SBIR/STTR at the National Institutes of Health (2015) / Chapter Skim
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Appendix E: Case Studies
Appendix E: Case Studies
Pages 323-429
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Appendix E Case Studies1 To complement our review of program data, we commissioned case studies of 15 companies that received Phase II awards from the National Institutes of Health (NIH)
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GMS Biotech Lpath Therapeutics, Inc. NOVA Research Company Sanaria, Inc.
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2 Primary sources for this case study are the meeting with 23andMe executives and a review of the 23andMe website (http://www.23andme.com) and related company documents.
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In February 2015, 23andMe's Bloom Syndrome Carrier Status Test report was given marketing authorization by the FDA through the de novo pathway -- making the test the first direct-to-consumer genetic test granted marketing authorization by the agency. In addition to the authorization to market the Bloom Syndrome Carrier Status test report, the U.S.
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Richard Scheller, former head of R&D and early stage therapeutics development at G enentech. Industry observers widely believe the consumer business is not yet profitable and is being sustained by the approximately $126 million in Series A-D venture funding rounds that 23andMe has received.4 23andMe has not disclosed revenue generated by its collaborations with industry researchers.
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23andMe has complied and now provides only raw, un-interpreted genetic data and ancestry analysis in its service for U.S. customers.8 In February of 2015 the FDA authorized for marketing the 23andMe Bloom Syndrome Carrier Status Test report -- the first direct-to-consumer genetic test to be authorized for marketing by the FDA.
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It is not yet clear how this will mesh with the much slower and more careful cultures that dominate both FDA and the medical community more generally. FUNDING 23andMe has relied mostly on venture capital to fund its development.
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. The total commitment from the NIH SBIR program has been $2.1 million through 2014, according to the company.
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RECOMMENDATIONS 23andMe has relatively limited experience with the NIH SBIR program and had few comments about program operations. However, 23andMe executives said that the current process took so long that in the very fast-paced innovation environment in which they operated, SBIR was not a primary option.
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Advantagene has applied GMCI™ to develop clinical trials in various solid tumors, including currently active programs in prostate cancer, adult and pediatric brain cancer, pancreatic cancer, pleural effusion, and mesothelioma. It has also done studies in other indications, including ovarian cancer and esophageal cancer.
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With over 650 courses of treatment already administered through multiple clinical trials, GMCI™-based vaccines are demonstrably safe and lack the grueling side effects associated with many current cancer therapies. GMCI™ therapies are adjuvant, combining with current surgical, radiation, and chemotherapeutic treatments to improve patient outcomes.
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after Diagnosis Clinical Trial Pancreatic Cancer 43,000 6 months Phase 2 Pleural Effusion / Mesothelioma 150,000 4 months Phase 1 Pediatric Glioma 4,000 - Phase 1
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The new protocol allows for evaluation of study results within 2 years for newly diagnosed prostate cancer cases -- something never previously approved despite the effort of large pharmaceutical companies such as Eli Lilly and Abbott Laboratories. Advantagene is now focused on raising money for the Phase 3 clinical trial for ProstAtak™.
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Advantagene received 15 SBIR awards amounting to $11.41 million from the Department of Health and Human Services (HHS)
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SBIR permits companies to take more risks, for example in developing an approach to prostate cancer, which is both high risk and long cycle. SBIR supports high-risk and longer-term projects and also in particular supports problems that may not be interesting to venture firms, such as newly diagnosed prostate cancer, which is not attractive for several reasons from a venture perspective.
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Dr. Aguilar- Cordova believed that the $5 million in funding provided by NIH al lowed dvantagene to complete work that would have cost more than A $100 million in a large pharmaceutical company, but he also noted that large funding decisions should be based in part on a better understand ing of the project's likely economic and social impact if it were to be successful.
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15 Primary sources for this case study are the meeting with Dr. William Pardridge and a review of the ArmaGen Technologies website and related company documents.
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Although treatment sometimes works in mouse or rat models, Dr. Pardridge explained that the failure of expensive Phase 3 clinical trials was to be expected, because diffusion in a mouse brain is much easier than in the massively larger human brain.
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Under an orphan drug designation -- which allows both accelerated approval and various R&D tax credits -- ArmaGen is moving toward clinical trials for enzyme replacement therapies targeting Hunter and Hurler syndromes. Although these conditions represent very small markets, FDA approval would demonstrate the value of the core technology, supporting either an exit or follow-on funding for other indications with much larger market value (such as Alzheimer's disease, Parkinson's disease, neuroinflammation, stroke, or brain cancer)
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Dr. Pardridge said that two clinical trials were now, or would soon be, under way for Hurler Syndrome and Hunter Syndrome, with the first Phase 1 trial to be completed in 2014 and the second in early 2015.
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Despite its recent round of venture funding, ArmaGen still lacks resources to pursue all development opportunities and is looking for collaborations with pharmaceutical companies either to accelerate development and commercialization of the products in their pipeline or co-develop additional products by using ArmaGen's technology to enable delivery of its partner's drugs across the BBB. Since 2003 ArmaGen has received $10.21 million to fund research examining applications of its technology for indications other than lysosomal storage diseases.
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1. Support for clinical trials.
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Dr. Pardridge noted that almost uniformly and across several institutes the program officers with whom he had worked were highly engaged and committed to successful translational research.
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and related company documents.
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. Over the past couple of years, it has received multiple SBIR grants to support research and clinical trials for FDA approval of its Versaring™ products: implant-based product intravaginal rings designed to provide women protection from infection with HIV and genital herpes.
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Since 2009 NIH has invested $4.03 million through SBIR in Versaring™. These grants have supported basic research, development of manufacturing c apability, and the performance of preclinical trials.
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Auritec retains an equity interest in O-Ray, which has received three SBIR grants and is investigating the use of four different drugs in extended-release formulations for inner ear disease.22 RESEARCH PARTNERSHIPS Auritec partners with numerous research organizations. These partners have included the University of Southern California; Albert Einstein College of Medicine; Oak Crest Institute of Science; International Partnership for Microbicides; CONRAD; Centers for Disease Control and Prevention; The University of North Carolina; University of California, Irvine; Emory University; North Carolina State University; and The University of Massachusetts.
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Aside from the awards he has received from NIH over the past 25 years, he has been a study section reviewer and a chairman. SBIR funding provides the critical bridge funding that allows small companies to reach the end of Phase 2 clinical trials, which Dr.
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Further, he observed that Scientific Research Officers (SROs) who manage study sections in general subscribe to and support the focus on novelty.
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Dr. Smith strongly supported the development of mechanisms that helped to provide funding for clinical trials.
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. Avanti can produce small-scale batches for research, preclinical, and clinical trials; at the same time, it can scale up production to support commercial launch of FDA-approved drugs.
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Developing a Manufacturing Capability In 1985 Avanti developed important new capabilities when it became a ajor m partner in developing and manufacturing Exosurf, a lung surfactant product developed by Burroughs, a major pharmaceutical company. This product changed health care and outcomes for neonates almost overnight.
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Custom Lipids: As a contract manufacturer, Avanti also develops new production and assurance processes to support its clients' development and commercialization of the new lipid-based molecules. In developing a custom product, Avanti assigns a development team of organic chemists and analysts to oversee process development and scale up as product volume increases from supporting FDA preclinical trials to enabling commercial launch.
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Non-Dilutive Grants Between 1997 and 2009, SBIR funded six projects with Avanti. Avanti received eight SBIR awards amounting to more than $6.89 million from HHS.
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The Phase I results were encouraging but Phase II would need to cover the clinical trials. The original budget submitted was for $2 million, which included a before and after study of patients.
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to address its research goals. The overall strategy is to commercialize by developing its products through early clinical trials (up to Phase 2)
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Avaxia has to date focused much of its research on inflammatory disease processes. Three of its projects use oral anti-tumor necrosis factor (TNF)
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Avaxia is pursuing related products in five areas: inflammatory bowel disease, celiac disease, gastrointestinal acute radiation syndrome (GI-ARS) , diabetes, and oral mucositis.
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A 28-day GLP toxicology study showed no drug-related adverse effects up to the highest levels tested." 32 Avaxia initiated a Phase 1B clinical trial of AVX-470 in ulcerative colitis p atients in February 2013 after FDA cleared an IND for this trial in late November 2012. The results of this trial should be available by December 2013.
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. In 2011, Avaxia received a Phase I SBIR grant from HHS to further develop its 2006 patent for an oral antibody-based therapeutic for celiac disease.
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There was accordingly neither time nor resources available to pursue further SBIR awards outside the scope of the BARDA-funded project. Equity Investment In February 2012, Avaxia successfully closed on $4.1 million in Series A investment.
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Dr. Fox observed, "We're pleased to have AbbVie join our board and engage their expertise in gastroenterology as we advance the development of innovative, gut-targeted therapeutics like AVX-470."34 Following the Series B, senior management is looking for a partner to license or co-develop the drug and to, in particular, help design a strong Phase 2 clinical trial and stabilize production of AVX-470.
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Dr. Fox had applied for a number of NIH SBIR awards before receiving her first Phase I in 2009.
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There are approximately 50 million surgeries annually in the United States, each requiring some form of wound closure.36 Conversion Energy has developed 35 Primary sources for this case study are the meeting with Barbara Soltz and a review of the C onversion Energy website and related company documents. http://www.conversionenergy.com.
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Current research is intended to optimize CEE's technology to encourage wound closure and further reduce infection rates as a precursor to clinical trials and FDA approval. The antimicrobial product has some significant differences to the original issue adhesive system: it uses visible wavelength lasers that, according to t Dr.
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The company anticipates that preliminary testing by a commercial partner will be completed by the end of March 2016 and that subsequent further partnerships will provide funding for the necessary clinical trials. PATENTS AND OTHER INTELLECTUAL PROPERTY At present, Conversion Energy is the assignee for the more recent patented technologies.
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Soltz said that there was one significant and growing problem with the program: the increasing tendency to make awards to university researchers rather than small operating companies. She participated in some NIH review panels, and was very concerned about this tendency.
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On the basis of participation in several review panels, she has concluded that most reviewers glanced at commercialization plans to primarily consider the potential of the project, but did not analyze commercial plans in depth. Reviewers have not been educated on this topic.
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Dr. Hoffman said that SBIR was key to funding the company, because Danya won four SBIR awards during its first year, which provided immediate revenue.
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is another major Federal source of free-to-the-user materials.40 Thus while many SBIR projects are successful in terms of delivering as promised, they face an insurmountable barrier to commercial success. In some cases, these materials can be sold if they meet detailed and specific federal requirements, but Dr.
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Danya's methodology is an end-to-end marketing-based solution involving developing a segmentation, identifying messaging to target key segments, identifying multiple channels to deliver the message, and finally developing metrics that allow ongoing improvement of the overall communication strategy. Monitoring and Evaluation Designing data collection and monitoring into program implementation, Danya facilitates both ongoing and overall evaluation of program impact.
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Overall, SBIR provided critical funding to grow the company to acquire the skills needed to expand the company as a government contractor. Danya also leveraged its SBIR awards effectively in some cases.
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• Investment in sales and marketing. SBIR awards need to include more commercial activities.
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, and related company documents. 43 July 2010, Genomics USA rebranded itself as GMS Biotech.
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Unfortunately, current techniques are complicated -- most require DNA purification of samples as an intermediate step -- and consequently do not scale well at a reasonable cost. GMS Biotech has developed a microarray technology for detecting variations in the HLA genetic sequence.
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PATENTS AND OTHER INTELLECTUAL PROPERTY GMS Biotech owns five patents on the core microarray sensing technology and its scaled application to HLA typing. (See Table E-8.)
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GMS Biotech received 14 awards amounting to $9.20 million from HHS to develop scalable microarray technology for performing HLA typing. Equity Investments GMS Biotech has sporadically received equity funding from both corporate and individual investors.
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SBIR Dr. Hogan said that SBIR was critical for the progress made at GMS Biotech: "We would never have made it otherwise." All of the company's initial R&D was based on SBIR, funding that continued through Phase IIB.
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He noted that the valley of death is a large and growing problem, and that such a program is critical given the absence of other NIH funding and declining interest in earlystage investments from venture capitalists and large pharmaceutical companies. In the current environment, he believes it is extremely difficult to attract outside funding if the company did not have a product ready to sell: it was not necessary to have substantial sales, but some sales did have to be at least imminent.
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Lpath did not accept venture capital, as many biotech companies do, to fund its clinical trials. Instead, it has paid for the Phase 1b/2a trials of its lead product candidates by selling exclusive rights to pharmaceutical companies such as Pfizer and Merck-Serono and by raising additional capital through the sale of stock on the public markets.
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designation for clinical trials. Two other products have already completed Phase 2 clinical trials.
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Large pharmaceutical companies were apparently impressed. "In December 2010, Lpath entered into an agreement with Pfizer" to provide an "exclusive option for a worldwide license to develop and commercialize iSONEP."51 Under the agreement, Pfizer provided Lpath with an upfront payment of $14.0 million and agreed to fund the costs of the planned Phase 2a clinical trials, bringing additional Pfizer's payments to Lpath of $23.0 million for the co-development of iSONEP.
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Problems arose before Phase 2 clinical trials focused on cancer. Senior management at Merck-Serono was faced with budgetary difficulties as more internal projects than expected had come successfully through initial clinical trials and hence required more funding than anticipated.
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Lpath's preclinical studies showed strong in vivo results with Lpathomab in several different pain models, which suggest that LPA may be an attractive target across a variety of chronic pain conditions, including diabetic peripheral neuropathy, post-herpetic neuralgia, chemotherapy-induced neuropathic pain and pain associated with lumbosacral radiculopathy. Other preclinical studies have also demonstrated the potential for Lpathomab as a treatment for traumatic brain injury.
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SBIR has provided $10.2 million, the public markets an additional $26.0 million, licensing agreements $37.0 million, and royalties $0.4 million. Non-Dilutive Grants Between 2004 and 2014, NIH funded 11 SBIR projects with Lpath, providing 16 awards amounting to $10.2 million to develop monoclonal antibodies for neutralizing bioactive lipids.
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Sabbadini was a strong supporter for the NIH SBIR program: "I love the SBIR program -- would still review and support it even if I never got another SBIR. It is critical to innovation in this country; without SBIR lots of innovation would die on the vine." He also offered two recommendations for improving the program: More flexibility in the application process.
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Young and a review of the NOVA Research website and related company documents.
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. NOVA provides services in five broad but related categories: • Research and Research Support Services • Program Planning and Evaluation • Health Information Technology • Health and Scientific Communications • Meetings, Conferences, and Exhibits Research and Research Support Services NOVA Research Company provides a complete range of support services to help researchers undertake research studies.
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Some of the technology within NOVA's Health Information Technology offering -- for example, survey instrument development and administration using its QDS -- has been funded and developed through SBIR grants. QDS is NOVA's primary product generated via the SBIR program.
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Young, QDS is used today by about 3,000 researchers worldwide with about 13,000 QDS modules having been sold. Many medical research institutions maintain multiple users -- University of California, San Francisco, for example, currently has about 60 registered users.
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SBIR FUNDING Between 1994 and 2007, NOVA Research Company received 13 Phase I and Phase II SBIR grants from HHS for various technology-related projects. In total, SBIR funding has amounted to $5.78 million, $1.51 million in Phase I and $4.27 million in Phase II.
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With the exception of a book on methodologies for research on drug abuse in Hispanic communities, QDS is the only product offering in the NOVA business model. However, NOVA currently is developing an educational game under SBIR contract to inform children about clinical trials, which eventually will be provided free on an NIH-maintained website and sold as an educational game foundation for other health topics.
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More broadly, the SBIR program at NIH has, in Mr. Young's view, changed substantially over the years.
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Kim Lee Sim, who had successfully utilized NIH SBIR awards at EntreMed, Inc., to fund antiangiogenesis (Endostatin and Angiostatin) and malaria vaccine (PfEBA-175)
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R ecently, in 2013 it received the Montgomery County Emerging Business of the Year award. In 2014, the Sanaria® PfSPZ Malaria Vaccine won the 2014 V accine Industry Excellence Award for "Best Prophylactic Vaccine." Other competitors for this award included major biopharmaceutical companies such as Sanofi asteur, GSK, and Novartis.59 P Sanaria maintains research relationships with a broad range of government, corporate, and nonprofit organizations including, but not limited to, multiple branches of NIH/NIAID, the Naval Medical Research Center, the Walter Reed Army Institute of Research, the Military Infectious Disease Research Program (MIDRP)
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Recently a path-breaking agreement was signed by Marathon Oil, Noble nergy, E and AMPCO and the government of Equatorial Guinea to completely fund clinical trials of Sanaria's PfSPZ vaccines through Phase 3 clinical trials through $48.5 million in support. In each case, the sponsor is responsible for funding the actual trial.
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Tanzanian Commission on Science and Technology (COSTECH) Equatorial Guinea Ministry of Health and Social Government of Equatoria Guinea, Welfare EG LNG Kenya Kenya Medical Research Institute; Wellcome Trust Laboratories; Centre for Research in Therapeutic Sciences (CREATES)
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of poor countries significantly every year. As a result, Sanaria has developed a new model for funding clinical trials.
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Although originally intended for dermal or subcutaneous injection, clinical trials showed that the vaccine did not generate sufficiently strong immunological responses when administered this way. This is primarily because the vaccine parasites must reach the liver to initiate the next stage of development, and this is best achieved by DVI injection, not injection in the skin.62 In 2011, Sanaria initiated a clinical trial of multiple doses (two to five over the course of the trial)
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Dr. Hoffman said that each technician can remove about 200 pairs of salivary glands per hour, and that on this basis the current manual approach has adequate capacity for all clinical trials and for initial sales.
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This will cost tens of millions of dollars, but Dr. Hoffman is confident that once a finalized immunization regimen has been established in the upcoming clinical trials, much more funding will become available.
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Sanaria also publishes it work in leading peer-reviewed journals. The results of the first two clinical trials of PfSPZ Vaccine were published as research articles in the prestigious journal Science.
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Following its recent successful clinical trials, senior management has indicated that it may partially fund upcoming trials through investments. It is focusing on socially conscious investors and possibly an initial public offering.67 Operations Sanaria generates significant income from the sale of aseptic mosquitoes, reagents, including sporozoites, and various services to the malaria research 64 "Addressing a Global Imperative: Malaria Eradication through Vaccination," https://sbir.nih.gov/ statistics/success-stories/sanaria.
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SBIR funding had both supported the initial founding of Sanaria, paying the salaries of the founding staff, and had consistently paid for much of the technology development, manufacturing capacity, and preparation for clinical trials. Sanaria has had a range of SBIR awards.
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Hoffman is concerned that the quality of staff working for companies on SBIR awards will suffer because the maximum permitted salaries have declined recently and are now well below market levels. Although there are good reasons to prevent excessive payments, it does seem that allowing the market to work will in almost all cases be more efficient, and there is now a real danger that senior researchers will simply be priced out of working on SBIR grants.
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Both the core technology, Stratagraft ®, and the world's first genetically enhanced human skin, Expressgraft™, are being evaluated in late-stage and early-stage clinical trials, respectively. The late-stage clinical development supporting the StrataGraft® product is in part funded by a 68 Primary sources for this case study are the meeting with Barbara-Allen Hoffman April 9 2015 and a review of the Avanti website (http://www.acousticmed.com)
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Army Institute of Surgical Research, Harvard Medical School, and an unnamed Fortune 200 consumer products company.69 However, even with a large support contract in hand from HHS/BARDA and continuing support from NIH, funding for later stage clinical trials and manufacturing infrastructure remains an ongoing challenge.
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In October 2014, StrataGraft® completed a Phase Ib clinical trial in p atients with deep partial-thickness burns. By 90 days after treatment, 27 of 28 patients achieved complete wound closure after a single application of StrataGraft® issue.
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Based on the NIKS® cell line, StrataTest® is a human skin model for in vitro consumer product testing, drug discovery and toxicity screening. Like StrataGraft®, StrataTest® tissue is composed of both epidermal and dermal ayers, l and displays the same physical, chemical and histological characteristics of h uman skin, enabling better prediction of in vivo biological responses than mono layer skin culture technologies.
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8,790,636 Human skin equivalents expressing exogenous polypeptides 2014 8,685,463 Dried and irradiated skin equivalents for ready use 2014 8,580,314 Dried and irradiated skin equivalents for ready use 2013 8,092,531 Human skin equivalents expressing exogenous polypeptides 2012 7,988,959 Method of treatment using organotypically cultured skin tissue 2011 comprising NIKS® cells that express exogenous HIF-1a 7,955,790 Skin substitutes with improved barrier function 2011 7,915,042 Keratinocytes expressing exogenous angiogenic growth factors 2011 7,888,496 Kit for species specific DNA detection 2011 7,807,148 Organotypically cultured skin tissue comprising NIKS® cells that 2010 express exogenous HIF-1a 7,674,291 Human skin equivalents expressing exogenous polypeptides 2010 7,541,188 Skin substitutes and uses thereof 2009 7,501,238 Skin Substitutes for irritancy testing 2009 7,498,167 Keratinocytes expressing exogenous angiogenic growth factors 2009 7,462,448 Species specific DNA detection 2008 7,407,805 Skin substitutes with improved barrier function 2008 6,974,697 Skin substitutes with improved barrier function 2005 6,846,675 Skin substitutes and uses thereof 2005 SOURCE: U.S. Patent and Trademark Office.
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One Fast Track provided by NIDDK is supporting Phase I clinical trials for an anti-nfective uman skin i h t issue that can be used to treat ulcerated skins from diabetic skin ulcers. Stratatech has received grants from other sources to support commercialization of its StrataGraft® product.
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The announced goal was to use extracts from the NIKS cell line to prevent wounds or ulceration by enhancing the resiliency of compromised or susceptible skin.
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Although program officers in general have a strong commitment to the SBIR/STTR program, the SBIR program coordinators possess specific knowledge and can be extremely helpful in guiding investigators. She recommended that small companies make sure that they established contact with the program coordinators.
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Because angiogenic tissue is produced by cancer, researchers evaluating cancer 73 Primary sources for this case study are the interview with Jack DeFranco and a review of the Targeson website http://www.targeson.com, and related company documents.
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The acoustic waves cause the microspheres to disintegrate and deliver their genetic payload on target to the targeted tissue. This phenomenon, known as onoporation, has been s shown for the transfer of DNA and other macromolecules.75 PRODUCTS Using SBIR funding, Targeson has improved both its imaging and transfection technologies.
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According to Mr. DeFranco, Targeson currently has a database of more than 5,000 potential customers, including all the major pharmaceutical companies, all the larger contract research organizations, and many academics and academic laboratories.
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He had comments about the NCI Bridge program, which offered $3 million over 3 years in support of clinical trials. He believed this was an important program given the difficulties in funding clinical trials, but also that it could be improved.
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P-selectin is a biomarker of myocardial ischemia in the context of Acute Coronary Syndrome. This progress was funded by Phase I and Phase II SBIR programs.
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Tseng, a key change 77 Primary sources for this case study are the meeting with Dr. Scheffer Tseng, and a review of the Bio-Tech and Amniox Medical websites (http://www.bio-tissue.com and http://www.amnioxmedical.com)
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g Both PROKERA® and AmnioGuard® are in clinical trials to measure efficacy.
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Amniox Medical has two products: CLARIX®, a general surgical wound covering or barrier, and NEOX®, a wound covering for dermal ulcers and other defects. Both CLARIX® and NEOX® are in clinical trials to measure efficacy.
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81 Samantha Rogers, "Sutureless Cryopreserved Amniotic Membrane Graft (ProKera) and Wound Healing After Photorefractive Keratectomy," https://clinicaltrials.gov/ct2/show/NCT00915759?
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The company has received an NIH SBIR grant to conduct Phase I FDA safety study using Cliradex® for treating demodex mite infestation in patients with blepharoconjunctivitis. PRODUCTS -- AMNIOX MEDICAL Amniox Medical is using cryogenically preserved amniotic tissues to improve healing of wounds created by surgery or disease.
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T issueTech received 17 SBIR awards amounting to nearly $5.50 million from the Department of Health and Human Services (HHS)
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SBIR funding has since been used to develop two additional products. The second additional product, PROKERA®, was approved as a Type II medical device, which had the effect of providing additional barriers to entry for potential customers.
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Operations Although TissueTech does not generate income from operations, TissueTech's subsidiary, Bio-Tissue, has shipped more than 200,000 units of amniotic membrane–based products and enabled over 150,000 transplants. Since 2007, its compound annual ground rate is 35 percent.
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This was of declining importance for his own company, which now had other resources available for this purpose, but he believed it would be a critical problem for other companies. Currently, SBIR funding was available for Phase I clinical trials, and it was just possible -- if resources were used very carefully -- to use SBIR Phase II awards to complete Phase 2 clinical trials.
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