Federal Budget Updates Related to Down Syndrome Research

Our Dr. Harpold stays closely connected to and works in the world of research, not only Down syndrome and Alzheimer’s disease, but also relevant research endeavors at a broad scale. Here’s his take on the Federal 2016 Omnibus Budget Bill.

By Dr. Michael Harpold, LuMind RDS Chief Scientific Officer

The just enacted Federal 2016 Omnibus Budget Bill, which includes a $2 billion increase for NIH, represents significantly good news for advancing biomedical research including Down syndrome research.

Over approximately the past decade, the budget for NIH has remained essentially flat, translating to a more than 25% decline in actual NIH “research-buying” power. This has made securing funding for NIH research grants by researchers extremely difficult and, closer to home, created significant challenges in gaining increased NIH funding dedicated to Down syndrome research.

This newly enacted increase in NIH funding will enable funding for more NIH grants as well as significantly increased funding to address Alzheimer’s disease… all potentially good news for Down syndrome research.

In addition to work focused on NIH funding for Down syndrome throughout this year, LuMind RDS contributed to a recent final push for this increased funding, especially Alzheimer’s disease research, through our continuing membership and work together with Leaders Engaged in Alzheimer’s Disease leveraging together 80 member organizations, as a signatory on advocacy letters, which also specifically included Down syndrome reference, to the respective US House and Senate Appropriations committees’ leadership.

Among other important relevant appropriations in this new Federal budget:

• National Institutes on Aging (NIA) Alzheimer’s disease and related dementias research funding will increase to $936 million, a $350 million, or almost 60%, increase above Fiscal Year 2015
• NIA’s overall funding will increase by $400 million, more than 85% of that for dementia
• The Center for Disease Control (CDC) will have 3.5 million for its Alzheimer’s Disease (brain health) program, and
• Food and Drug Administration (FDA) funding will increase 5%, roughly $90-100 million more than House and Senate appropriators passed earlier this year.

Thank you for the momentum you’ve helped to create to bring the importance of increasing funding for all types of research to the attention of the government.

Please consider continuing to show your support for Down syndrome research with a donation during our Annual Appeal.

Clinton Campaign Announces Investment Plan for Alzheimer’s Disease

LuMind Research Down Syndrome Foundation applauds the development and announcement by the Clinton presidential campaign of a formal plan for new investment to prevent, treat, and make an Alzheimer’s disease cure possible by 2025, which includes a commitment to reach the $2 billion annual funding level for NIH’s dementia research. You can read more details on Clinton’s announced plan in the following article.

We join with many of our other colleagues and partners in the Down syndrome and Alzheimer’s disease communities in encouraging all of the presidential campaigns to develop and support formal proposals for advancing Alzheimer’s disease and dementia research.

This research is especially important for individuals with Down syndrome since virtually all develop the brain characteristics of Alzheimer’s disease earlier, by their 40’s, and the majority subsequently progress to earlier onset of the associated dementia. In November, NIH announced significant new grant awards to find Alzheimer’s biomarkers in Down syndrome.

LuMind RDS is the leading source of private funding for Down syndrome cognition research, including funding initiatives to identify and develop effective new therapies to prevent and halt the progression of the earlier onset Alzheimer’s disease in people with Down syndrome and help avoid the loss of gains they achieve throughout their lives. If you would like to support this research, please consider a donation during our Annual Appeal.

NIH supports new studies to find Alzheimer’s biomarkers in Down syndrome

The National Institutes of Health announced a groundbreaking initiative to track dementia onset and the progress of Alzheimer’s disease in people with Down syndrome.

The studies will be funded by the National Institute on Aging (NIA) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), both part of NIH.

“We are very excited and grateful that the NIH Biomarkers of Alzheimer’s Disease in Adults with Down Syndrome Initiative has now been established with funding by the National Institute on Aging and the Eunice Kennedy Shriver National Institute of Child Health and Human Development,” said Dr. Michael Harpold LuMind RDS Chief Scientific Officer.

This initiative represents one of the major recommendations deriving from the 2013 NIH Workshop “Advancing Treatments for Alzheimer’s Disease in Individuals with Down Syndrome” with the participation, co-sponsorship and co-support by the LuMind RDS Foundation. This recommendation was also subsequently incorporated into the Federal National Plan to Address Alzheimer’s Disease.

“This is an extremely important and much needed research initiative to more deeply understand the earlier onset and course of Alzheimer’s disease in individuals with Down syndrome, and the results from this new five year research initiative will also be important in further accelerating clinical trials to develop effective new therapies,” said Dr. Harpold.

View the full press release from NIH here.

21st Century Cures Act Passes in US House – What It Means for Down Syndrome Research

By Dr. Michael Harpold, LuMind RDS Chief Scientific Officer

The 21st Century Cures Act, originating and developed out of the US House Energy and Commerce Committee, has been working its way through to a vote in the US House of Representatives. LuMind RDS signed the letter of support organized by National Health Council, in conjunction with our membership with the LEAD Coalition (Leaders Engaged on Alzheimer’s Disease), which had more than 250 organizations as signatories.

Prior to the vote on the overall Bill in the House of Representatives, there was a problematic “Brat et al. amendment” that had been introduced which would have jeopardized the increased funding for the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) provided in the Bill as well as the wide bipartisan support. Through the National Health Council/United for Medical Research, LuMind RDS, along with more than 270 other organizations, signed on in opposition to the “Brat amendment” (http://www.no2brat.com/).

I am quite pleased to update that Friday July 10, 2015, the 21st Century Cures Act passed the US House by 344-77, and the “Brat et al amendment” was defeated by vote of 141-281. Among other aspects that are important for Down syndrome, the Bill increases NIH’s budget by additional $8.75 billion over five years. 

This is good news because the flat (in actuality, significantly declining in real dollars) NIH budget over the past five years or so has had a major impact in reducing the number and size of NIH research grants. The increased funding should increase overall NIH grant applications’ funding success and increased numbers of NIH grants, including hopefully more grants for Down syndrome research.

But before that increase is realized, the Bill needs to now make its way through and pass the Senate… which will be an additional effort for continuing support from the Down syndrome community.

Dr. Harpold at the NIH Alzheimer’s Disease Research Summit 2015

We appreciate Dr. Michael Harpold for being such a road warrior on behalf of the Down syndrome community.

On February 9-10, 2015, Dr. Harpold, LuMind Foundation’s Chief Scientific Officer, attended the biennial NIH Alzheimer’s Disease Research Summit 2015, a major forum for the dynamic development of coordinated Alzheimer’s disease research efforts under the Congressionally-mandated National Alzheimer’s Plan.

As stated on the NIH website, the central goal of the AD Research Summit 2015 is to continue the development of an integrated multidisciplinary research agenda necessary to address critical knowledge gaps and accelerate the discovery and delivery of efficacious treatments for AD patients at all stages of disease.

Attending this conference provides an additional major forum to increase support and advocacy for greater inclusion of research on Alzheimer’s disease in individuals with Down syndrome and its contributions to a deeper understanding of Alzheimer’s disease and the development of effective new therapeutics, not only for individuals with Down syndrome, but everyone.

For more information about the summit including access to webcasts of the two-day event, please visit the NIH website.

Dr. Harpold Quoted in Education Week Articles on Down Syndrome Research

LuMind Foundation’s Chief Scientific Officer, Dr. Michael Harpold, was quoted in an article by Education Week on the NIH Down Syndrome Research report.

In the article, titled “NIH Resets Study Plans for Down Syndrome,” author Sarah Sparks summarizes the seven-year research plan, including discussing a greater focus on students in educational settings.

Dr. Harpold is quoted on the report illustrating an emphasis on improving cognition and the interrelationships between educational approaches and research areas. He also acknowledges that funding for research endeavors is a critical factor in progressing research.

Read more comments by Dr. Harpold on NIH’s research plan and read the entire Education Week article here.

Dr. Harpold was also quoted in another article, also on Education Week, discussing DS-Connect, the Down syndrome registry. Read that article here.

 

 

 

DS-Connect® Challenge Impact: A Look at the Map

At LuMind Foundation, we bring light to the science of Down syndrome cognition research. Thanks to to the amazing support for LuMind Foundation’s DS-Connect® Challenge, hundreds of you brought a glow to the DS-Connect® map!

The DS-Connect® Map on November 12, 2014 (courtesy NIH).

On the map of the major metropolitan areas where aggregate, de-identified information is displayed, six areas now glow bright red. A big shout-out to our friends in Texas who shifted from yellow to red, indicating more than 100 people support research.

Don’t see your area glowing red or yellow? That’s because the registry protects your privacy and is only displaying the major metropolitan areas. Your information is still there!

“We are thrilled with the response to the LuMind Challenge and the positive impact that it has had on increasing the number of registrants on DS-Connect®. We are grateful for all the families who have signed up for the registry and hope that they will continue to support research in Down syndrome. This resource will help connect families with the research that matters to them,” said Dr. Melissa A. Parisi, Chief of the Intellectual and Developmental Disabilities Branch at the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH).

Thank you to the NIH and all the people who joined DS-Connect® in October, or earlier or just helped to spread the word!

NIH Releases 2014 Research Plan

We’re very pleased to announce that NIH has just released the updated document “Down Syndrome Directions,” the NIH Research Plan on Down Syndrome. The research plan will provide another great way to work with the DS community to further research efforts.

“In succeeding the previous NIH Plan for Down Syndrome released in late 2007, ‘Down Syndrome Directions’ represents a very important plan for Down syndrome research,” said Dr. Michael Harpold, LuMind’s Chief Scientific Officer and also chair of the DS-Connect® Governance Board. “The plan builds on the very dramatic research progress and incorporates significant new directions to address the health of children and adults with Down syndrome.”

‘Down Syndrome Directions’ was developed with input from the entire Ds community and the many comments and ideas were compiled by the NIH staff.

Added Dr. Harpold, “We especially thank NIH for their sincere consideration and incorporation of the many feedback comments from those in the Down syndrome community, including individuals, organizations and the researchers and clinicians. We look forward to continuing to work together with the NIH, and all of the community, in implementing this plan and furthering significant progress in creating new opportunities for all children and adults with Down syndrome.”

To read or download a PDF of “Down Syndrome Directions,” visit NIH’s publication page.

For more information on the DS-Consortium, please visit their webpage.

Dr. Harpold Announced as Chair, DS-Connect® Governance Board

A longtime participant in the DS Consortium and DS-Connect® Registry Governance Board, LuMind Foundation’s Dr. Harpold will lead the Board overseeing DS-Connect® as the registry moves into its second year.

Dr. Michael Harpold, chief scientific officer at LuMind Foundation, has accepted an invitation from the National Institutes of Health (NIH) to serve as Chair of the Registry Governance Board for DS-Connect®.

Dr. Harpold has been serving as an active representative on the Down Syndrome Consortium, the private-public partnership that worked with the NIH to create DS-Connect®, the Down syndrome registry launched by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) last year. DS-Connect® is a health data registry for people living with a diagnosis of Down syndrome (DS). Dr. Harpold has also been serving as an inaugural member of the DS-Connect® Governance Board.

“Dr. Harpold’s commitment to research in Down syndrome and his contributions to the registry have had a major impact on its success. We are very pleased to have him serve as chair of the DS-Connect Governance Board,” said Dr. Melissa Parisi of NICHD, who serves as director of the registry and Chair of the Down Syndrome Consortium.

Dr. Harpold succeeds Dr. Yvonne Maddox, who served as Deputy Director of the NICHD until her recent appointment to serve as Acting Director of the National Institute on Minority Health and Health Disparities by the NIH Director.

“I am very honored to be asked to serve as the new chair of the DS-Connect® Governance Board and to continue working together with my distinguished fellow Governance Board colleagues, those on the DS-Connect® Operations Board and NICHD as DS-Connect® expands offerings, including launching a Professional Portal for approved researchers, clinicians and health practitioners to access aggregate de-identified data as well as design, develop and undertake important new research and clinical studies,” said Dr.Harpold. “I especially thank Dr. Yvonne Maddox for all of her tireless efforts in making DS-Connect® a reality, and her dedicated leadership as the inaugural chair of the DS-Connect® Governance Board. DS-Connect® represents a long-needed and incredibly important resource for researchers, clinicians and all of the Down syndrome community.”

“Dr. Harpold is a recognized leader in the Down syndrome research community,” said LuMind Foundation Executive Director Carolyn Cronin. “His experience, expertise and willingness to collaborate and connect with researchers, individuals with Down syndrome and families with a loved one with Down syndrome are all valuable assets to our organization and the greater Down syndrome community.”

DS-Connect® is designed to connect its registered participants with information about the larger Ds community, including providing people with Ds and their family members with important knowledge about medical and demographic information, new research findings and treatments and opportunities for participating in new research studies and clinical trials. All the data is kept secure and confidential and registrants have direct control over their information and if or how often they are notified of research opportunities. DS-Connect® currently has more than 2200 people registered.

DS Consortium: Collaborate to Innovate

Since the founding of LuMind Foundation a decade ago, the researchers receiving foundation grants are encouraged to share findings with others in their discipline and other important fields. That condition is based on the belief that collaborating yields better and faster research breakthroughs.

In that same spirit, LuMind Foundation is proud to be part of the DS Consortium, a public-private partnership between the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and a set of stakeholders interested in Down syndrome research.

“We all talk informally, but creation of the DS Consortium helped us come together to exchange information and work collaboratively on identifying and then developing approaches to issues of critical importance to the Down syndrome research effort,” said LuMind Foundation’s Chief Scientific Officer Dr. Michael Harpold. “When we collaborate as a group we can significantly facilitate and advance innovative ideas, research, and relationships. More can be accomplished with increased and focused interaction to benefit children and adults with Down syndrome.”

Through the initiative of Dr. Yvonne Maddox, then Deputy Director of the NICHD, the DS Consortium was kicked off in September 2011. As a long-time member of the Down syndrome research community, Dr. Harpold attended the inaugural meeting along with other research foundations, national advocacy groups, self-advocate representation, and medical and governmental organizations – all with an interest in Down syndrome research.

“The consortium fosters collaboration and discussion to improve outcomes for people and families with Down syndrome,” explained Dr. Melissa Parisi, Chief of the Intellectual and Developmental Disabilities Branch of the NICHD, the National Institutes of Health (NIH) division primarily tasked with Down syndrome research. “There was much discussion about the need for a patient registry in the group. NIH, together with the consortium, created a registry resource to connect the Down syndrome community with the researchers.”

That registry, DS-Connect™, now confidentially and securely holds basic medical and demographic information for more than 2000 people with Down syndrome. That data can then be utilized, with permission of the participants, to offer opportunities to join in clinical studies and trials. The de-identified information is being made available to the Down syndrome community, researchers and clinicians to provide insight to many medical concerns specific to people with Down syndrome.

Another Consortium goal was to design an updated NIH research agenda for Down syndrome. NIH, together with input from the Consortium members, developed the updated the NIH DS Research Plan for Down Syndrome and issued a draft report for public review in 2014.

“A major product of the Consortium so far has been involvement with the updated DS Research Plan,” said Dr. Parisi. “In the past we had a generic theme of ‘Living with Down Syndrome,’ but thanks to the insight from Dr. Harpold and others we added a module on “Down Syndrome and Aging” in direct response to those comments and received valuable feedback from the families.” The Down Syndrome and Aging section addresses the need for additional research areas as an individual with Down syndrome ages, particularly with respect to early onset Alzheimer’s disease.

“The consortium reflects a growing partnership,” added Dr. Sujata Bardhan, a Scientific Program Manager with the NICHD. “We are seeing huge benefits to other consortium members and the NIH through the Consortium.  We are all reaping its benefits.”

Dr. Harpold says collaboration in the research world is critical because when researchers and clinicians work together to understand and answer complex questions, a small discovery in one location can lead to a bigger one elsewhere. The spirit of collaboration is key in the laboratory and also in the meetings of the Consortium. Some of the organizations in the DS Consortium provide overlapping services, but they don’t view themselves as competitors. Dr. Harpold says the collaboration enhances everyone’s effectiveness.

“We all participate in the DS Consortium because we believe in collaboration, not in unproductive competition. We have a common goal: to improve the health outcomes for people with Down syndrome,” said Dr. Harpold.

Learn more about the DS Consortium including seeing a list of all the member organizations, by visiting the NIH website.