Apply by March 5, 2018: PA-18-517
SBIR and STTR Phase I grantees are invited to join the Innovation Corps (I-Corps™) at NIH program. I-Corps™ at NIH supports biomedical innovation and translation, with the goal of expediting the product development of technologies that address the leading causes of death and disability in the United States. The 8-week, hands-on program provides funding, mentoring, and networking opportunities to teach participants how to focus business plans and move a technology closer to those who need it most.
For more information or questions on the I-Corps™ at NIH program, please visit NCI SBIR Development Center or contact:
Mike Pieck, PhD, mike.pieck@nih.gov Health Scientist Administrator, Office of Translational Alliances and Coordination, NHLBI
Dates to remember:
March 5, 2018 – due date to apply to I‐Corps™ at NIH, Phase I grant must be active through at least June 1, 2018
April 9, 2018 – Phone Interview
April 30, 2018 - Notice of Award
June 18-21, 2018 - Course Kick-off
June 27, July 11,18 & 25, August 1 & 8, 2018 - Web-Ex Courses
August 13 & 14, 2018 - Course Close-out/Lessons-Learned
NIH has launched a new series of initiatives to enhance the accountability and transparency of clinical research. ALL applications, including SBIR/STTR, proposing any specific aims that meet NIH's definition of a clinical trial must now be submitted to a Funding Opportunity Announcement (FOA) that specifically states it accepts clinical trials. These initiatives target key points along the whole clinical trial lifecycle. READ the PHS 2018-2 SBIR/STTR Program Descriptions and Research Topics and learn more about these changes: HERE
Deadlines: April 5, 2018; September 5, 2018; January 7, 2019; April 5, 2019
New NIH "FORMS-E" Grant Application Forms and Instructions for Due Dates On or After January 25, 2018. Read the Full Notice: NOT-OD-18-009
Two informational webinars archived:
1. HHS SBIR/STTR PHS 2018-2 Grant Omnibus Clinical Trial Webinar
2. HHS SBIR/STTR PHS 2018-2 Grant Omnibus Non-Clinical Trial Webinar
For more information, please contact NHLBI SBIR through our NHLBI Small Biz Inquiry Form and checkout our YouTube channel: NHLBI Small Biz Hangouts
NIH has partnered with Leidos Health’s Life Sciences to
accelerate the biomedical research and development enterprise by matching
high-scoring (e.g., those within the 30th percentile), unfunded NIH
applications with private biomedical foundations and/or industries seeking to
fund promising research through the Online Partnership to
Accelerate Research (OnPAR).
To learn more, please visit OnPAR
The US Small Business
Administration has developed resources to educate small businesses on many
topics. Specific programs that may be of interest to you include:
- Legal Requirements for Small Business
- How to Write a Business Plan
- Market Research
- Finding and Attracting Investors
- Encore Entrepreneurship for Women
The full list of links to course materials including
webinars and any associated worksheets or additional materials can be accessed:
HERE
Webinar - Tuesday, March 20, 2018 at 3:00 PM ET
Combination
Product Updates for “Acceptance and Filing Reviews for Premarket Approval
Applications” and “Refuse to Accept Policy for 510(k)s”
On January 30, 2018, the FDA issued updated final guidance
documents:
These guidance documents explain the procedures and criteria
the FDA intends to use in accepting or refusing a 510(k) or PMA submission. It
includes checklists to identify the necessary elements and contents of a
complete application.
On February 20, 2018 the FDA issued the final rule on:
New Guidance Documents of Interest to the NHLBI Community
NOTE: FDA provides a comprehensive database of all draft,
final, and withdrawn guidance
documents.
August 13-14, 2018, FDA White Oak Campus
REGISTER
to attend this free event via webcast or in-person
Medical device development for children continues to lag
behind that for adults. The purpose of the meeting is to identify strategies
that enhance the medical device ecosystem toward development and innovation of
devices that serve the complex needs of children, and thereby accelerate
medical device innovation for all Americans.
20th Annual HHS SBIR/STTR Conference
October 30 - November 1, 2018
Dallas, Texas
Registration Not Yet Open
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
03/03 – 03/06 – CRT 2018 – Washington, DC
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