AADR Responds to National Children’s Study Alternative RFI

This week, AADR submitted a response to the National Institutes of Health (NIH) request for information inviting comments and suggestions on the Environmental Influences on Child Health Outcomes Program.  In our response we encouraged the ECHOP to (1) to include oral conditions in children as one of the additional high impact areas for the study, (2) partner with the National Institute of Dental and Craniofacial Research (NIDCR) in the areas of research on cleft lip and palate, (3) address gaps in access to oral health services for rural children and (4) emphasize the importance of fluoridated water as one of the most effective public health measures to prevent dental caries.

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AADR Responds to RFI Soliciting Input on a Vision for Health Disparities Research

Last month, AADR submitted comments in response to the National Institute on Minority Health and Health Disparities request soliciting input to the NIH Science Vision for Health Disparities Research.  Our comments recognized the longstanding leadership role of the National Institute of Dental and Craniofacial Research (NIDCR), illustrated the causes of oral health disparities and proposed a framework to study oral health disparities. We also highlighted recent policy interventions and provided recommendations for maximizing community-based studies.

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AADR Responds NIH Strategic Plan RFI

This week, AADR submitted a response to the National Institutes of Health (NIH) request for information inviting comments and feedback on a framework for the NIH wide strategic plan. The comments indicated AADR’s strong support for the proposed framework and applauded the efforts to maintain a high-level non-disease specific strategic vision. AADR also provided input on additional components that may be included in the plan including maximizing community engagement in research through big data. These comments were developed with input by the AADR Government Affairs Committee.

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NIDCR Seeks Comments on FY17 Research Themes

The National Institute of Dental and Craniofacial Research (NIDCR) is seeking public input on their proposed research initiatives for fiscal year (FY) 2017.  These themes are used during the annual budget development and in communication with NIH, the Department of HHS and Congress about future research goals.  The proposed research themes include the following:

  • Factors Underlying Differences in Female and Male Incidence Rates for Certain Dental, Oral, and Craniofacial Diseases
  • Glycoprofiling HIV and HIV/AIDS-related Oral Pathogens that Persist During Antiretroviral Therapy
  • Tailoring Dental Treatment Guidelines for Patients with Genetic Disorders and Other Conditions Known to Impact Oral Health
  • Three-dimensional Dental, Oral, and Craniofacial Tissue Models to Mimic Human Diseases
  • Wireless Biosensors in the Oral Cavity for Precise, Individualized Medical Care

How can you provide input? AADR members are strongly encouraged to provide feedback and input. You can either submit individual comments to NIDCR directly at FY2017Comments@nidcr.nih.gov by September 4, 2015 or send them to Carolyn Mullen cmullen@aadr.org by August 28, 2015 to include as part of AADR’s comments on the research themes.

NIDCR Director’s Dear Colleague Letter

Dear Colleagues:
As part of the budget planning process for Fiscal Year 2017, NIDCR is identifying topical themes for development into research initiatives. During this process, we welcome input from our scientific advisory boards, the extramural community, interested organizations, and the public at large.

What are Initiatives? Initiatives are a vehicle used by the Institutes and Centers to communicate future research goals to NIH, the Department of Health and Human Services, and Congress. NIDCR begins the initiative development process each year by identifying broad research topic areas, or themes. We then develop a specific initiative proposal for each theme, taking into consideration the input received. Themes identified for FY 2017 are listed below.

Please remember that initiatives are not a complete picture of the Institute’s planned research portfolio for the year indicated, nor do they signal that themes highlighted the previous year have been abandoned. Several initiatives from last year have become formal funding opportunities and are posted on NIDCR’s website​. Others are still under development. Proposed FY 2017 Initiatives will be integrated into this larger landscape as they are considered for funding.

How can you provide input? Please send your comments and suggestions related to these specific theme areas directly to us at FY2017comments@mail.nih.gov​. If you want to suggest additional topic areas, or comment on the process for developing research initiatives, please send those suggestions to the same email address. Please submit all comments no later than Friday, September 4, 2015.

Thank you for your interest and input. I look forward to hearing from you.

Sincerely,

Martha J. Somerman, D.D.S., Ph.D.
Director
National Institute of Dental and Craniofacial Research

Proposed NIDCR FY 2017 Research Themes (alphabetical by title)

 

Factors Underlying Differences in Female and Male Incidence Rates for Certain Dental, Oral, and Craniofacial Diseases The likelihood of developing a dental, oral, or craniofacial disease often varies according to sex of the individual.  For example, a woman is more likely than a man to be diagnosed with an orofacial pain condition such as temporomandibular joint disorder, the salivary gland tumor known as adenoid cystic carcinoma, or the oral manifestations of Sjögren’s syndrome. However, very little is known about the factors that cause such sex-related differences in incidence rates. This initiative encourages research to investigate possible genetic, hormonal, immune system, or environmental factors that may explain sex-related differences in the incidence of conditions that affect the dental, oral, and craniofacial region. Recent NIDCR investments in biorepositories and cohort studies can be leveraged to better understand sex-related differences in disease incidence. Advancing our understanding of the underlying reasons for sex-related differences in disease incidence is critical to identifying new therapeutic targets and developing precision medicine-based prevention, diagnosis, and treatment methods.

Glycoprofiling HIV and HIV/AIDS-related Oral Pathogens that Persist During Antiretroviral Therapy Recently, scientists have made tremendous advances in the characterization of the structure and abundance of glycans (sugars) on the surface of bacteria and viruses, but little is known about how microorganisms use glycans to infect an individual and cause disease. This initiative encourages research that uses glycoprofiling technologies to understand the role of glycans in HIV infection and other oral diseases and in the persistence of HIV/AIDS-related oral pathogens in patients who are undergoing antiretroviral therapy. This research could include the generation of electronic databases that catalog the glycoprofiles of HIV and HIV/AIDS-related opportunistic pathogens affecting the oral mucosa.  These datasets will serve as valuable resources for future identification of novel biomarkers and new therapeutic targets for HIV and oral opportunistic pathogens.

Tailoring Dental Treatment Guidelines for Patients with Genetic Disorders and Other Conditions Known to Impact Oral Health Certain genetic disorders such as ectodermal dysplasia and osteogenic imperfecta, many systemic diseases such as diabetes and Sjögren’s syndrome, and certain cancers are associated with collateral damage to oral tissues, and yet most current oral health treatment guidelines are based on studies of fairly healthy individuals. The goal of this initiative is to encourage research to understand the impact of a specific disorder, such as diabetes or osteogenic imperfecta, on oral health and to tailor guidelines for optimizing oral health in individuals with these specific disorders. Additional research in this area will help identify prognostic factors that predict treatment outcomes within specific population groups and will generate evidence for more precise dental treatment guidelines that are tailored to individuals.

Three-dimensional Dental, Oral, and Craniofacial Tissue Models to Mimic Human Diseases Model systems are essential for understanding biology and developing effective approaches to prevent and treat disease. Traditionally, researchers have used live animals, such as rodents, or cells cultured on plastic surfaces, but rodent and other lab animal models often cannot precisely mimic human physiology and pathology, and standard cell cultures lack normal tissue architecture. To overcome these limitations, this initiative supports the development of three-dimensional (3D) human dental, oral, and craniofacial microtissue models that will provide the structure and organization that are lacking in standard cell culture systems and also allow for the use of human rather than lab animal tissues. Recent progress in understanding tissue development, technical progress in bioengineering, and ongoing efforts to develop 3D models for tissues and organs outside of the oral region make this initiative particularly timely. These new model systems will provide opportunities for addressing important questions of both health and disease in dental, oral, and craniofacial tissues and identifying new approaches to prevent and treat disease.

Wireless Biosensors in the Oral Cavity for Precise, Individualized Medical Care Advances in wireless devices and nanotechnologies have enabled the development of compact, lightweight medical biosensors that provide real-time interactive communication between individuals and health care providers. In recent years, the field of wearable or implantable biosensor technologies has dramatically expanded; however, progress has been slowed by the fact that most regions of the body require an invasive procedure to place implantable devices. The oral cavity, on the other hand, is a region that offers both noninvasive device placement as well as easy access.  In addition, biosensors in the oral cavity are exposed to a broad range of salivary markers, including microorganisms, hormones, drugs, and dietary constituents. This initiative encourages the development of new wireless oral biosensors for noninvasive, dynamic monitoring of physiological processes associated with oral or systemic conditions. Such wireless biosensors offer potential for health monitoring and disease prevention through early detection and intervention. For example, wireless biosensors could help maintain the health of an individual by measuring the progression of caries or periodontal disease by analyzing changes in the oral microbiome or monitoring changes in diet or medication.

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AADR August Advocacy Challenge

AADR is calling on all members and students to meet with their members of Congress during the August recess.

Why?
Members of Congress will be in your state from August 10-September 7. They need to hear from you about the value and importance of dental, oral and craniofacial research because Congress will be making important funding decisions this fall.

Also, students participating in this activity will be automatically qualified to apply for the prestigious 2016 AADR Student Advocate of the Year Award!

Did you know?

  • Members of Congress make decisions every year on how much funding to provide to federal agencies including the National Institutes of Health and the National Institute of Dental and Craniofacial Research (NIDCR). These agencies provide funding for research programs and projects like yours.
  • As a result of Congressional decisions, in 2015 NIDCR awarded the lowest number of research grants in 14 years.
  • Since you vote for members of Congress, your voice carries more weight than a lobbyist in Washington, D.C. Research conducted by the Congressional Management Foundation found the most effective way to influence a policymaker is through an in-person meeting.

Why is it important?
This fall, Congress will make critical funding decisions. Some experts speculate there may even be another government shutdown. Congress needs to hear about your research, the impact of budget cuts (i.e. sequestration) and why a potential government shutdown is bad for the biomedical research enterprise.

How can you participate? It’s EASY!

Step 1: Contact AADR Director of Government Affairs Carolyn Mullen at cmullen@aadr.org. Carolyn will schedule the meeting with your member of Congress for you. She will also train you on how to be an effective advocate, provide written materials and answer any of your questions.

Step 2: After your meeting is scheduled, invite other students, faculty and AADR members to participate.

Step 3: Attend the meeting with your members of Congress using your newly learned advocacy skills.

Step 3: Try to remember to follow up with you member of Congress later by saying thank you. Remember a relationship with a member of Congress will be very useful in the future.

Students: Are you interested in receiving an award for this activity?

Click here to learn how you can become the 2016 AADR Student Advocate of the year!

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My Time in Washington, DC

By Josh Evans, AADR Gert Quigley FellowJosh at the White House

The Gert Quigley Fellowship was an unforgettable six week advocacy experience. During my time in Washington, DC I was able to participate in several important facets of advocacy. For example, I attended coalition meetings; observed hearings and bill mark-ups; visited the National Institute of Dental and Craniofacial Research; helped develop a call to action to inspire students to perform grassroots advocacy during the Congressional August recess and I met with members of Congress and their staff to discuss the importance of oral and craniofacial research.

I am currently a fourth year dental student at Indiana University School of Dentistry, but have been active in research since I attended Butler University, where I received my bachelors of science in chemistry. However, at that time I never got involved or took an interest in politics. I was unaware of the intricacies of Congress and its role in providing funding for research via annual appropriations bills to help curb prevalent disease in America. Early in my research career all I knew is that my proposals would “magically” get funded and I was allowed to conduct my research. Due to my experience in Washington, DC I better understand the role Congress plays in funding the federal governmental agencies such as the National Institutes of Health and the National Institute of Dental and Craniofacial Research.

In my short time here I have seen advocacy work first hand. Specifically, the Senate proposed legislation that would require Federal agencies with research expenditures over $100 million to develop a policy for free online public access to peer reviewed manuscripts no later than six months after publication in peer reviewed journals. It is important to note that the IADR and AADR Journal of Dental Research adhere to the current embargo period of 12 months established by NIH. As a result of advocacy efforts of the broader community and AADR compromise legislative language was developed–to preserve the current embargo period–in partnership with the Senate. The revised version of the bill will move forward this week.

In addition, since coming to The Hill I have noticed how Congress is trying to increase funding dedicated to research with the Senate and House Appropriations Committees approval of the fiscal year 2016 appropriations bills. While this attention is great for research it should also increase caution with advocates. These proposed increases in funding are coming at the expense of other important public health programs due to the continued tight budget climate. I was able to witness how AADR works with a broad coalition of research, public health and science advocates urging Congress to lift the caps on discretionary spending so the entire public health continuum can benefit.

Now that I understand more of the process of Congressional decision making I realize that advocacy is needed more than ever. Many members of Congress know only what they are told by their constituents which them helps prioritize how limited resources are spent by the federal government.  Therefore researchers, dentists and students play a vital role as advocates to carefully and thoroughly explain the importance of dental research and discovery to help Congress understand the value and importance of their work. Though advocacy can seem overwhelming at first it can actually be very simple. There are a variety of venues to start advocating, such as responding to action alert emails, sending letters of support, or students can schedule a meeting with their members of Congress. Getting involved in advocacy can help make a difference for the future of research.

 

Josh with NIDCRI look forward to continuing my work as the Gert Quigley Fellow this year as an active member of the AADR government affairs committee and National Student Research Group. If you want to become more involved with AADR advocacy please contact Carolyn Mullen, director of government affairs at cmullen@iadr.org

 

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What is Next? Federal Budget Update

Last month for the first time in many years both the US House of Representatives and the US Senate moved their versions of the fiscal year 2016 Labor, Health and Human Services and Education (LHHS) Appropriations bills through the committee mark-up process. The House proposed $31.2 billion for the National Institutes of Health and $404.8 million for the National Institute of Dental and Craniofacial Research (NIDCR) whereas the Senate proposed $32 billion for NIH and $415.1 million for NIDCR. Unfortunately, it is unclear is these proposed funding increases will ever become law.

Due to the sequester level caps on discretionary spending set in place by the Budget Control Act  of 2011 the aforementioned increases came at the expense of other important public health programs. For example, the House terminated the Agency for Healthcare Research and Quality (AHRQ) and the Senate decreased funding for AHRQ by 35% and decreased funding for the National Center for Health Statistics by $10 million. Importantly, President Obama has vowed to veto any legislation that adheres to the sequester level caps in the hopes of spurring Congress to negotiate a budget deal that would increase discretionary spending for defense and non-defense discretionary programs. The Democrats in both the House and Senate are holding firm that the caps must be raised in order for the appropriations process to continue.

This means that with 16 legislative days remaining Congress is at an impasse. It is unclear if Congress will be able to negotiate a broader deal on the budget prior to October 1 which is the start of the new fiscal year. Congress has three options before them either: 1) shutdown the federal government 2) approve continuing resolution funding the federal government at the current levels or 3) negotiate a budget deal prior to the October 1st deadline.  It is possible that Congress will approve a short term continuing resolution through December to buy “more time” to negotiate a deal. Many members of Congress are urging leaders to negotiate a deal now to avoid turmoil in the near future.

AADR remains actively engaged with the broader non-defense discretionary community (NDD United) urging Congress to replace sequestration with a balanced approach to deficit reduction that takes into account the deep cuts NDD has already incurred since 2010.

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NIH Requests Input on NIH-Wide Strategic Plan

On July 22nd the National Institutes of Health (NIH) solicited input from the stakeholder community on a NIH-wide five year strategic plan. This plan outlines a vision for biomedical research that identifies areas of opportunity across all biomedicine and unifying principles to guide NIH’s support of the biomedical research enterprise. With input from all 27 Institutes, Centers and Offices (ICOs) The framework identifies crosscutting areas of research exemplifying the breadth of ICOs priorities and aims to outline a set of unifying principles to guide NIH in pursuit of its mission. According to the request for information the NIH-wide strategic plan includes the following:

NIH-wide Strategic Plan Framework

Overview

  • This section will include a discussion on subjects such as the NIH mission, the status of and opportunities in biomedical research, the current NIH-supported research landscape (i.e., basic and applied research, extramural and intramural research, ICOs with their own strategic plans, Common Fund, challenges), and constraints confronting the community in the face of lost purchasing power

Areas of Opportunity that Apply Across Biomedicine

  • Promote Fundamental Science
    • Basic Science is the foundation for progress
    • Consequences of basic science discoveries are often unpredictable
    • Advances in clinical research methodologies stimulate scientific progress
    • Leaps in Technology often catalyze major scientific advances
    • Data science increases the impact and efficiency of research
  • Improve Health Promotion and Disease Prevention
    • Importance of studying healthy individuals
    • Advances in early diagnosis/detection
    • Evidence-Based interventions to eliminate health disparities
  • Advance Treatments and Cures
    • Unprecedented opportunities on the basis of molecular knowledge
    • Breakdown of traditional disease boundaries
    • Breakthroughs need partnerships and often come from unexpected directions

Unifying Principles

  • Set NIH Priorities – NIH sets priorities by incorporating measures of disease burden, understanding the need to foster scientific opportunity through nimble and adaptable methods,  supporting opportunities presented by rare disease research, and considering the value of permanently eradicating a pandemic
  • Enhance Stewardship – NIH enhances stewardship of the research enterprise by recruiting and retaining an outstanding biomedical research workforce, enhancing workforce diversity, , encouraging innovation, optimizing approaches to guide  how decisions are made, enhancing partnerships, promoting scientific rigor and reproducibility, reducing administrative burden, and employing risk management strategies in decision-making.

How can you provide input? AADR will be responding as an organization, but AADR members are strongly encouraged to provide feedback and input. We need a robust response from the oral, dental and craniofacial community. You can either submit comments to NIH directly by clicking here by August 16 or send them to Carolyn Mullen cmullen@aadr.org by August 3rd.

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House Approves 21st Century Cures Act (H.R. 6)

Earlier this month, the U.S. House of Representatives approved the 21st Century Cures Act (H.R. 6) by a 344-77 vote.  This bill reauthorizes the National Institutes of Health (NIH) for three years; establishes a fully paid for mandatory funding stream known as the Innovation Fund; revamps the Food and Drug Administration drug and medical device approval process and includes a number of provisions related to the interoperability of electronic health records.

Throughout the process, AADR monitored and analyzed provisions related to the National Institutes of Health. Specifically, the Innovation Fund provides $1.75 billion per year from FY16-FY20 for the Director of NIH to provide funding for basic, translational and clinical research. The funding provided via this mechanism can only be used for very specific activities including a new Accelerating Advancement Program; early stage investigators and promising investigators; high risk high reward programs and intramural research. Funding allocations are determined by the Director and tied to the NIH-wide strategic plan, which is still in development (see above). The resources of the NIH Innovation Fund can contribute to the goals of expanding knowledge to address and find more effective treatments for unmet medical needs including:

  • Biomarkers
  • Precision Medicine
  • Infectious diseases
  • Antibiotics

The legislation also states that the Innovation Fund will be used to supplement not supplant other amounts available to the Department of Health and Human Services (HHS). Essentially, Congress shouldn’t cut programs and back fill it with this mandatory funding. It is important to note, this provision is largely unenforceable.

Other Provisions in the Bill

In addition to the funding, the H.R. 6 proposes the following:

  • reauthorizes NIH for three years, increasing the authorization (but not the allocation) by $1.5 billion annually
  • requires the development of a NIH-wide strategic plan;
  • requires a 5 year appointment term of Directors of National Research Institutes and Centers (they can be reappointed after 5 years);
  • requires each Director of National Institutes and Centers to review and approve each R-series award;
  • requires a IOM study on duplication in federal biomedical research;
  • requires a plan to reduce the administrative burdens on researchers;
  • exempts NIH from paperwork requirements;
  • includes a Sense of the Congress that participation in sponsorship of scientific conferences and meetings is essential to the mission of the NIH;
  • Requires each research institute to develop a high risk high reward program to support research projects that pursue innovative approaches to major contemporary challenges in biomedical research that involve inherent high risk but have the potential to lead to breakthrough. This initiative will be paid for by a specific percentage set aside determined by the Director of NIH.
  • Creates a loan repayment program of no more than $50,000 for qualified health professionals to engage in research; updates other NIH loan repayment programs from $35,000 to $50,000 to help support young scientists
  • Establishes a capstone grant program to facilitate the successful transition or conclusion of research programs. An individual who receives the capstone award shall not be eligible to have principle investigator statues on subsequent awards from NIH.

What’s Next? This legislation faces an uncertain future in the Senate. According to CQ Healthbeat Senator Alexander indicated his version of the bill will not be released until later this fall and it is expected the Senate version will have a narrower focus. AADR will continue to work with members of Congress to ensure increased funding for NIH benefits the entire biomedical research enterprise, the National Institute of Dental and Craniofacial Research and our members.

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AADR Voices Opposition to the Reduction of AHRQ Funding

This month, AADR joined 184 other organizations voicing our concern with the proposed 35 percent reduction in funding for the Agency for Healthcare Research and Quality (AHRQ) in the Senate’s fiscal year (FY) 2016 Labor, Health and Human Services and Education (LHHS) appropriations bill.  We urged lawmakers to enact sequestration relief, increase the LHHS subcommittee allocation and restore AHRQ’s budget authority to $364 million.

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