The U.S. National Institutes of Health - Founding A National Biomedical "Innovation Ecosystem".

With its unique system of intramural and extramural research programs, funding for academic and corporate product development, along with its supporting foundations, the National Institutes of Health (NIH) has created a vibrant public "innovation ecosystem" that has changed not only the face of healthcare, but has also led to the creation of the biotech industry in the U.S. Whether your interest in the overall healthcare environment is scientific, medical, educational or commercial, there is something here for you.

A Guide to Time Lag and Time Lag Shortening Strategies in Oncology-Based Drug Development.

One of the ongoing challenges for academic, biotech and pharma organizations involved in oncology-related research and development is how to help scientists be more effective in transforming new scientific ideas into products that improve patients' lives. Decreasing the time required between bench work and translational study would allow potential benefits of innovation to reach patients more quickly. In this study, the time required to translate cancer-related biomedical research into clinical practice is examined for the most common cancer cases including breast, lung and prostate cancer. The calculated "time lag" typically of 10 years for new oncology treatments in these areas can create fatal delays in a patient's life. Reasons for the long "time lag" in cancer drug development were examined in detail, and key opinion leaders were interviewed, to formulate suggestions for helping new drugs reach from bench to bed side more quickly.

Partnering with the NIH: Now part of the "Value Proposition" for start-ups.

With its "value proposition" statement a start-up company needs to convince potential investors or pharma partners how it will add more value or solve a problem better than others. High value, low cost assets such as those from the NIH ranging from technology to funding to assistance provide such biomedical firms an excellent jump-start in reaching their goals.

Research Discoveries After Kubin.

This paper will discuss commercializing discoveries made at research organizations, particularly with a view to the In re Kubin case, decided April 3, 2009, by the Federal Circuit. Here, the existence of a general method of isolating DNA molecules was held to be relevant to the question whether the DNA molecules themselves would have been obvious under § 103 of the patent act. How are DNA inventions patented anyway? What does it take for academic research to reach patients? How might the decision of In re Kubin effect research commercialization and technology transfer?

Commercial Licensing of HIV-1 Protease: Applications of the NIH Research Tools Policy.

Licensing of the HIV-1 protease gene by the NIH Office of Technology Transfer (OTT) provides an example of the effective use of the principles of the NIH Research Tools Policy, which was designed to provide broad access to important biomedical technologies. The OTT licensing experience is presented in detail as it was applied to research reagents, diagnostics and drug development to thus enhance the overall development process for a wide variety of medical products.

Beyond Patents and Royalties: Perception and Reality of Doing Business with the NIH.

Young, and mid size biotech companies can benefit hugely from the US National Institutes of Health (NIH), not least because of the agency's non-dilutive funding, guidance, and opportunities for collaboration. Increasingly, however, there is a fair bit of misunderstanding about what the NIH can and cannot do for a biotech entrepreneur.

Nature's medicines: traditional knowledge and intellectual property management. Case studies from the National Institutes of Health (NIH), USA.

With the emergence and re-emergence of infectious diseases and development of multi-drug resistance, there is a dire need to find newer cures and to produce more drugs and vaccines in the pipeline. To meet these increasing demands biomedical researchers and pharmaceutical companies are combining advanced methods of drug discovery, such as combinatorial chemistry, high-throughput screening and genomics, with conventional approaches using natural products and traditional knowledge. However, such approaches require much international cooperation and understanding of international laws and conventions as well as local customs and traditions. This article reviews the forty years of cumulative experience at the National Institutes of Health (initiated by the National Cancer Institute) in natural products drug discovery. It presents (1) three major cooperative programs (2) the legal mechanisms for cooperation and (3) illustrative case studies from these programs. We hope that these discussions and our lessons learned would be helpful to others seeking to develop their own models of cooperation for the benefit of global health.

Developing products for personalized medicine: NIH Research Tools Policy applications.

For innovators at academic or industrial institutions to develop personalized medicine products at the accelerated pace required, rapid access to state-of-the-art research tools and reagents are needed. Unreasonable restrictions or delays in the use of such tools may undermine the development of these customized diagnostics and therapeutic products designed to provide significant treatment benefits to patients who frequently do not benefit from traditional therapeutic approaches. In its funding agreements and its own internal research programs, the National Institutes of Health is implementing policies to facilitate the exchanges of these research tools and related resources.

Monitoring of Biomedical License Agreements: A Practical Guide.

Because technology licensed from research organizations can play a significant role in drug innovation and the generation of novel biomedical products, licensee performance under such agreements must be effectively monitored. This is necessary so that resultant benefits, including public health improvement, may be returned to the innovator(s) as well as society at large. The tasks that comprise monitoring are varied, but all come under the general heading of 'enforcement of license provisions'.Since 1996, the license monitoring and enforcement program established by the US National Institutes of Health (NIH) Group has collected about $US17 million in unpaid and underpaid license royalties through formal financial audits and other investigative activities. During the same period, the Office of Technology Transfer (OTT) settled more than 60 cases of suspected patent infringement, generating around 60 new licenses and collected both back and ongoing royalties. As these numbers show, an active and effective monitoring program is an essential part of any technology transfer or biomedical licensing program.

Products, Partners & Public Health: Transfer of Biomedical Technologies from the U.S. Government.

The United States (U.S.) leads the world in government support for non-military research and development (R&D), especially support for work that directly relates to health and human development. A focal point for such investments to date in biomedical research has been the National Institutes of Health (NIH), receiving $23.3 billion in fiscal year 2002. Whether internal or externally based, the biomedical research performed has led to a large variety of novel basic, and clinical research discoveries - all of which generally require commercial partners in order to develop them into products for hospital, physician or patient use. This article describes the role of the NIH, including ways in which it works with corporate partners or licensees to commercialize its funded research into products in order to help fulfill it mission as a healthcare agency within the U.S. Department of Health and Human Services (DHHS).

Distribution and licensing of drug discovery tools--NIH perspectives.

Now, more than ever, drug discovery conducted at industrial or academic facilities requires rapid access to state-of-the-art research tools. Unreasonable restrictions or delays in the distribution or use of such tools can stifle new discoveries, thus limiting the development of future biomedical products. In grants and its own research programs the National Institutes of Health (NIH) is implementing its new policy to facilitate the exchanges of these tools for research discoveries and product development.