Seek NHLBI guidance while writing your Bridge
and Small Market Applications
Apply for up to $3M to
support continued development of your Phase II SBIR or STTR-funded heart, lung,
blood, or sleep technology requiring approval or clearance by a Federal
regulatory agency. The National Heart, Lung, and Blood Institute (NHLBI) SBIR Phase IIB Bridge
and Small Market Awards programs aim to de-risk your technology and encourage partnerships
between small businesses and investors and strategic partners.
Letters of Intent due May 19, 2017.
Applications due June 19, 2017.
For more information, please read the full Notice:
Planning to submit a new
or resubmission application to NIH? We have updated our application guide and supplemental
instructions. In addition to incorporating policy changes summarized in NOT-OD-17-035, the updated (FORMS-D)
application guide has been restructured and streamlined. Updates to form
instructions are listed at: Significant Changes. Learn more in NOT-OD-16-129.
It’s
also not too early to make sure you have all your required registrations (SAM must be renewed annually) and see if ASSIST electronic submission option is right for you
(it makes collaboration and submission easier Getting
Started: Step-by-Step).
The
next NIH Small Business Innovation Research (SBIR) and Small Business
Technology Transfer (STTR) Omnibus funding opportunity deadline is 5 months
away on September 5, 2017. Although PA-16-302 and PA-16-303 have
expired, stay tuned to this newsletter for information about the new FOA
numbers, we anticipate their release mid-summer. In the meanwhile, you
should still be preparing your application. Below are some tips to ensuring you
are ready to apply.
Get Ready
Additionally, NIH encourages investigators to use interim research products, such as preprints, to speed the dissemination and enhance the rigor of their work. Notice NOT-OD-17-050 clarifies reporting instructions to allow investigators to cite their interim research products and claim them as products of NIH funding.
Interim Research Products are complete, public research products that are not final.
For more information read the full Notice NOT-OD-17-050
Contact us at NHLBI Small Biz Inquiry form for advice and assistance.
As a current NHLBI small business awardee, you
may be eligible to apply for a competing revision to
your award. A planned FOA, known as the Regenerative Medicine Innovation
Project (RMIP), is expected to publish in April/May and will support revision
projects that propose solutions to widely recognized issues in the development
of safe and effective regenerative medicine therapies. Application receipt
dates are expected in May/June 2017, and awards are anticipated in FY 2017.
To
learn more about this opportunity, please read NOT-HL-17-497
R43/R44 (SBIR) or NOT-HL-17-499
R41/R42 (STTR).
NIH Request for Information NOT-RM-17-017
The NIH wants to hear how you can both contribute to and use
the resources of the Illuminating the Druggable Genome (IDG) program (find out
more HERE). In its
first three years, the IDG has mapped out the targets of every FDA approved
drug and created a user portal that combines data on all human proteins
from over 100 data sources. Users are able to access, query, filter, and
download any of this data from the Pharos
portal. If you have ideas to share with NIH, please submit them no later
than May 15, 2017.
Thursday, May 25
Friday, May 26
8:00AM - 5:00PM ET
REGISTER HERE
The American Institute for Medical and Biological
Engineering (AIMBE), the National Institute of Biomedical Imaging and
Bioengineering (NIBIB), and the National Center for Advancing Translational Sciences
(NCATS) will be hosting a series of workshops.
The overall goal of this series is to develop guidelines for
investigators developing new microphysiological platform tools for the
pre-clinical, and possibly clinical, drug development process on how to
validate and qualify these new technologies so that they become useful and
meaningful tools.
Workshop topics:
- Toxicological applications(Workshops 1-4)
- Efficacy evaluation (Workshop 5)
- An update on the current state of technology and how
these systems can be applied to rare disease applications as well as regulatory
considerations. (Workshop 6)
Location:
NIH Main Campus
Natcher Conference Center
Ruth Kirschstein Auditorium, Bldg 45
9000 Rockville Pike
Bethesda, MD 20892
For more information, please check out the event website HERE
Do you have questions for FDA on drug development or
regulations? CDER Small Business and Industry Assistance (SBIA) is often the
first stop for the pharmaceutical industry in trying to contact the Agency. Our
goal is to help small pharmaceutical business and industry navigate the wealth
of information that FDA offers, and to provide assistance in understanding the
regulation of human drug products. Providing support to industry through
education and resources is essential to advancing innovation and protecting
public health.
04/26 – 04/28 – 2017 Angel Capital
Association Summit – San Francisco, CA
05/01 – 05/03 – 10x Medical Device Conference – San
Diego, CA
05/14 – 05/17 – National
SBIR/STTR Conference – Washington, DC
05/19 – 05/24 – American Thoracic Society International
Conference – Washington, DC
06/19 – 06/22 – BIO 2017 - San Diego, CA
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