We’re back online and waiting for your feedback! We’ve redesigned the site to make it easier for us to hear from you and share information with you.
Thank you for all of the comments you have posted since our launch (see archived comments). We have heard from so many of you with your concerns, your support, and with praise for the programs that you love. Keep it coming.
Please use this space to leave your comments about the proposed NCATS.
Dear Dr. Collins,
On behalf of the Cystic Fibrosis Foundation, I want to thank you for this opportunity to offer our comments on the National Institutes of Health (NIH)’s proposed National Center for Advancing Translational Sciences (NCATS) and for your untiring efforts to bridge the “Valley of Death” to advance treatments for all diseases, including cystic fibrosis.
The Cystic Fibrosis Foundation applauds the formation of the National Center for Advancing Translational Sciences at NIH. We wholeheartedly support the mission of this new center, which will bring existing translational sciences programs at NIH under one roof and foster new and innovative methods for turning basic science discoveries into potential treatments for some of our most devastating diseases.
Creating a focal point for translational sciences at NIH will ensure a more robust, integrated, and systematic approach to this discipline. The new center will help convene cross sector collaborations between industry, government, and academia to advance drug development. By providing services and resources for high throughput screening, assay development and preclinical modeling, this new center will give industry, academia and others access to the tools they need to jump start the development of treatments that otherwise would prove too risky and cost prohibitive to cultivate.
We hope NIH will use the Cystic Fibrosis Foundation as a resource and a model to accelerate the development of treatments through NCATS. As you know, the CF Foundation has fostered a widely renowned drug development model that performs many of the functions outlined above. This approach encompasses everything from basic research through Phase 4 post-marketing drug safety monitoring, and has created the infrastructure required to accelerate the development of new CF therapies. The CF Foundation’s Therapeutics Development Network (TDN), a key element of CFF’s model, has been cited as an exemplar for NIH’s Therapeutics for Rare and Neglected Diseases (TRND) program, through which NIH partners with outside entities to move candidate drugs through the pipeline and creates collaborations among researchers in diverse disciplines and areas of expertise.
As a result of the CF Foundation’s efforts, we now have a pipeline of more than thirty potential therapies that are being examined to treat people with CF. One such treatment is VX-770, a drug being developed by Vertex Pharmaceuticals that was discovered in collaboration with the CF Foundation. This promising therapy actually targets the genetic defect that causes CF in patients with a particular mutation of cystic fibrosis, as opposed to only addressing symptoms of the disease. In late February we learned that Phase 3 clinical trial data of VX-770 showed profound improvements in lung function and other health measures in CF patients, and a New Drug Application is expected to be submitted to the FDA for review later this year.
This potential new treatment is a direct result of the Foundation’s innovative research agenda, advancing from bench to bedside through the Foundation’s research program which speeds the creation of new CF therapies.
The Cystic Fibrosis Foundation’s successes can serve as a map for the development of new treatments for other diseases, and we urge NIH to use CFF’s considerable expertise as a resource. Once again, we commend the National Institutes of Health for its planned formation of the National Center for Advancing Translational Sciences, and thank you for this opportunity to share our thoughts.
Sincerely,
Robert J. Beall, Ph.D.
President and CEO
Cystic Fibrosis Foundation
Bethesda, Maryland
Here’s a thought: Since NCRR already has the experience in translational research that NCATS wishes to encompass, fold all the programs envisioned for NCATS into a new division of NCRR. That way, you don’t have to create a new Center with a new bureaucracy.
Very well said.
Dear Dr. Tabak,
The University of Hawaii at Manoa has been a grateful recipient of NCRR funding to support research infrastructure since 1986 with the initiation of the RCMI program. We were also successful in securing funding with the IDeA program and were awarded one of the original BRIN grants, and later the INBRE. Presently, we are recipients of a newly funded INBRE, 3 separate COBRE’s and 3 RCMI program grants, as well as an additional NCRR funded SEPA grant. Through these grants, as documented also by other universities receiving NCRR research infrastructure support, the University of Hawaii at Manoa has advanced their research agenda not possible without the support of the NCRR and NIH. We can clearly link the resources provided by NCRR to increasing research capacity as well as to the success of its supported investigators through their graduation into R level, including RO-1, grant funding.
To this end, we have read the volumes of comments from the university community that are published on your website. They make for strong arguments attesting to the value of NCRR. Nevertheless, given the position that NCRR may be dissolved, we believe that certain programs like the RCMI and IDeA programs should remain administered in one centralized IC and not separated as proposed by the straw model. Indeed, many states are eligible for both types of funding – IDeA and RCMI, so this is particularly critical to this subgroup. Even in situations where states are not eligible for both funding sources, the skills and experience necessary to administer infrastructure grants effectively are unique, and therefore should be consolidated in one structural unit.
Funding research infrastructure is a tricky business. Without a clear mandate and a coordinated effort, silos of researchers may unknowingly apply for funding that may result in duplication of resources, separate administrative structures, and aims and objectives that fulfill the objectives of the RFA but do not coordinate and/or leverage the resources of the University with other major grant funded programs. This is indeed what we would fear occurring if IDeA and RCMI were administered separately.
The NCRR has become proficient at understanding the need to coordinate the various infrastructure opportunities of the IDeA and RCMI in order to optimally leverage the resources of the NIH with those of the institution, and to avoid duplication and administrative costs. This is only possible because they administer to both programs and they actively communicate with each other; the experience gained through tireless hours dedicated to multiple grant reviews, site visits, annual reports, personal interactions, national meetings and participation as co-managers in the many cooperative U type awards provide NCRR staff with comprehensive and detailed knowledge of the environment and investigator pool at each university receiving infrastructure funding. This would not be possible if these activities were dispersed over several NIH Institutes. NCRR has stressed collaborations and links among its funded programs, and increasingly held universities accountable for this value added component. Still, this has not been an easy task to accomplish. As an example, our Bioinformatics Core located at UH Manoa in the Department of Computer Science and Information is now co-funded by our INBRE, one COBRE and one RCMI program and these programs are accordingly linked. This accomplishment, in addition to consolidating resources and reducing costs, has fostered cross talk among programs that stimulates interdisciplinary research development in a transparent and natural manner.
In sum, we strongly support the continued administration of INBRE and RCMI programs in one IC as a matter of critical importance to NIH as well as to those institutions that are recipients of their support.
Sincerely,
Gary K. Ostrander, Ph.D
Vice Chancellor for Research & Graduate Education
PI-University of Hawai‘i RCMI Program
University of Hawai‘i-Manoa
I am the father of a boy with NF2, and I am writing so express my support for NCATS. NF2 like many other diseases are so rare that there is limited funding for extensive research and clinical trials. If programs like NCATS will potentially speed the discovery of drugs that will improve conditions for people with diseases like NF2, I endorse them whole heartedly.
Francis S. Collins, MD, PhD
Director
National Institutes of Health
Dear Director Collins,
Thank you for the opportunity to comment on the recently-proposed reorganization of the National Institutes of Health (NIH) programs.
The University of Kansas Medical Center enthusiastically supports the recent NIH announcement to create the National Center for Advancing Translational Sciences (NCATS). We appreciate your steadfast leadership in translational science at a critical time in our nation’s history – investing in innovation through our research universities is key to our long term economic recovery. As such, we were thrilled that you were able to participate with Secretary Sebelius in the Friends of Cancer Research Town Hall discussion highlighting public-private partnerships in drug discovery, delivery, and development, such as those being developed at The University of Kansas Cancer Center.
As you may recall from your visit, the University of Kansas and University of Kansas Medical Center have developed an innovative model for translational research called the Institute for Advancing Medical Innovation (IAMI). This model links private philanthropy, research, and entrepreneurism in order to move new pharmaceuticals and medical devices from the bench to the bedside. The program also focuses on educating graduate and postdoctoral students for careers in development and commercialization. KU Medical Center believes that its vision with the establishment of IAMI closely aligns with your vision in the creation of NCATS, and we are excited to explore the opportunities the new national center will generate.
However, as we develop new initiatives to harness the entrepreneurial opportunities in our universities, it is important to sustain existing programs that have been integral to the success of institutions such as ours. As you may know, Kansas receives significant funding from the Institutional Development Award (IDeA) program through the Centers of Biomedical Research Excellence (COBRE) program and the IDeA Networks of Biomedical Research Excellence (INBRE) program. Since 2000, the University of Kansas and University of Kansas Medical Center have received approximately $130.5 million in IDeA funding, which has leveraged an additional $176.1 million in external funding. This funding – in addition to providing resources for research – has assisted with recruitment packages and pilot grants, and has supported approximately 42 new faculty and 115 undergraduate researchers at our institutions. Because these funds are used to invest in the research infrastructure across the state, the financial, academic, and state economic benefits are very difficult to calculate – but we know they are huge.
Given our support for the IDeA program, we are concerned that the proposed elimination of the National Center for Research Resources (NCRR) might have negative consequences for the IDeA program. In order to ensure IDeA’s vitality going forward, we propose for consideration that the IDeA program be housed in the National Center on Minority Health and Health Disparities (NCMHD).
Although the NCMHD has historically focused on racial and ethnic disparities in health, the NCMHD has expanded its mission to include health disparities more broadly in recent years. Because the IDeA program serves unique populations – such as rural and medically underserved communities – housing the program within the NCMHD could be an ideal match. With an expanded mission, the NCMHD could synergize its current efforts to “promote, assist, and support research capacity building activities in the minority and medically underserved communities, focusing on research infrastructure development, faculty career development, and increasing the number of underrepresented minority students and students from health disparity groups with an interest in careers in biomedical and bio-behavioral research” with the similar goals of the IDeA program. An analysis that explores health disparities in the 23 IDeA states could provide a thoughtful initial approach to consider.
As the Chancellor for the University of Kansas and the Executive Vice Chancellor for the University of Kansas Medical Center, we want to thank you again for your tireless leadership and to offer our strong support for the NIH’s reorganization efforts – particularly as it pertains to additional resources for translational research. We also urge your support for the IDeA program, and appreciate your consideration of whether placing that program within the NCMHD could provide collateral benefits to both organizations and the populations they serve. Thank you for the opportunity to comment on the NIH reorganization efforts.
Best regards,
Barbara F. Atkinson, MD
Executive Vice Chancellor, University of Kansas Medical Center
Executive Dean, University of Kansas School of Medicine
Bernadette Gray-Little
Chancellor, University of Kansas
Dear Dr Tabak,
Thank you for requesting input for this new initiative on a Center for Advancing Translational Medicine. I read the Report delivered by the SMRB and wonder if, prior to the February 23 SMRB, the Board could have a therapy session to address their apparent cognitive dissonance. Their principles, as stated in the Report, are very enlightening but their practices are infinitely distant from the ideals and goals they proclaim. I was recently told by a psychiatrist that “is not uncommon for intellectually driven people:professors, doctors, artists etc to have delusional long-lasting episodes alternating with periods of sadness but they are treatable”, he said. Equally encouraging was his mentioning of Einstein, Mozart and a whole bunch of celebrities as individuals suffering, at some point in their lives, for a recently discovered and effciently treated “bipolar” disorder. I think that a one-session would do them good. You could just set up a video conference for them to avoid traveling, extra expense and taking them away from their daily responsibilities.
Dear Dr. Tabak,
As Principal Investigator of the Kansas IDeA Network for Biomedical Research Excellence (K-INBRE) from its inception until the present day, past member of the NCRR National Research Advisory Council and current member of the Council for the National Association of IDeA Principal Investigators, I am writing to ask that your committee consider recommending the National Institute on Minority Health and Health Disparities (NIMHD) as home to the IDeA program.
The IDeA program has much in common with the Research Centers in Minority Institutions (RCMI) program, which has been preliminarily assigned to the NIMHD. Both programs are committed to biomedical research excellence in minority and rural populations and are critically concerned as well with the educational and economic impacts these programs have in states where NIH funding is low. The genesis for each of these programs may be definitely ascribed to forward-thinking personnel in NCRR who were responsible for the design, implementation and oversight of the initiatives. Both have been externally evaluated for quality and outcome, with impressive positive results.
In Kansas, recruitment and support of new faculty, growing new researchers, and providing both faculty and students with highly sophisticated technology have been the goals of the K-INBRE. To date, faculty in the 9 universities supported by the K-INBRE have been awarded NIH grants totaling more than $55,000,000, which is double the NCRR investment, nearly 600 undergraduates have received on-hands research training, and a front-line bioinformatics network has been established that covers the state.
It is in the best interests of the country that the IDeA program, comprised of both COBREs, which focus on support for new investigators in specific areas of research, and INBREs, which build the infrastructure components that permit research to grow and develop, remains as a distinct entity in the capable hands of the skilled NCRR administrators who are highly familiar with the needs of the underserved states. Clustering with the RCMI program permits these professionals to guide both sets of programs, a very reasonable approach since both target underutilized human research resources in the IDeA states.
I join the other IDeA Principal Investigators in urging you to recognize the value of this program and place it in the most advantageous position possible, i.e., under the wing of NIMHD, which appears ready, willing and able to sustain and foster future growth and development of the RCMI and IDeA programs.
Sincerely,
Joan S. Hunt, PhD, DSc
Dear Dr. Tabak,
I am writing to add my voice to the many that are speaking in support of the IDeA program. I appreciate the fact that there are no plans at the NIH to harm or in any way diminish IDeA or any other of the NCRR programs that will not follow CTSA into NCATS. However, as the INBRE Principal Investigator for South Carolina, and the Secretary/Treasurer of the National Association of IDeA Principal Investigators (NAIPI), I sense a continued uneasiness in virtually all of the IDeA PI’s with the uncertainties that IDeA faces because of the restructuring of the NCRR. I suspect that this uneasiness will continue to permeate the group, until a stable long-term solution is devised and we know where IDeA will ultimately find its home.
I echo and fully support the opinions expressed by NAIPI President Dr. Van Houten on several occasions: we all want to see IDeA remain intact, and continue to develop the synergies it has established with other NCRR programs, particularly with RCMI. I know that you and the NIH administration are on the same page with us on this general point. I am also sure that you appreciate the magnitude of the impact IDeA has had on our states’ biomedical research infrastructure, and what that means for our institutions, our faculty and most importantly our students, but also for our communities and the Country as a whole.
Simply put, if we want for the USA to remain competitive in the biomedical fields, we have got to develop top-notch research programs and provide our students with a XXI-century science education across the country. We cannot afford to leave 24 of our 50 states behind. Graduate students from IDeA states fill the pipeline to postdoctoral positions and high-tech industry jobs across the country: The Ph.D. graduates I trained went to Harvard, Yale, Scripps, the Beckman Institute, the University of Wisconsin, Madison, UCSF, and UNC Chapel Hill. All of us send graduates to postdoctoral positions at the primary research institutions in the country on a routine basis. IDeA states have approximately 20 percent of the U.S. population, 25 percent of all doctoral institutions and an even larger fraction of undergraduate institutions, and 18 percent of employed academic scientists and engineers. The states, however, receive less than 15 percent of total R&D funding. Interestingly, the fraction of national R&D support allotted to EPSCoR/IDeA states used to be 10% less than a decade ago, therefore IDeA (as well as EPSCoR, in other national funding agencies) remediates somewhat this disparity, supporting the growth of science and education across all the states, bringing those states that have been traditionally underserved more closely in line with the others, and expanding research capacity and the development of an appropriately-trained workforce in our states. This is a point that I rarely see emphasized, and yet it is such an important concept: an improvement in the level and quality of science and science education in the IDeA states benefits all institutions, even those that are already known as centers of excellence in non-IDeA states. I could not emphasize enough the value of distributing resources for research and education in such a way that excellence can be fostered wherever excellence is possible. In addition, there is a ripple effect that local institutions produce when their culture changes, when research training is incorporated in their curriculum, when they can proudly offer first-class educational experiences to their students: slowly, the attitudes and knowledge base of the communities around the institutions also change. Our institutions, close as they are to the communities around them, are poised to make a difference in the health and health education of those communities. These changes are already evident in many places, and I invite you to look closely at the multi-faceted details of IDeA’s tremendous impact everywhere: far from being (as some have referred to it) “an entitlement”, IDeA in an invaluable resource that benefits all the states, directly or indirectly.
I too am concerned, as most of my colleagues, about the proposal of temporarily placing IDeA and other key NCRR programs into an Interim Infrastructure Unit in the office of the Director. We worry about the practical ramifications of such a decision for the day-to-day management of our programs, the competition for new awards, and the protracted uncertainty that this solution would imply for a permanent home of the IDeA program.
As I mentioned during one of the conference calls with you, perhaps you will determine that a Division of Research Infrastructure is indeed needed to house IDeA and those NCRR programs that are designed to support and augment infrastructure and are not based upon specific scientific thematic area, but may encompass many diverse areas of investigation. This option would maintain the current synergies and administrative structure of IDeA, RCMI, SEPA, and other infrastructure and training-based programs currently under the NCRR umbrella, while giving them a vantage point from which to establish new connections in many directions, including the NCATS. This DRI may be relatively small, but I predict that it would function effectively and efficiently. The issue is where to place it, as the Office of the Director cannot provide but a temporary home for it, I presume.
Should the creation/retention of a DRI unit not be a viable option, then moving IDeA into the NIMHD, so that it can be aligned and co-managed with RCMI by the staff who currently manage both programs, appears to me and my colleagues as a suitable alternative. Granted, the mission of NIMHD is specifically directed at improving minority health, ameliorating health disparities, and training minority scientists. Therefore, careful consideration will have to be given to how the scientifically diverse IDeA programs, which cover a whole host of biomedical research topics, areas, and disciplines, can be accommodated into the new Institute without compromising IDeA’s current range of scientific directions, or the mission of NIMHD.
One could reason that since Minorities are affected by virtually all the diseases that also affect the population as a whole, and disparities exist for many of these diseases, the fit is better than it may look at a first glance. The addition of IDeA and RCMI to NIMHD would considerably enhance this new institute’s portfolio and multiply the opportunities for training of minority students, and for conducting research in areas of interest to minority communities. Goals such as the increased recruitment and retention of minority students into the biomedical sciences are already included in the programmatic lines of INBRE, for example, and for INBRE the fit with NIMHD would be excellent. In addition, IDeA states are where a number of the underrepresented minority populations are accessible, and again the opportunity for new synergies is remarkable, provided that the mission of NIMHD does not become way too restrictive. Some careful work would need to be done to preserve the scientific freedom of COBREs which are vital to the development of competitive research programs at our comprehensive research universities. I believe that, with an intelligent and careful analysis of the various IDeA programs and some flexibility on the side of the NIMHD, we could make this work to everyone’s satisfaction.
I must add that we all welcome the formation of NCATS per se, we are not against change! In addition, removing the (real or perceived) competition between CTSA and IDeA for vital funds would certainly be a good thing. IDeA has paved the way for CTSAs in some of our states, South Carolina included, and I predict that IDeA programs and faculty will continue to build bridges with the translational programs in their states. There is no doubt in my mind that South Carolina would not have been successful in the competition for a CTSA, if not for the tremendous increase in research capacity and communication among institutions that IDeA produced in this state, and I am sure that my colleagues in Arkansas will fully support this notion.
Thank you again for your willingness to talk to us, and to listen to our concerns and suggestions as you continue to search for the best possible home(s) for so many valuable NCRR programs.
Sincerely,
Lucia
Lucia A. Pirisi-Creek, MD, Professor
Department of Pathology, Microbiology and Immunology
University of South Carolina School of Medicine,
Program Director, SC INBRE
Dear Dr. Collins and the NCATS planners:
First, we would like to applaud your efforts to expand NIH’s investments in efforts to speed the translation of basic discoveries to clinical application through the creation of the National Center for Advancing Translational Sciences (NCATS). Such a center has the potential to cut across institutional boundaries and address fundamental scientific and biomedical challenges regardless of disease type.
The transition from basic research to clinical application requires interdisciplinary and multidisciplinary expertise. As outlined in the recently released FasterCures whitepaper “Crossing Over the Valley of Death,” many new drugs drop out of the development pipeline for a variety of reasons including lack of funding for critical translational studies and insufficient investment in the technical expertise needed for technology development and transfer. These barriers inhibit both the scientists dedicated to improving health and the patients who ultimately need improved cures and care.
As you aware, 80 to 90 percent of research projects fail before they ever get tested in humans. By industry’s estimates the number may be even higher— for every 5,000 compounds tested, only 5 make it to clinical trials, and only 1 eventually receives FDA approval. Only half of all experimental drugs in Phase III trials ever become approved therapeutic agents. NIH’s new proposal for the National Center for Advancing Translational Sciences is a laudable attempt to change these statistics and change the current paradigm. Creating a new center capable of working across NIH institute boundaries and transitioning such programs as the Clinical and Translational Science Awards, the Molecular Libraries Initiative, and the proposed Cures Acceleration Network is smart science. This integration of efforts will produce synergy that will benefit Americans through improved health and more efficient and effective investment of their tax dollars.
We recognize that the biotechnology and pharmaceutical industries will continue to be the primary drivers of products into the marketplace. However, we need to address the declining productivity of the R&D system in order to address the many unmet patient needs that still remain. We need to bridge the void between basic discoveries and better medicine. The steps in between discovery and application, like target validation, assay qualification, product refinement, and pre-clinical development are necessary investments to move promising new interventions to the patient. These areas of focus are often the bottleneck to moving drugs forward and exist across the drug development enterprise regardless of the disease. We believe that NIH’s proposed new center will provide a significant stimulus to moving ideas out of the lab and into the clinic and fully support NIH’s willingness to disrupt its own paradigm in search of better solutions. Isn’t that what science is all about?
We view this as a significant development for the future of getting basic discoveries translated into much needed and long awaited treatments and cures, and we look forward to the planning efforts.
Margaret Anderson
Executive Director
FasterCures
http://www.fastercures.org
To Whom It May Concern,
Thank you for the opportunity to contribute to this open forum, as well as the opportunity to participate in the phone-in discussion regarding the disposition of the Science Education Partnership Awards (SEPA) programs during this time of change and the subsequent months to follow. I appreciation the information that helps us understand the value of having the SEPA programs move to the Office of Science Education in the Director’s Office, as part of this trantsition.
Our team and area teachers have benefitted from our SEPA funding, and, for some time, we have been hosting and maintaining the SEPA website, http://www.ncrrsepa.org, under Dr. Lawrence ‘Tony’ Beck’s direction. We are currently moving forward with improving the website’s capacity and increasing functionality.
Among many things, some of the plans include:
-creating stronger more robust search engines,
-providing more user tools and member services such as forum areas for working groups with login, and other collaborative tools
-developing a place in which the general public can learn of the various programs being offered to teachers and students, as well as guests of museums, through SEPA funding,
-maintain, build, and increase usefulness of the SEPA-funded science curriculum ‘warehoused’ and/or linked to the website
This website has been, and is hoped to be, an important resource for the SEPA community, as well as the beneificiaries of SEPA programming. It is not clear yet what position NIH Office of the Director may take on moving this website along with the SEPA program, and of course there will be a need to create a new url, which might be something like http://www.nihsepa.org, for example.
In addition, when/if this website moves with the SEPA project move, there may be additional functionalities, links, etc., that this useful SEPA site could provide to benefit the OSE or the Director’s Office. And, if so, it would be beneficial to dialouge about this at some point.
Thank you again for the open discussion forums.
Sincerely,
Linda Pruski, Educational Development Specialist
Positively Aging®: Maximizing the Healthspan – SEPA Project
Teacher Enrichment Initatiaves, Department of Medicine, GGPC
University of Texas Health Science Center at San Antonio
7703 Floyd Curl Drive, Mail Code 7780
San Antonio, Texas 78229-3900
210-567-2747
Genetic Alliance supports the newly proposed NCATS because it offers an unparalleled opportunity to advance translational medicine and improve human health. Currently, there are a number of programs spread across the NIH that are tailored to the goal of translating basic research into therapeutics, including the Molecular Libraries Program, Therapeutics for Rare and Neglected Diseases Program, NIH Rapid Access to Interventional Development Program, the Clinical and Translational Science Awards, and the NIH-FDA Regulatory Science Initiative. The opportunity to reorganize these programs into a single, cohesive center promises to be a powerful catalyst for advancing translational research.
Genetic Alliance network includes more than 10,000 health related organizations, 1,200 of which are disease-specific advocacy organizations representing the millions of Americans suffering from diseases and conditions. For us there is an urgent need to bring the promise of translation to fruition. Last year, despite more than 100 billion dollars in research spending, only 20 drugs came to market. This is much too slow and needs to be vastly improved. Further, fewer than 200 of the 7,000 rare diseases have any available therapy options. The current system of therapeutic development has been failing patients and consumers for far too long and the time to transform translational medicine is upon us.
Genetic Alliance believes that the National Institutes of Health (NIH) has both the potential and the responsibility to leverage its existing and emerging programs and resources to accelerate translational medicine. The passage of the Cures Acceleration Network highlights that both the American public and Congress share this expectation that NIH will play a leading role in improving human health outcomes through translational research. The establishment of TRND is another example.
Genetic Alliance has worked with all of the Federal agencies charged with promoting the nation’s health. We determined long ago that there are enormous silos preventing the coordination essential to developing timely and robust diagnostics and therapies. We have identified steps to accelerating translational research and see the NCATS is essential for this mission. We also work with academia, biotech and pharmaceutical companies and understand the limitations of each of them, and of NIH. A coordinated effort is critical to overcome the problems inherent in drug development, particularly in these early years of precision (personalized) medicine. All entities must come together without concern for turf, and consider what truly matters. NCATS provides the opportunity to create a space and process for this to happen. NIH is upping the ante – haven’t we all heard, in every meeting: “Someone has to lead, someone has to step up!” This is it. We must all step up to help put the pieces together for a new system of translation.
We thank NIH for this bold move to embrace the ‘health’ in NIH and support translational medicine. The men, woman and children who suffer daily are depending on your leadership. I have two children with a genetic disease that will lead to blindness in adulthood. I know the pitfalls of the current system, and as leader of Genetic Alliance, I hear the cries of dying children and adults everyday from all corners of the US. It is incumbent upon us to make a difference and, as a nation we have the tools to do so. Let’s work together to realize the promise that lies before us in a multitude of sciences that are ready to come to fruition in the form of solutions for those who suffer.
Sincerely yours,
Sharon F. Terry
President and CEO
Genetic Alliance
I will support NCATS whole-heartedly provided:
1) It does not get involved in drug “development”
2) It does not go beyond phase I/II clinical trials. Leave phase III (and, of course, phase IV) for pharmas. Collaborate as needed
3) Tremendous amount of “translational research” is going on in other ICs, some are meritorious, but most are copy-cat or w/o significant rationale. Triage and bring all under NCATS
4) NCATS could potentially be a very powerful and effective IC. Focus on the translational part (basic to clinical), but not clinical trials per se (leave it to the pharma, help them as necessary)
5) Although not pertinent here, several ICs also need to be consolidated/eliminated – too much overlap all around NIH – too many interest groups (program staff and extramural scientists) lobbying for their own pet projects! Consider the old Varmus model -a dozen or so ICs – strong but effective
Scientific Adjacency or Translational Efficiency?
The National Center for Research Resources (NCRR) is about to be disaggregated, with its various pieces distributed across the NIH according to the ‘principle of scientific adjacency’. The largest single element of the NCRR, the Clinical and Translational Science Award Program, will move to the new National Center for Advancing Translational Sciences. The rationale for this move is the belief that a dedicated translational center will hasten development and application of new therapies and preventive strategies aimed at improving public health. Part of the provisional plan also calls for all programs involving nonhuman primates (the National Primate Research Centers, the Chimpanzee Resource Centers, and the other primate model resources) to be placed in the Director’s Office in an ‘interim infrastructure unit’. The rest of what was formerly included in the Division of Comparative Medicine (DCM) will be parceled out to other NIH Centers and Institutes in a manner yet to be decided.
As the director of one of the nation’s oldest academic primate centers and as my institution’s head of Comparative Medicine, I see the disintegration of the DCM as detrimental to the advancement of translational research that a dismantled NCRR is designed to accomplish. It is true that the proposed interim infrastructure unit will maintain the contiguity of primate research resources. However, the academic discipline of comparative medicine – as represented by our program and those at other universities and medical centers – is not species specific. Rather, comparative medicine comprises veterinary scientists dedicated to the premise that suitable animal models can be discovered, developed, and applied to investigate virtually all diseases of public health relevance. Importantly, comparative medicine research is inherently translational because it enables the movement of hypotheses derived from basic science and clinical and epidemiological investigations into animal platforms that can model probable human outcomes, elucidate underlying mechanisms of disease, and identify potential therapeutic targets. Not surprisingly, the history of comparative medicine research and its translational contributions reflect a range of model organisms of many types – including rodents and nonhuman primates of course – but extending also to non-mammalian species.
The primary programs contained within the currently configured DCM include resource grants that facilitate the development and application of a broad spectrum of animal models, informatics resources that increase the utility of the large genetic and genomic databases required to make systems biology a reality, and research grants (R01s and R21s) that improve the ability of the NIH categorical institutes to conduct disease-specific investigations. Additionally, the DCM provides the support (T32, T35, R25, and K award mechanisms) necessary to train each new generation of veterinary scientists, whose expertise, participation, and clinical understanding are required to facilitate the conduct of translational research using animal models. History demonstrates that DCM programs and activities have enabled the NIH’s categorical institutes and centers to exploit the full translational continuum of animal models and thereby enhance human health and well-being. Based on the foregoing realities, I would argue that the infrastructure, animal models, research, and training activities comprising the DCM should be kept together, not because of scientific adjacency, but rather in the interests of both translational science and administrative efficiency.
Francis Collins, M.D., Ph.D.
Director, National Institutes of Health
Dear Dr. Collins,
I direct the BioQuest program at Seattle Biomedical Research Institute-including a SEPA-funded project wherein we are investigating the cross-section of rigorous content and and global health themes with the goal of mobilizing students of diverse backgrounds towards biomeedical careers in infectious disease research.
I appreciate the diligence and innovation demonstrated by NIH members in establishing National Center for Advancing Translational Sciences. I too am expressing strong support for the placement of the SEPA program in the Office of the Director, linked to the Office of Science Education—So much of the SEPA community’s efforts in transparency, advocacy, education and explicit training result in widespread beneficial outcomes across the NIH community as well as national literacy.
This year our independent research institute transitioned from a solely discovery research agency, to one that proudly engages in clinical research, with the launch of its Phase I malaria vaccine. The Malaria Clinical Trials Center includes BioQuest in its repertoire of appreciated stakeholders engaged, as over 900 students and teachers annually come through our programs to see the challenge and the hope offered in discovery and translational research. Across our organization, we thank you for your commitment to SEPA, SEPA programs and to precollege outreach. We dare to hope that this will be a year for both malaria diminishment and SEPA funding expansion. Thank you for your consideration.
Regards,
Theresa Britschgi, MS
BioQuest Director
“BioQuest Academy” SEPA PI
Seattle BioMed
I am also concerned with the placement of the National Primate Research Centers into an interim Infrastructure Unit. Since biomedical research conducted in nonhuman primate models is by definition “translational research”, the appropriate institute for the Primate Centers is within the new National Center for Advancing Translational Sciences (NCATS), together with the CTSCs. The research that my laboratory has been conducting for nearly 20 years at the California National Primate Research Center at UC, Davis in the areas of nutrition, obesity, and diabetes is strongly translational in nature and several findings we have made from experiments in rhesus monkeys have been followed up shortly after with clinical studies in humans. In addition, the Primate Centers are a critical resource for the pharmaceutical/biotechnology industry to engage in collaborative studies with academic investigators to validate new drugs and other treatments in nonhuman primates before comparatively much more expensive human trials are initiated.
Thank you for your consideration.
Peter J. Havel, DVM, PhD
Departments of Molecular Biosciences and Nutrition
University of California, Davis
Dear Dr. Collins and Dr. Tabak,
Thank you for engaging the NCRR community in a very transparent process through this transition. My comment is focused on the value and rightful placement of the SEPA program in the Office of the Director as well as the new opportunities that arise for interagency collaboration between NIH and NSF.
As education and outreach professionals it is in our, and the Nation’s, interest to promote scientific advances, improve the public’s awareness of the benefits and potential of scientific innovation, and foster a new generation of highly capable STEMM (Science, Technology, Engineering, Mathematics, and Medical) professionals.
There appears to be a growing reluctance from Congress, and the public, to fund science, technology and medical advances because of a lack of understanding of the benefits derived. We in the research community have developed myriad ways of engaging and educating students and the public, in formal and informal settings, yet our message is either not clear enough, not compelling, and/or just not reaching the majority of the population. Most people are inherently motivated to learn about innovations/discoveries that will have an impact on them – their body and health, lifestyle and recreation, family, nearby community, or pocketbook – yet the majority of innovations/discoveries that we bring to the public are either very distant from their everyday experiences, part of a “sea” of conflicting results, or a long way from having an impact on what they care about. The general expectation seems to be that science, technology and medical advances should have an immediate impact, a quick “return on investment.” As a community we have not been clear with the public about the real process of research and the path to products and impacts they can experience – an often arduous path that depends equally on research results/innovations, capital investments, regulatory systems, and business know-how.
Since both the NIH and the NSF are fundamentally here to improve the human condition and promote the generation of knowledge, it might be time to unite forces and share what we know about communicating with the public and with members of Congress. Since one of the primary NIH programs that communicates regularly to students and the public is SEPA, and SEPA is proposed to become part of the Office of the Director, this could be a prime opportunity to connect with the NSF Office of the Director, the NSF Office of Integrative Affairs, and the NSF Office of Legislative Affairs and share lessons learned and approaches to communicating the benefits of a strong research enterprise in the US within agencies, across agencies and with the public. Such an exchange should involve members of the funding agencies, select grantees whose job is to bring research to the public and educational system, and representative members of the public (potentially including congressional staffers). As the agencies cannot lobby for themselves but grantees and outside organizations can and do, involving such groups in the discussion may also prove fruitful.
Joining forces we can learn from each other and dramatically improve the way in which we communicate the value of scientific research/innovation and the path from research results to impactful products and activities. Additionally, we can share fruitful approaches to engaging students with the process of research, innovation and entrepreneurship, increasing our chances for a strong, and meaningful, future economy.
Marco Molinaro, Ph.D.
Chief Education Officer, Center for Biophotonics Science and Technology
PI of SEPA SBCE (Science, Biostatistics, and Cancer Education)
Associate program director for K-16 outreach of the UCD CTSC
University of California, Davis
I direct the Center for Public Health and Community Genomics at the University of Michigan School of Public Health. We are currently implementing a SEPA project, “Education for Community Genomic Awareness.”
I’m expressing strong support for the placement of the SEPA program in the Office of the Director, linked to the Office of Science Education. This placement should enable the SEPA program to achieve greater visibility among all NIH Centers and Institutes, facilitating relationships between them.
Our own SEPA project is an example of the way SEPA programs bring to students and adults an understanding of scientific research being conducted and funded by NIH units. Together with our School of Education we have developed a modern genomics educational unit now being enacted in Detroit and Flint public schools. The curriculum highlights the relationship between genomic research and community health, and is used to engage communities served by the schools as well as the high school students. In addition to student and community engagement in genomics, the program has been stimulating interest among inner-city minority students to consider careers in science.
Our program is one example of the way that SEPA programs advance the agendas of multiple NIH units – in our case, the National Human Genome Research Institute, the National Institute on Minority Health and Health Disparities, and the National Cancer Institute. SEPA programs thus bring NIH science closer to the public and to students of all ages, furthers their understanding of the way this research advances community health, and connects the agendas of multiple NIH units in carrying out these activities.
Situating SEPA in the Office of the Director, linked with the Office of Science Education, will facilitate these relationships, advance the agendas of NIH units, foster development of a new generation of scientists reflecting the diversity of the U.S., and help build public support for NIH research.
I have been a scientist at a National Primate Research Center for 35 years and served as director of that center for more than ten years. I am currently director for translational technologies and resources in the CTSA program at the same institution. I have also been a grantee and a reviewer of grant applications for NCRR. The flow of information from basic science to clinical practice in NCRR programs has been exciting and very gratifying for many of us who do fundamental research to improve human health and quality of life.
The portfolio of programs in NCRR has provided the infrastructure for the process of translational science for many years. This infrastructure is much more than buildings and administration; it has enabled cutting-edge research and essential training for scientists, clinicians and veterinarians to provide for interdisciplinary programs in the future. It has served as the substrate on which much of the work of NIH’s categorical institutes is nourished and cross-disciplinary projects are catalyzed. The addition of the CTSA program has given additional energy to the process. The accomplishments of NCRR are due in no small degree to the relatively seamless coordination of inter-connected programs. The committed staff of NCRR have been instrumental in this success.
At my institution we have benefitted greatly from synergies supported by NCRR to advance translational research. Grants and supplements from NCRR have enabled construction of an research animal vivarium in close proximity to clinical programs to enhance access by clinical investigators, funded projects that entail parallel studies of human subjects and nonhuman primate models to investigate genetic risk for disease, allowed for purchase of high end instrumentation that serves both clinical and basic science investigators, encouraged pooling funds for collaborative pilot projects across disciplines, leveraged institutional support and promoted the development of informatics systems that manage data and improve access to information. We have been perhaps unusually fortunate at our university, but we are not unique and other institutions have had similar successes through NCRR programs.
I fear that dismantling NCRR will impede the kind successes that are being accomplished in the present organization. I recognize the political advantage that comes from establishing a new center named explicitly for accelerating translational science, but to realize such acceleration will require careful orchestration of disparate essential programs. The NCRR has been doing a pretty good job of this. What is the anticipated benefit of separating the comparative medicine program from the CTSA program? New drugs and devices certainly need to be tested in animal models before they are tried in humans. The function of various genes is usually discovered in animals before their role in human health and disease is understood. Fragmentation of NCRR is a very risky step to take. I plead for very careful consideration of strengthening the existing structure rather than taking it apart and losing the synergy that has been made possible by the current adjacency of programs within NCRR.
Monday January 24, 2011
Francis Collins, M.D., Ph.D.
Director, National Institutes of Health
Dear Dr. Collins,
I am writing to recommend that NIH continues to administer the Institutional Development Award (IDeA) and the Research Centers in Minority Institutions (RCMI) Programs, currently managed by the National Center for Research Resources (NCRR), as two entities with their current missions in one NIH Institute. The IDeA and RCMI Programs have been extremely important in developing researchers and infrastructure in areas such as Puerto Rico that have historically received limited NIH funding. I am also supportive of the idea to create an NIH Institute dedicated to translational research since I believe it will contribute to speeding up the application of bench research findings to treatment of diseases, which is what the public wants and needs.
As a Program Director for the NIGMS MBRS RISE Program at the University of Puerto Rico Medical Sciences Campus, I can attest to the impact these two programs, but more so the RCMI Program, has had in student and faculty research development in our institution, both in basic and clinical sciences. Our researchers, mostly graduate, undergraduate and professional students, have received invaluable core laboratory support through the RCMI Program, that has allowed them to develop their research careers. The opportunities to train in the use of state of the art equipment provided by the RCMI program has allowed many of them to move on to competitive postdoctoral positions in the US mainland. The training and technical support received by our core laboratory personnel by many of our mainland collaborators have allowed us to pursue projects that address major health problems that impact minority populations more frequently as well as more common diseases that affect the US population as a whole.
For these reasons, we would like the RCMI Program to be placed in the proposed Interim Infrastructure Unit together with the IDEA programs, rather than the NIMHD, in order to keep the focus on improving infrastructure and the development of researchers, rather than limiting the focus of these valuable programs. Lumping all programs that benefit minority institutions in one institute is not the best way to support minority institutions and researchers, because it would be sending the wrong message, that minority institutions should dedicate themselves primarily to study minority health problems.
We thank the NIH Institutes that have provided research support to our institution and the NCRR for their valuable support of the research infrastructure of our campus, and urge caution in the proposed dismantling of a fine institution that has served the research community so well during its existence.
Thank you for allowing us to comment on the proposed changes at NIH.
Sincerely,
Carmen L. Cadilla, Ph.D.
Professor, UPR School of Medicine
MBRS RISE Program Director
RCMI Activity Coordinator
Medical Sciences Campus
My name is Dawn Martell, I teach Biology and Biotechnology at Wilmington High School in Wilmington Massachusetts. I have taught Biotechnology for the last twelve years and have had the unique opportunity to bring my students to Boston University CityLab SEPA Program in Boston for the last ten years. It has also been my good fortune to work with two excellent resources for both teachers and students, namely the Director Don DeRosa and Carla Romney.
CityLab is an essential part of our Biotechnology program, each semester the Biotechnology class looks forward to attending CityLab, here students have the opportunity to work in a professional laboratory setting and immerse themselves in a “hands-on” laboratory investigation, including role-play and student centered learning activities. This opportunity not only provides the students with valuable knowledge and experience but also has served to inspire some students to pursue a career in the science, something that has been recognized as a serious need.
Please continue the necessary funding so that CityLab can continue to offer their valuable support to the students throughout New England.
Thank you for your consideration.
Dawn Martell
Wilmington High School
Wilmington, Massachusetts