Informational Webinar on Wednesday, April 25, 2018 at 2:00PM
ET
Register HERE
Phase II SBIR/STTR Awardees
Are you a Phase II SBIR or
STTR awardee? Do you anticipate Phase II SBIR or STTR funding by August 2018?
If so, you may want to take advantage of the NIH Commercialization Accelerator
Program (CAP).
What is CAP? It’s a technical assistance program where you (the awardee)
work with a company NIH has engaged to help you plan out the next 18 months of
your company’s growth. Check out the latest full Notice: NOT-OD-17-097.
Find
out more during this webinar or reach out to:
J.P. Kim, J.D., M.B.A., M.P.P., M.Sc., M.A., jpkim@nih.gov
National Institutes of Health (NIH), sbir@od.nih.gov
Register HERE
View the AGENDA
Regulatory Education for
Industry (REdI) Conferences are a great way to learn what FDA’s Center for Drug
Evaluation and Research or Center for Diagnostics and Radiological Health
expect from companies developing new health products. These free, two-day
events are held twice per year and can be attended in person or virtually. The
next REdI conference will take place in San Francisco and will include the
following topics:
- CDER:
Nonclinical Assessment for Small Molecules and Biologic Drug Development;
FDA Regulatory Requirements for Clinical Investigators; Communication
Pathways; Inspections
- CDRH:
Digital Health; Design Controls; 510 (K) Program; Inspections
For more information, visit the event website: REdI Spring Conference 2018
You can access specialized
business frameworks and essential tools to successfully translate your
technology from the lab to market by applying for the Concept to Clinic:
Commercializing Innovation (C3i) funding supplement PA-18-702.
Due Dates: June 1, 2018 and August 1, 2018, by 5:00PM ET
C3i’s curriculum and customized mentoring will guide you as you
assess the commercial viability and potential business opportunity for your
innovation, and will help define your value proposition in addressing an unmet
market need.
More information is available in the full Funding Opportunity
Announcement PA-18-702 and by contacting
Mike Pieck, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-7986
Email: mike.pieck@nih.gov
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
August 13 & 14, 2018 FDA White Oak Campus
REGISTER
to attend this free event via webcast or in-person
Are you developing a pediatric
device? If so, consider marking your calendar to attend this public
meeting. Attendance can be in person (at FDA’s campus in Maryland) or
virtual. Hear the most current concerns and approaches FDA is exploring to
enhance the complex development and innovation aspects of pediatric devices
development.
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: 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
October 30 - November 1, 2018 Dallas, Texas
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
Read more: HERE
04/18 - 04/20 – 2018 ACA Summit – Boston, MA
05/13 - 05/16 - SBIR/STTR Innovation Conference - Anaheim, CA
05/18 - 05/23 - ATS 2018 - San Diego, CA
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