The MSc Pharmaceutical Enterprise programme is an applied multidisciplinary course
designed for entrepreneurial high-achieving individuals with ambition to take leading roles
in SME pharmaceutical companies.
As the major pharma business model changes, established and emerging SME
pharmaceutical companies are increasingly delivering novel candidate pharmaceuticals
(small molecules and biologicals). This trend is expected to continue and offers a very
nourishing environment for spin-out and other SME pharmaceutical companies that require
high calibre personnel who are knowledgeable about all aspects of pharmaceutical
enterprise.
Aims
The MSc Pharmaceutical Enterprise programme aims to provide students with a toolbox of skills to
enable you to:
 Select, develop and commercialise projects with therapeutic potential
 Create, fund and take leading roles in companies to exploit the commercial potential of
projects in a spin-out/SME environment
Module 1 – Early Drug Discovery
The focus of this module is pre-clinical drug development in pharmaceutical biotechnology. It will
cover small molecule drug discovery, including target identification, assay creation, hit-to-lead, and
proof-of-concept pre-clinical method development. Additionally, it will encompass sourcing drug
development compounds and projects through technology audits and licensing-in. Finally, the
module will examine the science behind, and clinical application of, recent successful drug
candidates.
20 credits
Assessment: In-course assessment , poster presentation and exam
Module 2 – Drug Development to IND and to Market
Following on from the module Early Drug Discovery Research, the focus of this module is the further
pre-clinical development of drugs or diagnostic tests. The module will examine how lead candidate
molecules are identified, whether that is through in house development, licensing-in, or compound
re-profiling. The highly important processes of pharmacological (ADME), toxicological testing, and
compound formulation of lead compounds will be addressed. The design of clinical trials and
pharmacovigilance will also be examined, highlighting the need for robust ethical and toxicological
considerations. Finally, the module will inform about the regulatory approval processes involved for
drug clinical assessment (IND application), the NDA submission, and potential marketing strategies.
20 credits
Assessment: Assignment, In-course assessment and presentation
Module 3 – Drug IP Management & Commercialisation
This module will focus on the importance of Intellectual Property (IP), and subsequent
commercialisation of biotechnology, in the drug development process. This knowledge will be vital
for students appreciation of how fledgling pharmaceutical companies control their drug portfolio;
this also being critical in the further commercialisation and economic success of the company.
Students will also examine and analyse current aspects of healthcare markets, leading to an
understanding of how to value a drug/project/company in the prevailing economic climate. Students
will investigate in detail the stage involved in creating spin-out companies, leading to the founding of
small- to medium-sized enterprises (SME). Examples of how successful SMEs are managed,
structured, and financed, will provide students with an in depth knowledge and critical awareness of
how pharmaceutical companies expand and develop.
20 credits
Assessment: Case report, presentation and exam
Module 4 – Contract Research Organisations and Drug Development
The focus of this module is to understand and critically appraise how Contract Research
Organisations (CROs) interact with pharmaceutical companies. A CRO can be defined as a service
organisation that provides support to the pharmaceutical and biotechnology industries in the form
of research services outsourced on a contract basis. CROs warrants particular attention as a modern
paradigm of the privatised biopharmaceutical sector. Therefore, this module will examine the
importance of CROs in the globalisation and commercialisation of scientific research, highlighting
their role in how science is becoming increasingly commercialised, and how this has affected the
conduct of scientific research. The module will investigate the rapid rise of CROs since the early
1980’s and how this has impacted upon biopharmaceutical development. CROs have been integral
to the innovation of many scientific areas, including the ethics behind the treatment of human
subjects and the subjection of research tools to commercialisation. Furthermore, the global CRO
market and consequent competition across organisations will also be critically examined. Students
will analyse CRO technology, the research CRO’s pursue, and the legal and policy initiatives that
CRO’s have fostered during their recently rapid rise.
10 credits
Assessment: poster presentation and essay
Module 5 – The Pharmaceutical SME: Corporate governance, legislation & finance
The module provides the students with fundamental knowledge and practical skills concerning the
establishing and maintenance of a pharmaceutical small or medium enterprise (SME) specifically
covering the setting up of a company, corporate governance including the requirements of
submissions to government authorities and the setting of budgets.
20 credits
Assessment : essay
Module 6 – Group Pharmaceutical Consultancy project
The module provides the students with the opportunity to use the theoretical scientific and
professional understanding they have developed through the proceeding taught components of the
programme to analyse and address a real-world scientific and/or business question and to formulate
justifiable recommendations (explicitly the question will not be ‘how to fund a business opportunity’
to avoid potential repetition of learning from the ‘Funding a Start-up Pharmaceutical Company’
module). The questions will be provided by relevant external business organisations and/or teaching
staff. Examples of the types of questions include: What is the competitive landscape for drugs in
development for the treatment of inflammation? Which contract research organisations offer a
particular named assay and what are their strengths and weaknesses?
20 credits
Assessment: group written report
Module 7 – Funding a start-up pharmaceutical company
The module provides the students with the opportunity to use the scientific and professional
understanding they have developed through the proceeding taught component of the programme
to create and develop a written and oral presentation business plan as if to pitch for venture capital
funding. Delivery will be via SGT, roundtable-type discussions and ‘drop-in’ clinics. The students are
expected to demonstrate novel thinking and application of knowledge to demonstrate the
investment readiness of the proposition.
10 credits
Assessment: group written report
Module 8 – Dissertation (MSc only)
The module provides the student with the opportunity to select (or propose) and develop their own
specific project relevant to pharmaceutical enterprise. They will need to apply the scientific and
professional understanding they have developed through the taught components of the programme
to select an area of interest from a list of proposed project areas (arising from relevant areas of
expertise within the UoB and associated external companies) or a project area generated by the
student (subject to acceptance by the module lead).
60 credits
Assessment; 10,000 word research project and presentation
Download

MSc Pharmaceutical Enterprise Course description and module