Thesis: S.M. in Technology and Policy, Massachusetts Institute of Technology, School of Engineering, Institute for Data, Systems, and Society, Technology and Policy Program, 2018. / Cataloged from PDF version of thesis. / Includes bibliographical references (pages 127-134). / Low-and-Middle Income Countries (LMICs) are experiencing a growing need for safe, effective, and affordable health services, especially medicines. Such trends are in part due to a continued epidemiologic transition from infectious to chronic, non-communicable diseases (NCDs). Today, NCDs account for a large portion of total global disease burden: 70% of deaths as per the World Health Organization (WHO). NCDs are projected to continue to undercut economic productivity and drive up health spending. Many NCDs are effectively treated using biologic therapies; or large molecules produced by, or involving, living cells. Recently, some of these therapies have been included on the WHO Model List of Essential Medicines. However, the molecular, manufacturing, regulatory, and supply chain features of biologics lead to relatively higher costs and complexity compared to small-molecule drugs, with implications on widespread access. As part of the Global Action Plan for the Prevention and Control of NCDs 2013-2020, an 80% target for global availability of affordable essential medicines has been set for all public and private providers. In order to reach this target, there is need to better understand the complex barriers to accessing biologics across the biopharmaceutical value chain. Current gaps in access indicate the potential need to re-orient the biopharmaceutical system in order to meet future projected healthcare demand in terms of quantity, quality, and affordability. There is also growing uncertainty within the biopharmaceutical ecosystem as to the best use of resources, design of policies, and development of technologies that will have the most cost-effective impact on maximizing the supply of and access to such biologics. This research specifically focuses on the manufacturing component of biologics access, providing an analysis of the benefits and risks across different production networks, with varying number and location of facilities. A cost modeling tool is presented for quantitatively analyzing different manufacturing design options. This is accomplished by comparing the cost of good (COGs) and net present cost (NPC) of different scenarios, using Trastuzumab (a monoclonal antibody drug used to treat HER-2+ breast cancer) as a case study. Finally, future research questions are presented, aimed at better understanding the drivers of variability in manufacturing cost across manufacturing networks, especially when considering differences in product type, locations, regulatory jurisdictions, geopolitical zones, and sociocultural norms. In light of changing global health patterns and increasing demand for quality, affordable care, the thesis presents tools that can be generalized for addressing tradeoffs, short-and- long term effects, and intended-and-unintended consequences of investments in global health. It holds the potential for assessing the potential impact of various innovations (policies, technologies, organizational structures and more) on complex, dynamic systems and provide an evidence-base to better inform future areas of research, design of policies, and development of technologies. / by Donovan G. Guttieres. / S.M. in Technology and Policy
| Identifer | oai:union.ndltd.org:MIT/oai:dspace.mit.edu:1721.1/117892 |
| Date | January 2018 |
| Creators | Guttieres, Donovan G |
| Contributors | Anthony J. Sinskey and Stacy L. Springs., Technology and Policy Program., Massachusetts Institute of Technology. Institute for Data, Systems, and Society., Technology and Policy Program. |
| Publisher | Massachusetts Institute of Technology |
| Source Sets | M.I.T. Theses and Dissertation |
| Language | English |
| Detected Language | English |
| Type | Thesis |
| Format | 134 pages, application/pdf |
| Rights | MIT theses are protected by copyright. They may be viewed, downloaded, or printed from this source but further reproduction or distribution in any format is prohibited without written permission., http://dspace.mit.edu/handle/1721.1/7582 |
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