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7 Nurturing Innovations Through Novel Ecosystems to Accelerate Research and Development
Pages 95-116

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From page 95...
... Sabrina Welsh, director of programs and operations, Human Vaccines Project, discussed the model of collaboration used by the Human Vaccines Project to broaden the understanding of the immune system in order to accelerate innovation. Maurizio Vecchione, executive vice president of Global Good and Research, Intellectual Ventures, explored the concept of reverse innovation as a radical approach to forging public–private partnerships and developing ecosystems of innovation.
From page 96...
... This motivated him to establish a new division of BARDA called the Division of Research, Innovation, and Ventures,1 along with a venture capital fund to stimulate investment of government funding in these areas. 1  For more information on BARDA's Division of Research, Innovation, and Ventures (DRIVe)
From page 97...
... The Human Vaccines Project's mission is to broaden the understanding of the immune system and to accelerate the development of therapeutics, diagnostics, and vaccines for major global diseases. A Paradigm Shift in Research and Development The established research and development system is proving poorly suited to today's problems, said Welsh.
From page 98...
... , and machine learning to gain a more comprehensive understanding of how the human immune system functions (Human Vaccines Project, 2020)
From page 99...
... In addition to conducting clinical trials, the Human Vaccines Project aims to leverage existing datasets and stored sample collections. She added that they have received approval from the Clinical Study Data Request Repository, which is a collection of sponsors who deposit clinical data in a repository that can be used for analyses.
From page 100...
... She noted that in the early 2000s, the Human Genome Project engaged multiple sectors and countries to develop fundamental knowledge of genetics and the genetic blueprint. The Human Vaccines Project aims to do for immunology what the Human Genome Project did for genetics, by providing better understanding of the complex interactions that govern immune responses.
From page 101...
... For the richest billion, noncommunicable diseases represent the majority of the burden of disease; for the poorest billion, communicable diseases account for more than half of the burden of disease. If divided into quartiles by daily income, the two lower quartiles of the global population have a far greater burden of communicable disease than the two higher quartiles.
From page 102...
... It takes Global Good approximately 6 months to develop a concept into a finished diagnostic product in the field with clinical trials, which collapses the normal development cycle for these types of technologies. Vecchione presented an example of a project that used a multidisciplinary approach that leverages the traditional modality of ultrasound.
From page 103...
... NURTURING INNOVATION TO ACCELERATE RESEARCH AND DEVELOPMENT Sally Allain presented on nurturing innovation to accelerate research and development, using the example of Johnson & Johnson Innovation's model for driving external partnership, venture capital investment, and working across the entrepreneurial ecosystem. She explained that Johnson & Johnson is the largest and most diverse health care company in the world, working across three sectors: pharmaceuticals, consumer products, and medical devices and medical device innovation.
From page 104...
... When Johnson & Johnson Innovation began building a model for external innovation, it decided to embed itself into existing ecosystems using its network of innovation centers, its corporate venture arm Johnson & Johnson Development Corporation (JJDC) , the JLABS Life Science Incubator model, and business development support.
From page 105...
... It creates cross-sector opportunities to build an environment for solutions and not only products, she added. Recognizing that companies are at various stages of development and may need different types of support, JLABS also offers mentorship and support ranging from preparation for clinical trials to medical device development to help move companies' products and drugs forward.
From page 106...
... SPURRING INNOVATION IN DIAGNOSTIC TOOLS Ranga Sampath emphasized that without appropriate diagnostic tools, the world's most pressing public health needs cannot be sustainably addressed because "without diagnosis, medicine is blind." For patients, diagnostics enable correct treatment and universal health coverage; for communities, diagnostics help halt the spread of antimicrobial resistance and disease outbreaks. For governments, diagnostics accelerate disease elimination, provide data for health interventions, and reduce spending.
From page 107...
... This group offers a quality management system for in vitro diagnostics clinical trials certified by the International Organization for Standardization. Sampath said that FIND's business model has been successful in transforming tuberculosis diagnostics in LMICs using modern molecular technologies, and it is now seeking to expand those efforts across multiple diseases.
From page 108...
... Multiplex rapid diagnostic tests are being developed that can differentiate multiple causes of fever. Lab-in-a-box innovations can facilitate portable rapid assessment of pathogens with pandemic potential, while point-of-care molecular platforms can support confirmatory diagnosis at patients' bedsides.
From page 109...
... Diagnostics Use Accelerator, an initiative designed to gather crucial evidence ­ for an AMR policy and practice guidelines globally and locally through a study of 22,000 patients with acute febrile illness in 6 countries: Burkina Faso, Ghana, India, Myanmar, Nepal, and Uganda. Sampath explained that the program is intended to gather harmonized global and local evidence to develop a package of interventions at the primary health care level.
From page 110...
... Most of these companies have since left the market, with repeat outbreaks highlighting the national and international manufacturing gaps for those Ebola diagnostic tests. Similarly, the majority of companies developing Zika products dropped out of the market as the epidemic waned alongside funding.
From page 111...
... The aim of this new technology is to transition cervical cancer treatment from a surgical procedure conducted by a specialist toward a preventionlike treatment. He added that this new technology is not intended to be an alternative to population-level vaccination; rather, it is being developed as a solution to contribute to cervical cancer elimination before population-level immunity is reached.
From page 112...
... Vecchione replied that the Bill & Melinda Gates Foundation tries to address gaps by reimagining problems through a lens of new technologies that may not be immediately endorsed by experts in the field. For example, when Global Good began working to address cervical cancer, leaders in the field said that machine learning could not work.
From page 113...
... The Human Vaccines Project's promise to these partners was that it would work in a different, more efficient way that could accommodate the needs of the research network, for example, by conducting flexible iterative clinical trials that begin with small groups then scale up depending on the needs of the product. These strategies allowed the Human Vaccines Project to change its risk profile for investors.
From page 114...
... Vecchione replied that AI could more accurately be called "statistical intelligence," because machine learning reveals statistical correlations. He suggested that the exuberance about machine learning and the sentiment that it is the solution to all problems may be running its course.
From page 115...
... For instance, the Human Vaccines Project oversees the Michelson Prize for young investigators who are interested in immunology. Such efforts not only spread the Human Vaccines Project's message and publicize its work, but they also encourage the next generation of scientists to innovate.


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