Robertson, George

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Engineering Conferences InternationalECI Digital ArchivesVaccine Technology IV ProceedingsSpring 5-21-2012Bringing Vaccine Manufacturing Capabilities to theDeveloping WorldGeorge RobertsonPATHFollow this and additional works at: http://dc.engconfintl.org/vaccine_ivPart of the Biomedical Engineering and Bioengineering CommonsThis Conference Proceeding is brought to you for free and open access by the Proceedings at ECI Digital Archives. It has been accepted for inclusion inVaccine Technology IV by an authorized administrator of ECI Digital Archives. For more information, please contact franco@bepress.com.Recommended CitationGeorge Robertson, "Bringing Vaccine Manufacturing Capabilities to the Developing World" in "Vaccine Technology IV", B. Buckland,University College London, UK; J. Aunins, Janis Biologics, LLC; P. Alves , ITQB/IBET; K. Jansen, Wyeth Vaccine Research Eds, ECISymposium Series, (2013). http://dc.engconfintl.org/vaccine_iv/7Bringing Vaccine Manufacturing Capabilities to the Developing WorldVaccine Technology IVMay 20-25, 2012Albufeira, PortugalOutline• About PATH• Vaccine Development at PATH• Vaccines against pneumonia• Vaccines against diarrheal diseases• Vaccines against influenza• Assessing Chinese Vaccine ManufacturersPATH: A catalyst for global healthPATH’s mission is to improve the health of people around the world by advancing technologies, strengthening systems, and encouraging healthy behaviors.Global presencePATH is working in countries shaded orange.Area of square indicates staff per office.PATH’s work in vaccines and immunizationRANGE OF ACTIVITIES• Increasing availability of existing vaccines.• Closing the gap in Vaccines & ImmunizationOther PATH Workuptake of newly available vaccines.• Developing technology in support of vaccines and immunization.• Working with partners to develop new vaccines.Comprehensive approach encompassing research and development, advocacy, financing, distribution, administration, and uptake.Vaccine development at PATHSome vaccines are not available while others are not affordable or available in sufficient quantity.Identify candidates and partner with industry, academia, public health organizations, and developing-world manufacturers.WHYHOWTo accelerate the development of new, lifesaving vaccines against selected major disease threats in the developing world.PATH’s key contributions are financial resources, technical expertise, and partnership facilitation.GOAL WHATPATH’s vaccine development projects• Pneumococcal disease• Diarrheal disease– Rotavirus– Enterotoxigenic E. coli and Shigella• Influenza• Malaria• Meningococcal disease Photo: PATHFocus on major disease threats• 2.5 million children die from vaccine-preventable diseases each year.• Pneumonia and diarrhea are the two leading causes of under-five deaths in the developing world.Source: WHO estimates of the causes of death in children, Lancet 2005.Establishing partnerships• Partners: industry, academia, nongovernmental organizations, and government agencies.• Partnerships direct R&D, manufacturing, and distribution strengths toward novel technologies.• Collaborations must lead to improved availability, accessibility, and affordability of vaccines.• PATH negotiates partnerships to ensure global access.Global accessKey components of commercial terms:• Affordability/pricing• Manufacturing capacity• Accessibility• Quality Role of product-development partnershipsDevelopment risk Risk-return thresholdDeveloping world risk/return• Mitigate riskPotential returnsDevelopment riskPrivate sectorPDP• Share costsVaccines against pneumoniaUp to 1 million children under age five die each year from pneumococcal disease—the number one cause of childhood pneumonia.1 dot = 1,000 deathsSource: PneumoADIP, 2008.Pneumococcal partnerships中 生 集 团 成 都 生 物 制 品 研 究所Chengdu Institute of Biological Products, CNBGDeveloping vaccines against diarrheal diseasesPATH is tackling diarrheal disease by addressing the most common cause of severe diarrhea, rotavirus, and the two leading bacterial causes of diarrhea, enterotoxigenic E. coliand Shigella.Vaccines against rotavirusMore than 500,000 children under five die each year from rotavirus infection—the number one cause of childhood diarrhea.Rotavirus partnershipsVaccines against bacterial diarrhea• At least one million children under five die each year from enterotoxigenic Escherichia coli (ETEC) and Shigella, combined, the leading bacterial causes of diarrhea. • Currently, no licensed vaccines against ETEC or Shigella are available.Enteric partnershipsEndoBiologics, Inc.Vaccines against influenza• Between 250,000 and 500,000 people die each year from seasonal influenza, and the most severe pandemic caused up to 50 million deaths. • A gap of nearly 6 billion courses exists between current influenza vaccine production capacity and what is needed to protect the global population in a pandemic.• Current influenza vaccines are difficult to produce quickly and in large quantities.Influenza partnershipsInstitute of Experimental MedicineBuilding influenza vaccine capacity in Vietnam• Human vaccine development in Vietnam against pandemic influenza has been a high priority for several years in response to H5N1.• Strongly supported by the governments of Vietnam, the United States, Japan, the WHO, and others.• Three entities initially engaged in human influenza A/H5N1 vaccine development and production.• Surveillance system to identify prevalence and seasonality of influenza.• Progress towards identifying gaps and establishing steps to continue development towards licensure.IVAC – new influenza facility~ 25mA factory of approx. 800 m2 will be built including Production division, QC and officesChicken farm and other facilities will be nearby Building site: Suoi Dau farm (20km far from HQ of IVAC)CNBG institutesSlide 23Conclusions• Vaccines represent one of the most successful and cost-effective public health interventions available today.• Millions of children remain underimmunized or unimmunized because of the shortage of affordable and available vaccines.• PATH is working to close the immunization gap by partnering to develop new vaccines and ensuring access to those vaccines for developing-country populations.For further information Maximizing the benefits of public-private partnerships Availability Accessibility Affordability www.path.orgGeorge A. Robertson, PhDgrobertson@path.org

Bringing Vaccine Manufacturing Capabilities to the Developing World

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Bringing Vaccine Manufacturing Capabilities to the Developing World

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