Register HERE
Today at 2:00 PM EST
Proposals due October 21, 5:00 PM EST
The annual NIH and CDC SBIR
Contract Solicitation (PHS2017-1) has been released (http://bit.ly/PHS2017-1). New electronic
submission process for contract proposals through the Contract Proposal
Submission (eCPS) website: https://ecps.nih.gov/sbirsttr. See NOT-OD-16-123 for all NIH and CDC topics,
contracting officer contact information, and other details.
- 098 Testing and Validation of
Technologies for Inclusion in the CART Demonstration Project for
Collaborative Aging Research
- 099 Inhalational 5A Apolipoprotein
A-I Mimetic Peptide for the Treatment of Asthma (SBIR-TT)
- 100 MRI Myocardial Needle
Chemoablation Catheter
- 101 Membranous Ventricular Septal
Defect (pmVSD) Transcatheter Occluder System
- 102 Transcatheter Occluder
Device for Paravalvular Leaks
Please direct all inquiries
on the contract process or topics to:
Mr. John Taylor, taylorjc@nhlbi.nih.gov
All questions must be submitted by September 1, 2016.
Thursday, August 25
1:00 PM - 2:30 PM EST
Webinar Details: HERE
On August 25, 2016, the FDA will hold a webinar for
industry to discuss the draft guidance documents:
Time: 1:00 -2:30 PM, Eastern Time.
NOTE: You must dial-in to hear the presentation and ask
questions:
Dial: 888-606-7035, passcode: 6372193
International Callers Dial: 1-517-308-9367
View the slide presentation
during the webinar: HERE
Conference Number: PW8727223
Recently released - Adaptive Designs for Medical Device Clinical Studies
FDA recently held a webinar to answer questions about the new guidance document: Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications. Webinar materials and the recording (once posted) can be found: HERE
The Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) have issued draft guidance - Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs.
FY17 User Fees announced
Phase II SBIR/STTR Companies - Apply
by August 30: HERE
The NIH Commercialization Accelerator Program (CAP) (https://sbir.nih.gov/cap) is designed to
help HHS SBIR and STTR Phase II awardees transition their SBIR and STTR
developed products into the marketplace. The CAP helps small businesses
evaluate their commercialization options based on their specific technologies
(including the need and prospect for investment, strategic partnerships, or
licensing) and helps them develop a solid market-entry plan covering an
18-month period. More details can be found in NOT-OD-16-172: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-127.html.
Inquiries
Please direct all program inquiries
to:
J.P. Kim, J.D., M.B.A., M.P.P., M.Sc., M.A., sbir@od.nih.gov
National Institutes of Health (NIH)
Please direct inquiries related to submission of the web
application to:
Judy Hsieh, jhsieh@larta.org
Larta, Inc.
Thursday, September 1
12:00 PM - 1:30 PM EST
Webinar Details: HERE
The guidance, issued on July 28, explains that the FDA does not intend to actively regulate low-risk technologies that are intended only for general wellness use. The FDA encourages the development of general wellness technologies, such as fitness trackers or mobile apps, which can empower individuals to take a more active role in their health. The FDA will continue to focus its oversight on medical devices that may pose inherent risks to a user’s safety.
NOTE: You must dial-in to hear the presentation and ask questions:
Dial: 888-566-5974, passcode: 7768031
International Callers Dial: 1-210-234-0118 passcode: 7768031
View the slide presentation
during the webinar: HERE
Conference number: PW9442410 Audience passcode: 7768031
The next NIH Small Business
Innovation Research (SBIR) and Small Business Technology Transfer (STTR)
Omnibus funding opportunity deadline is September 6, 2016. The National
Heart, Lung, and Blood Institute (NHLBI) welcomes all investigator-initiated
projects within our mission through the Omnibus funding
opportunities:
-
SBIR (PA-16-302)
and STTR (PA-16-303) Omnibus Solicitations for Phase I,
Phase II, and Fast-Track applications
-
SBIR
Direct-to-Phase II
Pilot (PAR-14-088)
for Direct to Phase II applications.
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.
Get Ready
Additional
Funding Opportunities Due Fall 2016
-
September
6 - New Technologies for Viral Hepatitis (SBIR PA-15-077
STTR PA-15-076)
-
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)
-
October
14 – Bioreactors
for Reparative Medicine (SBIR RFA-HL-15-008 STTR RFA-HL-15-004
D2P2 RFA-HL-15-017)
-
October
15 - Onsite
Tools and Technologies for Heart, Lung, and Blood Clinical Research
Point-of-Care (STTR RFA-HL-14-017)
-
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.
Monday, Sept. 12 at 8:00 AM
Tuesday, Sept. 13 at 8:00 AM
Register HERE
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.
DoubleTree by Hilton Hotel Bethesda - Washington DC 8120 Wisconsin Avenue, Bethesda, MD 20814 - View Map
For more information, please
visit U.S. Food
and Drug Administration (FDA).
Wednesday, September 28
Thursday, September 29
Register for this FREE event
HERE
Topics to be covered during this event include Drugs topics: Manufacturing
Process Validation; Interactions with FDA; Emerging Technology and Inspection
of NDA and BLA applications; Device topics: 510(k), De Novo, Design Controls,
and Complaints. The plenary seminar will focus on FDA Insights on
Products for Rare Diseases and Pediatrics. Attendance can be in person
(in Silver Spring, Maryland) or virtual via interactive webcast.
The June 21 Small Biz
Hangout on De-mystifying Small Business Review is now live on YouTube. Hear
from Scientific Review Officers from the NIH Center for Scientific Review and
NHLBI Office of Scientific Review to learn about the NIH peer review process, differences
between types of funding opportunities and where they are reviewed, how you can
participate as a reviewer yourself, and more.
The NHLBI Small Biz Hangouts
are designed to help you understand aspects of product and company development
that you didn’t learn in school. The series covers topics such as:
understanding intellectual property – what it is, and how to develop and defend
it; how to write a strong application for NIH small business funding; how to
identify your customer and talk with possible partners; FDA regulation of drugs
and devices; and reimbursement basics for therapeutics.
Check out other recently
posted videos:
Demystifying Small Business
Review, http://bit.ly/SBReviewHangout
Integrating Your Regulatory
and Research Plans, http://bit.ly/SBH-RegRes
Reimbursement Basics, http://bit.ly/ReimbursementHangout
How Pharma Evaluates New
Therapeutic Opportunities, http://bit.ly/SBHangout-PharmaEval
And the full YouTube playlist.
We are always looking for
ideas of what you would like to learn about and for presenters willing to share
their knowledge – contact us and be part of the NHLBI Small Biz
Hangouts.
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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