Government-Owned Inventions; Availability for Licensing, 48692-48695 [2013-19285]
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Federal Register / Vol. 78, No. 154 / Friday, August 9, 2013 / Notices
The meeting will be held at
the Washington Marriott at Metro Center
775 12th St. NW., Washington DC
20001.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Steve Morin, Office of Health and
Constituent Affairs, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 301–796–0161, FAX: 301–847–
8623, email: Steve.Morin@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. The FDA Patient Network
This is the second FDA Patient
Network Annual Meeting hosted by the
FDA Office of Health and Constituent
Affairs, formerly the Office of Special
Health Issues, the Agency’s primary
liaison with patient and health
professional communities. This annual
meeting is being hosted as part of the
larger FDA Patient Network program.
The FDA Patient Network is a new
resource for patients, caregivers,
independent patient advocates, and
patient advocate groups that seeks to:
• Educate and inform patient
stakeholders about FDA, its regulatory
authorities and processes, its initiatives
and programs, and
• Provide a venue for advocacy for
patient stakeholder involvement within
FDA, enhancing transparency of Agency
actions for patients. In addition to an
annual meeting, the FDA Patient
Network consists of:
• The FDA Patient Network Web
site—A new, patient-centered Web site
that contains educational modules,
centralized Agency information, and
multi-directional communication tools
(www.patientnetwork.fda.gov);
• The biweekly FDA Patient Network
News email newsletter containing FDArelated information on a variety of
topics, including new product
approvals, significant labeling changes,
safety warnings, notices of upcoming
public meetings, proposed regulatory
guidances and opportunity to comment,
and other information of interest to
patients and patient advocates; and
• Hosting of periodic meetings,
briefings, and listening sessions
between patient advocates and FDA
staff.
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II. Patient Involvement in the Drug
Development Life Cycle
We believe that enhancing patients’
understanding of the drug development
process will provide a better foundation
for their participation in regulatory
decision making, and clarify where
patient input can be most meaningful in
the drug development life cycle.
Patients who live with a disease have a
direct stake in the development of new
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therapies to treat and minimize
symptoms they are experiencing. They
are in a unique position to contribute to
the various product-specific regulatory
decisions that occur throughout the
drug development process, as well as
the policy decisions that impact the
drug development and review paradigm.
Though several programs exist that
facilitate patient representation on
Advisory Committees or participation in
selected review meetings, there are
currently few venues in which the
patient perspective is discussed outside
of a specific product’s marketing
application review. FDA believes the
medical product review process could
benefit from a more scientific,
systematic, and expansive approach to
obtaining input from patients who are
experiencing a particular disease
condition.
As part of the Food and Drug
Administration Safety and Innovation
Act, specifically section 1137 (see:
https://www.fda.gov/Regulatory
Information/Legislation/FederalFood
DrugandCosmeticActFDCAct/
SignificantAmendmentstotheFDCAct/
FDASIA/ucm311045.htm), FDA is
tasked with developing and
implementing strategies to solicit the
views of patients during the medical
product development process and
consider their perspectives during
regulatory discussions. This includes:
• Fostering participation of FDA
Patient Representatives as Special
Government Employees in appropriate
Agency meetings with medical product
sponsors and investigators; and
• Exploring means to provide for
identification of potential FDA Patient
Representatives who do not have any, or
have minimal, financial interest in the
medical products industry.
FDA is conducting this meeting with
patients, caregivers, patient advocates,
and patient advocate groups to provide
a forum to demystify the drug
development process and FDA’s role in
drug regulation, and facilitate a
discussion between these stakeholders
and the Agency to foster a collaborative
relationship. This meeting, intended to
build upon the objectives of the
inaugural Patient Network Annual
Meeting, held on May 18, 2012, will
provide an open forum for patients and
patient advocates to engage with FDA
on both ongoing and emerging medical
product regulatory issues.
Dated: August 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–19275 Filed 8–8–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
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. 209 and 37 CFR Part 404 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.
FOR FURTHER INFORMATION CONTACT:
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.
SUMMARY:
Rabbit Antibody to Mouse Sphingosine1-phosphate (S1P) Lyase
Description of Technology: The
cleavage of sphingoid base phosphates
by sphingosine-1-phosphate (S1P) lyase
to produce phosphoethanolamine and a
fatty aldehyde is the final degradative
step in the sphingolipid metabolic
pathway. Researchers at NIH injected
rabbits with the C-terminal peptide of
the mouse S1P lyase—551–
TTDPVTQGNQMNGSPKPR–568—to
develop an antibody that can be used in
western blotting to study this pathway.
Potential Commercial Applications:
The antibody can be used to detect and
measure S1P lyase.
Competitive Advantages: The
antibody works very well for western
blotting.
Development Stage: In vitro data
available.
Inventor: Richard L. Proia (NIDDK).
Publication: Bektas M, et al.
Sphingosine 1-phosphate lyase
deficiency disrupts lipid homeostasis in
liver. J Biol Chem. 2010 Apr
2;285(14):10880–9. [PMID 20097939].
Intellectual Property: HHS Reference
No. E–465–2013/0—Research Tool.
Patent protection is not being pursued
for this technology.
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Federal Register / Vol. 78, No. 154 / Friday, August 9, 2013 / Notices
Licensing Contact: Jaime M. Greene,
M.S.; 301–435–5559;
greenejaime@mail.nih.gov.
Rabbit Antibody to Mouse Sphingosine
Kinase 2 (SphK2)
Description of Technology: Two
isoforms of sphingosine kinase,
sphingosine kinase 1 (SphK1) and
sphingosine kinase 2 (SphK2), convert
sphingosine to sphingosine 1-phosphate
(S1P) in mammalian cells. While the
importance of SphK1 has been known
for some time, information about SphK2
is still being revealed. Therefore,
researchers at NIH have developed an
antibody against mouse SphK2, which
can be used to further understand the
role of this enzyme.
Potential Commercial Applications:
The antibody can be used to detect and
measure SphK2.
Competitive Advantages: The
antibody works very well for western
blotting.
Development Stage: In vitro data
available.
Inventor: Richard L. Proia (NIDDK).
Publication: Olivera A, et al. IgEdependent activation of sphingosine
kinases 1 and 2 and secretion of
sphingosine 1-phosphate requires Fyn
kinase and contributes to mast cell
responses. J Biol Chem. 2006 Feb
3;281(5):2515–25. [PMID 16316995].
Intellectual Property: HHS Reference
No. E–466–2013/0—Research Tool.
Patent protection is not being pursued
for this technology.
Licensing Contact: Jaime M. Greene,
M.S.; 301–435–5559;
greenejaime@mail.nih.gov.
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Video Monitoring System for Vivarium
Cage Racks
Description of Technology: This
invention pertains to a system for
continuous observation of rodents in
home-cage environments with the
specific aim to facilitate the
quantification of activity levels and
behavioral patterns for mice housed in
a commercial ventilated cage rack. The
home-cage in-rack provides daytime and
nighttime monitoring with the stability
and consistency of a home-cage
environment. The system is made up of
a dual-video camera hardware design
mounted on a video rack and an
executable software means for automatic
detection and processing for tracking
multiple animals.
Potential Commercial Applications:
• vivarium monitoring.
• laboratory test animal management.
Competitive Advantages:
• real-time monitoring.
• day or night monitoring.
Development Stage: Prototype.
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Inventors: James Mitchell (NCI),
Ghadi Salem (CIT), Thomas Pohida
(CIT).
Intellectual Property: HHS Reference
No. E–090–2013/0—US Provisional
Patent Application 61/841,064 filed
June 28, 2013.
Licensing Contact: Michael
Shmilovich, Esq., CLP; 301–435–5019;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate or
commercialize Video Monitoring
System for Vivarium Cage Racks. For
collaboration opportunities, please
contact John D. Hewes, Ph.D. at
hewesj@mail.nih.gov.
MRI Scanner Bore Covering
Description of Technology: This
invention pertains to a bore covering for
creating controlled environments and
specifically for maintaining temperature
within the bore of an MRI scanner. The
bore covering includes a covering sheet
with fastening means (e.g., weak-tack
adhesive, pressure-sensitive adhesive or
low-tack adhesive) around its inner
surfaces that permits reversible
attachment to the scanner. The adhesive
ends can be peeled away to expose an
edge of the bore opening or the entire
sheet may be constructed with peel
away gaps so that warm air can be
pumped into the bore. On the inner
surface the bore covering may include a
gap that is connected to a climate
control device or an exhaust vent to
expel air out of the MRI scanner bore.
Potential Commercial Applications:
MR imaging of infants and neonates.
Competitive Advantages:
• Temperature control.
• Comfort.
Development Stage: Prototype.
Inventors: Robert Balaban, Robert
Lederman, Michael Hansen, Anthony
Faranesh, Kanishka Ratnayaka (all of
NHLBI).
Intellectual Property: HHS Reference
No. E–026–2013/0—US Provisional
Patent Application 61/836,817 filed
June 19, 2013.
Licensing Contact: Michael
Shmilovich, Esq., CLP; 301–435–5019;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity:
The National Heart, Lung, and Blood
Institute (NHLBI) is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize MRI Scanner Bore
Covering. For collaboration
opportunities, please contact Dr. Denise
Crooks at crooksd@mail.nih.gov.
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Cotranslational Protein Expression
System for High-throughput Screening
Description of Technology: Reporter
gene-based assays are used extensively
in high-throughput screening (HTS) to
identify chemical modulators of cellular
pathways for drug discovery and
development. However, such screening
frequently results in a large number of
false ‘‘hits’’ due to interactions of
screened compounds with reporter
proteins, producing confounding
results. Thus, validation of results using
these assays often involves significant
time and expense.
The inventors have developed an
assay system that significantly improves
detection of target-relevant active
compounds by discriminating between
signals arising from the target activity
and those caused by reporter bias. This
system utilizes simultaneous detection
(also known as ‘‘coincidence detection’’)
of non-homologous reporter proteins
with dissimilar properties, such as
differing catalysis, light emission, or
fluorescence characteristics;
simultaneous observation of signals
from these reporters indicates a high
probability that it is a true target
response. The reporters are
cotranslationally expressed from a
single RNA transcript, which ensures
stable stoichiometry of the expressed
proteins.
Potential Commercial Applications:
High-throughput screening of chemical
libraries in a single assay platform for
commercial or research use.
Competitive Advantages: This method
will significantly enhance the ability to
identify and prioritize active
compounds from reporter gene-based
assays.
Development Stage: Early-stage.
Inventors: James Inglese, Ken C-C
Cheng, Samuel A. Hasson (all of
NCATS).
Publication: Chan K, Inglese J. A
coincidence reporter-gene system for
high-throughput screening. Nat
Methods. 2012 Oct;9(10):937. [PMID
23018994].
Intellectual Property: HHS Reference
No. E–300–2012/0—PCT Application
No. PCT/US2013/032184 filed March
15, 2013.
Licensing Contact: Tara L. Kirby,
Ph.D.; 301–435–4426;
tarak@mail.nih.gov.
Collaborative Research Opportunity:
The National Center for Advancing
Translational Sciences (NCATS) is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate or commercialize
Cotranslational Protein Expression
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System for High-throughput Screening.
For collaboration opportunities, please
contact NCATS Technology
Development Coordinator at
NCATSPartnerships@mail.nih.gov.
Human Melanoma Metastasis Cell
Lines Harboring Bcl-2-Like Protein 12
(BCL2L12) Mutations
Description of Technology: Using
whole-genome and whole-exome
sequencing to identify somatic (e.g.,
tumor-specific) alternations in human
melanoma samples, the researchers at
the NIH have found a recurrent
synonymous (or silent) somatic
mutation in the Bcl-2-Like Protein 12
(BCL2L12). The mutant BCL2L12 bound
to p53 and inhibited UV-induced
apoptosis more efficiently than wildtype BCL2L12 and therefore could be a
novel melanoma oncoprotein. This
appears to be the first report of a
mutation that does not alter the encoded
protein, yet affects the protein function
in the cancer genome. Consequently,
these cell lines could be used to further
investigate the effects of BCL2L12 in
melanoma and to develop therapeutics
targeting this gene and protein.
Potential Commercial Applications:
• Diagnostic array for the detection of
BCL2L12 mutations.
• In vitro and in vivo cell model for
the BCL2L12 mutation in melanoma.
This is a useful tool for investigating
BCL2L12 phenotype biology, including
growth, motility, invasion, and
metabolite production.
Competitive Advantages:
• Cell lines are derived from
melanoma patients.
• The BCL2L12 mutation is frequent
in melanomas.
Development Stage: Pre-clinical.
Inventors: Yardena Samuels (NHGRI)
and Steven Rosenberg (NCI).
Publication: Gartner JJ, et al. Wholegenome sequencing identifies a
recurrent functional synonymous
mutation in melanoma. Proc Natl Acad
Sci USA. 2013 Jul 30; Epub ahead of
print. [PMID 23901115].
Intellectual Property: HHS Reference
No. E–145–2012/0—Research Tool.
Patent protection is not being pursued
for the BCL2L12 melanoma metastatic
cell lines.
Related Technologies: HHS Reference
Nos. E–029–2012/0 (research tool), E–
013–2011/0 (patent app: US), E–024–
2012/0 (research tool), E–272–2008/0
(patent app: US, EP), E–229–2010/0
(research tool), E–232–2010/0 (research
tool).
Licensing Contact: Whitney Hastings;
301–451–7337; hastingw@mail.nih.gov.
Collaborative Research Opportunity:
The NHGRI is seeking statements of
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capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize this technology. For
collaboration opportunities, please
contact Claire Driscoll, Director, NHGRI
Technology Transfer Office, at
cdriscol@mail.nih.gov or 301–594–2235.
Gag-Based DNA Vaccines Against HIV
Description of Technology: Novel
DNA vaccine constructs against HIV
that express highly conserved elements
(CE) within the HIV Gag protein and
elicit strong, cross-clade cellular and
humoral responses. The DNA vaccine
vectors were engineered to express CEs
for protection against different clades of
HIV and prevention of
immunodominance, two issues
associated with current HIV vaccine
candidates.
In vivo studies of Rhesus macaques
vaccinated with variants of these
constructs expressing seven highly CEs
covering >99 of all known Gag
sequences elicited strong, cellular T-cell
and humoral antibody immune
responses. The Gag-specific antibody
responses were high titer and crossclade. Cross-clade protection is
important given the sequence diversity
of HIV as is the absence of
immunodominant epitopes that generate
antibodies which are not protective
against HIV.
Potential Commercial Applications:
HIV vaccines.
Competitive Advantages: Addresses
two key hurdles faced by current HIV
vaccines: sequence diversity of HIV and
immunodominance.
Development Stage:
• Early-stage.
• Pre-clinical.
• In vitro data available.
• In vivo data available (animal).
Inventors: George N. Pavlakis (NCI),
Barbara K. Felber (NCI), James Mullins
(University of Washington).
Intellectual Property: HHS Reference
No. E–132–2012/0—PCT Application
No. PCT/US2013/028932 filed March 4,
2013.
Related Technology: HHS Reference
No. E–308–2000/0—Patent family filed
in the U.S., Canada, Australia, Europe,
and Japan.
Licensing Contact: Kevin W. Chang,
Ph.D.; 301–435–5018;
changke@mail.nih.gov.
Diffusion Through Skull as Route of
Delivery for Treatment of Brain Injury
and Disease
Description of Technology: Traumatic
Brain injury (TBI) often results from
head impact and is a major cause of
death and disability. Brain injuries vary
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in severity and can be associated with
hemorrhaging, swelling, inflammation,
and death of brain tissue. Inventors at
NINDS developed a novel approach to
treating brain injuries that involves
transcranial application of small
molecules. They discovered, using two
photon laser scanning microscopy, that
compounds as large as 40,000 molecular
weight (MW) can pass directly through
the intact skull into the underlying
cerebral spinal fluid (CSF) that
circulates through the brain and spinal
cord. Small molecular weight
compounds (e.g. 600 MW) pass through
the skull more quickly than large ones
and appear to do so by simple diffusion.
Researchers have shown that
application of a variety of agents,
including glutathione, TNP–ATP
hydrase (P2X4 inhibitor), oxidated ATP
(P2X7 inhibitor), MRS2578 (P2Y6
inhibitor), MeSAMP (P2Y12 inhibitor)
and Carbenoxelone (Connexin
Hemichannel Inhibitor) directly to the
head results in delivery of the agents to
the brain. Transcranial drug application
can be used to pharmacologically target
several tiers of brain injury responses,
from the toxic mediators that cause cell
death to the molecular signals that drive
inflammation. Application can be by
direct application to the skull through
the scalp (e.g. rubbing it in), transdermal
patch, or subcutaneous injection under
the scalp.
Potential Commercial Applications:
• Treating Traumatic Brain Injury.
• Treating stroke.
• Treating other acute CNS
conditions, including encephalitis and
meningitis.
• Treating chronic CNS disorders
such as brain tumors, Alzheimer’s,
Parkinson’s, and multiple sclerosis.
Competitive Advantages:
• Quickly achieves a high local drug
concentration at the site of brain injury.
• Bypasses the blood brain barrier
and allows rapid administration of
therapeutic agents directly into injured
or inflamed brain.
• Current therapies to treat Traumatic
Brain Injury with neuroprotective agents
are often limited by ability to achieve
therapeutic concentrations of
therapeutic agent in the brain.
Development Stage:
• In vitro data available.
• In vivo data available (animal).
Inventors: Dorian McGavern and
Theodore Roth (NINDS).
Publication: Manuscript in
preparation.
Intellectual Property: HHS Reference
No. E–025–2012/0—PCT Application
No. PCT/US2013/24741 filed February
5, 2013.
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Licensing Contact: Betty B. Tong,
Ph.D.; 301–594–6565;
tongb@mail.nih.gov.
Collaborative Research Opportunity:
The National Institute of Neurological
Disorders and Stroke (NINDS) is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate or
commercialize treatment of brain injury
or disease through transcranial drug
delivery. For collaboration
opportunities, please contact Melissa
Maderia, Ph.D., M.B.A. at
maderiam@mail.nih.gov or 240–276–
5533.
Tri-functional Imaging Agent for
Monoclonal Antibody Tumor-Targeted
Imaging
Description of Technology: This is a
novel lysine-based trifunctional chelate
which bears both a chelating moiety
(CHX-A″) for sequestering radiometals
(86Y or 111In) and a near-infrared dye,
e.g., Cy5.5, for dual modality PET (or
SPECT) and fluorescence imaging.
Successful conjugation of monoclonal
antibody trastuzumab (Herceptin) or
cetuximab (Erbitux), has also been
achieved by efficient thiol-maleimide
chemistry, thereby yielding an
immunoconjugate (Signaling agent
(Cy5.5-Lys(SMCC)-CHX-A″) conjugated
to trastuzumab) or (Signaling agent
(Cy7-Lys(SMCC)-CHX-A″) conjugated to
cetuximab). Both specifically target
antigen expressing cells and
internalization of the agent has been
imaged over time. Trastuzumab can be
radiolabeled with isothiocyanate
derivatives of the bifunctional chelating
agents 1B4M (2-(4-aminobenzy1)-6methyldiethylenetriaminepentaacetic
acid); and CHX-A″ (N-[(R)-2-amino-3-(paminophenyl)propyl]-trans-(S,S)cyclohexane-1,2-diamine-N,N,N′,N″,N″pentaacetic acid).
Potential Commercial Applications:
• Cancer imaging.
• Cancer diagnostics.
Competitive Advantages:
• Target specific.
• Multifunctional (imageable through
multiple platforms).
Development Stage:
• Early-stage.
• In vivo data available (animal).
Inventors: Martin W. Brechbiel, Heng
Wu, Kwamena E. Baidoo (all of NCI).
Publications:
1. Xu H, et al. Design, synthesis, and
characterization of a dual modality
positron emission tomography and
fluorescence imaging agent for
monoclonal antibody tumor-targeted
imaging. J Med Chem. 2007 Sep
20;50(19):4759–65. [PMID 17725340]
2. Nayak TK, et al. PET and MRI of
metastatic peritoneal and pulmonary
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colorectal cancer in mice with human
epidermal growth factor receptor 1targeted 89Zr-labeled panitumumab. J
Nucl Med. 2012 Jan;53(1):113–20.
[PMID 22213822]
3. Dadwal M, et al. Synthesis and
evaluation of a bifunctional chelate for
development of Bi(III)-labeled
radioimmunoconjugates. Bioorg Med
Chem Lett. 2011 Dec 15;21(24):7513–5.
[PMID 22047687]
4. Song HA, et al. Efficient
bifunctional decadentate ligand 3p-CDEPA for targeted alpharadioimmunotherapy applications.
Bioconjug Chem. 2011 Jun
15;22(6):1128–35. [PMID 21604692]
5. Bumb A, et al. Preparation and
characterization of a magnetic and
optical dual-modality molecular probe.
Nanotechnology. 2010 Apr
30;21(17):175704. [PMID 20368682]
Intellectual Property: HHS Reference
No. E–194–2007/0—US Patent
Application No. 12/667,790 filed 05 Jan
2010 (allowed).
Related Technology: HHS Reference
No. E–111–2013/0—US Provisional
Application No. 61/779,016 filed 13 Mar
2013.
Licensing Contact: Michael A.
Shmilovich, Esq., CLP; 301–435–5019;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute Radiation
Oncology Branch is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize Trifunctional Imaging
Agent for Monoclonal Antibody TumorTargeted Imaging. For collaboration
opportunities, please contact John D.
Hewes, Ph.D. at hewesj@mail.nih.gov.
Dated: August 6, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2013–19285 Filed 8–8–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Environmental
Health Sciences; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Environmental
Health Sciences Council.
The meeting will be open to the
public as indicated below, with
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attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the 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.
Name of Committee: National Advisory
Environmental Health Sciences Council.
Date: September 10, 2013.
Open: 8:30 a.m. to 3:15 p.m.
Agenda: Discussion of program policies
and issues.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
111 T. W. Alexander Drive, Research
Triangle Park, NC 27709.
Closed: 3:30 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
111 T. W. Alexander Drive, Research
Triangle Park, NC 27709.
Date: September 11, 2013.
Closed: 8:30 a.m. to 3:15 p.m.
Agenda: To review and evaluate grant
applications.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
111 T. W. Alexander Drive, Research
Triangle Park, NC 27709.
Contact Person: Gwen W. Collman, Ph.D.,
Interim Director, Division of Extramural
Research & Training, National Institutes of
Health, Nat. Inst. of Environmental Health
Sciences, 615 Davis Dr. KEY615/3112,
Research Triangle Park, NC 27709, (919) 541–
4980, collman@niehs.nih.gov.
Any interested person may file
written comments with the committee
by forwarding the statement to the
Contact Person listed on this notice. The
statement should include the name,
address, telephone number and when
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Information is also available on the
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where an agenda and any additional
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(Catalogue of Federal Domestic Assistance
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Estimation—Health Risks from
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09AUN1
]]>Agencies
[Federal Register Volume 78, Number 154 (Friday, August 9, 2013)]
[Notices]
[Pages 48692-48695]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-19285]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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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. 209 and 37 CFR Part 404 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.
FOR FURTHER INFORMATION CONTACT: 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.
Rabbit Antibody to Mouse Sphingosine-1-phosphate (S1P) Lyase
Description of Technology: The cleavage of sphingoid base
phosphates by sphingosine-1-phosphate (S1P) lyase to produce
phosphoethanolamine and a fatty aldehyde is the final degradative step
in the sphingolipid metabolic pathway. Researchers at NIH injected
rabbits with the C-terminal peptide of the mouse S1P lyase--551-
TTDPVTQGNQMNGSPKPR-568--to develop an antibody that can be used in
western blotting to study this pathway.
Potential Commercial Applications: The antibody can be used to
detect and measure S1P lyase.
Competitive Advantages: The antibody works very well for western
blotting.
Development Stage: In vitro data available.
Inventor: Richard L. Proia (NIDDK).
Publication: Bektas M, et al. Sphingosine 1-phosphate lyase
deficiency disrupts lipid homeostasis in liver. J Biol Chem. 2010 Apr
2;285(14):10880-9. [PMID 20097939].
Intellectual Property: HHS Reference No. E-465-2013/0--Research
Tool. Patent protection is not being pursued for this technology.
[[Page 48693]]
Licensing Contact: Jaime M. Greene, M.S.; 301-435-5559;
greenejaime@mail.nih.gov.
Rabbit Antibody to Mouse Sphingosine Kinase 2 (SphK2)
Description of Technology: Two isoforms of sphingosine kinase,
sphingosine kinase 1 (SphK1) and sphingosine kinase 2 (SphK2), convert
sphingosine to sphingosine 1-phosphate (S1P) in mammalian cells. While
the importance of SphK1 has been known for some time, information about
SphK2 is still being revealed. Therefore, researchers at NIH have
developed an antibody against mouse SphK2, which can be used to further
understand the role of this enzyme.
Potential Commercial Applications: The antibody can be used to
detect and measure SphK2.
Competitive Advantages: The antibody works very well for western
blotting.
Development Stage: In vitro data available.
Inventor: Richard L. Proia (NIDDK).
Publication: Olivera A, et al. IgE-dependent activation of
sphingosine kinases 1 and 2 and secretion of sphingosine 1-phosphate
requires Fyn kinase and contributes to mast cell responses. J Biol
Chem. 2006 Feb 3;281(5):2515-25. [PMID 16316995].
Intellectual Property: HHS Reference No. E-466-2013/0--Research
Tool. Patent protection is not being pursued for this technology.
Licensing Contact: Jaime M. Greene, M.S.; 301-435-5559;
greenejaime@mail.nih.gov.
Video Monitoring System for Vivarium Cage Racks
Description of Technology: This invention pertains to a system for
continuous observation of rodents in home-cage environments with the
specific aim to facilitate the quantification of activity levels and
behavioral patterns for mice housed in a commercial ventilated cage
rack. The home-cage in-rack provides daytime and nighttime monitoring
with the stability and consistency of a home-cage environment. The
system is made up of a dual-video camera hardware design mounted on a
video rack and an executable software means for automatic detection and
processing for tracking multiple animals.
Potential Commercial Applications:
vivarium monitoring.
laboratory test animal management.
Competitive Advantages:
real-time monitoring.
day or night monitoring.
Development Stage: Prototype.
Inventors: James Mitchell (NCI), Ghadi Salem (CIT), Thomas Pohida
(CIT).
Intellectual Property: HHS Reference No. E-090-2013/0--US
Provisional Patent Application 61/841,064 filed June 28, 2013.
Licensing Contact: Michael Shmilovich, Esq., CLP; 301-435-5019;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute
is seeking statements of capability or interest from parties interested
in collaborative research to further develop, evaluate or commercialize
Video Monitoring System for Vivarium Cage Racks. For collaboration
opportunities, please contact John D. Hewes, Ph.D. at
hewesj@mail.nih.gov.
MRI Scanner Bore Covering
Description of Technology: This invention pertains to a bore
covering for creating controlled environments and specifically for
maintaining temperature within the bore of an MRI scanner. The bore
covering includes a covering sheet with fastening means (e.g., weak-
tack adhesive, pressure-sensitive adhesive or low-tack adhesive) around
its inner surfaces that permits reversible attachment to the scanner.
The adhesive ends can be peeled away to expose an edge of the bore
opening or the entire sheet may be constructed with peel away gaps so
that warm air can be pumped into the bore. On the inner surface the
bore covering may include a gap that is connected to a climate control
device or an exhaust vent to expel air out of the MRI scanner bore.
Potential Commercial Applications: MR imaging of infants and
neonates.
Competitive Advantages:
Temperature control.
Comfort.
Development Stage: Prototype.
Inventors: Robert Balaban, Robert Lederman, Michael Hansen, Anthony
Faranesh, Kanishka Ratnayaka (all of NHLBI).
Intellectual Property: HHS Reference No. E-026-2013/0--US
Provisional Patent Application 61/836,817 filed June 19, 2013.
Licensing Contact: Michael Shmilovich, Esq., CLP; 301-435-5019;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity: The National Heart, Lung, and
Blood Institute (NHLBI) is seeking statements of capability or interest
from parties interested in collaborative research to further develop,
evaluate or commercialize MRI Scanner Bore Covering. For collaboration
opportunities, please contact Dr. Denise Crooks at
crooksd@mail.nih.gov.
Cotranslational Protein Expression System for High-throughput Screening
Description of Technology: Reporter gene-based assays are used
extensively in high-throughput screening (HTS) to identify chemical
modulators of cellular pathways for drug discovery and development.
However, such screening frequently results in a large number of false
``hits'' due to interactions of screened compounds with reporter
proteins, producing confounding results. Thus, validation of results
using these assays often involves significant time and expense.
The inventors have developed an assay system that significantly
improves detection of target-relevant active compounds by
discriminating between signals arising from the target activity and
those caused by reporter bias. This system utilizes simultaneous
detection (also known as ``coincidence detection'') of non-homologous
reporter proteins with dissimilar properties, such as differing
catalysis, light emission, or fluorescence characteristics;
simultaneous observation of signals from these reporters indicates a
high probability that it is a true target response. The reporters are
cotranslationally expressed from a single RNA transcript, which ensures
stable stoichiometry of the expressed proteins.
Potential Commercial Applications: High-throughput screening of
chemical libraries in a single assay platform for commercial or
research use.
Competitive Advantages: This method will significantly enhance the
ability to identify and prioritize active compounds from reporter gene-
based assays.
Development Stage: Early-stage.
Inventors: James Inglese, Ken C-C Cheng, Samuel A. Hasson (all of
NCATS).
Publication: Chan K, Inglese J. A coincidence reporter-gene system
for high-throughput screening. Nat Methods. 2012 Oct;9(10):937. [PMID
23018994].
Intellectual Property: HHS Reference No. E-300-2012/0--PCT
Application No. PCT/US2013/032184 filed March 15, 2013.
Licensing Contact: Tara L. Kirby, Ph.D.; 301-435-4426;
tarak@mail.nih.gov.
Collaborative Research Opportunity: The National Center for
Advancing Translational Sciences (NCATS) is seeking statements of
capability or interest from parties interested in collaborative
research to further develop, evaluate or commercialize Cotranslational
Protein Expression
[[Page 48694]]
System for High-throughput Screening. For collaboration opportunities,
please contact NCATS Technology Development Coordinator at
NCATSPartnerships@mail.nih.gov.
Human Melanoma Metastasis Cell Lines Harboring Bcl-2-Like Protein 12
(BCL2L12) Mutations
Description of Technology: Using whole-genome and whole-exome
sequencing to identify somatic (e.g., tumor-specific) alternations in
human melanoma samples, the researchers at the NIH have found a
recurrent synonymous (or silent) somatic mutation in the Bcl-2-Like
Protein 12 (BCL2L12). The mutant BCL2L12 bound to p53 and inhibited UV-
induced apoptosis more efficiently than wild-type BCL2L12 and therefore
could be a novel melanoma oncoprotein. This appears to be the first
report of a mutation that does not alter the encoded protein, yet
affects the protein function in the cancer genome. Consequently, these
cell lines could be used to further investigate the effects of BCL2L12
in melanoma and to develop therapeutics targeting this gene and
protein.
Potential Commercial Applications:
Diagnostic array for the detection of BCL2L12 mutations.
In vitro and in vivo cell model for the BCL2L12 mutation
in melanoma. This is a useful tool for investigating BCL2L12 phenotype
biology, including growth, motility, invasion, and metabolite
production.
Competitive Advantages:
Cell lines are derived from melanoma patients.
The BCL2L12 mutation is frequent in melanomas.
Development Stage: Pre-clinical.
Inventors: Yardena Samuels (NHGRI) and Steven Rosenberg (NCI).
Publication: Gartner JJ, et al. Whole-genome sequencing identifies
a recurrent functional synonymous mutation in melanoma. Proc Natl Acad
Sci USA. 2013 Jul 30; Epub ahead of print. [PMID 23901115].
Intellectual Property: HHS Reference No. E-145-2012/0--Research
Tool. Patent protection is not being pursued for the BCL2L12 melanoma
metastatic cell lines.
Related Technologies: HHS Reference Nos. E-029-2012/0 (research
tool), E-013-2011/0 (patent app: US), E-024-2012/0 (research tool), E-
272-2008/0 (patent app: US, EP), E-229-2010/0 (research tool), E-232-
2010/0 (research tool).
Licensing Contact: Whitney Hastings; 301-451-7337;
hastingw@mail.nih.gov.
Collaborative Research Opportunity: The NHGRI is seeking statements
of capability or interest from parties interested in collaborative
research to further develop, evaluate or commercialize this technology.
For collaboration opportunities, please contact Claire Driscoll,
Director, NHGRI Technology Transfer Office, at cdriscol@mail.nih.gov or
301-594-2235.
Gag-Based DNA Vaccines Against HIV
Description of Technology: Novel DNA vaccine constructs against HIV
that express highly conserved elements (CE) within the HIV Gag protein
and elicit strong, cross-clade cellular and humoral responses. The DNA
vaccine vectors were engineered to express CEs for protection against
different clades of HIV and prevention of immunodominance, two issues
associated with current HIV vaccine candidates.
In vivo studies of Rhesus macaques vaccinated with variants of
these constructs expressing seven highly CEs covering >99 of all known
Gag sequences elicited strong, cellular T-cell and humoral antibody
immune responses. The Gag-specific antibody responses were high titer
and cross-clade. Cross-clade protection is important given the sequence
diversity of HIV as is the absence of immunodominant epitopes that
generate antibodies which are not protective against HIV.
Potential Commercial Applications: HIV vaccines.
Competitive Advantages: Addresses two key hurdles faced by current
HIV vaccines: sequence diversity of HIV and immunodominance.
Development Stage:
Early-stage.
Pre-clinical.
In vitro data available.
In vivo data available (animal).
Inventors: George N. Pavlakis (NCI), Barbara K. Felber (NCI), James
Mullins (University of Washington).
Intellectual Property: HHS Reference No. E-132-2012/0--PCT
Application No. PCT/US2013/028932 filed March 4, 2013.
Related Technology: HHS Reference No. E-308-2000/0--Patent family
filed in the U.S., Canada, Australia, Europe, and Japan.
Licensing Contact: Kevin W. Chang, Ph.D.; 301-435-5018;
changke@mail.nih.gov.
Diffusion Through Skull as Route of Delivery for Treatment of Brain
Injury and Disease
Description of Technology: Traumatic Brain injury (TBI) often
results from head impact and is a major cause of death and disability.
Brain injuries vary in severity and can be associated with
hemorrhaging, swelling, inflammation, and death of brain tissue.
Inventors at NINDS developed a novel approach to treating brain
injuries that involves transcranial application of small molecules.
They discovered, using two photon laser scanning microscopy, that
compounds as large as 40,000 molecular weight (MW) can pass directly
through the intact skull into the underlying cerebral spinal fluid
(CSF) that circulates through the brain and spinal cord. Small
molecular weight compounds (e.g. 600 MW) pass through the skull more
quickly than large ones and appear to do so by simple diffusion.
Researchers have shown that application of a variety of agents,
including glutathione, TNP-ATP hydrase (P2X4 inhibitor), oxidated ATP
(P2X7 inhibitor), MRS2578 (P2Y6 inhibitor), MeSAMP (P2Y12 inhibitor)
and Carbenoxelone (Connexin Hemichannel Inhibitor) directly to the head
results in delivery of the agents to the brain. Transcranial drug
application can be used to pharmacologically target several tiers of
brain injury responses, from the toxic mediators that cause cell death
to the molecular signals that drive inflammation. Application can be by
direct application to the skull through the scalp (e.g. rubbing it in),
transdermal patch, or subcutaneous injection under the scalp.
Potential Commercial Applications:
Treating Traumatic Brain Injury.
Treating stroke.
Treating other acute CNS conditions, including
encephalitis and meningitis.
Treating chronic CNS disorders such as brain tumors,
Alzheimer's, Parkinson's, and multiple sclerosis.
Competitive Advantages:
Quickly achieves a high local drug concentration at the
site of brain injury.
Bypasses the blood brain barrier and allows rapid
administration of therapeutic agents directly into injured or inflamed
brain.
Current therapies to treat Traumatic Brain Injury with
neuroprotective agents are often limited by ability to achieve
therapeutic concentrations of therapeutic agent in the brain.
Development Stage:
In vitro data available.
In vivo data available (animal).
Inventors: Dorian McGavern and Theodore Roth (NINDS).
Publication: Manuscript in preparation.
Intellectual Property: HHS Reference No. E-025-2012/0--PCT
Application No. PCT/US2013/24741 filed February 5, 2013.
[[Page 48695]]
Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565;
tongb@mail.nih.gov.
Collaborative Research Opportunity: The National Institute of
Neurological Disorders and Stroke (NINDS) is seeking statements of
capability or interest from parties interested in collaborative
research to further develop, evaluate or commercialize treatment of
brain injury or disease through transcranial drug delivery. For
collaboration opportunities, please contact Melissa Maderia, Ph.D.,
M.B.A. at maderiam@mail.nih.gov or 240-276-5533.
Tri-functional Imaging Agent for Monoclonal Antibody Tumor-Targeted
Imaging
Description of Technology: This is a novel lysine-based
trifunctional chelate which bears both a chelating moiety (CHX-A'') for
sequestering radiometals (86Y or 111In) and a near-infrared dye, e.g.,
Cy5.5, for dual modality PET (or SPECT) and fluorescence imaging.
Successful conjugation of monoclonal antibody trastuzumab (Herceptin)
or cetuximab (Erbitux), has also been achieved by efficient thiol-
maleimide chemistry, thereby yielding an immunoconjugate (Signaling
agent (Cy5.5-Lys(SMCC)-CHX-A'') conjugated to trastuzumab) or
(Signaling agent (Cy7-Lys(SMCC)-CHX-A'') conjugated to cetuximab). Both
specifically target antigen expressing cells and internalization of the
agent has been imaged over time. Trastuzumab can be radiolabeled with
isothiocyanate derivatives of the bifunctional chelating agents 1B4M
(2-(4-aminobenzy1)-6-methyldiethylenetriaminepentaacetic acid); and
CHX-A'' (N-[(R)-2-amino-3-(p-aminophenyl)propyl]-trans-(S,S)-
cyclohexane-1,2-diamine-N,N,N',N'',N''-pentaacetic acid).
Potential Commercial Applications:
Cancer imaging.
Cancer diagnostics.
Competitive Advantages:
Target specific.
Multifunctional (imageable through multiple platforms).
Development Stage:
Early-stage.
In vivo data available (animal).
Inventors: Martin W. Brechbiel, Heng Wu, Kwamena E. Baidoo (all of
NCI).
Publications:
1. Xu H, et al. Design, synthesis, and characterization of a dual
modality positron emission tomography and fluorescence imaging agent
for monoclonal antibody tumor-targeted imaging. J Med Chem. 2007 Sep
20;50(19):4759-65. [PMID 17725340]
2. Nayak TK, et al. PET and MRI of metastatic peritoneal and
pulmonary colorectal cancer in mice with human epidermal growth factor
receptor 1-targeted 89Zr-labeled panitumumab. J Nucl Med. 2012
Jan;53(1):113-20. [PMID 22213822]
3. Dadwal M, et al. Synthesis and evaluation of a bifunctional
chelate for development of Bi(III)-labeled radioimmunoconjugates.
Bioorg Med Chem Lett. 2011 Dec 15;21(24):7513-5. [PMID 22047687]
4. Song HA, et al. Efficient bifunctional decadentate ligand 3p-C-
DEPA for targeted alpha-radioimmunotherapy applications. Bioconjug
Chem. 2011 Jun 15;22(6):1128-35. [PMID 21604692]
5. Bumb A, et al. Preparation and characterization of a magnetic
and optical dual-modality molecular probe. Nanotechnology. 2010 Apr
30;21(17):175704. [PMID 20368682]
Intellectual Property: HHS Reference No. E-194-2007/0--US Patent
Application No. 12/667,790 filed 05 Jan 2010 (allowed).
Related Technology: HHS Reference No. E-111-2013/0--US Provisional
Application No. 61/779,016 filed 13 Mar 2013.
Licensing Contact: Michael A. Shmilovich, Esq., CLP; 301-435-5019;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute
Radiation Oncology Branch is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate or commercialize Trifunctional Imaging Agent for
Monoclonal Antibody Tumor-Targeted Imaging. For collaboration
opportunities, please contact John D. Hewes, Ph.D. at
hewesj@mail.nih.gov.
Dated: August 6, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-19285 Filed 8-8-13; 8:45 am]
BILLING CODE 4140-01-P
