Commercialization and transfer assistance program
COMMERCIALIZATION STRATEGY
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- Bu səhifədəki naviqasiya:
- Commercialization of the assay in Canada – Warnex partnership
- Commercialization of the assay in Africa – Continental Diagnostic partnership
- Other partnership and future development
COMMERCIALIZATION STRATEGYOur short-term goal is to grant licenses of the HPV test to companies or clinical laboratories. We are in a position to conclude many license agreements within specific fields of use and/or specific territories, since the inventors have developed both, a method for generating specific probes for multiplex diagnostic assay and a specific application of this method which is the HPV assay (both protected by the current patent application). So far we have got serious interest from Warnex, a company based in Québec and Continental Diagnostic, a company based in South Africa. They both would like to get exclusive rights for the HPV assay, in their respective territories. We have also got interest from Dr Gorska at CHUM to implement the HPV assay in their clinical laboratory. It is clear that the clinical validation of the commercial assay will be decisive to consolidate the interest of these groups and to conclude licensing agreement.
Warnex is a life sciences company devoted to protecting public health by providing laboratory services to the pharmaceutical and healthcare sectors. With its three divisions (analytical, bioanalytical and medical laboratory), Warnex provides, to clients in the pharmaceutical and biotechnology industries, a variety of quality control services as well as method development and validation. They also conduct bioavailability and bioequivalence studies for clinical trials, and perform contract R&D. Finally, Warnex provides specialized genetic and biochemical testing for the healthcare industry. This division also has extensive expertise in genetic testing for human identification, molecular diagnostics, and pharmacogenetics. They focus on the development of innovative assays as well as the refinement of existing diagnostic tests to produce assays with greater clinical value and relevance for reliable and cost-effective patient assessment and management. Warnex Medical Laboratories is an important source of specialized testing for hospitals, private laboratories, and medical specialists. As a development-driven medical laboratory, they work extensively in collaboration with medical discovery companies to adapt their research into viable clinical tools for improved diagnosis and monitoring of disease states. Warnex is clearly a relevant partner to bring the HPV assay on the Canadian market. Also, as mentioned in their letter of support, Warnex has accepted to provide in kind contribution for the design of the final format of the assay. Their expertise will also be highly valuable for the regulatory aspect of assay development.
Continental Diagnostics is a Sales and Marketing outfit that would be taking the HPV to the market once the clinical validity of the HPV assay will be established. Their business plan is to boost their current income with the HPV test, which represents a large market in South Africa: cervical cancer accounts for about 25 percent of cancer deaths among black women, there is no formal PAP smear program and women seeking PAP smears in the public health sector are only eligible for one every 10 years after the age of 30. Also the new vaccines are out of reach for most of these women and 15 out of every 100 000 die of Cervical Cancer every year. There are four partners in Continental Diagnostics as presented in Table 8. The company outsources research (validation studies and experience programs) to scientists at the University of Natal who work under Professor Indres Moodley. Prof. Moodley has satellite sites in most African countries through his work with the SA government Department of Science and Technology, where he can conduct validity assays for the HPV test. The company’s customers include pharmacies, private doctors (including specialists and physicians), government and private hospitals, private and government laboratories. Also, the company has a distinct advantage over their competitors in this area as they are a 100% black-owned company and therefore qualify for 60% in the Black Economic Empowerment (BEE) point system that the government uses to award tenders to those who are wholly or partly black-owned. They can also infer points to groups who source their products from us and therefore have a good standing with private companies (laboratories and hospitals) that source from us. Co-funding for the MDEIE project will come from the Industrial Development Corporation in SA, whose brief from the government is to partner African entrepreneurs who create sustainable businesses and jobs in South Africa.
Table 8. Continental Diagnostics
Business development activities carried by Anne-Marie Larose at Univalor already bring business relations with two relevant potential industrial partners, as described in the previous section. Ms Larose will continue seeking for companies that would be interested to commercialize the HPV kit in their own territory and/or to develop a new diagnostic kit using this innovative method of generating highly specific probes for multiplex assay. Worthwhile to mention, the proposed project focuses on the clinical validation of an HPV assay for the most frequent HPV types. This will be the first generation of our HPV assay. If we get success in developing a specific and sensitive assay and conclude agreement with at least one company for the commercialization of the assay, we will certainly pursue the development of a second generation of the HPV assay, to diagnose all types of HPV, since we already have probes for 39 types.
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