WEBINAR: Thursday, July 13, 2017
1:00PM - 2:45PM ET
Register HERE
Join FDA experts as they provide
an overview of recent updates made to FDA’s Study
Data Technical Conformance Guide as well as important information and
recommendations from the Center for Biologic Evaluation and Research (CBER)
review staff to help you optimize your study data submission to CBER, by
understanding required standards and expectations in order to aid the
efficiency of the review process and avoid technical rejection.
Presentations include:
-
Updates to the Study Data
Technical Conformance Guide
-
Providing Clinical Study Data
to the Office of Vaccines
-
Perspectives from CBER’s Office
of Compliance and Biologics Quality (OCBQ)
For more information, please check out the FDA website: Optimizing
Your Study Data Submissions to FDA – Updates from CDER and CBER
2017 NIH Small Business Innovation Research (SBIR: PA-17-302 ) and Small Business Technology Transfer (STTR: PA-17-303) Omnibus funding opportunities are now available. The deadline is 2 months away on September 5, 2017. Learn more in NOT-OD-17-070.
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 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).
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.
September 7 & 8, San Francisco, California
Register HERE
APPLY
to meet one-on-one
Johnson & Johnson Innovation, JLABS will host NHLBI and NCI to discuss new non-dilutive targeted funding opportunities in cancer and cardiovascular focused technology development. They will explain the application and review process at the NIH to help small businesses submit stronger applications. The team will discuss key requirements, timelines, important contacts as well as the best practices for successful applications. Additionally, the presentation will touch on the I-Corps at NIH program and other initiatives to facilitate the success of SBIR companies.
Don't miss this opportunity to learn about the NHLBI application process!
Dr. Kurt Marek from NHLBI will be presenting.
APPLY Today, to meet one-on-one with NHLBI and NCI
For more information, please visit the event website: JLABS Bay Area
19th Annual HHS SBIR/STTR Conferene
November 7 - 9, Milwaukee, Wisconsin
Register HERE
This conference is relevant to a diverse audience, including biomedical entrepreneurs; principal investigators; grants and contracts administrators; and industry partners and investors.
Top 3 Reasons to Attend:
1. Meet one-on-one with HHS SBIR/STTR program managers
Over 100 federal staff, including representatives from the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Small Business Administration (SBA), Administration for Community Living (ACL), and HHS Office of the Inspector General (OIG) will be holding one-on-one meetings and giving presentations. You will have the chance to get one-on-one feedback about your technology proposal!
2. Hear from successful HHS SBIR/STTR awardees
Gain first-hand knowledge from experienced and successful applicants, potential funding partners and companies during interactive workshops and sessions. These sessions include a diverse group of successful awardees, including women-owned small businesses and socially and economically disadvantaged small businesses.
3. Learn how to develop a competitive application
Many sessions focus on how to develop and submit your SBIR/STTR application. Topics include:
- How to submit your SBIR/STTR grant proposal electronically via ASSIST
- FDA regulatory requirements for drugs and devices
- Important considerations to protect your intellectual property
- Top 10 Dos and Don’ts for SBIR/STTR proposal development
- Understanding indirect costs and financial accounting systems
- What you need to know about human subjects and animal research
- The differences between SBIR grants and contracts
For more information, please visit Clinical &
Translational Science Institute
Have you wondered what resources,
beyond funding, NHLBI brings to its innovator community? Check out this
short talk delivered by Dr. Chris Sasiela at the 2017 10X Medical Devices
Conference
7/24 - 7/27 - Stem
Cells, Cell Therapies, and Bioengineering in Lung Biology and Diseases – Burlington, VT
9/7 - NIH BEST Practices
Workshop – Orlando, FL
9/7 - 9/8 – JLABS – San Francisco, CA
9/13 - 9/15 - SSTI'S 2017 ANNUAL CONFERENCE - Washington, DC
9/25 - 9/27 - The MedTech
Conference 2017 (AdvaMed) - San Jose, CA
10/3 - 10/5 - SBIR/STTR
Innovation Summit – Tampa, FL
10/31 - 2017 National
Innovation Conference - New York, NY
11/1 - 11/2 - Life Sciences Summit - New York, NY
11/7 - 11/9 - 19th
Annual HHS SBIR/STTR Conference - Milwaukee, WI
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