Professional Advisory Services for NHLBI Small Business Companies/Grantees
Not sure about how to make contact with the FDA? Wondering about how to protect your intellectual property? Need advice on your commercialization plan? The Office of Translational Alliances and Coordination has brought together a team of experts skilled in Regulatory Affairs, Intellectual Property, and Business Development. Please contact us to schedule a meeting.
NHLBI Small Business Hangouts
Our experts provide innovators with current, practical, and plain-language information for their technology development using these interactive Google Hangouts. Please click below for the links to our previous Google Hangouts and check our upcoming events page for information on future hangouts.
- Navigating the FDA Website
- First Contact with FDA
- Medical Device Classification and Regulation
- Drug and Biologics Regulation – Video Coming Soon!
- Writing your Phase II Commercialization Plan – Coming up February 10, 2015
- Coming Soon!
NHLBI Small Business Resources
Reporting: Final Progress Report Instructions for NHLBI Grantees.
The NIH has released new instructions (83 KB) for preparing your SBIR/STTR Final Progress Reports. View the instructions (83 KB) and the Guide Notice.
Commercialization Assistance Program (CAP)
The NIH Commercialization Assistance Program (CAP) is a FREE specialized technical assistance program for SBIR Phase II awardees. CAP is designed to help promising small life science companies develop their commercial businesses and transition their SBIR-developed technologies into the marketplace. CAP applications are accepted once per year, usually in the Fall. We will post more information here when the program is again selecting applications.
Learn more about CAP
Niche Assessment Program
The NIH SBIR Niche Assessment Program is a FREE nationwide program funded by the NIH to help jump-start an SBIR Phase I awardee's commercialization efforts. Services are provided by Foresight Science and Technology of Providence, RI.
Technology Niche Analyses™ (TNA™) are provided by Foresight for one hundred (100) NIH SBIR 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-developed technology;
- market size and potential market share (may include national and/or global markets);
- barriers to market entry (may include but are 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
Intellectual Property Resources
Protecting intellectual property (IP) generated during research is an important component of a successful business plan. A company that does not protect its IP rights cannot easily keep competitors from entering its space, and worse, may put itself out of business. Additionally, established companies are uninterested in acquiring unprotected IP from a start-up company, severely limiting the start-up's commercialization or licensing exit strategy.
The best IP protection strategy enables a start-up company to be successful, either by selling or licensing its products or services or by being acquired by a larger, established company.
Early IP protection is important because premature IP disclosure can render the IP unprotectable. Therefore, it is important for an inventor to think about what IP has been generated as a result of the research conducted, how the IP relates to envisioned products or services, and what forms of IP protection might be suitable.
The online resources on this page provide general IP-related information and present a series of user-friendly IP-protection options available to an inventor.
The World Intellectual Property Organization (WIPO) is one of the 17 specialized agencies of the United Nations. WIPO promotes the protection of intellectual property throughout the world and offers an e-tutorial in using and exploiting patent information. Modules include:
- Patent basics
- Patent search and retrieval
- Patent analysis
IP Awareness Assessment (takes 15-30 minutes to complete)
This tool from the U.S. Patent Office allows an inventor to assess his or her intellectual property awareness and provides customized training materials.
How to Conduct a Patent Search (video)
This step-by-step computer-based training course from the U.S. Patent Office provides online research resources for inventors interested in conducting a thorough search of U.S. patent files.
These six modules on intellectual property protection and enforcement were created by the Global Intellectual Property Academy. They cover all areas of intellectual property protection, including patents, copyrights, trademarks, geographical indications, international enforcement standards, trade, and the patent cooperation treaty.
This series, hosted by the National Council for Entrepreneurial Technology Transfer (NCET2), features in-the-field thought leaders discussing IP issues from an applied, pragmatic, and deeply experienced viewpoint. Topics covered include:
- Patents 101
- Securing a Patent and American Invents Act (AIA) Implementation
- Intellectual Property, Non-patented Topics - Copyrights, Trademarks, etc.
- Researcher's Life After Invention Disclosure Topics
- Working with a Patent Attorney/Agent and the USPTO
- Patent Trial and Appeal Board
- Protecting IP in Global Markets
- Picking the Right Global Markets
This site from the U.S. Copyright Office contains general information about the copyright process, as well as detailed instructions on conducting copyright searches, recording a document, and licensing procedures.
Trademarks (42-minute broadcast-style video)
This video from the U.S. Patent Office provides basic facts about trademarks. It gives guidelines on how to select the right mark - one that is both federally registrable and legally protectable.
This is a one-stop shop for U.S. government tools and resources on intellectual property rights. It is particularly useful for small and medium-sized enterprises, as well as consumers, government officials, and the general public.
Google Patents (non-federal resource for patent searching)
If after reviewing these materials you still have specific questions, please contact us to speak with NHLBI Intellectual Property Advisor Gautam Prakash, Ph.D., J.D.