while there have been rumblings in other corners about combining FY21 funding with the aforementioned next COVID-related supplemental rather than go the well-worn (and progress-stifling) continuing resolution route later this year. We sent a letter to appropriations leadership urging timely completion of the FY21 appropriations process and expressing support for modifying the FY21 budget caps to provide the flexibility needed to address COVID-19 and robustly fund ongoing scientific discovery focused on other health and societal threats.

 

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Upcoming Events: May 2020

Mary Woolley will join the American Society for Human Genetics for the first installment in their "Becoming an ASHG Advocate" series, "The Need for Science Advocacy and How to Get Started" on Wednesday, May 6 at 12 PM Eastern Time. The webinar will highlight the importance of advocating for science research, and how members can get involved in advocacy. Other participants will include Allison McCague, PhD (Rutgers University) and Lynn Jorde, PhD (University of Utah). Attendance is free with registration. 

Upcoming Research!America alliance member calls can be found on our website. If your organization is not a Research!America member and you’re interested in more information about the alliance, email Katie Goode at kgoode@researchamerica.org.

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In the News

17 Initiatives Strengthening the COVID Response

The nationwide and global response to the COVID-19 pandemic is relying on numerous research initiatives around the country to find treatments, vaccines, and more. Below we highlight just some of the many exciting initiatives involving our alliance members. Working on other efforts? Let us know! 

Academia

  1. Johns Hopkins University: Arturo Casadevall and collaborators at Johns Hopkins and beyond have worked around the clock to develop a convalescent serum therapy to treat COVID-19 using blood plasma from recovered patients. If early promising studies on the therapy done in China are confirmed by U.S. trials, thousands of survivors might soon line up to donate their antibody-rich plasma.

  2. University of Pennsylvania Perelman School of Medicine: Penn Medicine is a participant in the Phase I safety and immunogenicity clinical trial of INO-4800, a DNA vaccine designed to prevent COVID-19 infection. Approved by the U.S. Food and Drug Administration (FDA) on April 6, Phase I clinical testing of the vaccine started immediately, with first dosing planned to begin in up to 40 healthy volunteers the same day.

  3. Northwestern University McCormick School of Engineering: NSF awarded a $200,000 Rapid Response Research grant to scientists at Northwestern University who are working on a self-sanitizing face mask that would deactivate viruses on contact. Led by Jiaxing Huang, materials professor at Northwestern's McCormick School of Engineering, the scientists are developing an "accessory" embedded with virus-killing agents. It would attach to an existing mask and render virus particles inert before they make contact with the air. The device could be a sheet or sticker that could be wrapped or glued to the outside of a mask. 

  4. University of California at San Francisco: Researchers have initiated a study to test the effectiveness of 120 available antibody test kits (or serology tests) to examine potential immunity to SARS-CoV2. Blood tests for antibodies can compliment the standard swab test and determine whether a patient is in the early or late stages of the infection.

  5. University of Texas at Austin: A team at UT is investigating drug delivery methods that can repurpose existing drugs into more effective forms. The team first focused on the antiviral niclosamide, which is more potent than chloroquine, lopinavir and remdesivir. The research team has developed novel drug delivery technologies to overcome its current delivery limitations. The team has increased the drug’s solubility and is currently performing oral studies.

  6. Baylor College of Medicine: One of 50 sites participating in a clinical trial for treatment of patients with severe COVID-19 pneumonia with the drug Tocilizumab (TCZ). It will be tested alongside placebo in a randomized, double blind, controlled study. This drug is being tested because it could potentially target the body’s severe “cytokine storm” response to the virus. 

  7. Stanford University, UCSF, CZI BioHub: A collaboration is planning to study the spread of COVID-19 in the Bay Area. Researchers will recruit 4,500 Bay Area residents who previously came up negative for the virus, testing them one time each month with both a serological test that detects antibodies and a polymerase chain reaction (PCR) test, which detects the presence of infection. Using viral genome data, the research teams hope to glean insight on the chain of transmission within the area as well as any evidence about how that the virus traveled into the community from outside the region.

Industry, Academia and Government Partnerships

  1. AbCellera, Lilly, and DARPA: AbCellera and Eli Lilly and Company announced they have entered into an agreement to co-develop antibody products for the treatment and prevention of COVID-19, the disease caused by the SARS-CoV-2 novel coronavirus. The collaboration will leverage AbCellera's rapid pandemic response platform, developed under the DARPA Pandemic Prevention Platform (P3) Program, and Lilly's global capabilities for rapid development, manufacturing and distribution of therapeutic antibodies.

  2. AdvaMed, STERIS, 3M, HHS: The Advanced Medical Technology Association released the following statement from President and CEO Scott Whitaker on STERIS’s Emergency Use Authorization (EUA) from FDA for certain V-PRO® Low Temperature Sterilization Systems to allow health care providers to decontaminate N95 respirators on site: “ . . . The ability to quickly decontaminate protective masks . . . truly is a game changer for our heroes on the front lines treating patients with COVID-19. STERIS’s fast, innovative work, in partnership with 3M, is yet another example of the medical technology community mobilizing to save lives. We appreciate the FDA’s quick work to authorize this leap forward in our fight against the coronavirus.”

  3. Alnylam & Vir Pharmaceuticals: Alnylam and Vir are attempting to decrease the amount of available ACE2. On March 4, Vir and Alnylam expanded an existing collaboration to include development and commercialization of RNA interference (RNAi) therapeutics against SARS-CoV-2, which has since been expanded again. They will leverage Alnylam’s advances in lung delivery of novel conjugates of siRNA, the molecules that mediate RNAi, with Vir’s infectious disease expertise and capabilities. They are focused on developing siRNAs Alnylam recently identified that target highly conserved regions of coronavirus RNAs. Essentially, Vir and Alnylam’s overall approach is to silence a protein that causes a disease that is the result of an overproduction of the protein. In the case of COVID-19, the focus is on silencing the ACE2 receptor, with the rationale that without it, the virus won’t be able to infect cells.

  4. BD and BioMedomics: These partners have released a new point-of-care serology test that can detect antibodies in blood to confirm current or past exposure to COVID-19 in as little as 15 minutes. The test analyzes blood, serum or plasma samples for the presence of immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies associated with the coronavirus. The detection of COVID-19 IgM antibodies tends to indicate a recent exposure to COVID-19, and detection of COVID-19 IgG antibodies indicates a later stage of infection. 

  5. Johnson & Johnson and BARDA: Johnson & Johnson has teamed up with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to develop a vaccine against coronavirus. J&J is pooling money and resources with BARDA in an attempt to accelerate the progress of a vaccine candidate into phase 1 development. Having selected a lead candidate from the constructs it began working on in January, J&J has teamed up with BARDA to provide the resources needed to move the vaccine forward quickly. The partners have committed more than $1 billion to novel coronavirus vaccine R&D. J&J plans to start testing its COVID-19 vaccine in humans by September at the latest, post data by the end of 2020, and go on to land an emergency use authorization early next year. In trying to hit that timeline, very short by historical standards, J&J will commit personnel and infrastructure around the world to the vaccine program. Other teams at J&J will work in parallel to ensure there is the capacity to make the vaccine widely available if it clears the tests of its safety and efficacy.

  6. NIAID, Gilead Sciences, Northwestern University, University of Chicago Medicine, Cedars-Sinai Medical Center (many other sites enrolling/enrolled): A large-scale research effort sponsored by the U.S. National Institute of Allergy and Infectious Diseases (NIAID) is putting remdesivir to the "gold standard" test in medicine: a controlled clinical trial. Patients hospitalized with COVID-19 are being randomly assigned to receive either infusions of remdesivir or a placebo, in addition to standard care, including breathing support. 75 sites worldwide to [are planned to] participate. 

  7. Pfizer, BioNTech: In this collaboration, BioNTech’s COVID-19 mRNA vaccine program, BNT162, will be accelerated by the development, regulatory, and commercial capabilities that Pfizer offers. Both companies will implement multiple research and development sites, including in the United States and Germany, to house the activities identified by the collaboration agreement.

  8. Regeneron and U.S. Department of Health and Human Services: Regeneron used its proprietary VelociSuite technologies to produce fully human antibodies against the novel coronavirus from genetically edited mice. This time it took Regeneron a little over a month from when it expanded a collaboration with the U.S. Department of Health and Human Services (HHS) to focus on the novel coronavirus to isolate all those neutralizing antibodies for further screening. Regeneron is preparing for clinical-scale production with the goal of making hundreds of thousands of low prophylactic doses per month by the end of summer. Regeneron is also working with the HHS’ Biomedical Advanced Research and Defense Authority to ramp up manufacturing capacity even further.

  9. Sanofi & GlaxoSmithKline: Sanofi and GSK announced that they have signed a letter of intent to develop an adjuvanted vaccine for COVID-19, using innovative technology from both companies, to help address the ongoing pandemic. Sanofi will contribute its S-protein COVID-19 antigen, which is based on recombinant DNA technology. This technology has produced an exact genetic match to proteins found on the surface of the virus, and the DNA sequence encoding this antigen has been combined into the DNA of the baculovirus expression platform, the basis of Sanofi’s licensed recombinant influenza product in the U.S. GSK will contribute its proven pandemic adjuvant technology. The use of an adjuvant can be of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and therefore contributing to protecting more people.

  10. Vanderbilt University Medical Center, AstraZeneca: Vanderbilt University Medical Center is teaming up with academic, governmental, and corporate partners in an unprecedented, fast-tracked global effort to develop antibody-based treatments to protect people exposed to the 2019 novel coronavirus disease, COVID-19. Researchers from the Vanderbilt Vaccine Center (VVC) have rapidly responded to this outbreak by building a comprehensive “toolkit” to identify and analyze antibodies isolated from the blood of survivors for their ability to neutralize SARS-CoV-2. “Our goal is to prepare antibodies for human clinical trials by this summer,” said James Crowe, MD, director of the Vanderbilt Vaccine Center.

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Media Matters May 2020

Research!America board members, Advocacy Award honorees, and staff in the news

Georges C. Benjamin, MD, executive director of the American Public Health Association, was quoted in a Huffington Post article on “What to do if you live with someone who may have coronavirus.” Dr. Benjamin has been interviewed by a host of media outlets including the Washington Post, The Hill, Newsweek, The New York Times, and ESPN.

Ellie Dehoney, Research!America’s vice president, policy and advocacy, was quoted in Bloomberg Law on the topic of the COVID-19 stimulus package. “Our nation must fully empower federally funded research, coupled with private sector innovation, to defeat this virus,” she said. “Going forward, it will be critical to invest in sustaining and fostering the recovery of our nation’s research institutions so that U.S. scientific capability is strengthened, not dissipated, by COVID-19’s disruptive impact.”

Mikael Dolsten, MD, PhD Chief Scientific Officer and President of Worldwide Research, Development and Medical at Pfizer, was quoted in STAT News discussing a new potential drug to treat coronavirus. “Given that this is the most threatening pandemic in a century, affecting human health in an unprecedented manner and disrupting society and business, we have mobilized our capabilities across multiple fronts,” he said. The endgame, Dolsten said, would be “a vaccine that can protect our population and expel the virus from the soil of America and back to the empire of bats.”

Peter Hotez, MD, PhD, a dean at Baylor College of Medicine and co-director of the Center for Vaccine Development at Texas Children's Hospital in Houston, spoke with Lawrence O'Donnell on MSNBC about clinical trials for coronavirus vaccines. Dr. Hotez has been a frequent guest on CNN and other networks. Dr. Hotez received the 2018 Research!America Advocacy Award for Sustained National Leadership.

Anupam Jena, MD, PhD, associate professor of Health Care Policy at Harvard Medical School and physician in the Department of Medicine at Massachusetts General Hospital was recently featured on NPR for his TED Talk entitled: What Are Some Less Obvious Ways COVID-19 Could Change Our Lives? Dr. Jena was Research!America’s Eugene Garfield Economic Impact on Medical and Health Research Awardee in 2007.

Mark McClellan, MD, MBA, MPH, director of the Robert J Margolis Center for Health Policy and the Margolis Professor of Business, Medicine and Health Policy at Duke University, spoke in an interview with Fox News “The Story” with Martha MacCallum, “Former FDA commissioner expects antibody testing will reveal most people still don't have coronavirus immunity.” “Even though we've seen a lot of cases, most people, perhaps the vast majority of people still don’t have immunity. That’s something we’re going to have to plan ahead for." Dr. McClellan has appeared on multiple news outlets during the pandemic including PBS Newshour, CNN, and CBS Detroit.

Siddhartha Mukherjee, MD, DPhil, Pulitzer Prize-winning author, and Research!America 2019 Isadore Rosenfeld Award for Impact on Public Opinion awardee teamed with Ken Burns to bring his book “The Gene: An Intimate History” to a documentary format for PBS. The team previously joined forces on an adaptation of “The Emperor of All Maladies.”

Sudip Parikh, PhD penned a compelling opinion piece in STAT entitled CDC: remember who you are. The article reminds readers: “The CDC not only set the standard for what a national public health agency does, but it trained others to carry out that mission around the world.”

David R. Williams, PhD, MPH, who received the Research!America 2019 Herbert Pardes Family Award for National Leadership in Advocacy for Research, was quoted in The Hospitalist, “COVID-19 cases highlight longstanding racial disparities in health care.” “Many Americans are shocked” by the higher mortality rates among African American COVID-19 patients, said Dr. Williams. However, data from decades of research show that “black people in America live sicker and shorter lives,” he said. Dr. Williams is the Florence Sprague Norman and Laura Smart Norman Professor of Public Health, Chair of the Department of Social and Behavioral Sciences at the Harvard T.H. Chan School of Public Health, and Professor of African and African American Studies and Sociology at Harvard University.

Roy Wilson, MD, president of Wayne State University wrote an opinion piece in the Detroit Free Press entitled, Race disparities amid infectious diseases aren't new. It's time we took action. Per Dr. Wilson: “I urge that we focus now on what can be done to narrow this racial disparity in outcomes for COVID-19, starting with a more effective communication effort targeted toward African-American communities.”

Mary Woolley, president and CEO of Research!America, was published in the New York Times with a letter to the editor entitled, Let’s Commit to Invest in Science. Mary’s letter was in response to Eric Schmidt’s opinion piece: I Used to Run Google. Silicon Valley Could Lose to China.

Elias Zerhouni, MD was interviewed for a story in Science magazine, “To streamline coronavirus vaccine and drug efforts, NIH and firms join forces.” “We need the best research standards,” he said. “To me, the whole effort is to create a synergy between all of the players.”

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From Washington

Mary Woolley Joins Panel on Intersection of Science and Politics

The American Physical Society held its annual April Meeting on a virtual platform, its first-ever fully virtual meeting. Research!America president and CEO Mary Woolley joined as a panelist in a session entitled, “Intersection of Science and Politics.” The session was chaired by Dr. E. William Colglazier, Editor-in-Chief of Science & Diplomacy and Senior Scholar in the Center for Science Diplomacy at the American Association for Advancement of Science (AAAS). Dr. Juliette Mammei, Assistant Professor, Department of Physics and Astronomy, University of Manitoba moderated the session. Joining Mary on the panel were Jim Jenson, former director of congressional affairs for the National Academy of Sciences and David Goldston, director of the MIT Washington office and former Director of Government Affairs at the Natural Resources Defense Council.

“There is a well of support to draw from,” in seeking support for federal research funding, Goldston explained. The reason for that support, he continued, goes back to the beginnings of the major US presence in science. “The reason the government supports science is because it produces public benefits.” Advocates must connect what they are doing to the public concerns that members of Congress are elected to worry about. He added, “when you go and visit your member of Congress, you’re going into their world, not trying to drag them into your world.” 

“There’s an important allegiance to science in Congress,” said Jensen, “because illness and death do not have much of a constituency.” The way Congress learns about science is also due to the activities of organizations such as APS and Research!America, he said. It’s important that Congress “learn what it is you do,” he said, adding advocates have to be careful about how they deliver that message. 

Mary Woolley talked about the political context embedded in the public context of science. She cited Research!America Chair Emeritus John Edward Porter and his longtime belief that members of the scientific community need to be engaged in that political context.  She also pointed out it was Abraham Lincoln who best understood the importance of keeping a finger on the pulse of public sentiment. She highlighted a variety of Research!America’s public opinion survey findings, and provided inspiration and advice for scientists to become involved in the public context of science.

The panel then discussed specific strategies for advocating for science, including exploring shared values, relating science to concrete examples that people can understand, and connecting to the benefits of science for the public. They also encouraged attendees to take advantage of the opportunity presented by COVID-19 - the possible extra spare time and the fact that science is in the spotlight - to reach out to their members of Congress and get involved.

The panel discussion, and all the sessions from the April meeting, are available online, free of charge, with registration, at april.aps.org.

 
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Without research, there is no hope.
The Honorable Paul G. Rogers