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

Postgraduate Course: Regulation and Governance of New Therapies (PGSP11393)

Course Outline
SchoolSchool of Social and Political Science CollegeCollege of Humanities and Social Science
Credit level (Normal year taken)SCQF Level 11 (Postgraduate)
Course typeOnline Distance Learning AvailabilityAvailable to all students
SCQF Credits20 ECTS Credits10
SummaryThe main aim of this interdisciplinary, online course is to equip students with in-depth knowledge and critical understanding of the regulation and governance of drug innovation, including both early stage R&D and translation of new science/technology to the clinic for public health benefit and the needs of the growing health bioeconomy. The objectives will be to explore this in both national and international contexts, and highlight the systemic interactions between innovators, regulators/policymakers and stakeholders/users of new innovative therapies that are crucial to successful drug innovation. Drawing on the University of Edinburgh Innogen Institute¿s leading research in these areas, and using relevant illustrative case studies; this course covers the key global challenges and bottlenecks in the complex innovation process for new drugs, and the new commercialisation strategies and R&D processes, which must align to deliver both economic and clinical benefit in a socially and ethically responsible way. Students will be introduced to a range of empirical evidence and case material through which to understand and examine systemic issues around health innovation, health policy and clinical translation in the context of emerging developments in life sciences, particularly in relation to stratified medicine and new pharmacological approaches.
This course, which requires no prior knowledge of the area, 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; changes in regulatory, legal and ethical systems for novel therapies; and social, political and economic factors that shape innovation and delivery of novel therapies to the clinic.
Course description WEEK TOPIC
1 Challenges of Therapeutic Innovation and the Reorganisation of R&D in the Commercial and Public Sectors

2 Translational Medicine and the ¿Broken Middle¿ of the Health Innovation Pathway

3 Knowledge Networks, Markets and Open Innovation in Life Sciences

4 The Financing of Innovation in Biotechnology

5 Biobusiness in Emerging Economies

6 Regulatory Science and Governance: Challenges of Clinical Trials and New Approaches to Advanced Therapies

7 Creating and Exploiting Viable Business Models for ¿Stratified Medicine¿
8 The Role and Influence of Patients and Publics in Therapeutic Innovation

9 Legal Challenges of Commercialisation & Governance of Biological Materials

10 Interdisciplinary Skills and Therapeutic Innovation
Entry Requirements (not applicable to Visiting Students)
Pre-requisites Co-requisites
Prohibited Combinations Other requirements None
Information for Visiting Students
High Demand Course? Yes
Course Delivery Information
Academic year 2015/16, Available to all students (SV1) Quota:  None
Course Start Semester 2
Course Start Date 11/01/2016
Timetable Timetable
Learning and Teaching activities (Further Info) Total Hours: 200 ( Lecture Hours 20, Seminar/Tutorial Hours 10, Programme Level Learning and Teaching Hours 4, Directed Learning and Independent Learning Hours 166 )
Assessment (Further Info) Written Exam 0 %, Coursework 100 %, Practical Exam 0 %
Additional Information (Assessment) 4,000 word essay (100%)
Feedback Not entered
No Exam Information
Learning Outcomes
On completion of this course, the student will be able to:
  1. Have an Extensive, in-depth knowledge of the key opportunities and challenges of developing new life science-based therapies for broader public health benefit, and ensuring they are successfully and ethically delivered to patients through the health system.
  2. Have the Ability to critically analyse the broad and complex social, ethical, legal, economic and strategic management issues in therapeutic innovation and health care policy.
  3. Critically understand of the systemic role of regulation in both early and late stage R&D, and be able to think creatively about the broader governance of pharmaceuticals and its impact on innovation
  4. Have an In-depth knowledge of, and ability to identify and critically evaluate, different organisational models/strategies for the development of new drugs in both high and low resource settings, including the viability of new business models and value systems for novel therapies and approaches such as stratified medicine
Reading List
Athreye, S., Kale, D. and Ramani, SV., (2009) Experimentation with strategy and the evolution of dynamic capability in the Indian pharmaceutical sector, Industrial and Corporate Change 18 (4) : 729- 759
BMJ (2004) ¿National Institutes for Clinical Excellence and its Value Judgements¿, 329 (24), pp. 224-227
BMJ (2003) ¿Relationships between the Pharmaceutical Industry and Patient¿s Organisations¿, British Medical Journal, 326, pp. 1208-1210
Brevignon-Dodin, L. (2010) ¿Regulatory Enablers and Regulatory Challenges for the Development of Tissue-Engineered Products in the EU¿, Bio-Medical Materials and Engineering (in press)
Committee for Advanced Therapies (2010) ¿Challenges with Advanced Therapy Medicinal Products and How to Meet them¿, Nature Reviews Drug Discovery 9, pp 195-201
Courtney, A. et al (2011) ¿Balancing Open Source Stem Cell Science with Commercialisation¿, Nature 29, pp: 115-116
Drolet, B. & N. Lorenzi (2010) ¿Translational Research: Understanding the Continuum from Bench to Bedside¿, Translational Research 157 (1): 1-5
FDA. (2006) Critical Path Opportunities Report, US Department of Health and Human Services, March, 2006, available at
FDA (2011) Advancing Regulatory Science at the FDA: A Strategic Plan, August, 2011, available at
Haddow, G., Laurie, G., Cunningham-Burley, S., & Hunter, K. (2007). Tackling Community Concerns about Commercialisation and Genetic Research: A Modest Interdisciplinary Proposal. Social Science and Medicine, 64, 272-282
S. Harmon, G. Laurie & A. Courtney, ¿Dignity, Plurality and Patentability:
The Unfinished Story of Brüstle v Greenpeace eV¿ (2012) European Law Review OR N. Moran, "European court bans embryonic stem cell patents" (2011) 29 Nature Biotech 1057¿1059
Kenney, M., & Patton, D. (2012). Bayh¿Dole and Alternative University Technology Transfer Regimes. In Knowledge Perspectives of New Product Development (pp. 253-268). Springer New York.
Kolympiris, C., Kalaitzandonakes, N., & Miller, D. (2011). Spatial collocation and venture capital in the US biotechnology industry. Research Policy, 40(9), 1188-1199.
Mittra, J. (2013) ¿Repairing the ¿Broken Middle¿ of the Health Innovation Pathway: Exploring Diverse Practitioner Perspectives on the Emergence and Role of ¿Translational Medicine¿, Science and Technology Studies, 26 (3)
Mittra, J. & J. Tait (2012) ¿Analysing Stratified Medicine Business Models and Value Systems: Innovation-Regulation Interactions¿, New Biotechnology 29 (6): 709-719
National Institutes of Health (2010) Scientific Management Review Board Report on Translational Medicine and Therapeutics, available at
OECD (2012), Knowledge Networks and Markets for Life Sciences, OECD Publishing.
Orloff, J. et al (2009) ¿The Future of Drug Development: Advancing Clinical Trial Design¿, Nature Reviews Drug Discovery 8: pp. 949-957
Smart. A., P. Martin & M. Parker (2004) ¿Tailored medicine: Whom will it fit? The ethics of patient and disease stratification¿, Bioethics, 18 (4): 322-343

J. Tait (2007) ¿Systemic Interactions in Life Science Innovation¿, Technology Analysis and Strategic Management, 19 (3), pp. 257-277
Trusheim, M.R. et al, E.R. Berndt & F. L. Douglas (2011) ¿Quantifying factors for the success of stratified medicine: strategic and economic implications of combining drugs and clinical biomarkers¿, Nature Reviews Drug Discovery 106: 817-833287-293

Additional Information
Graduate Attributes and Skills Not entered
KeywordsNot entered
Course organiserDr James Mittra
Tel: (0131 6)50 2453
Course secretaryMiss Kate Ferguson
Tel: (0131 6)51 5122
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