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The next NIH Small Business
Innovation Research (SBIR) and Small Business Technology Transfer (STTR)
Omnibus funding opportunity deadline is only a couple months away on September
6, 2016. The National Heart, Lung, and Blood Institute (NHLBI) welcomes all
investigator-initiated projects within our
mission through these funding opportunities:
For Phase I, Phase II, and
Fast-Track applications
Clarification on eligibility
criteria: NOT-OD-16-052
Standard Application Due Dates:
September 6, 2016; January 5, 2017; and April 5, 2017.
Note:
the standard SBIR/STTR due date of September 5th falls on a Federal
holiday, so the deadline for SBIR/STTR will be September 6th at 5
pm, your local time.
Learn about the
NHLBI Mission
Get Ready
Additional
Funding Opportunities Due Fall 2016
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September 6 - New Technologies
for Viral Hepatitis (SBIR
PA-15-077 STTR PA-15-076)
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September 6 - Commercialization
Readiness Pilot (CRP) Program: Technical Assistance for Phase II Awardees
- (SB1 PAR-16-026,
Notice about NHLBI participation NOT-HL-15-283)
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October 14 – Bioreactors for Reparative Medicine (SBIR RFA-HL-15-008
STTR RFA-HL-15-004
D2P2 RFA-HL-15-017)
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October 15 - Onsite Tools and Technologies for Heart, Lung, and Blood Clinical
Research Point-of-Care (STTR RFA-HL-14-017)
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November 9 – Human Cellular Models for Predicting Individual Responses to
Cystic Fibrosis Transmembrane Conductance Regulator- Directed Therapeutics (SBIR RFA-HL-15-027)
View all NHLBI targeted funding
opportunities on our website (http://bit.ly/NHLBI-SBIR-FOA).
The NHLBI accepts
investigator-initiated grant applications relevant to the NHLBI mission through
the Omnibus Grant Solicitations. NHLBI has identified specific Topics of Special Interest though
we also encourage mission-aligned applications for innovative technologies
outside these targeted areas. Applications
for TOSI are submitted in response to the Omnibus Grant Solicitations (SBIR PA-16-302, STTR PA-16-303, and Direct to Phase II SBIR PAR-14-088).
TOSI are not the same as the
list of topics approved for awards over statutory budget limitations; for these
waiver topics, please see Appendix A of the
Program Descriptions and Research Topics document.
The Center for Scientific Review covers the top 10
preventable errors that keep your application from being reviewed. Make sure
these don’t happen to you!
1. Not having proper registrations in place
2. Not realizing that application submission is a
multi-step process
3.
Submitting your application at the last minute
4.
Attempting to fix a warning after the deadline
5. Not
using the correct application
form for the funding opportunity
6. Not paying close enough attention to the SF424 SBIR/STTR application
instructions
7. Submitting an incomplete application
8. Trying to avoid page limits by stuffing
information in the wrong places
9.
Referring to previous review outcomes or comments in a
new application
10. Using too small a font
Register
Today HERE
For small
businesses participating in the SBIR/STTR programs, understanding Intellectual
Property (IP) - Patents, Trade Secrets, Trademarks, and Copyrights - is
necessary to protect ideas, products and product names in today's knowledge
economy.
Hosted by
the United States Patent and Trademark Office (USPTO), these 90-minute webinars
have been designed specifically to address the most common IP issues facing
small businesses funded by the SBIR/STTR programs. They will cover all aspects
of Intellectual Property protection, as well as help you understand your IP
Data Rights under the SBIR/STTR grant/contract. Space is limited to 200
people per webinar! Register early!
Monday, July
11 at 1 pm ET
Overview:
U.S. Intellectual Property Rights and the SBIR-STTR Stakeholders
– Presenter
Henry Wixon (Chief Counsel for NIST)
Tuesday,
July 12 at 1 pm ET
Basics US
Patent Practice for the SBIR-STTR Stakeholders
– Presenter
Michael Razavi (Office on Innovation Development, USPTO)
Wednesday,
July 13 at 1 pm ET
Trademarks
in the US
– Presenter
Scott Baldwin (Trademark Attorney, USPTO)
Thursday,
July 14 at 1 pm ET
Copyright
(Domestic and International)
– Presenter
Susan Anthony (Copyright Attorney, USPTO)
Monday,
July 18 at 1 pm ET
The
International Trademark Portfolio
– Presenter
Susan Anthony (Copyright Attorney, USPTO)
Tuesday,
July 19, at 1 pm ET
Patent
Cooperation Treaty (PCT) and Hague Strategies for Filing Abroad
– Presenter
Michael Neas (Deputy Director, International Patent Legal Administration,
USPTO)
Wednesday,
July 20, at 1 pm ET
Intermediate/Advanced
US Patent Practice for the SBIR/STTR Stakeholders
–Presenter
Oleg Asanbayev (Patent Examiner, USPTO)
Register HERE
For webinar
questions, please contact Oleg Asanbayev at USPTO: Oleg.Asanbayev@USPTO.GOV
Register HERE
The FDA CDER
Regulatory Education for Industry Pharmaceutical Quality Symposium is a free two-day in-depth exploration of
pharmaceutical quality issues. Investigators and businesses can interact with
FDA experts from the Office of Pharmaceutical Quality (OPQ) as they discuss
topics of universal interest in drug manufacturing.
Attendance can be in person
in Silver Spring Maryland, or virtual.
For more information, visit the event website: ReDI
Pharmaceutical Quality Symposium 2016
The FDA published a final
guidance, describing the regulatory framework for extrapolating existing
data to evaluate a device’s performance in pediatric patients in pre-market
approval applications (PMAs), humanitarian device exemptions (HDEs) and de
novo requests.
This guidance:
- explains the conditions
in which FDA believes it may be appropriate to leverage existing clinical
data to support pediatric device indications and labeling;
- outlines the approach
FDA uses to determine whether extrapolation is appropriate and to what
extent; and
- describes statistical
methodology that can be used to leverage data for pediatric implications.
FDA will discuss this final guidance document at a webinar
scheduled for August 8, 2016. The webinar is intended to help
manufacturers and other interested stakeholders understand the information
provided in this final guidance document.
Following a brief presentation, the FDA will respond to
questions regarding this guidance document.
Webinar details:
Registration is not necessary.
- Date: August 8,
2016
- Time: 1:00 PM – 2:30 PM
ET
- To hear the presentation
and ask questions: Dial: 888-603-7015; passcode: 3007138 | International:
1-517-308-9255; passcode:3007138
-
View the slide
presentation during the webinar
Following the webinar, a transcript, recording and slides will be
available at: FDA's site. The slide presentation will be available at this site on the morning of the
webinar.
The purpose of this workshop is to provide investigators
with training and expertise in designing and conducting clinical trials in
pediatric patients that will lead to appropriate labeling. Although we have
learned a lot about conducting pediatric trials over the past two decades,
there are still challenges that need to be addressed. The training course is
intended to provide investigators with:
(1) A clear understanding of some of the challenges of
studying products in the pediatric population, including: Pediatric study
design, neonates, biomarkers, endpoints, orphan drugs and rare disease trial
design, formulations;
(2) an overview of extrapolation as it relates to the
pediatric population; and
(3) an overview of ethically appropriate methods related to
the design of clinical trials in the pediatric population
Interested parties can attend in person (at the Bethesda
Doubletree) or via webcast. For more information please
visit U.S. Food
and Drug Administration (FDA) or register HERE.
7/11 - NIH
Day Hosted by Kentucky Science and Technology Corporation - Webinar
9/13 - RESI 2016
– Boston, MA
9/19 - 9/20 - Arizona
Bioscience Week (AZBio) – Phoenix, AZ
9/29 - 9/30 - 14th
Annual Dartmouth Device Development Symposium – Woodstock, VT
10/17 - 10/19 - AdvaMed 2016 –
Minneapolis, MN
10/18 - 10/19 - BIO Investor Forum –
San Francisco, CA
11/1 - NHLBI
Innovation Conference – New York City, NY
11/1 - 11/3 - SSTi
2016 Annual Conference – Columbus, OH
11/2 - 11/3 - Life
Sciences Summit – New York City, NY
11/13 - 11/15 - Partnering
for Cures – New York City, NY
11/15 - 11/17 - 18th Annual HHS SBIR/STTR Conference - Orlando, FL
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