Postgraduate Course: Regulation and Governance of New Therapies (PGSP11393)
|School||School of Social and Political Science
||College||College of Humanities and Social Science
|Credit level (Normal year taken)||SCQF Level 11 (Postgraduate)
|Course type||Online Distance Learning
||Availability||Available to all students
|Summary||The 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.
This interdisciplinary, online course equips 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 objective is 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.
The course requires no prior knowledge of the area, and focuses 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.
1.Translational/Stratified Medicine and the 'Broken Middle' of the Health Innovation Pathway
This session explores some the different definitions and framings that have been built around translational medicine (TM) in the context of a purportedly broken drug R&D pipeline and the promises built around new life science approaches.
2.New Models of Innovation in Commercial and Public Sectors
This session explores how the organisation and management of R&D has changed, within both commercial pharmaceutical firms and the public sector, in response to advances in new biology and the promise of stratified medicine. In particular, we will look at the rise of the public-private partnership, through case examples, in the context of trying to identify and validate new biomarkers.
3. Regulatory Science and Governance 1: The Clinical Trial System
This session investigates some of the challenges of designing and conducting clinical trials for novel therapies, and explores the relationship between developers of new drugs and the regulatory institutions that govern them.
4.Regulatory Science and Governance 2: New Approaches to Advanced Therapies
This session focuses on more general regulatory responses to risk governance and regulation of novel, advanced therapies, particularly stem cells and tissue-engineered products.
5.Regulation and Economics of Pharma R&D The Case of Antimicrobial resistance
This session provides an overview of the economics of conventional pharma R&D and the standard value chain that operates for small-molecule blockbuster drugs and the challenges facing that model, before exploring the case study of antimicrobial resistance
6.The Challenge of Business Models and Regulatory Systems for 'Stratified Medicine'
This session will explore some of the key commercial, regulatory and social issues associated with ongoing developments in the identification and validation of molecular biomarkers and their potential use in a Stratified Medicine value system, which is an approach to healthcare innovation and clinical practice that is really gaining currency in policy circles, as well as within the commercial and regulatory sectors.
7.The Role and Influence of Patients and Publics in Therapeutic Innovation
This session explores some of the current and emerging social, ethical and political issues that pose a challenge to those responsible for the regulation and governance of life science research. In particular, we will explore issues around informed consent, protection of confidentiality, access, and research participation/recruitment in the context of patient specific biological material and genomic data.
8.Legal Challenges of Commercialisation & Governance of Biological Materials
This session will explore some of the legal issues around commercialising biological material of human origin, doing so within the context of debates and jurisprudence around embryonic stem cells.
9.Stratified medicines and pharmacogenomics in low resource settings
This session considers debates around stratified medicine and pharmacogenomics in the context of infectious disease in low resource settings and their potential in improving global public health.
10.Knowledge Networks, Markets and Open Innovation in Life Sciences
This session explores the emergence of a variety of networks and markets that are currently shaping the pace and direction of the innovation process in various industries/sectors affected by the application of the life sciences.
This course is provided through the Moodle learning Platform. Each week, you will be provided with detailed Session Notes or an audio/video lecture with slides, which present an overview of the topic and discussion of some of the key literature. These notes should be the starting point for each weeks work. You will also be provided with required readings and discussion topics/activities, including online videos, to be discussed using the online discussion boards. Although not part of the assessment, contribution to discussion boards is compulsory and an important element of the learning experience. This is where you have the opportunity to ask questions and discuss ideas with your fellow students, which will help you when it comes to writing your essays. The course organiser will facilitate and monitor the discussion boards, but it is the responsibility of students to engage with the lecture material and fellow students.
Entry Requirements (not applicable to Visiting Students)
||Other requirements|| None
Information for Visiting Students
|High Demand Course?
Course Delivery Information
|Academic year 2018/19, Available to all students (SV1)
|Course Start Date
|Learning and Teaching activities (Further Info)
Lecture Hours 20,
Seminar/Tutorial Hours 10,
Programme Level Learning and Teaching Hours 4,
Directed Learning and Independent Learning Hours
|Assessment (Further Info)
|Additional Information (Assessment)
||1. A 1,000 word blog post, which could be a comment piece on one of the week¿s topics, or a short critical review of one or two of the articles in the reading list, or videos used in the course. This shorter assessment requires students to use a different style of writing and tests their ability to present a clear and concise critical commentary.
2. A 3000 word essay weighted at 75% due at the end of the course (students provided with a list of essay questions)
||Formative, non-assessed feedback will be provided on a 1-2 page essay plan submitted half way through the course.
|No Exam Information
On completion of this course, the student will be able to:
- 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.
- 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.
- 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
- 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
|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 http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/UCM077254.pdf
FDA (2011) Advancing Regulatory Science at the FDA: A Strategic Plan, August, 2011, available at http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/RegulatoryScience/UCM268225.pdf
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 http://smrb.od.nih.gov/dec/TMAT_Meeting_Formatted.pdf
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
|Graduate Attributes and Skills
|Course organiser||Dr James Mittra
Tel: (0131 6)50 2453
|Course secretary||Ms Maria Brichs
Tel: (0131 6)51 3205