One of the ongoing challenges for academic, biotech and pharma organizations involved in oncology... more 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.
Journal of the Association of University Technology Managers / Association of University Technology Managers, Inc, 2005
After a heart attack, patients often undergo a procedure to open up the clogged artery and instal... more After a heart attack, patients often undergo a procedure to open up the clogged artery and install a tiny meshlike device called a stent to keep the artery propped open. In most cases, the body reacts to this foreign object with scar-tissue formation, and the artery narrows again. To combat this re-clogging process, National Institutes of Health inventors developed paclitaxel-coated stents and later licensed it to Angiotech. Approved by the Food and Drug Administration in March 2004, these stents are expected to substantially reduce the use of coronary artery bypass surgery, an expensive operation now performed annually on 350,000-plus Americans. This and three other examples of NIH licensing success stories are described in this paper: (a) Kepivance, which improves the quality of life for cancer patients by eliminating mouth sores, (b) AIDS drug ddI, an important component of many combination drug therapies, and (c) Vitravene, the first and only antisense drug to be approved by FDA...
Licensing of the HIV-1 protease gene by the NIH Office of Technology Transfer (OTT) provides an e... more 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.
Young, and mid size biotech companies can benefit hugely from the US National Institutes of Healt... more 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.
In a time of global vaccine shortages, especially for COVID-19 products, Serum Institute of India... more In a time of global vaccine shortages, especially for COVID-19 products, Serum Institute of India (SII) is straining to meet demand for vaccines in India. While this organization is not known worldwide, they entered into a recent alliance with AstraZeneca, who is partnered with Oxford University for Covid-19 vaccine, to manufacture their supply of vaccines for distribution in India. Several other such partnerships are also underway. And, SII is considering plans to become a much larger player, not only in India, but globally. This commentary is focused on if, when, where, why, and how global expansion could proceed. Our work was carried out as a class project to identify options and strategies appropriate for expansion and has been expanded subsequently as events continued to develop.
LES nouvelles. Licensing Executives Society (U.S.A.), 2011
Biopharmaceuticals are therapeutic products based on biotechnology. They are manufactured by or f... more Biopharmaceuticals are therapeutic products based on biotechnology. They are manufactured by or from living organisms and are the most complex of all commercial medicines to develop, manufacture and qualify for regulatory approval. In recent years biopharmaceuticals have rapidly increased in number and importance with over 400() already marketed in the U.S. and European markets alone. Many companies throughout the world are now ramping up investments in biopharmaceutical R&D and expanding their portfolios through licensing of early-stage biotechnologies from universities and other non-profit research institutions, and there is an increasing number of license agreements for biopharmaceutical product development relative to traditional small molecule drug compounds. This trend will only continue as large numbers of biosimilars and biogenerics enter the market.A primary goal of technology transfer offices associated with publicly-funded, non-profit research institutions is to establish...
With its unique system of intramural and extramural research programs, funding for academic and c... more 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.
With its "value proposition" statement a start-up company needs to convince potential i... more 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.
This paper will discuss commercializing discoveries made at research organizations, particularly ... more 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?
The United States (U.S.) leads the world in government support for non-military research and deve... more 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).
One of the ongoing challenges for academic, biotech and pharma organizations involved in oncology... more 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.
Journal of the Association of University Technology Managers / Association of University Technology Managers, Inc, 2005
After a heart attack, patients often undergo a procedure to open up the clogged artery and instal... more After a heart attack, patients often undergo a procedure to open up the clogged artery and install a tiny meshlike device called a stent to keep the artery propped open. In most cases, the body reacts to this foreign object with scar-tissue formation, and the artery narrows again. To combat this re-clogging process, National Institutes of Health inventors developed paclitaxel-coated stents and later licensed it to Angiotech. Approved by the Food and Drug Administration in March 2004, these stents are expected to substantially reduce the use of coronary artery bypass surgery, an expensive operation now performed annually on 350,000-plus Americans. This and three other examples of NIH licensing success stories are described in this paper: (a) Kepivance, which improves the quality of life for cancer patients by eliminating mouth sores, (b) AIDS drug ddI, an important component of many combination drug therapies, and (c) Vitravene, the first and only antisense drug to be approved by FDA...
Licensing of the HIV-1 protease gene by the NIH Office of Technology Transfer (OTT) provides an e... more 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.
Young, and mid size biotech companies can benefit hugely from the US National Institutes of Healt... more 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.
In a time of global vaccine shortages, especially for COVID-19 products, Serum Institute of India... more In a time of global vaccine shortages, especially for COVID-19 products, Serum Institute of India (SII) is straining to meet demand for vaccines in India. While this organization is not known worldwide, they entered into a recent alliance with AstraZeneca, who is partnered with Oxford University for Covid-19 vaccine, to manufacture their supply of vaccines for distribution in India. Several other such partnerships are also underway. And, SII is considering plans to become a much larger player, not only in India, but globally. This commentary is focused on if, when, where, why, and how global expansion could proceed. Our work was carried out as a class project to identify options and strategies appropriate for expansion and has been expanded subsequently as events continued to develop.
LES nouvelles. Licensing Executives Society (U.S.A.), 2011
Biopharmaceuticals are therapeutic products based on biotechnology. They are manufactured by or f... more Biopharmaceuticals are therapeutic products based on biotechnology. They are manufactured by or from living organisms and are the most complex of all commercial medicines to develop, manufacture and qualify for regulatory approval. In recent years biopharmaceuticals have rapidly increased in number and importance with over 400() already marketed in the U.S. and European markets alone. Many companies throughout the world are now ramping up investments in biopharmaceutical R&D and expanding their portfolios through licensing of early-stage biotechnologies from universities and other non-profit research institutions, and there is an increasing number of license agreements for biopharmaceutical product development relative to traditional small molecule drug compounds. This trend will only continue as large numbers of biosimilars and biogenerics enter the market.A primary goal of technology transfer offices associated with publicly-funded, non-profit research institutions is to establish...
With its unique system of intramural and extramural research programs, funding for academic and c... more 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.
With its "value proposition" statement a start-up company needs to convince potential i... more 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.
This paper will discuss commercializing discoveries made at research organizations, particularly ... more 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?
The United States (U.S.) leads the world in government support for non-military research and deve... more 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).
Uploads
Papers by Steven Ferguson