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From page 275...
... PREPUBLICATION COPY 275 TABLE APP-A-58 NRC - Change in employment caused by SBIR Change in employment % Change Responses <0 63 39.7 0 40 11.6 1-10 123 6.1 11-25 36 1.9 26-50 19 1.0 50-75 6 4.8 76-99 3 1.3 101-250 15 0.3 251-500 4 100.0 +>500 1 0.0 310 TABLE APP-A-59 NRC - Sales expectations % of re Responses sponses 95 19.2 Sales expected 32 6.5 Sales not expected 226 45.6 Sales 143 28.8 No response 353 Totasl responses 496 All responses to survey UNEDITED PROOFS
From page 276...
... 276 PREPUBLICATION COPY TABLE APP-A-60 NRC - Sales by licensees Revenues re ported for licen see Responses 39 <$1M 5 $1M - <$5M 5 $5M - <$50M 3 $50M+ 52 Total 496 All responses q_4_b_licensee These data are as reported by the recipient, not the licensee 70000000 TABLE APP-A-61 NRC - additional investment Average Total invest- Number of Investment ($) Source of investment ment $ % Investments % Private Investment from 154,617,045 33.9 15 3.9 10,307,803 US venture capital Private Investment from Other private equity 141,992,212 31.1 40 10.4 3,549,805 Private Investment from 39,616,075 8.7 12 3.1 3,301,340 Foreign investment Private Investment from Other domestic private 21,624,866 4.7 31 8.1 697,576 company 82,118,851 18.0 188 49.1 436,802 Your own company State or local govern 6,290,000 1.4 23 6.0 273,478 ment 9,850,408 2.2 67 17.5 147,021 Personal Funds 236,500 0.1 7 1.8 33,786 College or Universities Total 456,345,957 100.0 383 100.0 1,191,504 UNEDITED PROOFS
From page 277...
... 277 PREPUBLICATION COPY TABLE APP-A-62 NRC - The "Go" decision In the absence of this SBIR award, would your company have undertaken this project? Definitely yes 5% 8% Probably yes Uncertain 14% Probably not 28% Definitely not 46% TABLE APP-A-63 NRC - Patents and Publications Patent applications and awards Applications Awarded 249 58.7 280 66.0 No 175 41.3 144 34.0 Yes 424 100.0 424 100.0 679 305 Total Publications Total Publications Responses pubs 72 72 1 52 104 2 32 96 3 19 76 4 15 75 5 15 133 6-10 9 146 11-30 7 420 30+ Totals 236 1123 UNEDITED PROOFS
From page 278...
... 278 PREPUBLICATION COPY TABLE APP-A-64 NRC - Time to Market Years to market Responses % of reponses -11 1 0.4 -7 1 0.4 -4 1 0.4 -3 4 1.8 -2 6 2.7 -1 9 4.0 0 18 8.0 1 29 12.9 2 50 22.3 3 48 21.4 4 26 11.6 5 17 7.6 6 8 3.6 7 3 1.3 8 1 0.4 9 2 0.9 224 Note that negative answers are possible if the research represents enhancement of an existing product Award_Year All respondents sales no sales yet years since award 1992 21 10 11 13 1993 34 14 20 12 1994 27 10 17 11 1995 32 17 15 10 1996 35 15 20 9 1997 59 25 34 8 1998 57 29 28 7 1999 81 44 37 6 2000 63 26 37 5 2001 87 34 53 4 UNEDITED PROOFS
From page 279...
... Sampling Approaches and Issues The Phase II survey used an array of sampling techniques, to ensure adequate coverage of projects to address a wide range of both outcomes and potential explanatory variables, and also to address the problem of skew. That is, a relatively small percentage of funded projects UNEDITED PROOFS
From page 280...
... In determining questions that should be in the UNEDITED PROOFS
From page 282...
... Project surveys were begun on 1916 Phase II awards. Of the 4085 firms that received Phase II SBIR awards from DoD, NIH, NASA, NSF, or DOE from 1992 to 2001, an additional 7 firms were identified as out of business (total of 25)
From page 283...
... Considering the length of the survey and its voluntary nature, the rate achieved was relatively high and reflects both the interest of the participants in the SBIR program and the extensive follow-up efforts. At the same time, the possibility of response biases that could significantly affect the survey results must be recognized.
From page 284...
... A sale also includes licensing, the sale of technology or rights UNEDITED PROOFS
From page 285...
... , when did the first sale occur, and what is the approximate amount of total sales resulting from the technology developed during this project? If multiple SBIR awards contributed to the ultimate commercial outcome, report only the share of total sales appropriate to this SBIR project.
From page 287...
... U.S. Foreign Companies/Investors Companies/Investors UNEDITED PROOFS
From page 288...
... In the absence of SBIR funding, (Please provide your best estimate of the impact)
From page 289...
... 20. How many SBIR awards has your company received that are related to the project/technology supported by this Phase II award ?
From page 291...
... . The percentages are computed against the 444 who answered question 31, not just UNEDITED PROOFS
From page 292...
... 1.3% Not Approved e. 3.2% IND: Clinical trials f.
From page 293...
... In conjunction with that information, the following additional information will help us understand how the SBIR program is contributing to the formation of new small businesses active in federal R&D and how they impact the economy. Questions A-G are autofilled from Firm database, when available.
From page 294...
... b. Phase II: ________ Average number of Phase II reported was 7 27% 1 Phase II 44% 2 to 5 Phase II 15% 6 to 10 Phase II 8% 11 to 20 Phase II 5% 21 to 50 Phase II 1% >50 Phase II Four firms reported >100 Phase II UNEDITED PROOFS
From page 295...
... 5. What percentage of your company's growth would you attribute to the SBIR program after receiving its first SBIR award?
From page 296...
... 11. Which, if any, of the following has your company experienced as a result of the SBIR Program?
From page 297...
... 11% None of the Above UNEDITED PROOFS
From page 299...
... , seeks to determine both the extent to which the SBIR programs meet their mandated objectives, and to investigate ways in which the programs could be improved. Over 1200 firms have participated earlier this year in extensive survey efforts related to firm dynamics and Phase II awards.
From page 300...
... Phase I only Received Phase II Assisted/Most Useful Assisted/ Most Useful 10/3 State agency provided assistance 11/10 15/9 Mentor company provided assistance 21/15 31/17 University provided assistance 34/22 16/8 Federal agency SBIR program Managers 25/19 or technical representatives provided assistance 3. Did you receive a Phase II award as a sequential direct follow on to this Phase I award?
From page 303...
... rights to technology, sale of spin of company, etc.) 2 % Licensing fees UNEDITED PROOFS
From page 304...
... , when did the first sale occur, and what is the approximate amount of total sales resulting from the technology developed during this phase I? If other SBIR awards contributed to the ultimate commercial outcome, estimate only the share of total sales appropriate to this Phase I project.
From page 305...
... 75 % Reduced scope 4 % Increased scope 21 % No Response to scope 5 % Faster completion 51 % Slower completion 44 % No Response to completion rate 14 % Uncertain 40 % Probably not 16 % Definitely not 4 % No Response to question 12 UNEDITED PROOFS
From page 307...
... Primary Outcomes: • One product with FDA clearance and a second that has been submitted for clearance, both entering Phase III • 6 patents • Publications • Additional employment • Partnerships: Possible pilot program with Waste Management Inc. 1 Interview: In Carlsbad, CA, at Advanced Brain Monitoring, Inc., with Daniel Lebedowski, Chief Scientific Officer, and Chris Berkas, CEO.
From page 308...
... Overall, the company has received more than $6M from NIH in SBIR awards and an additional $700,000 from DARPA under the Augmented Cognition program. ABM has worked with Honeywell and Lockheed in the context of its DARPA-sponsored research.
From page 309...
... integrates physiological data acquired inhome with clinical history and anthropomorphic data to quantify level of risk for Obstructive Sleep Apnea (OSA)
From page 311...
... The rejected application defunded the pilot, and ABM is now seeking other mechanisms to implement this program. More generally, addressing the problem of undiagnosed sleep apnea potentially opens companies such as Waste Management to significant liability issues.
From page 312...
... REGULATORY APPROVAL Both of the company's products have received the FDA CE mark after completing FDA clinical trials. PROGRAM MANAGEMENT DIFFERENT IC'S ABM has had dramatically different experiences at different IC's, which it believes are entirely due to the capabilities and approaches of the different program managers.
From page 313...
... An application to take the technology developed during earlier SBIR awards and apply it in to the needs of the trucking industry. An agreement for a pilot implementation program was made with Waste Management Inc., one of the largest operators of commercial trucks.
From page 314...
... . • Study sections often suffer from substantial confusion between the functions and objectives of RO1's and R44's (SBIR awards)
From page 315...
... However, this contradicts points made in interviews at other companies, who noted that while funding is delayed to October, it does become available as soon as the appropriation is passed, in contrast to funding allocated toward the end of the fiscal year where there may be a liquidity crunch. SBIR AND VENTURE CAPITAL ABM has experienced mixed reviews of its SBIR awards from venture capitalists.
From page 316...
... o ABM supported two phase reviews, with an initial screening by study sections focused entirely on science, and a second level screening of commercialization plans for Phase II. Problems at the second level could then be fixed within a single funding cycle, or applicants could be asked to resubmit for commercialization review only, substantially shortening the entire application process for many awards while improving quality and eliminating many of the current problems with commercialization review.
From page 317...
... 317 PREPUBLICATION COPY Annex A: Advanced Brain Research NIH SBIR Awards Phase Funding Type IC FY Award Project title Comments 1996 Phase I $99,980 Ambulatory, battery powered, physiological recording NS 1999 Phase II $543,000 Ambulatory brain monitoring device NS 2000 Phase II $204,167 Ambulatory brain monitoring device NS 1997 Phase I $99,940 Alertness quantification system using normative indices NS 1999 Phase II $798,773 Alertness quantification system using normative indices NS 2000 Phase II $276,228 Alertness quantification system using normative indices NS 1997 Phase I $99,400 Portable self applying drowsiness detection device NS 1999 Phase II $365,994 Portable drowsiness monitoring device NS 2000 Phase II $41,556 Portable drowsiness monitoring device NS 2000 Phase II $347,762 Portable drowsiness monitoring device NS 2001 Phase I $125,306 In-home sleep apnea risk evaluation system HL Validation of In-Home Sleep Apnea Risk Evaluation 2002 Phase II $838,890 System HL Validation of In-Home Sleep Apnea Risk Evaluation 2003 Phase II $318,195 System HL 2002 Phase I $139,428 Biobehavioral Measurements of Alertness in Sleep Apnea HL 2003 Phase II $691,925 Automated Detection of Sleep Disordered Breathing HL 2003 Phase II $683,352 Biobehavioral Measurements of Alertness in Sleep Apnea HL Drowsiness Detection: Effects of Feedback Based on 2001 Phase I $99,991 EEG MH 2001 Phase I $99,994 Novel systems to evaluate sleep apnea and vigilance HL UNEDITED PROOFS
From page 318...
... 318 PREPUBLICATION COPY ABM Grant Name Description Award $$ Start Date Institute ABMD - I Solid state digital recorder 99,831 11/1/1996NS Drowsy - I Quantify sleep onset 99,648 5/1/1997NS Alertness - I Quantify states of alertness 99,940 3/1/1988NS Drowsy - II Quantify sleep onset - large clinical study 755,312 1/1/1999NS ABMD - II Wireless EEG system 747,167 5/1/1999NS Alertness - II Clinical and validation studies 1,075,001 6/1/1999NS ARES-A - II Prototype ARES and baseline AMP for OSA 99,994 1/1/2001 HLB CAPTIP Commercialization and EEG sensor production 175,000 1/1/2001 HLB ARES-B - I ARES Questionnaire 125,306 8/1/2001 HLB DMD - I Assess real-time recognition of sleep onset 99,991 8/1/2001 MH ARES-A - II Development of ARES & clinical studies 1,157,083 1/1/2002 HLB AMP - I Development of AMP 139,428 3/1/2002 HLB AMP - II AMP Clinical Studies 968,669 4/1/2003 HLB ARES-B - II Enclosure, Nasal Pressure, clinical studies 978,327 7/1/2003 HLB Total NIH 6,620,697 DARPA - I Assess workload 50,715 5/1/2002 DARPA DARPA - II.a Assess workload 100,000 1/1/2003 DARPA DARPA II.b Assess workload 250,000 1/1/2004 DARPA Total DOD 400,715 Total grants awarded 7,021,412 UNEDITED PROOFS
From page 319...
... The company is based on the application of targeted toxins to neuroscience, where the selective approach offered by what the company calls Molecular Neurosurgery offers obvious advantages if successful. Initial products have been sold to other research companies, but the company is now reaching the clinical trials stage for products aimed at addressing chronic pain.
From page 320...
... Wylie's key insight, according to Lappi, was that "cancer people could learn nothing from us, but we could learn a lot from them." Essentially, there were many possibilities for applying the science of targeted toxins from cancer to neurological research. The field of targeted toxins and the brain was largely ignored by mainstream research, and the company UNEDITED PROOFS
From page 321...
... is now in use in laboratories world wide. PRODUCTS The ATS product line includes targeted toxins, antibodies, and custom services for assisting neuroscientists in studying nervous system function, and brain-related diseases and disorders.
From page 322...
... The project is aimed addressing the problem of chronic pain, a very difficult area to understand, with high levels of complexity and multiple areas of research, including the spinal cord and neuron receptors within the brain. ATS research has addressed a central question in chronic pain research, namely whether chronic pain can be defined in terms of a unique pathway within the nervous system, or whether it results from some characteristic of the system as whole.
From page 323...
... Chronic pain sufferers won't need to take a pill every day. Advanced Targeting Systems has excellent pre-clinical data that leads us to believe that SP-SAP will be safe and effective and compels us to develop SP-SAP for clinical use." Researchers at UCSD have now completed preliminary toxicology studies with SPSAP in one of the FDA-required large animal models (funded under 2001 SBIR award from NIMH)
From page 324...
... This CCA award was part of a Program Announcement at NIMH, "Competing Continuation Awards of SBIR Phase II Grants for Pharmacologic Agents and Drugs for Mental Disorders." ATS notes that "For small businesses like Advanced Targeting Systems, this latest expansion of the SBIR program provides important support at a time when alternative funding is expensive and difficult to find." UNEDITED PROOFS
From page 325...
... Lappi sees scientific publications as "the highest form of advertising." Publications have also had in important impact on the company. In the course of its research on chronic pain, ATS submitted a Phase II application that was originally not funded with a score of 220.
From page 326...
... Results from these studies were published in Science in 1997, 6 providing enormous validation to the ATS approach. Mantyh's laboratory published a second Science article in 1999,7 demonstrating the long-term elimination of chronic pain with SP-SAP.
From page 327...
... ATS suggests resolving the Phase III problem in neurological sciences by building a hospital for clinical trials, with the costs shared by multiple IC's. Claims that this approach has been adopted at NCI.
From page 328...
... 328 PREPUBLICATION COPY Annex A: Advanced Targeting Systems NIH SBIR Awards FY Phase type Award IC Project title 1995 Phase I $96,844.00 Ns Specific tool for modeling neuronal degeneration 2001 Phase II $282,235.00 Ns A specific tool for targeting neurodegeneration 2002 Phase II $237,928.00 Ns A specific tool for targeting neurodegeneration 2003 Phase II $245,067.00 Ns A specific tool for targeting neurodegeneration $862,074.00 1999 Phase I $113,227.00 Mh Mab's to target specific neuronal populations 2003 Phase II $341,281.00 Mh Monoclonal antibodies to target neuronal populations $454,508.00 1996 Phase I $99,997.00 Mh New tool for basic neurobiological research 1998 Phase II $404,567.00 Mh New tools for basic neurobiological research 1999 Phase II $344,750.00 Mh New tools for basic neurobiological research 2001 Phase II $397,984.00 Mh Toxicology/safety studies of a chronic pain therapeutic 2002 Phase II $276,089.00 Mh New tools for basic neurobiological research 2003 Phase II $799,709.00 Mh Drug development of a chronic pain therapeutic $2,323,096.00 1999 Phase I $100,000.00 Ns Tools for the dissection of pain transmission pathways 2000 Phase I $100,000.00 Da A tool to study the diverse behavior effects of galanin 2001 Phase I $133,547.00 De Targeting neurons involved in chronic pain transmission Total $3,973,225.00 UNEDITED PROOFS
From page 329...
... In addition to the SBIR awards, and the ONR award referred to above, the UNEDITED PROOFS
From page 330...
... Asima Pattanaik was hired as a result of an SBIR award and remained with the company for eight years, becoming a PI on several SBIR awards. To quote Mr.
From page 331...
... A list of publications is provided in Appendix A, representing the scholarly work accomplished during the existence of Bioelastics. A number of these papers can be attributed to SBIR awards.
From page 332...
... " He believes that one would see a higher success rate coming out of SBIR funding if the agency paid more attention to the business plan.
From page 333...
... Channe Gowda, Timothy M Parker, and Dan W
From page 334...
... Urry, D Channe Gowda, ShaoQing Peng, Timothy M
From page 335...
... McPherson, Jie Xu, D Channe Gowda, and Timothy M
From page 336...
... Hayes, D Channe Gowda, ShaoQing Peng and Naijie Jing, "Electro-chemical Transduction in Elastic Protein-based Polymers," Biochem.
From page 337...
... McPherson, Jie Xu, D Channe Gowda, Timothy M
From page 338...
... Channe Gowda, David McPherson, Jie Xu, and Timothy Parker, "ΔTt-Mechanism in the Design of Self-Assembling Structures," in Self Assembling Peptide Systems in Biology, Medicine and Engineering, Edited by Amalia Aggeli, Neville Boden,Kluwer Academic Publishers, The Netherlands, Chapter 23, pp.
From page 339...
... M Parker, "Elastic Protein-Based Biomaterials: Elements of Basic Science, Controlled Release and Biocompatiblity", In: Tissue Engineering and Novel Delivery Systems, Marcel Dekker, Inc., New York, pp.
From page 340...
... His initial position at CNS was that of Group Leader/Staff Scientist II; at the time that the company was closed by CeNeS Pharmaceuticals, he was Vice President, Research. During his time with the company, he was the PI on five funded SBIR grants and the company obtained support from at least 13 SBIR grants.
From page 341...
... Although SBIRs played no role in the founding of the company, "right off the bat" the company applied for SBIR funding. This was facilitated by the fact that from the beginning, with seed money from venture capitalists, the company was able to hire a team of fairly experienced staff scientists.
From page 342...
... did not show efficacy during Phase III and the trials were terminated, both for the treatment of stroke and for TBI. "It was really close…it is possible that if the trial were rerun and using more narrow inclusion criteria, it might work." SBIR funding was involved at some early stage of the work that developed CERESTAT.
From page 343...
... Neither do they want to. "Venture Capitalists want you to be extremely focused and often give you one chance to succeed." Non-commercial outcomes Cambridge NeruoScience had many patents; it is difficult to determine which ones specifically related to SBIR grants.
From page 344...
... The first concerns the recent VC rule which states that a company that is majorityowned by VC is not eligible for SBIR awards. This rule excludes firms that, in his view, are strong candidates for SBIR awards, not needing to rely exclusively on SBIR awards for funding, but using the SBIR awards to enhance and diversify the research of the company.
From page 345...
... He consistently made the case that the SBIR program affects firm performance through the enhancement of its front-burner programs and the ability to diversity its research portfolio. Moreover, it allows the firm to hire new scientists, thereby creating jobs and providing training consistent with the firm's research agenda.
From page 346...
... By virtue of this SBIR support, several product candidates advanced into clinical trails or were partnered with major pharmaceutical companies as part of Phase III commercialization. Thus, not only has it been accepted practice for the NIH SBIR program to support the growth of emerging biotechnology companies, but it has helped to accomplish the mission of the NIH and create new jobs as well.
From page 347...
... . The firm has developed proprietary processes for the preservation of human heart valves, veins and connective tissue.
From page 348...
... KEY OUTCOMES FROM SBIR The company reports that the SBIR program has proven key to funding the research and development behind almost all new products of the company, and the company continues to see SBIR funding as an important source of research funding. To quote one of the scientists, "SBIR funding has basically been our external source of funding when we want to build a new product." The company has used the SBIR program to develop proprietary property that it has purchased.
From page 349...
... The company sees SBIR awards as a continuing source of research and development support. SBIR PROGRAM ADMINISTRATION The company has not always chosen to follow up a Phase I with a Phase II application.
From page 350...
... Finally, some frustration was expressed that the SBIR program is becoming increasingly competitive as the number of applications from university faculty members' labs increases. The hypothesis expressed was that faculty are increasingly creating companies to apply for SBIR funding to support the research of postdocs and research scientists working directly with the faculty on research.
From page 351...
... Bechtel Early Failure of the Tissue Engineered Porcine Heart Valve SYNERGRAFT in Pediatric Patients; Eur J Cardiothorac Surg 2003 Jun;23(6)
From page 352...
... Mayer, Jr., M.D. Tissue Engineered Heart Valves, The Journal of Biolaw & Business, Vol.
From page 353...
... Goldstein, J Ollerenshaw 1997 Acellular Porcine Pulmonary and Aortic Heart Valve Bioprostheses (book chapter)
From page 354...
... Sievers Multicenter Clinical Outcomes with a Decellularized Porcine Pulmonary Heart Valve (SynerGraft Heart Valve, Model 700) for Reconstruction of the Right Ventricular Outflow Tract; Advances in Tissue Engineering and Biology of Heart Valves; R
From page 355...
... Shaddy; 2002 In Vivo Resistance to Calcification of SynerGraft Tissue Engineered Heart Valve Grafts, American Association of Thoracic Surgeons, R Elkins, S
From page 356...
... Elkins, M.F. O'Brien, 2001 SynerGraft: The First Successful Reconstruction and Regeneration Tissue Products, Tissue Engineering for Heart Valve Substitutes Symposium, K
From page 357...
... Ollerenshaw, 2000 In Vivo Arterialization of SynerGraft® Processed Non-Vascular Xenogeneic Conduit; American Heart Association Scientific Sessions; 2000 Successful Use of Natural Revitalizing XenoGraft Connective Tissue Matrices in Animal and Human Heart Valve Replacement [poster presentation] , International Society for Applied Cardiovascular Biology, S
From page 358...
... Clarke; 1999 Successful Trans-Species Implant of a Tissue Engineered Heart Valve; First Satellite Symposium on Tissue Engineering for Heart Valve Bioprostheses; K Black; 1999 Transpecies Heart Valve Transplant: Advanced Studies of a Bioengineered Autograft; The European Association for Cardio-Thoracic Surgery; S
From page 359...
... Goldstein, D Fronk; 1995 1994 Development of a Chimeric Heart Valve: Effects of Cell Removal upon Leaflet Mechanics and Immune Responses in a Xenogeneic Model; VI International Symposium Cardiac Bioprostheses; S
From page 360...
... However, according to its founder and one of its key initial researchers, Dr. Mark Chee, SBIR did provide funding for projects that would not have been funded in the normal course of company business – and these projects turned out to be of critical importance for the development of core Illumina product lines.
From page 361...
... Illumina's technology platform has been developed into a line of products that can address the scale of experimentation and the breadth of functional analysis required. ILLUMINA TECHNOLOGY BeadArray Technology Illumina has developed a proprietary array technology that enables the large-scale analysis of genetic variation and function.
From page 362...
... SOURCE: Illumina. BeadArray technology is deployed by Illumina in two different array formats, the Array Matrix and the BeadChip.
From page 363...
... Therefore, it is important to investigate many SNPs together in order to discover medically valuable information. Current efforts to understand genetic variation and function have primarily centered around SNP genotyping and gene expression profiling.
From page 364...
... Each synthesizer can produce up to 3072 oligos in parallel, using very small amounts of material. PRODUCT ROLLOUT AND COMMERCIAL RESULTS In 2001, Illumina launched its commercial genotyping service product line, combining BeadArray technology with an automated process controlled by a laboratory information management system to provide high throughput identification of the most common form of genetic variation, known as single nucleotide polymorphisms, or SNPs.
From page 365...
... a gene expression product line on both the Sentrix Array Matrix and the Sentrix BeadChip that allows researchers to analyze a focused set of genes across eight to 96 samples on a single array; and 3) a benchtop SNP genotyping and gene expression system, the BeadStation, for performing moderate-scale genotyping and gene expression using our technology.
From page 366...
... THE ROLE OF SBIR Dr. Chee is the source for SBIR related activities at Illumina, as he was the principal investigator on most early SBIR awards, and has been a strong champion of the program within the company.
From page 367...
... The genotyping project became the technical foundations for a critical product line, which in turn became the base for Illumina's work with The International HapMap Project, a highly prestigious international genotyping project. The Illumina technology has been enormously important for cutting end-user costs, which is especially important for some of the developing nations participating in the project – for example China, which is using the technology to meet its commitments to the HATMAP project SBIR funding was used to start work on the foundation research used to determine the best way to implement design of the array-based system.
From page 368...
... Dr.Chee said that in general, he believed the SBIR program was highly successful. He had some observations about areas of possible improvement.
From page 369...
... Dr. Chee emphatically noted that the primary problem with the SBIR program was the funding cycle and the long delays between application and funding.
From page 370...
... Chee also recognized that the review process is intrinsically difficult, and that the SBIR program does this work reasonably well, in comparison with other NIH selection panels with which he has been involved. Award Size In general, Dr.
From page 371...
... Veronate has been awarded Fast Track and Orphan Drug status by the FDA. Clinical trials started in 2002.
From page 372...
... IMPACT OF SBIR ON THE FIRM The company does not see the SBIR award as playing a key role in the company's strategy and currently does not anticipate applying for further SBIR awards. "I have UNEDITED PROOFS
From page 373...
... the states related to SBIR opportunities. The company clearly sees the size and duration of the SBIR awards (at least as they existed in the late 1990s and early 2000's)
From page 374...
... "If you are successful, VC owns lots of your company." SBIRs provide peer recognition of quality science. SBIR awards are noted in BioWorld as well as trade magazines.
From page 375...
... SBIR awards from DOD and NIH supported part of the research underlying SIRAD.
From page 376...
... SOURCES: SBA, DOD, NIH, NSF. These SBIR awards have supported the R&D activities at JP Laboratories in four major research areas (SBIR funding agencies in parentheses)
From page 377...
... Six of products, indicators for monitoring sterilization of medical supplies are licensed to NAMSA, Northwood, OH. Research funded through the SBIR program also played an important role in the development of their Self-indicating Instant Radiation Alert Dosimeter (SIRAD)
From page 378...
... ISSUES WITH THE CURRENT SBIR PROGRAM Dr. Patel does not see any significant problems with the SBIR Program.
From page 382...
... through 2005. Table APP-C-2 lists the date, agency, topic, and phase for Nanoprobes' SBIR awards (Fast Track awards are identified in the topic field)
From page 383...
... Powell, the management at Nanoprobes decided to maintain a steady stream of SBIR grants. This steady stream has been valuable to the company's success in a variety of ways.
From page 384...
... For their FluoroNanogold product, Dr. Powell notes that it "owes the most to the SBIR program." In 1992, the NIH funded Phase I research into combined fluorescent and gold immunoprobes.
From page 385...
... ISSUES WITH THE CURRENT SBIR PROGRAM Dr. Powell does not see any significant problems with the SBIR Program.
From page 386...
... This research has in some cases subsequently led to internally funded research and to integration into Neurocrine's primary product pipeline. Key issue/concern: The new interpretation of SBA guidelines, which Neurocrine continues to vigorously contest (Neurocrine in fact continues to apply for SBIR awards)
From page 387...
... Indiplon has two formulations that have completed all clinical trials with apparent success.
From page 388...
... Paul Conlon, now VP research and development and Principal Investigator on the first awards, noted that they played a key role in allowing Neurocrine to test ideas and explore possible directions for the company. They also gave Neurocrine valuable credibility when exploring partnerships with other much bigger and more established companies: "Validation was important – UNEDITED PROOFS
From page 389...
... However, even if smaller companies have little alternative to accepting these new demands from reviewers, they may still be unfair, and they may still pose long-term problems for the NIH SBIR program. Other interviews may help to determine whether this is an unusual case, or UNEDITED PROOFS
From page 390...
... And further SBIR funding allowed the company to explore R1 and R2 receptors, identifying ways to separate out the different R1 and R2 receptor sites. This exploration would not have been possible without SBIR.
From page 391...
... OTHER ISSUES In discussing SBIR with Conlon and Maki, it became apparent both that the company is very experience with and sophisticated about SBIR. Maki has served on NIH study sections, but only for RO1's, not SBIR.
From page 392...
... • Study sections. If commercialization reviews are not eliminated, Neurocrine believes changes should be made in the composition of review panels, and that venture capitalists should be excluded (and possibly representatives from large drug companies)
From page 393...
... From Neurocrine's perspective, these new demands would mandate withdrawal from the SBIR program were they to be fully implemented (i.e. were detailed structures to become a necessary part of SBIR filing)
From page 394...
... To date however, no small molecule compounds have 3 1999 Phase II 351,700 NOVEL CRF RECEPTOR NS progressed into clinical trials. CRF BINDING PROTEIN AND 1 1996 Phase I 100,000 DK OBESITY Effort discontinued in preclinical CRH BINDING PROTEIN AND 2 1998 Phase II 595,586 DK studies due to lack of progress OBESITY CRH BINDING PROTEIN AND 3 1999 Phase II 570,105 DK OBESITY Research assisted in the development CRF RECEPTOR ANTAGONISTS 01A1 1997 Phase I 100,000 NS of a CRF-1 Receptor antagonist that IN NEUROPROTECTION showed efficacy in depressed patients CRF RECEPTOR ANTAGONISTS in the clinic.
From page 395...
... ANTI Effort discontinued in preclinical 01A1 1995 Phase I 100,000 INFLAMMATORY/EFFECTS OF AR studies due to lack of progress CRF BINDING PROTEIN NOVEL TYPE III INTERLEUKIN Effort discontinued in preclinical 1 1996 Phase I 99,634 AI 1 RECEPTOR studies due to lack of progress IGFBP 3 LIGAND INHIBITORS Effort discontinued in preclinical 1 1997 Phase I 100,000 FOR THE TREATMENT OF DK studies due to lack of progress DIABETES DEVELOPMENT OF A TOXIC Research assisted in the development 01A1 2000 Phase I 133,067 CA FUSION PROTEIN FOR BRAIN of a Fusion Toxin that has been TUMORS through Phase II clinical studies. DEVELOPMENT OF Effort discontinued in preclinical 01A1 2000 Phase I 99,390 EY NEUROPROTECTIVE DRUGS studies due to lack of progress FOR RETINAL DISEASE Research assisted in the development 1 2001 Phase I 207,018 Melanocortin-4 Receptor Antagonists CA of a MC-4 Receptor antagonist that is still being evaluated preclinically.
From page 396...
... Research assisted in the basic Selective CRF Antagonists for Bowel 1 2002 Phase I 139,497 DK understanding of CRF-1 Receptor Disorders antagonist. Research assisted in the basic Corticotropin Releasing Factor 1 2002 Phase I 170,479 MH understanding of CRF-1 Receptor Receptor Function in CNS antagonist.
From page 397...
... After considerable experimentation, the team determined that when tuned to 520 vibrations per second, the vibrating brush head generated fluid dynamics that would erode plaque beyond the reach of the brush itself. To commercialize the product, Giuliani raised $500,000 from 25 private investors, and also benefited from an NIH SBIR award which effectively doubled the size of the investment.
From page 398...
... The company's sales strategy focused on dentists, partly mandated by its situation as small under-capitalized company without distribution agreements. For Giuliani, leverage was key: he developed the company's core strategic thrust of "borrowing other assets and using them UNEDITED PROOFS
From page 400...
... Philips has strongly backed the product line, continuing to introduce new products, and has retained the Snoqualmie operation as world headquarters for the division. Philips has also leveraged its international capabilities – noting for example that after successful launches, more than 65% of UK dentists recommend Sonicare®, and that the product had captured 21% of the Dutch market four months after launch in the Netherlands.20 The product has also clearly had a significant impact on public health.
From page 401...
... . THE IMPACT OF SBIR FUNDING Even though Optiva received only one SBIR award (for both Phase I and Phase II)
From page 402...
... In addition, the SBIR application process generated very important advice and contacts. Most unusually, the study section visited both the company and the University of Washington.
From page 403...
... He believed that two improvements might be especially useful: • Rebuttal, whereby applicants would be provided with an electronic copy of the lead reviewer's written summary some period before the meeting of the study section, and would be able to submit a short rebuttal. Giuliani suggested that this approach might help to clarify issues concerning technical aspects of the application, as well as UNEDITED PROOFS
From page 405...
... OSI has been successful at discovering and developing novel pharmaceutical agents through its research activities supported by large pharmaceutical partners, the SBIR program, and other sources of private investment. They now have three FDA-approved drugs on the market.
From page 406...
... However, he stressed the difficulty of assessing the SBIR program using commercialization outcomes and readily-quantifiable measures. Pharmaceutical innovation takes an average of 12-15 years from concept to market and most SBIR awards are facilitating concept and pre-clinical research.
From page 407...
... Helpful for obtaining follow-on funding and business deals Specific technological and scientific knowledge generated with SBIR funding laid the foundation for new contract research projects for big pharmaceutical firms that provided an important source of additional funds for OSI. The SBIR knowledge base helped to create opportunities for additional projects with companies like Pfizer, Aventis, Novartis and others.
From page 408...
... SBIR funding is not nimble enough to change as research opportunities evolve within a project. SBIR funds are tied immutably to the specific aims laid out in the initial proposal.
From page 409...
... Private investors may not see these as attractive opportunities and the SBIR Program, in principal, can fund these higher risk projects. This problem is intertwined with the SBIR Program's focus on commercialization.
From page 411...
... It is also clear that SBIR had a significant role to play in the evolution of RTI; while the company was not founded specifically on the basis of the SBIR funding, its primary product (sole product for some years) was derived directly from the SBIR-funded project.
From page 414...
... In August 2005, RTI signed a licensing agreement with BTMD, a Chinese government-designated medical device manufacturer, for distribution of RTI's safety needle devices in China. Despite these limited successes (RTI is still not making an operating profit as of 2006, although sales reached a record $25M for the year)
From page 417...
... Gevins systematically divided it into essential individual subprojects, and sought funding for them through unsolicited Federal basic research and SBIR awards. This minimized overall risk, and SAM's work has been supported by many SBIR awards from many agencies, as the project covers many possible applications of the technology.
From page 418...
... SAM is currently working with consultants under the LARTA commercialization support program to develop a strategic alliance with a large corporation in order to make the SAM Test commercially available as a fee-for-service medical test. The partner will need to undertake independent clinical trials, FDA registration, approval for third party reimbursement and a major marketing and sales campaign, activities that could take at least 3 years and cost in excess of $15M.
From page 419...
... Image VueTM Image VueTM is a software package for visualizing brain function and structure by fusing EEG data with MRI (Magnetic Resonance Images) , using patented algorithms to integrate functional and structural information about the brain, in order to localize epileptic seizures in a patient's brain.
From page 420...
... A number of competing products worldwide have been modeled on Image VueTM MANSCAN® MANSCAN® evolved from basic research completed under prior NIH R01s, which with the aid of SBIR awards has been turned into robust algorithms embodied in a convenient, integrated system to enable research on human brain function that would not otherwise be commercially available. MANSCAN® is an integrated software and hardware system for performing brain function research via high-resolution EEG and event-related potential (ERP)
From page 421...
... Conflict of interest Dr. Gevins is very concerned about potentially major conflicts of interest stemming from the use of industry participants on study sections.
From page 422...
... Scores should be normalized across study sections, just as they are for RO1's. Otherwise it is perfectly possible - indeed likely - that one study section will tend to systematically provide higher scores than another.
From page 423...
... Dr. Gevins also noted that being a program manager with responsibilities for many SBIR awards was not a plum job at NIH; as a result, it was often handed off to the least senior staff member.
From page 424...
... • Supports the view that drug development funding could be distorting the overall shape of the SBIR program. • Supports competing continuation awards.


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