|
|
HOUSE AND SENATE APPROVE NEW BILL EXTENDING FDA AUTHORITY
A bill that amends the Federal Food, Drug, and Cosmetic Act and extends U.S. Food and Drug Administration authority regarding drug safety was passed by The U.S. House of Representatives September 19 and the Senate September 20. President Bush is expected to sign the bill into law shortly
The bill contains a number of NIH-specific provisions that:
We will keep you informed of implementation plans and progress in future editions of the
NIH Extramural Nexus.
Back
to top
|
|
|
|
|
|
|
|
|
COMMUNICATE
WITH THE
NIH EXTRAMURAL NEXUSWE WANT TO HEAR FROM YOU
Feedback from recipients and subscribers of the
NIH Extramural Nexus is vital. Comments,
questions, and suggestions for topics will enable
Nexus editorial staff to deliver appropriate
content to the grantee community.
Back
to top |
|
|
This Issues Printer-Friendly Version
(Adobe® Reader®
Required) |
|
|
NEWS FROM THE DIRECTOR OF OER:
Creating and Maintaining a Sustainable
Scientific Workforce |
Dear
Extramural Community, One of the most important aspects of my job is to
hear your concerns, and to the extent that I am able,
address them so that you can continue to conduct
the groundbreaking biomedical research that in this
21st century will help us predict and prevent disease
and personalize treatments. In the last two years, I have heard
increasing concern for the health of the “the pipeline”—the new
generation of investigators that will make the discoveries of the future.
And many of you tell me that you are unable to recruit and retain the best
minds to conduct research.
I can assure you that the NIH remains committed
to the support of a stable and sustainable scientific
workforce. Like you, we are concerned about
the health of the pipeline and the aging of
the NIH Principal Investigator (PI) pool. Will
we have enough new investigators to carry out
the health-related research of the future? It is clear that the age
distribution of the
pool of NIH PIs with research project grants
has changed tremendously. Of particular interest
is the relationship of NIH-funded PIs to the
age distribution of medical school faculty,
from 1980 to 2006,using data supplied by the
Association of American Medical Colleges (AAMC).
The average age of NIH PIs increased from 39.1
to 50.8 over the period from 1980 to 2006. The
average age of medical school faculty increased
from 43.1 to 48.7 over the same period. The NIH has attempted several interventions over the years to ensure a sufficient cadre
of new investigators into the biomedical investigator
pool.
These include the New Investigator Research Award (NIRA), the FIRST
Award and most recently, the New Investigator Check Box. Other
interventions include the Pathway
to Independence Award and the
Director’s Innovator Award. In fiscal year (FY) 2007, based on historical trends, the NIH established a target of 1,500 new R01 investigators in an
attempt reinvigorate the new investigator pool, which in FY 2006 had
declined to a nine year low.
Data recently published by Howard Garrison and Kimberly McGuire of
the Federation of American Societies for Experimental Biology (FASEB)
provide additional insights. In recent years, graduate enrollments have
increased and the number of doctoral
degrees conferred has climbed
rapidly along with the number of biomedical
postdocs. Of note, the
postdoc increase is driven by steady increases in the total number of
international scholars—an increase of about 1,000 per year since 1980.
Furthermore, the supply of individuals with sufficient training to consider
academic track positions is increasing even though the numbers who
find their way into tenured faculty positions is declining. The decline
seems to be related in part to fewer available employment opportunities
in academia, partially compensated by an expansion of industrial jobs.
The decline may also be related to a decline in tenure
and tenure track positions as a proportion of all academically employed Ph.D.s In United
States medical schools, Ph.D. faculty numbers seem to be declining for
the first time since 1970, based on information provided by AAMC.
What percent of the overall biomedical research workforce should be
comprised of new investigators to ensure a vigorous biomedical research
enterprise? We are all struggling to answer this seemingly simple, yet
difficult question. As we think about the broader health-related scientific
workforce and about matching the supply of new graduates and
international postdocs with the demand for expansion of the biomedical
research workforce and its replacement needs, it is clear that we need
more information. The academe accounts only for about one-half of the
total academic and non-academic workforce, and PIs probably account
for about one sixth of all the individuals involved in NIH extramural
research. We need to know more about the entire demand from this
enterprise; and we need to know about clinicians, which I haven’t
discussed at all here.
The NIH is now engaged in an aggressive effort to collect relevant
information. One particular effort involves looking at key personnel
involved in the research supported by NIH grants in FY 2006. The
findings will inform methods for collecting similar data on an ongoing
basis. We are also developing workforce models to determine if we can
create simulations that will help identify points of sensitivity that might
inform future policies. Professional societies, health-related companies,
universities, faculty, postdocs, and students can all play a role in this
data gathering exercise, and we will be asking for help over the next
several months. The new information will be made available to the
community and considered in the quadrennial research personnel needs
study conducted by the National Academies of Science. I know that we
are all interested in a stable, efficient and productive biomedical research
workforce. I am looking forward to working with you toward that end.
If you have comments or questions please write to me at DDER@NIH.
gov.
|
Norka Ruiz Bravo, Ph.D.,
Director, Office of Extramural Research and NIH Deputy
Director for Extramural Research |
Back
to top |
IN THEIR OWN WORDS |
An Interview with OPASI Director Dr. Alan Krensky |
Editors note: Welcome to a new feature in the NIH Extramural Nexus,
where on an occasional basis we will showcase interviews with NIH
leaders.
An Interview with OPSAI
Director Dr. Alan Krensky: “I want to show
value added to the NIH”
The NIH Extramural Nexus met September
13 with Alan M. Krensky, M.D., NIH deputy director
for the Office of Portfolio Analysis and Strategic
Initiatives (OPASI). Dr. Krensky leads OPASI,
a newly established office in the NIH Office
of the Director that will help identify important
areas of emerging scientific opportunities and
public health challenges. OPASI will help accelerate
investments in these areas to make sure new
ideas have a chance to develop. Dr. Krensky
came to the NIH from Stanford University where
he served both as a researcher and an
administrator (see the NIH Record, February 9, 2007, page 3).
What are your priorities as the first director of this new office at the
NIH?
I think the important word is “new” office, and I am a “new” director. Dr.
Zerhouni’s vision of the Roadmap, portfolio analysis, strategic initiatives,
and evaluation are ideas that resonate for me. I wholeheartedly believe
in that construct. So the simple answer to your question is that I want to
show value added to the NIH through portfolio analysis, strategic
initiatives, and evaluation. Other than these, there is no one particular
area on which I will focus, other than those that the Institute and Center
(IC) directors have chosen for the Roadmap.
Please define knowledge management and discuss
how successful knowledge management will help
NIH in its mission to improve the public health.
Knowledge management is a tool for portfolio
analysis. What does the NIH spend its money
on? Each IC historically has accounted for that
using it own definitions, its own rules, its
own methodologies. What Congress and stakeholders
have said for some time now is that it is better
to have one system that is communicated the
same way each time and that can be duplicated.
Knowledge management itself consists of computer
systems that have to do with how you deal with
data. How you go about taking grants and giving
them a particular “fingerprint” (just like a human fingerprint) that
will identify what a grant is about and then how you use that
information—this represents the cutting edge of information sciences.
The techniques and technologies are still evolving. What is done with
that information, be it by stakeholders, Congress, or the ICs, is up to
each of those groups. OPASI is about providing this functionality. It is
about having one system that is credible, reproducible, transparent, and
available.
How would you describe OPASI’s relationship
to the extramural community—both the internal
extramural staff and the external research community?
This raises many issues. One issue for me is the concept of boundaries.
OPASI is going to work across boundaries—in the intramural community
and the extramural communities, both inside and outside NIH. When you
say extramural, per se, I go back to portfolio analysis, strategic
initiatives, and evaluation.
In terms of portfolio analysis, folks will
be able to see not only where their IC stands
but also the whole NIH—where there may be gaps, where
there may be redundancies. This should be very helpful for the
extramural community.
As for strategic initiatives, the Roadmap itself
is a learning laboratory where, in a sense,
we are doing experiments. The Pioneer Awards
program is an example of one experiment. This
program has been very successful and now some
of the ICs want to have one of their own.
In
terms of evaluation, evaluations help to determine
policies. If something works well, we should
do it. If it does not work well, we should rethink
it or redo it. ICs have already done a lot in
this area, and I believe that OPASI will enhance
the effort.
All three arms of OPASI have relevance
for the extramural community both here at NIH
and for the outside world. For example, we just
announced
nine new research consortia that will
be our proof of principle on this (see related
article NIH
Interdisciplinary Research Consortia Launched in this issue). These consortia are
what OPASI is all about.
The consortia forge
new disciplines made of a spectrum of people,
broadbased teams working together as a single
discipline. It’s meant to be a
paradigm shift, not that it wasn’t happening already. But by making this a
Roadmap initiative, it will gain the recognition it should have as a model.
ICs are already doing this by bringing their interdisciplinary people
together. We are seeing ICs coming together in new ways. There is a lot
of collaboration, a lot of coordination.
Now that OPASI is formally established, what
difference might NIH extramural grantees (scientists
and institutions) notice in their interactions with NIH?
Because of what is going on in science, we have to analyze our portfolio.
I believe in a portfolio of large, medium, and small and a balance. This is
not to the exclusion of R01s. R01s are still the major mechanism for
supporting science.
We have an expert evaluation team in OPASI
and its efforts are extremely important in deciding
if the process is good and if the outcome is
appropriate.
The establishment of OPASI represents
something “new under the
sun” in the planning and managing of the NIH research portfolio.
As is normal with any organizational change, anxieties arise. How
are you addressing these concerns?
I personally don’t think there is anything "new under the sun." What
attracts the sunlight at different times may vary. All these ideas have
been percolating and all these functions have been done before; but they
have not been brought together into one office in the Office of the
Director. What is different is that NIH is bringing these functions together
in a central coordination effort to do what the ICs feel, in the end, is value
added. This is not top down. It is not manipulating 27 ICs. It is really
seeing where there is commonality, where there are places to work
together. When I use my hands in explaining OPASI’s function, I use
them like this. Note: Dr. Krensky put his arms out waist high, palms up,
as if he were supporting something important.
There will be change, but it will be change
for the better, change managed in the direction
that the community defines as the right way
to go. There is outreach at every level, intramural
NIH, extramural NIH, Congress, stakeholders,
professional societies, and advisory committees
to the ICs. I think the idea of portfolio analysis
resonates with everyone; the idea of strategic
initiatives resonates with everyone. I am finding
tremendous support for the Roadmap initiatives
and understanding in the community that the
Roadmap is a learning laboratory for short-term
projects that we will test and, if they work
well, support for use broadly.
We are about
the approach to science, the process, and the
ICs working together. The process is just like research, and OPASI is a special place
where ICs can cooperatively come together to manage the process.
OPASI is institutionalizing a lot of what was already going on at NIH in
terms of cooperation and collaboration—putting an institutional structure
together to serve as a lightning rod to bring people together.
Visit the OPASI
Web site for more information
on the organization, its three divisions and
its mission.
Back
to top |
NEW RESOURCE FOR ADVANCING INNOVATIVE TECHNOLOGIES JOINS THE COMMERCIAL ASSISTANCE PROGRAM |
Moving a promising technology
from bench to bedside entails an arduous trek for
NIH licensees and
SBIR/STTR awardees. As part of
continuing efforts to foster the development and
entry into the marketplace of new technologies,
NIH recently launched the
Pipeline to Partnerships (P2P) Web-based
resource.P2P is a searchable database
of technologies available for development
opportunities that allows NIH licensees and
Small
Business Innovation Research/Small Business
Technology Transfer (SBIR/STTR) awardees to showcase
their technologies for an audience of potential
strategic partners and investors. P2P will further
advance emerging technologies by facilitating
partnerships with potential investors to share
costs, infrastructure and expertise. All
submissions by licensees and grantees will be on a
voluntary basis, with no endorsement or direct
involvement from NIH in the partnering.P2P
joins the
Commercial Assistance Program (CAP), now in
its fourth year. CAP
helps NIH SBIR Phase Two awardees with business
and strategic planning.
NIH recently
announced the CAP for 2002-2007 SBIR
awardees. About 75 participants will be selected
to attend training workshops and mentoring and
consulting sessions. Selected participants will
receive individualized assistance in areas such as
strategic
business planning, regulatory approvals, preparing
an investor brochure, establishing licensing
opportunities, and investment and strategic
partnerships. The program also includes a
forum for companies to present their business
opportunities to potential investors and partners.
Questions about these programs may be directed to
sbir@od.nih.gov.
Back
to top |
THE NIH SYSTEM FOR ENHANCING THE SCIENCE, SAFETY AND ETHICS OF RECOMBINANT DNA RESEARCH |
The techniques of
recombinant DNA have revolutionized biological research since their
development over 30 years ago, enabling many critically important research
methods and products. Although controversial when first developedand to
this day raising many important scientific, ethical and safety
considerationsour experience with this technology has been positive,
thanks in large part to the biosafety standards found in the
NIH Guidelines for Research Involving Recombinant DNA Molecules
(NIH Guidelines). Institutions receiving any
NIH funding for research involving recombinant DNA must adhere to the
NIH Guidelines and apply them to all research involving
recombinant DNA, regardless of funding source. This is sensible since, for
biosafety and containment practices to be maximally effective, they must be
uniformly observed.These institutions are
required to establish an Institutional Biosafety Committee (IBC) to review,
approve, and oversee research subject to the NIH Guidelines. They
must also register the IBC with the NIH Office of Biotechnology Activities
(OBA), which is responsible for overseeing implementation of the NIH
Guidelines. More information on IBCs can be found in
Frequently Asked Questions (FAQs) on
OBAs Web site.Putting recombinant DNA into
humans raises special safety and ethical considerations. These are detailed
in
Appendix M of the NIH Guidelines, which specifies points to
consider in the design and submission of human gene transfer trials to NIH.
Trials raising notable scientific, safety or ethical considerations may be
selected for public review by the NIH
Recombinant DNA Advisory Committee. Once a trial is initiated,
additional information is to be submitted to NIH, including reports of
serious adverse events. More information about Appendix M requirements can
be found on OBAs Web site in a set of
FAQs regarding protocol review.Investigators are encouraged
to report adverse events using the
Genetic Modification Clinical Research Information System. This system
provides an online reporting format enabling the creation of reports that
can be submitted electronically to the NIH and that can also be sent to the
FDA and institutional oversight committees.Careful adherence to the
NIH Guidelines will help ensure that our experience with recombinant
DNA will prove equally positive into the next 30 years. Toward that end,
NIH is developing modifications to the grant application that will address
recombinant DNA research and help identify studies for IBC review and
oversight. In the meantime, investigators and administrators are encouraged
to
contact OBA for guidance on how they can ensure compliance with the
spirit and the letter of the NIH Guidelines.
Back
to top |
NIH POLICY FOR GWAS DATA SHARING ANNOUNCED |
The NIH achieved a major milestone in the
development of personalized medicine with the
release of a new policy, published at the end of
August and focused on
sharing data from genome-wide association studies
(GWAS).
A genome-wide association study is any study of
genetic variation across the entire human genome
that is designed to identify genetic associations
with observable traits (such as blood pressure or
weight), or the presence or absence of a disease
or condition. The GWAS sharing policy is a new
component of NIHs overall research-sharing
policies, which include
data sharing,
model organism sharing and
resource sharing.
Whole genome information, when combined with
clinical and other phenotype data, offers the
potential to identify common genetic factors that
influence health and disease, to increase
understanding of basic biological processes
affecting human health, and to improve disease
prediction and patient care. Therefore, the NIH
GWAS policy is intended to facilitate sharing of
genetic data and information from GWAS, while
protecting research participants in GWAS and their
genetic information from potential harm.
The new policy applies to competing grant
applications and proposals for contracts that
include GWAS and are submitted to the NIH for the
January 25, 2008 and subsequent receipt dates, and
to NIH intramural projects approved on or after
January 25, 2008. An application or
proposal will be identified as including
GWAS by applicants and/or NIH staff.
Information about the policy, answers to pertinent
questions, and an explanation of the public
consultation process are available on the
NIH GWAS Web site.
Detailed implementation guidance will be provided
for the extramural community in the coming months
through various resources, including the
NIH GWAS Web site and future editions of the
NIH Extramural Nexus.
Please direct any questions or comments related to
the GWAS sharing policy to
GWAS@mail.nih.gov.
Back
to top |
POWERFUL AWARD TREND RESOURCE
IN THE WORKS |
Have you ever wondered which
applications were awarded for a specific Funding
Opportunity Announcement (FOA) or wanted to know
the award dollars break down by FOA type for a
specific NIH Institute or Center?The NIH Office of Extramural
Researchs Division of Information Systems is
building a powerful new resource to its
Award Trends Web site that puts this type of
reporting right at your fingertips. Check out
Total Award Dollars by Type of Funding Opportunity
Announcement FY 2006 and 2007.
This tool was created in
response to research community requests for
greater transparency in award funding and easier
access to reporting data.
We expect to improve the tool based on your needs. Direct your
questions, comments or suggestions
on this work in progress to
DISHelp@mail.nih.gov.
Back
to top |
EYE ON PI |
NIH Educational Debt Repayment Available to Ph.D. Research Scientists |
NIHs Loan Repayment Program
(LRP) recently announced its
Strength in Numbers campaign, which offers
a renewed commitment to qualified postdoctoral
scientists who are seeking careers in biomedical
and behavioral research. The program funds up to
$35,000 annually in educational loan repayment.Not limited to NIH grantees,
any research scientist may take advantage of the
LRP. To qualify,
applicants must possess a doctoral-level degree,
devote 50 percent or more of their time to
research funded by a
nonprofit
organization
or government entity and have educational loan
debt equal to or exceeding 20 percent of their
institutional base salary. Applicants must also be
U.S. citizens or permanent residents.Visit the
NIH LRP Web site for more details and to
apply. For additional information or questions,
contact
Suman King.
Back
to top |
|
From Commerce to the Community:
New Patent Rules Issued |
In
the
August 21, 2007 edition of the Federal Register,
the United States Patent and Trademark Office
(USPTO) announced its final rules on patent claim
examination and continuation applications. The
USPTO expect the rule to to
improve the effectiveness and efficiency of patent
examination. Highlights of these
rule changes are available at the USPTO and
have an effective date of November 1, 2007.
Many NIH-funded institutions, from R01 to Small
Business Innovation Research (SBIR) grantees,
pursue patenting of their discoveries made under
federal funding. However, the long-term costs and
effects of these rule changes on biotechs,
universities, and nonprofit institutions continue
to be discussed in the community.The
USPTO is the federal agency in the Department of
Commerce that grants U.S. patents to inventors who
have successfully convinced the USPTO that their
discoveries are patentable. It is charged with
promoting the progress of science and the useful
arts by securing, for limited times, to inventors
the exclusive right to their respective
discoveries.
The USTPO has a
glossary of terms available.For additional information, contact The Office of Patent Legal
Administration by telephone at (571) 272-7704, by mail addressed to: Mail
Stop CommentsPatents, Commissioner for Patents, P.O.Box 1450, Alexandria,
VA 22313-1450, or by FAX to (571) 273-0100, marked to the attention of the
Office of Patent Legal Administration.
Back
to top |
|
Principal Investigators eRA Commons Account |
Did you know that Principal
Investigators (PIs) are assigned one
eRA Commons account that follows them
throughout their entire careers? With more and
more grant administration tasks moving away from
paper in favor of electronic alternatives, proper
maintenance of your eRA Commons account is
critical. Here are a few tips:
|
If you change institutions, provide your eRA
Commons User Name and the email address listed in
your Personal Profile to the business office of
your new institution and ask them to affiliate
your account. Your account can be affiliated with
multiple institutions. Each institution will be
able to view your history within that institution.
You will have access to your full history at all
institutions. |
|
Whenever your personal information (e.g., email
address, phone, address, employment history,
degree) changes, take a few minutes to review and
update your eRA Commons Personal Profile
information. |
|
Keep your email address current. Not only is the
email address used for certain NIH notifications,
the email address in your profile is used if you
need to take advantage of the Forgot Password?
link beneath the login fields on the
eRA Commons home page. |
Back
to top |
|
Multiple PI Update |
Since the inception of the
NIH policy to allow
multiple Principal Investigators
on grant applications in February, NIH has
received more than 1,800 applications.To date, NIH has made approximately 50 multiple PI
awards and expects to make more in fiscal year 2008. The program will be evaluated as part of the
Roadmap Interdisciplinary Research initiative,
and, in a future NIH Extramural Nexus,
we will provide an update on the multiple PI
initiative.
Back
to top |
ELECTRONIC SUBMISSION UPDATE |
Updated Application Guides Now
Available |
The U.S. Department of Health and
Human Services Public Health Service
Grants.gov
Application Guide SF424 (R&R)
and the corresponding
Grants.gov
SBIR/STTR Application Guide
have been updated to include additional guidance
on dealing with subaward budgets, recent policy
change to exclude federal holidays from the two
day application viewing window, and suggested
clarifications from the applicant community (see
summary of
changes).
We realize posting an updated application guide
close to a major R01 grant application submission
deadline may cause some anxiety. However, the
updates simply incorporate previously announced
policy and applicant-suggested clarifications into
a single
information source.Thanks to all the applicants
who took the time to provide feedback on the
application guide. Keep the feedback coming. Email
the NIH Electronic Submission team at
NIHElectronicSubmiss@mail.nih.gov.
Back
to top |
|
Future Electronic Submission Transitions Still on Hold |
The transition of NIH
Training Grants (T), Career Development Awards (K)
and Fellowships (F) to electronic application
submission remains on hold until Grants.gov can
develop new forms. Grants.govs current focus at
the current time is on finalizing Adobe® versions
of all existing forms and incorporating additional
federally mandated data fields into existing form
sets.
Back
to top |
|
Use of Adobe Forms |
NIH will continue to use
PureEdge forms at least through March 2008 grant
application submission deadlines. Grants.gov deployed
an updated system on September 4 that incorporates
new search functionality powered by Google
technology and allows for the use of fillable Adobe
forms®. Although some Grants.gov Adobe forms are now
available for agency use, NIH is still awaiting the
final Adobe forms to complete the SF424 (R&R) form
set used by NIH for electronic application
submission.Once Grants.gov delivers the
full set of Adobe forms, NIH will need to test and
make any necessary adjustments prior to their use.NIH will post its plans to
transition to Adobe forms in the
NIH Guide for Grants and Contracts, when they
are finalized.
Back
to top |
ROADMAP UPDATE |
NIH Director Announces Recipients of New Innovator Award |
NIH Director Elias A. Zerhouni, M.D. September 18
announced the recipients of the
NIH Director's New Innovator Award, a part of the
NIH Roadmap for Medical Research.
The NIH Director's New Innovator Award addresses two important goals:
stimulating highly innovative research and supporting promising new
investigators. Many new investigators have exceptionally innovative
research ideas, but not the preliminary data required to fare well in the
traditional NIH peer review system. As part of NIH's commitment to
increasing opportunities for new scientists, it has created the NIH
Director's New Innovator Award to support exceptionally creative new
investigators who propose highly innovative projects that have the
potential for unusually high impact.
This award complements ongoing efforts by NIH and its institutes and
centers to fund new investigators through R01 grants and other mechanisms.
The 29 New Innovator Award recipients will each receive $1.5 million in
direct costs over five years.
Back
to top |
|
NIH Directors 2007 Pioneer
Awardees Announced at Symposium |
The NIH September 19 held its third annual
NIH Directors Pioneer Award Symposium. It
featured research talks by the 2006 Pioneer Award
recipients, poster presentations by the 2004, 2005
and 2006 awardees, and
announcement of the twelve 2007 awardees.
The NIH Directors
Pioneer Award programa key component of the
NIH Roadmap for Medical Researchsupports
exceptionally creative scientists who take highly
innovative, and potentially transformative
approaches to major challenges in biomedical
research.The symposium was streamed live over the
Internet via
NIH VideoCasting and is now
archived for viewing.
Back
to top |
|
NIH Interdisciplinary Research
Consortia Launched |
NIH has announced that its
Roadmap for Medical Research will fund nine interdisciplinary research
consortia as a way to integrate aspects of different disciplines to address
health challenges that have been resistant to traditional research
approaches.Funded at $210 million over five years, the consortia
consist of multiple research projects with multiple principal
investigators, core research support facilities, training, career
development, and education components. These components will be divided
among several NIH Institutes and Centers for programmatic oversight. To
maintain the interdisciplinary research program as a whole, the grants will
remain linked electronically through unique identifiers, and the National
Center for Research Resources (NCRR) and the
Office of Portfolio Analysis and Strategic Initiatives (OPASI) will
oversee the entire program.Complete information is available in the official
Research Consortia Launch press release.
Back
to top |
|