The University of Southampton
Courses

BIOL3058 Bioscience Business

Module Overview

The aim of this module is to provide third year students with an introduction to commercialisation of biosciences. The current focus is on the process of drug discovery, the subsequent management of clinical trials, marketing, and sales of commercial drug products. The main topics will include the scientific rationale and justification of novel targets and the associated assay development and experimental design to show efficacy of such a target. In addition, the module will provide further guidance and information on pharmacokinetics, regulatory affairs, clinical trial design, intellectual properties and business planning to make a chosen target commercially viable. At the end of the module student will be able to address the following questions: What makes a good drug and how to produce, protect and get a drug to the market?

Aims and Objectives

Module Aims

The content of this module provides an introduction to key business processes such as: (A) the generation of ideas and the concept of ‘the inventive step’ in the research context; (B) market research; (C) intellectual property protection; (D) raising finance, (E) Developing an individual’s team working, project planning, time management and transferrable skills.

Learning Outcomes

Learning Outcomes

Having successfully completed this module you will be able to:

  • Appreciate the challenges of drug discovery including target validation and lead identification
  • Understand the process and key techniques of preclinical testing, including in vitro assay design, high throughput screening, pharmacokinetics and toxicology
  • Describe different approaches for production and scaling of compounds, including packaging and distribution
  • Describe the process of clinical trials and apply the concepts learned to a specific drug target
  • Understand the concepts of marketing to develop a credible business idea
  • Be familiar with protecting novel drugs, including intellectual properties, patents, financing and licencing
  • Write a credible and informed drug development plan and transform an idea or concept into a well-argued business case for a chosen target ( e.g. small molecule or biological
  • Work within a team structure
  • Develop presentation skills.

Syllabus

This module is concerned with the principles of drug discovery from target validation to management of clinical trial, and commercialising a drug product. The module will focus on the scientific challenges of drug development and will increase understanding of the business challenges of bringing a pharmaceutical or biological product to market. Topics covered include, but are not limited to target validation, preclinical testing, high throughput screening, methods of production, relevance of biomarkers, bioethics, pharmacokinetics/pharmacodynamics, clinical trial design and management, regulatory affairs, intellectual property, patent law, and marketing.

Learning and Teaching

Teaching and learning methods

Seminars/workshops from academics, research innovation and pharmaceutical companies Tutorials on’ science and business’ marketing and communication Verbal and written feedback.

TypeHours
Independent Study275
Lecture25
Total study time300

Assessment

Assessment Strategy

Students are required to work in small teams (indicative group size 4) and select a 'drug target' of choice. In the first semesters students conduct their own research using literature and other resources to identify the scientific rational and justification of the chosen target. Student will have the opportunity to interact with a tutor and work in groups to discuss the progress of their research. Workshops on assay design, production, and target validation will be organised to assist the student research. At the end of semester 1 each student will be tasked to write an individual written assay on the target and assay design to justify drug development. In semester 2, each student that will take on a role of Chief Executive officer, Chief Scientific Officer, Production manager, Patent Lawyer, Head of Marketing or Medical Director/Clinical trial manager and generate an jointly prepared case study/business plan describing the components of drug development that will be required for commercialising the chosen drug target, for example clinical trial design, marketing, intellectual property. This part of the research will be collated to form the final jointly prepared case study/business proposal (maximum 20 pages outlining business plan, its attraction and viability) that is presented to a panel of experts (assessed), which will include members from pharmaceutical companies and research innovation.. The assessment also includes a marketing assignment where student generate a leaflet, brochure and/or additional creative methods on their chose drug target.

Summative

MethodPercentage contribution
Business presentation 25%
Written exam 75%

Referral

MethodPercentage contribution
Business presentation 25%
Written exam 75%
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