The Small Business Innovation Research Program An Assessment of the Department of Defense Fast Track Initiative (2000) / Chapter Skim
Currently Skimming:
Role of the Department of Defense in Building Biotech Expertise
Role of the Department of Defense in Building Biotech Expertise
Pages 251-274
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 251... ...
In truth, however, DoD is a task-oriented agency, and biotechnology, as an emerging broad-based technological platform, offers novel solutions that enhance DoD's mission. These include applications related to disease prevention and mitigation, rapid emergency medical response and trauma management, environmental remediation, and advanced materials.
|
From page 252... ...
All of the DoD SBIR-funded companies that we interviewed have developed commercial products. Two companies that were interviewed, MedImmune and Martek, had a strong DoD legacy and the SBIR awards helped the companies to convert to commercial, civilian applications.
|
From page 253... ...
This paper investigates only one aspect of DoD biotech funding: the SBIR program. In this way, it underestimates the role of DoD because no consideration is given to dedicated research facilities, such as the Walter Reed Army Institute for Research (WRAIR)
|
From page 254... ...
The next section provides data on DoD SBIR awards related to bioscience applications.2 This analysis is based on a database constructed for this project. A comparison is made to NIH SBIR funding because NIH is the largest dedicated federal funder of biotech research.
|
From page 255... ...
The total amount spent by DoD on SBIR biotech research was $240,866,001, in 1997 dollars, over the 14-year period for which we have data. Table 1 provides an overview of DoD funding to SBIR biotech projects from 1984 to 1997.5 For every year, the number of awards, the total amount awarded, and the average amount of the award is listed, by Phase and for the total.
|
From page 256... ...
256 SBIR: DOD'S FAST TRACK INITIATIVE TABLE 1 DoD SBIR Biotech Awards FY1984-FY1997 (1997 real dollars) Type of Total Amount Average Year Awarded Award Count Awarded Award 1984 Phase II 2 1,291,690 645,845 Total 2 1,291,690 1985 Phase II 8 4,958,783 619,848 Total 8 4,958,783 1986 Phase II 9 5,520,467 613,385 Total 9 5,520,467 1987 Phase II 12 7,975,713 664,643 Total 12 7,975,713 1988 Phase II 14 8,929,105 637,793 Total 14 8,929,105 1989 PhaseII 12 4,372,354 364,363 Total 12 4,372,354 1990 Phase I 46 3,103,910 67,476 Phase II 20 10,028,279 501,414 Total 66 13,132,190 1991 Phase I 64 3,804,775 59,450 Phase II 15 12,044,014 802,934 Total 79 15,848,790 1992 Phase I 43 2,503,535 58,222 Phase II 21 12,543,755 597,322 Total 64 15,047,290 1993 Phase I 51 3,166,938 62,097 Phase II 27 15,072,733 558,249 Total 78 18,239,671 1994 PhaseI 102 8,863,993 86,902 Phase II 26 15,692,876 603,572 Total 128 24,556,869 1995 Phase I 100 8,058,951 80,590 PhaseII 48 33,839,580 704,991 Total 148 41,898,531 1996 Phase I 92 8,139,534 88,473 Phase II 51 32,258,781 632,525 Total 143 40,398,314 1997 Phase I 99 9,164,828 92,574 Phase II 44 29,531,407 671,168 Total 143 38,696,235 Total Phase I 597 46,806,464 78,403 Phase II 309 194,059,537 628,024 Total 906 240,866,001
|
From page 257... ...
Whereas NIH is charged to fund health applications, DoD's charge allows it to fund research in a greater variety of application areas.6 Table 4 provides an overview of the applications that DoD awards supported. The 6Data on application area were not collected for NIH for this project.
|
From page 258... ...
258 Cq At so _' Cq 3 ¢ _.
|
From page 259... ...
DoD funded 9 percent of the Phase II projects that NIH funded; however, on average, DoD Phase II SBIR awards were 57 percent higher. The probability of receiving a Phase II award from NIH after a Phase I award was 62 percent whereas it appears that DoD SBIR projects had a lower probability, 42 percent, of continuing with a Phase II award.
|
From page 260... ...
Phytotech is a biotech firm that focuses on environmental remediation. Specifically, the SBIR award allowed Phytotech to develop technology to mitigate the metal accumulation from firing ranges.
|
From page 261... ...
The technology is appropriate for use in environmental remediation on firing ranges, which contain high concentrations of noxious materials. As might be expected, the Army was very interested in Phytotech's technology and the company has benefited from Army SBIR Fast Track funding of Phase I and Phase II projects: 1996, Army, $111,404 (Phase I)
|
From page 262... ...
At that time the company had sales of $500,000 for testing devices for Rocky Mountain spotted fever, rickettsial typhus, and other immunodeficiency diseases. The founders of Maryland Medical Labs were looking for an investment and became silent partners in Paxton's developing enterprise.
|
From page 263... ...
Because the company has received prior SBIR awards, there is not much incentive in terms of leveraging the match for increased federal funds. In this regard the penalty put in place to deter "mills" from applying to Fast Track acts to deter small companies that have received prior awards
|
From page 264... ...
In its first 10 years, the company has built a pipeline rich with products and drug development projects for infectious diseases, transplant medicine, cancer prevention therapy, and autoimmune disorders. The company currently has three commercial successes: CytoGam(D, an intravenous immune globulin that prevents cytomegalovirus, a viral infection common after solid organ transplants; RespiGam™, also an intravenous immune globulin, which prevents respiratory syncytial virus (RSV)
|
From page 265... ...
It also sealed codevelopment and copromotion agreements with American Home Products Corporation. After two years of tireless dedication to RespiGam™ by the company, the FDA approved it for the prevention of RSV disease in certain high-risk infants.
|
From page 266... ...
market to about 325,000 children annually. RespiGam™ was marketed only to prevent RSV disease in severely premature infants and infants with lung disease (about 100,000 annually)
|
From page 267... ...
It has raised over $80 million in equity capital and obtained approximately $6 million from over 40 small business innovation grants, primarily from NIH. The first funding for this radical and experimental technology was from non-NIH sources, with DoD SBIR awards playing a role in the develop~ng company.
|
From page 268... ...
In 1992, Martek, which then had 50 employees, also was able to supplement $9 million raised from private investors with more than $5 million received from 32 federal SBIR grants from the NIH. In 1994, Martek, went public, selling 2.3 million shares at $7 a share to raise about $14.5 million after expenses.
|
From page 269... ...
, for virtual environment training for trauma management; 1996, NAVY, $748,521 (Phase II ) , for virtual environment training for trauma management; i2CathSim improves on prior training techniques in which medical practitioners practice on oranges, plastic models, or each other.
|
From page 270... ...
To commercialize the VR technology that resulted from the NAVY SBIR project, the Maryland Health Care Product Development Corporation (MHCPDC) invested $400,000 in HT in 1996.~5 In return for the investment, MHCPDC negotiated royalties for 14 percent of HT's annual net profits.
|
From page 271... ...
Fast Track allows a company to begin processing the application for a Phase II SBIR grant while it applies for Phase I Securing Phase I practically guarantees the company will get Phase II, but HT's experience exposed a frustrating Catch-22: to get Phase II funding.
|
From page 272... ...
All of the DoD SBIR-funded companies that we interviewed have developed commercial products. Two companies that were interviewed for this paper, MedImmune and Martek, had a strong DoD legacy and the SBIR awards helped the companies to convert to commercial, civilian applications.
|
From page 273... ...
ROLE OF DOD IN BUILDING BIOTECH EXPERTISE REFERENCES 273 Alic, John A., Lewis Branscomb, Harvey Brooks, Ashton B Carter, and Gerald L
|
From page 274... ...
We eliminated projects that did not substantially involve research, development, or manufacture of (1) biologically active molecules, (2)
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.