APPLY today through
The Niche Assessment Program provides market insight and data that can be used to help small businesses strategically position their technology in the marketplace. The results of this program can help small businesses develop their commercialization plans for their Phase II application, and be exposed to potential partners.
Technology Niche Analyses® (TNA®) are provided by Foresight, for one hundred and fifty (150), HHS SBIR/STTR Phase I awardees. These analyses assess potential applications for a technology and then for one viable application, it provides an assessment of the:
- Needs and concerns of end-users;
- Competing technologies and competing products;
- Competitive advantage of the SBIR/STTR-developed technology;
- Market size and potential market share (may include national and/or global markets);
- Barriers to market entry (may include but is not limited to pricing, competition, government regulations, manufacturing challenges, capital requirements, etc.);
- Market drivers;
- Status of market and industry trends;
- Potential customers, licensees, investors, or other commercialization partners; and,
- The price customers are likely to pay.
Each participant receives an in-depth report of Foresight's findings. Oftentimes the small businesses can use this information in their commercialization plans which are part of their Phase II applications.
All active HHS (NIH, CDC, FDA) SBIR/STTR Phase I awardees and Phase I
Fast-Track awardees (by grant or contract) are eligible to apply. Registration
is on a first come, first serve basis!
For more information, please visit: Niche Assessment Program
Notice: NOT-OD-16-144
Last Receipt Date!
SBIR: RFA-
HL-15-008
STTR: RFA-
HL-15-004
Direct to Phase II (SBIR): RFA- HL-15-017
To support multidisciplinary
small business teams in the development of complex, three-dimensional
engineering systems for growing heart, lung, or bone marrow tissue.
View a recording of the
02/16/16 webinar here.
Submit your request for slides
through the SmallBiz
Inquiry form.
Questions? Contact:
Martha S. Lundberg, PhD, lundberm@nhlbi.nih.gov
Program Director, Division of Cardiovascular Sciences
Please visit our website for a
full list of Targeted Funding Opportunity Announcements (FOAs)
Last Receipt Date!
STTR: RFA-HL-14-017
The purpose of this Funding
Opportunity Announcement (FOA) is to support research using advanced
technologies (e.g., bio-chips, microfluidics, and mobile technologies) to
develop novel point-of-care (POC) devices and implement existing technologies
in clinical settings with a goal to guide diagnostic and therapeutic efforts
for the heart, lung, blood, and sleep disorders. Applicants are
encouraged to form a multidisciplinary team/network (i.e., from technical to
clinical expertise) to develop devices that will significantly empower
patients, physicians, and clinical researchers to better manage or treat HLB
and sleep disorders.
Questions? Contact:
Erin Iturriaga, RN, iturriae@mail.nih.gov
Program Director, Division of Cardiovascular Science
Please visit our website for a
full list of Targeted Funding Opportunity Announcements (FOAs)
APPLY through PA-16-414 by November 1, 2016
SBIR and STTR Phase I grantees
are invited to join the Innovation Corps (I-Corps™) at NIH
program. Part of President Obama’s Strategy for American Innovation, I-Corps™
at NIH aims to support biomedical innovation and translation, with
the goal of expediting the development and commercialization of technologies
that address the leading causes of death and disability in the United
States. I-Corps™ participants will have dedicated time to focus on
translating ideas from the lab into a viable product on the market and help
avoid common failure points.
For more information or
questions on the I-Corps™ at NIH program, please visit NCI
SBIR Development Center, watch the archived
webinar from September 28, or contact:
Jennifer C. Shieh, PhD, jennifer.shieh@nih.gov
Small Business Coordinator, Office of Translational Alliances and Coordination,
NHLBI
Dates to remember:
February 2017 Cohort
November 1, 2016 – due date to apply to I‐Corps™ at NIH for Cohort 1, Phase I grant must
be active through at least March 28, 2017
February 5 - 8, 2017 – Course Kick-off (in-person)
March 27 - 28, 2017 – Course Close-out/ Lessons Learned (in-person)
April 2017 Cohort
January 9, 2017 – due date to apply to I‐Corps™ at NIH for Cohort 2, Phase I grant must
be active through at least June 9, 2017
April 23 - 26, 2017 – Course Kick-off (in person)
June 12 - 13, 2017 – Course Close-out/ Lessons Learned (in-person)
Proposals due October 21, 5:00 PM ET
- 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
The question period ended on
September 1. View answers to submitted
questions in the Q&A Amendment.
Please visit our website for a
full list of Targeted Funding Opportunity Announcements (FOAs)
USPTO
Intellectual Property Webinar Series for Small Businesses
Patents, Trademarks,
and Copyrights!
Register
Today: HERE
For small
businesses participating in the SBIR/STTR programs, understanding Intellectual
Property (IP) - Patents, Trade Secrets, Trademarks, and Copyrights - is
necessary to protect ideas, products and product names in today's knowledge
economy.
Hosted by
the United States Patent and Trademark Office (USPTO), these 90-minute webinars
have been designed specifically to address the most common IP issues facing
small businesses funded by the SBIR/STTR programs. They will cover all aspects
of Intellectual Property protection, as well as help you understand your IP
Data Rights under the SBIR/STTR grant/contract. Space is limited to 200
people per webinar! Register early!
Webinars
will be offered at 1 P.M. Eastern on the following days:
Monday,
November 7
Overview:
U.S. Intellectual Property Rights and the SBIR-STTR Stakeholders
Henry Wixon
(Chief Counsel for NIST)
Tuesday,
November 8
Basics US
Patent Practice for the SBIR-STTR Stakeholders
Office on
Innovation Development, USPTO
Wednesday,
November 9
Trademarks
in the US
Scott
Baldwin (Trademark, USPTO)
Thursday,
November 10
Copyright
(Domestic and International)
Susan
Anthony (Director (Acting), Global Intellectual Property Academy, USPTO
Monday,
November 14
The
International Trademark Portfolio
Susan
Anthony (Director (Acting), Global Intellectual Property Academy, USPTO
Tuesday,
November 15
Patent
Cooperation Treaty (PCT) and Hague Strategies for Filing Abroad
International
Patent Legal Administration, USPTO
Wednesday,
November 16
Intermediate/Advanced
US Patent Practice for the SBIR/STTR Stakeholders
Oleg
Asanbayev (Patent Examiner, USPTO)
Last Receipt Date!
SBIR: RFA-HL-15-027
This program will support the
technical development and validation of novel in vitro human cell-based tools
for predicting the responses of individual patients to cystic fibrosis
transmembrane conductance regulator (CFTR)-directed therapies for cystic
fibrosis (CF) lung disease. NHLBI anticipates that outcomes of successful STTR
projects will help attract strategic partners or investors to support ultimate
commercialization of a personalized medicine platform that could accelerate
translation of CFTR-directed therapy in patients with CF lung disease.
View a recording of the
09/23/15 webinar here.
Submit your request for slides
through the SmallBiz
Inquiry form.
Questions? Contact:
Nancy Macgarvey, MD, nancy.macgarvey@nih.gov
Program Director, Division of Lung Diseases
Please visit our website for a
full list of Targeted Funding Opportunity Announcements (FOAs)
18th Annual HHS SBIR/STTR
Conference
November 15 – 17, Orlando, Florida
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 a full listing view, the agenda
FDA’s Center for Devices and
Radiological Health (CDRH) has been exploring opportunities to improve patient
access to safe and effective medical devices by shortening the time between FDA
approval or clearance and device coverage. CDRH recognizes that the
clinical evidence required for FDA approval or clearance can be different than
the evidence required to obtain coverage. This difference may delay
coverage decisions if the medical device sponsors are unaware of the coverage
data requirements, and/or need to conduct another trial or gather additional
evidence. These potential delays in coverage decisions may ultimately
delay patient access to innovative medical devices.
In February 2016,
CDRH’s Payer Communication Task Force (PCTF), part of
CDRH Innovation, highlighted a voluntary opportunity for private payer
coverage organizations and health technology assessment groups (HTAs) to
express interest in providing input to medical device sponsors on clinical
trial design or other plans for gathering clinical evidence needed to support
coverage decisions.
CDRH has updated their website to share the names of the private
payers and HTAs who have expressed interest in attending a Pre-Submission meeting to learn more about new
devices and provide input on the clinical evidence needed to support coverage
decisions. This list will be periodically updated as other private
payers and HTAs express interest in participating.
Please note, participation in
this opportunity is voluntary for both medical device sponsors and coverage
organizations. Participation will not change the evidentiary standards the FDA
uses for decision-making.
If you have any questions
about this voluntary opportunity, please contact the PCTF at CDRHPayerCommunications@fda.hhs.gov.
In order to promote consistent
use of biomarker terms and concepts, the FDA and NIH have developed the Biomarkers, EndpointS, and other Tools (BEST) Resource,
which clarifies terminology and uses of biomarkers and endpoints as they
pertain to the progression from basic biomedical research to medical product
development to clinical care. Learn more about the BEST Resource, how it will
advance biomarker development, and how you can contribute by reading CDER’s new
fact sheet "THE
BEST RESOURCE: HARMONIZING BIOMARKER TERMINOLOGY".
The U.S. Food and Drug
Administration updated the Expedited Access Pathway Program website with
two Data Development Plan examples that serve as a resource for sponsors.
In April 2015, the FDA
issued the Expedited Access for Premarket Approval and De Novo
Medical Devices Intended for Unmet Medical Need for Life Threatening or
Irreversibly Debilitating Diseases or Conditions guidance.
This guidance introduced a new, voluntary program to promote the
development of innovative products to address unmet medical needs for life
threatening or irreversibly debilitating diseases or conditions. The EAP
Program started accepting requests for EAP designation on April 15, 2015.
As part of an EAP Designation
Request, sponsors should submit an acceptable draft Data Development Plan,
which includes a description of the clinical and nonclinical data that the
sponsor proposes to be collected both premarket and postmarket, as well as a
timeline for the development and marketing of the device. The two examples
added to the FDA’s website offer a format for how the Data Development Plan
information recommended in the EAP guidance can be organized.
Join NHLBI for a December double-header
Tuesday December 13, 2 pm ET
Taking Care of
Business: Managing SBIR/STTR Grants
Register HERE
Hear from NHLBI grants management staff experts about how to speed
up getting an NIH award; when you need to get approval from NIH & when you
don't; and common myths and misconceptions about the SBIR/STTR grants
process.
Andre Walker, BS
Grants
Management Specialist, NHLBI
Jennifer Shieh, PhD
Small Business Coordinator, NHLBI
Friday December 16,
1 pm ET
Adopting New
Technologies: A System’s Perspective
Register HERE
Panelists from MedStar Health, a $5B not-for-profit regional healthcare
system, will discuss the process by which a large system evaluates new
technologies and ultimately adopts them as part of their clinical arsenal, to
provide innovators with some insight into the barriers and hurdles they should
anticipate when creating their commercialization plans.
Neil J. Weissman, MD
President, MedStar Health Research Institute
Denise C. Noll, RN, CPHM, CMCN
Director, Institutional Contracting & Clinical Ops
Support
MedStar Health Managed Care Operations
Ron Waksman, MD
Associate Director, Division of Cardiology
MedStar Heart Institute
Eric Padmore,
MHSA
Scientific Program Analyst, NHLBI
If you haven’t participated in or watched one of our NHLBI
Small Biz Hangouts yet, you may be missing out. These webinars are
designed to help you understand aspects of product and company development that
you didn’t learn in school. Posted videos include:
Demystifying Small Business Review
Finding the Right Regulatory Consultant
Patent Litigation, Part 1 and Part 2
Check out the full YouTube playlist.
We are always interested in hearing what you would like to
learn about or looking for presenters willing to share their knowledge, so contact us and be part of the NHLBI
Small Biz Hangouts.
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
11/29
– 12/1 – National SBIR/STTR
Innovation Summit – Austin, TX
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