Global Health Risk Framework Research and Development of Medical Products: Workshop Summary (2016) / Chapter Skim
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3 Discovery Research
3 Discovery Research
Pages 25-38
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From page 25... ...
It will be beneficial to work across those silos to shape research and development plans from the beginning with the end in mind, and to guide early researchers on conducting 1 Formore information about the Global Health 2035 initiative see http://globalhealth2035. org (accessed October 30, 2015)
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From page 26... ...
o Promising vaccine platforms discussed included the sea sonal influenza vaccine platform, nucleic acid–based vac cines (RNA-based vaccines, DNA plasmid vaccines, live viral-vectored vaccines) , and vectored delivery of immuno genic antigen (e.g., adeno-associated virus [AAV]
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From page 27... ...
, reviewed some of the platforms or approaches that could be used to address unanticipated pathogens for which there are no tools available, and for which traditional methods are unlikely to be successful. New vaccine platforms in development include nucleic acid–based vaccines (RNA-based vaccines, DNA plasmid vaccines)
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From page 28... ...
The seasonal influenza vaccine experience does provide a model for the concept of having a flexible platform in which a new product can be rapidly approved based on an existing set of safety and efficacy data. However, it becomes more complicated, and there is less confidence, when the platform would be dealing with potential unknown factors including the nature of the disease and the level of risk people are willing to take in the context of a true public health emergency.
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From page 29... ...
government to be a potential biothreat, yet several Ebola vaccine candidates had been tested in animals 10 to 15 years ago and then sat in freezers with no further development until recently. To help span the development gap, Mahmoud and others have proposed a Global Vaccine Development Fund that would fund activities spanning from the discovery of a candidate to the end of phase II clinical testing (Plotkin et al., 2015)
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From page 30... ...
The practical field realities for deploying Ebola diagnostics included blood samples that were a "pink slurry" upon arrival, samples without names or addresses, or all samples labeled with the same name. Pauwels emphasized the importance of bringing diagnostic testing capability closer in time and space to where the patients are (i.e., at the point of care)
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plays an important role in delivering health care during infectious disease outbreaks. PPE is regulated relative to both approval for marketing and conditions for use, as proper use is essential for protection of the worker.
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Hamburg highlighted several critical areas of science that are ripe for further development including identification, characterization, and validation of biomarkers; the use of surrogate end points; the development of innovative clinical trial designs; the use of information technologies for disease detection and surveillance or post-market pharmacovigilance; the use of modeling and simulation; and predictive toxicology. INTELLECTUAL PROPERTY AND SHARING OF DATA AND REAGENTS Researchers, public health institutions, and companies alike have concerns over the access to the building blocks of knowledge, key research tools, and technology platforms necessary for developing a diagnostic, drug, or vaccine, said Anthony So, Professor of the Practice of Public Policy and Global Health at Duke University.
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From page 33... ...
Erasmus has countered that the MTA was modeled on the UBMTA and did not overly restrict access to virus samples. The Erasmus MTA, however, gave Erasmus ownership rights over any inventions made by recipients that directly relate to the material.
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To be effective, these pooling arrangements must have strategic fit within a larger innovation ecosystem, So said. He cited the Pandemic Influenza Preparedness Framework as one such innovation ecosystem that brings together multiple stakeholders who, in exchange for access to virus samples, commit to donating pandemic vaccine or drug or reserving production capacity to supply the World Health Organization (WHO)
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From page 35... ...
grants policy, the UBMTA, the WHO Pandemic Influenza Preparedness Framework, and the BMGF AIDS research agreement. Examples of data-sharing efforts discussed by Marks and others included Data Sphere (which facilitates sharing of de-identified patient-level data from cancer clinical trials)
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Michelle Mulder, Manager of Technology Transfer, Grants, and HIV Program at the South African Medical Research Council (SAMRC) 6 said that SAMRC has a dual role in both funding and conducting health research, and supports IP protection for three main reasons: to ensure control over how it is used, to leverage partnerships, and to incentivize private investment.
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Sharing Negative Data The importance of sharing negative data was emphasized. A participant observed that during the Ebola outbreak there were negative data that were not publicly available, and treatment decisions were informed only by the publicly available data.
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From page 38... ...
Typically, national governments are involved, funding may be derived from a manufacturer's tax, the products that are covered vary, and eligibility and compensation decisions might depend on a standard of proof. In the United States, for example, systems include the National Vaccine Injury Compensation Program, and the countermeasures injury compensation provisions of the Public Readiness and Emergency Preparedness (PREP)
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