Cooperative Research and Development Agreement (CRADA) Opportunity With the National Heart Lung and Blood Institute and Licensing Opportunity for Development of Multi-Domain Amphipathic Helical Peptides for the Treatment of Cardiovascular Disease, 8702-8704 [E8-2750]
Download as PDF
<![CDATA[
8702
Federal Register / Vol. 73, No. 31 / Thursday, February 14, 2008 / Notices
will be measured at baseline and at a
final follow-up visit 15–24 months after
the baseline visit. A DNA sample will be
obtained once at the baseline visit to
assess three key iron protein
polymorphisms. Donors will also
complete a self-administered survey
assessing past blood donation, smoking
history, use of vitamin/mineral
supplements, iron supplements, aspirin,
frequency of heme rich food intake, and,
for females, menstrual status and
pregnancy history at these two time
points. This study aims to identify the
optimal laboratory measures that would
predict the development of iron
depletion, hemoglobin deferral, and/or
iron deficient hemoglobin deferral in
active whole blood and double red cell
donors at subsequent blood donations.
The data collected will help evaluate
hemoglobin distributions in the blood
donor population (eligible and deferred
donors) and compare them with
NHANES data. Other secondary
objectives include elucidating key
genetic influences on hemoglobin levels
and iron status in a donor population as
a function of donation history; and
establishing a serum and DNA archive
to evaluate the potential utility of future
iron studies and genetic
polymorphisms.
This study will develop better
predictive models for iron depletion and
hemoglobin deferral (with or without
iron deficiency) in blood donors; allow
for the development of improved donor
screening strategies and open the
possibility for customized donation
frequency guidelines for individuals or
classes of donors; provide important
baseline information for the design of
targeted iron supplementation strategies
in blood donors, and improved
counseling messages to blood donors
regarding diet or supplements; and by
elucidating the effect of genetic iron
Estimated
number of responses per
respondent
Estimated
number of
respondents
Type of respondents
protein polymorphisms on the
development of iron depletion, enhance
the understanding of the role of these
proteins in states of iron stress, using
frequent blood donation as a model.
Frequency of Response: Twice.
Affected Public: Individuals. Type of
Respondents: Adult Blood Donors. The
annual reporting burden is a follows:
Estimated Number of Respondents:
Baseline visit: 2,340, Follow up Visit:
1,530; Estimated Number of Responses
per Respondent: 1; Average Burden of
Hours per Response: Baseline Visit:
0.37, Follow up Visit: 0.17; and
Estimated Total Annual Burden Hours
Requested: Baseline visit: 866, Follow
up Visit: 260. The annualized cost to
respondents is estimated at: Baseline
Visit: $15,588, Follow up Visit: $4,680
(based on $18 per hour). There are no
Capital Costs to report. There are no
Operating or Maintenance Costs to
report.
Average burden hours per
response
Estimated total
annual burden
hours
requested
2,340
1,530
1
1
0.37
0.17
866
260
Total ..........................................................................................................
rwilkins on PROD1PC63 with NOTICES
Blood donors at Baseline Visit ........................................................................
Blood donors at Follow-up Visit .......................................................................
........................
........................
........................
1,126
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and the assumptions used;
(3) Ways to enhance the quality, utility,
and clarity of the information collected;
and (4) Ways to minimize the burden of
the collection of information on those
who are to respond, including the use
of appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Dr. George Nemo,
Project Officer, NHLBI, Two Rockledge
Center, Suite 10042, 6701 Rockledge
Drive, Bethesda, MD 20892–7950, or
call 301–435–0075, or E-mail your
request to nemog@nih.gov.
VerDate Aug<31>2005
16:49 Feb 13, 2008
Jkt 214001
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Dated: February 4, 2008.
George Nemo,
NHLBI Project Officer, NHLBI, National
Institutes of Health.
[FR Doc. E8–2748 Filed 2–13–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Cooperative Research and
Development Agreement (CRADA)
Opportunity With the National Heart
Lung and Blood Institute and
Licensing Opportunity for
Development of Multi-Domain
Amphipathic Helical Peptides for the
Treatment of Cardiovascular Disease
National Institutes of Health,
PHS, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: Pursuant to the Federal
Technology Transfer Act of 1986 (FTTA,
15 U.S.C. 3710; and Executive Order
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
12591 of April 10, 1987, as amended,
and in accordance with 35 U.S.C. 207
and 37 CFR Part 404, the National
Institutes of Health (NIH) of the Public
Health Service (PHS) of the Department
of Health and Human Services (HHS)
seeks a Cooperative Research and
Development Agreement (CRADA) and/
or license(s) with a pharmaceutical or
biotechnology company to develop and
commercialize amphipathic helical
peptides potentially useful for the
treatment and prevention of
cardiovascular disease. The CRADA
would have an expected duration of one
(1) to five (5) years. The goals of the
CRADA include the rapid publication of
research results and timely
commercialization of products, methods
of treatment or prevention that may
result from the research. The CRADA
Collaborator will have an option to
negotiate the terms of an exclusive or
non-exclusive commercialization
license to subject inventions arising
under the CRADA defined by the
CRADA Research Plan, subject to any
pre-existing licenses already issued for
other fields of use, and can apply for
background licenses to the existing
patent applications encompassed within
HHS Reference Nos. E–114–2004/0–US–
01 (United States Patent Application
E:\FR\FM\14FEN1.SGM
14FEN1
Federal Register / Vol. 73, No. 31 / Thursday, February 14, 2008 / Notices
rwilkins on PROD1PC63 with NOTICES
Serial No. 11/577,259), E–114–2004/0–
AU–03 (Australian Patent Application
Serial No. 2005295640), E–114–2004/0–
CA–04 (Canadian Patent Application
No. 2584048), E–114–2004/0–EP–05
(European Patent Application No.
05815961.7) and E–114–2004/0–JP–06
(Japanese Patent Application No. 2007–
536912) titled: Multi-Domain
Amphipathic Helical Peptides and
Methods of Their Use.
DATES: Inquiries regarding CRADA
proposals and scientific matters may be
forwarded at any time. Confidential
preliminary CRADA proposals,
preferably two pages or less, must be
submitted to the NHLBI on or before
April 14, 2008. Guidelines for preparing
final CRADA proposals will be
communicated shortly thereafter to all
respondents with whom initial
confidential discussions will have
established sufficient mutual interest.
There is no deadline by which license
applications must be received by the
Office Technology Transfer however
applicants are encouraged to respond on
or before April 14, 2008. This notice
replaces that published in the Federal
Register on May 11, 2005 (70 FR 24832).
ADDRESSES: Proposals and questions
about this CRADA opportunity may be
addressed to Dr. Denise Crooks, Office
of Technology Transfer and
Development, NHLBI 6705 Rockledge
Drive, MSC 7992, Bethesda, MD 20892
(phone: 301–402–5579, Fax: 391–594–
3080, E-mail: Crooksd@nhlbi.nih.gov).
Scientific Inquiries should be directed
to Dr. Alan T. Remaley, NHLBI, 10
Center Drive, Building 10, Room 2C–
433, MSC 1508, Bethesda, MD 20892
(phone: 301–402–9796; fax: 301–402–
1885; E-mail: aremaley1@cc.nih.gov).
Licensing inquiries and requests for
license application should be directed
to Ms. Fatima Sayyid, Technology
Licensing Specialist, Office of
Technology Transfer, NIH, 6011
Executive Blvd., Suite 325, Rockville,
MD, 20852 (phone: 301–435–4521, Fax:
301–402–0220, E-mail:
Fatima.Sayyid@nih.hhs.gov).
SUPPLEMENTARY INFORMATION:
Technology Available
HHS scientists within the Lipoprotein
Metabolism Section (LMS), NHLBI, have
discovered a novel class of nonhemolytic amphipathic synthetic
peptides that are specific for effluxing
excess cellular cholesterol by the
ABCA1 transporter. These agents have
been shown to significantly inhibit the
progression of atherosclerosis in a
mouse model of cardiovascular disease.
Details are noted in HHS Reference #s
E–114–2004/0–US–01 (United States
VerDate Aug<31>2005
16:49 Feb 13, 2008
Jkt 214001
Patent Application Serial No. 11/
577,259), E–114–2004/0–AU–03
(Australian Patent Application Serial
No. 2005295640), E–114–2004/0–CA–04
(Canadian Patent Application No.
2584048), E–114–2004/0–EP–05
(European Patent Application No.
05815961.7) and E–114–2004/0–JP–06
(Japanese Patent Application No. 2007–
536912) titled: Multi-Domain
Amphipathic Helical Peptides and
Methods of Their Use. They are
available for review under an
appropriate Confidential Disclosure
Agreement.
Technology Sought
Accordingly, HHS now seeks
collaborative arrangements to provide
more extensive biological and
pharmacological evaluation of both
current and any new amphipathic
peptides that are being developed
within the Lipoprotein Metabolism
Section of NHLBI. The ultimate purpose
of the collaboration would be to
advance the most promising agents into
clinical trials for the prevention and
regression of cardiovascular disease. For
collaboration with the private sector, a
Cooperative Research and Development
Agreement (CRADA) will be established
to provide for equitable distribution of
intellectual property rights developed
under the collaboration. CRADA aims
will include rapid publication of
research results as well as full and
timely exploitation of commercial
opportunities.
NHLBI and Collaborator
Responsibilities
The role of LMS, NHLBI in this
CRADA may include, but not be limited
to:
1. Providing intellectual, scientific,
and technical expertise and experience
to the research project.
2. Perform in conjunction with
Collaborator in vitro studies to identify
novel peptides.
3. Perform in conjunction with
Collaborator animal studies on peptides
with anti-atherosclerotic properties.
4. Provide the Collaborator with
sequences of any novel peptides for
future pharmaceutical development.
5. Planning and conducting research
and clinical studies and interpreting
research results.
6. Publishing research results.
The role of the CRADA Collaborator
may include, but not be limited to:
1. Providing significant intellectual,
scientific, and technical expertise or
experience to the research project.
2. Planning scientific and clinical
research studies and interpreting
research results.
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
8703
3. Providing some financial support
for CRADA-related research as outlined
in the CRADA Research Plan.
4. Publishing research results.
Selection criteria for choosing the
CRADA Collaborator may include, but
not be limited to:
1. The ability to collaborate with
NHLBI on further research and
development of this technology. This
ability can be demonstrated through
experience and expertise in this or
related areas of technology indicating
the ability to contribute intellectually to
on-going research and development.
2. Expertise and experience in the
following areas: Peptide design and
synthesis, performance of preclinical
studies including animal model studies
of atherosclerosis, animal toxicology
studies, knowledge of GMP grade
production and scale up and lipid
reconstitution of synthetic peptides, and
design, U.S. Food and Drug
Administration regulatory filings, and
performance of clinical trials. The
demonstration of adequate resources to
perform the research, development and
commercialization of this technology
(e.g. facilities, personnel, expertise and
funds) and accomplish objectives
according to an appropriate timetable to
be outlined in the CRADA Collaborators
proposal.
3. The willingness to commit best
efforts and demonstrated resources to
the research, development and
commercialization of this technology.
4. The demonstration of expertise in
the commercial development,
production, marketing and sales of
products related to this area of
technology.
5. The willingness to cooperate with
the National Heart Lung and Blood
Institute in the timely publication of
research results.
6. The willingness to accept the legal
provisions and language of the CRADA
with only minor modifications, if any.
These provisions govern the equitable
distribution of patent rights to CRADA
inventions. Generally, the rights of
ownership are retained by the
organization that is the employer of the
inventor, with (1) the grant of a license
for research and other Government
purposes to the Government when the
CRADA Collaborator’s employee is the
sole inventor, or (2) the grant of an
option to elect an exclusive or nonexclusive license to the CRADA
Collaborator when the Government
employee is the sole or joint inventor.
E:\FR\FM\14FEN1.SGM
14FEN1
8704
Federal Register / Vol. 73, No. 31 / Thursday, February 14, 2008 / Notices
Dated: February 7, 2008.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E8–2750 Filed 2–13–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
rwilkins on PROD1PC63 with NOTICES
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301–
496–7057; fax: 301–402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Use of Amyloid Proteins as Vaccine
Scaffolds
Description of Technology: Amyloid
proteins are composed of peptides
whose chemical properties are such that
they spontaneously aggregate in vitro or
in vivo, assuming parallel or antiparallel
beta sheet configurations. Amyloid
proteins can arise from peptides which,
though differing in primary amino acid
sequences, assume the same tertiary and
quaternary structures. The amyloid
structure presents a regular array of
accessible N-termini of the peptide
molecules.
Claimed in this application are
compositions and methods for use of
amyloid proteins as vaccine scaffolds,
on which peptide determinants from
microorganisms or tumors may be
presented to more efficiently generate
and produce a sustained neutralizing
antibody response to prevent infectious
diseases or treat tumors. The inventors
VerDate Aug<31>2005
16:49 Feb 13, 2008
Jkt 214001
have arrayed peptides to be optimally
immunogenic on the amyloid protein
scaffold by presenting antigen using
three different approaches. First, the Nterminal ends of the amyloid forming
peptides can be directly modified with
the peptide antigen of interest; second,
the N-termini of the amyloid forming
peptides are modified with a linker to
which the peptide antigens of interest
are linked; and third, the scaffold
amyloid may be modified to create a
chimeric molecule.
Aside from stability and enhanced
immunogenicity, the major advantages
of this approach are the synthetic nature
of the vaccine and its low cost. Thus,
concerns regarding contamination of
vaccines produced from cellular
substrates, as are currently employed for
some vaccines, are eliminated; the
robust stability allows the amyloid
based vaccine to be stored at room
temperature for prolonged periods of
time; and the inexpensive synthetic
amino acid starting materials, and their
rapid spontaneous aggregation in vitro
should provide substantial cost savings
over the resource and labor-intensive
current vaccine production platforms.
Application: Immunization to prevent
infectious diseases or treat chronic
conditions or cancer.
Developmental Status: Vaccine
candidates have been synthesized and
preclinical studies have been
performed.
Inventors: Amy Rosenberg (CDER/
FDA), James E. Keller (CBER/FDA),
Robert Tycko (NIDDK).
Patent Status: U.S. Provisional
Application No. 60/922,131 filed 06 Apr
2007 (HHS Reference No. E–106–2007/
0–US–01).
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Peter A. Soukas,
JD; 301–435–4646;
soukasp@mail.nih.gov.
Collaborative Research Opportunity:
The FDA, Division of Therapeutic
Proteins (CDER) and Office of Vaccines,
Division of Bacterial Products (CBER) is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize
amyloid based vaccines for prevention
of infectious disease or treatment of
malignant states. Please contact Amy
Rosenberg at
amy.rosenberg@fda.hhs.gov or (301)
827–1794 for more information.
Inhibiting HIV Infection Using Integrin
Antagonists
Description of Technology: Infection
with HIV depletes and impairs CD4
cells, a key component of the immune
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
system. Effective therapies such as
highly active antiretroviral therapy
(HAART) have focused on preserving
CD4 cells. However, long term HAART
has significant toxicity associated with
it. The current technology describes the
use of integrin antagonists as an
alternative to treating or preventing HIV
infection and replication. Specifically,
a4 integrin plays a role in directing
lymphocytes to the primary site of HIV
replication. Inhibition of the interaction
of a4b1 or a4b7 with gp120 can
therefore be important in the
development of effective HIV
treatments.
Applications: Inhibiting HIV
infection; Inhibiting HIV replication.
Development Status: In vitro data.
Inventors: James Arthos, Diana Goode,
Claudia Cicala, and Anthony Fauci
(NIAID).
Patent Status:
U.S. Patent Application No. 60/873,884
filed 07 Dec 2006 (HHS Reference No.
E–055–2007/0–US–01)
U.S. Patent Application No. 60/920,880
filed 03 Mar 2007 (HHS Reference No.
E–055–2007/1–US–01)
U.S. Patent Application No. 60/957,140
filed 21 Aug 2007 (HHS Reference No.
E–055–2007/2–US–01)
PCT Patent Application No. PCT/
US2007/086663 filed 06 Dec 2007
(HHS Reference No. E–055–2007/3–
PCT–01)
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Susan Ano, PhD;
301–435–5515; anos@mail.nih.gov.
Collaborative Research Opportunity:
The NIAID Laboratory of
Immunoregulation is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize this technology. Please
contact Dr. James Arthos at 301–435–
2374 for more information.
Coacervate Microparticles Useful for
the Sustained Release Administration
of Therapeutics Agents
Description of Technology: The
described technology is a biodegradable
microbead or microparticle, useful for
the sustained localized delivery of
biologically active proteins or other
molecules of pharmaceutical interest.
The microbeads are produced from
several USP grade materials, a cationic
polymer, an anionic polymer and a
binding component (e.g., gelatin,
chondroitin sulfate and avidin), in
predetermined ratios. Biologically active
proteins are incorporated into
preformed microbeads via an
introduced binding moiety under
nondenaturing conditions.
E:\FR\FM\14FEN1.SGM
14FEN1
]]>Agencies
[Federal Register Volume 73, Number 31 (Thursday, February 14, 2008)]
[Notices]
[Pages 8702-8704]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-2750]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Cooperative Research and Development Agreement (CRADA)
Opportunity With the National Heart Lung and Blood Institute and
Licensing Opportunity for Development of Multi-Domain Amphipathic
Helical Peptides for the Treatment of Cardiovascular Disease
AGENCY: National Institutes of Health, PHS, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Pursuant to the Federal Technology Transfer Act of 1986 (FTTA,
15 U.S.C. 3710; and Executive Order 12591 of April 10, 1987, as
amended, and in accordance with 35 U.S.C. 207 and 37 CFR Part 404, the
National Institutes of Health (NIH) of the Public Health Service (PHS)
of the Department of Health and Human Services (HHS) seeks a
Cooperative Research and Development Agreement (CRADA) and/or
license(s) with a pharmaceutical or biotechnology company to develop
and commercialize amphipathic helical peptides potentially useful for
the treatment and prevention of cardiovascular disease. The CRADA would
have an expected duration of one (1) to five (5) years. The goals of
the CRADA include the rapid publication of research results and timely
commercialization of products, methods of treatment or prevention that
may result from the research. The CRADA Collaborator will have an
option to negotiate the terms of an exclusive or non-exclusive
commercialization license to subject inventions arising under the CRADA
defined by the CRADA Research Plan, subject to any pre-existing
licenses already issued for other fields of use, and can apply for
background licenses to the existing patent applications encompassed
within HHS Reference Nos. E-114-2004/0-US-01 (United States Patent
Application
[[Page 8703]]
Serial No. 11/577,259), E-114-2004/0-AU-03 (Australian Patent
Application Serial No. 2005295640), E-114-2004/0-CA-04 (Canadian Patent
Application No. 2584048), E-114-2004/0-EP-05 (European Patent
Application No. 05815961.7) and E-114-2004/0-JP-06 (Japanese Patent
Application No. 2007-536912) titled: Multi-Domain Amphipathic Helical
Peptides and Methods of Their Use.
DATES: Inquiries regarding CRADA proposals and scientific matters may
be forwarded at any time. Confidential preliminary CRADA proposals,
preferably two pages or less, must be submitted to the NHLBI on or
before April 14, 2008. Guidelines for preparing final CRADA proposals
will be communicated shortly thereafter to all respondents with whom
initial confidential discussions will have established sufficient
mutual interest.
There is no deadline by which license applications must be received
by the Office Technology Transfer however applicants are encouraged to
respond on or before April 14, 2008. This notice replaces that
published in the Federal Register on May 11, 2005 (70 FR 24832).
ADDRESSES: Proposals and questions about this CRADA opportunity may be
addressed to Dr. Denise Crooks, Office of Technology Transfer and
Development, NHLBI 6705 Rockledge Drive, MSC 7992, Bethesda, MD 20892
(phone: 301-402-5579, Fax: 391-594-3080, E-mail:
Crooksd@nhlbi.nih.gov).
Scientific Inquiries should be directed to Dr. Alan T. Remaley,
NHLBI, 10 Center Drive, Building 10, Room 2C-433, MSC 1508, Bethesda,
MD 20892 (phone: 301-402-9796; fax: 301-402-1885; E-mail:
aremaley1@cc.nih.gov).
Licensing inquiries and requests for license application should be
directed to Ms. Fatima Sayyid, Technology Licensing Specialist, Office
of Technology Transfer, NIH, 6011 Executive Blvd., Suite 325,
Rockville, MD, 20852 (phone: 301-435-4521, Fax: 301-402-0220, E-mail:
Fatima.Sayyid@nih.hhs.gov).
SUPPLEMENTARY INFORMATION:
Technology Available
HHS scientists within the Lipoprotein Metabolism Section (LMS),
NHLBI, have discovered a novel class of non-hemolytic amphipathic
synthetic peptides that are specific for effluxing excess cellular
cholesterol by the ABCA1 transporter. These agents have been shown to
significantly inhibit the progression of atherosclerosis in a mouse
model of cardiovascular disease. Details are noted in HHS Reference
s E-114-2004/0-US-01 (United States Patent Application Serial
No. 11/577,259), E-114-2004/0-AU-03 (Australian Patent Application
Serial No. 2005295640), E-114-2004/0-CA-04 (Canadian Patent Application
No. 2584048), E-114-2004/0-EP-05 (European Patent Application No.
05815961.7) and E-114-2004/0-JP-06 (Japanese Patent Application No.
2007-536912) titled: Multi-Domain Amphipathic Helical Peptides and
Methods of Their Use. They are available for review under an
appropriate Confidential Disclosure Agreement.
Technology Sought
Accordingly, HHS now seeks collaborative arrangements to provide
more extensive biological and pharmacological evaluation of both
current and any new amphipathic peptides that are being developed
within the Lipoprotein Metabolism Section of NHLBI. The ultimate
purpose of the collaboration would be to advance the most promising
agents into clinical trials for the prevention and regression of
cardiovascular disease. For collaboration with the private sector, a
Cooperative Research and Development Agreement (CRADA) will be
established to provide for equitable distribution of intellectual
property rights developed under the collaboration. CRADA aims will
include rapid publication of research results as well as full and
timely exploitation of commercial opportunities.
NHLBI and Collaborator Responsibilities
The role of LMS, NHLBI in this CRADA may include, but not be
limited to:
1. Providing intellectual, scientific, and technical expertise and
experience to the research project.
2. Perform in conjunction with Collaborator in vitro studies to
identify novel peptides.
3. Perform in conjunction with Collaborator animal studies on
peptides with anti-atherosclerotic properties.
4. Provide the Collaborator with sequences of any novel peptides
for future pharmaceutical development.
5. Planning and conducting research and clinical studies and
interpreting research results.
6. Publishing research results.
The role of the CRADA Collaborator may include, but not be limited
to:
1. Providing significant intellectual, scientific, and technical
expertise or experience to the research project.
2. Planning scientific and clinical research studies and
interpreting research results.
3. Providing some financial support for CRADA-related research as
outlined in the CRADA Research Plan.
4. Publishing research results.
Selection criteria for choosing the CRADA Collaborator may include,
but not be limited to:
1. The ability to collaborate with NHLBI on further research and
development of this technology. This ability can be demonstrated
through experience and expertise in this or related areas of technology
indicating the ability to contribute intellectually to on-going
research and development.
2. Expertise and experience in the following areas: Peptide design
and synthesis, performance of preclinical studies including animal
model studies of atherosclerosis, animal toxicology studies, knowledge
of GMP grade production and scale up and lipid reconstitution of
synthetic peptides, and design, U.S. Food and Drug Administration
regulatory filings, and performance of clinical trials. The
demonstration of adequate resources to perform the research,
development and commercialization of this technology (e.g. facilities,
personnel, expertise and funds) and accomplish objectives according to
an appropriate timetable to be outlined in the CRADA Collaborators
proposal.
3. The willingness to commit best efforts and demonstrated
resources to the research, development and commercialization of this
technology.
4. The demonstration of expertise in the commercial development,
production, marketing and sales of products related to this area of
technology.
5. The willingness to cooperate with the National Heart Lung and
Blood Institute in the timely publication of research results.
6. The willingness to accept the legal provisions and language of
the CRADA with only minor modifications, if any. These provisions
govern the equitable distribution of patent rights to CRADA inventions.
Generally, the rights of ownership are retained by the organization
that is the employer of the inventor, with (1) the grant of a license
for research and other Government purposes to the Government when the
CRADA Collaborator's employee is the sole inventor, or (2) the grant of
an option to elect an exclusive or non-exclusive license to the CRADA
Collaborator when the Government employee is the sole or joint
inventor.
[[Page 8704]]
Dated: February 7, 2008.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E8-2750 Filed 2-13-08; 8:45 am]
BILLING CODE 4140-01-P
