The National Heart, Lung, and Blood Institute (NHLBI) provides global leadership for a research, training, and education program to promote the prevention and treatment of heart, lung, and blood diseases and enhance the health of all individuals so that they can live longer and more fulfilling lives.
On September 19th and 20th, Chris Sasiela, PhD, RAC of the Office of Translational Alliances and Coordination
Division of Extramural Research Activities, National Heart, Lung and Blood Institute joined us during Arizona Bioscience Week for a two-part series designed to help Arizona innovators learn how to apply for NIH SBIR programs and how to leverage the wide array of NIH SBIR resources. The following is republished directly from the most recent (9/22/2016) information provided by NHLBI.
- Important Changes in NIH Clinical Trial Policies
- Important Changes in NIH Application Material Policies
- Sept 27 – 28 FDA Regulatory Education for Industry (REdI) Conference
- Sept 28 – Why You Should Join Innovation Corps (I-Corps™) at NIH
- Sept 30 – Early Bird Deadline for HHS SBIR/STTR Conference in Orlando
- Oct 6 – 7 FDA/NHLBI Workshop on Pre-Clinical Evaluation of Red Blood Cells for Transfusion
- Oct 14 Deadline – Bioreactors for Reparative Medicine
- Oct 15 Deadline – Onsite Tools and Technologies for Heart, Lung, and Blood Clinical Research Point-of-Care
- Oct 21 Deadline – 5 NHLBI SBIR Contract Topics
- Nov 9 Deadline – Human Cellular Models for Predicting Individual Responses to CFTR-Directed Therapeutics
- Meet NHLBI Small Business Experts
Important Changes in NIH Clinical Trial Policies
NIH has published new guidance/policy on the conduct of clinical studies that may affect ongoing and future research planning. We encourage all investigators planning clinical research to be aware of the new policies, expectations, and implementation dates. In some instances, these announcement may be followed by Institute-specific implementations.
CAUTION: This list is a starting point, and must not be considered a complete guide to all policy changes. NIH (and individual Institutes) anticipate additional announcements in 2017.
NIH News Releases:
HHS takes steps to provide more information about clinical trials to the public
Summary Table of HHS/NIH Initiatives to Enhance Availability of Clinical Trial Information
Open Mike and Under the Poliscope blog:
Building Better Clinical Trials through Enhanced Stewardship and Transparency
Improving Visibility of NIH-supported Clinical Trial Activities and Results Information
Policy on Funding Opportunity Announcement (FOA) for Clinical Trials
(NOT-OD-16-147)
NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
(NOT-OD-16-149)
Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-
funded Clinical Trials
(NOT-OD-16-148)
Important Changes in NIH Application Material Policies
New Policy Eliminates Most Appendix Material for NIH/AHRQ/NIOSH Applications Submitted for Due Dates On or After January 25, 2017 (NOT-OD-16-129)
NIH is eliminating most appendix materials for applications submitted for due dates on or after January 25, 2017. The policy change is intended to rectify inequities in the peer review process that can arise from submission of inappropriate or excessive appendix materials by some applicants and consideration of appendix materials in peer review by some, but not all reviewers. Application instructions and other materials will be updated by November 25, 2016 to reflect this change. The notice provides specific guidance on what appendix materials will be allowable and consequences for submitting disallowed materials.
Changes to the NIH/AHRQ Policy on Post-Submission Materials for Applications Submitted for Due Dates On or After January 25, 2017 (NOT-OD-16-130)
Post-submission application materials are those submitted after submission of the grant application but prior to the initial peer review. This notice simplifies and consolidates current policy concerning post-submission materials. For the majority of applications, the only post-submission materials we will accept are those resulting from an unforeseen event. We do not allow correction of oversights/errors discovered after submission of the application. The notice provides a specific list of allowable post-submission materials.
Sept 27 – 28 FDA Regulatory Education for Industry (REdI) Conference
September 27 – 28, Silver Spring, MD and virtual
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.
Sept 28 – Why You Should Join Innovation Corps (I-Corps™) at NIH
REGISTER for next week’s webinar
Wednesday, September 28 at 1:30 PM ET
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 November, 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)
Sept 30 – Early Bird Deadline for HHS SBIR/STTR Conference in Orlando
18th Annual HHS SBIR/STTR Conference
November 15 – 17, Orlando, Florida
Register HERE Today & Save!
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
Oct 6 – 7 FDA/NHLBI Workshop on Pre-Clinical Evaluation of Red Blood Cells for Transfusion
October 6 – 7, Bethesda, MD and virtual
Register for this FREE event HERE
The Food and Drug Administration (FDA) is hosting a public workshop entitled: “Pre-Clinical Evaluation of Red Blood Cells for Transfusion.” The purpose of the public workshop is to discuss new methodologies for pre-clinical evaluation of the safety and efficacy of red blood cell transfusion products. The workshop has been planned in partnership with the National Heart, Lung and Blood Institute, National Institutes of Health (NIH), the Department of Defense and the Office of the Assistant Secretary for Health, Department of Health and Human Services. The workshop will include presentations and panel discussions by experts from academic institutions, industry, and government agencies.
National Institutes of Health Campus
Ruth Kirschstein Auditorium, Natcher Conference Center, Bldg. 45,
9000 Rockville Pike Bethesda, MD: View Map
Oct 14 Deadline – Bioreactors for Reparative Medicine
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)
Oct 15 Deadline – Onsite Tools and Technologies for Heart, Lung, and Blood Clinical Research Point-of-Care
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)
Oct 21 Deadline – 5 NHLBI SBIR Contract Topics
Proposals due October 21, 5:00 PM ET
View recorded webinar
NHLBI Topics for FY2017
- 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. Answers to submitted questions will be publicly posted in an amendment on FedBizOpps.
Please visit our website for a full list of Targeted Funding Opportunity Announcements (FOAs)
Nov 9 Deadline – Human Cellular Models for Predicting Individual Responses to CFTR-Directed Therapeutics
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)
Meet NHLBI Small Business Experts
9/29 – 9/30 – 14th Annual Dartmouth Device Development Symposium – Woodstock, VT
9/29 – 9/30 – AUTM 2016 Eastern Region Meeting – Philadelphia, PA
10/5 – 10/6 – SBIR Road Tour Event – Cambridge, MA
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
SOURCE: NHLBI
The NHLBI SBIR/STTR Programs provide support for small businesses developing and commercializing novel technologies and products to prevent, diagnose and treat heart, lung, blood, and sleep diseases and disorders. The NHLBI provides grant and contract funding for research and development of technologies related to the mission of NHLBI. For more information about the NHLBI SBIR/STTR Program, including funding opportunities, visit their web page.
Contact:
Office of Translational Alliances and Coordination
Division of Extramural Research Activities
National Heart, Lung and Blood Institute
6701 Rockledge Dr, Suite 7109
Phone: (301)496-2149
Stay up to date with announcements about resources and funding opportunities for innovators…
- Sign up for regular updates: http://bit.ly/NHLBI-SBIR-Updates(link is external)
- Follow us on Twitter: https://twitter.com/NHLBI_SBIR(link is external)
For questions or to schedule a time to speak with our staff members, please use the