Government-Owned Inventions; Availability for Licensing, 24076-24078 [E8-9535]
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Federal Register / Vol. 73, No. 85 / Thursday, May 1, 2008 / Notices
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Yvette
Waples or John Lauttman at least 7 days
in advance of the meeting.
FDA is committed to the orderly
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meetings. Please visit our Web site at
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meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: April 22, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–9549 Filed 4–30–08; 8:45 am]
BILLING CODE 4160–01–S
Paperwork Reduction Act of 1995. To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, call the HRSA Reports
Clearance Officer on (301) 443–1129.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Proposed Project: Health Centers
Patient Survey—Pretest (NEW)
Health Resources And Services
Administration
The Health Center program supports
Community Health Centers (CHCs),
Migrant Health Centers (MHCs), Health
Care for the Homeless (HCH) projects,
and Public Housing Primary Care
(PHPC) programs. Health Centers (HCs)
receive grants from HRSA to provide
primary and preventive health care
services to medically underserved
populations.
The proposed Patient Survey will
collect in-depth information about HC
patients, their health status, the reasons
they seek care at HCs, their diagnoses,
the services they utilize at HCs and
elsewhere, the quality of those services,
and their satisfaction with the care they
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to OMB under the
receive, through personal interviews of
a stratified random sample of HC
patients. The survey pre-test, which is
the subject of this Notice, will serve as
a pilot test of the survey instrument,
survey sampling methodologies and
procedures. This pre-test will also
include cognitive interviews to ensure
that the questions are being understood
as was intended; as a result, it is
estimated that each pre-test patient
interview will take 2 hours.
The Patient Survey being pre-tested
builds on previous periodic User-Visit
Surveys which were conducted to learn
about the process and outcomes of care
in CHCs and HCH programs. The
original questionnaires were derived
from the National Health Interview
Survey (NHIS) and the National
Hospital Ambulatory Medical Care
Survey (NHAMCS) conducted by the
National Center for Health Statistics
(NCHS). Conformance with the NHIS
and NHAMCS allowed comparisons
between these NCHS surveys and the
previous CHC and HCH User-Visit
Surveys. The new Patient Survey was
developed using a questionnaire
methodology similar to that used in the
past, and so will allow some
longitudinal comparisons for CHCs and
HCH programs with the previous UserVisit survey data, including monitoring
of process outcomes over time. In
addition, this survey will include
interviews of patients drawn from
migrant populations and from residents
of public housing, populations not
included in the previous surveys.
The estimated response burden for the
pilot test is as follows:
PRETEST
Number of
respondents
Type of respondent; activity involved
Responses
per
respondent
Total number
of
responses
Burden per
response
(hours)
Total hour
burden
Grantee/Site Recuitment ..................................................
Patient Recuitment ...........................................................
Patient Survey ..................................................................
2
90
70
3
1
1
6
90
70
3.75
.167
2
22.5
15
140
Total—Pretest ...........................................................
92
........................
166
..........................
177.5
pwalker on PROD1PC71 with NOTICES
Send comments to Susan G. Queen,
PhD., HRSA Reports Clearance Officer,
Room 10–33, Parklawn Building, 5600
Fishers Lane, Rockville, MD 20857.
Written comments should be received
within 60 days of this notice.
Dated: April 24, 2008.
Alexandra Huttinger,
Director, Division of Policy Review and
Coordination.
[FR Doc. E8–9517 Filed 4–25–08; 8:45 am]
BILLING CODE 4165–15–P
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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:
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
PO 00000
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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
E:\FR\FM\01MYN1.SGM
01MYN1
Federal Register / Vol. 73, No. 85 / Thursday, May 1, 2008 / Notices
pwalker on PROD1PC71 with NOTICES
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.
Human and Improved Murine
Monoclonal Antibodies Against CD22
Description of Technology: CD22 is a
cell surface protein that is highly
expressed in a number of B cell
lymphomas, such as hairy cell leukemia
(HCL), non-Hodgkins lymphoma (NHL)
and chronic lymphocytic leukemia
(CLL). Several clinical trials using antiCD22 antibodies are ongoing. However,
all of these antibodies are murine in
nature, and have the potential to elicit
immune responses in patients. The
immunogenicity may adversely affect
the ability to provide patients with
repeated doses of a therapeutic
comprising the antibody, limiting the
clinical application of those
therapeutics.
In order to address the issue of
immunogenicity in a patient, NIH
inventors have generated two anti-CD22
antibodies of human origin. Each
antibody has the ability to recognize
CD22 on the surface of Raji cells. Thus,
these antibodies represent an attractive
alternative to the murine anti-CD22
antibodies currently being tested in
clinical trials.
Additionally, the inventors have
generated a modified murine anti-CD22
antibody with increased binding affinity
and solubility. This antibody could also
be a suitable alternative for the murine
antibodies currently available.
Applications:
Use as an antibody therapeutic for B
cell lymphomas.
Use in an immunotoxin therapeutic
for B cell lymphomas.
Diagnostic for the detection of CD22
positive tumors.
Advantages:
Antibody against a proven target for
immunotherapy.
Fully human antibody reduces
potential immunogenicity, thereby
allowing repeated dosing.
Murine antibody has increased
binding affinity and solubility relative
to current murine anti-CD22 antibodies.
Benefits: The antibody based
therapeutic market is likely to grow
steadily in the next decade, with the
present estimate of the market at more
than ten billion U.S. dollars.
Approximately five billion U.S. dollars
are spent annually for treatment of
lymphoma. The development of a
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17:13 Apr 30, 2008
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successful antibody therapeutic for B
cell lymphomas would occupy a
significant portion of that market as
approximately eighty-five percent of all
lymphomas are B cell-linked.
Inventors: Dimiter S. Dimitrov et al.
(NCI).
Patent Status: U.S. Provisional
Application No. 61/042,329 filed 04 Apr
2008 (HHS Reference No. E–080–2008/
0-US–01).
Licensing Status: Available for
licensing.
Licensing Contact: David A.
Lambertson, PhD; 301–435–4632;
lambertsond@mail.nih.gov.
Collaborative Research Opportunity:
The NCI CCR Nanobiology Program is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize
anti-CD22 human monoclonal
antibodies. Please contact John D.
Hewes, PhD at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
Human Monoclonal Antibody Against
Mesothelin
Description of Technology:
Mesothelin is a cell surface protein that
is naturally expressed at very low levels.
However, the expression of mesothelin
is significantly increased in aggressive
tumors, such as mesotheliomas and
pancreatic and ovarian tumors. As a
result, mesothelin is an excellent
candidate for tumor targeted
immunotherapeutics.
Currently, the only antibodies against
mesothelin that are available for clinical
trials are of murine origin. These
antibodies have the potential to elicit
immune responses in patients, which
may adversely affect the ability to
provide patients with repeated doses.
As a result, the clinical application of
the antibodies may be limited.
In order to address the issue of
immunogenicity in patients, NIH
inventors have generated an antimesothelin antibody of human origin.
The antibody has the ability to
efficiently recognize mesothelin on the
surface of cells, and induce ADCC in
mesothelin-positive cells. Thus, this
antibody represents an attractive
alternative to the murine antimesothelin antibodies currently
available.
Applications:
Use as an antibody therapeutic for
mesotheliomas and pancreatic and
ovarian tumors.
Use in an immunotoxin therapeutic
for mesotheliomas and pancreatic and
ovarian tumors.
PO 00000
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24077
Diagnostic for the detection of
mesothelin positive tumors.
Research agent for the detection of
mesothelin.
Advantages:
Fully human antibody reduces
potential immunogenicity, thereby
allowing repeated dosing.
First human antibody against
mesothelin.
Benefits: The antibody based
therapeutic market is likely to grow
steadily in the next decade, with the
present estimate of the market at more
than ten billion U.S. dollars. The
development of a successful antibody
therapeutic for mesotheliomas and
pancreatic and ovarian cancers would
occupy a significant portion of that
market.
Inventors: Dimiter S. Dimitrov et al.
(NCI).
Patent Status: U.S. Provisional
Application filed 27 Mar 2008 (HHS
Reference No. E–079–2008/0–US–01)
Licensing Status: Available for
licensing.
Licensing Contact: David A.
Lambertson, PhD; 301–435–4632;
lambertsond@mail.nih.gov.
Collaborative Research Opportunity:
The NCI CCR Nanobiology Program is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize the
antibody. Please contact John D. Hewes,
PhD at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
New Insect SF–9ET Cell Line for
Determining Baculovirus Titers
Description of Technology: The
baculovirus based protein expression
system has gained increased
prominence as a method for expressing
recombinant proteins that are used in a
wide range of biomedical applications.
An important step in the use of this
system is the ability to determine the
virus infectious titer, i.e., the number of
active baculovirus particles produced
during an infection of the insect host
cell. The current ‘‘gold standard’’
methods used for determining
baculovirus titers, such as the plaque
and end point dilution assays, can be
costly, take a long time to complete (up
to 7–8 days), and are sometimes difficult
to interpret as they involve observing
the cytopathic effects (CPE) that
baculovirus infection has on the
infected insect host cell. To solve these
problems, a modified insect cell line,
SF–9ET, was developed to genetically
express the green fluorescent protein
(GFP) when infected with baculovirus.
In these cells, the gene for GFP is placed
E:\FR\FM\01MYN1.SGM
01MYN1
24078
Federal Register / Vol. 73, No. 85 / Thursday, May 1, 2008 / Notices
pwalker on PROD1PC71 with NOTICES
under the control of a baculovirus
promoter so that the cells express GFP
when they are infected with the virus.
The baculovirus titer can then be
quantitated from the level of GFP
expression in the insect host cell. The
results are obtained within 3 days
compared to the 7–8 day period typical
of the traditional CPE based methods.
The GFP based system is capable of
replacing the traditional methods as it is
faster, more accurate and may be less
expensive than the currently used
systems. This proprietary technology
can become an indispensible tool for the
quantitation of baculovirus titers; a step
that is important in the production of
recombinant proteins and vaccine like
particles (VLPs) for academic and
commercial purposes.
Applications: Baculovirus based
recombinant protein expression.
Advantages: Fast, accurate, and
inexpensive determination of
baculovirus titers for protein expression.
Inventors: Ralph F. Hopkins III and
Dominic Esposito (SAIC/NCI).
Patent Status: U.S. Provisional
Application No. 61/019,562 filed 07 Jan
2008 (HHS Reference No. E–009–2008/
0–US–01).
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Jasbir (Jesse) S.
Kindra, J.D., M.S.; 301–435–5170;
kindraj@mail.nih.gov.
A Molecular Grading System for Ductal
Carcinoma In Situ (DCIS) of the Breast:
A New Molecular Diagnostic To
Determine Disease Stages of DCIS
Description of Technology: The
technology describes the comprehensive
profiling of Ductal Carcinoma in situ
(DCIS) in breast cancer patients. The
inventors have developed a molecular
grading system for DCIS utilizing both
gene expression profiling and genomic
change profiling. The inventors have
identified molecular profiles that
identify early stage patients at risk of
disease progression requiring more
aggressive therapy. These observations
suggest that a clinical assay could be
developed for the grading of DCIS.
Furthermore, the invention
demonstrates that the profiles correlate
with the molecular grade and with cell
proliferation, suggesting that a clinical
assay using routine methods, based on
the nuclear grade and staining for Ki67
as a measure of proliferation, could also
potentially be developed.
Advantages and Applications:
The technology has the potential of
being developed into an accurate
diagnostic test for DCIS patients
according to their risk of tumor
progression.
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The diagnostic profiling can assist
physicians in making clinically
informed and personalized therapy
decisions for DCIS patients.
In the studies, tissue samples
collected via laser capture microdissection from in situ breast cancer
patients were used, which validate and
authenticate the relevance of the study.
Development Status: Larger clinical
study is currently being planned.
Inventors: Paul S. Meltzer et al. (NCI).
Patent Status: U.S. Provisional
Application No. 60/936,526 filed 20 Jun
2007 (HHS Reference No. E–192–2007/
0–US–01).
Licensing Status: Available for
exclusive and non-exclusive licensing.
Licensing Contact: Mojdeh Bahar, J.D.;
301–435–2950; baharm@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute, Genetics
Branch, is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize molecular grading of
DCIS. Please contact John D. Hewes,
Ph.D. at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
April 24, 2008.
David Sadowski,
Deputy Director, Division of Technology
Development and Transfer, Office of
Technology Transfer, National Institutes of
Health.
[FR Doc. E8–9535 Filed 4–30–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Dental &
Craniofacial Research; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
PO 00000
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Name of Committee: National Institute of
Dental and Craniofacial Research Special
Emphasis Panel.
Date: June 19, 2008.
Time: 2 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, One
Democracy Plaza, 6701 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Sooyoun (Sonia) Kim, MS,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Activities,
NIDCR/NIH, 6701 Democracy Blvd, Rm 675,
Bethesda, MD 20892–4878, (301) 594–4827,
kims@email.nidr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.121, Oral Diseases and
Disorders Research, National Institutes of
Health, HHS)
Dated: April 23, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–9404 Filed 4–30–08; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HOMELAND
SECURITY
Office of the Secretary
Public Workshop: Privacy Compliance
Fundamentals—PTAs, PIAs, and
SORNs
Privacy Office, Department of
Homeland Security (DHS).
ACTION: Notice announcing public
workshop.
AGENCY:
SUMMARY: The Department of Homeland
Security Privacy Office will host a
public workshop, ‘‘Privacy Compliance
Fundamentals—PTAs, PIAs, and
SORNs.’’
The workshop will be held on
May 23, 2008, from 9 a.m. to 4:30 p.m.
ADDRESSES: The workshop will be held
in the auditorium at the DHS Offices at
the GSA Regional Headquarters
Building located at 7th and D Streets,
SW., Washington, DC, 20024.
FOR FURTHER INFORMATION CONTACT:
Tamara Baker, Privacy Office,
Department of Homeland Security,
Washington, DC 20528; by telephone
703–235–0780; by facsimile 703–235–
0442; or by e-mail at
privacyworkshop@dhs.gov.
DATES:
The
Department of Homeland Security
(DHS) Privacy Office is holding a public
workshop that will provide in-depth
training on the privacy compliance
process at DHS, and specifically how to
write privacy impact assessments (PIAs)
SUPPLEMENTARY INFORMATION:
E:\FR\FM\01MYN1.SGM
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]]>Agencies
[Federal Register Volume 73, Number 85 (Thursday, May 1, 2008)]
[Notices]
[Pages 24076-24078]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-9535]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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
[[Page 24077]]
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.
Human and Improved Murine Monoclonal Antibodies Against CD22
Description of Technology: CD22 is a cell surface protein that is
highly expressed in a number of B cell lymphomas, such as hairy cell
leukemia (HCL), non-Hodgkins lymphoma (NHL) and chronic lymphocytic
leukemia (CLL). Several clinical trials using anti-CD22 antibodies are
ongoing. However, all of these antibodies are murine in nature, and
have the potential to elicit immune responses in patients. The
immunogenicity may adversely affect the ability to provide patients
with repeated doses of a therapeutic comprising the antibody, limiting
the clinical application of those therapeutics.
In order to address the issue of immunogenicity in a patient, NIH
inventors have generated two anti-CD22 antibodies of human origin. Each
antibody has the ability to recognize CD22 on the surface of Raji
cells. Thus, these antibodies represent an attractive alternative to
the murine anti-CD22 antibodies currently being tested in clinical
trials.
Additionally, the inventors have generated a modified murine anti-
CD22 antibody with increased binding affinity and solubility. This
antibody could also be a suitable alternative for the murine antibodies
currently available.
Applications:
Use as an antibody therapeutic for B cell lymphomas.
Use in an immunotoxin therapeutic for B cell lymphomas.
Diagnostic for the detection of CD22 positive tumors.
Advantages:
Antibody against a proven target for immunotherapy.
Fully human antibody reduces potential immunogenicity, thereby
allowing repeated dosing.
Murine antibody has increased binding affinity and solubility
relative to current murine anti-CD22 antibodies.
Benefits: The antibody based therapeutic market is likely to grow
steadily in the next decade, with the present estimate of the market at
more than ten billion U.S. dollars. Approximately five billion U.S.
dollars are spent annually for treatment of lymphoma. The development
of a successful antibody therapeutic for B cell lymphomas would occupy
a significant portion of that market as approximately eighty-five
percent of all lymphomas are B cell-linked.
Inventors: Dimiter S. Dimitrov et al. (NCI).
Patent Status: U.S. Provisional Application No. 61/042,329 filed 04
Apr 2008 (HHS Reference No. E-080-2008/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: David A. Lambertson, PhD; 301-435-4632;
lambertsond@mail.nih.gov.
Collaborative Research Opportunity: The NCI CCR Nanobiology Program
is seeking statements of capability or interest from parties interested
in collaborative research to further develop, evaluate, or
commercialize anti-CD22 human monoclonal antibodies. Please contact
John D. Hewes, PhD at 301-435-3121 or hewesj@mail.nih.gov for more
information.
Human Monoclonal Antibody Against Mesothelin
Description of Technology: Mesothelin is a cell surface protein
that is naturally expressed at very low levels. However, the expression
of mesothelin is significantly increased in aggressive tumors, such as
mesotheliomas and pancreatic and ovarian tumors. As a result,
mesothelin is an excellent candidate for tumor targeted
immunotherapeutics.
Currently, the only antibodies against mesothelin that are
available for clinical trials are of murine origin. These antibodies
have the potential to elicit immune responses in patients, which may
adversely affect the ability to provide patients with repeated doses.
As a result, the clinical application of the antibodies may be limited.
In order to address the issue of immunogenicity in patients, NIH
inventors have generated an anti-mesothelin antibody of human origin.
The antibody has the ability to efficiently recognize mesothelin on the
surface of cells, and induce ADCC in mesothelin-positive cells. Thus,
this antibody represents an attractive alternative to the murine anti-
mesothelin antibodies currently available.
Applications:
Use as an antibody therapeutic for mesotheliomas and pancreatic and
ovarian tumors.
Use in an immunotoxin therapeutic for mesotheliomas and pancreatic
and ovarian tumors.
Diagnostic for the detection of mesothelin positive tumors.
Research agent for the detection of mesothelin.
Advantages:
Fully human antibody reduces potential immunogenicity, thereby
allowing repeated dosing.
First human antibody against mesothelin.
Benefits: The antibody based therapeutic market is likely to grow
steadily in the next decade, with the present estimate of the market at
more than ten billion U.S. dollars. The development of a successful
antibody therapeutic for mesotheliomas and pancreatic and ovarian
cancers would occupy a significant portion of that market.
Inventors: Dimiter S. Dimitrov et al. (NCI).
Patent Status: U.S. Provisional Application filed 27 Mar 2008 (HHS
Reference No. E-079-2008/0-US-01)
Licensing Status: Available for licensing.
Licensing Contact: David A. Lambertson, PhD; 301-435-4632;
lambertsond@mail.nih.gov.
Collaborative Research Opportunity: The NCI CCR Nanobiology Program
is seeking statements of capability or interest from parties interested
in collaborative research to further develop, evaluate, or
commercialize the antibody. Please contact John D. Hewes, PhD at 301-
435-3121 or hewesj@mail.nih.gov for more information.
New Insect SF-9ET Cell Line for Determining Baculovirus Titers
Description of Technology: The baculovirus based protein expression
system has gained increased prominence as a method for expressing
recombinant proteins that are used in a wide range of biomedical
applications. An important step in the use of this system is the
ability to determine the virus infectious titer, i.e., the number of
active baculovirus particles produced during an infection of the insect
host cell. The current ``gold standard'' methods used for determining
baculovirus titers, such as the plaque and end point dilution assays,
can be costly, take a long time to complete (up to 7-8 days), and are
sometimes difficult to interpret as they involve observing the
cytopathic effects (CPE) that baculovirus infection has on the infected
insect host cell. To solve these problems, a modified insect cell line,
SF-9ET, was developed to genetically express the green fluorescent
protein (GFP) when infected with baculovirus. In these cells, the gene
for GFP is placed
[[Page 24078]]
under the control of a baculovirus promoter so that the cells express
GFP when they are infected with the virus. The baculovirus titer can
then be quantitated from the level of GFP expression in the insect host
cell. The results are obtained within 3 days compared to the 7-8 day
period typical of the traditional CPE based methods.
The GFP based system is capable of replacing the traditional
methods as it is faster, more accurate and may be less expensive than
the currently used systems. This proprietary technology can become an
indispensible tool for the quantitation of baculovirus titers; a step
that is important in the production of recombinant proteins and vaccine
like particles (VLPs) for academic and commercial purposes.
Applications: Baculovirus based recombinant protein expression.
Advantages: Fast, accurate, and inexpensive determination of
baculovirus titers for protein expression.
Inventors: Ralph F. Hopkins III and Dominic Esposito (SAIC/NCI).
Patent Status: U.S. Provisional Application No. 61/019,562 filed 07
Jan 2008 (HHS Reference No. E-009-2008/0-US-01).
Licensing Status: Available for exclusive or non-exclusive
licensing.
Licensing Contact: Jasbir (Jesse) S. Kindra, J.D., M.S.; 301-435-
5170; kindraj@mail.nih.gov.
A Molecular Grading System for Ductal Carcinoma In Situ (DCIS) of the
Breast: A New Molecular Diagnostic To Determine Disease Stages of DCIS
Description of Technology: The technology describes the
comprehensive profiling of Ductal Carcinoma in situ (DCIS) in breast
cancer patients. The inventors have developed a molecular grading
system for DCIS utilizing both gene expression profiling and genomic
change profiling. The inventors have identified molecular profiles that
identify early stage patients at risk of disease progression requiring
more aggressive therapy. These observations suggest that a clinical
assay could be developed for the grading of DCIS. Furthermore, the
invention demonstrates that the profiles correlate with the molecular
grade and with cell proliferation, suggesting that a clinical assay
using routine methods, based on the nuclear grade and staining for Ki67
as a measure of proliferation, could also potentially be developed.
Advantages and Applications:
The technology has the potential of being developed into an
accurate diagnostic test for DCIS patients according to their risk of
tumor progression.
The diagnostic profiling can assist physicians in making clinically
informed and personalized therapy decisions for DCIS patients.
In the studies, tissue samples collected via laser capture micro-
dissection from in situ breast cancer patients were used, which
validate and authenticate the relevance of the study.
Development Status: Larger clinical study is currently being
planned.
Inventors: Paul S. Meltzer et al. (NCI).
Patent Status: U.S. Provisional Application No. 60/936,526 filed 20
Jun 2007 (HHS Reference No. E-192-2007/0-US-01).
Licensing Status: Available for exclusive and non-exclusive
licensing.
Licensing Contact: Mojdeh Bahar, J.D.; 301-435-2950;
baharm@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute,
Genetics Branch, is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate, or commercialize molecular grading of DCIS. Please contact
John D. Hewes, Ph.D. at 301-435-3121 or hewesj@mail.nih.gov for more
information.
April 24, 2008.
David Sadowski,
Deputy Director, Division of Technology Development and Transfer,
Office of Technology Transfer, National Institutes of Health.
[FR Doc. E8-9535 Filed 4-30-08; 8:45 am]
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