Government-Owned Inventions; Availability for Licensing, 57927 [2016-20162]
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NICEATM administers ICCVAM,
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Dated: August 16, 2016.
John R. Bucher,
Associate Director, National Toxicology
Program.
[FR Doc. 2016–20159 Filed 8–23–16; 8:45 am]
BILLING CODE 4140–01–P
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 invention listed below is
owned by an agency of the U.S.
Government and is available for
licensing and/or co-development 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 and/or co-development.
ADDRESSES: Invention Development and
Marketing Unit, Technology Transfer
Center, National Cancer Institute, 9609
Medical Center Drive, Mail Stop 9702,
Rockville, MD 20850–9702.
FOR FURTHER INFORMATION CONTACT:
Information on licensing and codevelopment research collaborations,
and copies of the U.S. patent
applications listed below may be
obtained by contacting: Attn. Invention
Development and Marketing Unit,
Technology Transfer Center, National
Cancer Institute, 9609 Medical Center
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
20:16 Aug 23, 2016
Jkt 238001
Drive, Mail Stop 9702, Rockville, MD
20850–9702, Tel. 240–276–5515 or
email ncitechtransfer@mail.nih.gov. A
signed Confidential Disclosure
Agreement may be required to receive
copies of the patent applications.
SUPPLEMENTARY INFORMATION:
Technology description follows.
Title of invention: Methods of
Analyzing Virus-Derived Therapeutics.
Description of Technology:
Researchers at the National Cancer
Institute’s Biopharmaceutical
Development Program recently
developed massively parallel
sequencing methods for virus-derived
therapeutics such as viral vaccines and
oncolytic immunotherapies. The
methods allow for the determination of
micro-heterogeneity and quantitation of
low frequency sequence variants, which
have the possibility of supplanting
monkey neurovirulence safety testing
(MNVT), mutant analysis by PCR, and
restriction enzyme cleavage (MAPREC)
methods that are currently used to
screen RNA virus-derived therapeutics.
Potential Commercial Applications:
• Improved methods for detecting
mutations in GMP-manufactured virusderived therapeutics, including viruses,
viral template plasmids, or vaccines;
• The method allows for at least two
different virus-derived therapeutics to
be assayed simultaneously.
Value Proposition:
• Provides a cost- and time-effective
means of assaying a virus-derived
therapeutic, such as oncolytic viruses,
for viral sequence variants, for
regulatory approval;
• RNA virus preparation steps
increase the amount of viral RNA
obtained;
• Demonstrated superiority of
massively parallel sequencing (‘‘MPS’’)
over mutant analysis by PCR and
restriction enzyme cleavage
(‘‘MAPREC’’) analysis.
Development Stage: Clinical Phase I.
Inventor(s): Trevor Broadt (NCI),
Michael D. Harwich (American
International Biotechnology, LLC),
William T. Budd (American
International Biotechnology, LLC),
Gregory A. Myers (American
International Biotechnology, LLC).
Intellectual Property:
HHS Ref. No. E–240–2015/0–U.S.–01,
corresponding to U.S. Provisional
Patent App. No. 62/199,663, filed July
31, 201562/173,777, entitled
‘‘Methods of Analysis of RNA VirusDerived Therapeutics’’
HHS Ref. No. E–240–2015/0–PCT–02,
corresponding to International Patent
App. No. PCT/US2016/044788, filed
July 29, 2016, entitled ‘‘Methods of
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
57927
Analyzing Virus-Derived
Therapeutics’’
Related Technologies: HHS Reference
#E–267–2014/0 entitled ‘‘Processes for
Production and Purification of Nucleic
Acid Containing Compositions’’.
Contact Information: Requests for
copies of the patent application or
inquiries about licensing, research
collaborations, and co-development
opportunities should be sent to John D.
Hewes, Ph.D., email: john.hewes@
nih.gov.
Dated: August 16, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology
Transfer Center, National Cancer Institute.
[FR Doc. 2016–20162 Filed 8–23–16; 8:45 am]
BILLING CODE 4140–01–P
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E:\FR\FM\24AUN1.SGM
24AUN1
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[Federal Register Volume 81, Number 164 (Wednesday, August 24, 2016)]
[Notices]
[Page 57927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20162]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The invention listed below is owned by an agency of the U.S.
Government and is available for licensing and/or co-development 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 and/or co-development.
ADDRESSES: Invention Development and Marketing Unit, Technology
Transfer Center, National Cancer Institute, 9609 Medical Center Drive,
Mail Stop 9702, Rockville, MD 20850-9702.
FOR FURTHER INFORMATION CONTACT: Information on licensing and co-
development research collaborations, and copies of the U.S. patent
applications listed below may be obtained by contacting: Attn.
Invention Development and Marketing Unit, Technology Transfer Center,
National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702,
Rockville, MD 20850-9702, Tel. 240-276-5515 or email
ncitechtransfer@mail.nih.gov. A signed Confidential Disclosure
Agreement may be required to receive copies of the patent applications.
SUPPLEMENTARY INFORMATION: Technology description follows.
Title of invention: Methods of Analyzing Virus-Derived
Therapeutics.
Description of Technology: Researchers at the National Cancer
Institute's Biopharmaceutical Development Program recently developed
massively parallel sequencing methods for virus-derived therapeutics
such as viral vaccines and oncolytic immunotherapies. The methods allow
for the determination of micro-heterogeneity and quantitation of low
frequency sequence variants, which have the possibility of supplanting
monkey neurovirulence safety testing (MNVT), mutant analysis by PCR,
and restriction enzyme cleavage (MAPREC) methods that are currently
used to screen RNA virus-derived therapeutics.
Potential Commercial Applications:
Improved methods for detecting mutations in GMP-
manufactured virus-derived therapeutics, including viruses, viral
template plasmids, or vaccines;
The method allows for at least two different virus-derived
therapeutics to be assayed simultaneously.
Value Proposition:
Provides a cost- and time-effective means of assaying a
virus-derived therapeutic, such as oncolytic viruses, for viral
sequence variants, for regulatory approval;
RNA virus preparation steps increase the amount of viral
RNA obtained;
Demonstrated superiority of massively parallel sequencing
(``MPS'') over mutant analysis by PCR and restriction enzyme cleavage
(``MAPREC'') analysis.
Development Stage: Clinical Phase I.
Inventor(s): Trevor Broadt (NCI), Michael D. Harwich (American
International Biotechnology, LLC), William T. Budd (American
International Biotechnology, LLC), Gregory A. Myers (American
International Biotechnology, LLC).
Intellectual Property:
HHS Ref. No. E-240-2015/0-U.S.-01, corresponding to U.S. Provisional
Patent App. No. 62/199,663, filed July 31, 201562/173,777, entitled
``Methods of Analysis of RNA Virus-Derived Therapeutics''
HHS Ref. No. E-240-2015/0-PCT-02, corresponding to International Patent
App. No. PCT/US2016/044788, filed July 29, 2016, entitled ``Methods of
Analyzing Virus-Derived Therapeutics''
Related Technologies: HHS Reference #E-267-2014/0 entitled
``Processes for Production and Purification of Nucleic Acid Containing
Compositions''.
Contact Information: Requests for copies of the patent application
or inquiries about licensing, research collaborations, and co-
development opportunities should be sent to John D. Hewes, Ph.D.,
email: john.hewes@nih.gov.
Dated: August 16, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology Transfer Center, National
Cancer Institute.
[FR Doc. 2016-20162 Filed 8-23-16; 8:45 am]
BILLING CODE 4140-01-P