Intellepharm, Inc. Licensing, Intellectual Property, Legal Expert    LICENSING DRUG DISCOVERY TECHNOLOGIES The research and development activities required to put new medicines into the marketplace require an enormous commitment of funds. The failure rate in drug discovery is high, and the cost of discovering a new drug and bringing it to market is currently estimated at $802 million, considering the failure rate and costs of capital. It has been estimated that a shortfall of 30 NCE's per year (i.e. 0.6 NCE’s per company per year) exists if the top 50 pharmaceutical companies are to maintain a 10% growth rate. Peter Drucker has said, “The greatest change in the way business is being conducted is in the accelerating growth of relationships based not on ownership but on partnership.” Pharma has increasingly adopted virtualization (outsourcing of numerous R&D elements) as a cost cutting strategy. Whereas previously outsourcing involved development technologies such as toxicology, large-scale chemistry and clinical development, virtualization is now outsourcing discovery technologies that include target identification through genomics, combinatorial chemistry, and high throughput screening. The ultimate expression of this trend is the in-licensing of clinical candidate compounds, rather than internal discovery. A predictable downside of in-licensing clinical stage candidates is the huge costs of these contracts. Large up-front payments as well as substantial milestone and royalty payments are normally required. Thus, there remains a strong interest in in-licensing promising new target opportunities that are still at the level of a well developed assay system capable of high throughput screening applications. By contrast to most technologies available from small biotechnology companies, university licensing opportunities are usually at a relatively early stage in the product cycle. Indeed, most university opportunities comprise enabling technologies, rather than product opportunities. Maximum success in benefiting from productive university technologies demands a sophisticated technology access program that includes not only a comprehensive opportunity identification process, but also a correspondingly comprehensive evaluation process. Moreover, sophisticated personnel, familiar with both the industrial and academic environment, are required. At Intellepharm, Manfred E. Wolff PhD has developed and utilized the personnel, identification procedures, and evaluation processes required to successfully access university pharmaceutical discovery technologies for Intellepharm clients. SBIR GRANT PREPARATION Small biotechnology firms represent a unique national resource for economic growth that may be the fastest and most efficient mechanism to create technological innovation to convert cutting edge biomedical research into new technology breakthroughs and competitive new products.The NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grant programs provide an opportunity for ALL key players in biomedical research to benefit. SBIR grants provide $850,000 (Phase I and II) or more and STTR grants provide $600,000 (Phase I and II) or more in research dollars to catalyze the commercialization of innovative projects that will benefit public health.. With rapidly expanding biological knowledge, even large corporations can develop only a limited number of promising lead ideas. Large pharmaceutical corporations often look to small biotechnology companies for the initial development of embryonic technology. Thus, the end of a successful project for a small biotechnology company is often the beginning of R&D for a large pharmaceutical corporation. NIH small business grants can help bridge the needs of both by providing early-stage funding for research that adds value to an idea, promoting partnerships that lead to a marketable product. Manfred E. Wolff PhD has a record of 25 years of RO-1 and SBIR grant support and is skilled in successfully applying for such funds. Through the grant preparation services of Intellepharm, Dr. Wolff's expertise is available to obtain support for suitable drug discovery and biomedical technologies.