Project Financing provides credit-qualified clients with an integrated financing solution that matches the scope of business transactions duration the implementation and ongoing maintenance and management of system applications and services. A customized application includes an extensive assessment of a client’s infrastructure and is tailored to meet short and long-term requirements. Project Financing structures the simplicity of the overall implementation of integrated healthcare information management systems, infrastructure investments, hardware/equipment purchasing and consulting services.

The cost of financing a pharmaceutical and drugs development projects has been estimated to be more than $1 billion. Development of this scale involves multiple financing mechanisms, as well as the involvement of numerous partners throughout the process.

As background for the workshop discussions, Dr. Caskey provided an overview of the current financial landscape at various stages of drug development, including the investors at each stage and the current state of investments, and put forth several suggestions for ways to facilitate drug development.

Investors in Financing a Pharmaceutical and Drug Development

The principal investors in financing a pharmaceutical and drug development differ at each stage. While basic discovery research is funded primarily by government and by philanthropic organizations, late-stage development is funded mainly by pharmaceutical companies or venture capitalists. The period between discovery and proof of concept, however, is considered extremely risky and therefore has been difficult to fund. Several initiatives discussed below have been undertaken to overcome this funding gap.

Early-and Late-Stage of Drug Development

The largest government investments in basic drug discovery research have been made by the National Institutes of Health (NIH). The Defense Advanced Research Projects Agency (DARPA) has also contributed to the discovery stage by taking on some relatively high-risk biologic projects. Moreover, in part as a result of the public’s impatience with the slow pace of the discovery process, state governments are increasingly taking the initiative in this area. One such example is the California Institute for Regenerative Medicine, a state agency established in 2005 by the California Stem Cell Research and Cures Initiative, which provides grants and loans for stem cell research and facilities at California’s research institutions and universities. Another example is the Texas Cancer Initiative, under which state funds are dedicated to cancer research conducted in Texas. Beyond these public investments, private foundations are also taking a significant financial interest in the discovery process, facilitating progress by funding research in their particular areas of interest.

At the other end of the continuum is late-stage development, which is funded primarily by pharmaceutical companies or venture capitalists with some collaborative support from government sources, such as NIH. Such partnerships are critical in the transition from proof of concept to clinical development.

CURRENT STATUS OF INVESTMENTS

In light of the increasing uncertainty of the regulatory process and possible increases in regulatory requirements throughout the development process, investors may shy away from investing in a product before there is clear evidence of its safety and effectiveness. An example is FDA’s initiative to address biomarker evaluation. Although FDA currently allows the use of biomarkers as surrogate end points in some cases, evaluation of biomarkers is difficult, and the agency is working to determine the best approach to the regulatory assessment of biomarker data.

Havelet Finance Limited, a Channel Island private finance and loan is liable of funding and implementing a Large Scale projects as financing a pharmaceutical and Drugs development projects. Our services includes Project financing and advisory services.

Opportunities to Improve the Financial Landscape

In addition to funding for the discovery and development of drug candidates, funding is needed for research on new technology platforms for validating targets and therapeutics. Recently, venture capitalists have taken an interest in companies developing new platforms. These new technologies can play a significant role in facilitating drug discovery and enhancing drug safety High-throughput screening platforms that evaluate DNA, RNA, or proteins have already advanced the art of drug discovery. One example is mRNA expression profiling, a powerful micro-array technology platform that was discovered by an academic laboratory, received additional research funding from NIH, and was then commercialized by industry. Profiling of mRNA expression can indicate the phenotype of cells and be used to characterize cancers, but has also been employed successfully in the drug discovery process to identify and validate new targets and measure the responsiveness of a target to a drug. Another platform example is biochemical pathway analysis using mass spectrometry to measure analytes, rather than nucleic acid methods or proteomics. Such a high-throughput method for assessing numerous markers and pathways associated with a disease or drug action can contribute to efficacy and safety analysis prior to clinical use of a drug.

Ways to facilitate Financing of Pharmaceutical and Drug Development projects

• Academic initiatives: The academic research community needs to increase investments in technology that can improve target validation and drug safety.
• Government initiatives: Government research funding aimed at addressing health challenges needs to be more focused on forecast morbidity and the cost of care in the United States.
• FDA needs to be adequately funded so it can partner with drug developers and direct the research being performed toward answering important regulatory questions.
• Private initiatives: Small Business Innovation Research and Small Business Technology Transfer regulations need to be revisited and revised to allow for greater investment.
• New incentives for high-risk investors need to be created, perhaps through tax law.
• Private disease foundations’ provision of support to the academic community for discovery and to industry for development is beneficial and should be embraced.
• Experienced investors need to be brought into the innovation process earlier.
• Inventory Financing: Inventory financing solutions enable manufacturers and distributors to increase the volume and management of products distributed to their reseller chains and as a direct result, meaningful revenue streams evolve increasing distribution channels across the board.
• Receivables Financing: Accounts receivables financing enables the borrowing of funds against future receivables including loans and lines of credit secured by inventory. Qualified business partners and clientele may obtain working capital in support of ongoing growth.

Our Main business is to implement and fund. All project financing request are welcomed at Havelet Finance Limited. We have the capacity to fund 50–70% of your large projects.

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