MSc Pharmaceutical Industrial Advanced Training (PIAT) / Course details
Year of entry: 2020
Course unit details:
Introduction to the Healthcare Industry (PLG 1)
|Unit level||FHEQ level 7 – master's degree or fourth year of an integrated master's degree|
|Teaching period(s)||Variable teaching patterns|
|Available as a free choice unit?||No|
This introductory unit will provide an overview of the industry with specific reference to the role of business development. It covers the structure and dynamics of the industry, R&D and drug discovery and development, including basic regulatory concepts. The unit also addresses company strategies and the external factors that impact on the industry’s future.
- Understand the history and development of the pharmaceutical industry.
- Appreciate the contribution made by the industry with emphasis on the contribution from intercompany licensing of products.
- Appreciate the different company strategies within the industry and the role of business development in each type of company.
- Introduce the framework of the industry - research, development, manufacture and distribution of pharmaceutical products on an international level.
- Understand the relevant regulatory procedures applicable to the research, development and marketing of pharmaceutical products within the European Union, USA and Japan.
- Have an insight into the legislation relevant to the manufacturing and commercialisation of pharmaceutical products.
- Understand the role of Business Development within different types of pharmaceutical companies.
- Familiarise with Business Development operational metrics and norms within companies, the ethics of Partner of Choice.
- Gain an appreciation of the history and development of the pharmaceutical industry.
- Gain an understanding on a global basis of the basics of health economics with emphasis on the development and pricing of new products.
- Gain an insight into the contribution made by different types of businesses in the healthcare arena.
- Gain an awareness of the role and contribution made by pharmaceutical and biotechnology business development activities to corporate growth.
- Recognise the key drivers which shape and govern the industry.
- Contrast the different means by which pharmaceutical business raise their finance.
- Appraise the impact of such finance on the cost of capital of the organisation and its effect on appraisals of company value and deal structures.
- Undertake a range of analyses of corporate strategy and tactics identifying the strengths and weaknesses of different pharmaceutical businesses.
- Demonstrate ability to use a range of communication pathways to produce a Partner of Choice campaign package using a number of methodologies.
- Assess a business proposal and to critically appraise the strengths and weaknesses of an opportunity.
- Understand the impact of risk on the industry and on individual company strategies.
- Explain the nature and importance of business development within a typical pharmaceutical business and construct basic information relevant for making decisions on business development strategy.
Industry Overview and Historical Perspective, reviews the growth of the industry from its origins in traditional therapies. It charts the role of pharmacists in the development of the drug industry and the progression from the antibiotic revolution through the emergence of biotechnology to the current trend of industry consolidation.
The Pharmaceutical industry’s Key Statistics and Metrics, addresses the economics and statistics underpinning the pharmaceutical industry and considers R&D investment and expenditure in depth. The major players, key pharmaceutical market and the importance of blockbuster drugs are reviewed as well as the role of the generics industry in delivering cost effective medication to the masses. The role of government and industry organisations such as ABPI, JPMA is also considered.
The Structure of Healthcare Systems. The finances behind the markets are reviewed in this unit, with the role of mechanisms for control of healthcare expenditure via NICE, pharmaco-economics and the fourth hurdle. The influence of non-governmental organisations (NGOs) and patient advocacy groups are assessed.
Drug Discovery. Are there any remaining unmet therapeutic needs? This unit studies the current aims of drug discovery and issues around testing and safety and the ethics of using animals in research. The Human Genome Project and the role of genomics and informatics are also evaluated.
Clinical Development, addresses the costs of clinical development and the need for paediatric trials. Study design, clinical trial ethics, safety assessment of marketed medicines and health economics are considered. The current drive for outsourcing of clinical trials and transparency is also addressed.
Regulatory Issues. The role and organisation of the MHRA, EMEA and FDA, regulatory strategy and the regulatory processes in Europe and the US are covered in this unit.
Market Dynamics, Companies Strategies and the Role of Business Development, is a review of corporate development from start ip to mid cap. The potential role of biotech's as engines for R&D. The need for alliances or acquisitions in managing product life cycles and planning the portfolio.
The Industry in the Future. Where will the industry go in the future - continuation of mega-mergers? What is the role remaining for mid cap companies? What are the new market trends, are there any more new niche markets? Disease trends—the emergence of AIDS, SARS, the next flue pandemic. Cost containment measures, and new pathways to reach the patient
|Written assignment (inc essay)||100%|
Assessed by 1 x 6000 word essay.
Provisional marks and feedback for coursework returned within 15 working days.
Exam marks and final marks returned after ratification at exam board.
|Independent study hours|
|Matthew Shaw||Unit coordinator|