The American Recovery and Reinvestment Act of 2009 was signed into law by President Obama on February 17, 2009.  Thankfully, all the funding won’t go to the Wall Street financial firms who helped get us in this mess in the first place.  Private companies, including those in emerging sectors, such as alternative energy technology, stem cell research and healthcare information technology (IT), will benefit from various stimulus programs. 

Stimulus funds related to healthcare, which total about $137 billion, are headed in a bunch of different directions through a bunch of different initiatives.  They include funding to build and renovate health centers (which are non-profits, but contract with private firms); expand Medicaid benefits (a governmental program, but one that reimburses medical services provided by the private sector); and provide the unemployed with the means to obtain private insurance (which could benefit health insurance providers).  Private firms are eligible to directly apply for various grants.

But deadlines are coming soon; some funding has already been granted.  Here are three deadlines that are rapidly approaching for entrepreneurial companies that are seeking funding.

The Recovery Act has allocated $200 million to this program in the forms of two year grants. Private firms are eligible. This new program will support research on topic areas which address specific scientific and health research challenges in biomedical and behavioral research that would benefit from 2-year jumpstart funds. The maximum grant is $1 million for two years. The topics are below and there are well over 100 grant opportunities. These are some of the hottest topics in medical research and were chosen by the scientific leadership at the NIH.

(01) Behavior, Behavioral Change, and Prevention

(02) Bioethics

(03) Biomarker Discovery and Validation

(04) Clinical Research

(05) Comparative Effectiveness Research (CER)

(06) Enabling Technologies

(07) Enhancing Clinical Trials

(08) Genomics

(09) Health Disparities

(10) Information Technology for Processing Health Care Data

(11) Regenerative Medicine

(12) Science, Technology, Engineering and Mathematics Education (STEM)

(13) Smart Biomaterials – Theranostics

(14) Stem Cells

(15) Translational Science

Here's a real "challenge" of the program. For years, NIH funding for biomedical research programs has been anemic. All of a sudden, grants for research that has been "bootstrapped" in academic research labs around the US are available. According to recent reporting on news stations like CNN, these researchers are already ready with reems of proposal information to submit to the 2 year Challenge Program.  If fact, one experienced and respected grant writing consultant told me that most of these grant opportunities were actually written with a specific researcher or lab in mind, as evidenced by their specificity.  If your firm decides to apply, act fast, and work with an established grant writer if possible (see other recommendations below).

Follow-on round deadlines: August 5, December 5.

Per the NIH, the SBIR program is designed to support small business concerns conducting innovative research/research & development with potential for commercialization. The related SBTT program is intended to support cooperative research/research & development with potential for commercialization, through a formal cooperative effort between a small business and a U.S. research institution.

Both programs generally occur in two phases. Phase I awards are capped at $100,000 for a funding period of up to 6 months. Phase II awards are capped at $750,000 for a period of up to 2 years (these are guidelines, but not hard caps). A small business can also apply for both phases at the same time through the NIH’s Fast-Track program, which is a more extensive application process.

Who’s Eligible?

Any US small business (a firm with under 500 employees) can apply for the program. Criteria considered in the SBIR phase I application include (quoted from the program's website):

“Overall Impact. Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).

Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance. Does the proposed project have commercial potential to lead to a marketable product, process or service? Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?”

The NIH also publishes specific topics it would like studied. This year there are over 50 additional specific topics to pursue. They include:

· Manufacturing Processes of Medical, Dental, and Biological Technologies

· New Technologies for Liver Disease

· Advanced Neural Prosthetics Research and Development

· Tools for Germplasm Cryopreservation

· Probes and Instrumentation for Monitoring and Manipulating Nervous System Plasticity

Obviously, your company would need to have significant research – and grant writing – capabilities. Here are a few pointers for both the Challenge Grant and SBIR/STTR programs.

Quick Recommendations for Businesses:

• Take a look at the list of grant opportunities and determine if your company fits into the categories listed and whether any of the grant opportunities make sense for you.
• Request the specific grant application and work as fast as you can.
• We suggest you seek out a local research-focused professional who has been successful applying for and receiving NIH funding. Writing NIH grants is a very specific – and learnable – skill.
• Your company will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov process. This takes a couple days, so do it before the deadline.
• Make those April 27^th (for Challenge grants) and/or the three deadlines for SBIR/STTR programs.

HHS is providing “Access Point” grants that total $155 million to 126 health centers across the country, which would employ 5,500 health workers and help 750,000 low-income Americans get primary and preventive care.(1) There are 1,100 Centers. Over the next two years, a total of $2 billion in Recovery Act funding will be invested in Community Health Centers to support:

• renovations and repairs,
• investments in health information technology, and:
• critically needed health care services. (2)

The 126 Centers out of the 1,100 total facilities that are receiving funding generally applied for finding in 2006 and 2007 but did not get funded. Those applications were used to quickly distribute the program’s funding.

Case Study - North Shore Community Health Center, Gloucester, Massachusetts

Amount to be Funded: $1.3 million two year funding award

The North Shore Community Health center applied unsuccessfully in both 2006 and 2007 for federal funding from the federal Health Resources and Services Administration to open the new center. In 2007, the Gloucester center proposal was placed on a list of "approved but unfunded" health-center projects.

Use of New Funding:

· $650,000 to offset the costs of medical and dental providers (e.g., doctors, dentist, hygienist);

· $500,000 will be used to buy new equipment (e.g., dental equipment), and:

· $150,000 for additional renovations. (3)

Quick Recommendations for Businesses:

1. Firms that will benefit: businesses that often provide services to such Centers: office equipment providers and distributors; medical equipment suppliers and distributors; construction and renovation contractors; and providers of information technology and related services; among others.

2. Check to see if any Centers have been funded in your area.

3. Conduct a “Google News” search on that Center to see if it’s been mentioned in the press and if a representative has mentioned what they will use the funds for.

4. Contact them to offer your services – hopefully remembering that they are still a non-profit that could benefit from quality service at a discount. Doing good will mean good business for your firm.

Conclusion

There is an unprecedented amount of government funding being spent to save the economy, much of it healthcare related. And it’s coming fast. Businesses that have a science, technology and research focus are most likely to be eligible for funding. But there’s also an opportunity for many other businesses, especially small businesses, that can move quickly and effectively to apply directly for funding or pursue business opportunities with those organizations that have received funding.

Good luck!

(1) John Laidler, “Health center to expand,” The Boston Globe, March 15, 2009, online version. (2)http://www.bizjournals.com/pittsburgh/stories/2009/03/02/daily17.html (3) Source HHS Website <http://www.hhs.gov/recovery/hrsa/healthcentergrants.html>