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DEGREE REGULATIONS & PROGRAMMES OF STUDY 2016/2017

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DRPS : Course Catalogue : School of Social and Political Science : Postgrad (School of Social and Political Studies)

Postgraduate Course: Health, Innovation and Policy (PGSP11289)

Course Outline
SchoolSchool of Social and Political Science CollegeCollege of Humanities and Social Science
Credit level (Normal year taken)SCQF Level 11 (Postgraduate) AvailabilityAvailable to all students
SCQF Credits20 ECTS Credits10
SummaryThe aim of this course is to equip students with an in-depth understanding of the drug development process, including both early stage innovation processes and eventual translation of new science/technology to the clinic for broad public health benefit in international contexts. The key global challenges and bottlenecks in this complex process will be examined through specific case studies, and students will be introduced to a range of theoretical, conceptual and empirical evidence through which to examine systemic issues around innovation, health policy and translational research in the context of the new life sciences.

The course will focus on a range of issues that affect the successful development and market uptake of new therapies; including commercial R&D processes, public/private translational models for innovation; public health systems and global demand for new drugs; regulatory systems for novel technologies; and social, political and ethical factors that shape innovation processes and delivery to the clinic.
Course description Week 1. Introduction to Health innovation, Translation and Policy: Introduction to the defining features, drivers and barriers to "translational" health innovation and policy.

Week 2. Challenges of Modern Drug Development and New R&D Strategies: This session will focus on the early stage development of new drugs and address how companies and public sector organisations have sought to exploit the life sciences. A particular theme will be the globalisation of pharmaceutical R&D through the rise of new, niched approaches, global PPPs and emergence of new pharma producing countries.

Week 3. Science, Technology and New Organisational Structures: This session will explore, through case studies, the opportunities and challenges of new health innovation initiatives that involve collaboration between the public and private sectors.

Week 4. Regulation and its Impact on Innovation: This session will explore regulation in both the context of designing and conducting clinical trials and granting market approval for new, advanced therapies. Using a variety of illustrative case studies, the session will uncover the systemic relationship between innovation and regulation.

Week 5. Health Innovation in Low Resource Settings: This session will explore new health innovation initiatives in a developing country context. The case study of the International Aids Vaccine Initiative (IAVI) will be used to critically explore the role of health product development partnerships and their use of novel forms of technology development and institutional arrangements to deliver solutions to affected populations, including knowledge brokerage and integration.

Week 6. Role of Health Systems in Determining the Uptake of Novel Technologies and Therapies: This session focuses on the challenges of getting new treatments delivered through to the clinic; exploring the role of organisations such as NICE and health technology assessment in both private and publicly funded healthcare settings

Week 7. Challenges of Global Public Health: This session focuses on broader global health challenges and explores models of good practice for addressing them through innovation, regulation and policy.

Week 8. The Economics of Innovation and Health Policy: This session will focus on the economics of health innovation and reimbursement issues for new therapies. It will explore methods for measuring the cost of R&D and identifying, through illustrative case studies, business models and value systems for new types of therapeutic product, such as stem cells.

Week 9. Role of Patients and Patient Lobby Groups in Health Innovation: This session will explore the important and active role patients and their representative organisations play in both the development and delivery of new therapies to the clinic, and address some of the key challenges to successful patient engagement.

Week 10. Ethical Challenges Facing Contemporary Health Innovation: This final session will address broader ELSI issues raised by new life science innovation and translational strategies for healthcare reform. Generation Scotland may be used as a case study to highlight legal and ethical challenges of increased demands for access to patient data and participation in health studies.
Entry Requirements (not applicable to Visiting Students)
Pre-requisites Co-requisites
Prohibited Combinations Other requirements None
Information for Visiting Students
Pre-requisitesNone
Course Delivery Information
Not being delivered
Learning Outcomes
By the end of this course, students will:

1. Understand the key opportunities and challenges of developing and new life science-based therapies for broader public health benefit internationally, and ensuring they are successfully delivered through public health systems.
2. Have a critical understanding of the broad and complex social, legal, ethical and strategic management issues in therapeutic innovation and health care policy.
3. Appreciate the systemic role of regulation in both early and late stage R&D, and be able to think critically about the broader governance of pharmaceuticals and its impact on innovation
4. Have in-depth knowledge and understanding of different organisational models/strategies for the development of new drugs in both high and low resource settings
Reading List
Cambrosio, A., Keating, P., and Mogoutov, A. (2004) Mapping collaborative work and innovation in biomedicine, Social Studies of Science, 34 (3), pp. 325-364

Chiesa, V. & Toletti, G. (2004) 'Network of Collaborations for Innovation: The Case of Biotechnology', Technology Analysis and Strategic Management, 16 (1), pp. 73-96

Coombs, R., and Metcalfe, S. (2002) Innovation in pharmaceuticals: perspectives on the co-ordination, combination and creation of capabilities, Technology Analysis and Strategic Management, 14 (3), pp. 261-271

Dimasi, J.A., & H.G. Grabowski (2007) 'The Cost of Biopharmaceutical R&D: Is Biotech Different?', Managerial and Decision Economics, 28 (4/5), pp. 469-479

Drews, J. (2000) Drug discovery: a historical perspective, Science, 287, pp. 1960-1964

Drews, J. and Ryser, S. (1996) Innovation deficit in the pharmaceutical industry, Drug Information Journal, 30, pp. 97-108

Hedgecoe, A., & Martin, P. (2003) The drugs don't work: expectations and the shaping of pharmacogenetics, Social Studies of Science, 33 (3), pp. 327-364

Horig, H., and Pullman, W. (2004) From bench to clinic and back: perspective on the first 1st IQPC Translational Research Conference, Journal of Translational Medicine, 2 (44)

Horrobin, D. F. (2001) Realism in drug discovery could Cassandra be right? Nature Biotechnology, 19, pp. 1099-1100

Howells, J. (2002) Mind the gap: information and communication technologies, knowledge activities and innovation in the pharmaceutical industry, Technology Analysis and Strategic Management, 14 (3), pp. 356-367

Mittra, J (2007) 'Life Science Innovation and the Restructuring of the Pharmaceutical Industry: Merger, Acquisition and Strategic Alliance Behaviour Large Firms', Technology Analysis and Strategic Management, 19 (3), pp. 279-301

Mittra, J. (2008) 'Impact of the Life Sciences on Organisation and Management of R&D in Large Pharmaceutical Firms', Int. J. Biotechnology, 10 (5), pp. 416-440

Mittra, J. & R. Williams (2007) 'Editorial: Evolution of the Life Science Industries', Technology Analysis and Strategic Management, 19 (3), pp 251-255

Nightingale, P. (2000) Economies of scale in experimentation: knowledge and technology in pharmaceutical R&D, Industrial and Corporate Change, 9, 2000, pp. 315-359

Niiler, E. (2000) 'Demise of the Life Science Company Begins', Nature Biotechnology, 18, p. 14

Pardridge, W, M. (2003) 'Translational Science: What is it and Why is it so Important?' Drug Discovery Today, 18, pp. 813-815

Rosen, M.R. (2006) 'Are Stem Cells Drugs?: The Regulation of Stem Cell Research and Development', Journal of the American Heart Association, 114, pp. 1992-2000

Schmid, E.F., & Smith, D.A. (2005) Managing innovation in the pharmaceutical industry, Journal of Commercial Biotechnology, 12 (1), pp. 50-57

Smith et al (2006) 'Generation Scotland: The Scottish Family Health Study; a new resource for researching genes and heritability', BMC Medical Genetics, 7 (74)

Tait, J. with Wield, D., Chataway, J. and Bruce. A. (2008) Health Biotechnology to 2030. Report to OECD International Futures Project, "The Bio-Economy to 2030: Designing a Policy Agenda", OECD, Paris, pp 51; http://www.oecd.org/dataoecd/12/10/40922867.pdf.

Tait, J. (2007) Systemic interactions in life science innovation, Technology Analysis and Strategic Management, 19 (3), pp. 257-277

Tait, J. & Mittra, J. (2004) 'Industry Challenges', Chemistry and Industry, 6 December, 2004, No. 23, p. 24

Walsh, V., and Lodorfos, G., (2002), "Technological and Organisational Innovation in Chemicals and Related Products", Technology Analysis and Strategic Management,Vol. 14, No.3., pp. 273-298.

Williams et al (2008) 'Promoting Research Participation: Why not Advertise Altruism?', Social Science and Medicine, 66, pp. 1451-1456
Additional Information
Graduate Attributes and Skills Not entered
KeywordsNot entered
Contacts
Course organiserDr James Mittra
Tel: (0131 6)50 2453
Email: james.mittra@ed.ac.uk
Course secretaryMiss Lindsay Hunter
Tel: (0131 6)51 1587
Email: L.Hunter@ed.ac.uk
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