THE UNIVERSITY of EDINBURGH

DEGREE REGULATIONS & PROGRAMMES OF STUDY 2021/2022

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

Postgraduate Course: Biobusiness (PGSP11331)

Course Outline
SchoolSchool of Social and Political Science CollegeCollege of Arts, Humanities and Social Sciences
Credit level (Normal year taken)SCQF Level 11 (Postgraduate) AvailabilityAvailable to all students
SCQF Credits20 ECTS Credits10
SummaryA number of regions across the world are considered to be at the forefront of life science research. When it comes to the commercial exploitation of bioscience and biotechnology, however, the results are often disappointing. Often the approach adopted consists of attempts to turn scientists into entrepreneurs by providing them with basic training in business, (planning, small business finance and patent/licensing strategy) and showing them how these can be used in combination with their scientific skills.
While teaching scientists how to exploit commercial opportunities constitutes a legitimate motivation for business training, the ambition and target audience of this course are much wider. Turning science into innovative products and services requires not only basic training in business but also a more fundamental understanding of how scientific advances contribute to, and influence, industrial structures, innovation, and the dynamics of collaboration and competition at the level of the single industrial sector. Furthermore, in the context of the bioeconomy, innovation processes interact with, and can be shaped by, existing and evolving institutions and social attitudes and perceptions. Finally, this point of view is required not only by scientists, but also by a wider group of professionals working for government, industry and public research organisations.
This course is designed to provide students with a comprehensive overview of and the ability to assess how innovation in the life sciences is changing production methods, industrial structures, market dynamics and strategic decision making. To fully grasp these issues inevitably involves tackling the complex ethical and legal issues that individuals and society face as a result of these changes.
Course description The commercial exploitation of bioscience and biotechnology requires entrepreneurs to be able to use a basic training in business, (planning, small business finance and patent/licensing strategy) in combination with scientific skills. It also however requires a wider understanding of the commercial enterprise in context. The modern bioeconomy is situated in a broad landscape where a variety of actors interact. These actors include government, users (e.g. patients and farmers), the public and third sectors. There are also a variety of governance frameworks that biobusiness has to contend with, around clinical trials, intellectual property, ethics etc. In the context of the bioeconomy, innovation processes interact with, and can be shaped by, existing and evolving institutions and social attitudes and perceptions. This point of view is required not only by scientists, but also by a wider group of professionals working for government, industry and public research organisations.

This course guides students towards a fundamental understanding of how scientific advances contribute to, and influence, industrial structures, innovation, and the dynamics of collaboration and competition at the level of the single industrial sector.
The course is designed to provide students with a comprehensive overview of and the ability to assess how innovation in the life sciences is changing production methods, business and financial models, markets, society and strategic decision making. To fully grasp these issues inevitably involves tackling the complex ethical and legal issues that individuals and society face as a result of these changes.

This course will be delivered through a 10-week lecture and seminar discussion format. Each session will typically consist of a short lecture by a guest speaker (introducing the key themes of the week¿s topic and the core readings provided), followed by an hour and a quarter of classroom discussion and/or student-led presentations. Each week¿s class will typically cover conceptual, theoretical and empirical material related to the topic. Discussion with staff and with others on the course is a key element in learning.

Outline Content

1 An overview of the pharma industry and its evolution over time
2 Gut bacterial to gene therapy; academia meets biotech and delivers products and services.
3 Translational Medicine and the ¿Broken Middle¿ of the Health Innovation Pathway
4 Biotech Startups
5 Bio business in Emerging Economies: The Case of African Ag-Bio
6 Animal Biotechnology ¿ Does a Controversial Technology have a Commercial Future?
7 Biofuels: Promises and Challenges
8 Mapping Value Systems and Business Models in Agricultural Biotechnology.
9 Products of biotechnology: regulation, risk assessment
10 Overview, assignment guidance
Entry Requirements (not applicable to Visiting Students)
Pre-requisites Co-requisites
Prohibited Combinations Other requirements None
Information for Visiting Students
Pre-requisitesNone
High Demand Course? Yes
Course Delivery Information
Academic year 2021/22, Available to all students (SV1) Quota:  50
Course Start Semester 2
Timetable Timetable
Learning and Teaching activities (Further Info) Total Hours: 200 ( Programme Level Learning and Teaching Hours 4, Directed Learning and Independent Learning Hours 196 )
Assessment (Further Info) Written Exam 0 %, Coursework 100 %, Practical Exam 0 %
Additional Information (Assessment) Component 1 - 1,000 word blog on a new biotechnology.

Component 2 - Essay 3,000 words and a list of essay titles will be provided. Some essay questions may focus on a particular week's topic, while others may cover a broad range of issues covered throughout the course. Alternatively, students may choose their own question/topic for the assessment, but this must be agreed with the course organiser and students should discuss this at the earliest opportunity.
Feedback Formative, non-assessed feedback will be provided on a 1-2 page essay plan submitted during the course.
No Exam Information
Learning Outcomes
On completion of this course, the student will be able to:
  1. Have a critical understanding of policy, economic and social issues shaping innovation in the life sciences and hence reshaping a number of industrial sectors, and be ability to analyse industrial trends, examine competitive and collaborative strategies, compare business development trajectories, and assess management strategies.
  2. Be able to demonstrate knowledge and understanding of Industry/Product life cycle analysis, develop a critical understanding of the theories and concepts about the different phases through which an industry normally evolves and how production and commercial strategy can be organised to meet the competitive challenges posed by each phase.
  3. Possess extensive, detailed and critical knowledge of different business development methods in the context of various sub-sectors of the bioeconomy.
  4. Be effective communicators about critical aspects of strategic management in sectors characterised by complex ethical and legal issues of which there are many in the bioeconomy, if not in all sectors, and be able to plan and execute a strategic analysis of options for open innovation examined from the alternative perspectives of open source, open innovation, knowledge markets, and closed approaches to intellectual property and knowledge management.
  5. Be able to use critical knowledge and skills related to organizational management, including how organisations translate human capital into intellectual capital, recognise their firms competence base and organisational capacity, and integrate these factors into a strategy for marketable products and services.
Reading List
Franco Malerba & Luigi Orsenigo (2015): The evolution of the pharmaceutical industry, Business History, DOI: 10.1080/00076791.2014.975119.
Available at: http://dx.doi.org/10.1080/00076791.2014.975119

Emerging business models for pharma. http://www.pmlive.com/pharma_news/emerging_business_models_for_pharma_470892

Alasdair Breckenridge, Peter Feldschreiber, Simon Gregor and June Raine (2011)
Evolution of regulatory frameworks. Nature Reviews Drug Discovery Volume 10, 3-5 January 2011 http://www.nature.com/nrd/journal/v10/n1/full/nrd3348.html

Ronald Evens and Kenneth Kaitin (2015). The Evolution Of Biotechnology And Its Impact On Health Care. Health Affairs 34:2 http://content.healthaffairs.org/content/34/2/210.full

Dougherty, D. & P.H.Conway (2008) ¿The 3Ts Roadmap to Transform US Healthcare: The ¿How¿ of High-Quality Care¿, JAMA 299: 2319-2321

Drolet, B. & N. Lorenzi (2010) ¿Translational Research: Understanding the Continuum from Bench to Bedside¿, Translational Research 157 (1): 1-5

Mankoff, S.P. et al (2004) ¿Lost in Translation: Obstacles to Translational Medicine¿, Journal of Translational Medicine 2 (14)

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)

Juma, C., Serageldin, I. Freedom to Innovate: Biotechnology in Africa's Development Report of the High-Level African Panel on Modern Biotechnology. African Ministerial Council on Science and Technology [online], (2007). http://belfercenter.ksg.harvard.edu/files/freedom_innovate_au-nepad_aug2007.pdf

Bailey, R., Willoughby, R., and Grzywacz, B., (July, 2014) On Trial: Agricultural Biotechnology in Africa. Energy, Environment and Resources. Chatham House. The Royal Institute of International Affairs.
http://www.chathamhouse.org/sites/files/chathamhouse/field/field_document/20140716BiotechAf rica.pdf?dm_i=1TY5,2N30J,BHZLN4,9NERT,1

Norman Clark, N., Mugabe, J., and Smith, J., GOVERNING AGRICULTURAL BIOTECHNOLOGY IN AFRICA. Building Public Confidence and Capacity for Policy- Making http://dspace.africaportal.org/jspui/bitstream/123456789/34394/1/biotech.pdf?1

These two readings are intended to give you a basic grounding in the subject of Genetically Modified (GM) animals.

Bruce, A., Castle, D., Gibbs, C., Tait, J., Whitelaw, CBA (2013) Novel GM animal technologies and their governance. Transgenic Research 22: 681-695

Waltz, E. (2016) GM salmon declared fit for dinner plates. Nature Biotechnology 34(1):7-9

Harvey, M & Pilgrim, S (2011) The New Competition for Land: Food, Energy and Climate Change, Food Policy 36, S40-S51 http://www.sciencedirect.com/science/article/pii/S0306-9192(10)00123-5

Kloverpris, J.H & Mueller, S (2013) Baseline time accounting: Considering global land use dynamics when estimating the climate impact of indirect land use change caused by biofuels, Int. J. Life Cycle Assessment, 18(2), 319-330, http://link.springer.com/article/10.1007%2Fs11367-012-0488-6

OECD (2004) Biotechnology for Sustainable Growth and Development http://www.oecd.org/science/biotech/33784888.pdf

OECD (2008), ¿Rising Food Prices: Causes and Consequences¿, http://www.oecd.org/trade/agricultural-trade/40847088.pdf

Pienkos, PT & Darzins, A (2009), ¿The Promise and Challenges of Microalgal-Derived Biofuels¿ Biofpr, 3, 431-440 http://www.afdc.energy.gov/pdfs/microalgal_biofuels_darzins.pdf

Popp, D (2010) Innovation and Climate Policy, NBER Working Paper 15673 https://www.humphreyfellowship.org/system/files/INNOVATION%20AND%20CLIMATE%20POLICY.pdf

Searchinger, T. et al (2008) Use of U.S. Croplands for Biofuels Increases Greenhouse Gases Through Emissions from Land-Use Change, Science, Vol. 319 no. 5867 pp. 1238-1240

Timilsina, G.R & Shrestha, A (2011), How Much Hope Should We Have for Biofuels?, Energy, 36, 2055-2069 http://www.sciencedirect.com/science/article/pii/S0360544210004597

Tait, J. (1993) Written evidence on behalf of ESRC to Report of House of Lords Select Committee on Science and Technology on Regulation of the United Kingdom Biotechnology

Tait, J. and Chataway, J. (2007) The governance of corporations, technological change and risk: examining industrial perspectives on the development of genetically modified crops. Environment and Planning C: Government and Policy, 25, 21-37.


Tait, J. and Banda, G. (2016) Proportionate and Adaptive Governance of Innovative Technologies: the role of regulations, guidelines and standards. Reports to British Standards Institution. [http://www.bsigroup.com/research-pagit-uk]

Garcia-Alonso, M., & Raybould, A. (2013). Protection goals in environmental risk assessment: a practical approach. Transgenic research, 1-12.

Kearns, P., Dagallier, B., & Suwabe, K. (2013). The risk/safety assessment of transgenic crops: the transportability of data. Transgenic research, 1-9.

Ledford, H. Crispr, the Disruptor (2015) Nature (522) 20-24

Philp, J. C., Ritchie, R. J., & Allan, J. E. (2013). Synthetic biology, the bioeconomy, and a societal quandary. Trends in biotechnology, 31(5), 269-272.

Roberts, A., Devos, Y., Raybould, A., Bigelow, P., & Gray, A. (2013). Environmental risk assessment of GE plants under low-exposure conditions. Transgenic research, 1-13.
Additional Information
Graduate Attributes and Skills Not entered
KeywordsNot entered
Contacts
Course organiserDr Farah Huzair
Tel: (0131 6)50 6386
Email: farah.huzair@ed.ac.uk
Course secretaryMr Dave Nicol
Tel: (0131 6)51 1485
Email: dave.nicol@ed.ac.uk
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