Working With the NIH – What Biotechs Need to Know

Oct 31, 2017

The NIH can be powerful partner for biotechs, but many companies do not know how to begin connecting with its various Institutes. We asked representatives from agencies within the NIH (NCI, NINDS, NHLBI, NIAID) and an expert on the process, all of which will be speaking at our forum on 11/15, to answer some of the most commonly asked questions, and here’s what they said:

What are the most common ways biotechs fund their research?  

With regard to private dollars, there are many ways biotech can fund their research, including VCs, private equity, venture debt, venture philanthropy and corporate venture capital. Companies are also increasingly looking to crowd-sourced networks and investment groups to raise money (e.g, OurCrowd). Angel/crowd investing will become more prevalent in the age of cryptocurrency that is enabled by blockchain technology wherein anyone worldwide can invest small amounts of money in any enterprise by simply having access to a mobile phone.

Biotechs can also receive funding through the NIH by applying for a grant or entering into a cooperative agreement in which the NIH may share in some costs for a collaborative project.

How can smaller biotechs go about partnering with the NIH?

The first step for biotechs is to identify the NIH Institute(s) that are most relevant to their technology, and then choose an investigator working in a similar area with whom they’d like to partner with. These investigators have terrific experience and can be invaluable advisors to any therapeutic company but especially for emerging biotechs that may have more limited resources.

The next step is to either: 1) contact that Institute’s Technology Transfer Office to guide the process and contact the investigator, or 2) the company can directly contact the investigator and explore a joint project. It’s important to remember that the sooner a company can get tech transfer staff involved the sooner they can get the right agreements in place to start working with the lab.

Are there any restrictions or concerns biotechs should keep in mind when partnering with the NIH?

As a federal lab paid for with public tax dollars, there are a few restrictions to keep in mind when partnering with the NIH, including:

  • There are certain legal provisions the NIH cannot agree to, for example they cannot agree to indemnification, and cannot promise rights to future inventions.
  • They must also take a limited role in the company – cannot travel/speak with the company or on behalf of the company, and usually cannot serve in any official capacity for the company.
  • If a company wants an exclusive license, it has to be publicly disclosed for a short period of time so that the technology could still potentially be sought by others. This is due to fair access provisions. 
  • If it’s a partnership, the company will likely need to execute a Cooperative Research and Development Agreement (CRADA), which can be reviewed by an outside attorney but will have limitations on a company’s ability to adjust terms and provisions, like all government contracts.

Interested in learning more about partnering with the NIH? Join MassBio’s forum on November 15th – individuals can also schedule one-on-one meetings with NIH representatives.

To register and/or schedule a 15 minute 1:1 meeting, please contact Susan Silberman directly at Timeslots are limited and will be assigned on a first come basis.

Authors: Michael Salgaller, PhD, Unit Supervisor, Invention Development and Marketing, Technology Transfer Center, National Cancer Institute (NCI); Michael Shmilovich, Esq., CLP, Sr. Licensing & Patenting Manager, Office of Technology Transfer and Development, National Heart, Lung, and Blood Institute (NHLBI); and Marc R. Cote, Area Representative & Certified Business Coach, FocalPoint Business Coaching.


See all MassBio News