Tuesday, January 31 at 2:00 PM ET
You’ve got an amazing idea for
a new medical product, it’ll save lives, speed recovery, be less expensive,
more accurate and durable than the product already available on the market – or
it may fill a gap where there is no product available. You have an enthusiastic
team, strong IP, an understanding of the regulatory and reimbursement coverage
data requirements – all you need to get to market is MORE MONEY! In this
Small Biz Hangout one of NHLBI’s funded companies will demonstrate how to
deliver a strong pitch to investors and our Investor-in-Residence will comment
on the most effective and impactful aspects of the delivery.
Steve Flaim, PhD
Senior Special Advisor, NHLBI
Sven Karlsson
Platelet Biogenesis
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.
The
HHS SBIR/STTR Conference in Orlando - everything from the details of review
and accounting
systems to Dos
& Don’ts for Ph I and Ph
II applications:
Session
Materials
Presentations
from NHLBI staff:
Defense Innovation Summit/National SBIR/STTR
Conference - conference
presentation
The National Heart Lung and
Blood Institute (NHLBI) welcomes administrative supplement requests to increase
diversity in the Small Business workforce.
The requested funds can support research salaries for high school,
undergraduate, post-baccalaureate/post-master’s degree holders, and
post-doctoral candidates.
PA-16-288 Research Supplements to Promote Diversity in
Health-Related Research (Admin Supp)
PA-16-289 Research Supplements to Promote Re-Entry into
Biomedical and Behavioral Research Careers (Admin Supp)
These administrative
supplements are designed to provide support for research experiences for
individuals from the identified groups throughout the continuum from high
school to the faculty level. In all cases, the proposed research experience
must be an integral part of the approved, ongoing research of the parent award,
and it must have the potential to contribute significantly to the research
career development of the candidate. Supplement requests are considered on a
rolling basis and must be submitted at least 3 months prior to
the start date of the diversity candidate. So, if you are considering taking on
a summer intern to start in May, you must submit your request no later
than January 31.
More information about the
NHLBI guidelines for the supplements may be viewed HERE
Please contact Eric Padmore (eric.padmore@nih.gov) if you are
interested in applying.
REGISTER to attend this free event HERE
February 8, 2017, from 8:30AM to 4:30PM
February 9, 2017, from 8:30AM to 12:30PM
The Food and Drug Administration
(FDA) is hosting an in-person-only public workshop “Identification and
Characterization of the Infectious Disease Risks of Human Cells, Tissues, and
Cellular and Tissue-based Products”.
Location:
Wiley Auditorium located in
the Harvey H. Wiley Federal Building, 5100 Campus Dr., College Park, MD 20740.
The workshop will include a
scientific discussion of the current methods available for identifying and
characterizing infectious disease risks associated with human cells, tissues,
and cellular and tissue-based products (HCT/Ps). REGISTER HERE
FDA's recommendations on the use of eIC
The Office of Human Research
Protections and the Food and Drug Administration have issued joint guidance in
the form of 16 questions and answers on the Use of Electronic Informed Consent
(eIC) for institutional review boards (IRBs), investigators, and sponsors
engaged in or responsible for oversight of human subject research under HHS
and/or FDA regulations. The guidance provides recommendations on the use
of eIC and covers topics such as:
- the presentation of information
in an eIC
- the eIC process
- documentation of an eIC
- privacy, security, and
confidentiality of eIC information
- IRB responsibilities
The guidance can be found HERE
2017 Guidance Plans Published
The lists of CDRH, CDER, and CBER guidance documents planned for publication or review in 2017 has
been published.
Noteworthy Documents from FDA’s Guidance Database:
The “Framework for Defining
Evidentiary Criteria for Biomarker Qualification” developed in partnership with
government and industry stakeholders has been published. The document
suggests biomarker developers focus on five specific steps: describing a
statement of need, defining a specific context of use, performing a benefit
analysis, performing a risk analysis and concisely describing available
evidence. It is hoped that the framework will promote collaborative discussions
between biomarker developers and the FDA, improve upon the quality of biomarker
qualification submissions to the FDA and inform future FDA efforts to develop
relevant guidance for evidentiary criteria in biomarker qualification.
The framework can be found HERE
The Commercialization Readiness Pilot (CRP)
Program Solicitation(s) will stop accepting applications as the Congressional
authority to offer these pilots expire.
Last due date for Commercialization Readiness Pilot (CRP) program (PAR-16-026, also see NHLBI Notice of Correction NOT-HL-15-283) is Apr 5, 2017.
02/13 - 02/14 – BIO CEO & Investor Conference -
New York, NY
02/18 - 02/21 – CRT17 – Washington, DC
03/09 – BD Boston Biotech
Conference 2017 - Boston, MA
03/12 – 03/15 – AUTM 2017 Annual Meeting - Hollywood, FL
03/17 – 03/19 – American College of Cardiology (ACC. 17) –
Washington, DC
03/23 –
3/25 - Venture Well – Washington, DC
03/30 –
3/31 - AdvaMed Innovation Summit – Washington,
DC
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