The Influence of then occurs. A recent study found most optimistic outlook is that these Political Forces on that from the years 1983 to 2002, funds will be dispersed to individual the political effect on this process scientists or groups of scientists us- Research Funding ranged from 2.85% to 6.74%. ing the effective peer review system Robert J. Genco, DDS, PhD Clearly, this is a minor effect, and already in place at the NIH, which State University of New York at it is encouraging to know that peer is relatively insulated from the po- review is the main mechanism by litical process. Buffalo which NIH research and training Advocacy efforts for dental re- awards are made. search are carried out mainly by 2 Non–defense research carried Major, multi–year shifts in over- organizations, which interact with out in American universities is 60% all federal funding of biomedical the NIDCR: the Friends of the NID- federally funded, and most biomed- research often comes through major CR, which is a group of individuals ical research is funded through the economic crises such as the one we interested in promoting the strate- National Institutes of Health (NIH). are in now, or major advocacy ef- gic plan and other programs of the We will address the effects of politi- forts of scientists, the biomedical NIDCR to many different audienc- cal forces on the awarding of indi- industry and other groups, such as es, including legislators. The other vidual grants and the overall level patient advocacy groups working group is the National Oral Health of research funding from the NIH. closely with legislators. Two recent Advocacy Committee, which is The awarding of individual examples of this include the dou- a combined advocacy committee grants to university faculty and oth- bling of the NIH budget from 1998 of the American Association for er researchers by the NIH is based to 2003, which came about largely Dental Research and the American mainly on peer review. The process because of well–reasoned and co- Dental Education Association. The of determining the yearly national ordinated arguments from scientific primary purpose of these organi- research budget, including that of organizations such as the American zations is to increase and enhance the NIH, is complex as congres- Association for the Advancement of the efficacy of advocacy efforts on sional appropriations wind their Science, and from biomedical de- behalf of dental research and den- way through to become law. These vice and pharmaceutical companies tal education. To this end, there is a decisions are not insulated from as well as patent advocacy groups National Advocacy Network, which political influence. A recent study arguing that strong basic research is the infrastructure through which reported the effect of representation was needed for a viable health care members and advocacy coordina- on congressional or senate commit- system. tors can carry out joint advocacy tees involved in the grants obtained The most recent major change in and mobilize members of the House by the state or congressional region. federal funding for research result- and Senate to take legislative action. The process behind government ed from efforts to reverse the results Those interested in participating in appropriations involves the Appro- of the recent economic crisis by this network should contact Mon- priations Committees of the House passing the American Recovery and ette McKinnon at mckinnonm@ and Senate, the Labor, Health and Reinvestment Act (ARRA) of 2009, adea.org. Advocacy organizations Human Services, Education–relat- which was signed into law by Presi- can be effective vehicles for those ed Agencies Subcommittee and the dent Obama on February 17, 2009. interested in promoting broad bio- subcommittee of the Senate Appro- The overall budget of the NIH rose medical and dental research, as can priations Committee. from $8.3 billion in fiscal year 1984 participation in the efforts of patient It all begins with a budget which to $28.7 billion in fiscal year 2008, advocacy groups. Also, local ef- is presented by the President which and in 2009–2010 will increase forts can be effective in educating NIH negotiates with the Department another $10 billion based on the legislators. A simple measure such of Health and Human Services and ARRA. The National Institute of as inviting congressmen and other the Office of Management and Bud- Dental and Craniofacial Research legislators to visit laboratories, clin- get within the Executive Office of (NIDCR) has a series of programs ics, dental or dental hygiene schools the President. The various govern- supported by the ARRA, and these is often effective to help convince ment committees mark–up the ap- can be reviewed at www.nidcr.nih. legislators on the value of our edu- propriations bill from the President, gov/Recovery/. However, these are cational and research programs to and present it to the House and Sen- temporary funds, and their func- oral and general health. ate for a vote. The allocation and tion is to support the best science disbursement of approved funding while stimulating the economy. Our

Volume 83 Issue 4 Fall 2009 The Journal of Dental Hygiene 203 Building Relationships elements for the discovery phase is property and publication rights. It is from an Industry increasing. In order for these col- absolutely critical to have these ele- laboration models to be sustainable ments defined up–front because this Perspective and deliver the desired impact on has been the cause of many irresolv- J. Leslie Winston, DDS, PhD oral health, they must be flexible able conflicts. Procter & Gamble Oral Health and need proper funding from both There are a number of potential government and industry sources to strategies for building research re- Much of the interest in fostering succeed.1 The potential to develop lationships with industry. Enter into collaborations between academia common best practices is enormous these relationships with eyes wide and industry began in the 1980s, and there is great need to publish the open. There will be big issues along when the government encouraged experiences with industry–universi- the way that stall progress. In order collaboration that would foster a ty collaborations so that knowledge to survive in the current research quicker pace of innovation. While and experience may be disseminat- climate all parties need to roll up industry sought out relationships ed appropriately.2,3 their sleeves and work through it with universities earlier, it became While collaborations between with the end goal in mind. more widely accepted due to the academia and industry are encour- The most common downfall “blessing” of institutions, such as aged, there has been greater empha- when academia approaches indus- the National Institutes of Health sis on whether these kinds of collab- try regarding potential partnerships and Medical Research Council of orations have the potential to create is a lack of understanding of the Canada. University–industry col- conflict of interest that may jeopar- business which is targeted. Great laborations foster economic growth, dize the safety of study participants ideas which are not framed appro- improve standards of living and ex- and the integrity of the data.4 Esca- priately are summarily dismissed tend humanity’s intellectual reach. lating awareness is being driven by because the audience is not under- With these lofty goals a long–term the intense focus of the media on stood. Identify partners with similar relationship mindset is essential. these types of issues which cast an interests and complementary needs Industry enters into collabora- unfavorable light on many positive, – all sides need to gain from the col- tive relationships for many reasons. productive relationships. laboration. Most often it is to access a technol- Over the past 20 years, fewer than The most efficient way to build ogy and gain expertise. Leveraging a dozen dentistry–specific drugs a research relationship is to find a the credibility that an investigator have gained US Food and Drug way in. Champions are critical in brings and enabling the credential- Administration (FDA) approval. these endeavors. Interestingly, many ing of the end result with the broad- Only one area, locally delivered an- of these partnerships are forged er oral health community is highly timicrobials for periodontitis, has through informal means such as desirable. at least 3 new drug approvals and, networking during poster sessions Academia often needs expertise or sadly, none of these could readily at research conferences. capability that an industrial partner be classified as a blockbuster. This There is an increasing emphasis may provide. Industry has to oper- reality has made industry question on translational research in the den- ate efficiently to remain competitive the return on investment of the drug tal research community. The skill and deliver desirable returns on in- development route. Instead, oral set to take the great inventions in the vestment for their shareholders. The care research and development has laboratory and make them relevant introduction of process, a system to more typically been focused on to the daily care of patients is un- move towards goals efficiently, is a FDA monograph actives (fluoride likely to occur in a single individu- strength that industry cultivates in for caries) and devices such as im- al. While dental hygienist scientists order to survive. This experience plants, toothbrushes or restorative have the potential to play important managing large programs from start materials.5 roles in all phases of collaboration, to finish is a capability that industry The risks associated with entering this is the place where the hygienist brings to any academic and govern- into university–industry collabora- has the highest potential. Given the ment relationship. tions on the part of a corporate en- close relationships that are forged The classic pharmaceutical mod- tity is often framed around concerns between dental hygienist and their el of drug development is becoming about whether academia is unbiased patients, the practicality and value less common, and industry is play- and ethical, and whether the inves- of ideas can be fully vetted and ing a lesser role in drug discovery. tigator or institution is respected. honed into great ideas. Without the As universities and government There are also concerns about the ability to leverage the outcomes of develop core facilities and capa- role of the broader university, espe- research, the return on investment bilities, the ability to leverage these cially when it comes to intellectual for all parties is never enough.

204 The Journal of Dental Hygiene Volume 83 Issue 4 Fall 2009 Disclosure: The author of this man- Drisko CL, Douglass CW, Farrell nerships—a marriage of conve- uscript is employed by Procter & L, Fletcher K, Makoni F, Monaco nience? Crit Care Med. 2009; Gamble Oral Health. M, Nordquist B, Park NI, Riggs S, 37(1):Suppl,S159–64. References Schou L, Smales FC, Stamm JW, 4. Broccolo BM, Geetter JS. Today’s Toh CG, Volpe T, Ward P, Warren conflict of interest compliance 1. Tralau–Stewart CJ, Wyatt CA, P. Exploring opportunities for col- challenge: how do we balance the Kleyn DE, Ayad A. Drug discov- laboration between the corporate commitment to integrity with the ery: new models for industry–aca- sector and the dental education demand for innovation? J Health demic partnerships. Drug Discov community. Eur J Dent Educ. Life Sci Law. 2008;1(4):3–65. Today. 2009; 14(1–2):95–101. 2008;12 Suppl 1:64–73. 5. Gerlach RW. Clinical trials and 2. Alexander D, Clarkson J, Buch- 3. Abraham E. Better infrastruc- oral care R&D. J Am Coll Dent. anan R, Chadwick G, Chesters R, ture: industry–academia part- 2006;7(2):26–31.

Volume 83 Issue 4 Fall 2009 The Journal of Dental Hygiene 205 Strategic Planning and competitive activity within the cat- turn on the investment will all need Research Priorities in egory they may be exploring. They to be considered. need to understand the activities and If it is determined that the re- Private Industry products in the competitive land- search priority will be in a non–core Karen A. Raposa, RDH, MBA scape that are gaining traction. In competency or new area, then it is Colgate–Palmolive Company addition, the internet can be a won- important to first evaluate the cost derful tool to acquire knowledge of entry. This can be accomplished about trends and fads via Google, by reviewing and applying Michael Prior to any strategic planning of You Tube and various blogs. Porter’s “Five Forces” in his 1998 industry–supported research work, it Understanding technology, activ- publication On Competition.1 The is important to identify the priorities ities, products and procedures that company must also consider how of the corporate organization. These are approved and available in other this expansion of the corporate priorities will be critical to under- parts of the world can also be a key brand image would be perceived stand in order to ensure that the re- driver in identifying research pri- and what the options to entry are. search you are proposing is relevant orities. In some cases this learning For example, is it in the organiza- to the corporation and meets their may come from a competitor, but tion’s best interest to research and strategic needs. often times it is a result of exploring develop a new product or procedure Corporations will identify their worldwide trends, fads and emerg- alone? Or is a strategic partnership priorities based on many different ing sciences. the better choice? Is an acquisition approaches. One approach might be Finally, and probably most im- of the product/procedure/ technol- to look at market research results to portantly, a corporate organization ogy the best approach? Once the consider feedback and insights from must be mindful of its core compe- plan of entry is decided, a plan after both consumers and professionals. tencies, but must also understand if entry must be formulated including These studies might be conducted at there is opportunity to move beyond a timeline, cost and return on invest- conventions, through experts or key the competencies that exist today to ment. opinion leaders in the field, via advi- a competency that may be acquired. Now that the key priorities have sory board meetings, through focus Ultimately, any new competencies been listed, they need to be priori- groups (qualitative research) and/ would need to be a strong strategic tized in rank order. Strategic plans, or broad surveys (quantitative re- fit in order to avoid potential disas- both short and long term, must then search). Often during these research trous results. be developed around these priori- studies, unmet consumer/patient Once the corporate priorities are ties. It will be important to ensure needs may be uncovered or an un- identified, they must then be priori- that the appropriate resources are met need within the profession may tized in order to come to a key deci- allocated for all proposed research be revealed and explored. sion on what research should be pur- and that key performance indicators Many companies will also review sued. For example, recognizing the are in place in order to consistently new and emerging trends in the mar- corporate strategy for the study (i.e. monitor the progress of the research ketplace. These can be either prod- long or short term, local, regional or project. uct or procedure trends. Some ex- global) will be critical to the design It is important to consider both amples of emerging markets today of the study. In addition, the core the advantages and challenges asso- might be dry mouth, erosion, sensi- competency of the organization is ciated with merging research inter- tivity, minimally invasive dentistry critical to the decision making and ests between academia, government or even spa dentistry. prioritizing process. In reviewing and industry. Several advantages do In addition to considering what this aspect, it is important to deter- exist, including the fact that these research needs to be conducted in the mine how the option expands the types of collaborations are relation- future, companies will look to ex- current portfolio and if it does so ship based and develop as a result plore the research that may already in a meaningful way. In looking at of solid relationships between aca- exist on a specific topic to date. This the possibility of a product line ex- demia and industry. Because of this research may have been conducted tension, a company must consider platform, funding support is usually within the company or outside of whether the additional products in straightforward and predictable. the organization. It may be research the line will contribute meaningful In addition, there is solid support conducted on other products, on a product benefits or will move the for proposed methodologies and specific ingredient(s) or on a- spe product line into a different or new techniques, as well as a dedicated, cific subset of the population. and meaningful area. Finally, the reliable team of corporate research Organizations seeking to iden- timeline to get the results, the cost and development employees who tify priorities must also be aware of of getting those results and the re- are always available as an ongoing

206 The Journal of Dental Hygiene Volume 83 Issue 4 Fall 2009 resource. Once the data has been The challenges with these merg- from these types of academic, gov- collected, an additional advantage ing research interests include the ernment and industry research inter- to this type of collaboration is that need for common interests, the fact actions and collaborations. there are corporate employees who that the priorities of either team may are able to run the statistical analy- change mid–stream or the economic Disclosure: The author of this manu- ses that are needed for final report pressures that may exist as the re- script is employed by Colgate–Pal- and article submissions. Finally, the search study progresses, as well as molive Company. end result of this type of collabora- the level of oversight the corpora- tion can lead to even more interac- tion may choose to impose on the References tion between these groups, such as researcher. Overall, however, the 1. Porter M. On competition. Bos- additional studies, consulting or on- advantages far outweigh the chal- ton: Harvard Business School going long–term collaborations. lenges and great opportunities exist Publishing; 1996.

Volume 83 Issue 4 Fall 2009 The Journal of Dental Hygiene 207 The Academic/Industry one must ask who else would pay of Reporting Trials (CONSORT) Relationship: Common for this research. It is only through and Conflict of Interest statements education and understanding of the are all initiatives created to limit misconceptions about research process that some of these bias and increase transparency in bias. misconceptions can be cleared. clinical trials. Regulatory efforts MaryAnn Cugini, RDH, MHP Any scientist appreciates that re- include established federal, profes- The Forsyth Institute duction in bias is a basic part of the sional and advertising guidelines. scientific method. While practicing The Clinical Trial Registry (www. professionals have been far removed clinicaltrials.gov) is a repository of Criticisms of bias in sponsored from their basic science classes, federal and privately funded stud- research programs regularly gen- most have forgotten that there are ies conducted in the U.S. allowing erate media interest, both in the internal and external threats to the consumer, industry and investigator academic world and beyond. This validity of research results. Internal access to clinical trials. At this time, climate of mistrust has been fueled threats include subject selection, trial registration is voluntary, except by reports of negative study results history, repeated testing (learning for federally funded clinical trials. being withheld by industry as well over time) and maturation (aging Publications in peer reviewed as falsified data being presented by process, fatigue). External threats journals have now adopted use of academic investigators, thus ques- including randomization, masking CONSORT (www.consort–state- tioning the validity of support for and multicenter participation are ment.org) to address publication drugs and devices. controlled so that results can be ap- bias. Most journals, including den- Inherent industry bias is the as- plied to other populations. Individu- tal health journals, require authors sumed culprit, suggesting that ac- als involved in research conscious- reporting on clinical trial data to tive sponsor involvement in study ly account for these confounding follow these guidelines when pub- design, analysis, control of data- issues by rigorous approaches to lishing. Use of CONSORT makes bases and publication set the stage study design and analysis. published clinical trial data more for biased research results. Finan- There are also other, more subtle amenable to systematic reviews as cial considerations also play an forms of bias, for example: the full data are included for easy important role in the conduct of • Publication Bias – studies with access and meta–analysis. clinical trials. Product development positive findings are published Conflict of Interest or statements costs, especially for drugs, can run more often and faster than those of financial disclosure are now re- into the millions of dollars. This with negative results4 quired of investigators by most or- financial burden relies mainly on • Funding Bias – biases in re- ganizations. The NIH states “This industry. In fact, over 70% of fund- search design, outcome and regulation promotes objectivity in ing from clinical trials comes from reporting may be influenced research by establishing standards industry.1 Researchers pressured to by the source of funding or the to ensure there is no reasonable ex- obtain funding increasingly look desire to obtain continued fund- pectation that the design, conduct to industry in this era of shrinking ing or reporting of research funded un- federal dollars. Interestingly, two • Outcome Bias – studies that der NIH grants, cooperative agree- thirds of academic medical centers collect many types of data of- ments or contracts will be biased by hold an equity interest in compa- ten report only the significant any conflicting financial interest of nies that sponsor research at their results an Investigator.”5 institution.2 New approaches in • Grey Literature Bias – results It seems that most of these efforts the evaluation of drugs have been appear in many forms that are described have focused on the bias suggested, such as an Institute for not referenced in journals. This of the investigator. Actually, indus- Prescription Drug Trials within the includes abstracts, working pa- try sponsors of clinical trials must National Institutes of Health (NIH), pers, conference reports, pat- adhere to regulations imposed by which would administer clini- ents and progress reports that government and professional orga- cal trials sponsored by industry.3 can contain conflicting data nizations. All clinical trials involv- While most of the negative media Efforts to reduce these types of bias ing human subjects adhere to the is related to prescription drug trials, with the aim of “increased transpar- U.S. Code of Regulations (CFR), bias towards industry sponsored tri- ency” have been initiated by regu- which defines the procedures that als for oral health products exists latory agencies, professional orga- must be met for studies involving as well. Although dental clinicians nizations, academic institutions and drugs, medical devices and over are wary of product claims when journal editors. Clinical Trial Regis- the counter health products. Inter- research is sponsored by industry, tries, use of Consolidated Standards national agencies, including Health

208 The Journal of Dental Hygiene Volume 83 Issue 4 Fall 2009 Canada, also provide regulations for requires clinical claim support for JAMA. 2003;289(4):454–465. marketing of products and approval all advertising. In addition, clini- 3. Angell M. Industry–sponsored of advertising claims. Claims used cal study guidelines adopted by the clinical research: A broken system. in advertising are regulated by the profession often dictate what study JAMA. 2008;300(9):1069–1071. Federal Trade Commission (FTC) designs are accepted for product 4. Hopewell S, Loudon K, Clarke and the National Advertising Divi- evaluation and claim approval. MJ, Oxman AD, Dickersin K. sion (NAD) of the Better Business In summary, elimination of bias Publication bias in clinical trials Bureau. These agencies have ju- in clinical research is a shared re- due to statistical significance or risdiction over national advertis- sponsibility. As professionals, we direction of trial results. Cochrane ing, including print, packaging and are called upon to be both support- Database of Syst Rev. 2009;(1) labels, broadcast in TV, radio and ive of new product development MR000006. infomercials, direct mail and the in- and critical of claims validity. 5. US Department of Health and Hu- ternet. Advertisers must substantiate man Services, National Institutes all claims, whether overt or implied. References of Health, Office of Extramural For “clinically proven” claims, the 1. Doucet M, Sismondo S. Evaluat- Research. Conflict of Interest, FTC, working in partnership with ing solutions to sponsorship bias. J Frequently Asked Questions [In- the FDA, requires industry to sup- Med Ethics. 2008;34(8):627–630. ternet]. Cited April, 2009. Avail- ply 2 clinical trials in support of 2. Bekelman JE, Li Y, Gross CP. able from: http://grants.nih.gov/ the claim. Professional associations Scope and impact of financial grants/policy/coifaq.htm. may also oversee product claims. conflicts of interest in biomedi- The American Dental Association cal research: A systematic review.

Volume 83 Issue 4 Fall 2009 The Journal of Dental Hygiene 209 Exploring the lion STTR). Current budgets (fis- maximum amounts subcontracted Government/Industry cal year 2009) are $600 million for for the SBIR program are one–third SBIR and $72 million for STTR in Phase I and one–half in Phase Interface – the NIH (The fiscal year 2009 budgets for II. Those research projects needing SBIR STTR Program the National Institute of Dental and substantial support by a non–profit Kay Etzler Craniofacial Research (NIDCR) are research institution usually consider SBIR/STTR Program, National $7.8 million and $0.9 million). the STTR program. There are 3 phases to both SBIR The other major difference be- Institutes of Health and STTR with federal funds avail- tween the programs involves the PI. able for Phases I (a feasibility SBIR requires that the PI be primar- The National Institutes of Health study) and II (full research/R&D). ily employed with the small busi- (NIH) participates in 2 Congres- Phase III is the commercialization ness awardees and STTR permits sionally–mandated programs that stage and awardees are responsible the PI to be employed with either offer funding explicitly for small for obtaining the necessary follow- the small business or the collabo- U.S. companies to do innovative ing on funding and strategic part- rating research institution. Those research work in the biomedical nerships to bring the SBIR/STTR– projects for which the expertise, and behavioral sciences that have developed products or services into leadership and technical guidance the potential for commercialization. the marketplace. No SBIR or STTR are to be provided by a university These are the Small Business In- funding is available for Phase III. employee usually find the STTR novation Research (SBIR) and the Both of these programs share the program is a better fit. Small Business Technology Trans- following goals: NIH has exercised great flex- fer (STTR) programs. • Stimulate technological inno- ibility in the implementation of SBIR was enacted in 1982 and vation its SBIR and STTR programs to has 11 federal agencies participat- • Use small businesses to meet maximize their use. The following ing. In order of their SBIR budgets Federal R&D needs are just a few of the many nuances (largest to smallest), they are: • Foster and encourage participa- that have helped to make these pro- • The Department of Defense tion by minorities and disad- grams not only effective, but also • The Department of Health and vantaged persons in technologi- viable sources of funding for small Human Services (which in- cal innovation businesses to consider as part of cludes NIH) • Increase private–section com- their business plans to fund their re- • The National Aeronautics and mercialization innovations de- search and R&D efforts: Space Administration rived from Federal R&D • NIH offers both grant and con- • The Department of Energy There are 2 major differences be- tract opportunities with most • The National Science Founda- tween the programs that must be (95%) of its awards being tion considered when deciding which is grants. As an assistance mecha- • The Department of Homeland best. They are the amount of sub- nism, grants offer more flex- Security contracting needed and the principal ibility than contracts which is a • The U.S. Department of Agri- investigator’s (PI’s) employment. procurement mechanism culture The SBIR program allows col- • NIH offers 3 grant application • The Department of Commerce laborations with private industry, submission dates each year: • The Department of Education universities, foundations or other April 5, Aug. 5 and Dec. 5 • The Environmental Protection U.S. entities. However, the STTR • An applicant may exceed the Agency program requires a collaborative ef- budgetary and project duration • The Department of Transporta- fort between the small business and period guidelines, providing tion a non–profit research institution. they are adequately justified SBIR’s sister program, STTR, was The small business must perform and the research plans warrant enacted in 1992 and includes the a minimum of 40% of the effort doing so. These guidelines are: top 5 SBIR–participating agencies. and the collaborating institution a • SBIR Phase I – $100,000 Each agency is required to set minimum of 30%. The remaining for 6 months aside 2.5% of their extramural R&D 30% may be allocated to either of • SBIR Phase II – $750,000 budget for SBIR and three–tenths these entities or an additional third for 2 years of 1% for STTR. Combined NIH party, leaving the possibility of as • STTR Phase I – $100,000 budgets over the past several years much as 60% of the effort to be for 12 months have been approximately $650 mil- performed by the non–profit re- • STTR Phase II – $750,000 lion ($580 million SBIR, $70 mil- search institution. Generally, the for 2 years

210 The Journal of Dental Hygiene Volume 83 Issue 4 Fall 2009 • Grant applicants must respond cations that are deemed scien- the marketplace to the NIH mission of improv- tifically and technically meri- Only small businesses may apply ing human health rather than torious, this allows for greater and receive SBIR and STTR funds, a narrowly focused scientific chance of being selected for an but university involvement is also technical topic. This allows for award encouraged. University individu- submission of investigator– • NIH offers Phase II Competing als may serve as consultants or as initiated projects for which the Renewals that provide addition- key personnel on subcontracts to investigator is encouraged to al Phase II funding for complex the small businesses. In the case of “think outside of the box” to instrumentation projects, clini- STTR, they may serve as principal provide innovative solutions to cal research tools, behavior in- investigators. University individu- real problems terventions/treatments or clini- als who own their own small com- • All applications are peer re- cal projects preparing for FDA panies may also apply and receive viewed and applicants receive approval awards. However, they and their the reviewers’ comments. These • NIH offers the opportunity to universities must be cognizant of the comments are especially useful submit FastTrack applications conflict–of–interest issues that may when an applicant decides to (combined Phase I and Phase arise and properly handle them. revise and resubmit their appli- II applications). Funding gaps Additional information about cation for review and consider- between phases can be dramati- the NIH SBIR and STTR programs ation again cally reduced or perhaps elimi- and how to submit an application is • Applications may be given as- nated for FastTrack applicants available from the NIH Small Busi- signments to multiple NIH in- • NIH offers technical assistance ness Research Funding Opportuni- stitutes and centers for funding programs to help transition ties Web site http://grants1.nih.gov/ consideration. For those appli- SBIR–developed products into grants/funding/sbir.htm.

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